[Senate Hearing 117-386]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 117-386

                        ADDRESSING NEW VARIANTS:
             A FEDERAL PERSPECTIVE ON THE COVID	19 RESPONSE

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             SECOND SESSION

                                   ON

 EXAMINING A FEDERAL PERSPECTIVE ON THE COVID-19 RESPONSE, FOCUSING ON 
                        ADDRESSING NEW VARIANTS

                               __________

                            JANUARY 11, 2022

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions






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                 U.S. GOVERNMENT PUBLISHING OFFICE

48-897 PDF                WASHINGTON : 2023











          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                    PATTY MURRAY, Washington, Chair

BERNIE SANDERS (I), Vermont          RICHARD BURR, North Carolina, 
ROBERT P. CASEY, JR., Pennsylvania       Ranking Member
TAMMY BALDWIN, Wisconsin             RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut   SUSAN M. COLLINS, Maine
TIM KAINE, Virginia                  BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire         LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota                MIKE BRAUN, Indiana
JACKY ROSEN, Nevada                  ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico            TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado          MITT ROMNEY, Utah
                                     TOMMY TUBERVILLE, Alabama
                                     JERRY MORAN, Kansas

                     Evan T. Schatz, Staff Director
               David P. Cleary, Republican Staff Director
                  John Righter, Deputy Staff Director











                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                       TUESDAY, JANUARY 11, 2022

                                                                   Page

                           Committee Members

Murray, Hon. Patty, Chair, Committee on Health, Education, Labor, 
  and Pensions, Opening statement................................     1

Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State 
  of North Carolina, Opening statement...........................     4

                               Witnesses

Walensky, Rochelle, M.D., M.P.H., Director, United States Centers 
  for Disease Control and Prevention, Atlanta, GA................     8
    Prepared statement...........................................    10

Fauci, Anthony, M.D., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health, Bethesda, 
  MD.............................................................    14
    Prepared statement...........................................    16

Woodcock, Janet, M.D., Acting Commissioner, United States Food 
  and Drug Administration, Silver Spring, MD.....................    24
    Prepared statement...........................................    25

O'Connell, Dawn, Assistant Secretary for Preparedness and 
  Response, United States Department of Health and Human 
  Services, Washington, DC.......................................    42
    Prepared statement...........................................    44

                         QUESTIONS AND ANSWERS

Response by Rochelle Walensky to questions of:
    Hon. Robert P. Casey, Jr.....................................   102
    Hon. Maggie Hassan...........................................   103
    Hon. Ben Ray Lujan...........................................   104
    Hon. Bill Cassidy............................................   107
    Hon. Mike Braun..............................................   109
    Hon. Tim Scott...............................................   110
    Hon. Tommy Tuberville........................................   116
Response by Anthony Fauci to questions of:
    Hon. Robert P. Casey, Jr.....................................   123
    Hon. Maggie Hassan...........................................   126
    Hon. Ben Ray Lujan...........................................   127
    Hon. Rand Paul...............................................   128
    Hon. Bill Cassidy............................................   131
    Hon. Mike Braun..............................................   134
    Hon. Tim Scott...............................................   135
    Hon. Tommy Tuberville........................................   135
Response by Janet Woodcock to questions of:
    Hon. Robert P. Casey, Jr.....................................   142
    Hon. Tina Smith..............................................   144
    Hon. Richard Burr............................................   151
    Hon. Bill Cassidy............................................   154
    Hon. Mike Braun..............................................   154
    Hon. Tim Scott...............................................   155
    Hon. Tommy Tuberville........................................   157
    Hon. Maggie Hassan...........................................   158
Response by Dawn O'Connell to questions of:
    Hon. Robert P. Casey, Jr.....................................   159
    Hon. Tammy Baldwin...........................................   161
    Hon. Maggie Hassan...........................................   163
    Hon. Tina Smith..............................................   163
    Hon. Ben Ray Lujan...........................................   165
    Hon. Richard Burr............................................   165
    Hon. Bill Cassidy............................................   166
    Hon. Tim Scott...............................................   167
    Hon. Tommy Tuberville........................................   170









 
                        ADDRESSING NEW VARIANTS:
             A FEDERAL PERSPECTIVE ON THE COVID-19 RESPONSE

                              ----------                              


                       Tuesday, January 11, 2022

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.

    The Committee met, pursuant to notice, at 10:03 a.m., in 
room G50, Dirksen Senate Office Building, Hon. Patty Murray, 
Chair of the Committee, presiding.

    Present: Senators Murray [presiding], Casey, Baldwin, 
Murphy, Kaine, Hassan, Smith, Rosen, Hickenlooper, Burr, Paul, 
Collins, Murkowski, Braun, Marshall, Scott, Romney, Tuberville, 
and Moran.

                  OPENING STATEMENT OF SENATOR MURRAY

    The Chair. Good morning. The Senate Health, Education, 
Labor and Pensions Committee will please come to order. Today 
we are holding a hearing with members of the President's COVID-
19 response team on the pandemic and our efforts to address new 
variants like Omicron. After the witnesses give their 
testimony, Senators will each have 5 minutes for a round of 
questions. And while we were unable to have this hearing fully 
opened to the public or media--is my mic working?

    While we are unable to have the hearing fully open to the 
public or media for in-person attendance, live video is 
available on our Committee website at help.senate.gov. And if 
you are in need of accommodations, including closed captioning, 
you can reach out to the Committee or the Office of 
Congressional Accessibility Services. I want to start this 
morning by recognizing the difficult moment we are in with this 
pandemic.

    The Omicron variant has caused an unprecedented number of 
infections across the country over the past month. Thanks to 
the hard work of so many, we have new tools to address the 
threat caused by this new variant, including vaccines, 
boosters, and high quality masks. But the sheer number of 
infections is inputting an enormous strain on hospitals, health 
care workers, schools, families, and communities across the 
country. We all need to do our part to address this new 
challenge by getting vaccinated and boosted and wearing high 
quality masks.

    That is why we are having this hearing in a larger hearing 
room where we can be socially distanced, limiting the number of 
people who are here in this hearing room, and taking additional 
measures such as wearing masks. I will be wearing my mask 
during the entire hearing and would respectfully request others 
in the room today do the same.

    As always, I appreciate the work from the staff of the 
Sergeant-at-Arms, the Architect of the Capitol, and our 
Committee Clerk and his staff to make this hearing as safe as 
possible. Nearly 2 years into this pandemic, people are 
exhausted after all we have been through, and even as the Delta 
strain is still circulating, we are all alarmed by how quickly 
Omicron has spread and anxious about what is next.

    People back in my home State of Washington and across the 
country are frustrated and worried about the course of this 
pandemic and its persistent challenges, like how hard it still 
is to get a test. I have heard from so many people who are 
waiting in long lines and going from pharmacy to pharmacy, 
trying to find a test, or who are giving up on getting tested 
because tests are unavailable or cost too much. I have also 
heard from people who have found the communication about new 
isolation and quarantine guidance confusing and frustrating. 
They are trying to keep themselves and their families safe as 
this pandemic evolves and we continue to learn more.

    But I am hearing more and more questions like, what kind of 
tests should I get? When should I get tested? Why can't I find 
a test? Do I need to isolate 10 days, 5 days, or even at all? 
Testing, in particular, is a huge concern for parents who are 
starting 2022 exhausted from the last 2 years and worried about 
schools staying open safely this year. I know what a struggle 
it is for parents scrambling to figure out childcare when they 
have got to go to work, or how tough it is for kids to keep up 
with classwork while transitioning back and forth from in-
person to online learning.

    While most schools are still safely open for in-person 
learning and we all want to make sure they stay that way, we 
know schools are struggling with this, especially as Omicron 
creates new challenges. I am hearing from schools in my States 
that they are worried they will have to shut down again if they 
can't get the support for testing they need, or they have staff 
shortages because of staff who are ill. Nobody wants that.

    Based on what we now know about this virus and the tools we 
have to fight it, schools should be able to stay open safely if 
they have tests, masks, ventilation, and people are vaccinated. 
Hospital and health care providers are worried too. They have 
been stretched too thin after two exhausting years, and now 
Omicron is causing the worst surge in cases and 
hospitalizations yet. Because while it may be less severe in 
most cases, especially for those who are vaccinated and 
boosted, it is so much more contagious, meaning we are still 
seeing high rates of hospitalization overall.

    We also have to protect children who are too young to get 
vaccinated and people with health conditions and disabilities 
that put them at high risk. Back in my State, hospitals are 
asking our State leaders to declare a crisis for our medical 
facilities. I have heard from health care providers in 
Washington who have been well over their staffed bed capacity 
for several days and are pausing nonessential procedures.

    Families are wondering whether they can get care for non-
COVID related conditions and alarmed by how long ER wait times 
are getting. Health care providers are concerned about how we 
continue to keep health care workers safe, and also address the 
fatigue and burnout and mental health challenges that they 
face. These are not new challenges. I have been raising many of 
these concerns since the earliest days of the pandemic, so I am 
frustrated we are still behind on issues as important to 
families as testing and supporting schools.

    That is not to say we have not made progress, it is just 
clear we haven't made enough. But even though we aren't where 
we need to be yet, we are not back at the starting line when it 
comes to COVID-19 either. We have safe and effective vaccines 
for everyone ages five and up. We have booster shots available 
for those 12 and up. More and more people are getting their 
shots each day. The Administration is also working to help get 
the world vaccinated to end this pandemic and has already 
pledged over a billion vaccine doses to that effort. We have 
new life saving therapeutics.

    We have additional resources Congress passed in the 
American Rescue Plan, which can help increase our testing 
capacity, protect workers, and give schools the support they 
need to stay safely open. And we have an Administration that is 
focused on following the science, facing this pandemic head on, 
and addressing the frustration people are feeling. That is 
crucial at this moment when the path forward requires steady 
leadership and clear communication about the challenges we are 
still facing and the work ahead to tackle them.

    President Biden has said plainly that he shares families' 
frustration around testing, and he wants to make sure schools 
stay safely open. And he has announced steps to address these 
challenges by making 500 million tests available free of 
charge, ordering over 200 million courses of antivirals, 
expanding manufacturing to be able to make hundreds of millions 
of tests a month, providing schools with guidance on how to 
test to stay protocols which can help keep students in the 
classroom, standing up more testing and vaccinationsites across 
the country, and providing medical personnel to struggling 
areas.

    I expect to hear more detail on those efforts today, along 
with what other steps the Administration plans to take, and I 
will be watching closely as they are implemented. But I also 
want to be clear, when we talk about these problems, we have to 
be focused on solutions. You can't just say our schools must 
stay open if you don't vote to provide additional resources 
schools need to do so.

    You can't just say the latest health guidance is confusing 
and not call out the blatant misinformation that has come from 
so many members of the Republican Party. We are not going to 
get out of this crisis by treating each challenge as a 
political opportunity. We are going to get through it by being 
honest about what we are facing and clear about what we are 
going to do about it. And as we continue working to get through 
this pandemic, it is important we also look at what we can do 
to prevent future health crises.

    That is exactly why Senator Burr and I have been working in 
a bipartisan way over the last several months on legislation to 
learn from and improve on our pandemic response, like 
strengthening our supply chain for medical products, updating 
old and incompatible public health data systems, modernizing 
the process for developing tests, fighting misinformation, 
addressing root causes of health inequities and more. We will 
be unveiling a discussion draft soon, and I look forward to 
working with all of our colleagues to finalize and pass this 
important package. In the meantime, we will continue working to 
address the pandemic at hand.

    People across the country are worried this will be another 
year of uncertainty, uncertainty for their work, their schools, 
and their everyday lives. But there is no reason it should be. 
People should be able to make plans for the future without 
fearing that everything they are looking forward to, or even 
the everyday things they used to take for granted, will be 
upended by this virus.

    We all want that, and we have the tools we need to get us 
there. We have the tools to get everyone tested quickly, 
easily, and for free, to keep schools safely open during the 
Omicron surge and beyond, to keep workers, especially our 
health care workers, safe and healthy in the workplace. We have 
the tools to mitigate this virus, to protect those at high risk 
like seniors or kids who were too young to get vaccinated and 
people with other health conditions, to get people back to 
their friends and their lives, and to give families back some 
certainty and stability.

    We can do all this now thanks to the incredibly hard work 
on the part of health care providers and scientists, parents 
and teachers, workers, and our witnesses who are here with us 
today. So what I hope to hear from this Administration at this 
hearing is what are you doing right now to make sure every 
American can make use of that progress they have worked so hard 
for. What can my constituents expect to see improved this week 
and the week after?

    We have come a long way since the start of this pandemic, 
and I look forward to hearing from each of you today about what 
you are going to do to build on what we know, bring this virus 
under control, and bring certainty and stability back to 
families who are burnt out after 2 years of fighting this 
pandemic. Thank you. And with that, I will turn it over to 
Ranking Member Burr for his opening remarks.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Madam Chairman, thank you. And before my 
opening statement, I hope the Chair will indulge with me for 
just a second since this is a hearing on preparation. I want to 
help my good friend, Senator Kaine, as he gets ready for his 
weekly travels.

    I want to make sure that he has got an orange for his car, 
that he has got a Dr. Pepper, and I provided a Lumbee blanket 
to make sure that things are three things you have got in your 
car regardless of what you run into on I-95, and I will have my 
staff bring them over to you.

    The Chair. I hope you provide those for everyone has to be 
used to say to our kids in the classroom, do you have a piece 
of gum for everyone?

    [Laughter.]

    Senator Burr. Well, in his particular case, I think he is 
the only one that makes that trip on a weekly basis. Tim, we 
are sorry you had to spend 27 hours, but you are now qualified 
to be the Secretary of Transportation if you are looking for a 
second job.

    [Laughter.]

    Senator Kaine. Thank you. It is sad when a career in the 
Senate's most notable highlight is my long commute, but----

    [Laughter.]

    Senator Burr. Madam Chairman, thank you for holding this 
hearing. To our witnesses, welcome back. Today is going to be a 
tough hearing, but the American people deserve accountability 
and transparency. I appreciate that all of you have cleared 
your schedules to allow multiple rounds of questions today. 
Next week marks 1 year of this Administration. It also marks 2 
years since the first COVID case was confirmed. President Biden 
said in his first, second, and third priorities would be 
bringing us out of COVID pandemic and that his team would shut 
down the virus.

    This Administration was lucky. It started off on day one 
with the tools to change the trajectory of COVID response. 
Operation Warp Speed worked with the private sector to bring us 
groundbreaking vaccines and treatments in record time.

    Although we had a very bumpy start with testing early in 
the pandemic, we successfully built some strong partnerships 
with the private sector to support the development and 
manufacturing of more tests. State and local leaders were 
rising to the challenge of testing and vaccinating their 
citizens. There was reason for hope.

    Instead, now, a full year later, here is where we are. More 
than 830,000 deaths caused by COVID, the majority of which 
occurred under this Administration, despite having many tools 
and significant resources from Congress, including $80 billion 
plus for testing. A variant now spreading out of control across 
the country with places like Washington, DC. seeing a 
staggering increase in case counts over the holidays, and now 
my State of North Carolina is following suit with a 319 percent 
increase as of yesterday.

    Over the holidays, when Americans were instructed to do the 
responsible thing and get tests before they see loved ones, 
there were no tests on the shelves or online, and hours long 
lines were the norm at testing sites across the country. The 
testing situation was worse when many sought tests to safely 
return to work or to school. And the most vulnerable Americans 
who contracted the virus could not get the treatments designed 
to help because they were now in short supply.

    This Administration has time and again squandered its 
opportunities and made worse in the decisions you have made on 
testing and treatment, and most crucially in communications 
with the American people. The American people are right to be 
confused. It seems like you all don't talk among yourself. Some 
examples. Last August, the President announced that boosters 
would be available to all vaxxed by the week of September 20th. 
The three of you here today signed that statement, but neither 
the FDA nor the CDC had yet approved boosters when the 
President made the promise.

    When you went to your advisory panels with a predetermined 
outcome already made, those independent experts pushed back and 
ultimately had to be overridden to meet the President's goal on 
boosters. I know the data shows that boosters are necessary. I 
am boosted. I want everybody to get vaccinated and booster. The 
facts about the value of vaccines and booster are crystal 
clear. But the way this Administration rolled out boosters was 
a disaster. You created skepticism and mass confusion.

    Example two, last summer the President dramatically 
announced that CDC recommendations changed so that vaccinated 
Americans didn't need to wear a mask indoors, implying that the 
worst of the pandemic was behind us, even as the Delta variant 
was exploding in India. Only after Delta hit America did CDC 
begin to take it seriously and the Administration had to change 
course.

    Example three, last week Dr. Fauci said that the CDC was 
going to update its guidance on quarantine. He left the 
American people with the impression that CDC guidance was going 
to include some testing component to reduce the quarantine to 5 
days. But when CDC did update its guidance, there wasn't a 
testing requirement. Again, I am not questioning the science. I 
am glad you refrained from testing mandates, but I am 
questioning your communication strategies.

    It is no wonder the American--it is no wonder that the 
American people are confused. When the President announced on 
December 21st that 500 million tests were going to be 
purchased, he left out that the contract wasn't going to be 
signed for weeks and it would take even longer for those tests 
to be--to materialize. Immediately, other experts and medical 
professionals were asking what the value of just 1.5 tests per 
person was when CDC's own guidance said that you need multiple 
at home tests to be assured of the results.

    Yesterday, the Administration mandated that insurers now 
cover the 170 million Americans that are covered by private 
insurance. They must cover up to eight tests per person per 
month. That would be 16 billion tests. And we have 500 million 
today that are aspirationally going to be contracted for. It is 
still unclear when these tests will be available, how to get 
them, whether any more are on their way.

    But it is especially frustrating that the White House press 
Secretary had previously mocked the very idea of doing what the 
President later announced in a sarcastic and withering tone 
when this was first proposed. She had four questions, whether 
we should just send one to every American, then what happens, 
how much does it cost, what happens after that? Those are all 
good questions that remain unanswered by the Administration. My 
final example, though, there are many to choose from, happened 
last week too.

    The White House press Secretary, a repeat offender in poor 
communications was asked about boosters. The press Secretary 
said, and I quote, ``they can get boosted now, regardless of 
what CDC guidance is, whether you just approved for a booster, 
or you have been approved for weeks.'' ``Regardless of what CDC 
guidance is,'' from the White House podium. And then I was 
amazed when I got home on Sunday, and I had this letter from 
the Centers for Medicare and Medicaid Services telling me as a 
Medicare beneficiary, that I am eligible to get a free vaccine 
booster.

    Five months after the President announced we are going to 
have boosters, we are--this is the first communication from CMS 
that I have gotten as a Medicare beneficiary in the 2-years of 
COVID and all of a sudden I get a request to get a booster. 
When a Republican Governor, or a Senator, including some on 
this Committee, suggests concerns about CDC guidance, Twitter 
and MSNBC can't react fast enough with scorn and anger. So it 
can't come as a surprise that there is confusion and anger when 
the White House says to ignore CDC guidance.

    I tell my staff, as I have repeatedly said to you all in 
all previous hearings, to look 30, 60, 90 days ahead. Look 6 
months ahead. Look abroad. See what is happening in Asia, 
Europe, Israel, Africa, UK, and elsewhere around the world. 
What do we need to anticipate? In our hearing on July 20th, and 
I warned that Delta would be--would not be our last variant. 
And I pleaded with each of you to have a plan in place for the 
next mutation of the virus. So why was the vice President 
surprised that Omicron came to our shores?

    Well, I will say it is very clear--very clearly, so the 
Administration does not yet again say they are surprised, 
viruses change, viruses mutate. There will be more variants. 
They will come to America, period, end of sentence. I don't 
understand why after tens of billions of Federal dollars being 
appropriated, this Administration has failed to ensure that the 
Americans have the tests they need.

    I don't understand why suddenly it is okay to take into 
account the economic and job impact of your guidance and 
recommendations. You shortened quarantine guidance because too 
many people would be out of work. Was that because of science 
or was it because you now know that lockdown, shutdowns, and 
school closures come with a significant downside impact?

    You ask the American people to trust you. Quite frankly, 
you have lost their trust. Rather than attempting to gain their 
trust back, the Administration chooses to litigate mandate 
requirements for employers with over 100 employees. I have 
asked before, what is the plan? Never gotten a response. Very 
seldom do I get a letter responded to by this Administration. 
The Administration has not responded to my letters. Maybe folks 
at the White House don't think they need to respond to 
Republican Senators.

    I think my record shows, I am approaching all of this as I 
have for the last 20 years. I am trying to help. I love this 
country, love its people, and I know we can do better than we 
have done. I know we have to do better. Maybe I am wrong about 
this. Maybe you will tell me where I got it wrong. Instead, I 
am hoping that you will understand that my criticism comes from 
a place of concern because the communication efforts are a mess 
and have only made things worse.

    Now, I admit it. I am at the end of my rope. I think you 
will see today that most of my colleagues are as well. I have 
tried to give my best advice and share what we hear and what we 
see because no one is paying attention to the message from this 
Administration right now. Maybe today you respond to my request 
to learn what the plan is.

    Hopefully, you will take this challenge to rebuild the 
trust, not just with me, not just with my colleagues, but with 
the American people we all serve. What do you change in 
inflection to restore the confidence with the American people 
that there is a strategy for testing, for treatments, for 
fixing your communication strategy, because if you don't, 
things are going to get worse before they get better? Madam 
Chairman, I yield back.

    The Chair. Thank you, Senator Burr. We will now introduce 
today's witnesses. Dr. Rochelle Walensky is the Director of the 
Centers for Disease Control and Prevention and the 
Administrator of the Agency for Toxic Substances and Disease 
Registry.

    Dr. Anthony Fauci is the Director of the National Institute 
of Allergy and Infectious Diseases and the Chief Medical 
Adviser on President Biden's COVID-19 response team. Dr. Janet 
Woodcock is the Acting Commissioner of the Food and Drug 
Administration.

    Dawn O'Connell is the Assistant Secretary for Preparedness 
and Response. And Director Walensky, Director Fauci, Acting 
Commissioner Woodcock, and Assistant Secretary O'Connell, I 
want to thank you all for joining us today. We all look forward 
to your testimony. And we will begin with Dr. Walensky on your 
opening statement.

STATEMENT OF ROCHELLE WALENSKY, M.D., M.P.H., DIRECTOR, UNITED 
 STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Walensky. Good morning. Chair Murray, Ranking Member 
Burr, Members of the Senate HELP Committee, I appreciate the 
opportunity to join you to provide an update on the COVID-19 
pandemic and the impact of the Omicron variant. It has been 
just over 2 years since we were first alerted to the emergence 
of SARS-CoV-2 in China.

    Since that time, CDC has worked with our partner agencies 
and you and Congress to make--take remarkable action to protect 
the health and safety of Americans. Omicron is now the dominant 
variant in the United States, driving case counts to 
unprecedented heights here in the United States and around the 
world.

    Despite the increases in cases, there are promising 
emerging data from South Africa and the United Kingdom that 
hospitalization rates for people infected with Omicron are 
lower compared with prior variants. These data seem consistent 
with what we are seeing so far in the United States.

    However, despite a potential decrease in severity, the 
substantial number of absolute cases is resulting in 
hospitalization increases across all age groups, including 
children aged zero to four. The emergence of the Omicron 
variant again emphasizes the importance of vaccinations and 
boosters, which decrease the risk of infection, severe disease, 
and death caused by COVID-19.

    Just last week, we made important progress toward 
increasing booster coverage through key--four key actions. 
First, we expanded eligibility of booster doses to those 12 to 
15 years old. Second, CDC strengthens its booster 
recommendation for adolescents, now recommending that 
adolescents aged 12 to 17 years old should receive a booster 
shot 5 months after their initial Pfizer-BioNTech vaccine 
series. Third, we recommended that moderately or severely 
immunocompromised 5 to 11 year olds receive an additional 
primary dose of vaccine 28 days after their second shot.

    Fourth, we shortened the recommended time between a primary 
mRNA series and a booster dose from 6 months to 5 months. Each 
action increases access to vaccines and booster doses at a time 
when protection is critical. As we continue to monitor this 
rapidly evolving virus, we are working quickly to adapt with 
it.

    Over the holidays, CDC updated our quarantine and isolation 
guidance, first for health care workers, and then for the 
general public. I know this update has resulted in numerous 
questions, so I would like to take a moment to walk through it 
now.

    For people who tested positive for COVID-19, CDC recommends 
isolation for 5 days. If you are asymptomatic or if your 
symptoms are resolving, for example, you are without a fever 
for 24 hours, you no longer need to isolate. However, you 
should continue to wear a well-fitting mask at all times when 
around others, including at home and in public for an 
additional 5 days. We recommend that you avoid activities where 
you are unable to wear a mask and that you avoid travel for the 
full 10 days.

    In addition, CDC changed the recommended duration of 
quarantine. And quarantine is what you do after you are 
exposed. People who are not up to date on recommended COVID-19 
vaccines should quarantine for 5 days if they come in contact 
with someone with COVID-19. People who do not develop symptoms 
by day five should get tested. If you test positive, you should 
begin isolation.

    People who test negative may end quarantine and should 
continue to wear a well-fitting mask when around others for an 
additional 5 days. These recommendations are consistent with 
over 100 studies collected over the past 2 years, indicating 
that people are most infectious during their first few days of 
infection and significantly less infectious 6 to 10 days after 
infection. A core part of CDC's mission is to translate science 
into recommendations for best practices and real world 
circumstances.

    Over the holidays, we saw the growing surge of Omicron and 
took swift science based action to address the very real 
possibility of staffing shortages in hospitals and in other 
essential areas of the workforce, including schools, 
pharmacies, public safety, public labs, grocery stores, and 
other sites, where shortages could have and have proven to have 
dire public health consequences. This is the right guidance for 
what we currently know about transmission and the real world 
circumstances we currently face.

    As we will learn more, we will continue to update 
accordingly. Omicron is likely not to be the last curveball 
this virus throws at us, but we have the tools to prevent 
further spread of this virus. This means for everyone five and 
older, please get vaccinated. For those 12 and older, get your 
booster shot.

    Please continue to adhere to the multi-layer prevention 
measures, including masking, and yes, washing your hands. Thank 
you, and I look forward to your questions.

    [The prepared statement of Dr. Walensky follows:]
                prepared statement of rochelle walensky
    Chair Murray, Ranking Member Burr, and distinguished Members of the 
Committee:

    It is an honor to appear before you today to discuss the Centers 
for Disease Control and Prevention's (CDC) ongoing response to the 
COVID-19 pandemic. It is my privilege to represent CDC, America's 
health protection agency. Since launching an agency-wide response to 
the COVID-19 pandemic nearly 2 years ago, CDC has learned more every 
day about this novel pathogen, how it spreads, and how it affects 
people and communities. We are committed to continuing to work to 
provide science-based guidance about how we can best protect ourselves 
and our communities as the virus and the pandemic evolves.
                           Update on Omicron
    On November 24, 2021, South Africa reported the identification of a 
new SARS-CoV-2 variant, B.1.1.529 (Omicron), to the World Health 
Organization (WHO). Omicron was first detected in specimens collected 
on November 11, 2021, in Botswana and on November 14, 2021, in South 
Africa. South Africa has since also detected Omicron in specimens 
collected on November 8, 2021. As of January 4, 2022, Omicron has been 
detected in 144 countries around the world, including the U.S., where 
cases have been confirmed in most states and territories. CDC estimates 
that for the week ending January 8th, the national proportion of 
lineages designated as Omicron to be 98.3 percent with a 95 percent 
prediction interval of 96.9-99.1 percent. The national proportion of 
lineages designated as Delta is predicted to be 1.7 percent with a 95 
percent prediction interval of 0.9-3 percent.

    Data are emerging on how easily Omicron may spread, the severity of 
illness it causes, and how well available vaccines and therapeutics 
work against it. The variant has many concerning spike protein 
substitutions, some of which are known from other SARS-CoV-2 variants 
to be associated with reduced effectiveness of available 
countermeasures, including vaccines and therapeutics. The rapid growth 
rate in Omicron infections is believed to result from a combination of 
increased transmissibility and the ability to evade immunity conferred 
by past infection or vaccination (i.e., immune evasion).

    At present, early data suggest Omicron infection might be less 
severe than infection with prior variants; however, reliable data on 
clinical severity remain limited. Even if the proportion of infections 
associated with severe outcomes is lower than with previous variants, 
given the increase in number of infections, the absolute number of 
people with severe outcomes could be substantial. In addition, demand 
for ambulatory care, supportive care for treatment of mild cases, and 
infection control requirements, including quarantining/isolation of 
exposed/infected workforce could also stress the healthcare system. 
These stresses likely will be in addition to the ongoing Delta variant 
infections and a rising burden of illness caused by other respiratory 
pathogens, such as influenza, which have begun circulating at greater 
frequencies.

    CDC is working hard with domestic and international partners to 
better understand how easily Omicron might be transmitted and the 
effectiveness of currently authorized, cleared, or approved medical 
countermeasures, such as vaccines and therapeutics, against this 
variant. In addition, we are working, together with FDA, to ensure that 
diagnostic tests and variant genomic sequencing accurately measure the 
spread of Omicron. We continue to monitor and evaluate vaccine 
effectiveness data from the U.S. Initial data from international 
partners suggest vaccine effectiveness against infection is 
significantly reduced; those data also suggest that a booster does 
provide increased protection against infection, and importantly further 
decreases the risk of severe disease, including hospitalization, and 
death from COVID-19. CDC continues to strongly encourage COVID-19 
vaccination for everyone 5 years of age and older and boosters for 
everyone 12 years of age and older. In January 2022, CDC updated its 
recommendation for when many people can receive a booster shot, 
shortening the interval from 6 months to 5 months for people who 
received a Pfizer-BioNTech or Moderna COVID-19 vaccines as their 
primary series. In addition, CDC recommended that moderately or 
severely immunocompromised 11-year-olds receive an additional primary 
dose of vaccine 28 days after their second shot. Scientists are also 
working to determine how well existing treatments for COVID-19 work for 
Omicron infections. Based on the changed genetic make-up of Omicron, 
some treatments are likely to remain effective, while others may be 
less effective.

    With the growing number of COVID-19 cases from the Omicron variant, 
and consistent with current understanding of the disease trajectory, on 
December 23, 2021, CDC released updated guidance for isolation and 
quarantine for healthcare workers, decreasing their isolation time 
after infection with COVID-19. Healthcare workers with COVID-19 who are 
asymptomatic and not immunocompromised can return to work after 7 days 
with a negative test. If health care personnel test positive at day 5-
7, they can return to work 10 days after their initial test, as long as 
symptoms have improved and at least 24 hours have passed since last 
fever without the use of fever-reducing medications. Additionally, CDC 
released an update to guidance for contingency and crisis management in 
the setting of significant healthcare worker shortages. Healthcare 
workers who have received all recommended COVID-19 vaccine doses, 
including a booster, do not need to quarantine at home following high-
risk exposures, as long as they remain fully compliant with masking 
requirements. These updates provide healthcare facilities with the 
strategies to limit the effects of staff shortages caused by COVID-19 
on patient care.

    On December 27, 2021, CDC updated and shortened the recommended 
isolation and quarantine time for the general population. It is 
important to note that this guidance does not supersede the guidance 
for health care workers or guidance from state or local public health 
jurisdictions. CDC shortened the recommended time for isolation from 10 
days for people with COVID-19 to 5 days, if asymptomatic or improved 
and fever-free for at least 24 hours, followed by 5 additional days of 
wearing a well-fitting mask both at home and in public when around 
others. The change is motivated by science demonstrating that the 
majority of SARS-CoV-2 transmission occurs early in the course of 
illness, generally in the 1-2 days prior to onset of symptoms and the 
2-3 days after. Additionally, CDC changed the recommended quarantine 
period for those exposed to COVID-19. For people who are unvaccinated 
or are more than 5 months out from their second mRNA dose (or more than 
2 months after the J&J vaccine) and not yet boosted, CDC now recommends 
quarantine for 5 days followed by strict mask use for an additional 5 
days. Alternatively, if a 5-day quarantine is not feasible, it is 
imperative that an exposed person properly wear a well-fitting mask at 
all times when around others for 10 days after exposure. Individuals 
who have received their booster shot do not need to quarantine 
following an exposure, but should properly wear a mask for 10 days 
after the exposure. For all those exposed, best practice would also 
include either an antigen test or nucleic acid amplification test 
(NAAT) for SARS-CoV-2 at day 5 after exposure. If symptoms occur, 
individuals should immediately quarantine until a negative test 
confirms symptoms are not attributable to COVID-19.

    On January 6, 2022, CDC reduced isolation and quarantine periods in 
school settings to align with current CDC recommendations for isolation 
and quarantine. CDC recommends that students, teachers, and staff who 
are asked to quarantine, including those who are not fully up to date 
on recommended vaccinations, should not go to school or school events 
in-person during their quarantine period unless they are participating 
in a school sponsored ``test-to-stay'' program.

    Schools may consider Test to Stay as an option for keeping 
asymptomatic school-associated close contacts in the classroom as an 
alternative to traditional quarantine at home. This includes people who 
are a school-associated close contact, are not up to date on 
recommended vaccinations, do not test positive for SARS-CoV-2, and have 
no symptoms. Test to Stay combines contact tracing and serial testing 
that is repeated at least twice during the 5-to-7-day period post-
exposure to allow asymptomatic school-associated close contacts who are 
not up to date on recommended vaccinations and do not test positive to 
continue in-person learning. Outside of the school setting, quarantine 
recommendations would still apply.

    New data about the virologic, epidemiologic, and clinical 
characteristics of the Omicron variant are rapidly emerging. CDC will 
continue to actively monitor for and respond to this variant, and we 
will continue to work diligently with state, local, and global public 
health officials, and industry partners to learn more, monitor the 
spread of Omicron, and inform the public.
                                Testing
    On December 2, the White House announced new steps to ensure that 
Americans have access to no-cost self-testing. CDC is working on 
multiple fronts to expand access to testing, in support of this aim. 
CDC has awarded approximately $30 billion to public health departments 
to support activities, including testing, through the Epidemiology and 
Laboratory Capacity cooperative agreement. For schools, CDC has 
provided $10 billion to states to support COVID-19 screening testing 
(i.e., testing of asymptomatic persons in order to identify unknown 
cases of the disease and avoid further transmission) for teachers, 
staff, and students to assist schools in staying safely open for in-
person instruction. More than 23.5 million tests were conducted in 
schools between April 2021 and November 2021.

    CDC also supports Operation Expanded Testing, which provides no-
cost screening testing for schools, underserved populations, child care 
settings, and congregate settings. The program is available to all 
states and territories and can be tailored to each site's testing 
needs. Three federally funded contractors (coordination hubs) provide 
testing materials, supplies, and results reporting at no direct cost to 
recipients through a hub and spoke model.

    The Increased Community Access to Testing (ICATT) program is 
another testing initiative jointly managed by CDC and other agencies 
with three primary objectives: working with pharmacies to ensure 
equitable access to COVID-19 diagnostics, establishing surge testing 
sites to provide infection control to populations at elevated risk for 
SARS-CoV-2 transmission, and establishing community testing sites to 
increase access to COVID-19 testing in under--resourced communities. In 
October 2021, ICATT reached its goal of establishing 10,000 community 
testing sites and plans to double that number in 2022 to 20,000 sites.

    At the community level, CDC is supporting the HHS Office of the 
Assistant Secretary for Preparedness and Response (ASPR) and other 
agencies with the distribution of tests to Community Health Centers, 
food banks, and rural clinics that receive grants from the Health 
Resources and Services Administration (HRSA). Support includes the 
provision of updated self-testing guidance and materials to accompany 
test distribution to ensure the public is educated about the use of 
these tests and how to handle positive results. These materials are 
publicly available on CDC's website.

    Together, these actions will help Americans access the tests they 
need to help them stop the spread of COVID-19.
                  Genomic Sequencing and Surveillance
    Viruses are constantly changing, and this includes SARS-CoV-2. 
Currently, the only way to definitively determine if an infection was 
caused by Omicron is by genomic sequencing. Genomic sequencing allows 
scientists to identify and monitor how SARS-CoV-2 changes over time, 
understand how these changes affect the characteristics of the virus, 
and use this information to better evaluate how it might impact health.

    Building on years of investments, CDC has intensified efforts to 
vastly expand genomic sequencing capacity at both the Federal and state 
levels over the past year. In addition to direct support to public 
health laboratories, CDC provides support to academic institutions to 
conduct genomic surveillance research in collaboration with public 
health agencies and augments sequencing capacity through contracts with 
commercial diagnostic laboratories to support the national genomic 
surveillance system. Collectively, CDC's national genomic surveillance 
efforts can reliably detect very low levels of variants, even variants 
that account for as little as 0.1 percent of all COVID-19 cases, 
circulating in the U.S. with high confidence.

    The CDC Advanced Molecular Detection program established the SARS-
CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and 
Surveillance (SPHERES) to coordinate SARS-CoV-2 sequencing. The SPHERES 
collaboration includes scientists from clinical and public health 
laboratories, academic institutions, and the private sector. The 
SPHERES consortium is led by CDC's Advanced Molecular Detection (AMD) 
program, which over the past 6 years has invested in Federal, state, 
and local public health laboratories to expand the use of pathogen 
genomics and other advanced laboratory technologies to strengthen 
infectious disease surveillance and outbreak response.

    On November 28, 2021, in partnership with U.S. public health 
laboratories and the Association of Public Health Laboratories, CDC 
rapidly activated enhanced surveillance for specimens with specific 
characteristics indicating a possible case of Omicron. The agency 
requested that public health laboratories send these specimens to CDC 
as quickly as possible to accelerate the confirmation of Omicron cases 
and to enable subsequent virological characterization. This led to the 
rapid identification of the first cases of Omicron in the U.S. CDC 
began detecting Omicron through its routine baseline genomic 
surveillance on December 5, 2021. CDC and other Federal agencies 
continue to work with international partners to learn more about 
variants circulating globally and will continue to monitor all data 
sources closely to identify cases of Omicron in the U.S.

    The rapid detection of Omicron in the U.S. reflects the work that 
CDC and partners have done over the course of the pandemic to build 
local capacity, enhance communication and information exchange, and 
advance new technologies. CDC continues to accelerate this work, as it 
is essential to the Nation's ability to rapidly detect and respond to 
emerging threats.
                            Travel Screening
    As of December 6, 2021, all air travelers, regardless of 
citizenship or vaccination status, are required to show a negative pre-
departure COVID-19 viral test administered no more than 1 day before 
travel, or documentation of having recovered from COVID-19 in the past 
90 days, before they board their flight to the U.S. CDC continues to 
recommend that all travelers get a COVID-19 viral test 3-5 days after 
arrival, and that unvaccinated travelers quarantine for 5 days after 
travel. CDC's December 2021 amended air travel order strengthens 
already robust protocols in place for international travel, including 
requirements for most foreign travelers to be fully vaccinated before 
travel to the U.S.

    This new 1-day testing requirement will help to protect travelers 
and the health and safety of American communities from COVID-19. In 
light of concerns and unknowns regarding Omicron, these measures will 
bring an additional layer of public health security and give us time to 
ramp up surveillance, continue our messaging about the need for 
vaccination and boosters, encourage non-pharmaceutical interventions 
like mask-wearing and distancing, and continue to learn more about this 
emerging variant and its capabilities. Both the U.S. Government and the 
airline industry are committed to making this process as seamless as 
possible for the traveling public.

    In addition, CDC is collaborating with commercial partners on SARS-
CoV-2 surveillance programs that involve voluntary testing of arriving 
international travelers at some of the busiest airports in the U.S. 
Arriving international air travelers are offered pooled testing 
conducted in the airport and offered at-home kits to be used 3-5 days 
after arrival. Participants and their respective health departments are 
notified of positive test results. Some positive samples are sequenced, 
enabling detection of novel SARS-CoV-2 variants among travelers 
entering the U.S.
                          Vaccination Efforts
    The recent emergence of the Omicron variant further emphasizes the 
importance of vaccination, boosters, and prevention efforts needed to 
protect against COVID-19. As of January 6, 2022, nearly66.3 percent of 
the U.S. population over the age of 5 have completed a primary 
vaccination series, and approximately 35.3 percent of the eligible 
population has received their booster dose, indicating there is still 
more work to be done. Even as we learn more about the Omicron variant, 
vaccination remains the best public health measure to protect from 
disease, slow the spread of SARS-CoV-2, and reduce the likelihood of 
new variants emerging. Scientists are currently investigating Omicron, 
including how well vaccinated people will be protected against 
infection, hospitalization, and death. CDC recommends that everyone 5 
years and older protect themselves from COVID-19 by getting vaccinated.

    On November 29, CDC strengthened its recommendation on booster 
doses for individuals who are 18 years and older. Data from clinical 
trials showed that a booster shot increased immune response in trial 
participants. With an increased immune response, people have improved 
protection against COVID-19. For the Pfizer-BioNTech and J&J/Janssen 
vaccines, clinical trials also showed that a booster shot helped 
prevent symptomatic COVID-19. CDC recommends that everyone ages 12 
years and older should get a booster shot 5 months after vaccination 
with an initial Pfizer-BioNTech or Moderna series, or 2 months after 
the J&J/Janssen vaccine. CDC recommends clinical preference for 
individuals to receive an mRNA COVID-19 vaccine over Johnson & 
Johnson's COVID-19 vaccine for primary and booster vaccination due to 
risk of rare, but serious adverse events. In addition, CDC recommends 
that moderately or severely immunocompromised 5 years of age and older 
receive an additional primary dose of vaccine 28 days after their 
second shot.
                             Global Efforts
    CDC works closely with public health authorities around the world, 
including Ministries of Health. CDC also supports critical multilateral 
partners, including WHO, Africa CDC and UNICEF. CDC's support to other 
nations includes a range of activities to strengthen capacity to 
prevent, detect, and respond to local COVID-19 cases. These efforts 
help provide timelier and more accurate data to inform public health 
decisionmaking, strengthen the public health workforce globally, 
mitigate COVID-19 transmission across borders, and minimize disruptions 
to essential health services. CDC's international collaborations and 
support for special investigations contribute to the scientific 
understanding of COVID-19 and address crucial unknowns regarding 
clinical severity, extent and pathways of transmission, and infection.

    In addition, CDC is working with global partners and over 50 low-
and middle-income countries to support planning, implementation, and 
evaluation of COVID-19 vaccination programs, including vaccine safety 
programs. We are currently developing plans to extend additional 
support to countries that are unable to effectively manage and 
distribute donated vaccines. CDC is also supporting countries' 
development of timely, high-quality data on vaccine delivery and safety 
and providing technical assistance and personnel to Gavi, COVAX, and 
WHO to assist with the development and implementation of strategies to 
distribute vaccines and implement vaccine programs.

    Of particular importance related to detection of and response to 
the Omicron variant and in addition to ongoing efforts, CDC is building 
on a strong foundation of decades of work to augment laboratory 
capacity in partnership with ministries of health around the world. CDC 
also has participated in partnerships to develop sequencing capacity in 
southern Africa.
                               Conclusion
    Although we are still learning about Omicron, we have been fighting 
COVID-19 for the last 2 years, and we know what people can do to 
protect themselves. Until we know more about the risks of Omicron, it 
is especially important to use all tools we have available to protect 
ourselves and our communities. If you are not yet vaccinated now is the 
time. If you are eligible, please get your booster. In areas of high 
and substantial transmission, regardless of vaccination status, wear a 
mask in indoor public places. Remember, where possible, to stay 6 feet 
away from people and avoid crowds and poorly ventilated areas. If you 
are experiencing symptoms or have been exposed to someone with COVID-
19, get tested and stay home.

    Last, we also must continue to focus on how we can better prepare 
for the future. Recent investments in public health have increased 
surveillance and sequencing capabilities that have proven effective to 
quickly identify Omicron here and around the world. We must make 
investments now to make sure we maintain and address the long-standing 
vulnerabilities in our public health system. I am committed to working 
with Congress to find common ground to support our public health system 
and make meaningful strides toward achieving health security for all 
Americans now and into the future.
                                 ______
                                 
    The Chair. Thank you.

    Dr. Fauci.

STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE 
  OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
                      HEALTH, BETHESDA, MD

    Dr. Fauci. Madam Chair, Ranking Member Burr, Members of the 
Committee, thank you for giving me the opportunity to discuss 
with you the role of the National Institute of Allergy and 
Infectious Diseases in the conduct and support of research 
addressing our Nation's response to COVID-19. In our most 
recent hearing before this Committee on November the 4th, I 
discussed the importance of booster shots to enhance immunity 
against the Delta variant that wanes over time.

    Indeed, booster shots have dramatically reconstituted the 
waning immunity and has increased protection over and above the 
original level afforded by the primary vaccine regimen. Today 
we are faced with a different challenge, a new variant called 
Omicron that has rapidly spread throughout the world, including 
a massive, unprecedented surge in the United States.

    This variant possesses a large number of mutations that are 
associated with an increased efficiency of transmission, immune 
evasion from certain monoclonal antibodies, convalescent 
plasma, and antibodies induced by our current vaccines. Thus 
far, data from our own laboratories at NIAID, as well as from 
laboratories throughout the world, have indicated that vaccine 
induced antibodies lose a considerable amount of potency in 
neutralizing the Omicron variant.

    Although this is of obvious concern, the encouraging news 
is that a third shot boost of an mRNA vaccine significantly 
reconstitutes and enhances the ability of antibodies from 
boosted individuals to neutralize the Omicron variant, strongly 
suggesting that boosters will play a major role in protecting 
our population, at least from severe disease, in the context of 
the ongoing massive surge of the Omicron variant that we are 
currently experiencing, underscoring why it is so important for 
the unvaccinated to get vaccinated and for those who are 
already vaccinated to obtain the booster shot.

    Therapies in general are an important part of our 
armamentarium against COVID. In this regard, the NIH has been 
heavily involved in the development and, or clinical testing of 
several effective monoclonal antibodies against SARS-CoV-2. 
However, we have ascertained that certain of the authorized 
monoclonal antibodies are negatively impacted by the Omicron 
variant. Direct antiviral therapies also are an extremely 
important tool in the fight against COVID-19.

    Importantly, it appears that the mutations expressed by the 
Omicron variant do not interfere with the oral antiviral drugs 
Paxlovid and Molnupiravir that NIH funded investigators played 
an early role in developing and that have recently received 
emergency use authorization from the FDA. Nor do they appear to 
interfere with the FDA fully approved drug remdesivir shown by 
NIH sponsored studies to be highly effective in preventing 
severe disease.

    Looking ahead in the context of the inevitable continual 
emergence of new variants, the importance of developing a pan-
coronavirus vaccine, namely one that would be effective against 
all SARS-CoV-2 variants and ultimately against all 
coronaviruses, becomes even more apparent. My colleagues and I 
recently published a paper in the New England Journal of 
Medicine emphasizing the urgent need for such an effort. In 
this regard, we have made significant progress in that 
direction.

    We have identified antibodies that neutralize multiple 
different coronaviruses, and in addition, NIAID has issued new 
awards to fund pan-coronavirus vaccines at four academic 
institutions. These awards will fund multidisciplinary, 
collaborative teams to conduct research focused on coronavirus 
virology, immunology, immunogen design, and innovative vaccine 
and adjuvant platforms, as well as technologies to discover, 
design, and develop a pan-coronavirus vaccine candidates.

    Finally, I would like to close by looking forward to how we 
might best enhance our preparedness for what inevitably will be 
the emergence of future pandemics. The NIAID will play an 
important role in the multibillion dollar all of Government 
plan for pandemic preparedness.

    Our mission is the rapid development and implementation of 
successful countermeasures against several prototype pathogen 
families of viruses that threaten the health and safety, not 
only of our Nation, but of the entire world. Thank you for your 
attention, and I would be happy to answer your questions 
following the presentations.

    [The prepared statement of Dr. Fauci follows:]
                  prepared statement of anthony fauci
    Madam Chair, Ranking Member Burr, and Members of the Committee:

    Thank you for the opportunity to discuss the role of the National 
Institute of Allergy and Infectious Diseases (NIAID) in the research 
response to coronavirus disease 2019 (COVID-19) and its etiologic 
agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 
Within the Department of Health and Human Services (HHS) and the 
National Institutes of Health (NIH), NIAID is responsible for 
conducting and supporting basic and clinical research on emerging and 
re-emerging infectious diseases, including COVID-19. As the Director of 
NIAID and the Chief Medical Advisor to the President, I am pleased to 
discuss NIAID's research addressing this once-in-a-lifetime global 
infectious disease pandemic.

    The public health response to COVID-19 has required an 
unprecedented global public-private research effort. NIAID has played a 
central and important role in this response. NIAID capitalized on 
decades of fundamental basic research, including groundbreaking 
structure-based vaccine design at the NIAID Vaccine Research Center 
(VRC), to facilitate the rapid development of COVID-19 vaccines. NIAID 
also initiated clinical trials with creative and adaptive designs, 
allowing the evaluation of the safety and efficacy of multiple new and 
existing therapeutics for the treatment of COVID-19, which has helped 
support authorization of some of these products by the U.S. Food and 
Drug Administration (FDA). In addition, NIAID has engaged domestic and 
international clinical research infrastructure and leveraged highly 
productive partnerships in the public and private sectors to support 
multiple COVID-19 vaccine candidates to progress in record time from 
concept to Emergency Use Authorization (EUA) by FDA. Use of these 
vaccines throughout the world will continue to play a critical role in 
reducing the threat of COVID-19 in the United States and globally.

    One of the most concerning developments of the ongoing pandemic has 
been the spread of SARS-CoV-2 variants, including the newly described 
Omicron variant. The Omicron variant is highly transmissible and is now 
the predominant variant in much of the United States. Early data 
suggest that the severity of disease caused by infection with the 
Omicron variant is lower compared to previous variants. However, the 
increased transmissibility of Omicron and the large number of new 
infections may lead to substantial numbers of hospitalizations and 
deaths, particularly among unvaccinated individuals at highest risk. 
The emergence of the Omicron variant makes it critical that we continue 
to vaccinate as many people as we can, as quickly as possible, 
including with booster doses.

    The COVID-19 vaccines authorized or approved in the United States 
appear to remain effective against severe disease for most individuals, 
despite data showing waning of vaccine-and infection-induced immunity. 
While antibodies generated by the primary COVID-19 vaccine series do 
not neutralize the Omicron variant as well as prior variants, 
laboratory studies show that booster doses of COVID-19 vaccines induce 
high levels of antibodies against the Omicron variant. Early clinical 
data also show that booster doses of vaccines restore levels of 
immunity such that people are, at least initially, well-protected 
against the Omicron variant, particularly against severe disease. 
Further research to assess immune protection against Omicron is 
underway, including studies of the durability of protection offered by 
COVID-19 vaccination and boosters. NIAID efforts to enhance the 
protection afforded by COVID-19 vaccines and understand the effects of 
SARS-CoV-2 variants on immunity will help to address the Omicron 
variant and any future variants that may emerge.
             Responding to Emerging Variants of SARS-CoV-2
    NIH, including NIAID, participates in the HHS-established SARS-CoV-
2 Interagency Group, along with the Centers for Disease Control and 
Prevention (CDC), FDA, Biomedical Advanced Research and Development 
Authority (BARDA), Department of Defense (DOD), and U.S. Department of 
Agriculture to track variants in real time and address the potential 
impact of emerging variants on critical SARS-CoV-2 countermeasures 
including vaccines, therapeutics, and diagnostics. Active monitoring of 
variants has allowed the U.S. Government to optimally deploy 
therapeutics to treat COVID-19 patients. NIH, CDC, and DOD are 
assessing the extent to which vaccine-induced immunity or post-
infection immunity prevent infection by variants. NIH, BARDA, and DOD 
also are assessing the efficacy of authorized and candidate 
therapeutics against emerging variants in cell lines and animal models.

    NIAID and our collaborators have rapidly assessed vaccines, 
monoclonal antibodies, and antiviral drugs to assess their 
effectiveness against the Omicron variant. Research suggests that 
although effectiveness of certain monoclonal antibodies against Omicron 
has been markedly diminished, one of the three monoclonal antibodies 
authorized for COVID-19 treatment retains its effectiveness against the 
Omicron variant. A monoclonal antibody authorized for pre-exposure 
prophylaxis (prevention) in high-risk people also retains its 
effectiveness. In addition, antiviral drugs used to treat COVID-19 
appear to be effective against the Omicron variant.

    NIAID also is supporting the development of next-generation 
vaccines that could provide protection against emerging SARS-CoV-2 
variants by targeting several viral antigens, all of which are highly 
conserved among viral strains. On March 25, 2021, NIAID launched a 
Phase 1 clinical trial in healthy adults to assess the safety and 
immunogenicity of second-generation COVID-19 vaccine candidates 
developed by Gritstone Oncology, Inc. Gritstone's COVID-19 vaccine 
candidates utilize a strategy aimed at inducing both neutralizing 
antibodies and T cell responses to elicit a broad immune response 
against conserved viral antigens. NIAID also is conducting early stage 
research on pan-coronavirus vaccines designed to provide broad 
protective immunity against multiple coronaviruses, especially SARS-
CoV-2 and other viruses with pandemic potential. In 2021, NIAID 
announced awards to four academic institutions to conduct research to 
develop vaccines to protect against multiple types of coronaviruses and 
viral variants.

    NIAID, the National Human Genome Research Institute, and the 
National Library of Medicine are participating in the SARS-CoV-2 
Sequencing for Public Health Emergency Response, Epidemiology, and 
Surveillance (SPHERES) initiative. SPHERES is a national genomics 
consortium led by CDC that helps to coordinate SARS-CoV-2 sequencing 
across the United States. NIAID is working with partners to identify, 
monitor, and calculate the frequency of current variations in the SARS-
CoV-2 genome to help predict emerging variants. NIAID also facilitates 
the use of cutting-edge modeling and structural biology tools to 
understand how variants might affect interactions between the virus and 
the immune system or COVID-19 therapeutics. These efforts add to our 
knowledge about SARS-CoV-2 variants and our ability to combat them.
                Developing Vaccines to Prevent COVID-19
    Sustained domestic and international research investments by NIAID 
prior to the emergence of SARS-CoV-2 enabled the unprecedented pace of 
COVID-19 vaccine development. Two activities in particular predate 
successful COVID-19 vaccines: the development of versatile vaccine 
platforms and the adaptation of structural biology tools to design 
specific proteins (immunogens) that powerfully stimulate the immune 
system. Long before the pandemic, NIAID VRC scientists and their 
collaborators made the critical scientific discovery of how to 
stabilize--in a highly immunogenic form--viral proteins that are 
important for infection. These included the spike protein of Middle 
East respiratory syndrome coronavirus (MERS-CoV), which was stabilized 
using a double mutation known as S2P. This strategy facilitated the 
design of vaccine candidates that generate robust immune responses not 
only against coronaviruses but also other viruses of public health 
importance such as respiratory syncytial virus. As soon as the sequence 
of SARS-CoV-2 was made available in January 2020, VRC researchers 
rapidly generated a stabilized SARS-CoV-2 spike protein for use in 
COVID-19 vaccine development. This crucial breakthrough in structure-
based vaccine design led to the development of safe and effective 
COVID-19 vaccine candidates, several now authorized or approved by the 
FDA, across a range of vaccine platforms.

    Six candidate COVID-19 vaccines have been assessed in completed or 
ongoing large-scale Phase 3 clinical trials in the United States. 
Clinical trials assessing COVID-19 vaccine candidates in certain 
pediatric populations have been completed or are still ongoing. On 
August 23, 2021, a candidate vaccine developed by Pfizer and BioNTech 
became the first to be approved by the FDA for the prevention of COVID-
19 in individuals 16 years of age and older. The vaccine also is 
authorized for emergency use and is available under the EUA as a two-
dose primary series for individuals 5 years of age and older, as a 
third primary series dose for individuals 5 years of age and older who 
have been determined to have certain kinds of immunocompromise, and as 
a single booster dose for individuals 12 years of age and older 5 
months after completing a primary series of the Pfizer/BioNTech COVID-
19 vaccine. The Pfizer/BioNTech COVID-19 vaccine also is authorized for 
use as a heterologous single booster dose following completion of 
primary vaccination with a different available COVID-19 vaccine. The 
Pfizer/BioNTech vaccine is one of six COVID-19 vaccine candidates NIAID 
has helped advance through support for the fundamental research 
underlying the vaccine concepts, as well as for clinical testing. Two 
additional vaccine candidates, from Moderna, Inc., and Johnson & 
Johnson/Janssen, are available under an FDA EUA.
                          mRNA-1273 (Moderna)
    As part of a longstanding collaboration, the NIAID VRC collaborated 
with the biotechnology company Moderna to develop a vaccine candidate 
designated mRNA-1273, which uses a messenger RNA (mRNA) vaccine 
platform to express the stabilized SARS-CoV-2 spike protein. After 
promising results in early clinical trials, NIAID and BARDA began 
working with Moderna on a Phase 3 clinical trial. NIAID scientists and 
their collaborators published updated results from this trial 
indicating that the vaccine had 93.2 percent efficacy in preventing 
COVID-19 illness, 98.2 percent efficacy in preventing severe disease, 
and 63 percent efficacy in preventing asymptomatic infection. 
Importantly, the efficacy of mRNA-1273 in preventing COVID-19 4 months 
or more after the second dose was maintained at greater than 90 
percent. In addition, in observational studies in ``real-world'' 
conditions in broader segments of the population, mRNA--based vaccines 
continue to display high levels of effectiveness.

    FDA has authorized mRNA-1273 for emergency use for prevention of 
COVID-19 in individuals 18 years of age and older as a two-dose primary 
series, as a third primary series dose for individuals 18 years of age 
and older who have been determined to have certain kinds of 
immunocompromise, and as a single booster dose in people 18 years of 
age and older 5 months after completing a primary series of the 
vaccine. mRNA-1273 also is authorized for use as a heterologous single 
booster dose for individuals 18 years of age and older following 
completion of primary vaccination with a different available COVID 
vaccine.
                Ad26.COV2.S (Johnson & Johnson/Janssen)
    Decades of NIAID support for basic, preclinical, and clinical 
research on adenovirus (Ad)-based HIV vaccines underpin the development 
by Johnson & Johnson/Janssen of a coronavirus vaccine candidate based 
on the Ad26-vector. The vaccine is known as Ad26.COV2.S or JNJ-
78436735. NIAID has supported a Phase 3 clinical trial of Ad26.COV2.S 
and has provided immunological testing of the candidate using NIAID-
funded core laboratory infrastructure. As reported in the New England 
Journal of Medicine, the one-dose vaccine candidate was 66 percent 
efficacious overall at preventing moderate to severe/critical COVID-19 
occurring at least 28 days after vaccination and 85 percent efficacious 
overall in preventing severe/critical COVID-19 in the Phase 3 trial 
across several geographical regions, including areas where viral 
variants predominated. In the United States, the efficacy against 
moderate to severe/critical disease 28 days after vaccination with 
Ad26.COV2.S was 72 percent. FDA has authorized Ad26.COV2.S for 
emergency use for prevention of COVID-19 in individuals 18 years of age 
and older as a single primary vaccination dose and as a single booster 
dose for individuals 18 years of age and older 2 months after 
completing primary vaccination with the vaccine.
           Ensuring Protection with COVID-19 Vaccine Boosters
    FDA-authorized and FDA-approved COVID-19 vaccines have maintained 
remarkable effectiveness in preventing severe COVID-19. However, 
protection against mild and moderate disease begins to decrease over 
time following the primary vaccine series; this effect is seen with 
both the Delta and Omicron variants circulating in the United States. 
As noted, the Omicron variant appears to be more transmissible than 
previous variants and more apt to evade immunity. Individuals who 
receive a booster dose of a COVID-19 vaccine have markedly higher 
levels of antibodies against SARS-CoV-2 variants compared to levels in 
individuals who received just the primary regimen, and early clinical 
data still being evaluated suggest these boosted individuals are, at 
least initially, well-protected against the current Delta and Omicron 
variants, particularly against severe disease.

    FDA amended the EUAs for the Moderna and Johnson & Johnson/Janssen 
COVID-19 vaccines, respectively, to allow for use of a single booster 
dose for individuals 18 years of age and older. FDA also amended the 
EUA for the Pfizer/BioNTech COVID-19 vaccine to allow for the use of a 
single booster dose for individuals 12 years of age and older. CDC 
recommends receiving a booster dose of the COVID-19 vaccine at least 5 
after completion of the primary series of the Pfizer/BioNTech and 
Moderna COVID-19 vaccines, and at least 2 months after completion of 
the single-dose primary regimen of the Johnson & Johnson/Janssen COVID-
19 vaccine.

    NIAID has initiated several studies to specifically address the 
Omicron variant and has several more in planning stages. For example, 
NIAID is testing the impact of a higher dose of the Moderna vaccine as 
a booster. In addition, the NIAID VRC is conducting preclinical testing 
of an Omicron-specific booster candidate (mRNA-1273.529) and of mixed 
(bivalent) booster candidates (mRNA-1273 plus a Beta variant-specific 
booster) against the Omicron variant. NIAID also plans to examine 
whether individuals who received boosters--either mRNA-1273 or 
investigational COVID-19 vaccine boosters designed to incorporate 
mutations found in emerging variants--generate antibodies that can bind 
to and neutralize the Omicron variant.

    NIAID is leading a study in fully vaccinated individuals to assess 
the safety and immune responses following boosting with a COVID-19 
vaccine different than the one used for the initial vaccination (``mix 
and match''). This trial includes a booster candidate (mRNA-1273.211) 
that incorporates several mutations that are present in the Omicron 
variant. NIAID released early data from this trial demonstrating that 
administering the Pfizer, Moderna, or Johnson & Johnson/Janssen COVID-
19 vaccines at least 12 weeks after individuals received a different 
vaccine regimen effectively enhanced the immune response to SARS-CoV-2. 
Additionally, no safety concerns were identified. The results of this 
trial were made available to FDA during FDA's decisionmaking process to 
authorize the use of heterologous, or ``mix and match,'' booster dosing 
in eligible individuals following completion of primary vaccination 
with a different available COVID-19 vaccine for persons 18 years of age 
and older.

    NIAID is supporting additional preclinical and clinical research to 
assess the durability of immunity induced by COVID-19 vaccines, as well 
as the effect of COVID-19 vaccine boosters.

    On April 23, 2021, NIAID launched an observational study at the NIH 
Clinical Center assessing how people with immune system deficiencies or 
dysregulations respond to COVID-19 vaccination. NIAID investigators 
also will gather information about COVID-19 illness in these 
individuals. This study will inform decisionmaking about COVID-19 
vaccination in people with immune deficiencies and dysregulation 
conditions. In August 2021, NIAID launched multiple additional studies 
to assess and enhance the immune response to COVID-19 vaccines in 
immunocompromised individuals with autoimmune diseases as well as solid 
organ transplant recipients. This effort features a study with a 
multicenter, adaptive design to assess the immune responses to an 
additional dose of the COVID-19 vaccine in immunocompromised 
individuals. Data from this research will inform future considerations 
of additional doses of COVID-19 vaccines for these populations. CDC has 
made a recommendation, after review of the available scientific data, 
that people with moderately to severely compromised immune systems 
receive an additional dose of mRNA COVID-19 vaccine at least 28 days 
after a second dose of Pfizer/BioNTech COVID-19 vaccine or Moderna 
COVID-19 vaccine.
 Clinical Trials of COVID-19 Vaccine Candidates in Special Populations
    To effectively end the COVID-19 pandemic, it will be important to 
vaccinate as many people as possible, including those in special 
populations, such as pregnant and lactating women and children. Many 
pregnant and lactating women already have received the available COVID-
19 vaccines. Data from these individuals demonstrate no safety concerns 
for pregnant women or their babies. In addition, protective antibodies 
against SARS-CoV-2 have been detected in babies born to pregnant women 
who received mRNA COVID-19 vaccines. On June 23, 2021, NIAID launched 
an observational study, MOMI-VAX, to evaluate the immune responses 
generated by COVID-19 vaccines administered to individuals during 
pregnancy or up to 2 months postpartum. The study also will assess 
vaccine safety and evaluate the transfer of vaccine-induced antibodies 
to infants across the placenta and through breast milk.

    Efforts to evaluate COVID-19 vaccines in pediatric and other 
special populations are ongoing. This includes KidCOVE, a Phase 2/3 
study launched by Moderna, in collaboration with NIAID and BARDA, to 
evaluate the safety and efficacy of mRNA-1273 in children ages 6 months 
to less than 12 years. This study is in addition to Moderna's ongoing 
TeenCOVE study of mRNA-1273 in adolescents between the ages of 12 and 
17. Pfizer also is evaluating their vaccine candidate in children 
younger than age 5, including a three-dose primary series. Other 
vaccine developers have begun, or are planning to begin, trials to test 
their vaccine candidates in children, adolescents, and other special 
populations.
                   Other COVID-19 Vaccine Candidates
    NIAID also is supporting Phase 3 clinical trials of COVID-19 
vaccine candidates from AstraZeneca (AZD1222) and Novavax (NVX-
CoV2373). FDA has not yet authorized either of these vaccine candidates 
for emergency use.
           Understanding the Nature of Immunity to SARS-CoV-2
    NIAID is conducting and supporting research to enhance our 
knowledge of immunity against SARS-CoV-2 and to identify components of 
the immune response that provide protection against COVID-19. NIAID 
also is examining the quality and durability of the immune response to 
SARS-CoV-2, generating information that may be leveraged to develop 
novel SARS-CoV-2 therapeutics or vaccines and inform public health 
measures.

    Data on infection-induced immunity from natural infection with 
SARS-CoV-2, including studies by NIAID scientists and NIAID-supported 
researchers, clearly demonstrate that most individuals generate a 
protective immune response to COVID-19 after infection. However, 
uncertainty surrounds several variables that can affect the generation 
of a protective immune response to SARS-CoV-2 following either 
infection or vaccination. Variables affecting the immune response 
include the age of the individual; their immune status; the medical 
treatments they have received; the impact of SARS-CoV-2 variants; and 
the impact of the severity of initial infection and time since 
infection, if applicable. Given that COVID-19 vaccination after 
infection with SARS-CoV-2 is safe and markedly enhances immune 
responses, COVID-19 vaccination is recommended for eligible individuals 
regardless of history of symptomatic or asymptomatic SARS-CoV-2 
infection. NIAID continues to support research to understand immune 
responses to SARS-CoV-2 infection and/or COVID-19 vaccination, 
including projects investigating the durability of immune responses; 
whether immunity differs in certain populations; and how SARS-CoV-2 
variants may affect immunity.

    NIAID also is supporting research to improve understanding of the 
role of T cells in protection against COVID-19 and COVID-19 disease 
progression. NIAID supported a collaborative longitudinal study by 
researchers at Emory University and the Fred Hutchinson Cancer Research 
Center that demonstrated that SARS-CoV-2-specific T cells were 
detectable for up to 8 months in patients after mild to moderate COVID-
19. NIAID also supported two separate studies examining T cell 
responses in recovered COVID-19 patients and individuals vaccinated 
against COVID-19. They found robust immune responses to the original 
strain as well as multiple variants of SARS-CoV-2 in both groups. 
Additional work by NIAID researchers and grantees showed that most 
individuals with existing T cell responses against SARS-CoV-2 should 
generate a T cell response against the Omicron variant, and that SARS-
CoV-2 has thus far not evolved extensive T cell escape mutations. Other 
work from NIAID-supported investigators has shown that vaccine-induced 
T cell responses recognize the Omicron variant. In another NIH-
supported study, researchers uncovered features of T cells that 
distinguish fatal from non-fatal cases of severe COVID-19, which could 
lead to new treatments for this disease. However, it is important to 
note that although we are learning important information about T cell 
responses in SARS-CoV-2 infected and vaccinated individuals, we still 
do not know the extent to which T cell responses mediate protection 
against COVID-19.

    To help prepare for future pandemic threats, the NIAID VRC has 
established the Pandemic Response Repository through Microbial/Immune 
Surveillance and Epidemiology (PREMISE) program. The program will use 
data from the measurement of T and B cell immune responses to inform 
the discovery and development of diagnostic, prophylactic, and 
therapeutic countermeasures and accelerate the global response to 
pandemic threats. NIAID anticipates the research conducted by PREMISE 
will advance our knowledge of immune response to vaccination and 
infection and help inform the response to future pandemic threats.
               Identifying Therapeutics to Treat COVID-19
    Safe and effective therapeutics are urgently needed to treat 
patients with COVID-19. NIAID has worked quickly from the earliest days 
of the pandemic to evaluate promising therapeutics for COVID-19 in 
rigorous, randomized, controlled clinical trials. COVID-19 therapeutics 
that inhibit essential viral processes or address the host response to 
COVID-19 are expected to maintain their effectiveness against emerging 
variants, such as the Omicron variant. As noted above, some monoclonal 
antibodies appear to be ineffective against Omicron, while others 
maintain their activity. NIAID is conducting and supporting additional 
research to determine how Omicron and other variants impact the 
effectiveness of monoclonal antibodies and other therapeutics as well 
as working to develop new drugs.
                 The Adaptive COVID-19 Treatment Trial
    Early in the outbreak, NIAID launched a multicenter, randomized 
placebo-controlled clinical trial, the Adaptive COVID-19 Treatment 
Trial (ACTT), to evaluate the safety and efficacy of multiple 
investigational therapeutics for COVID-19. ACTT-1 examined the 
antiviral drug remdesivir for treatment of severe COVID-19 in 
hospitalized adults. Based on positive data from ACTT-1, the FDA 
approved the use of remdesivir for treatment in adults and children 12 
years of age and older and weighing at least 40 kg hospitalized due to 
COVID-19. ACTT-2 evaluated the anti-inflammatory drug baricitinib in 
combination with remdesivir, and based on favorable data from ACTT-2, 
the FDA issued an EUA for the use of baricitinib in combination with 
remdesivir for treatment of adults and children older than 2 years 
hospitalized with COVID-19 and requiring supplemental oxygen, invasive 
mechanical ventilation, or extracorporeal membrane oxygenation. The FDA 
subsequently revised the EUA for baricitinib to remove the requirement 
that baricitinib be administered in combination with remdesivir. ACTT-3 
evaluated the treatment of hospitalized COVID-19 patients with 
remdesivir plus interferon beta-1a, which is used to treat individuals 
with multiple sclerosis, and found no clinical benefit from the 
addition of interferon beta-1a. ACTT-4 assessed baricitinib plus 
remdesivir versus the glucocorticoid dexamethasone plus remdesivir in 
adults hospitalized with COVID-19 and requiring oxygen, showing that 
these two regimens led to similar outcomes.
                  The ACTIV Public-Private Partnership
    NIAID, in collaboration with other NIH Institutes, also launched 
two clinical trials as part of the ACTIV partnership, which utilizes 
master protocols allowing the addition of other investigational 
therapeutics as the trials continue. ACTIV-2 and ACTIV-3 initially 
evaluated the use of the monoclonal antibody bamlanivimab to treat 
COVID-19 in outpatient and inpatient settings, respectively. ACTIV-2, 
which is focused on outpatients, has been expanded and is currently 
evaluating two investigational therapeutics: SAB-185, a fully human 
polyclonal antibody produced in cattle, and SNG001, an inhalable beta 
interferon. After completing the Phase 2 portion of the ACTIV-2 trial, 
AstraZeneca is independently pursuing a Phase 3 trial of their 
investigational long-acting monoclonal antibody combination, AZD7442. 
Brii Biosciences announced a rolling EUA submission for their 
combination monoclonal antibody therapy, BRII-196 plus BRII-198, based 
on promising results from ACTIV-2 for the treatment of COVID-19. Among 
patients at high risk of clinical progression, those receiving BRII-196 
plus BRII-198 had 178 percent decreased risk in hospitalization and 
death. On September 24, 2021, SAB Biotherapeutics announced the 
graduation of SAB-185 into Phase 3 efficacy studies in ACTIV-2.

    ACTIV-3 currently is evaluating the AZD7442 monoclonal antibody 
combination and PF-07304814, a protease inhibitor, in hospitalized 
patients. PF-07304814 inhibits a critical part of the replication 
process of SARS-CoV-2. On April 22, 2021, NIAID and the National Heart, 
Lung, and Blood Institute (NHLBI) launched a new trial, known as ACTIV-
3 Critical Care, to test Zyesami and remdesivir (alone and in 
combination), for their safety and efficacy in hospitalized COVID-19 
patients who are experiencing acute respiratory distress syndrome, a 
life-threatening condition. Zyesami is a synthetic version of 
vasoactive intestinal peptide, which is made naturally in the human 
body and appears to have lung-protective antiviral and anti-
inflammatory effects.

    Three monoclonal antibody therapies currently have FDA EUAs for the 
treatment of COVID-19 in outpatients. Due to concerns of variant 
resistance to monoclonal antibody therapies, the FDA now includes 
information on the susceptibility of SARS-CoV-2 variants to various 
monoclonal antibodies in its fact sheets for health care providers. 
NIAID-supported scientists and collaborators are evaluating the 
potential impact of emerging SARS-CoV-2 variants on the efficacy of 
monoclonal antibodies. NIAID and BARDA have shared their expertise with 
FDA as FDA has modified EUAs for monoclonal therapies regarding the 
testing of these products against variants and the conduct of 
independent assessments of potency against variants as they emerge.
           Additional NIAID-supported Therapeutics Activities
    NIAID also launched the ACTIV-5/Big Effect Trial (BET), which is 
designed to streamline the identification of experimental COVID-19 
therapeutics that demonstrate the most promise. BET, an adaptive Phase 
2 clinical trial, compares different investigational therapeutics to a 
common control arm to identify treatments with relatively large effects 
as promising candidates for further study in large-scale trials. BET 
initially evaluated two therapeutics: risankizumab, an immunomodulatory 
monoclonal antibody developed by Boehringer Ingelheim and AbbVie that 
is FDA-approved for the treatment of severe plaque psoriasis; and 
lenzilumab, an investigational immunomodulatory monoclonal antibody 
developed by Humanigen. Recently, a third therapeutic was added: 
danicopan, an oral drug that inhibits a key inflammatory pathway and 
was originally designed to treat a rare but serious disorder called 
Paroxysmal Nocturnal Hemoglobinuria.

    NIAID, in collaboration with the DOD Defense Threat Reduction 
Agency, supported basic research and product development for the oral 
antiviral drug molnupiravir. Merck and Ridgeback Biotherapeutics 
announced clinical data from their Phase 3 trial which showed that 
molnupiravir reduced the risk of hospitalization or death by 
approximately 30 percent in at risk, non-hospitalized adult patients 
with mild-to-moderate COVID-19. In December 2021, FDA authorized the 
use of molnupiravir for the treatment of mild-to-moderate COVID-19 in 
adults who are at high risk for progression to severe COVID-19 and for 
whom alternative COVID-19 treatment options authorized by the FDA are 
not accessible or clinically appropriate. NIAID also provided support 
for the development of Paxlovid, an oral antiviral candidate developed 
by Pfizer. In a Pfizer-supported Phase 2/3 clinical trial, a course of 
Paxlovid given within the first 3 days of symptoms reduced the risk of 
COVID-19-related hospitalization or death by 89 percent among non-
hospitalized adults with COVID-19 at high risk of progressing to severe 
illness. In December 2021, FDA authorized the use of Paxlovid for the 
treatment of mild-to-moderate COVID-19 in adults and pediatric patients 
12 years of age and older weighing at least 40 kilograms who are at 
risk for progressing to severe COVID-19 and/or hospitalization.

    NIH has launched the Antiviral Program for Pandemics, an NIH-BARDA 
collaboration that aims to develop safe and effective antivirals to 
treat and prevent SARS-CoV-2 infection. The program will build 
sustainable platforms for targeted drug discovery and development of 
antivirals directly targeting viruses with pandemic potential. As part 
of this effort, NIAID will establish Antiviral Drug Discovery Centers 
for Pathogens of Pandemic Concern. These multidisciplinary research 
centers will create platforms that will target coronaviruses and 
additional RNA viruses with pandemic potential, helping to better 
prepare the Nation for future viral threats. Oral drug candidates for 
broad use in outpatient settings are the primary focus of this effort.

    NIH also has established the COVID-19 Treatment Guidelines Panel to 
provide recommendations to health care providers regarding specific 
COVID-19 treatments based on the best available science. The Guidelines 
address considerations for hospitalized and non-hospitalized patients 
as well as special populations, including pregnant women and children. 
Each Treatment Guidelines section is developed by a working group of 
Panel members with expertise in the area addressed in the specific 
section; these members conduct systematic, comprehensive reviews of 
relevant information and scientific literature. The Panel comprises 
representatives of NIH and five other Federal agencies along with 
representatives of 11 professional organizations, academic experts, and 
treating physicians including providers from high COVID-19 incidence 
areas, and community representatives. The Panel meets regularly to 
evaluate possible treatment options for COVID-19 and update the 
Treatment Guidelines as new clinical evidence emerges.
        Understanding the Incidence and Pathogenesis of COVID-19
    NIH is supporting studies to understand the incidence of SARS-CoV-2 
infection in specific populations, including children, as well as 
certain aspects of the clinical course of infection, including 
thromboses, strokes, heart attacks, and other sequelae of infection. 
NIAID also is working with partners to delineate biological and immune 
pathways responsible for the varied manifestations of COVID-19.

    Early in the pandemic, the intramural research programs of NIAID, 
the National Cancer Institute, the National Center for Advancing 
Translational Sciences, and the National Institute of Biomedical 
Imaging and Bioengineering partnered to rapidly deploy the SARS-CoV-2 
Pandemic Serosurvey. The study investigated whether adults in the 
United States without a confirmed history of SARS-CoV-2 infection have 
antibodies to the virus, thus indicating prior infection. Findings from 
the first time point of this longitudinal study suggest that the 
prevalence of COVID-19 may have exceeded the number of cases medically 
diagnosed by an additional 16.8 million infections through mid-July 
2020. Continued analysis of the 1-year follow-up data from the study 
will be important in better understanding mortality rates, prevalence 
of immunity, and the impact SARS-CoV-2 has had on various communities 
in the United States.

    NIAID scientists are participating in leadership of the COVID Human 
Genetic Effort, an international consortium of hospitals and genetic 
sequencing hubs that aims to discover genetic factors conferring 
resistance to SARS-CoV-2 infection or predisposing to severe COVID-19. 
The consortium identified a subgroup of patients with severe COVID-19 
that have ineffective immune responses to SARS-CoV-2, some of whom have 
mutations in key immune pathways.

    NIAID also is engaged in efforts to understand the rare, but 
extremely serious, multisystem inflammatory syndrome in children (MIS-
C) that has been associated with SARS-CoV-2 infection in children and 
adolescents. NIAID supports the Pediatric Research Immune Network on 
SARS-CoV-2 and MIS-C (PRISM) to evaluate acute and long-term clinical 
and immunological effects of MIS-C and SARS-CoV-2 infection in 
children. In addition, NIAID is collaborating with Children's National 
Medical Center to follow 1,000 children with a history of SARS-CoV-2 
infection, including those with MIS-C, to determine long-term effects 
of the illness. NIAID is participating in a trans-NIH effort to 
coordinate MIS-C research led by NHLBI and the Eunice Kennedy Shriver 
National Institute of Child Health and Human Development. This 
centralized effort, the Collaboration to Assess Risk and Identify Long-
term Outcomes for Children with COVID (CARING for Children with COVID), 
will permit data to be shared across studies to determine the spectrum 
of illness and predict long-term consequences of infection.
              Addressing the Long-term Effects of COVID-19
    Many people who have had COVID-19 experience continued symptoms or 
other sequelae as they transition from the acute to post-acute phases 
of the disease, and we continue to learn more about the duration and 
manifestations of COVID-19 as we hear from these patients.

    NIH has announced the Researching COVID to Enhance Recovery 
(RECOVER) Initiative, a trans-NIH effort to address PASC, including 
targeted funding for research in this critical area. The NIH RECOVER 
Initiative will complement ongoing NIAID studies to better understand 
the various post-acute manifestations of COVID-19 in various 
populations. On June 10, 2021, NIH announced awards to New York 
University (NYU) to build the RECOVER research consortium, harmonize 
and coordinate data within the consortium, and develop methods for 
monitoring protocols; and to Massachusetts General Hospital to provide 
statistical analyses and coordinate data standardization, access, and 
sharing among RECOVER projects. On September 15, 2021, NIH announced, 
through NHLBI and the National Institute of Neurological Disorders and 
Stroke, awards to NYU to develop the RECOVER Cohort with funding from 
the American Rescue Plan Act of 2021 (P.L. 117-2). NYU is engaging more 
than 100 researchers at more than 30 institutions to build a diverse 
national study population and support large-scale studies on the long-
term effects of COVID-19.

    NIAID intramural scientists initiated the Longitudinal Study of 
COVID-19 Sequelae and Immunity to better understand PASC and determine 
the extent to which people who have recovered from acute SARS-CoV-2 
infection develop an immune response that provides protection against 
reinfection. NIAID-supported investigators also have established the 
Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) to determine 
how immunological markers correspond to, or may even predict, the 
clinical severity of COVID-19. Since May 1, 2020, IMPACC researchers 
have collected detailed clinical data along with blood and respiratory 
samples from more than 1,200 hospitalized COVID-19 patients of diverse 
race and ethnicity at approximately 20 hospitals nationwide. The cohort 
will be followed during hospitalization and up to 1 year after 
discharge to assess their functional and immunologic recovery.
                               Conclusion
    NIAID continues to expand efforts to elucidate the biology, 
pathogenesis, and clinical manifestations of SARS-CoV-2 infection, 
including emerging variants such as Delta and Omicron, and to employ 
this knowledge to develop safe and effective interventions to diagnose, 
treat, and prevent SARS-CoV-2 infection and COVID-19. NIAID is focused 
on developing safe and effective SARS-CoV-2 vaccines and therapeutics 
and sensitive, specific, rapid point-of-care molecular diagnostic and 
serological tests. NIAID also is conducting early stage research on 
candidate vaccines that could protect against multiple strains of 
coronaviruses. All these efforts will improve our response to the 
current pandemic and bolster our preparedness for the next, inevitable 
viral disease outbreak.
                                 ______
                                 
    The Chair. Thank you.

    Dr. Woodcock.

STATEMENT OF JANET WOODCOCK, M.D., ACTING COMMISSIONER, UNITED 
     STATES FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD

    Dr. Woodcock. Good morning, Chair Murray, Ranking Member 
Burr, and Members of the Committee. Thank you for the 
opportunity to testify. FDA's thousands of employees remain 
steadfast in fighting this pandemic.

    Our work continued during the holiday season and led to 
critical advancements in combating the virus. The agency has 
been closely monitoring the potential impact of the Omicron 
variant on the currently available vaccines, diagnostics, and 
therapeutics. I will provide a brief update and actions the 
agency has taken in these three areas since I last testified 
before this Committee.

    First, regarding vaccines. The currently authorized and 
approved vaccines remain highly effective at preventing serious 
outcomes associated with COVID-19 infection, including 
hospitalization and death. Additionally, data evaluated by the 
FDA suggests that an additional booster shot following the 
completion of primary vaccination series provides further 
protection against these outcomes.

    Following these data, FDA updated the Pfizer-BioNTech and 
Moderna vaccine EUAs to shorten the time between completion of 
a primary series and a booster dose to at least 5 months rather 
than 6 months. FDA also updated the Pfizer-BioNTech EUA, so is 
now available for a primary series in children 5--ages 5 and 
older, and for the use of a booster dose in all individuals 12 
through 15 years of age after completion of primary 
vaccination, as you have already heard from Dr. Walensky as the 
CDC followed up on this.

    The agency also authorized the Pfizer vaccine for a third 
primary series dose for certain immunocompromised children that 
are 5 through 11. These vaccines have met FDA's rigorous 
standards, and the bottom line is getting vaccinated or 
receiving a booster with one of the currently available 
vaccines is the best thing the public can do right now to 
protect themselves and those they care about. It is not too 
late to get vaccinated or get boosted.

    Second, diagnostic tests, which are another key line of 
defense in this pandemic. Increasing access to accurate, rapid 
at home tests continues to be a priority for FDA. Since I last 
testified, the agency has authorized four additional over-the-
counter at home tests, bringing the total number to 15, and the 
agency continues to prioritize the review of these type of 
tests. We also partnered with the NIH to establish ITAP, which 
streamlines validation and authorization of antigen tests with 
potential for large scale manufacturing.

    We expect shorter review times for such EUA request due to 
our partnership with ITAP. In fact, the first two tests that 
participated in this program were authorized in 2 days or less 
from the time FDA received the final data. So this is a very 
good model for Government assistance of diagnostic 
manufacturers. In this new program, ITAP will prioritize new 
over-the-counter test submissions that could be manufactured at 
significant scale to accelerate the availability of high 
quality, accurate, and reliable tests for the public as quickly 
as possible.

    Third, as new variants continue to emerge, it is crucial to 
expand the country's arsenals of COVID-19 therapeutics, 
especially for those unable to get vaccinated or who can't 
respond to vaccination. Since I last testified, three 
therapeutics have been authorized for use in the treatment of 
COVID-19 for emergency use. The first of these EUAs, Evusheld, 
was authorized for the prevention of COVID-19.

    The other two therapies, Paxlovid and Molnupiravir, as you 
heard from Dr. Fauci, are the first authorized treatments for 
COVID-19 in the form of a pill that can be taken orally, which 
is a major step in the fight against this global pandemic. 
These authorizations provide new tools to combat COVID-19 at a 
crucial time, and it should make antiviral therapy more 
accessible to people at high risk for progression.

    Now, while these are important tools, they are not a 
substitute for vaccination and people for whom vaccination is 
recommended, and I continue to urge the public to get 
vaccinated if eligible. And fourth, we continue our mission of 
protecting the public from fraudulent medical products.

    Since March, we have refused admission of more than 23,000 
lines of FDA regulated products that were trying to get into 
the country illegally. And finally, I want to assure the public 
the FDA is committed to continue to use every tool in our 
toolbox to fight this pandemic with the best available 
diagnostics, lifesaving therapeutics, and vaccines.

    Thank you, and I look forward to your questions.

    [The prepared statement of Dr. Woodcock follows:]
                  prepared statement of janet woodcock
                              Introduction
    Chair Murray, Ranking Member Burr, distinguished Members of the 
Committee, I am Dr. Janet Woodcock, Acting Commissioner of the U.S. 
Food and Drug Administration (FDA or the Agency). Thank you for the 
opportunity to testify before you today to describe FDA's coronavirus 
disease 2019 (COVID-19) response efforts. All of our efforts are in 
close coordination and collaboration with our partners, both within the 
Department of Health and Human Services (HHS) and across the Federal 
Government, to help ensure the development, authorization, licensure, 
approval, and availability of critical, safe, and effective medical 
products to address the COVID-19 public health emergency.

    I want to note that this testimony is just a snapshot of some of 
our extensive work and is in the context of efforts across the Agency 
to address this pandemic. There are thousands of FDA employees who have 
been working on COVID-19 response efforts non-stop since the start of 
the pandemic. I want to commend and recognize their efforts and thank 
them for their dedication and service. I also want to thank all FDA 
employees who have continued to work on the myriad issues the Agency is 
responsible for that do not directly involve COVID-19.

    From the beginning of this public health emergency, FDA has taken 
an active leadership role in the all-of-government response to the 
COVID-19 pandemic, inspired by the resiliency of the American people 
and our great innovators. FDA stood up an internal cross-agency group 
that continues to ensure we are doing everything possible to protect 
the American public, help ensure the safety, efficacy, and quality of 
FDA-regulated medical products, and provide the industries we regulate 
with the guidance and tools to do the same. We continue to focus on 
facilitating the development and availability of medical 
countermeasures to diagnose, treat, and prevent COVID-19, surveilling 
the medical product and food supply chains for potential shortages or 
disruptions, and helping to mitigate such impacts, as necessary to 
protect the public health.

    This includes working to quickly address any potential impacts of 
the new omicron variant. FDA is working as quickly as possible to 
evaluate the potential impact of this variant on the currently 
available diagnostics, therapeutics and vaccines. We are closely 
monitoring the situation and are committed to communicating with the 
public as we learn more. Just a couple weeks ago we updated the SARS-
CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new 
information on the omicron variant and its impact on antigen diagnostic 
tests. FDA is committed to continuing to use every tool in our toolbox 
to fight this pandemic, including pivoting as the virus adapts, to arm 
ourselves with the best available diagnostics, and life-saving 
therapeutics and vaccines to fight this virus.

    At this time, the current vaccines remain highly effective at 
preventing serious clinical outcomes associated with a COVID-19 
infection, including hospitalization and death. Additionally, currently 
available data from our international partners and vaccine 
manufacturers that has been evaluated by the Agency, suggests that an 
additional booster shot following the completion of a primary 
vaccination provides further protection.

    Getting vaccinated or receiving a booster with one of the currently 
available vaccines is the best thing Americans can do right now, in 
addition to standard precautions like wearing a mask, to help protect 
themselves and their families.
                     Biologics, Including Vaccines
    FDA's Center for Biologics Evaluation and Research (CBER) continues 
to use every tool available to help facilitate the development and 
availability of vaccines and other biological products to combat the 
COVID-19 pandemic expeditiously and safely.

    CBER is working on multiple fronts to address the COVID-19 
pandemic, including:

          Helping to facilitate expedited clinical trials for 
        vaccines and certain therapeutic biological products that hold 
        promise to prevent or treat COVID-19 by providing timely 
        interactions, scientific advice, and recommendations for 
        individual sponsors and through issuance of guidance documents;

          Supporting product development and facilitating the 
        scaling up of manufacturing capacity for high priority products 
        to treat COVID-19 and conducting timely reviews;

          Expediting the review of Emergency Use Authorization 
        (EUA) requests and Biologics License Applications (BLAs) for 
        vaccines and other critical medical products to address COVID-
        19, including the evaluation of booster doses of COVID-19 
        vaccines and the use of COVID-19 vaccines in certain pediatric 
        populations;

          Helping to ensure an adequate and safe blood supply; 
        and

          Providing information to healthcare providers and 
        researchers to help them submit expanded access investigational 
        new drug application (IND) requests to permit the use of CBER-
        regulated investigational products for patients with COVID-19.

    CBER's work on COVID-19 vaccines, as discussed below, has made a 
tremendous difference in addressing the pandemic by facilitating the 
availability of COVID-19 vaccines, that meet the Agency's rigorous 
standards, as expeditiously as possible. Through our transparent 
scientific evaluation process, FDA has issued EUAs for three COVID-19 
vaccines and has approved one vaccine for use in individuals 16 years 
of age and older. In doing so, we have relied upon the Agency's 
rigorous standards for safety, effectiveness, and manufacturing 
quality. These COVID-19 vaccines were developed without cutting corners 
or compromising our regulatory and scientific standards. Intensive 
interactions between FDA and manufacturers minimized the time between 
different studies in the clinical development process; allowed seamless 
movement throughout the different phases of clinical trials; and 
simultaneously facilitated manufacturers proceeding with manufacturing 
scale-up before it was clear whether the safety and effectiveness data 
for a vaccine would support an EUA, allowing for quicker access to 
products once FDA reviewed the data and found the products met the 
Agency's rigorous standards for authorization or approval.

    For the approved vaccine, as well as those that have been 
authorized for emergency use, our process included a thorough 
evaluation of the data by the Agency's career staff. We also solicited 
input from independent scientific and public health experts through our 
public advisory committee meetings for the COVID-19 vaccines that we 
have authorized. Throughout our scientific and regulatory process, FDA 
took additional steps to facilitate transparency, such as posting 
sponsor and FDA briefing documents and key decisional memoranda.

    The COVID-19 vaccines that are available in the United States have 
shown clear and compelling efficacy in large, well-designed phase 3 
trials. These vaccines are helping the country in the fight against 
this pandemic and have met FDA's rigorous standards for safety and 
effectiveness to support either EUA or approval. All the COVID-19 
vaccines that FDA has authorized for emergency use have far surpassed 
being at least 50 percent more effective than a placebo in preventing 
COVID-19, which was recommended in our June 2020 guidance document, 
Development and Licensure of Vaccines to Prevent COVID-19. \1\ A 
vaccine with at least 50 percent efficacy, we noted, would have a 
significant impact on disease, both at the individual and societal 
level. The vaccines are approved or authorized to prevent COVID-19, and 
have been shown to significantly reduce the associated serious 
outcomes, including hospitalization and death.
---------------------------------------------------------------------------
    \1\  https://www.fda.gov/media/139638/download
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    During this past year, we have continued to make great strides with 
regard to COVID-19 vaccines. As part of our continued efforts to be 
transparent and educate the public, we have a wealth of information on 
our website about the COVID-19 vaccines available for use in the United 
States. The information includes fact sheets for healthcare providers 
(vaccination providers) and fact sheets for vaccine recipients and 
caregivers in multiple languages, with important information such as 
dosing instructions; information about the benefits and risks of each 
vaccine; and topical Questions and Answers developed by FDA for the 
approved vaccine and each authorized vaccine. \2\
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    \2\  https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-frequently asked-questions
---------------------------------------------------------------------------
    It is also important to highlight that, as part of each EUA or 
approval, manufacturers and vaccination providers are required to 
report serious adverse events, cases of Multisystem Inflammatory 
Syndrome (MIS), and cases of COVID-19 that result in hospitalization or 
death to the Vaccine Adverse Event Reporting System (VAERS), a national 
vaccine safety surveillance program jointly run by FDA and the Centers 
for Disease Control and Prevention (CDC).

    COVID-19 vaccine safety is a top priority for the Federal 
Government, and we take all reports of health problems following COVID-
19 vaccination very seriously. FDA and CDC have implemented a 
coordinated and overlapping approach for continuous safety monitoring 
of all COVID-19 vaccines using state-of the art technologies. 
Specifically, the Agency's monitoring following authorization of the 
COVID-19 vaccines uses a multi-pronged approach including: 1) passive 
surveillance using VAERS consisting of safety reports submitted by 
healthcare providers (providers in the CDC COVID-19 Vaccination Program 
are required to report adverse events following COVID-19 vaccination to 
VAERS), patients, parents and other members of the public, combined 
with 2) active surveillance, using large population-based healthcare 
datasets. These latter healthcare data systems offer a higher 
likelihood of detecting rare adverse events because they capture 
medical data on millions of Americans, cover diverse subpopulations 
(i.e., pregnant women, elderly, and patients with comorbidities) and 
can provide a longer duration of follow-up when compared to the 
prelicensure clinical studies. In addition, COVID-19 vaccine recipients 
are encouraged to enroll in CDC's v-safe After Vaccination Health 
Checker smartphone-based tool that uses text messaging and web surveys 
to check-in with vaccine recipients over time after they receive a 
COVID-19 vaccine. Through v-safe, they can quickly tell CDC if they 
have any side effects after getting a COVID-19 vaccine. Together, the 
passive and active safety surveillance provide a coordinated and 
overlapping approach to vaccine safety monitoring for COVID-19 
vaccines.

    On August 23, 2021, FDA announced the first approval of a COVID-19 
vaccine. The vaccine previously known as the Pfizer-BioNTech COVID-19 
Vaccine was approved and is now marketed as Comirnaty, for the 
prevention of COVID-19 in individuals 16 years of age and older. 
Comirnaty has the same formulation as the originally authorized Pfizer-
BioNTech COVID-19 Vaccine. Since the approval of Comirnaty, the Pfizer-
BioNTech COVID-19 Vaccine has continued to be available under an EUA, 
including for the two-dose primary series in individuals 12 through 15 
years of age and as a third primary series dose for individuals 5 years 
of age and older who have been determined to have certain kinds of 
immunocompromised conditions. While millions of people have already 
safely received COVID-19 vaccines, we recognize that for some, the FDA 
approval of a vaccine may now instill additional confidence to get 
vaccinated. To be clear, the American public should feel confident in 
receiving any of the available vaccines.

    On September 22, 2021, FDA amended the EUA for the Pfizer-BioNTech 
COVID-19 Vaccine to allow for use of a single booster dose, to be 
administered at least 6 months after completion of the primary series 
in the following groups: individuals 65 years of age and older, 
individuals 18 through 64 years of age at high risk of severe COVID-19, 
and individuals 18 through 64 years of age whose frequent institutional 
or occupational exposure puts them at high risk of serious 
complications of COVID-19 including severe COVID-19.

    On October 20, 2021, FDA further amended the EUA to clarify that a 
single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may also be 
administered at least 6 months after completion of the primary series 
to individuals 18 through 64 years of age with frequent institutional 
or occupational exposure to severe acute respiratory syndrome 
coronavirus 2(SARS-CoV-2).

    On October 20, 2021, FDA also amended the Moderna COVID-19 Vaccine 
EUA to include use of a single booster dose at least 6 months after 
completion of the primary series in the following groups: individuals 
65 years of age and older, and those 18-64 years of age at high-risk of 
severe COVID-19 or with frequent institutional or occupational exposure 
to SARS-CoV2. The Agency also amended the Janssen EUA to include the 
use of a single booster dose of the Janssen (Johnson & Johnson) COVID-
19 Vaccine, administered at least 2 months after completion of the 
single-dose primary regimen to individuals 18 years of age and older. 
As of this announcement, all three COVID-19 vaccines had been 
authorized for a booster dose, but with varying eligibility.

    Additionally, FDA authorized the use of heterologous, or ``mix and 
match,'' booster dosing in eligible individuals following completion of 
primary vaccination with a different available COVID-19 vaccine.

    On October 29, 2021, the FDA authorized the emergency use of the 
Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to 
include children 5 through 11 years of age. The authorization was based 
on the FDA's thorough and transparent evaluation of the data that 
included input from independent advisory committee experts who 
overwhelmingly voted in favor of making the vaccine available to 
children in this age group. We are confident in the safety, 
effectiveness and manufacturing data behind this authorization. As part 
of our commitment to transparency around our decisionmaking, which 
included a public advisory committee meeting, we have posted documents 
supporting our decision. We hope this information gives parents the 
confidence they need to have their children vaccinated.

    On the same day, FDA also authorized a manufacturing change for the 
vaccine to include a formulation that uses a different buffer; buffers 
help maintain a vaccine's pH (a measure of how acidic or alkaline a 
solution is) and stability. This authorization is for two 
presentations: one for individuals 12 years of age and older and one 
for individuals 5 through 11 years of age. This new formulation is more 
stable at refrigerated temperatures for longer periods of time, 
permitting greater flexibility for vaccination providers. The new 
formulation of the vaccine developed by Pfizer Inc. contains Tris 
buffer, a commonly used buffer in a variety of other FDA-approved 
vaccines and other biologics, including products for use in children. 
FDA evaluated manufacturing data to support the use of Pfizer-BioNTech 
COVID-19 Vaccine containing Tris buffer and concluded it does not 
present safety or effectiveness concerns. FDA has since approved this 
new Tris formulation as part of the Comirnaty BLA.

    On November 19, 2021, FDA amended the EUA for both the Moderna and 
Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster 
dose for all individuals 18 years of age and older 6 months after 
completion of primary vaccination with any FDA-authorized or approved 
COVID-19 vaccine. On December 9, 2021, FDA amended the EUA for the 
Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single 
booster dose for administration to individuals 16 and 17 years of age 
at least 6 months after completion of primary vaccination with the 
Pfizer-BioNTech COVID-19 Vaccine.

    On January 3, 2022, FDA amended the EUA for the Pfizer-BioNTech 
COVID-19 Vaccine to expand the use of a single booster dose to include 
use in all individuals 12 through 15 years of age after completion of 
primary vaccination and authorized a third primary series dose for 
certain immunocompromised children 5 through 11 years of age. 
Additionally, FDA authorized the shortening of the time between the 
completion of primary vaccination of the Pfizer-BioNTech COVID-19 
Vaccine and a booster dose to at least 5 months. Last Friday, January 
7, 2022, FDA also amended the EUA for the Moderna COVID-19 Vaccine to 
shorten the time between the completion of a primary series of the 
vaccine and a booster dose to at least 5 months for individuals 18 
years of age and older.

    At this time FDA is closely monitoring the emergence of the Omicron 
variant in order to determine what, if anything, needs to be changed in 
the composition of COVID-19 vaccines moving forward to best protect the 
population. The Agency has already issued COVID-19 vaccine-specific 
guidance to address the emergence and potential future emergence of 
variants of SARS-CoV-2, the virus that causes COVID-19.

    Figure 1
    
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    This pandemic is dynamic and evolving, with new data continuously 
emerging about vaccine safety and effectiveness. As we obtain more data 
about the safety and effectiveness of COVID-19 vaccines, including the 
use of a booster dose, we will continue to evaluate the rapidly 
changing science and keep the public informed.

    At this time, it is clear that the approved or authorized vaccines 
reduce the risk of severe illness; however, data are not yet available 
to make a determination about how long they will provide protection. 
Additionally, although we do not yet know the full range of SARS-CoV-2 
variants that each of the vaccines will protect against, there is 
evidence that the available vaccines protect against disease caused by 
variants circulating in the United States.

    Finally, manufacturers whose COVID-19 vaccines have been authorized 
for emergency use are expected to continue their clinical trials in 
order to obtain additional safety and effectiveness information and 
pursue licensure (approval).

    To date, having three authorized vaccines and one approved vaccine 
that meet FDA's expectations for safety and effectiveness at this point 
of the COVID-19 pandemic is a tremendous achievement and a testament to 
the dedication of vaccine developers and FDA's career scientists and 
physicians. We are highly engaged in ensuring that all COVID-19 
vaccines meet the high quality that the American public expects and 
deserves. The Agency is very proud of these efforts, and we believe 
that the vaccines will help bring this pandemic to an end.

    In addition to its work on COVID-19 vaccines, CBER also has been 
actively involved in reviewing data related to COVID-19 convalescent 
plasma and on December 28, 2021, the FDA updated the EUA for COVID-19 
convalescent plasma. The update limits the authorization to the use of 
COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 
antibodies for the treatment of COVID-19 in patients with 
immunosuppressive disease or who are receiving immunosuppressive 
treatment. These patients may be treated in outpatient or inpatient 
settings. Additionally, to help assure the manufacture of high titer 
COVID-19 convalescent plasma, the update to the EUA revises acceptable 
tests and increases qualifying result cutoffs to be used for 
manufacturing COVID-19 convalescent plasma with high titers of anti-
SARS-CoV-2 antibodies.
                             Drug Products
    Since the beginning of the COVID-19 pandemic, FDA's Center for Drug 
Evaluation and Research (CDER) has been working tirelessly to 
facilitate the development and availability of therapeutics for use by 
patients, physicians, and health systems as expeditiously and safely as 
possible. FDA accelerated the development and publication of guidance 
and other information for industry and researchers on developing COVID-
19-related treatments. Further, on March 31, 2020, FDA announced the 
creation of an emergency review and development program for possible 
therapies for COVID-19, the Coronavirus Treatment Acceleration Program, 
or ``CTAP.'' The primary goal of CTAP is to help accelerate the 
development of therapeutics for patients and consumers. The Agency has 
supported the program by reassigning staff and working continuously to 
review requests from companies and researchers who are working to 
develop therapies. Under CTAP, FDA is using every available authority 
and regulatory flexibility to facilitate the development of safe and 
effective products to treat patients with COVID-19. As of November 30, 
2021, there are more than 670 drug development programs in the planning 
stages and the Agency has reviewed more than 470 trials of potential 
therapies for COVID-19. These include antivirals, immunomodulators, 
neutralizing antibodies, cell and gene therapies, and combinations of 
these products. The diversity of therapeutic approaches being 
investigated is important because it rapidly expands our understanding 
of the effect of different categories of potential treatments.

    Figures 2 & 3
    
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
        
        
    As of December 31, 2021, FDA has approved one drug to treat COVID-
19 and 14 therapeutics are currently authorized for emergency use. On 
December 8, 2021, FDA issued an EUA for AstraZeneca's Evusheld 
(tixagevimab co-packaged with cilgavimab and administered together) for 
the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults 
and pediatric individuals (12 years of age and older weighing at least 
40 kilograms [about 88 pounds]).

    On December 22, 2021 FDA issued an EUA for the first oral 
antiviral, Paxlovid, manufactured by Pfizer. Paxlovid (nirmatrelvir 
tablets and ritonavir tablets, co-packaged for oral use) is authorized 
for the treatment of mild-to-moderate coronavirus disease (COVID-19) in 
adults and pediatric patients (12 years of age and older weighing at 
least 40 kilograms or about 88 pounds) with positive results of direct 
SARS-CoV-2 testing, and who are at high risk for progression to severe 
COVID-19, including hospitalization or death.

    On December 23, 2021, FDA issued an EUA for another oral antiviral, 
molnupiravir, manufactured by Merck. Molnupiravir is authorized for the 
treatment of mild-to-moderate coronavirus disease (COVID-19) in adults 
with positive results of direct SARS-CoV-2 viral testing, and who are 
at high risk for progression to severe COVID-19, including 
hospitalization or death, and for whom alternative COVID-19 treatment 
options authorized by the FDA are not accessible or clinically 
appropriate.

    Both Paxlovid and Molnupiravir are available by prescription only.

    In considering EUA requests for therapeutics, we promptly and 
carefully evaluate the totality of the scientific evidence to determine 
whether the statutory criteria for issuance under section 564 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) 
are met. Among other criteria, this evaluation considers whether the 
product may be effective for its proposed authorized uses, and whether 
the product's known and potential benefits outweigh its risks.

    Our goal is to be as transparent as possible about the scientific 
basis for recommending that a drug or biological product be authorized 
for emergency use under section 564 of the FD&C Act or for recommending 
that an EUA be revised or revoked. For example, last month, FDA held a 
meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to 
discuss Merck and Ridgeback's request for an EUA for molnupiravir, an 
investigational antiviral drug to treat COVID-19. The advisory 
committee discussed the available data supporting the use of 
molnupiravir to treat mild-to-moderate COVID-19 in adults who have 
tested positive for COVID-19, and who are at high risk for progression 
to severe COVID-19, including hospitalization or death. The meeting was 
scheduled as soon as possible following the submission of the EUA 
request by the company. FDA thoroughly evaluated the data and 
information submitted in the EUA request before the meeting and engaged 
in a robust public discussion with the advisory committee members.

    FDA continues to work closely with manufacturers to mitigate and 
prevent shortages as the COVID-19 pandemic evolves. For example, the 
Agency has issued four EUAs to authorize the emergency use of certain 
therapeutic products intended to treat serious or life-threatening 
diseases or conditions (e.g., Acute Kidney Injury, Acute Respiratory 
Distress Syndrome) caused by COVID-19 after determining that sufficient 
FDA-approved alternatives to these products were not available to fully 
meet the emergency need. This has helped to alleviate shortages of some 
therapies that are essential for the care of critically ill COVID-19 
patients. FDA is working with manufacturers to increase supplies to 
meet current demand by expediting review of applications. In addition, 
the Agency has prioritized the review of generic drug applications for 
potential treatments and supportive therapies for patients with COVID-
19, such as sedatives used in ventilated patients, anticoagulants, and 
pulmonary medications. In June 2021, FDA reached a milestone of 
approving 1,000 original and supplemental generic drug applications 
since the start of the pandemic to help in the treatment of patients 
with COVID-19. This supports FDA's everyday mission of improving access 
to safe, effective, high-quality treatment options, especially during 
the COVID-19 pandemic.
                            Medical Devices
    FDA's Center for Devices and Radiological Health's work to support 
access to medical devices for the COVID-19 pandemic began in January 
2020--before the Public Health Emergency (PHE) was declared in the U.S. 
and 2 months before the pandemic was declared worldwide--due to the 
immediate need for COVID-19 tests and testing supplies, collection 
kits, personal protective equipment (PPE), and other devices. The need 
for medical devices to respond to the COVID-19 pandemic has far 
exceeded what we experienced in any prior PHE. The first EUAs issued 
for the COVID-19 PHE were for medical devices, and the volume of EUA 
requests quickly surpassed (by two orders of magnitude) that of any 
prior PHE or other situation. Since January 2020, FDA has received over 
7,500 EUA requests and Pre EUA (PEUA) submissions for devices. Further, 
the emergency use requests included submissions for devices that FDA's 
Center for Devices and Radiological Health (CDRH) had never received 
EUA requests for during prior PHEs. This included ventilators and novel 
devices such as extracorporeal blood purification devices, as well as 
novel indications for devices such as continuous renal replacement 
therapy devices. Since the start of the pandemic, FDA has issued EUAs 
or granted marketing authorization to nearly 2,000 medical devices for 
COVID-19-related uses. In addition, FDA rigorously monitors safety 
signals and medical device reports, using the information to publish 23 
letters to healthcare providers and 9 safety communications. FDA 
completed other pivotal work activities such as addressing supply chain 
shortages and counterfeit products related to COVID-19.

    Diagnostic tests are the first line of defense in an outbreak, and 
FDA plays an important role to ensure these work through the EUA 
review. The EUA process expedites access to appropriately accurate 
diagnostic tests during emergencies, when information gaps and false 
results may adversely affect individual patient care and public health 
decisionmaking. Through this process, molecular diagnostic tests are 
able to be developed, validated, authorized, and deployed within weeks 
rather than several months to over a year, as is typical for test 
development and traditional premarket submissions. The Agency employed 
its EUA authorities to facilitate availability of tests in six previous 
emergencies. Careful review of tests is critical because false test 
results can adversely impact the Nation's response. In PHEs, FDA is 
generally open to receiving and reviewing EUA requests for tests from 
any developer, including commercial kit manufacturers and laboratories, 
for tests that address the public health need.

    FDA sought to facilitate COVID-19 test evaluation and authorization 
through the development and availability of templates for EUA requests. 
The templates provide recommendations for test validation and a fill-
in-the-blank form to streamline the paperwork and make it easier for 
developers to provide information in support of a request for an EUA. 
Since providing the first template in January 2020, FDA has been in 
daily contact with test developers to answer questions and help them 
through the EUA process. This has proved to be a helpful tool for many. 
FDA had as many as ten posted templates and continues to update, add, 
combine, and remove templates as the science evolves and as necessary 
to support developers of COVID-19 tests. As of October 8, 2021, these 
templates have received over 556,635 hits from those visiting FDA's 
website. FDA also supported test developers through establishment of a 
dedicated mailbox, 24-7 toll-free hotline that ran until July 2020, the 
posting of over 100 frequently asked questions on our website, and by 
hosting 74 weekly virtual town halls for test developers. The Agency 
has worked with over 1,000 test developers since January 2020.

    The Agency prioritizes review of EUA requests for at-home rapid 
antigen tests and is actively engaging with test developers to increase 
their availability. The Agency first discussed this prioritization in 
the Spring of 2020, during one of its weekly virtual Town Halls on 
COVID-19 tests, due to their potential impact on test accessibility and 
public health. To further encourage such test development, on July 29, 
2020, FDA posted a template for at-home diagnostic tests. This template 
includes recommendations for validating over-the-counter (OTC) tests 
for screening asymptomatic individuals with general performance 
expectations that are lower than for lab-based tests. The Agency 
recognizes the benefits of increased availability of OTC tests, and 
these recommendations have helped to increase OTC screening test 
availability, particularly rapid antigen tests.

    Throughout the pandemic, FDA has also monitored evolving 
circumstances and growing scientific knowledge and made adjustments 
when appropriate to help streamline and expedite the path to market for 
these and other tests as much as possible while assuring they are 
supported by sound science. In March 2021, FDA obtained results from an 
NIH-sponsored study that supported further streamlining of FDA's at-
home test recommendations. Based on these data, on March 16, 2021, FDA 
issued an EUA that provides a streamlined path to authorize tests with 
at least 80 percent sensitivity in symptomatic individuals, with 
sensitivity falling in a range as low as 70 percent in certain 
circumstances, for developers to offer their test for OTC serial 
screening without additional data collection. Multiple tests were 
authorized under this approach within weeks.

    FDA authorized the first at-home test on November 17, 2020. At-home 
tests, also referred to as self-tests, are those that can be performed 
by a lay user at home, or in other settings, with a self-collected 
sample. In Fall 2021, the Agency added home tests from ACON 
Laboratories, Celltrion Diatrust, iHealth, and InBios International to 
the growing list of home tests authorized in the U.S. Two of the FDA's 
recent authorizations alone may result in up to 400 million more at-
home tests available monthly to American consumers by early 2022, based 
on projections by the manufacturers and dependent on Federal subsidies. 
As of December 31, 2021, FDA has authorized 15 distinct at-home COVID-
19 tests.

    FDA further streamlined the process for manufacturers developing 
over-the-counter at-home tests on October 25, 2021, by facilitating at-
home single-use testing for symptomatic individuals for tests currently 
authorized only for serial testing. Developers of certain tests may 
request authorization to add single-use testing for symptomatic 
individuals without submitting additional data. For example, right now 
when people go to a pharmacy to buy an at-home test, they are sold in 
two-packs. This change would allow tests authorized for single use to 
be sold in singles, meaning more individual tests for sale potentially 
at a lower price.

    On November 15, 2021, FDA published an update to its Policy for 
Coronavirus Disease-2019 Tests During the Public Health Emergency that 
describes our review priorities based on the current needs of the 
pandemic. Going forward the FDA generally intends to focus its review 
on EUA requests for the following types of tests:

          At-home and point-of-care (POC) diagnostic tests for 
        use with or without a prescription and that can be manufactured 
        in high volumes;

          Certain high-volume, lab-based molecular diagnostic 
        tests (and home collection kits for use with such tests) that 
        expand testing capacity or accessibility such as through 
        pooling of specimens to increase throughput, testing specimens 
        collected at home and shipped to the lab, screening 
        asymptomatic individuals or detecting multiple different 
        respiratory viruses at once;

          Certain lab-based and POC high volume antibody tests 
        that can measure the amount of antibodies (fully quantitative 
        antibody tests) or the amount of neutralizing antibodies; and

          Tests for which the request is from, or supported by, 
        a U.S. Government stakeholder, such as the Biomedical Advanced 
        Research and Development Authority or the National Institutes 
        of Health's Rapid Acceleration of Diagnostics (RADx) 
        initiative.

    These priorities help developers focus their prospective efforts 
where they are most needed, and reduce inefficient use of developer and 
FDA time on tests with less public health impact. Ultimately, we 
anticipate we will receive EUA requests only for those tests identified 
in the guidance for which the public health need is greatest, and we 
will be able to focus our attention on the review of such tests.

    FDA also worked with NIH to establish an Independent Test 
Assessment Program (ITAP) to streamline validation and authorization of 
antigen tests with potential for large-scale manufacturing. This 
program is an extension of the RADx program which has already supported 
development of several authorized tests, including the first at-home 
OTC COVID-19 test. ITAP goes further to conduct studies on over-the-
counter tests and work with companies to help them provide complete, 
high quality submissions for FDA review. ITAP is conducting independent 
laboratory and clinical evaluations using protocols developed jointly 
with FDA. FDA uses information from these evaluations in deciding 
whether to grant EUAs. On December 24, FDA authorized the first at home 
COVID-19 test where validation data were gathered through ITAP and the 
second followed shortly after on December 29. We expect to continue 
shorter review times for such EUA requests due to our partnership with 
ITAP in establishing the evaluation program to address our regulatory 
needs.

    Going forward, FDA continues to take steps to increase access to 
reliable, accurate rapid antigen tests. This includes continuing to 
prioritize review of EUA requests for at-home antigen tests, and 
increasing staffing on the antigen test review team as resources 
permit. FDA is actively working to increase the pipeline of at-home 
tests by engaging with companies to obtain data that can be used to 
support their EUA, working with developers with authorized POC tests to 
expand their authorization for at-home use, continuing support of ITAP 
and engagement with RADx and international regulators, and conducting 
targeted outreach to manufacturers of home tests in non-U.S. markets.

    Because of these various efforts, as of December 31, 2021, FDA has 
authorized over 400 tests and sample collection devices for SARS-CoV-2. 
As noted in Figure 4 below, these include 290 molecular tests and 
sample collection devices, 87 antibody and other immune response tests, 
and 43 antigen tests. Among these are 16 authorizations for diagnostic 
tests that can be run at home without a prescription (three molecular 
and 13 antigen authorizations). We have also authorized 33 tests for 
serial screening programs (24 antigen and nine molecular). The volume 
and variety of authorized tests is a testament to FDA's support of 
innovative test design and our commitment to public health. FDA will 
continue to adapt to address public health needs and increase access to 
tests for consumers, including at-home diagnostic tests, adopting an 
approach that is grounded in sound science.

    Figure 4
    
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    In addition to these efforts, FDA has been actively monitoring for 
the possible emergence of SARS-CoV-2 variants since early in the 
pandemic and has worked with test developers when a new variant (or 
mutation) emerges that could impact test performance. FDA also works 
with test developers, who are required to monitor their authorized test 
for the impact of viral mutations. As the FDA's or the developer's 
analysis identifies tests whose performance could be impacted by SARS-
CoV-2 viral mutations, these tests are added to FDA's SARS-CoV-2 Viral 
Mutations: Impact on COVID-19 Tests webpage. This includes posting the 
latest information on the omicron variant and testing implications as 
they become available. FDA also works with other agencies and divisions 
in HHS, such as NIH, as we monitor tests for potential effects of 
genetic variation on test performance on an ongoing basis.

    Since early 2020, FDA has adopted agile, interactive, and 
innovative approaches to review EUA requests for all types of devices. 
For example, FDA developed the umbrella EUA approach to efficiently 
authorize multiple devices of the same type falling within the scope of 
authorization and meeting the statutory criteria for issuance. The 
Agency has also issued 28 guidance documents (including 21 revisions) 
outlining policies to help expand the availability of medical devices 
needed in response to COVID-19. For example, developers of certain 
tests offered their tests, upon validation and notification to FDA, 
prior to issuance of an EUA during Agency review of the EUA request. 
Further, FDA made several improvements to our EUA review processes to 
make the most efficient use of our resources, including a front-end 
triage process to identify devices that would have the greatest impact 
on the public health. These improvements incorporate the latest 
information on device availability and shortages, prioritizing novel or 
critical devices not yet available on the market or those that would 
address significant device shortages.

    Given the magnitude of the COVID-19 PHE, the FDA recognizes that 
continued flexibility, while still providing necessary oversight, will 
be appropriate to facilitate an orderly and transparent transition back 
to the eventual resumption of normal operations. In December 2021, FDA 
issued draft guidance for public comment to help manufacturers begin to 
plan a future return to normal operations, including a proposed phased-
in transition period and recommendations relating to submitting 
marketing submissions. The Agency hopes that providing additional 
transparency on our current thinking now will facilitate advance 
planning for an orderly transition to normal operations after the 
public health emergency with fewer supply disruptions for device 
manufacturers, healthcare providers, and patients.

    At the beginning of the pandemic, when there were relatively few 
diagnostic tests authorized, FDA's priority was to rapidly increase the 
availability of tests. For medical devices, review times have increased 
over time as the number of EUA requests and Pre-Emergency Use 
Authorization (PEUA) submissions for medical devices have increased to 
unprecedented levels. This is demonstrated in the tables we have 
provided with review times for IVD EUA requests over time, and 
submission volume for IVD EUA requests over time (see Figures 5 & 6 
below). At the beginning of the pandemic, FDA was authorizing tests and 
other devices in as little as 1 or 2 days upon receipt of complete data 
packages. Congress has provided critical, one-time funding that FDA has 
used to leverage contractors from outside organizations, to provide 
technical expertise to supplement our review staff in the review of EUA 
requests and other marketing submissions. These personnel are 
authorized to work alongside full-time employees, integrated into our 
internal review teams to help with the massive workload for tests, 
ventilators, PPE, and other devices, but the workload has continued to 
greatly exceed capacity even with the additional support.


    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Please note that FDA's actions have reduced the review times for 
tests from a peak average of 90 days for EUA requests received in 
September 2020 to approximately 35 days for those received since 
February 2021.

    FDA has authorized a wide variety of other medical devices for use 
in combating the pandemic, including a wide range of PPE, ventilators, 
and other therapeutic devices. As of December 31, 2021, FDA has 
authorized 269 PPE devices, including 51 surgical masks, 205 filtering 
facepiece respirators (FFRs), and issued 13 EUAs for face shields and 
other barriers intended to protect the user from bodily fluids, liquid 
splashes, or potentially infectious materials. See Figure 7. In 
addition to issuing EUAs, FDA has also cleared, through its premarket 
notification pathway, over 500 PPE 510(k)'s, which not only support the 
response to this pandemic but also future PHEs as well.

    Figure 7

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    FDA recognizes that medical devices, particularly tests, will 
continue to play an important role in the next phase of the pandemic 
response. The Agency is continuing to monitor its policies, the 
marketplace, and national needs, and will continue to adapt as the 
circumstances of the evolving pandemic warrant.
Human and Animal Food (Center for Food Safety and Applied Nutrition and 
                    Center for Veterinary Medicine)
    Throughout the pandemic, FDA has worked with Federal, state, and 
local partners, as well as industry, to help ensure a safe and adequate 
food supply for both people and animals.

    While there is no evidence to show that SARS-CoV-2 is likely to be 
transmitted by food, some components of the food system are 
experiencing challenges and supply chain imbalances. We saw this at the 
outset of the pandemic with the dramatic shift in where people were 
eating, and most recently, we are seeing that the broad supply chain 
issues impacting so many commodities are also impacting food. Overall, 
food production and manufacturing in the U.S. has been remarkably 
resilient, but we continue to monitor the food supply chain systems 
closely to efficiently and promptly identify supply chain challenges 
and apply mitigation strategies when necessary.

    In response to the pandemic, FDA's Foods Program developed 21 
Forward, a food supply chain data management tool, to help identify 
where risks for interruptions in the continuity of the food supply may 
be greatest. As part of 21 Forward, FDA conducted targeted outreach to 
the food industry to offer additional resources and technical 
assistance in addressing challenges.

    FDA also recognizes that food supply chain continuity and worker 
safety are two sides of the same coin. Thus, a robust food supply 
depends on the safety and health of the Nation's food and agricultural 
workforce. Along with our Federal, state, and local partners, we have 
provided best practices for food and agricultural workers, industry, 
and consumers on how to stay safe, and help ensure the continuity of 
operations in the food and agriculture critical infrastructure sector 
during the pandemic.

    In collaboration with HHS, CDC, Health Resources and Services 
Administration (HRSA) and U.S. Department of Agriculture (USDA), data 
from 21 Forward on the estimated numbers and distribution of food and 
agricultural workers have been made available to assist states with 
their vaccine distribution efforts for workers in the food and 
agriculture sectors, including migratory and seasonal agricultural 
workers. Now, FDA is using the information from 21 Forward to help 
identify and react to supply chain challenges and elevate as needed to 
the appropriate agencies or other entities. In addition, FDA has worked 
with its Federal partners to provide both COVID-19 and flu vaccination 
encouragement messages for the food industry.

    FDA's Coordinated Outbreak Response and Evaluation team has been 
working throughout the pandemic looking for signs of foodborne illness 
outbreaks and initiating responses as needed. FDA's Center for 
Veterinary Medicine is monitoring the animal food supply and initiating 
needed foodborne illness and natural disaster responses. In terms of 
inspectional work, FDA's Office of Regulatory Affairs (ORA) 
investigators continue to conduct mission-critical inspections 
domestically and abroad, including inspections and investigations in 
response to foodborne outbreaks, as they have done throughout the 
pandemic. FDA resumed standard operations for domestic surveillance 
inspections in July 2021. FDA continues to screen every line of every 
shipment of imported food entering the U.S. utilizing our Predictive 
Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) 
tool. We adjusted the algorithm in PREDICT to place increased scrutiny 
on shipments from facilities where foreign surveillance inspections 
have been postponed. FDA has made greater use of our Foreign Supplier 
Verification Program (FSVP) regulation to oversee compliance with FDA 
Food Safety Modernization Act (FSMA) requirements. The shift to remote 
FSVP inspections, along with other tools utilized by the foods program, 
has been critical to ensuring the safety of human and animal food from 
foreign suppliers during the COVID-19 pandemic. Since March 2020, FDA 
has conducted approximately 2,982 FSVP inspections, which represents a 
95 percent increase in inspections (1,527) over the 18 months prior to 
the pandemic. Additionally, FDA continues to identify human and animal 
foods that are unsafe, misbranded, or may cause a serious health 
concern for the public at the border with over 10,481 lines being 
refused admission since March 2020.

    In July 2020, FDA announced the New Era of Smarter Food Safety 
Blueprint outlining the Agency's plans over the next decade to create a 
more digital, traceable, and safer food system. The Agency has learned 
from its response to the pandemic that there is an accelerated need for 
certain goals in this blueprint, especially those involving supply 
chain continuity and resilience, modernized inspectional approaches, 
strengthening food safety infrastructures with regulatory partners, and 
the safety of foods ordered by consumers online. The number of 
consumers ordering food online has been steadily increasing over the 
years, but it has skyrocketed during the COVID-19 pandemic. FDA 
recently hosted a virtual Summit on E-Commerce to help the Agency 
improve its understanding of how human and animal foods are sold 
through e-commerce models and to identify courses of action for 
addressing potential food safety vulnerabilities, including those that 
may arise in the ``last mile'' of delivery.
    Inspections, Compliance, and Protecting the Medical Supply Chain
    Similar to their work protecting the food supply, import 
investigators have been onsite protecting the medical supply chain at 
our ports of entry, courier facilities, and the international mail 
facilities (IMFs) throughout the pandemic with uninterrupted support 
from ORA's laboratories. Through continued vigilance, FDA has prevented 
unsafe and unproven pharmaceuticals and other medical products from 
entering the country. Since March 2020, with the cooperation of and in 
coordination with the U.S. Customs and Border Protection (CBP), FDA has 
received and destroyed almost 85,500 products, totaling over 15,050,242 
capsules, tablets, and other dosage forms of unapproved drugs.

    Since March 2020, FDA has maintained the same level of screening 
for imported products as pre-pandemic and refused approximately 121,759 
lines of imported violative medical products. However, FDA has focused 
examinations on COVID-19 relief supplies to ensure compliant products 
are expedited while maintaining our commitment to refusing imported 
medical products that are unsafe, misbranded, unapproved, counterfeit, 
or may cause serious illness or injury to the public. In fact, our 
import investigators have evaluated donations of shipments destined for 
the Federal Emergency Management Agency (FEMA) and met the first 
vaccines (Pfizer Belgium) on their arrival into the United States in 
December 2020 to ensure proper transport, storage, and reconciliation 
of products, and also assisted with expediting the importation of other 
compliant vaccine-related shipments as well as other COVID-19 
necessities.

    Despite generally pausing domestic and foreign surveillance 
inspections in March 2020 to safeguard the health and well-being of our 
staff, as well as employees at facilities we inspect, our investigators 
continued to conduct mission critical inspections both domestically and 
abroad to ensure FDA-regulated industries were meeting applicable FDA 
requirements. In July 2020, FDA resumed prioritized domestic 
inspections. To arm our investigators with the most reliable and 
accurate information, FDA developed a rating system to assist in 
determining when and where it was safest to conduct prioritized 
domestic inspections until we resumed standard inspectional operations 
for domestic surveillance inspections in July 2021.

    On May 5, 2021, FDA issued a report titled, ``Resiliency Roadmap 
for FDA Inspectional Oversight,'' \3\ outlining the Agency's 
inspectional activities during the COVID-19 pandemic and its detailed 
plan to move toward a more consistent state of operations, including 
FDA's priorities related to this work going forward. The report was 
updated on November 22, 2021. \4\
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    \3\  https://www.fda.gov/media/148197/download
    \4\  https://www.fda.gov/media/154293/download
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    The report described our oversight work during the pandemic and 
outlined the inspectional activities that the Agency had postponed due 
to travel restrictions or inability to ensure the safety of our 
workforce or the workforces within the industries the Agency regulates. 
The report also outlined the number of mission-critical inspections FDA 
completed during that time, such as inspections of facilities for which 
there was a drug shortage, inspections needed for the approval of novel 
drugs or drugs related to the potential treatment of COVID-19, support 
of pre-market and pre-license applications, and response to foodborne 
disease outbreaks or other food safety risks such as food contaminated 
with pathogens.

    Additionally, the Resiliency Roadmap outlines FDA's continued, 
successful use of alternative tools and approaches where inspections 
are not feasible, including remote assessments (e.g. requests to 
regulated establishments to remotely view records) and remote 
interactive evaluations that include remote livestreaming video of 
operations, teleconferences, or screen sharing, and leveraging 
information from trusted regulatory partners. For example, FDA made 
over 1,300 requests to human and animal drug and biological product 
manufacturers to remotely view records, to support on-time regulatory 
decision actions. Our review of records requested under section 
704(a)(4) of the Federal Food, Drug, and Cosmetic Act supported more 
than 300 approval recommendations for new or abbreviated drug 
applications, as well as support for authorization decisions for EUA 
requests, potentially allowing new products to come to market and 
provide access to lower cost generic drugs to patients more quickly 
than may have otherwise been possible.

    Notably, FDA's bioresearch monitoring program staff have conducted 
more than 130 remote assessments that were directly used in application 
decisions. \5\ The new tool was incentivized for and supported by 
industry and continues to provide the Agency with valuable information 
to assist with risk-based targeting for inspections. FDA recognizes 
that remote approaches do not replace physical onsite inspections, and 
that there are situations where only an onsite inspection is 
appropriate, based on risk and history of compliance with FDA 
regulations.
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    \5\  https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/remote-interactive-evaluations-drug-manufacturing-
and-bioresearch-monitoring-facilities-during-covid
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    The Resiliency Roadmap further outlined the ongoing steps the 
Agency is taking to resume standard operational levels of inspection 
activities, including how it intends to prioritize domestic and foreign 
inspections that could not be performed during the pandemic. On July 1, 
2021, FDA transitioned to standard operations for domestic surveillance 
inspections and other prioritized operational work through the end of 
September 2021. As noted in the updated November 2021 report, FDA has 
exceeded the goals for completing domestic surveillance inspections 
that were detailed in the May Resiliency Roadmap. We also exceeded our 
performance goal related to following up on previous inspections 
classified as official action indicated (OAI). Additionally, of the 
more than 13,500 applications for medical product approval or 
authorization received between March 2020 and September 2021, only 68 
applications had been delayed due to the inability to conduct 
inspections--the vast majority of these applications are not deemed 
mission-critical. From the time FDA first issued the Resiliency Roadmap 
in May to September 2021, the FDA has been able to make decisions on 
nearly half of the 68 applications.

    When planning surveillance inspections, the Agency is prioritizing 
higher-risk establishments. For example, a sterile manufacturing site 
that has not been previously inspected and is making narrow therapeutic 
index drugs would likely be deemed a higher risk than a site that had a 
well know inspectional and compliance history that is making over-the-
counter solid oral dosage form drugs. This means that postponed 
inspections will be prioritized based on risk and conducted over a 
longer period of time, ultimately increasing the amount of time between 
inspections of certain lower-risk facilities in order to focus on 
products that present the greatest risk to public health.

    The Agency launched a multi-year modernization effort in July 2021 
to further transform our data enterprise platforms and cross-program 
interoperability infrastructure to better support innovation related to 
its regulatory oversight role. This includes adopting technology to 
support regulatory assessments to improve our remote receipt, review, 
and analysis of industry data and records, and improve remote 
interactions with industry entities to be easier, more efficient, more 
consistent, and more secure. This modernization effort includes a 
review of inspectional approaches using next-generation assessment 
technologies and improvements. FDA established an Agency-wide 
Inspectional Affairs Council (FIAC) that provides coordination of 
inspection approaches and assessment processes. The Agency intends to 
share more information on these efforts as this work progresses. FDA 
will continue to leverage and maximize every available tool and 
resource to meet its regulatory oversight responsibilities, while 
achieving optimal public health outcomes.
                       Compliance and Enforcement
    FDA exercises its regulatory authority by, among other things, 
issuing warning letters and by pursuing civil and criminal enforcement 
actions against firms and individuals who do not comply with regulatory 
requirements, including those distributing unapproved products with 
false or misleading claims that the products prevent, treat, mitigate, 
diagnose, or cure COVID-19. In March 2020, FDA launched Operation Quack 
Hack, which leverages the Agency's expertise and advanced analytics to 
protect consumers from fraudulent medical products, including unproven 
cures, illegitimate test kits, and substandard or counterfeit 
respirators. FDA has sent hundreds of abuse complaints to domain name 
registrars and internet marketplaces. The Agency also has sent more 
than 260 warning letters to sellers of unproven products claiming to 
treat or cure COVID-19. Working with the Department of Justice (DOJ), 
FDA has sought and obtained preliminary injunctions that require 
defendants to halt the sale of unproven products claiming to treat or 
prevent COVID-19, including one product, ``Miracle Mineral Solution,'' 
that, when used as directed, is equivalent to industrial bleach. In 
addition, since the start of the COVID-19 pandemic, FDA has issued 17 
warning letters to owners and/or operators of illicit internet pharmacy 
websites that offer for sale unapproved and misbranded drugs purported 
to treat COVID-19 to U.S. consumers.

    In addition, ORA's Office of Criminal Investigations (OCI), working 
with other Federal and local law enforcement agencies, has conducted 
criminal investigations involving unproven COVID-19-related products. 
In one such example, OCI investigated a physician who attempted to 
profit from the pandemic by marketing and selling an unproven COVID-19 
treatment. The physician marketed and sold treatment kits--which 
included hydroxychloroquine--as a cure for COVID-19. In July 2021, the 
physician pleaded guilty to, among other things, trying to smuggle 
hydroxychloroquine into the United States to sell in his COVID-19 
``treatment kits.'' In another case, OCI investigated an individual who 
attempted to import approximately 1,000 unlawful COVID-19 test kits 
from China, which were intercepted at a FedEx facility in Memphis, 
Tennessee. As a result of OCI's investigation, the individual pleaded 
guilty in October 2021 to a felony smuggling charge. OCI also has 
conducted criminal investigations to bring to justice those who tamper 
with COVID-19 vaccines. For example, OCI investigated a hospital 
pharmacist who tampered with COVID-19 vaccine doses at a Wisconsin 
hospital where he worked. On two successive nights, the pharmacist 
purposefully removed a box of COVID-19 vaccine vials from the 
hospital's refrigeration unit intending to render the vaccines inert 
and no longer effective. Before the full extent of his conduct was 
discovered, 57 people received doses of the vaccine from these vials. 
In January 2021, the pharmacist pleaded guilty to two counts of 
attempting to tamper with consumer products with reckless disregard for 
the risk that another person will be placed in danger of death or 
bodily injury. He has been sentenced to 3 years imprisonment, followed 
by 3 years of supervised release, and he must pay approximately $83,800 
in restitution to the hospital.

    In addition, FDA investigators remain on the front lines at ports 
of entry, quickly examining, reviewing, and sampling import entries, 
and refusing admission of violative products where appropriate. We 
protect the supply chain in two equally critical ways: first, we help 
ensure safe products are coming in; and second, that illegal, 
dangerous, and fraudulent products do not get into the country. These 
efforts include partnering with U.S. Customs and Border Protection 
(CBP) in establishing satellite laboratories at selected International 
Mail Facilities (IMFs) with scientists using state-of-the-art screening 
tools to rapidly identify unapproved, counterfeit and illicit products.

    In March 2020, OCI, with the help of domestic law enforcement 
partners and foreign counterparts in the United Kingdom, led the 
investigation of fraudulent COVID-19 ``treatment kits'' that were 
falsely declared as ``water treatment.'' Import examination of these 
shipments found misbranded ``kits'' intended to treat COVID-19. As a 
result of this investigation, a British national was charged and 
arrested for shipping mislabeled and unapproved products. In May 2020, 
FDA worked with CBP to intercept several shipments of counterfeit 
facemasks, with the result that they were refused and destroyed before 
entering U.S. commerce.

    FDA also has taken steps to address hand sanitizer products that 
pose safety concerns, such as products that do not meet the required 
ethanol or isopropanol levels or that contain or may contain toxic 
ingredients like methanol or 1-propanol. FDA has tested several hundred 
products using field-based and laboratory-based tools and found more 
than a hundred violative products. FDA also has taken steps to help 
ensure that these dangerous or subpotent products do not enter domestic 
commerce, including coordinating with CBP to identify such products, 
and we have listed products made by more than 65 manufacturers on 
import alert. FDA also placed all alcohol-based hand sanitizers from 
Mexico on a countrywide import alert to help stop products from 
entering the U.S. that appear to be in violation until the Agency is 
able to review the products. That action marked the first time the FDA 
has issued a countrywide import alert for any category of drug product.
                      Medical Product Supply Chain
    FDA monitors and responds to worldwide demand and supply chain 
disruptions for medical products caused by the COVID-19 pandemic. \6\ 
We work closely with manufacturers, within our current resources and 
authorities, to help ensure they continue to notify the Agency of any 
permanent discontinuance or interruption of drug (human and animal), 
biological product, and device manufacturing in a timely manner and, as 
noted in FDA's Fiscal Year (FY) 2022 budget, we are working to better 
position the Agency and our health care system to assure a strong 
domestic supply chain in future emergencies. \7\
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    \6\  https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-
supply chain-review-report.pdf
    \7\  FDA Fiscal Year 2022 Justification of Estimates for 
Appropriations Committees (https://www.fda.gov/media/149616/download)
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    This is especially important as the COVID-19 pandemic has exposed 
major vulnerabilities in the supply chain that FDA continues to face as 
it works to help ensure access to the treatments and devices that 
patients and healthcare providers need.

    In addition to our usual communications with drug manufacturers, we 
work closely with healthcare and pharmacy systems, hospitals, 
providers, and others on the frontlines of COVID-19 patient care to 
identify problems with access to critical care drugs used to treat 
COVID-19.

    FDA understands the significant impact shortages can have on 
patient care and we are using our authorities to help prevent and 
alleviate disruptions. When we identify a shortage, we react swiftly to 
help mitigate the impact to U.S. patients and health care 
professionals, and quickly share that information with the public. 
Restoring and increasing the supply of approved drugs has been the 
agency's priority. In addition, where necessary, FDA has issued 
temporary policies during the COVID-19 emergency to respond to reports 
from hospitals of increased demand and interruptions in supply, some of 
which have not resulted in a drug shortage but caused concern about 
continuing access to drugs to support hospitalized patients with COVID-
19. We issued temporary policies for outsourcing facilities registered 
with FDA and pharmacists in state-licensed pharmacies or Federal 
facilities, regarding the compounding of certain drugs used for 
hospitalized patients with COVID-19. The Agency has published guidances 
to help applicants and manufacturers provide FDA with timely and 
informative notifications about changes in the production of certain 
human drugs, including biological products, and certain animal drugs. 
We urged the timely submission of these notifications, which may assist 
in our efforts to prevent or mitigate shortages of such products. In 
addition, section 503B(a)(2)(A) of the FD&C Act permits outsourcing 
facilities to use bulk drug substances to compound drug products that 
appear on the drug shortage list in effect under section 506E of the 
FD&C Act at the time of compounding, distribution, and dispensing, when 
all conditions of section 503B are met.

    Our experience with COVID-19 demonstrates that a strong domestic 
supply chain depends on a resilient supply chain for medical devices as 
well. Indeed, multiple entities across both the public and private 
sector collectively have important roles to play in strengthening the 
domestic medical device supply chain. FDA can play a critical role in 
identifying and preventing shortages for devices, because the Agency 
not only reviews and authorizes these products, but has unique, 
collaborative relationships that allow direct engagement with device 
manufacturers, patients, distributors, healthcare organizations, and 
other stakeholders. Even before the pandemic hit the U.S., there were 
disruptions in the supply chain due to higher demand for devices in 
other nations where COVID-19 was already prevalent and shutdowns in 
locations from which supplies were sourced. As a result, FDA began 
shortage mitigation activities for medical devices in January 2020 
before the PHE was declared in the U.S., and 2 months before a pandemic 
was declared worldwide. At that time, the Agency did not have any 
dedicated funding or explicit authority regarding prevention or 
mitigation of medical device or animal drug shortages. The Agency 
lacked dedicated staff necessary to mitigate supply chain disruptions 
and/or shortages. Nevertheless, the Agency took several actions to 
rapidly respond to supply chain needs, including reassigning over 130 
staff to perform shortages work across CDRH and contacting over 1,000 
manufacturing facilities in 12 countries in just a few weeks' time to 
get as much information as possible about critical devices. However, 
because the Agency lacked any explicit shortages authority at this 
time, only about one-third of facilities that were contacted responded 
even in part to CDRH requests because response was voluntary. This lack 
of explicit authority, staff and supply chain information significantly 
hampered our efforts to mitigate and prevent shortages at the outset of 
the pandemic.

    On March 27, 2020, the CARES Act was signed into law. The CARES Act 
gave FDA, for the first time, authority related to device shortages 
(see section 506J of the FD&C Act). The enactment of the CARES Act at 
the height of the initial pandemic response gave some authority to help 
prevent or mitigate medical device shortages during the public health 
emergency. Specifically, section 506J of the FD&C Act requires 
manufacturers to notify FDA of a permanent discontinuance in or 
interruptions in the manufacture of certain devices that are likely to 
lead to a meaningful disruption in supply of that device in the United 
States during, or in advance of, a public health emergency. Section 
506J also requires FDA to maintain a publicly available list of devices 
the Agency has determined to be in shortage, as well as devices that 
have been discontinued. The Agency is also directed to, as it deems 
appropriate, prioritize and expedite inspections and review of 
premarket submissions to help alleviate the supply chain constraint.

    Since receiving this new authority, during the pandemic response, 
FDA has among other actions:

          issued guidance on submitting notifications to FDA 
        during the COVID-19PHE and updated the guidance to provide 
        better assistance based on stakeholder feedback;

          published a list of device types it has determined to 
        be in shortage at this time, as well as a list of devices for 
        which we have been notified by manufacturers the device has 
        been permanently discontinued;

          created the infrastructure around receiving, 
        processing, and analyzing notifications to determine devices 
        that are in shortage and publicly post a list of the devices 
        that FDA has determined to be in shortage;

          worked with manufacturers to plan for an expedited 
        device premarket submission, which allows us to increase device 
        availability for products that are most needed.

    In addition to the implementation of the new device shortages 
authorities, FDA has conducted horizon scanning to assess demand for 
devices needed to respond to the pandemic, including PPE, ventilators, 
diagnostic supplies, infusion pumps, and non-contact infrared 
thermometers; and established a rapid response team, working with field 
personnel to address fraudulent imports. The Agency has likewise worked 
to prevent and mitigate shortages of testing supplies. For example, FDA 
collaborated with U.S. Cotton, one of the world's largest manufacturers 
of cotton swabs, to develop and produce a polyester-based Q-tip-type 
swab for testing. FDA also collaborated with laboratories and clinical 
investigators validating potential alternative sources of control 
materials, transport media, and swabs. As individual developers 
validated these alternative components, FDA requested their permission 
to share their findings publicly so that others could benefit, and we 
posted these alternatives on our website. In this way, FDA has been 
serving as a clearinghouse for scientific information that the entire 
community can leverage to mitigate shortages and increase testing 
capacity. FDA continues to post this information on a rolling basis on 
an FAQ website so that labs have access to the latest information 
regarding alternative controls, transport media, extraction, 
instruments, and swabs.

    FDA continues to work to implement and operationalize the new 
device shortage authority and utilizing one time funding from COVID 
supplementals, stand up a new state-of-the-art Resilient Supply chain 
and Shortages Prevention Program (RSCSPP). Medical device shortages not 
only put patients in harm's way but also jeopardize our health care 
workers on the front lines, during PHEs like the COVID-19 pandemic and 
every day in our health care system. Moreover, device shortages 
disproportionately affect at-risk populations and exacerbate health 
disparities. For these reasons, FDA continues to do all it can within 
its current authorities and resources to mitigate shortages and supply 
chain interruptions for COVID-19 and within the U.S. health care system 
generally.

    Congress has acknowledged the importance of FDA's work on shortages 
in our health care system and we want to continue working with this 
Committee and others to make sure FDA has the resources and authorities 
needed to ensure U.S. patients and health care providers have the 
medical products they need each day. To ensure the U.S. is properly 
prepared now, and in the future, we must take action to secure our 
medical device supply chain, including related materials, parts, and 
components. The FDA recognizes that this will take resources and 
expanded authority.
                               Conclusion
    FDA continues to advance its mission to protect and promote public 
health by helping to ensure the safety of human and animal food, and 
the safety and effectiveness of medical products. We take our public 
health mandate very seriously and will continue to work each day to 
help end this pandemic. We continue to communicate with the American 
public and make regulatory decisions based on data and sound science. I 
look forward to continuing to work with the Committee on these efforts 
and thank you again for the opportunity to testify today.
                                 ______
                                 
    The Chair. Thank you.

    Assistant Secretary O'Connell.

     STATEMENT OF DAWN O'CONNELL, ASSISTANT SECRETARY FOR 
 PREPAREDNESS AND RESPONSE, UNITED STATES DEPARTMENT OF HEALTH 
               AND HUMAN SERVICES, WASHINGTON, DC

    Ms. O'Connell. Chair Murray, Ranking Member Burr, and 
distinguished Members of the Committee, it is an honor to 
testify before you today on efforts within ASPR to respond to 
the pandemic since the emergence of the Omicron variant. When 
Omicron first emerged, as we have done with each new variant, 
we immediately evaluated its impact on our current vaccines, 
therapeutics, and diagnostics, and adjusted our response 
accordingly. Data suggests that our current vaccine doses with 
a boost confer protection against Omicron.

    As a result, we have continued distributing the three 
authorized and approved vaccines. Over 600 million doses of 
vaccine have been developed and delivered since the start of 
the pandemic. We have ample supply of both primary and booster 
doses, contributing to more than 200 million Americans now 
being fully vaccinated. However, we have had to make 
adjustments to our therapeutics supply in light of Omicron.

    Two of our workhorse monoclonal therapies, one from Lilly, 
the other from Regeneron, are not as effective against Omicron. 
As a result, we have increased our supply of GSK's monoclonal, 
which is effective. We continue to purchase all that we can 
from GSK, though this supply is still limited. We are on track 
to have 250,000 courses available this month. A force 
monoclonal by AstraZeneca is targeted for immunocompromised 
individuals at high risk and is taken prior to exposure to 
prevent infection.

    It has retained effectiveness against Omicron, and we will 
have made nearly half a million courses available through the 
end of this month. All four monoclonal that are currently 
available for States and jurisdictions to order free of charge 
on a weekly basis to treat either Omicron or Delta infections. 
Also, we now have antivirals by Pfizer and Merck that are 
effective against Omicron and are being delivered to States 
free of charge every other week. We have procured 3.1 million 
courses of Merck that are now available.

    Last week, we doubled our commitment to order 20 million 
courses of Pfizer's product. We have 265,000 courses available 
through this month and anticipate delivering the first 10 
million courses to States by mid-summer. We remain in frequent 
communication with States and territorial health officials on 
the distribution of therapeutic products and continue to focus 
on ensuring these lifesaving therapies are available to 
Americans across the country. The dramatic rise in cases due to 
Omicron has put a significant strain on our testing capacity. 
Despite significant effort and investment, there is more work 
to do, and we are working every day and night with 
manufacturers to increase the availability of tests.

    As soon as we saw the dramatic increase in cases in South 
Africa and Europe, we reached out to test manufacturers to 
understand their surge capacity and supply chain constraints. 
We are engaging daily with the lab test providers to mitigate 
any supply chain constraints with their sub-tier suppliers. We 
are also working with the commercial and public health labs to 
prioritize their needs.

    We continue to use the Defense Production Act's authorities 
when needed. To further increase test availability, we are 
procuring 500 million rapid tests to distribute to American 
households. As a requirement of this procurement, none of these 
tests can interfere with what is available in the current 
commercial market so as not to diminish what consumers are able 
to access now.

    We are currently shipping 2.8 million tests to long term 
care facilities per week, as we have throughout the pandemic. 
We continue to work to send 50 million rapid tests to federally 
qualified health centers and food banks, with 7 million having 
shipped so far. And we will keep working around the clock with 
manufacturers and our Government partners to increase and 
sustain the number of tests available now and in the future.

    Finally, in addition to vaccines, therapeutics, and 
testing, ASPR continues to provide on the ground support to 
States and communities in need. Since July 40, National 
Disaster Medical System teams, nearly 880 team members have 
deployed to 19 separate States and the Commonwealth of the 
Northern Mariana Islands to support a range of functions, 
including hospital augmentation and decompression, setting up 
medical overflow centers for patients, and mortuary support.

    We continue to send supplies as requested from the 
Strategic National Stockpile, including 300 ventilators to six 
jurisdictions since the emergence of our Omicron. We are 
grateful for the support from this Committee and Congress, and 
I look forward to answering your questions.

    [The prepared statement of Ms. O'Connell follows:]
                  prepared statement of dawn o'connell
    Chair Murray, Ranking Member Burr, and distinguished Members of the 
Committee, it is an honor to testify before you today on efforts within 
the U.S. Department of Health and Human Services (HHS) Office of the 
Assistant Secretary for Preparedness and Response (ASPR) to respond to 
the current pandemic, restore and strengthen our capabilities, and 
prepare for future health emergencies. I am grateful for this 
opportunity to address this Committee and appreciate your continued 
support.
               Update on ASPR's COVID-19 Response Effort
    As we enter the third year of the pandemic, we continue to apply a 
whole of government approach to protect Americans from COVID-19. At the 
direction of Secretary Becerra and in my role as ASPR, I am responsible 
for leading HHS' COVID-19 response coordination. In this role, I work 
closely with my fellow panelists on all facets of the Department's 
response, however, for the purposes of this testimony, I will focus my 
update on the work for which the ASPR organization is chiefly 
responsible.
        HHS Coordination Operations and Response Element (HCORE)
    The vaccines and therapeutics available to us today are the result 
of an unprecedented partnership between HHS and the Department of 
Defense, through the Countermeasures Acceleration Group (CAG), 
previously known as Operation Warp Speed. Together this team, has 
helped develop and deliver over 600 million doses of vaccine and 3.9 
million treatment courses to protect the American people from COVID-19.

    On December 31, 2021, our Memorandum of Understanding with DOD 
expired and on January 1, 2022, we successfully completed the planned 
transition of this work to the recently established HHS Coordination 
Operations and Response Element, or HCORE. HCORE institutionalizes the 
efforts previously led by the CAG within ASPR. It will allow us to 
build on the progress to date, retain expertise and skills, and 
continue providing the necessary tools to the American people to 
respond to the COVID-19 pandemic.

    Since my last appearance before the Committee, HCORE continues to 
lead, in partnership with CDC, the rollout and distribution of the 
Pfizer, Moderna, and Johnson & Johnson vaccines and boosters. While the 
data suggests that primary doses of vaccine confer reduced levels of 
protection against Omicron, we know that boosters strengthen protection 
significantly. These vaccines are being administered widely at 90,000 
locations around the country, and ample supply is available in the 
field to meet the needs for both booster and primary series 
vaccinations. Additionally, the introduction of vaccines for children 
ages 5 through 11 has resulted in over 6.7 million doses delivered for 
this population. Significant work with the state, Federal, territorial, 
and pharmacy partners continues to ensure that there is ample vaccine 
available at locations where young children are likely to receive their 
vaccines.

    In addition to vaccines HCORE continues to purchase and distribute 
to states and jurisdictions a wide variety of treatments including 
monoclonal antibodies and oral antivirals. In total, we have bought 
nearly 30 million treatment courses for patients with COVID-19.

    Some of these therapies may be less effective against Omicron, 
however. The new variant is predicted to have markedly reduced 
susceptibility to two of the monoclonal antibody treatments we have 
purchased (Lilly's bamlanivimab/etesevimab and Regeneron's REGEN-COV). 
However, two of the monoclonal antibody treatments we have procured are 
expected to retain activity against Omicron--GSK's Sotrovimab and 
AstraZeneca's EVUSHELD. We are increasing our supply of the GSK 
monoclonal to 1 million courses over the next few months and are on 
track to have more than 250,000 courses available in January. 
AstraZeneca's monoclonal is a pre-exposure therapy which is targeted 
for immunocompromised individuals at high risk. We will have more than 
half a million courses on hand in January.

    In addition to these monoclonal antibody treatments, the newly 
authorized oral antiviral pills developed by Merck and Pfizer are 
expected to retain activity against Omicron and HCORE is distributing 
doses to all states and jurisdictions. More than 360,000 courses were 
delivered to dispensing sites in December--with a total of about 3 
million courses of the Merck antiviral and more than 265,000 of the 
Pfizer antiviral on the way in January. The Administration recently 
announced plans to double the Pfizer antiviral order from 10 million to 
20 million treatment courses.
         Biomedical Advanced Research and Development Authority
    The Biomedical Advanced Research and Development Authority (BARDA) 
continues to leverage the supplemental appropriations provided by 
Congress to support the development of vaccines, therapeutics, and 
diagnostics to end the COVID-19 pandemic. BARDA has awarded contracts 
for 78 medical countermeasure projects to aid the COVID-19 response to 
date. All of these contract awards are listed on 
medicalcountermeasures.gov in detail and include 16 therapeutics, 55 
diagnostics, and seven vaccine candidates. Notably, BARDA has placed 
1.5 billion doses of vaccine under contract (including a combination of 
adult primary, booster, and pediatric doses), distributed over 3.3 
million doses of monoclonal antibodies, and shipped more than 182 
million diagnostic kits.

    BARDA also supports research on expanding eligibility for the 
current authorized and approved vaccines as well as the continued 
development of vaccine candidates that have not yet been authorized or 
approved. This ongoing work on vaccines is critical as we begin to look 
for next generation vaccines that are easier to store, ship, administer 
and may prove more durable than the current authorized and approved 
vaccines.

    BARDA's work on therapeutics is critical as we seek to balance the 
ease of administration with the benefits of the treatment. For example, 
many of the available monoclonal antibodies are administered by 
infusion which must be done in clinical settings. BARDA's collaboration 
with industry on developing oral antivirals offer an important 
alternative to monoclonal antibodies. As a result, there are now two 
antivirals available under EUA for the prehospital treatment of 
patients at high risk for progression to severe COVID-19.

    BARDA continues to play an important role in the development of 
diagnostic tests that expand beyond central labs to point of care and 
at home solutions. This includes contracts for three molecular and two 
antigen point of care and home use tests and for two molecular and five 
antigen point of care only tests. In addition, BARDA has funded six 
manufacturing capacity expansion efforts to increase domestic testing 
capacity.
         Strategic National Stockpile and Medical Supply Chain
    The pandemic has severely strained our public health and medical 
supply chains. As this Committee is well aware, the medical supply 
chain ecosystem is complex, with different private sector players and 
market dynamics across multiple domains of medical equipment and 
supplies. Many vital products and their raw materials are primarily 
made overseas, and practices like ``just in time'' inventory management 
resulted in difficulty accelerating manufacturing when demand surged 
last spring. This created significant and devastating challenges for 
States and healthcare systems that required access to these key 
supplies.

    Over the course of the COVID-19 response, the SNS has worked to 
backstop States' medical supply needs at an accelerated pace. Since the 
beginning of the pandemic, the SNS has deployed more than 250 million 
items to aid the national response including Personal Protective 
Equipment (PPE), ventilators, Federal Medical Stations, and 
pharmaceuticals. In particular, the SNS deployed almost 3,000 
ventilators to 17 jurisdictions between July and October 2021, to 
respond to the Delta variant case surge. The SNS has deployed more than 
300 ventilators and High Flow Nasal Cannula to six jurisdictions since 
Omicron emerged.

    I highlighted in my testimony in July that ASPR continues to work 
to replenish SNS inventory to levels at or above pre-COVID-19 amounts 
to ensure we are prepared for any subsequent wave of additional cases 
and to do so to the extent possible with domestically manufactured 
supplies and equipment. As of December 29, 2021, the SNS has utilized 
approximately $12 billion from COVID-19 supplemental appropriations 
provided by Congress to have in its inventory approximately: 747 
million N95 respirators (59 times pre-pandemic levels); 274 million 
surgical and procedure face masks (8.5 times pre-pandemic levels); 19.6 
million face shields (two times pre-pandemic levels); 59.6 million 
gowns and coveralls (12.5 times pre-pandemic levels); 4 billion gloves 
(240 times pre-pandemic levels); and 158,000 ventilators (10 times pre-
pandemic levels). SNS has also made investments to ensure there is 
capacity to make these critical supplies.

    In addition, to better identify and understand baseline issues 
during the COVID-19 response and improve future response operations, we 
supported three meetings with Tribal representatives to determine if 
changes or updates are needed regarding how federally recognized Tribal 
governments request SNS support. These listening sessions were in 
collaboration with the Indian Health Service (IHS), the Centers for 
Disease Control and Prevention (CDC)/Division of State and Local 
Readiness, and the HHS/Office of Intergovernmental and External Affairs 
(IEA). The SNS team continues to engage other key state and local 
leaders and organizations as it seeks input on how to improve access to 
the stockpile.

    While replenishing the SNS is essential, it is also critical to 
address the root cause of why supply chains were so strained in the 
first place. ASPR is taking on this work as well since ensuring a safe 
and consistent public health supply chain for medical materials, 
ingredients, and supplies is critical for any national response to 
public health emergencies.

    Throughout the COVID-19 response, ASPR has leveraged the 
authorities delegated to the Secretary under the Defense Production Act 
(DPA) to issue 66 priority ratings for U.S. Government (USG) contracts 
for health resources, eight priority ratings for USG contracts for 
industrial expansion, three priority ratings for non-USG contracts to 
support the production of resins for both diagnostics and infusion 
pumps, and the manufacture of closed suction catheters for treatment of 
patients with COVID-19--all to ensure private sector partners making 
life-saving products are able to acquire the raw materials, components, 
and products requisite to deliver for the response.

    Also under the DPA, ASPR is strengthening the industrial base to 
secure and develop domestic capacity, retool and expand industry 
machinery, scale production facilities, train workforces, and 
ultimately infuse the supply chain and marketplace with products the 
U.S. needs to contain further pandemic waves. ASPR continues to invest 
in critical funding in expanding domestic manufacturing including 
investments in manufacturing PPE, testing consumables, vaccine raw 
material, vaccine vials, at home and point of care tests, and testing 
raw materials. Each of these domestic manufacturing initiatives meets 
current, as well as future COVID-19 needs, and seeks to create or 
sustain high-value domestic jobs.

    All of these investments, and the industrial base overall, require 
dedicated and persistent management and engagement. As such, my intent 
is to institutionalize this mission in ASPR. I am working to integrate 
and organize supply chain situational awareness and industrial 
analysis, domestic industrial base expansion, and supply chain 
logistics into a new office within ASPR. Bringing these pieces together 
will strengthen our industry partnerships and support our work to 
establish and maintain resilient supply chains. I ask for your support 
as we work to address this effort and would be happy to provide future 
briefings on this effort as needed.

    As you are likely aware, several groups outside of ASPR are 
reviewing the SNS as well as other Federal stockpiles. Specifically, 
the HHS Inspector General (IG) is completing a 3-year SNS review. The 
IG began the review when the SNS transitioned from CDC to ASPR in 2018 
but shifted the review slightly in 2020 with the onset of the COVID-19 
pandemic to review holdings, requirements, and available resources to 
meet needs.

    In addition, the National Academies (NAS) has reviewed at our 
request the Public Health Emergency Medical Countermeasures Enterprise 
(PHEMCE), the interagency group of experts that advise, among other 
things, what should go into the SNS. The full report is available via 
the NAS website: https://www.nap.edu/read/26373/chapter/1. We are 
reviewing the findings in the National Academies report to determine 
how to strengthen both the PHEMCE and the SNS. Restoring and rebuilding 
the SNS is one of my priorities and I look forward to reviewing both of 
these reports and incorporating their findings or recommendations into 
the strategic work we are undertaking to rebuild and restore the 
stockpile and realign it with the PHEMCE. I would be happy to discuss 
both of these reports with this Committee once both are released and 
made public. As chair of the PHEMCE, I plan to incorporate lessons 
learned from the COVID-19 response into future PHEMCE planning. I'm 
pleased to report that we will relaunch the PHEMCE next month.
                     Healthcare System Preparedness
    Next, I want to share more about ASPR's work to prepare our 
healthcare system to surge to meet the demands of those being treated 
for COVID-19, without compromising day-to-day healthcare needs.

    Through ASPR's Hospital Preparedness Program (HPP), ASPR has 
invested $350 million from supplemental appropriations in the National 
Special Pathogen System (NSPS). These investments span the 62 HPP 
funding recipients, their associated 55 Special Pathogen Treatment 
Center sub-recipients, 10 Regional Ebola and Special Pathogen Treatment 
Centers (RESPTC) recipients, the National Ebola Training and Education 
Center (NETEC) (a consortium of three academic medical centers), and 53 
hospital associations, while leveraging and amplifying technical 
guidance from the CDC. These components work together to provide a 
coordinated, national approach to preparing healthcare systems to surge 
for public health and medical emergencies.

    We also continue to support our Regional Disaster Health Response 
System (RDHRS) demonstrationsites. The goal of the RDHRS is to link 
together existing health systems to address health care preparedness 
challenges, establish best practices, expand access to specialty 
clinical care, and increase medical surge capacity at the regional 
level. As I mentioned in my November 2021 statement, a fourth RDHRS 
demonstrationsite was established at Emory University. With this award, 
we now have demonstrationsites based at Massachusetts General Hospital, 
Nebraska Medical Center, and Denver Health and Hospital Authority. The 
ultimate goal of this system is to support a more coordinated, 
comprehensive, and capable health care disaster response system able to 
respond to health security threats.

    As part of our COVID-19 pandemic response, the National Special 
Pathogen System coordinated national expertise, regional capabilities, 
and state and local healthcare capacities across the public and private 
sectors to support an effective pandemic response. Looking ahead, I 
look forward to examining ways to strengthen investments like these in 
preparedness to ensure the healthcare system is ready to surge for 
future public health and medical incidents.

    Further, if a public health or healthcare system becomes 
overwhelmed with patients, States can request National Disaster Medical 
System (NDMS) personnel to provide additional support. Since July 2021, 
forty National Disaster Medical System teams nearly 880 team members 
were deployed to support sites in 19 separate states and the 
Commonwealth of the Northern Mariana Islands (CNMI). There is currently 
an NDMS team in New York and Missouri. For these deployments, NDMS 
personnel support a range of functions including hospital augmentation 
and decompression, setting up medical overflow centers for patients, 
and mortuary support. As we learn more about Omicron, and if additional 
needs are identified, we will continue to make resources available to 
states and communities to respond.

    Of note, this critical system requires a renewal of its direct 
hiring authority, which was set to expire on September 30, but was 
extended as part of the continuing resolution. NDMS has utilized this 
authority to bring on additional personnel over 1,000 personnel hired 
to date and will continue to utilize the expedited authority, if 
extended by Congress, to continue to enhance the force.
                                Testing
    In addition to the Industrial Base Expansion efforts I mentioned 
previously, ASPR continues to support COVID-19 testing for the Nation. 
The HHS Testing and Diagnostics Working Group (TDWG) mission was 
established early in the pandemic to increase testing capacity through 
interagency coordination and partnerships with industry and state, 
tribal, local, and territorial public health agencies. TDWG was created 
as part of the Federal response to COVID-19 in March 2020, residing 
with Operation Warp Speed temporarily, and then established under the 
Office of the Assistant Secretary of Health (OASH) leadership and was 
located in the Joint Coordination Cell (JCC) run by the U.S. Coast 
Guard. In March 2021, when the JCC was officially stood down, TDWG's 
administrative and contracting support were moved to ASPR.

    While there is more work to do to increase the supply of rapid 
tests, we have significantly increased our country's testing capacity 
over the past several months. In fall 2021, ASPR invested $3 billion to 
accelerate the production of rapid tests and expand capacity. As a 
result, we have quadrupled the number of rapid at home-tests available 
since we made those investments in September. To further increase 
testing supply, ASPR, is leading the Administration's procurement of 
500 million Over-the-Counter (OTC) tests, an investment of over $3 
billion, with plans for initial tests to be available this month. ASPR 
has also shipped over 40 million rapid antigen tests and 2.3 million 
point-of-care PCR tests to our most vulnerable populations, including 
nursing homes, federally qualified health centers, and long-term care 
facilities since May 2021. In addition to the purchase and distribution 
of these tests, ASPR continues to work with manufacturers, companies, 
and laboratories to identify and proactively address any supply issues.
                               Conclusion
    Thank you again for inviting me to testify before you on efforts 
within ASPR to support the COVID-19 response. I look forward to 
answering your questions and working with my team at ASPR and our 
colleagues across HHS to end the COVID-19 pandemic.
                                 ______
                                 
    The Chair. Thank you to all of our witnesses. We will now 
begin a round of 5 minute questions of our witnesses, and I 
again ask my colleagues to keep track of your clock and stay 
within those 5 minutes. As the Omicron variant of COVID-19 
continues to spread at an alarming rate, people are looking for 
clear, straightforward guidance on how to protect themselves 
and those around them.

    It is really critical that we reduce the infection rates so 
we can relieve pressure on our health care workers, protect 
people with disabilities and older Americans, young kids and 
anyone else who has been disproportionately impacted by COVID-
19.

    However, I have heard from so many people who find the 
latest CDC isolation and quarantine guidance confusing and hard 
to interpret. So, Dr. Walensky, can you please clearly explain 
CDC's latest guidance on what people need to do to protect 
themselves and others if they are exposed to or contract COVID-
19? And let me start with vaccinated people. What is your 
guidance to them?

    Dr. Walensky. Thank you, Chair Murray, for the opportunity 
to clarify. Maybe if I could just rewind the clock to just 
before the holidays, where we were hearing from hospitals that 
they were--their staff were going out and that they were in a 
real crunch in terms of beds. They had plenty of beds, but they 
didn't have staff to staff them.

    ICU beds were starting to close. So immediately we worked 
toward our updated health care worker guidance, but when we did 
so, we recognized that we were going to have challenges and 
that this Omicron surge that we were about to face was 
threatening many other places of our health care----

    The Chair. I appreciate the background, but I just want to 
know straight forward if someone is exposed to or has COVID-19 
and they are vaccinated, what do they do?

    Dr. Walensky. If they are exposed to COVID-19 and they are 
completely boosted, they should--they do not need to stay home, 
but they should get a test at day five. If they have COVID, our 
guidance is--does not distinguish between your vaccination 
status, and our science has demonstrated that you are maximally 
infectious 2 days before and two to 3 days after.

    By 5 days after your symptoms, if you are feeling better, 
if your fever is better, if you are cough and sore throat are 
better, then on day six you can go out, but you have to wear a 
mask, you have to wear a mask reliably and you should not go to 
places you can't wear a mask. You probably shouldn't go and 
visit Grandma. You shouldn't get on an airplane.

    The Chair. For vaccinated. What about unvaccinated?

    Dr. Walensky. Same for unvaccinated for isolation. So 
isolation being those who have had disease--who have disease.

    The Chair. Well, let me just say, nearly 2 years ago, when 
this Committee first started having Congressional hearings on 
COVID-19, the very first thing I asked was where are the tests? 
And we have made progress since then, and we are now producing 
300 million rapid at home tests each month, along with ramping 
up our lab based testing.

    But I am disappointed, as I said, by the testing challenges 
that we are facing. Tests are hard to find. They are costly. 
People are unable to find the at-home tests in pharmacies, 
online. They are waiting in long lines, and often after that, 
waiting days for results. So it is ineffective at the end of 
the day.

    Ms. O'Connell, I want to ask you, what are you doing to 
address the frustrations and challenges we are hearing about 
COVID testing?

    Ms. O'Connell. Chair Murray, thank you so much for this 
very important question. Testing remains a critical priority 
for this Administration. When we saw the unprecedented cases of 
Omicron sweep into South Africa and Europe, we immediately 
reached out to our manufacturers to understand any supply 
constraints they had and to evaluate their surge capacity.

    We have also met daily with them to make sure that they 
have what they need from their suppliers and have used the 
Defense Production Act authorities 12 times throughout this 
pandemic in support of testing needs. Most recently in the last 
few weeks for two tests, we were able to unlock supplies and 
manufacturing capacity. We continue to invest in rapid, over-
the-counter tests, which are in high demand.

    In the fall we invested $3 billion to increase 
manufacturing line staffing and to commit to those 
manufacturing lines for 13 months. As a result, we went from 
50--46 million tests, over the counter tests available in 
October, to the 300 million, Chair Murray, that you just 
mentioned that are available now. But that is not enough. We 
are continuing to bring tests to the American people.

    As a result, the President has announced, and we are in the 
process of procuring the 500 million tests, which every 
American household will be able to order and have shipped 
directly to their house. We have completed four contracts so 
far, have secured 50 million tests, and are in the process of 
securing the additional tests over the next several days.

    The U.S. Postal Service has agreed to do the distribution, 
and the U.S. Digital Services is going to help with the 
website. We anticipate the first tests going out at the end of 
this month, with the remaining tests going out over the next 60 
days.

    The Chair. Okay, I am out of time, but I do want to just 
say this, I am hearing from so many schools that are having 
trouble staying open. They want to stay open. Part of it is 
they have staff that are sick. That is understandable. But a 
big part of it is they don't have access to the safety measures 
like masks and testing supplies. What do I tell them about 
where they go to get that?

    Ms. O'Connell. Chair Murray, thank you. Having--schools 
having enough supply, testing supplies to stay open as a 
critical priority for us. We have invested $10 billion of the 
American Rescue Plan given to States to support and stand up 
testing programs. We have also invested $60--$650 million in a 
program called Operation Expanded Testing, which set up 
regional hubs of labs that schools could contract with to run 
their testing programs.

    But that doesn't work if there aren't tests available, so 
ASPR is working directly with States to match additional 
manufacturing capacity with States that need it. Not only that, 
we are in the process within ASPR of looking at our contracts 
to see if we have any additional capacity, and we will commit 
to sending that capacity to the school programs.

    The Chair. Senator Burr.

    Senator Burr. Thank you, Madam Chairman. Let me just cut to 
the chase. Dr. Fauci, you said CDC was going to update its 
guidance and include antigen testing or suggested that it 
would. Dr. Walensky and CDC came out with the guidance that 
didn't include it. Was that part of the communications plan to 
start with and they diverted it, or was that something you just 
chose to inject?

    Dr. Fauci. Thank you for that question, Senator Burr. In 
discussions about the real gray zone, which Dr. Walensky 
described about after the 5-days where you have a considerable 
diminution in the likelihood of being transmitting, we had been 
in discussions about what the role of antigen testing would be.

    As a matter of fact, when Dr. Walensky came out with the 
final guidelines, they include that if you have a test 
available, you may take a test. So at the end of the day, we 
were quite in concordance with our views.

    Senator Burr. Well, I think the Chair and I share this, we 
found it very confusing, and I think the American people found 
it confusing, and I don't see it lightly when I say not too 
many people in America listening to what comes out of 
Washington, whether it is Congress or out of the Administration 
as it relates to COVID.

    The President makes an announcement, Ms. McConnell, of 500 
million at home test. Is this the first time that you have 
thought about purchasing at home test or have you tried to 
before and it was rejected?

    Ms. O'Connell. Thank you, Ranking Member Burr. This is the 
first time the Administration has committed to purchasing tests 
to send to the American households.

    Senator Burr. So is that ASPR or is that DOD? Because of 
all the notifications of contracts signed, I have seen them 
from DOD. I haven't seen them from HHS.

    Ms. O'Connell. Thank you for that question, Ranking Member 
Burr. We use--we have a relationship with DOD for assisted 
acquisitions, so ASPR will request that DOD put out a 
solicitation or manage a contract on our behalf.

    They are able to do it extraordinarily quickly. And we have 
had an MOU in place with DOD for this work that will run 
through June 2023. We have used this relationship to purchase 
vaccines and therapeutics, and we are now using it for testing.

    Senator Burr. So the best I can find, you mentioned 50 
million doses having been contracted. I can identify 27 million 
out of two companies, Medea and Atlantic Trading. Neither one 
of them are manufacturers of test, and I believe the third one, 
Revival, is not a manufacturer of test.

    Medea actually came to fame with the importation of vodka 
and tying cell phones to vodka. And like a lot of other 
companies, they got the PPE business in 2020 with some nominal 
FEMA contracts. Why should we have any confidence in these 
contracts if in fact we are dealing with companies that don't 
manufacture anything? And can you assure me that the tests that 
are coming in are not coming from China?

    Ms. O'Connell. Thank you, Ranking Member Burr. Absolutely, 
these tests--what we initially did to be able to access tests 
for the initial shipments that will go toward the end of 
January, we worked with warehouses to see where additional 
tests were stored and assessed that additional capacity and are 
bringing that capacity to bear for these initial tests that are 
going out, which is why you are seeing contracts with 
warehouses and not with test manufacturers.

    Senator Burr. So is what you are telling me, they have got 
50 million tests in warehouses in the United States, and all we 
did was access that inventory?

    Ms. O'Connell. That is my understanding.

    Senator Burr. Well, will you confirm your understanding? 
This is a very, very important piece, when you have got 
companies that don't manufacture tests and all of a sudden we 
are giving them $190 million contract for about 14 million home 
tests and their expertise is importation of vodka.

    I encourage you to look through the list of people that we 
are signing up with. Are you aware that some of the larger test 
manufacturers in 2021 shut down lines because of the lack of 
purchases for at home test?

    Ms. O'Connell. One of the things we did in the fall was a 
$3 billion investment that we made was to turn lines on and to 
commit to those lines for 13 months so they wouldn't be turned 
off again.

    Senator Burr. Dr. Woodcock, let me just--last question, 
Chair. Of the 15 tests that you have currently approved for 
over the counter, how many detect Omicron?

    Dr. Woodcock. We are still working on that, but we believe 
all of them detect Omicron. We simply feel they are somewhat 
less sensitive than they were to some of the previous variants.

    Senator Burr. Of the 50 million tests that the ASPR has 
contracted for, how many of those tests detect Omicron?

    Dr. Woodcock. I don't know which tests they are. We can get 
back to you on that.

    Senator Burr. So you haven't consulted with what we are 
purchasing on the $500 million, and they haven't consulted with 
FDA to figure out whether the tests they are buying actually 
detect Omicron.

    Dr. Woodcock. I believe they have. I simply don't have that 
list.

    Senator Burr. Okay. I think thank the Chair.

    The Chair. Senator Kaine.

    Senator Kaine. Thank you. Thank you, Chair Murray and to 
the witnesses. Dr Fauci, can you provide us a general breakdown 
of what percentage of hospitalized individuals are vaccinated 
versus unvaccinated, and what percentage of COVID deaths are 
among vaccinated or unvaccinated individuals?

    Dr. Fauci. Thank you for that question, Senator Kaine. One 
of the ways to answer that question would be to look at people 
who are in the hospital and take a look at if you are 
vaccinated versus unvaccinated.

    If you look at vaccinated versus unvaccinated, there is 
about a 10 times greater chance that you be infected if you 
were unvaccinated, about a 17 times greater chance that you 
would be hospitalized if you were unvaccinated, and about a 20 
times likelihood that you would be--that you would be dead if 
you were unvaccinated.

    When you look at every parameter, 10 times, 17 times, 20 
times infection, hospitalization, death.

    Senator Kaine. Thank you, Dr. Fauci. Ms. O'Connell, I want 
to ask you a question about vaccine--additional vaccine 
development. The current vaccines against COVID, as was 
indicated by Dr. Fauci's answer, have been very successful in 
reducing deaths, severity of illnesses, and hospital 
admissions.

    However, they have had more limited success in preventing 
forward transmission from vaccinated individuals after 
breakthrough cases, and the existing vaccines are not as 
durable as vaccines in other areas, so we need booster shots to 
continue to protect against the virus.

    Is the Administration considering supporting the 
development of additional vaccines that might be able to 
address the gaps in the current vaccines' capabilities?

    Ms. O'Connell. Senator Kaine, thank you so much for that 
question. Yes, absolutely. I think we all see the need for next 
generation vaccines. We are also looking for next generation 
antivirals and therapeutics as well.

    We are in the process of working with Dr. Fauci's team to 
develop a unified NIH, BARDA research agenda and budget to 
address these issues, to identify candidates that might already 
be in the pipeline, to help support the research into 
candidates that are just starting in the pipeline, just so we 
can accelerate the availability of the next generation vaccines 
and therapeutics.

    Senator Kaine. Thank you for that answer. Dr. Walensky, I 
would like to ask you a question about access to testing, and 
in particular, what is the CDC doing to make sure that testing 
capacity is robust in rural America and also among community 
health centers in disadvantaged parts of the country?

    Dr. Walensky. Thank you, Senator Kaine. So we have this 
program, increased community access to testing, in 
collaboration with ASPR as well. This is a program that has 
collaborated with FEMA to increase surge testing just over the 
holidays.

    We have increased testing, Federal testing sites for PCR, 
12 Federal testing sites doing thousands of tests over the 
holiday. We also work with pharmacies in collaboration with 
pharmacies, and in that stead, we are able to map where the 
pharmacies are and their social vulnerability index, and we can 
actually put PCR tests in areas of High Social Vulnerability 
Index through all of our pharmacy partners, CVS, Walgreens, 
Rite Aid, and whatnot.

    Then we actually put tests in our community centers as 
well. So really a broad stretch in order to be able to get 
access to testing, especially among those most vulnerable. And 
then, of course, as ASPR O'Connell mentioned, $10 billion for 
testing supplies to our schools and working closely with our 
schools in peer to peer support, in technical support, to allow 
those tests to be used well in those school settings. Thank 
you.

    Senator Kaine. Thank you for that answer. And Dr. Fauci, 
one more question for you. I ask a version of this question 
every time we have this panel before us. What is the NIH doing 
right now, or what is the current status of NIH research to 
better understand long COVID, to look at symptoms and potential 
treatments?

    Dr. Fauci. There are several levels of activity going on. 
Some news since we spoke last. I had mentioned to you, Senator, 
that in fact, there was a $1.15 billion program for studying 
long COVID that is now developing cohorts to look at various 
incidences, prevalence, pathogenesis, and potential 
interventions.

    There have been a number of awards that have been given. 
Most recently in September, there was an additional $470 
million funding supported through the American Rescue Plan, 
engaging about 100 researchers from 30 institutions to get 
individuals together.

    One of the things that is really interesting that we are 
seeing right now is that when you look at individuals who have 
these symptoms that go on, as you know and have experienced 
yourself, for a considerable period of time, a recent study 
that is in the preprint stage, so it hasn't been peer reviewed, 
has some very interesting information that needs to be 
validated and verified.

    It was an autopsy study in people who had varying levels of 
COVID, from relatively mildly symptomatic to moderately 
symptomatic individuals who actually died, and when they looked 
at the spread of what was not necessarily replication competent 
virus, but was PCRable virus, which means you could have 
nucleotides that were there, there was, it seems to be a 
persistence in multiple organ systems, indicating that even if 
you clear the virus, one of the possibilities.

    I have to emphasize possibility because it needs to be 
validated, is that you don't completely clear the fragments of 
the virus and you have continual stimulation, not that you are 
infectious or that you are going to infect anybody else, but 
that it is still generating perhaps an aberrant response in 
your immune system.

    I underscore again, it is preliminary, it is in the pre-
print stage, and it needs to be peer reviewed, but that is some 
of the information we are starting to gather.

    Senator Kaine. Thank you very much for that answer. Thank 
you, Chair Murray.

    The Chair. Senator Paul.

    Senator Paul. Dr. Fauci, the idea that a Government 
official like yourself would claim unilaterally to represent 
science, that any criticism of you would be considered a 
criticism of science itself is quite dangerous. Central 
planning, whether it be of the economy or of science, is risky 
because of the fallibility of the planner.

    It would not be so catastrophic if the planner were simply 
one physician in Peoria. Then, the mistakes would only affect 
that physicians' patients, the people who chose that physician. 
But when the planner is a Government official like yourself who 
rules by mandate, the errors are compounded and become much 
more harmful.

    A planner who believes he is the science leads to an 
arrogance that justifies in his mind using Government resources 
to smear and to destroy the reputations of other scientists who 
disagree with him. In an email exchanged with Dr. Collins, you 
conspired, and I quote here directly from the email, ``to 
create a quick and devastating published takedown of three 
prominent epidemiologist from Harvard, Oxford and Stanford.''

    Apparently, there is a lot of fringe epidemiologists at 
Harvard, Oxford, and Stanford. And you quote in the email that 
they, or from Dr. Collins and you agree, that they are fringe. 
And immediately there is this takedown effort. A published 
takedown, though doesn't exactly conjure up the image of a 
dispassionate scientist.

    Instead of engaging them on the merits, you and Dr. Collins 
sought to smear them as fringe and take them down, and not in 
journals, in lay press. This is not only antithetical to the 
scientific method, it is the epitome of cheap politics, and it 
is reprehensible, Dr. Fauci. Do you really think it is 
appropriate to use your $420,000 salary to attack scientists 
that disagree with you?

    Dr. Fauci. The email you are referring to was an email of 
Dr. Collins to me. If you look at the email----

    Senator Paul. That you responded to and hurried up and 
said, I can do it, I can do it, we got something in wire----

    Dr. Fauci. No, no, I think in usual fashion, Senator, you 
are distorting everything about me.

    Senator Paul. Did you ever object to Dr. Collins's 
characterization of them as fringe? Did you write back to Dr. 
Collins, no, they are not fringe, they are esteemed scientists, 
and it would be beneath me to do that?

    Dr. Fauci. I did not----

    Senator Paul. You responded to him that you would do it, 
and you immediately got an article and sent it back to him, and 
said, hey, look, I got him, I nailed him in Wired of all 
scientific publications.

    Dr. Fauci. That is not what went on. There you go again. 
You just do the same thing every hearing.

    Senator Paul. That was your response--that was your 
response? And this wasn't the only time. So your desire to take 
down people----

    Dr. Fauci [continuing]. you are incorrect--as usual, 
Senator, you are incorrect with almost everything said----

    Senator Paul. Well, no, you deny, you deny, but the emails 
tell the truth of this.

    Dr. Fauci. No.

    Senator Paul. This wasn't the only time your desire to take 
down those who disagree with you didn't stop with Harvard, 
Oxford, and Stanford. You conspired with Peter Daszak, who you 
communicated with privately, and other members of the 
scientific community that wrote opinion pieces for Nature.

    Five of them signed a paper for Nature, an opinion piece. 
17 signed a paper that called it conspiracy theory, the idea 
that the virus could have originated in the lab. Do you think 
words like conspiracy theory should be in a scientific paper?

    Dr. Fauci. Senator, I never used that word when I was 
referring to it. You are distorting virtually everything----

    Senator Paul. Did you communicate with the five scientists 
who wrote the opinion piece in Nature, where they were 
describing, oh, there is no way this could come from the lab?

    Dr. Fauci. That was not me----

    Senator Paul. Did you talk with any of those scientists--?

    Dr. Fauci. See, but you keep distorting the truth. It is 
stunning how you do that----

    Senator Paul. Did you--talk to any of the scientists 
privately who wrote the opinion----

    Dr. Fauci. Yes.

    Senator Paul. You did. What were they telling you 
privately?

    Dr. Fauci. Well, let me explain. You know, you are going 
back to that original discussion when I brought together a 
group of people to look at every possibility with an open mind. 
So not only are you distorting it, you are completely turning 
it around as much as you usually do.

    Senator Paul. Well, most of the scientists who came to you 
privately, did they come to you privately and say no way this 
came from the lab or was their initial impression, Dr. Gary and 
others that were involved, was their initial impression 
actually that it looked very suspicious for a virus that came 
from lab.

    Dr. Fauci. You know, Senator, we are here at a Committee to 
look at a virus now that has killed almost 900,000 people. And 
the purpose of the Committee was to try and get things out, how 
we can help to get the American public. And you keep coming 
back to personal attacks on me that have absolutely no 
relevance to reality.

    Senator Paul. Do you think anybody has had more influence 
on our response to this than you have?

    Dr. Fauci. Madam Chair, can I----

    Senator Paul. Do you think it is a great success what has 
happened so far? Do you think the lockdowns were good for our 
kids? Do you think we slowed down the death rate?

    More people have died now under President Biden than did 
under President Trump. You are the one responsible. You are the 
architect. You are the lead architect for the response from the 
Government, and now 800,000 people have died.

    Dr. Fauci. Right.

    Senator Paul. Do you think it is a winning success what you 
have advocated for Government?

    Dr. Fauci. Senator, first of all, if you look at everything 
that I said, you accuse me of in a monolithic way telling 
people what they need to do. Everything that I said has been in 
support of the CDC guidelines, wear a mask, get boosted, get 
vaccinated----

    Senator Paul. You have advocated to make it coercive and 
done through force----

    Dr. Fauci. Take everything that I have said----

    Senator Paul. You have advocated it be done by mandate. You 
have advocated that you are infallible opinion be dictated by 
law.

    Dr. Fauci. Right. So again, Madam Chair, I would like just 
a couple of minutes because this happens all the time. You 
personally attack me and with absolutely not a shred of 
evidence of anything you say. So I would like to make something 
clear to the Committee. He is doing this for political reasons. 
What you need to do is--he said in front of this Committee----

    Senator Paul. Do you think your takedown of three prominent 
epidemiologists was not political?

    Dr. Fauci. You don't want me to finish----

    Senator Paul. That was my question.

    Dr. Fauci [continuing]. because you know what I am going to 
say.

    Senator Paul. That was the question.

    The Chair. Senator----

    Senator Paul [continuing]. were you political in taking 
down these three prominent epidemiologists?

    The Chair. Senator Paul, if you would, please, I am going 
to allow this--Dr. Fauci to respond. We have a number of 
Senators who would like to ask questions, and I would like him 
to be able to respond. Please do so.

    Dr. Fauci. The last time we had a Committee or the time 
before, he was accusing me of being responsible for the death 
of 5, 4 to 5 million people, which is really irresponsible, and 
I say, why is he doing that? There are two reasons why that is 
really bad. The first is it distracts from what we are all 
trying to do here today, is get our arms around the epidemic 
and the pandemic that we are dealing with, not something 
imaginary.

    No. 2, what happens when he gets out and accuses me of 
things that are completely untrue is that all of a sudden that 
kindles the crazies out there and I have life--threats upon my 
life, harassment of my family and my children with obscene 
phone calls because people are lying about me.

    Now, I guess you could say, well, that is the way it goes. 
I can take the hit. Well, it makes a difference because as some 
of you may know, just about three or 4 weeks ago, on December 
21st, a person was arrested who was on their way from 
Sacramento to Washington, DC. at a speed stop in Iowa, and they 
asked, the police to ask him where he was going and he was 
going to Washington, DC to kill Dr. Fauci, and they found in 
his car an AR-15 and multiple magazines of ammunition because 
he thinks that maybe I am killing people.

    I ask myself, why would the Senator want to do this? So go 
to Rand Paul website and you see fire Dr. Fauci with a little 
box that says, contribute here you, can do $5, $10, $20, $100. 
So you are making a catastrophic epidemic for your political 
gain. So the only thing----

    Senator Paul. You have politically attacked your 
colleagues, and in a politically reprehensible way, you have 
attacked their reputations. You won't defend it. No, going to 
argue it. You will just simply turn around the attack.

    The Chair. We are going to continue this hearing. We have a 
number of questions.

    Dr. Fauci. Just one more minute, if I----

    The Chair. Dr. Fauci, I really appreciate your response, 
but we do have a number of questions from Senators, and we do 
have a second round and I am being asked to make sure that 
everybody has their time, so thank you.

    Dr. Fauci. Thank you very much for allowing me, Madam 
Chair.

    The Chair. We will move to Senator Murphy.

    Senator Murphy. Thank you, Madam Chair. Dr. Fauci, thank 
you. Thank you, first of all, for what you do. You shouldn't 
have to put your life at risk. You shouldn't have put your 
family's life at risk to simply stand up and do your job to try 
to protect my constituents from a pandemic disease. And thank 
you for calling out this agenda for what it is, an attempt to 
score political points, to build a political power base around 
the denial of science and around personal attacks on you and 
your family.

    On social media I follow many of President Trump's advisers 
and family members and they make us sport out of attacking you 
personally in some of the most vicious, hateful, ugly ways that 
are possible. They do it because it gets clicks. They don't do 
it because they are legitimately engaged in a honest debate 
about the science revolving--surrounding COVID. Those people 
attack you because it gains them political followers.

    I appreciate the fact that you are willing to stand up for 
yourself and for your colleagues who have been dragged into the 
political muck, not because those that followed President Trump 
are interested in an honest, science based debate about how to 
attack COVID, but because they see political opportunity.

    Thank you, Dr. Fauci, for your work, for the panel's work, 
and for sticking up for yourself, which is not always easy. Dr. 
Walensky, I want to take my time to just do a little bit of an 
update on best practices for schools. I know we talk about this 
a lot here, but you know part of what I think is frustrating 
for a lot of parents is that the guidance they are getting from 
the schools changes.

    I get it, educators are sort of adjusting as the variant 
changes, as technology changes but what has changed since the 
last time, has there been any change since the last time you 
were here about what you were recommending for schools to stay 
open? And I appreciate what you said in the last hearing is 
that schools should be the first places to open and the last 
places to close.

    Man, as the parent of two public school kids, I couldn't 
agree more. The trauma on these kids during this pandemic has 
been significant, and the data tells us that especially for 
poor kids and kids of color, distance learning just doesn't 
work.

    I am grateful that I have got a Governor who has gone to 
extraordinary lengths to make sure that the Federal dollars are 
used to keep schools open. But anything new that you can share 
with us about what you are recommending for schools to stay 
open for the rest of the year?

    Dr. Walensky. Thank you, Senator Murphy. And in fact, that 
you took the words right out of my mouth. Schools should be the 
first places to open and the last places to close. We had a 
Delta surge in the fall, and 99 percent of our schools were 
safely open. And one of the things that is majorly different 
between September 2021 and today is we have pediatric 
vaccinations.

    We have vaccines that are available for every child over 
the age of five. And the children who are in the hospital now 
are largely those who are unvaccinated. So first and foremost, 
one of the most important things that has changed is we should 
be getting our children and our teenagers vaccinated. And if 
our teenagers are eligible, we have boosters available for our 
teenagers as well.

    We saw through the Delta surge that we were able to keep 
our children safely in school before we had vaccines. So now 
today, what do we have for our children? We have vaccines, of 
course, that we can use. We have school testing programs.

    We have new science that demonstrates tests to say. This is 
where a child might be exposed in the classroom, but if they 
are exposed, they don't have to stay home in quarantine. They 
can test every other day or twice a week and stay in the 
classroom safely. And what that has demonstrated is hundreds of 
thousands of person days of children in school rather than at 
home.

    We have new science that has demonstrated the value of 
masking, 3.5 times increased risk of school outbreaks if you 
are masking--if you are unmasked in schools versus if you are 
masking in schools. And just this week we updated our K-12 
guidance so that it is consistent with our isolation and 
quarantine guidance for the general public so that people can 
come back to school after isolation after 5 days.

    Senator Murphy. Thank you, Dr. Walensky, for that and for 
your commitment to keeping our schools open. Final quick 
question for you, Ms. O'Connell. Talking about in-home tests, 
obviously, a lot of focus on in-home tests today, but these are 
antigen tests. There are some interesting research going on 
about the ability to make PCR tests available at home.

    There are companies all over the country, including one in 
Connecticut, that believe that with some additional investment 
to bring those tests to scale, we could get PCR tests into 
families hands at home for a cost that is at or below what we 
are currently charging, or companies are currently charging for 
antigen tests. Is that a possibility?

    Ms. O'Connell. Senator Murphy, thank you. We share your 
interest, of course, in seeing as many tests available for the 
American people as quickly as possible. And at BARDA, have 
worked very closely with several of the manufacturers that you 
mentioned for these at home PCR tests.

    We have contracted with one of them and have reached 5 
million per month manufacturing capacity in contract with them 
and continue to look at the others in ways that we can support 
them.

    I would also like to say NIH colleagues in a program called 
RADx, the rapid acceleration of diagnostics, are working very 
closely with many of these companies as well as they go through 
the development stages. So we remain very committed to the work 
that these companies are doing and look forward to partnering 
with them as they begin to bring these products forward.

    The Chair. Thank you.

    Senator Collins.

    Senator Collins. Thank you. Ms. O'Connell, over the past 2 
years, Congress has appropriated $82.6 billion specifically for 
testing. In addition, we have given the Department flexibility 
to use other sources of funding.

    Yet, as you have heard repeatedly today, our frustrated 
constituents cannot find rapid tests when they need them. This 
testing crisis appears to have been entirely preventable, as is 
evidenced by the availability, the widespread availability of 
rapid tests in Europe, for example. The fact is that it appears 
the Administration simply failed to anticipate our testing 
needs.

    As the former Assistant Secretary of Health recently 
pointed out, a lack of Federal orders for tests between January 
and September 2021 caused the manufacturers to reduce their 
lines and lay workers, including at Abbott facilities in the 
State of Maine where 400 workers were laid off.

    As a Member of the Appropriations Committee, I share the 
concerns that have been expressed by Senators Burr and Blunt. I 
don't believe that we are in the position that we are in now 
due to a lack of funding, but rather a lack of planning. My 
question to you is, has any of this funding, as close to $83 
billion that was supposed to be used for testing, been diverted 
for other purposes?

    Ms. O'Connell. Senator Collins, thank you for this 
question. Testing remains a priority for this Administration. 
And all the work we have done on testing has been to promote 
the priorities of expanding the number of testing sites 
available, expanding the type of tests that are available for 
use in the United States, expanding the supply of tests in the 
United States, and lowering the cost of tests.

    We used the $47 billion that came in the American Rescue 
Plan. $10 billion of that went to schools through the States to 
set up the school testing programs. $8.3 billion has gone to 
community testing sites, including for the uninsured and at the 
community health centers and the pharmacy program Dr. Walensky 
mentioned.

    $5 billion has gone to procure tests and supplies, and an 
additional $4.5 billion will go toward this 500 million that we 
are in the process of procuring. $29 billion has gone directly 
to States from previous supplementals for them to build and 
promote testing programs within their jurisdictions. The 
testing money, as you recall, was for testing, contact tracing, 
and mitigation efforts, and some of that, the funds have been 
used for mitigation efforts.

    For example, when children are crossing the border one of 
the responsibilities that we have within HHS is to make sure 
that anyone who has--that the children that are unaccompanied 
are cared for, and we used some of the funds to test those 
children and then to separate them from COVID negative children 
at the border.

    Senator Collins. Was--I am going to repeat my question 
because you did not answer it. Has any of that money been used 
for non-testing related purposes at the border?

    Ms. O'Connell. For the mitigation purposes as well, which 
the legislation allowed the funding to be used for.

    Senator Collins. I will follow-up with you because I don't 
feel like I am getting an answer. Dr. Fauci, just last week, 
the President once again said that COVID-19 is a pandemic of 
the unvaccinated. And let me make very clear that I have been 
encouraged vaccinations. I believe in them.

    But contracting--contradicting the President's statement, 
in Maine our largest health system reported that absences of 
vaccinated staff caused by COVID-19 last week was at the 
highest point since vaccines became available. It has increased 
by four fold.

    Does the message that COVID is a pandemic of the 
unvaccinated still hold true with the emergence of Omicron? And 
do you agree with the New York Times, which has twice reported 
that while the COVID vaccine is critical in preventing 
hospitalizations and death, it is less effective against the 
Omicron variant?

    Dr. Fauci. Thank you for that question, Senator. Yes, 
indeed there is no doubt that the Omicron variant, when you 
look at the protection against symptomatic disease and 
asymptomatic infection, it dramatically goes down to about 30 
percent.

    What maintains itself, it goes up to about 70--it is about 
70 percent against severe disease. When you boost, when you 
boost, what happens is you get a rather significant 
reconstitution of the protection, particularly against 
hospitalization. So if you were to say that Omicron or even 
COVID-19 as it is, is really a pandemic, when you are talking 
about a pandemic that causes serious disease, there is no doubt 
that there is an extraordinary divergence of risk between 
vaccinated and unvaccinated person.

    In response to the question just a bit ago when I said 
that, if you look at vaccinated versus unvaccinated, there is a 
17 times greater chance of being hospitalized and a 20 times 
greater chance of dying if you are unvaccinated versus 
vaccinated.

    The Chair. Thank you.

    Senator Hassan.

    Senator Hassan. Thank you, Madam Chair and Ranking Member 
Burr, and thank you to all of our witnesses for being here 
today and for your ongoing work. I deeply appreciate it. Dr. 
Fauci, I want to start with a couple of questions for you.

    We need to make sure that individuals who become seriously 
ill with COVID-19 can receive treatment, and that doctors have 
clear guidelines on the effectiveness of each treatment for the 
latest variant.

    You touched on this in your opening statement, but I would 
like you to just expand a little bit on this. In light of 
Omicron, how is the Administration evaluating new COVID-19 
treatments and monitoring the effectiveness of existing 
treatments?

    Dr. Fauci. Thank you for that question, Senator. There are 
a number of studies that have been conducted and that are being 
conducted right now, and they have to do with studies that NIH 
sponsored, one of which is the adaptive COVID-19 treatment 
trials, or ACTT, which in fact have been from the very 
beginning as early as February 2020, was the basis for the FDA 
approval of the antiviral remdesivir.

    Other of those studies, particularly those on monoclonal 
antibodies, showed several of them in the clinical trials to be 
effective at first against Delta. We know now that a couple of 
them, except for one, has now lost some of its effectiveness.

    There is another group of studies called Activ and there 
are six of those, and that stands for accelerating COVID-19 
therapeutic interventions and vaccines, and the whole gamut of 
oral, IV monoclonal antibodies, direct antivirals. And as I 
mentioned in my opening statement, antivirals like Paxlovid and 
Molnupiravir, the original research had been done in the early 
trials by the NIH.

    But importantly in direct answer to how we know what to 
use, the NIH has put together a guidelines panel made up of 48 
highly qualified clinicians and individuals with experience in 
COVID-19 to give a prioritization of what you do if you are 
infected and with advanced disease in the hospital, as well as 
what you do as an outpatient, and they have fairly clearly 
delineated in the guidelines, which is easily accessible by 
just going to the NIH website and going to nih.gov and then 
guidelines panel, and people can get a good idea, clinicians 
throughout the country and the world, of how to use these 
antivirals. Thank you.

    Senator Hassan. Thank you. I want to follow-up, I am 
grateful that the Administration heeded my call to send FEMA 
teams to New Hampshire to help administer COVID-19 treatments.

    However, the teams were delayed in arriving and are 
scheduled to stay only for a short period of time. So, Dr. 
Fauci, what additional personnel and support is the 
Administration planning to provide to New Hampshire and other 
States to help treat COVID-19 patients in the most effective 
way possible?

    Dr. Fauci. Well, there are several things, perhaps 
Assistant Secretary O'Connell can answer, but I can start off 
by saying that there are surge teams right now, at least 60 
surge teams that have been deployed to help those areas that 
have difficulty because of the surge and the fewer volume of 
cases to be able to handle them with regard to everything from 
hospitalizations to treatment and other implementations.

    Senator Hassan. I appreciate that Assistant Secretary 
O'Connell is in a good position to follow-up, and I would like 
to follow-up after the hearing, but I did want to ask one other 
question to Dr. Walensky.

    We have long had problems with accurate State vaccination 
data in New Hampshire. It has come to light that the CDC's data 
on New Hampshire's vaccination rates is also inaccurate. 
Apparently, the CDC can't consistently distinguish in its data 
between first doses of the vaccine and boosters, and as a 
result, the agency incorrectly records boosters as first doses, 
artificially raising the vaccination rate.

    The CDC's data is inaccurate for other States as well. We 
have been looking at this for other States too. So what steps 
is the CDC taking to resolve these data inaccuracies, and when 
will the CDC have accurate data for New Hampshire?

    Dr. Walensky. Thank you, Senator. This is a really 
important question. So CDC is the compiler of the data, and we 
rely on the State immunization services to provide CDC the data 
at the State level. Now, among the challenges with these 
accuracy is that if people don't bring in their card, they are 
counted as a first dose when in fact their card would have been 
a third dose.

    We rely on the States to work to reconcile any differences 
if a person put in a middle initial on one card, but not on 
another. And we are working closely with every single State to 
increase their accuracy.

    We are encouraging people to bring their cards because that 
also increases the accuracy. We recognize this challenge, and 
we are working State by State, including in New Hampshire, to 
reconcile these inaccuracies to get them more accurate in our 
comprehensive reporting of every State.

    Senator Hassan. Well, I appreciate that very much. Thank 
you, Madam Chair. I will just say that what I am hearing you 
say to the general public is it is really important to help 
with the accuracy of data by keeping your car, taking a photo 
of your card, making sure that you are sharing all your 
information at the site where you are getting a vaccine or 
booster shot.

    Dr. Walensky. Very helpful. Yes. Thank you very much.

    Senator Hassan. Thank you.

    The Chair. Thank you.

    Senator Marshall.

    Senator Marshall. President Biden inherited a vaccine, a 
distribution plan, trillions of dollars in funding, but 
unfortunately, this Administration has chosen to put all its 
eggs in one basket, prioritized unconstitutional vaccine 
mandates and testing.

    Yet comparing 2021 to 2022, COVID infections have increased 
72 percent and deaths increased 27 percent. This we know, if 
you look at this data, your current plan is not working. The 
current plan is not working, we need therapeutics at warp 
speed. Ms. O'Connell, who is responsible for this failure?

    Ms. O'Connell. Senator Marshall, thank you for that 
question. We are making six therapies available to the American 
people free of charge.

    Senator Marshall. Who is responsible for the failure?

    Ms. O'Connell. Senator Marshall, we continue to make 
therapies available at warp speed to the American people.

    Senator Marshall. The Biden administration has allocated 
over $80 billion for testing and only $15 billion on 
therapeutics. It is obvious that your plan has failed. We can't 
keep throwing good money after bad money. This is insanity. We 
have to admit our mistakes and go a different direction. Ms. 
O'Connell, would you commit to an Operation Warp Speed for 
therapeutics?

    Ms. O'Connell. Senator Marshall, thank you. Therapeutics 
are part of Operation Warp Speed. And that is how we have the 
six therapies that we are currently making available to States 
free of charge.

    Senator Marshall. They will be available after Delta has 
already been come and gone and also after, of course, Omicron 
will be said and done as well. Dr. Fauci, 59 percent of 
Americans and 81 percent of Republicans do not have a favorable 
opinion of you. Frankly, honestly, you have lost your 
reputation.

    The American people don't trust the words coming out of 
your mouth. Every day you appear on TV, you do more damage than 
good when it comes to educating the public on COVID. Suppose 
you were leading a team in an effort to try to get people to 
stop smoking cigarettes, but every time your spokesperson goes 
on television, over half the Nation goes out and buys a pack of 
Marlboros, wouldn't you stop that person from appearing on 
national television?

    Dr. Fauci. Once again, Senator Marshall, I believe that is 
a real distortion of the reality. If you look at everything 
that I have said on TV, it is to validate, encourage, and get 
people to abide by the recommendations of the Centers for 
Disease Control and Prevention. Look at everything I have ever 
said----

    Senator Marshall. Dr. Fauci--but perception is reality. And 
you are hurting the team right now. You are hurting the team 
right now. Dr. Fauci, you previously told this Committee under 
oath that NIH and NIAID have never funded gain of function 
research with the EcoHealth Alliance. However, a report from 
the Department of Defense Inspector General released yesterday 
States that EcoHealth Alliance opposed DARPA in 2018, seeking 
funding to conduct gain of function research on bat-borne 
coronaviruses.

    This proposal, named Project DEFUSE, was rejected by DARPA 
because the project didn't address the current researcher's 
potential to violate the gain of function moratorium. ``The 
proposal does not mention or assess potential risk of gain of 
function research.'' That is a direct quote from the DARPA 
rejection letter.

    The same proposal rejected by DARPA for gain of function 
potential was not rejected by NIAID under your leadership. You 
funded Project DEFUSE and its research that took place at the 
Wuhan Institute of Virology. Why did you tell the Committee 
that your agency has never funded gain of function research?

    Why did your agency award this grant, despite it being 
rejected by DARPA due to its concerns about violating the 
moratorium that was in place? And finally, will you commit 
today to release all records fully unredacted by the end of 
this week so Congress and the American people can know the 
truth about NIH's role in the origins of COVID-19?

    Senator Marshall. So again, Senator, it really pains me to 
have to just point out to the American public how absolutely 
incorrect you are. What came out last night on Project Veritas 
was a grant that was submitted to DARPA. Then it distorted and 
said we funded the grant.

    We have never seen that grant and we have never funded that 
grant. So once again, you are completely and unequivocally 
incorrect, when you joined the DARPA proposal was a grant that 
we never saw, and we did not fund. So you are incorrect.

    Senator Marshall. Our social media will have all the 
supporting documents and we will be entering into the record as 
well.

    Dr. Fauci. Senator, you are backing down on this. Why don't 
we go and look at the very tossed statement? They were talking 
about a grant that was submitted to DARPA----

    Senator Marshall. Are you saying this is not--are you 
saying that this was viral gain of function research?

    Dr. Fauci. I am telling you that you are saying----

    Senator Marshall. Are you saying that this was not viral 
gain of function research?

    Dr. Fauci. By the definition that you were very well 
aware----

    Senator Marshall. The--definition is just legalese to get 
away and allow you to do the viral gain of function.

    Dr. Fauci. This is what I am talking about, Senator----

    The Chair. Senator Marshall, please allow the witness to 
respond.

    Dr. Fauci. Senator, we know and misinformation that the 
guide rails for what can be done or not were not established by 
me, they were established by a 3-year process led by the Office 
of Science and Technology Policy of the White House----

    Senator Marshall. And decided by you in a secret meeting at 
the White House in December 2019.

    Dr. Fauci. Senator, that is incorrect, and this refers 
exactly to what I was talking about in response to Senator Rand 
Paul. You are incorrect completely, and every time I try to 
explain----

    Senator Marshall. You are saying you are incorrect, but the 
facts are on my side. So why--would you not commit to sharing 
everything, open, unredacted with this Congress?

    The Chair. Senator Marshall----

    Dr. Fauci. So here is an example----

    The Chair. Dr. Fauci--this hearing is critically important 
to the American people. There are millions of people infected 
with the COVID virus. It is impacting every part of our 
economy. Every family is asking for answers to critical 
questions.

    Both sides of the aisle have asked tough questions, but we 
are not going to allow this Committee hearing to be another 
personal attack that undermines our ability to deal with this 
terrible virus that is impacting so many people. I will then 
turn to Senator Smith. Thank you.

    Dr. Fauci. Thank you, Senator.

    Senator Smith. Thank you. Thank you, Chair Murray, and 
well, I will just let that go. So as we move into the third 
year of the COVID-19 response, it seems to me that our strategy 
is shifting. We are shifting from a goal of trying to get to 
zero COVID cases to eradicating the virus. And our goal is 
really much more about minimizing the damage of this pandemic. 
You and I have talked about this, Dr. Fauci, as well as with 
Dr. Walensky. So we need, of course, to minimize 
hospitalizations and deaths caused by COVID.

    We do that through vaccines and through therapies. And we 
also need to minimize the COVID damage by understanding how to 
keep kids in school, how to keep businesses open, and how to 
protect against the damage that is caused by social isolation 
and burnout and other stresses that injures our mental health.

    It seems to me that while--this is happening while COVID 
continues to seriously stress our health care system, and while 
we still have people in this country, including sadly, some 
Members of Congress who continue to spread misinformation and 
lies about the pandemic. So it seems like we have to be 
realistic that these cycles of the pandemic, until it becomes 
endemic, are going to continue. We are going to probably 
continue to see some unpredictable variants arise.

    Madam Chair, I just want to say that I hope that this 
Committee can find some time to discuss these issues as they 
relate to global vaccine strategy, because this is going to be 
crucial to our work to protect Americans' health as we go 
forward since we are not an island.

    But let me ask, I am very interested in how we think about 
like the data that is important for Americans to keep in their 
minds as they are trying to measure relative risk. Last week, 
public health experts published some interesting articles that 
suggested that we should maybe think about incorporating COVID-
19 data into aggregate risk for all respiratory viruses that 
are circulating, including the flu and RSV, and that maybe this 
data, if we could look at it in real time from medical 
facilities and ERs and so forth, testing facilities and private 
homes even, and would give us a better picture of what is 
happening.

    Let me ask Dr. Walensky and Dr. Fauci, if you could talk a 
little bit, I want to understand about this--I want to 
understand how you think about this question of relative risk, 
how we should be transitioning in what we consider from daily 
case counts, for example, to looking at other data and 
particularly how you evaluate this idea of looking at all 
respiratory illnesses in one basket.

    Dr. Walensky. Yes, Senator Smith, this is such a critically 
important question. Thank you for raising this. So we have to 
do two things simultaneously. Right now, we are dealing with an 
Omicron surge where we have the most number of cases we have 
ever had in a day in this country.

    We have to get out of this Omicron surge. But in the 
meantime, we have to look down the field and we have to 
understand what is this going to look like when we are not in a 
surge? How do we deal with endemic disease? And what don't we 
start looking at with regard to endemic disease?

    You are absolutely right. We need to think about the 
severity of that disease because now with 62 percent of 
Americans vaccinated, some of that disease is not as severe as 
it was. That is the success of our vaccines. We have to look 
critically at hospital capacity. What can our hospitals handle, 
because if people are coming in with COVID or have hospital 
staff are out with COVID that is a really important measure 
that we are going to look at. And one of the things we probably 
still are going to examine, although perhaps with less import, 
is the actual number of the cases.

    Why that is important in general is because it generally 
foreshadows what is coming into the hospital. So knowing that 
and understanding what that might mean for the future of 
hospitalizations, future of severity, future of capacity, and 
all of those are things that we are looking at right now. But 
one of the things that you critically mentioned was our efforts 
in data modernization.

    How do we take the efforts that we have had so far with 
COVID and increase them, continue to keep the pedal to the 
metal as it were? When we started here, we were not collecting 
racial and ethnicity data. We didn't have a way to link in a 
personal--with personal identifiers removed, electronic health 
records with our testing records. We had 187 hospital systems 
who could do that.

    Now we have 10,000. So what we really need to do is scale 
up our data modernization efforts and do it, as you say, not 
just for COVID, but--and not just for other respiratory 
diseases like flu, RSV, as you note, but for all diseases.

    We are looking at doing this for maternal mortality, for 
sickle cell disease, for opioid injury, for many, many diseases 
and this is going to be the power of our data modernization 
efforts and I am really grateful for resources from Congress to 
be able to leverage those. Thank you.

    Senator Smith. Thank you. Madam Chair, I believe I am out 
of time, but I will have other questions if we have a second 
round.

    The Chair. We will have a second round.

    Senator Tuberville.

    Senator Tuberville. Thank you, Madam Chair. Thank you for 
being here today. You know, this Administration has been in 
charge of the Federal COVID response for a year. I have to say 
I don't think it has been a job well done. Our Federal 
Government not only sets the tone and the guidance for how 
millions of Americans should be handling COVID, we set the 
standard for the world.

    Our information has to be correct. I continue to hear that 
we need to follow the science and I agree. But we have to yet 
hear the clarity from this Administration. We are conflicting 
guidance across the board. In order to be effective, guidance 
has to be understood and implemented by the average American, 
but most Americans can't make heads or tails of anything coming 
out of this Administration.

    We are all, all of us, are failing this test. One thing I 
do know is that when we finally toward the end of this thing, 
Congress is going to have an investigation. We all know that. 
We have heard that the FDA and President Biden say 55 years 
will be needed to share data related to a lot of those 
decisions. But we will have to investigate. This group will 
have to investigate and have the information before 2076.

    Heck, most of us won't be here in 2076. This investigation 
will look into what--who had authority to make decisions. I 
know there are more people making decisions behind the scenes. 
So what I would like to know is I am just concerned how badly 
the response has been. It is handled--President Biden has 
handled this in his first year. We have heard all the pluses 
and minuses.

    This Administration took office with three successful 
vaccines and numerous effective therapeutics and basically 
drove the response into a ditch. At times, it doesn't seem like 
anyone is in charge. You started the year by dismantling 
Operation Warp Speed, canceling contracts of monoclonal 
antibodies, underinvesting in testing, and we spent billions in 
that, first with Delta now on Omicron, people can't find a 
test.

    I am getting text as we speak sitting here, where do I get 
a test. We spent billions on this. You know, if we can't find a 
test and test positive, they can't get treatment. Monoclonal 
antibodies are rationed. Antiviral pills are months away.

    I just got a simple question, of all of you up there and 
whoever wants to answer this, if you have a problem in your 
coordinates, who do you go to? Who is the head coach of this 
virus that you have to go to, whether it is an Administration, 
whether it is one of you? Dr. Fauci, who do we go to?

    Dr. Fauci. The person who is in charge of that is Jeff 
Zients----

    Senator Tuberville. At the White House?

    Dr. Fauci. At the White House. And we meet very, very 
regularly, the entire medical team as well as others going over 
all of the data, going over what the strategies are, going over 
what the issues are, what the problems are, what we have done 
right, what we have done wrong. We examine literally 
continually, sir,.

    Senator Tuberville. Has he done a good job?

    Dr. Fauci. You know, I think given the circumstances that 
we are in right now, I believe he has done a very good job. I 
really do this. This is an extraordinary virus, the likes of 
which we have not seen even close to in well over 100 years. It 
is a very wily virus. It is fooled everybody all the time from 
the time it first came into Delta to now Omicron. Very 
unpredictable and we are doing the best we possibly can.

    Senator Tuberville. Yes. Dr. Walensky, it has been reported 
by some virologists and scientists that this year around 170 
people have died from taking the regular flu vaccine. The 
Vaccine Advisory Adverse Reporting System reported that the 
number of people dying after or following the COVID vaccine is 
actually in the thousands.

    Now this is what I am hearing. I will give you a chance to 
refute that or confirm it here. You know, is this true? Are we 
having that many people die after taking one of these vaccines?

    Dr. Walensky. Senator Tuberville, thank you for that 
question. The Vaccine Adverse Event Reporting System is a 
mandatory system of any adverse event that happens after being 
vaccinated.

    If you get hit by a car tragically after getting 
vaccinated, that gets reported in the vaccine adverse reporting 
system, VAERS system. So the vaccines are incredibly safe. They 
protect us against Omicron, they protect us against Delta, they 
protect us against COVID. They don't protect us against every 
other form of mortality out there.

    Senator Tuberville. Do we keep numbers of people that died 
following taking a COVID test--from taking this vaccine? Do we 
have any idea? I am just asking.

    Dr. Walensky. I am sorry, those who have died after taking 
a COVID test?

    Senator Tuberville. Following taking the vaccine. Is there 
any number or count? Do we keep records on that from----

    Dr. Walensky. Absolutely, yes. I couldn't give you the 
absolutely number off the top of my head, but our staff could 
absolutely get back in touch with you. We collect this data.

    Senator Tuberville. Do you know, Dr. Fauci? Do you have any 
clue on that?

    Dr. Fauci. About how many died----

    Senator Tuberville. 100?

    Dr. Fauci. I don't know the number, but I think it is 
really important for----

    Senator Tuberville. Microphone, microphone.

    Dr. Fauci. I am sorry, I don't have a number, but I think 
part of the confusion is that when you do a reporting, if you 
get vaccinated and you walk out and get hit by a car, that is 
considered a death--I mean, that is the thing that gets 
confusing, that everything that happens after the vaccination, 
even if you die of something completely obviously unrelated, it 
is considered a death. So if I had metastatic cancer, got 
vaccinated and died 2 weeks later that is a death that gets 
counted.

    Senator Tuberville. I understand that.

    Dr. Walensky. And every one of those is adjudicated.

    Senator Tuberville. Yes. And one quick question before we 
get through here, I am in rural Alabama, but I get one of these 
home tests. I test positive. I have--asymptomatic. What do I 
do? People call--what do I do? I don't have a doctor. What do I 
do?

    Dr. Walensky. Thank you. So you are asymptomatic? You are 
asymptomatic, no symptoms, feel well?

    Senator Tuberville. Yes.

    Dr. Walensky. You stay home for 5 days and the next 5 days, 
if you continue to be asymptomatic, you can go out, wear a 
mask. Don't go traveling. Don't go to gyms----

    Senator Tuberville. If I get real sick, then what do I do?

    Dr. Walensky. Then--well, first you go and call your 
physician. And in fact, I tell you, call your physician 
regardless, but call your physician, call your provider. If you 
are continuing to have symptoms, then you stay home until your 
symptoms are resolved.

    Senator Tuberville. No therapeutics?

    Dr. Walensky. Well, that is where I would say call your 
physician and see if you are eligible for therapeutics.

    Senator Tuberville. A lot of these people don't have 
physicians. They have got a drug store.

    The Chair. Senator, we do need to move on.

    Senator Tuberville. Thank you.

    The Chair. Thank you.

    Senator Rosen.

    Senator Rosen. Thank you, Madam Chair. Thank you, Ranking 
Member Burr. This hearing is so very important. I really want 
to thank all of the witnesses here for testifying today, for 
your continued work. Thank you so much as we combat this 
pandemic in real time, in real time.

    First, I just want to want to echo the concerns my 
colleagues have raised about access to testing, both in-person 
PCR tests and the at home rapid test. We do know that home test 
kits are scarce. Americans are standing in extremely long lines 
to get a COVID test, and hospital emergency Departments in my 
home State of Nevada have seen a significant increase in people 
coming solely for tests because there just aren't enough 
alternatives.

    This is just really only adding to the stress, as again, I 
can say speak to Nevada on our health systems. Nevada has been 
expanding our testing options but increased Federal support on 
the ground in addition to home testing, we feel is absolutely 
critical. And in the future, the Federal response must be more 
proactive in this space.

    I am a little bit concerned about the testing keeping up 
with the variants because we are--this is all happening in real 
time. COVID is evolving. You don't know which strain may become 
the dominant strain. And so we want to ensure just in addition 
to the effectiveness of the vaccines and therapeutics that the 
testing accuracy must also keep up.

    Dr. Fauci, with some recent reports about the current 
variant settling more in the throat than in the nose for some 
patients, what are we doing with the development and deployment 
of rapid at home tests based on saliva versus a nasal swab?

    Then, Dr. Woodcock, how rapidly do you think of the over-
the-counter testing can be delivered, approved--looked at 
approved, delivered to the American public to make sure that 
they are less anxious?

    Dr. Fauci. Thank you for that question, Senator. Yes, there 
have been recent reports that in fact the sensitivity and the 
ability to detect in a swab of the throat versus the nose of 
pharynx, at least with omicron, that is the preliminary report.

    I think it needs to be validated and verified. If the data 
were strong enough, then we--the company, whatever, who makes 
that will likely go to the FDA to ask to change the indication 
because the emergency use authorization is for a nasal swab.

    If the data, the scientific data indicate that is better to 
get an oral or other swab, they would present that to the FDA. 
So I would leave that to Dr. Woodcock to answer the rest of 
that question.

    Senator Rosen. Thank you.

    Dr. Woodcock. Certainly. Well, we can act very rapidly. But 
first, I would like to say people should not use swabs that are 
designed as nasal swabs and try to swab their throat. They may 
stab themselves, Okay. That would not be good.

    What we need to do is have tests that see whether the 
throat swab, as Dr. Fauci said, could provide more sensitivity. 
We do know the tests are picking up omicron, but right now with 
less sensitivity than they did some of the other variants.

    As far as time, as I said, after the ITAP program does the 
testing at NIH, FDA has been able to approve--authorize within 
a day or two of getting those data. However, the companies 
would have to change the test configuration to accommodate the 
swab, the larger swab that you would use in the throat, and 
that is probably what would take the most time, as well as 
seeing whether that was better.

    Senator Rosen. To continue with that point, as we have seen 
with some of the testing, the reagents or the materials that it 
really takes to use the test, is there the ability for people 
to return a test that may no longer work?

    Can those agents, any of that be recycled or upcycled if 
they are returned to the company unopened? Like, how can--how 
do we not dispose them and not get some recyclability out of 
that? Is that possible in some way?

    Dr. Woodcock. We can get back to you on those parameters. 
Would be happy to do that.

    Senator Rosen. Thank you, I appreciate that. I would like 
to talk a little bit again, people are talking about the public 
health data. You know, we are noting about all the daily 
statistics, noting about some of the statistics about possibly 
deaths, and so positive or negative, critical--this data is 
critical even for us to make our decisions as far as what we 
fund.

    Sometimes there is no choice to say that we shouldn't 
include home testing in the daily statistics because they might 
not be reliable. So Dr. Walensky, to build on some of that 
testing and the statistics that you need to do your job, that 
all of us need to do our job, how is the CDC working with the 
State, local health, our hospitals to be sure that the 
voluntary self-reporting guidance, it is going to be accurate 
and give us the kind of statistics we need going forward?

    Dr. Walensky. Yes, thank you for that question, Senator. So 
we are routinely reporting PCR tests. That is what is routinely 
reported from the State and that is what our updated statistics 
are. There are--there is passive reporting that occurs with 
rapid tests, but I also want to--understand, the importance of 
rapid tests, at home tests for people to be empowered to use 
these rapid tests to do the right thing.

    Regardless of whether we can count them, generally they 
tend to be people who have milder symptoms. They might have 
been vaccinated, have a runny nose, and they decide to go and 
get a rapid test and do the test at home. Less important is 
counting that case than it is that person stay home, isolate, 
do the right thing, and not be forward transmitting.

    I think that many of these tests have different purposes. 
But one of the really important purposes of these rapid tests, 
even if we don't count them, is to empower the public to do the 
right thing through this pandemic.

    The Chair. Thank you.

    Senator Rosen. Thank you very much.

    The Chair. Senator Romney.

    Senator Romney. Thank you. Thank you, Madam Chairman. Just 
a couple of thoughts. One, it has been 2 hours since we have 
been here. As one of the people at the low level here--out in 
the hinterlands. Just a couple of thoughts. One, I think it 
would be helpful if, and please excuse me for this comment, if 
the Chair and Ranking Member limited their opening comments to 
the 5-minutes, just like you expect those folks to limit their 
comments to 5 minutes.

    We didn't get started till 25 minutes after asking these 
folks their questions. I do want to note also that in this 
process, as I am sure you who are testifying here today 
recognize, that some of what we do is performing, and so what 
we do is to become informed. And I do both from time to time, 
so I am not just in one camp or the other in that regard, but I 
do want to point out how much I personally and I believe the 
great majority of the people in our country respect you 
individually and professionally for the work that you do. You 
are scientists, not politicians.

    Nevertheless, you are being made subject to the political 
whims of various political individuals and that comes at a high 
cost, which unfortunately I fear will lead some to not want to 
participate in helping our Government make scientific choices. 
But I very deeply appreciate your commitment to the American 
people and your desire to do things as well as we possibly know 
how to do. That doesn't mean they will be done perfectly. That 
doesn't mean you won't make mistakes. Doesn't mean there won't 
be changes from time to time.

    Sometimes as data comes in that is different than what you 
had anticipated, and sometimes just because you were wrong. I 
mean, it is the nature of being a human being. That is where we 
are. I think unfortunately, the Administration was wrong in not 
building testing capacity at a time when we all thought COVID 
was kind of going away.

    I remember the summer and the fall, going into a grocery 
store--excuse me, into a drugstore and seeing two rapid tests 
on the shelf, and those things stayed there for days. No one 
was interested in buying a rapid test. And apparently the 
Administration didn't think that it should be aggressively 
building rapid tests.

    Omicron came along, cut people by surprise, and we were 
obviously badly mistaken, the Administration was, and we are 
suffering in part because of that. Let me ask with regards to 
Paxlovid. Ms. O'Connell, is that being subject to Warp Speed?

    My understanding is that Paxlovid is far superior to other 
oral antivirals. Should we not be much more aggressively 
producing that and getting that out so that it can be 
prescribed?

    Dr. Walensky. Thank you, Senator Romney. We are in active 
conversations with Pfizer about how to increase their time 
limits. It is my understanding, and the scientists on the panel 
can feel free to jump in, is that the process required in order 
to generate this particular antiviral is months-long. It is a 
chemical process.

    It is one that is very, very hard to accelerate. What we 
have been able to do is to find additional doses to work with 
Pfizer to try to unlock additional capacity, where they can 
find it. And we are continuing to do that actively.

    Senator Romney. Thank you. Dr. Walensky, good to see you 
again. I appreciate the chance we had to speak earlier this 
week or last week rather. As I have looked on the CDC's COVID 
tracker report, I note the data goes through November 20th and 
I remember my days in business, if we didn't have daily 
information, we couldn't make good decisions.

    I wonder, do we need to invest in either developing a new 
sub-agency or a task force to get basically immediate data, 
daily data so we know what is going on. And that is not just 
for the public that is for those of you who are making those 
decisions. Do we need do a much better job moving faster 
getting data?

    Dr. Walensky. Senator, first of all, let me thank you for 
your earlier comments. But also to comment on our COVID data 
tracker, I think you are speaking to the seven--I am sorry, the 
27 jurisdictions that we now compile data, that allows those 
jurisdictions to report together their testing data, their 
cases data, their immunizations data, their age data, as well 
as their death data.

    It is over two-thirds of the country that we do, and we 
update that about once a month, and it is about three or 4 
weeks in a year. So mid-January, we will be having data through 
the end of December, and it simply does take that long for our 
jurisdictions to compile those data.

    Of course, our death data are generally lagging. It takes a 
while for those to get reported and adjudicated. So we are now 
updating those are about 6 weeks in a year and that is in--we 
are working hard to keep those in real time.

    Senator Romney. Yes, I know retailers like Zara, for 
instance, they apparently get data and correlate it daily. So I 
would hope we could find a way to increase the speed with which 
we get that data. I know my time is up. If I could just going 
to make a comment, and that is that I think it would be helpful 
if people knew when they should get tested, when it is called 
for, because I think a lot of individuals, myself included, get 
tested when there is no indication that I need to get tested, 
other than just want to make sure I am not sick.

    There is huge demand for tests which are in short supply, 
in part because of that. And No. 2, when you say when people 
have been exposed, please let us know what it means to be 
exposed. We are in a room right now. I am sure someone here has 
Omicron.

    Are we all exposed and therefore need to get tested? What 
does it mean to be exposed and when do we need to get tested? 
And I know--I wanted to ask that of Dr. Fauci. I can't do that 
given my time. Those are topics I would love to have elaborate 
on that. Thank you.

    The Chair. Senator Romney, I think that is a question we 
all want answered, and I will give Dr. Fauci the opportunity to 
respond to that.

    Senator Romney. Dr. Fauci.

    Dr. Fauci. Well, the CDC guidelines make that very clear, 
and it is if you are exposed to an individual with known--if 
you are in a period of 15 minutes at a time or a total of 15 
minutes over a 24 hour period, in a situation where you come 
into close contact, perhaps Dr. Walensky could expand on that, 
but that is the fundamental core of the CDC guidelines.

    Dr. Walensky. That is exactly right in terms of the 
definition of exposure. In terms of who should get tested, you 
should get tested if you have symptoms of COVID-19. If you do a 
rapid at home test and you continue to have symptoms and that 
test is negative, you should do another test or get a PCR.

    You should get tested within 5 days of your exposure or 
after 5 days of your exposure with the definition that Dr. 
Fauci mentioned. And we are testing through tests to stay and 
other mechanisms as well.

    Many reasons to test, but really, most importantly, if you 
are exposed, if you have symptoms, and also if you are going 
into a setting where you might be seeing an immunocompromised 
person, somebody who is vulnerable, not able to be--to take a 
vaccine.

    The Chair. Thank you very much.

    Senator Casey.

    Senator Casey. Chair Murray, thank you very much for this 
hearing. And I want to start by commending the public service 
of all of the members of the panel, Dr. Walensky, Dr. Fauci, 
Dr. Woodcock, and Assistant Secretary O'Connell. This is 
difficult work, and we appreciate your public service.

    In particular, I want to reiterate statements I think I had 
to make before in light of Dr. Fauci's commendable public 
service, not just in the middle of this pandemic, throughout 
the pandemic, but also for decades. I think I speak for a lot 
of people back home and across the country that not only have 
confidence in your integrity, but also your work in public 
health, and so we are grateful for that. Let me start with a 
question for Dr. Walensky.

    Doctor, I am quoting from a statement you made on Friday on 
television in the context of a question about COVID-19 deaths. 
And I will quote two sentences. One is, ``the overwhelming 
number of deaths, over 75 percent occurred in people who had at 
least four co-morbidities. So really, these are people who were 
unwell to begin with and, yes, really encouraging the news in 
the context of Omicron.''

    Now, this statement, and I know it was part of a broader 
interview, caused great concern. I know from my work as a 
Senator for years that you and your team at CDC, whether it is 
your, the policy or the work that you do, that policy and that 
work are both focused on ensuring that all Americans receive 
the best possible treatment and protection.

    This is especially important for older adults and people 
with disabilities who may need additional supports and 
protections. So context is important in an interview like this. 
So please explain what point you were making, that is No. 1, 
the point you were making. And second, outline CDC's commitment 
to protecting older adults and people with disabilities as we 
continue to address the pandemic.

    Dr. Walensky. Senator Casey, I am really grateful for the 
opportunity to explain this. And to step back, that interview 
on Friday, I recently spoke to a study on the high level of 
protection against vaccines. It was a pre-taped interview and 
much of it was cut and that phrase was taken out of context, as 
you note.

    The study was a cohort of 1.2 million people who were 
vaccinated and 36 people passed, demonstrating their remarkable 
effectiveness of our vaccines. But no less tragic is the 36 
people who passed because of COVID-19, and that many of them 
had comorbidities, comorbidities that I have spent my career 
taking care of, comorbidities that just prior to coming to the 
CDC, we saw time and time again disproportionately impacting 
people with COVID-19 and the hospitals that I cared for 
patients.

    What are we doing at CDC given the critical importance? 
Well, we have toolkits for COVID-19 for patients with 
disabilities. We have accessible materials that are available 
in braille and in American sign language so that people with 
disabilities, in easier to read and understand language, so 
that people with disabilities can access our materials. We have 
improved data collection systems on our COVID data tracker. You 
can track vaccination status by disability.

    We have worked with States to make sure that those are 
reporting. And the more funding partners in our public health 
partners to do more for patients with disability. And if 
anything, this issue on Friday has redoubled our commitment to 
continuing to make sure that we have access for people with 
disabilities. Thank you for allowing me to clarify.

    Senator Casey. Well, I appreciate that, and I appreciate 
the time it took to respond. I would also suggest and maybe 
even ask you to spend some time meeting with leaders from both 
the disability and aging communities to walk through what you 
just walk through and even expand beyond that.

    Dr. Walensky. We are already planning. Thank you.

    Senator Casey. Thanks very much. I want to turn now to 
vaccine development for children. The recent setbacks in 
vaccine trials for children under five is of great concern. So 
many parents are exhausted from this pandemic.

    I know we can't change the outcome of the trials, but we 
can take steps to reassure parents that their young children 
will still get vaccinated as soon as possible. Dr. Fauci, Dr. 
Woodcock, if you could briefly talk about these trials and 
any--anything you can tell us about speeding up the development 
of safe and effective vaccines for children under five.

    Dr. Fauci. Thank you for that question. Senator, I will 
take a quick shot at it and then pass it over to Dr. Woodcock. 
The situation that I believe the public needs to understand is 
that the trials from children from 6 months to 4 years was 
broken up into two groups. It was 6 months to 24 months, 24 
months to 4 years.

    In the dosage that was used, the individual, the children, 
the younger group, the trial met the end point of 
noninferiority, comparing it to what would be the standard of 
what would be success. However, for the middle group, the 24 
months to 4 year group, they did not meet that standard of 
noninferiority.

    Because of that, it was felt that this likely will be a 
three dose vaccination for children in that group, so the 
trials are being done now as quickly as possible to see if they 
can get that data to have a uniform dose and a uniform regimen. 
But I will pass it over to Dr. Woodcock.

    Dr. Woodcock. Yes, well, of course, I can't say a lot, but 
we are working very closely with the manufacturers of vaccines 
on accelerating and making sure that vaccines are available for 
the youngest children.

    Senator Casey. Thank you very much.

    The Chair. Thank you.

    Senator Murkowski.

    Senator Murkowski. Thank you, Chairman--Madam Chairman. It 
says a lot about 2021 when the most appreciated gift under the 
Christmas tree in our family was COVID kits for everybody. I am 
still getting thank yous for those. Dr. Walensky, there has 
been a lot of discussion here today about the--some of the 
confusion with guidance and just some very clear asks to tell 
us what that is.

    A question that I am going to forward to you from a teacher 
is, if the teacher is fully vaccinated, boosted, tests positive 
for COVID, but after they test positive, they feel pretty fine, 
there is no fever, there is no nothing, after 5 days, can that 
teacher return to school without testing negative just so long 
as that individual wears a mask?

    Dr. Walensky. Yes. Thank you, Senator.

    Senator Murkowski. Great. That is exactly what I needed to 
know. I am going to be having a meeting, a zoom meeting later 
this afternoon with several different Alaska based companies 
that have more than 100 employees. They are quite concerned 
about the mandate that requires testing of unvaccinated 
employees.

    We all know that this is under litigation now, and things 
may change on that. But right now their real concern is, if 
this goes into place and we are required to ensure that these 
unvaccinated individuals receive testing, right now testing all 
around the State is in limited supply. The front page of the 
Anchorage Daily News shows the line of cars that are waiting to 
get there their PCR tests.

    You can't find the at home tests available in the stores 
now. It is becoming harder and harder. And then again, if you 
really do have a mandate in place, it is going to require this. 
So I know that the question has been asked about what more is 
being done. I know we have heard the extraordinary Federal 
resources that have gone that way, but the facts on the ground 
remain that we are in an extraordinarily short supply of 
testing, whether it is the at home kits or whether it is the 
ability to get the testing that you need.

    It is cold back home right now and my hearts go out to 
those workers who are working in the outdoor drive in where 
they have to go out when it is 20 below as it is in Fairbanks. 
That is more of a statement rather than a question there, but I 
think it is important for folks to realize that we are still in 
a very difficult place when it comes to accessibility.

    Dr. Walensky, this is a question for you, and you and I 
have had many conversations last year about the specific impact 
of conditional sail orders as it relates to the cruise 
industry. That industry was effectively shut down or all of 
2020, and we were able to salvage a bit of it as things relax 
last year.

    But in fairness, the industry itself has undertaken 
extraordinary precautions as one industry to make sure that 
people are protected from this virus. So the question to me--to 
you is, I want to make sure that Alaskan communities and 
businesses can have a season this coming year. And right now 
people are making their decisions as to whether or not to book 
a trip to Alaska for the summer or not.

    I understand the conditional sail order is set to expire in 
a few days in recognition that the companies have practices 
that adhere to or even exceed the guidance in the orders. So I 
guess I would like some assurance from you that they can count 
on that, that this is clear guidance and messaging to those 
within the industries and to those who are counting on being 
able to have a season is coming summer.

    Dr. Walensky. Yes, thank you, Senator. And I think the 
conditional sails order and the fact that the industry has 
stepped up and is now interested in doing and exceeding, as you 
note, the compliance with the sail order without the order even 
necessarily needing to be in place is a real testimony to how 
well that has worked and how we work collaboratively with the 
industry.

    What I can say is that just over the last 2 weeks with 
Omicron, we have seen a 30 fold increase in cases on ships 
during this season because of Omicron. So while I anticipate 
that with ships following conditional sail order, we still will 
continue to follow--do the oversight and watch and do all the 
technical assistance and support in every single way.

    We anticipate that this order will not be renewed and that 
the cruise ship industries will continue to understand that 
this is a really safe practice for those industries. What I 
can't predict is what the summer will bring.

    Senator Murkowski. I understand that, but for right now, 
you expect this guidance to stay in place.

    Dr. Walensky. That is my anticipation.

    Senator Murkowski. Thank you. Thank you, Madam Chair.

    The Chair. Thank you.

    Senator Hickenlooper.

    Senator Hickenlooper. Now it is on. Thank you, Madam Chair 
and Ranking Member Chair, right. First, I want to reiterate a 
little bit about what Senator Romney said. You know, I was the 
odd one out, I was--worked as a scientist for a number of 
years, then I was a Mayor of a big city and was pretty much the 
only scientist among all the Mayors. I was a Governor and 
pretty much the only scientists around Governors. And now I am 
one of the only scientists among Senators and I recognize from 
that long list of experience the frustration that you must feel 
having to put up with the attacks and assaults when you are out 
there trying to do your job. It is something that each of you 
have committed to, the service of society.

    I just want you to know that I appreciate how difficult 
science is, it is not perfect, and when you combine that with 
the complexity of dealing with any large bureaucracy, I am not 
making apologies, these are just like just like any--well, we 
are having a war against this virus, and just like in any 
wartime situation, mistakes have serious consequences, but I 
appreciate more than I can say how much work you all have done.

    I don't think anyone here thinks you are not trying your 
very best all the time. Really appreciate that. Dr. Fauci, I 
think one of the problems we haven't gotten far enough on is 
innovation, and how do we stimulate innovation to go faster and 
better? How do we increase not just the breadth of our 
vaccines, but the durability so that as we get the next wave--I 
am not sure how many letters there are in the Greek alphabet, 
but I know there is going to be another one?

    In that process, because I think we are, this country is 
known for innovation, it is one of the tools that we have that 
we know work. I am hoping that you can take the opportunity to 
be a little bit optimistic and feel that you are not going to 
be judged and held accountable because I think people want to 
hear that we are going to come through and begin to look at 
some of these things successfully.

    Dr. Fauci. Well, thank you very much, Senator, for your 
original kind comments. And I will answer your question now. As 
a scientist, that there are fundamental basic issues that are 
discovery, that once you get the discovery, then you could do 
the implementation of that discovery--we were very fortunate in 
that the basic research and clinical research investments that 
had been made literally for decades prior to the new revelation 
that we had a very threatening virus among us was the reason 
why we were able to use new platform technologies as well as 
immunogen designed to get highly successful and safe vaccines.

    That same thing is going on right now. It isn't well known 
because it isn't front page yet. And as a scientist, when you 
are doing your basic research, it is only until you get the 
result that people really understand what you have been doing.

    There is a lot of investment not only in improving the 
vaccines that we have for COVID, for SARS-CoV-2, but a lot of 
work, as I mentioned in my opening statement, about looking at 
using the tools of fundamental, basic, and applied science to 
develop next generation of vaccines, particularly universal 
coronavirus vaccines, or at least universal SARS-CoV-2 
vaccines, so we won't be chasing after the next variant. That 
we will be able to have a vaccine that has the capability of 
responding to every iteration of a variant.

    There is a lot of work going on with that right now. But 
again, when you are doing basic research, as you can appreciate 
as well more than anyone that usually isn't very well 
recognized by the public.

    Senator Hickenlooper. Point made. In terms of testing, a 
parallel thought, Dr. Woodcock, maybe you can address this, but 
the testing now by the time it gets the retail is somewhere in 
the $15 to $20 range, maybe as high as $22 or $23 in some 
places.

    Is there the prospect of--because I keep reading about 
different approaches to testing, that we might find a way to 
do--reduce the cost of testing down to service instead of $15 
could be $0.15 cents, or at least for the chemical side of it? 
I realize then you have got a manufacturer and put it in cases 
and packaging. Maybe you can provide a little optimism on that.

    Dr. Woodcock. Sure. Well, I believe the RADx program, which 
Congress provided funding for quite some time ago, is really 
cutting edge, and they have a sort of a shark tank approach. 
They are really looking for innovation.

    They are--they provide assistance to developers, and I 
really believe that is promising, that we will come up with 
additional technologies that are easier to manufacture and 
actually easier for people to use and cheaper.

    Senator Hickenlooper. Great. Thank you, and I have 
obviously more questions, but I will yield the floor back--for 
now.

    The Chair. Thank you.

    Senator Braun.

    Senator Braun. Thank you, Madam Chair. Reading the paper 
last night, lead editorial in The Washington Post, and I about 
dropped it when I read the first paragraph. In the title of the 
editorial is, living with COVID. ``Quite understandably, the 
coronavirus pandemic at first was a dire emergency, but it 
can't be one forever. The crisis will have to shift to a 
manageable health threat without massive disruption and 
overwhelming anxiety. President Biden has been fighting the 
virus as an emergency in his first year, but a shift must come 
before too long.'' Never thought I would read anything like 
that in a place like Washington Post, but I think it reflects 
where we are at in the journey.

    Generally when you wrestle with something of this magnitude 
where it has dominated the conversation for now 2 years and you 
are still seeing results similar to, if not worse, from when we 
started, it would beg the question, do we need to take a 
different approach? It has been very top-down, been put in 
place, I think understandably, by the agencies that would be 
most pertinent.

    But when you look at the results, you look at the fact that 
a third of the country, for whatever reason, is not going to 
get vaccinated. You got a mandate that now is going to force 
the hand. And when you get someplace like The Washington Post 
saying that we have got to take a different approach, I am 
wondering, do we have it within our constitution here, when we 
have been brought in for so long that this is the way it has 
got to be?

    Listening to Senator Casey earlier, made a very good point, 
everybody talks about data, paying attention to the data, and 
when this is so ravaged such a small percentage so 
significantly of a population with comorbidities that are 
elderly, it just keeps saying, why don't we change the 
approach?

    You don't want to have the legacy of being a country in 
disruption and full of anxiety. And kind of what I am hearing 
here today, I am not sensing that we are going to see a real 
change in approach, and even more so, doubling down on what now 
for 2 years has arguably not gotten us in a place where we feel 
better about it, where we are not drowning in anxiety. And I am 
going to pose the question to Dr. Woodcock.

    You have been involved in Federal health care in one way or 
another for a long time, Acting Commissioner at the FDA. 
Normally, a Board of Directors, a CEO would be fired as a CEO, 
No. 1, a Board of Directors would be questioned in terms of how 
good they are, meaning maybe us here in the Senate, to where 
you are not directing for something other than what we have 
had, which in my opinion, would be decentralizing it, providing 
the information to the American public to make their own best 
decisions.

    Dr. Woodcock, do you think that is sensible? Do you think 
The Washington Post makes sense? And are you willing to change 
up there on this panel to reflect accordingly?

    Dr. Woodcock. Well, I think that we are talking about a 
natural disaster, and you can fire your Board of Directors 
because your factory was devastated by a hurricane or tornado 
or a wildfire, but I don't know whether that would improve this 
situation. I think right now we need to focus on continuity of 
operations for hospitals and other essential services as this 
variant sweeps through the population.

    I don't think that will last a really long time, but that 
is what--where I think we are right now. So I don't think prior 
approaches reflect what is going on right now. I think it is 
hard to process what is actually happening right now, which is 
most people are going to get COVID, alright.

    What we need to do is make sure that hospitals can still 
function, transportation other essential services are not 
disrupted while this happens. I think after that will be a good 
time to reassess how we are approaching this pandemic.

    Senator Braun. I am out of time, but I think if you want to 
regain the trust of the American public, you probably need to 
look at a total revamp on what we do in terms of how we contend 
with it over the next year or so, or I think you are going to 
get more forceful editorials from places that you would never 
imagine. If you keep doing the same thing, generating the same 
results, that isn't the formula for success in any endeavor.

    The Chair. Thank you.

    Senator Baldwin.

    Senator Baldwin. Thank you, Madam Chair. And I want to 
thank all of our witnesses today. And I also want to just 
underscore the preface that our colleague, Senator Romney, gave 
to his questioning. I like the way he described it, sometimes 
we come to perform, sometimes we come to be informed.

    I guess I would just speculate a little bit beyond that if 
there were to be a true tit for tat on the performance angle, 
there is any number of areas we could go. I reflect on 
proposals for ultraviolet light and drinking bleach and 
drinking hydroxychloroquine. We could go there, but it is not 
constructive.

    I am going to be constructive in my questions, and I just 
urge my colleagues to do that. We are all in this together, and 
we have a duty to act responsibly in that fashion. And again, 
thank you to our witnesses. Dr. Walensky, I am going to start 
with you on a topic that I bring up frequently when you are in 
our presence, and that is the tools we have now to sequence, do 
genomic sequences to better understand variants, to better 
track variants.

    I know that there has been much investment in that. I would 
like to hear what tools that we have in place now that we 
didn't before and what you see the future of this genomic 
sequencing is, especially as this Committee looks at pandemic 
preparation for future potential pandemics.

    Dr. Walensky. Thank you, Senator Baldwin, and for your 
championing our ability to ramp up our genomic sequencing 
efforts and the resources from the American Rescue Plan. Once 
that $1.7 billion really did allow us to detect Omicron 
swiftly.

    Maybe I will just tell you the story of what happened with 
Omicron, and that as we heard about this variant that was 
coming from South Africa and we didn't know if it was here yet, 
but we did know it had this unique footprint of the S-gene 
target failure on PCR.

    What we did immediately after hearing about this is to 
enhance surveillance for this footprint and do enhanced 
sequencing so that any sequence that had this footprint--I 
shouldn't say any. Many sequences that had this footprint, we 
were specifically looking for this Omicron variant.

    Within days, we found it. So within 3 days, I think that we 
started doing this enhanced surveillance, and then within days 
we had tens, forties. By about 4 days later, by December 5th is 
when we started detecting it in our background genomic 
sequencing. So that background genomic sequencing now does tens 
of thousands of sequences a week. It is a collaboration with 
academic partners, industry commercial labs, CDC labs, public 
health partners to do tens of thousands of sequences a week.

    What we do is we look at the number of cases that are out 
there, and our goal is to detect a variant that is present at 
0.1 percent with 99 percent confidence, so that we see the menu 
of variants that are out there. We are enthusiastic about this 
program.

    We are intending to ramp up this program for potentially 
other viruses with the potential to do so there, for other 
foodborne outbreaks, as well as for wastewater investigation. 
We have the capacity to do that there as well. So again, thank 
you for championing this effort, which truly did allow us to 
detect Omicron in real record speed. Thank you.

    Senator Baldwin. Thank you. Next, Assistant Secretary 
O'Connell, when we last met in this Committee, I asked you for 
a commitment that a significant portion of the $10 billion for 
the Defense Production Act funding that I helped secure as part 
of the American Rescue Plan be invested in the raw materials 
needed to make N95 masks here in America.

    The alarming spread of Omicron has made the need for N95 
even more clear, and yet ASPR has not spent any of this 
American Rescue Plan funding on the raw material needed to make 
N95s in America, while it has invested $3.1 billion on other 
priorities, primarily using prior supplemental funding.

    The FDA reports now that 60 percent of the KN95 masks that 
are being imported from China are fake, and Americans still 
can't go to a local pharmacy and purchase an American made N95. 
So President Biden has now personally urged Americans to 
upgrade the quality of the masks they wear.

    I want to know when the American people will be able to buy 
an American made N95 mask that they know will protect them, and 
when we can expect ASPR to invest the American Rescue Plan 
funding into the raw materials necessary.

    Ms. O'Connell. Senator Baldwin, thank you for that 
question. You can buy an N95 mask manufactured in America now. 
We have 737 millions of those in the Strategic National 
Stockpile. We are also in the process, this month, we hope, to 
award--or next month as contracts go, to award an agreement for 
warm based manufacturing of N95 masks.

    What we are asking the vendors to return to us as part of 
the proposal is their ability to manage 141 million masks a 
month at a surge capacity and to be able to maintain that 
manufacturing at a 20 to 30 percent rate in times where demand 
is not as high.

    We are very invested in N95 masks being made available, and 
we will continue to look, and I appreciate your support in 
getting us the American Rescue Plan dollars that we are 
currently investing. And we will continue to look at the right 
ways to invest that and have really appreciated the 
conversations you and I have had around that.

    The Chair. Thank you very much. I appreciate the witnesses 
have been here well over two and a half hours. We are going to 
have a second round of questions. So I am going to recess for 
10 minutes to allow a break for our witnesses. We will 
reconvene at 12.45 p.m.

    [Recess.]

    The Chair. This Committee will reconvene. And before I 
start, I do want to make clear that this Committee will conduct 
itself with decorum and respect, and if I do hear personal 
attacks, I will gavel, and we will move on to the next 
questions. And I want to thank the Committee Members and 
witnesses.

    I also am going to be very strict with the 5-minute rule as 
we have moved way past our time here and we need to move on. So 
with that, I look forward to the next round of questions so we 
can get to the essential work of addressing this pandemic, 
which has upended so many lives and that continues to threaten 
the public health. And we will begin with Senator Baldwin.

    Senator Baldwin. Thank you, Madam Chair. Dr. Walensky, 
during our last hearing, we discussed the critical need for my 
Bio-Preparedness Workforce Act legislation that I introduced 
with Senators Collins, Rosen, and Murkowski to strengthen our 
outbreak response workforce so that we can better prepare for 
the next pandemic.

    This legislation would address the serious workforce 
shortages and recruitment challenges that you mentioned by 
establishing a new loan repayment program focused on 
encouraging students to pursue careers as clinicians and bio 
preparedness health professionals.

    As this Committee assembles a package of policies to 
respond to the next pandemic, it is important to remember that 
without people, there is no preparedness. In the midst of the 
Omicron surge, it has never been clearer that we need a robust 
and capable workforce to fully respond to public health 
emergencies.

    The Bio Preparedness Workforce Act would go a long way 
toward that goal. So Dr. Walensky, as an infectious disease 
physician and public health leader, can you share more about 
how a strong clinical and public health workforce is key to 
responding to outbreaks, and how legislation like the Bio 
Preparedness Workforce Act is important to prepare for the 
future--for future public health emergencies?

    Dr. Walensky. Yes. Thank you, Senator. There is so much 
here. So first, let me just say there has been a recent study 
that had demonstrated that our public health workforce is now 
down about 80,000 jobs. So just to give you a sense of massive 
public health workforce--that is not physicians who are 
actually doing the work on the ground, right, in the hospitals. 
This is a public health workforce down 80,000 jobs.

    We saw through this pandemic the challenges in sort of the 
volume of people who are doing public health work, but also 
where they were located and their experience. We need an up 
skilled public health workforce.

    For example, we need people to do those genomic sequences. 
We need genomic epidemiologists. We need people who are 
diverse, as diverse as the communities they serve. We also need 
to make sure that they are compensated and have the right 
salaries, and as you say, have loan repayment for their work.

    To give folks a sense, the infectious disease physicians 
are among the lowest paying physicians in hospitals. They don't 
do procedures. And by virtue of not doing procedures, there is 
not a large incentive from a financial standpoint to continue 
to go into infectious diseases, which are the bread and butter 
of what outbreak investigation and clinical does.

    There have been many resources that we are moving forward 
to expand our public health workforce. Public Health AmeriCorps 
is a big piece of that. And that is something that we are 
working on and really grateful to resources from Congress to be 
able to do so.

    But there is a vital need now to expand our public health 
workforce in laboratory capacity, in genomic surveillance, in 
disease outbreak investigation, and a workforce that is 
upskilled and as diverse as the communities we serve. Thank 
you.

    Senator Baldwin. Thank you. We all know that vaccines 
remain the best way to protect yourself against existing 
variants of COVID-19. And I have been encouraged by the FDA's 
work to authorize vaccines for the public.

    But parents continue to be concerned that we don't have a 
vaccine for their kids as Omicron surges. Dr. Woodcock, can you 
provide an update on where we are in examination of the 
authorization of COVID-19 vaccines for children under five?

    Dr. Woodcock. Certainly. As Dr. Fauci said earlier, there 
were--one of the companies, Pfizer had done trials. There were 
other trials going on. There were probably complications with 
the dose in the slightly older of the younger children, perhaps 
indicating that a third dose, as Dr. Fauci said, might be 
needed to the primary regimen.

    FDA is working with the company very closely. Trials are 
ongoing. I too have heard from many, many parents of the 
youngest children. They have other children in school. They may 
have immunocompromised individuals in their household, and 
there are people who really want to get this vaccine, so--one 
of the vaccines and get the children vaccinated.

    We are working very intensely on this right now, and we are 
working, of course, with NIH and with the companies.

    Senator Baldwin. Thank you. I yield back.

    The Chair. Thank you.

    Senator Paul.

    Senator Paul. Dr. Fauci, it is disappointing for you to 
suggest that people who dare to question you are responsible 
somehow for violent threats. Realize that by attacking me you 
are attacking the one Member who actually has suffered from 
violent attacks. I was at the ballfield the day Steve Scalise 
almost died.

    I was 10 feet away from a staffer who was shot in the leg. 
We had over 160 rounds of semiautomatic weapons fired at us, 
ammunition. So for you to somehow suggest that somehow I or 
people who dare to oppose you are responsible for a threat that 
is insulting. The person who shot at us and almost killed Steve 
Scalise was a rabid supporter of Bernie Sanders.

    But the one thing you will find if you look at the record 
is not one of us accused Bernie Sanders of being responsible 
for that. So this is the kind of ignorant sort of personal 
attacks that you have engaged in.

    You engaged in these attacks with fellow scientists. Not 
only was it three scientists from Harvard, Oxford, and Stanford 
that you chose to malign, 50,000 scientists and medical doctors 
signed this petition. And what they wanted was something that 
most Americans think is pretty reasonable, is a different kind 
of approach. Instead of saying that everyone is the same and 
everyone should get the same treatment, and everybody ought to 
just get vaccinated, what it did is it said that the death rate 
for this disease is extraordinary in the risk being different 
according to ages.

    If you look at an 80 year old, it is at least a thousand 
times greater death rate than it is for a 10 year old. So 
wouldn't we want to say that well, we are going to assess the 
risks of each individual and have the treatment according to 
that? Or would we just simply say everyone should be 
vaccinated? The death rate for kids under 18 is about one in a 
million, a little bit less than the chance of being struck by 
lightning.

    We don't yet know fully whether or not kids who have 
already had COVID might be at risk for some of the side effects 
of the vaccine. It still needs to be explored. But for a kid 
under 18 who has already had COVID, the death rate of about one 
in a million, even if you haven't had a disease, even if you 
haven't had COVID, it is about one in a million.

    It is extraordinarily uncommon for a child to die. If you 
have already had the disease, it is probably a great deal less 
than that. Many Americans wonder why you steadfastly refused 
and worked with others to try to hide any kind of knowledge of 
natural immunity and how it would affect our decisionmaking.

    For example you have a 10 year old kid and his mom comes 
up, and all of a sudden he gets myocarditis from the vaccine 
and dies. Admittedly, a rare complication. But what are you 
going to tell her when she says, well, he had COVID 3 months 
ago, I mean, why would you force me to vaccinate my kid? Why 
would you force me to vaccinate my kid without even checking to 
see whether he is already immune?

    Now, the idea of natural immunity is the idea upon which 
vaccines are based. We have believed in, and all of medicine is 
based on the idea of acquiring natural immunity. People often 
respond and say, but you don't know how long it will last. 
Well, we don't know how long vaccines will last and that 
doesn't make us anti-vaccine. We do know that the vaccines are 
waning very quickly in potency.

    We do know that the vaccine against Omicron really isn't 
preventing transmission. You have noticed that the debate has 
shifted, and the debate is now talking about trying to prevent 
hospitalizations and death. And I agree with those statistics. 
I think it is a good idea if you are at risk to be vaccinated. 
I have always been pro-vaccine. I am just simply against 
authoritarianism and against mandates.

    The anger that has developed with you, Dr. Fauci, is that 
you don't want to give us advice, you want to tell us what to 
do. You think you are the science and that anybody responds to 
you, how dare you, how dare you criticize science, as if you 
somehow our science. That kind of arrogance, that hubris is 
really--that is where the anger is coming toward you.

    If you were one doctor among hundreds of doctors in the 
Government who gave advice, I don't think anybody--people might 
object to your advice, but there wouldn't be such a degree of 
anger. But you are so certain that you are right, they are not 
willing to hear anyone else.

    Three epidemiologists, of which you are not even an 
epidemiologist, but three epidemiologists prominent in their 
field, Oxford, Stanford, and Harvard, you maligned them. You 
spoke openly with Dr. Collins, and you did not disagree that 
let's paint them as fringe. You went after them and said, we 
will do a public takedown, not in science or Nature, or Lancet, 
in Wired, in the Nation, a left wing publication.

    You have engaged in base politics. You will wonder why 
there is so much anger? You are not an objective scientist. You 
have lost that long ago. And so many of the things that people 
want, it is like, they say they want to know why you are 
forcing their children to be vaccinated when 95 percent of 
people at risk have been vaccinated.

    Over 95 percent of people over 65, it is huge voluntary 
success. And yet you won't rest until you force every child to 
get this. So yes, there is a great deal of dissatisfaction with 
you and many people want you to go, but nobody wishes you 
violence.

    The Chair. Senator Paul, your time has expired. I will use 
one time of my remaining 5 minutes to allow Senator Fauci to 
respond.

    Dr. Fauci. Thank you very much----

    The Chair. Dr. Fauci.

    Senator Paul. Thank you, Dr. Murray----

    [Laughter.]

    The  Chair. No, no.

    Dr. Fauci. So first of all, Senator, again, at a hearing 
such as this, where there are almost 900,000 people in this 
country have died from this outbreak, you have chosen to just 
personal attacks on me that go back to multiple hearings.

    Again, just for the record, for people to check, I have 
never said take people down in that email. It was an email that 
was sent to me see, and again----

    Senator Paul. You agreed with Dr. Collins in the email.

    The Chair. Senator Paul, this is my time.

    Dr. Fauci. You know, you personally attacked me and the 
things that you do are incorrect and proven incorrect. You have 
publicly accused me at a hearing of being responsible for the 
deaths of 5 million people when there is not a single, single 
shred of evidence that anything that was done with the NIH had 
anything to do with COVID-19. You talk about things like gain 
of function----

    The Chair. Dr. Fauci, I am going to let you respond 
continually, but I think you have responded, and I appreciate--
--

    Dr. Fauci. Okay, I appreciate the time. Thank you very 
much, Madam Chair. But I just want to say I am actually stunned 
by the amount of misinformation. The only thing I have ever 
done, and this will take 20 seconds. If you look at the things 
I have said, they have been to support the recommendations of 
the CDC, of their advisory committees, and of the FDA.

    I have told people that it is important to get vaccinated, 
to get boosted, to wear a mask, and to be prudent. That is the 
only thing I said. I haven't dictated anything that is only a 
monolith with me. It is always public health practices. And 
anybody goes back over any record of me, they know that.

    The Chair. Thank you and I will retain the balance of my 
time. Thank you very much.

    Senator Casey.

    Senator Casey. Thank you, Chair Murray. I want to start 
with Dr. Walensky. Doctor, as the CDC has been working with my 
staff on an outstanding nursing home vaccine data request. I 
would appreciate it if you and your team would continue to work 
with me and with our team at the Aging Committee to resolve 
this matter.

    Dr. Walensky. Yes, thank you, Senator, I am aware of that 
matter, and we are committed to continuing to that work with 
you. Thank you.

    Senator Casey. Thank you. Let me turn to a matter for 
Health and Human Services. Assistant Secretary O'Connell, you 
know that our Nation's long term care facilities were ground 
zero during the first year of COVID-19. 200,000 residents and 
workers, when we add up the number of residents plus the number 
of workers who died, it gets to 200,000 over these 2 years.

    However, nursing home deaths have declined, declined 
dramatically thanks to the safety and effectiveness of the 
vaccines. It is a credit to the Administration that 90 percent 
of nursing home residents and 80 percent of workers have been 
vaccinated. We know that infections are on the rise right now, 
though, in nursing homes, raising safety concerns and putting 
additional pressures on workers who have been stretched thin.

    For instance, we know the pandemic has worsened existing 
staffing shortages and turnover issues. So we also know at the 
same time that the rescue plan the Democrats passed in March 
helped to fill the staffing gap with a $500 million initiative 
for strike teams based upon legislation that I was leading 
recently.

    These strike teams provide medical personnel and other 
supports that help nursing homes get through the surges like 
the one that we are seeing right now. On the 22d of December of 
last year, I along with three of my colleagues sent a letter to 
Secretary Becerra asking how Health and Human Services was 
protecting nursing home residents and workers in the current 
COVID-19 surge, including the distribution of booster shots.

    What is HHS doing to ensure nursing homes have the support 
they need to protect residents and workers who care for those 
residents?

    Ms. O'Connell. Senator Casey, thank you so much for your 
question. We share your concern for nursing home staff and long 
term care facility residents and have continued to do all we 
can to make sure they have access to boosts.

    We have worked with pharmacies to bring in vaccination 
clinics, bring those to the long term care facilities and 
skilled nursing facilities so that vaccines are available on 
the ground and the residents don't have to travel or access the 
vaccines on their own.

    In addition, ASPR has been sending since the beginning of 
the pandemic or since the beginning that these tests were 
available, 2.8 million tests per week to long term care 
facilities across the country. We know how important it is that 
they are able to surveil any disease in their facilities and 
having access to these tests is one of the ways they can stay 
on top of where they are.

    We share your concern, and we will look forward to 
responding to your letter.

    Senator Casey. Thanks very much.

    The Chair. Senator Burr.

    Senator Burr. Thank you, Madam Chairman. Ms. Woodcock, I 
know you said a while ago that you are excited about what RADx 
accomplished, and I think we all are. But FDA issued revised 
guidance stating that it would focus its review efforts on at 
home testing and point of care COVID test applications from 
developers, with the capacity to manufacture more than 500,000 
tests per week within 3 months of being authorized.

    Why did the FDA move the goalpost at this particular time 
and suggest to companies that can't ramp up to that 
manufacturing that they are not going to get an accelerated EUA 
pathway?

    Dr. Woodcock. Well, because of what some of the Members 
have been discussing over the last several hours that we have 
an urgent need for high volume, home based tests, and we have a 
queue--we have done, moved heaven and earth to get as many done 
as possible.

    We have approved, authorized over 400 different kinds of 
tasks or test collection devices during this pandemic. But as 
far as what the queue is a priority, we are prioritizing the 
highest volume and just putting them to the front so that we 
can get home test kits into the hands of people.

    Senator Burr. I get what you are doing. My question is 
this, what does this say to the innovative company that is out 
there that doesn't have the manufacturing capacity, and without 
us marrying them to a large manufacturing capacity, it is 
basically saying don't innovate because you are not going to 
get consideration under the EUA if you don't have a 
manufacturing capacity 500,000 tests a week.

    Dr. Woodcock. It says these are prioritized. It doesn't say 
we won't get to the others.

    Senator Burr. Well, get to the others. I mean this there is 
all--a sense of urgency here. I just think that might have been 
thought of before we did this. Let me go to you, Ms. O'Connell. 
I am really challenged on this procurement of 500 million 
tests, as you can tell.

    I don't understand why there has not been a release that 
came out of ASPR or BARDA publicly announcing here is how many 
we have contracted, that I have got to find it somewhere in a 
DOD contract that a very limited amount of people go to, 
certainly not one that I regularly looked at.

    But based on what of your contracts, we have got 13.6 
million tests costing $190 million. I think that is from the 
vodka distributor. When I break that down, that is about $14 a 
test. Now, CMS just put out a new rule that mandated that 
insurers must cover up to eight tests per person per week--per 
month for a family of four, that is 32 tests, and that they can 
reimburse at $12.

    Now, if I am a manufacturer and I am under a $12 
reimbursement or I can go over here and I can sell directly to 
the Federal Government and get $14, I am probably going to sell 
to the Federal Government to get $14. Where am I wrong?

    Ms. O'Connell. Thank you, Senator Burr. We continue to work 
to access the tests that will be distributed as part of the 500 
million and the tests that you are referring to.

    First of all, DOD by tradition has put out, whenever we 
have done and assisted acquisitions with them, they put out 
within the first 24 hours of that contract going out an 
announcement that the contract has gone out.

    That is what you are seeing and that has been the rigor. It 
has been what--the way DOD has approached us through our entire 
relationship. We are continuing to----

    Senator Burr. Why would ASPR not putting out a similar 
public statement?

    Ms. O'Connell. We would be happy to and thank you, Senator. 
I will go back and talk to the communications team and see if 
there is a companion press release that makes sense for us to 
put out.

    Senator Burr. Well, I am not sure you addressed my concern, 
which is it is more profitable to sell to the Federal 
Government than it is to put it on retail based on the 
reimbursements that this Administration has now required of 
insurers. I hope you will think about that. This is alarming to 
me.

    As we have all displayed, there are no tests out there. 
There are no tests on the shelves of Walgreens, CVS that people 
can go in, buy, and take home, and do it. So it makes it even 
more confusing CDC's policy that if you want to take a test, go 
ahead and take it. It is not required, but you can take it. You 
can't get it.

    Dr. Fauci, just very quickly. South African data suggests 
that Omicron may have an ability to build immunity to Delta. 
Delta does not have an immunity--it does not build an immunity 
to Omicron. Have you got any comments on that? Cyprus announced 
a Deltacron variant. Are you worried about that?

    We have been about 3 weeks behind Israel throughout this 
whole thing. And even though we have seen South African data go 
up and go back down very quickly, Israel epidemiologists just 
this week said they expect that for the next 2 weeks, they will 
see a doubling of the infections in Israel, meaning they are 
not following the same timeline that we saw in South Africa. 
How should we interpret that for the U.S.?

    Dr. Fauci. Okay, thank you very much for those questions, 
Senator. With regard to the cross-protection, I think it is too 
early to tell because you are dealing with multiple population 
demography of people who have been previously infected, 
vaccinated, or what have you.

    It seems pretty clear that if you get infected with 
Omicron, you are going to get good protection against Omicron, 
but also good protection against some of the other spillover. 
So we really yet to have seen, and I think the basis of your 
question is a reasonable one. If we wind up getting infected 
with Omicron at a very, very low level of pathogenicity, is 
that going to be sort of almost like a live attenuated vaccine?

    I don't think we can say that right now. We really have to 
see how things spread out when we see how that affairs in the 
next variant. So there will be invariably another variant. We 
are going to have to take a look at whether or not there is 
going to be any protection there. That is the first thing. With 
regard to the Deltacron, this new variant, right now, even 
though it has got a bunch of mutations that people look at, it 
is not something that at least the WHO has looked at this 
carefully, feels that has to be something that is of great 
concern, but we always keep our eye on it to make sure.

    When you say it is not of a great concern now--the one 
encouraging thing about it is that it has been around for a 
while. It isn't something that just popped up, and yet Omicron 
completely outstripped it, as did Delta. So it doesn't look 
like it has the capability of being transmissible enough to be 
a problem.

    Nonetheless, we still keep an eye out on it. With regard to 
Israel, I mean, I am not--I am sorry. I forgot your question 
about Israel. Could you repeat it?

    The Chair. We are way over time here.

    Senator Burr. They are on about 3 weeks in front of us but 
yet their experience is not up and down drastically. Like South 
Africa, data begins to show, they went up, and now it looks 
like over the next 2 week, their epidemiologists say it is 
going to double and maybe double again before they hope it 
comes down. What should we expect?

    Dr. Fauci. Yes, I think it is a bit--that is a great 
question, Senator. But what it really reflects is that when you 
have an outbreak of a particular variant, how high it goes up, 
when it peaks and comes down is a reflection of what the status 
is in your country.

    Because if you look at what you saw in South Africa, they 
were almost free of Delta when they got Omicron. So Omicron--so 
it had the unfettered capability of going way up and way down. 
When you talk about what happened in Israel that is a different 
population. It is a mostly vaccinated population, so they are 
likely going to see breakthrough infections.

    In the United States, we have such a large country with 
such differences in vaccinations versus infections, etcetera, 
that we believe we will see it peak, and we will see it come 
down. But it is very difficult to predict whether it is going 
to be a sharp decrease or whether it is going to do this.

    Our own feeling, and I believe that Dr. Walensky feels the 
same way as I do, that it is going to vary depending upon where 
in the country you are, how much infection you had previously, 
what at the level of vaccination is. So we may see a peak up 
and down in some regions of the country and a pickup and doing 
this in other regions of the country. Thank you.

    The Chair. Thank you very much.

    Senator Smith.

    Senator Smith. Thank you, Madam Chair. I would like to ask 
a question of Dr. Walensky, if I could. I think we all know 
that Americans need better access to rapid testing, and this is 
a big deal for us in terms of trying to figure out what are our 
health risks, how do we protect ourselves, and how do we also 
go about our lives?

    I think that we are making headway here, that we have a 
long way to go. Dr. Walensky, I would like you to talk about 
this issue of how we should be or not collecting and analyzing 
the data from rapid home tests. Should we be incorporating this 
data into like should be trying to capture that data? Is this 
important for local communities as they are trying to make 
decisions about masking and other public health strategies that 
they want to deploy?

    Should we be thinking of the data from rapid tests as a 
tool for individual risk assessment or as an important tool for 
population level understanding of what is happening? How do you 
see that?

    Dr. Walensky. Yes, thank you so much, Senator Smith. So we 
have been using the PCR test, not the rapid tests, the lab 
tests, the molecular tests to really capture our case counts 
and really get a good view of where we are in terms of the 
epidemiology, anticipating what was going to be coming into the 
hospitals. But the tests are a really important valuable tool 
for people to empower themselves, their own health, to not 
expose themselves to other people, to get some information 
about their own health.

    If an individual were to test positive, if they are feeling 
unwell, they should certainly consult with a health care 
provider, consult with a pharmacist, and your health 
Department. But if you are feeling well, then use that rapid 
test to say, okay, my test was positive, I need to stay home 
and isolate, protect myself from the community, protect myself 
or the community from me, and protect me--my loved ones so that 
they don't get infected themselves.

    I think that it is less about the absolute case count of 
understanding whether you have asymptomatic infection, or a 
runny nose and your rapid test was positive, than it is really 
about empowering you to do the right thing and not be forward 
transmitting.

    Senator Smith. Could you talk a little bit about what other 
countries are doing. Are other countries in trying to 
incorporate this rapid testing data into their population 
metrics--how is that working in other places around the world?

    Dr. Walensky. Some countries are, and some countries 
aren't. London and UK have been doing more reporting of rapid 
testing, but they too are saying that they are missing I think 
somewhere around 40 percent, I would have to confirm that 
number, but they too, well they capture more than we have tried 
to. They also agree that they are missing some as well.

    Senator Smith. Okay. Thank you very much. Madam Chair, I am 
going to cede back the rest of my time. I just want to 
acknowledge something I think has been going on here today that 
I think just deserves being called out.

    Dr. Fauci has been the target of a concerted and 
coordinated campaign of disinformation and distortion and 
personal attacks, and then he is being blamed for all of this 
hatred and anger that has been generated against him.

    I think we just need to be honest here that this is being 
done by some members of the Republican Party that are using it 
for fundraising. I am not saying that is happening by members 
of this--I am just saying that is happening. It was just 
pointed out to me that somebody sent out earlier in 2021, a 
Fauci for prison email.

    I just think it is important that we--I have to call this 
out, and I think it is important that we see it and we have to 
try to rise above this kind of behavior. Our Committee here 
should be focusing on these kinds of nitty gritty policy 
questions, and we are not always going to agree.

    I have never heard Dr. Fauci, or Dr. Walensky, for that 
matter, declare themselves to be invincible. I certainly am 
not. But that should not mean that an individual's career, 
public servants are subjected to this kind of abuse. Thank you, 
Madam Chair.

    The Chair. Thank you.

    Senator Collins.

    Senator Collins. Ms. O'Connell, I want to follow-up on my 
previous questions to you because I don't feel, frankly, that I 
got answers. I asked you specifically how much money was 
diverted from the testing budget to deal with the surge of 
people, including unaccompanied minors, illegally crossing the 
Southern border, and how much money was diverted out of the 
funds allocated for the strategic stockpile?

    Ms. O'Connell. Thank you, Senator Collins. Again, all of 
the funds, as they were appropriated to the American Rescue 
Plan, were for testing, contact tracing, and mitigation 
efforts.

    Of those funds, funds were used to test unaccompanied 
children at the border and then to mitigate the COVID positive 
cases so they wouldn't enter the community and spread COVID, 
which was a use of the funds that was allowed under the 
testing, contact tracing, and mitigation requirements.

    Senator Collins. Well, you are still not answering my 
question on the amount of money that was used to deal with the 
crisis at the Southern border, so I will tell you that our 
staff's investigation found that $850 million out of the 
testing budget and another $850 million out of the allocation 
for the stockpile were instead used to deal with the crisis at 
the Southern border. Do those numbers sound right to you?

    Ms. O'Connell. Senator, I will be happy to take that back 
and discuss that with our finance team to make sure that those 
numbers are the same numbers that they are tracking.

    Senator Collins. Well, I have to say that it is interesting 
to me that you knew all of the numbers, and I commend you for 
this, that we are going to community programs, to schools, 
etcetera, but you can't tell me how much was reallocated to 
deal with the crisis at the Southern border, a crisis that we 
are it right under control, we would have these funds for the 
purposes that they were intended. Let me ask you further, what 
do you mean when you say mitigation as applied to the Southern 
border and the surge, the unprecedented surge of people 
crossing?

    Ms. O'Connell. Thank you. One of the important things that 
we needed to do when we identified a COVID positive 
unaccompanied child was to make sure, for example, they didn't 
ride on the same bus to a shelter with a COVID negative child. 
So there were additional costs for transportation to keep the 
children separate to mitigate spread as the statute allowed us 
to spend those funds.

    In addition, within the shelters, it was necessary to set 
up a separate room where COVID positive unaccompanied children 
would reside so they wouldn't interact with their COVID 
negative children. And that required additional resources in 
those shelters in order to keep them separate.

    When the children entered the community with their 
sponsors, they were not bringing COVID into the communities.

    Senator Collins. Well, I will tell you, having visited the 
Southern border in late March, testing was being done, but 
people had been there for weeks at a time with no testing, and 
there were people, adults who were released into the community 
with no testing.

    The fact remains that if we had the Southern border under 
control, we would be using the $850 million designated for 
testing to buy more rapid tests. We would be using the money 
out of the stockpile, the $850 million for the purposes for 
which it was intended.

    I think that this is a problem that has contributed to the 
shortage of testing, the uncontrolled crisis at the border, and 
I also am perplexed by the lack of Federal orders for tests 
between January and September 2021, which I know from my 
experience in Maine caused the major manufacturer, Abbott, to 
lay off 400 workers that were producing those tests because it 
lacked the Federal orders. That makes no sense to me and seems 
very shortsighted. Thank you.

    The Chair. Thank you, Senator.

    Senator Hickenlooper.

    Senator Hickenlooper. Great. Thank you, Madam Chair. Again, 
thank each of you for your public service. Dr. Walensky, I 
wanted to talk to you just for a moment about genomic 
sequencing. Even before COVID-19 appeared, Colorado made a 
genomic sequencing of diseases a high priority, and we are now, 
I think, one of the leading States in detecting changes as they 
evolve and COVID-19.

    We test about 15 percent of all positive COVID tests. I 
think that is still one of the highest rates in the country. 
And we also monitor wastewater for community detection. So, Dr. 
Walensky, how would we or how can we expand genomics 
surveillance and expand those capabilities in order to try to 
stay ahead of existing but also future threats, COVID-19 or 
otherwise? How do we close the gap between the states that are 
heavily sequencing and following this and those that aren't?

    Dr. Walensky. Yes. Thank you for that and for your 
leadership in Colorado in genomic sequencing. As I have 
mentioned we need to have both numbers and breadth and 
geographic distribution in order to get a real good view of 
what is happening genomic--in genomic sequencing.

    We need to sample from State labs, so we get samples from 
every single lab. We also get samples from commercial labs, 
which gives us a lot of volume. We have partnerships now with 
19, I believe, academic medical centers in order to do so. And 
what we do and power our genomic sequencing is so that we are 
able to detect a sequence that is present in less than 0.1 
percent.

    We scale up and based on the number of cases that we have, 
we scale up or scale down our genomic sequencing so we can 
detect it. And what we were able to do with Omicron is when we 
saw the footprint of the S-gene target failure in PCR, a 
similar footprint as Alpha, we were able to do targeted 
enhanced surveillance of sequences that actually had that 
initial footprint and able to identify sequences even before 
they reach that 0.1 percent threshold.

    As you said, we can scale this up in wastewater. We are 
able to potentially scale it up for purposes of antimicrobial 
resistance, for foodborne outbreaks, and many other things, 
which we are really looking forward to doing now that we have 
established this incredible capacity.

    Senator Hickenlooper. Right. Great. Perfect. Ms. O'Connell, 
I want to ask you a question in terms of the, we have talked a 
lot about the distribution of tests and whether it is schools 
or workplaces, hospitals, and we have talked about how at this 
moment we don't have enough tests out there and we are not 
getting results quickly enough.

    In terms of the distribution of tests on a national level, 
we are still obviously working on a system, I know the 
Administration is hard at work on this, but some States like 
Colorado already have systems in place where tests are being 
mailed directly to people in their home.

    I guess, I am not--I don't know, is the Federal Government 
working with States like Colorado and trying to look at those 
systems already in place, and how do we integrate the Federal 
system with those States?

    Ms. O'Connell. Absolutely. Thank you, Senator. That is 
terrific what Colorado is doing. We have invested $29 billion 
with the State so they could set up such testing programs 
however they saw fit. And we are seeing States like Colorado 
use those funds to be able to do exactly what we are hoping to 
do on a national level. We are in the process, as we have 
talked about today, setting this up, working with the U.S. 
Postal Service.

    As the Federal Government, we will allow American 
households to order and have them delivered to their house as 
well. I imagine that we will--these will be in addition to what 
Colorado is able to provide. And we want to have as many tests, 
of course, available to all Americans as possible.

    If Colorado is already doing it that is terrific. I am sure 
we will learn some lessons from the experiences you have had in 
your State and apply those to this national initiative.

    Senator Hickenlooper. Great. Thank you on that. And then 
just real quickly, Dr. Fauci, we have heard from Dr. Walensky, 
who was just talking about how you integrate the aggregation of 
large amounts of data, and we have had a discussion about 
Israel versus South Africa, and it really is a question of how 
do we take--my question is, is how do we take information from 
global sources and learn from those countries who are ahead of 
us on the curve, make sure that we are learning from their 
experiences. And I think how can we do a better job working 
with our international partners to make sure that we are 
prepared for the next Greek letter?

    Dr. Fauci. Yes. Well, thank you very much. Excellent 
question, and we are just actually doing that. Every week to 10 
days, I have a long phone call with Chris Whitty and Patrick 
Vallance, who are the two leading medical and scientific 
advisers to the Prime Minister of England to get a feel of what 
is going on there. We have regular phone calls with our Israeli 
colleagues.

    Every Saturday or Sunday morning, depending upon what it 
is, Dr. Walensky and I and others are on the phone with our 
South African colleagues. So we are in literally constant 
communication with them.

    Senator Hickenlooper. Great. Thank you. I yield back.

    The Chair. Thank you.

    Senator Marshall.

    Senator Marshall. The American people my family, all of our 
families, are struggling as this pandemic continues to drag on 
with no end in sight. The words I hear every day, multiple 
times each day, continue to resonate and echo in my mind as I 
said here, words like I am tired, confused, burnout, scared, 
and frustrated. The list goes on.

    What is making the situation worse are the officials 
leading our Nation's COVID response going on national 
television and contradicting each other. And of course, some 
Supreme Court justices are spreading misinformation as well.

    Dr. Walensky, this past week, you recommended asymptomatic 
people be able to return to work after 5 days. But Dr. Fauci 
ambiguously corrected you on national television and suggested 
folks needed a test before return.

    How does that make you feel when Dr. Fauci or someone like 
Justice Sotomayor upstages a previous statement or policies of 
yours, blatantly contradicts and undermined your guidance, or 
offers false claims that cause more confusion for the American 
people?

    Dr. Walensky. Thank you, Senator. I have the great honor of 
leading the agency of 12,000 public health servants in this 
country, and we work collaboratively with tens of thousands of 
public health officials around the country to provide guidance.

    I also get to work with a COVID-19 task force that is full 
of a multidisciplinary group of people with diverse expertise, 
from immunology to drug regulation to epidemiology. This 
science is moving really quickly, and I know you will 
appreciate that it is moving fast, and it is changing. And our 
responsibility----

    Senator Marshall. Right. You are not answering my question.

    Dr. Walensky [continuing]. is to convey that science.

    Senator Marshall. I will move on. The FDA has recently set 
up protocols for monoclonal antibodies and antiviral 
pharmaceuticals to be prioritized based upon race. Dr. Woodcock 
has the CDC or FDA getting multiple regression analysis on race 
to see if indeed it is an independent factor for increased 
morbidity and mortality. And if it has, don't you think zip 
code would actually be more predictive?

    Wouldn't it make sense to prioritize these antivirals and 
testing, for that matter, to senior citizens and those with 
significant comorbidities regardless of race, especially if the 
multiple regression analysis proves my opinion? Dr. Woodcock.

    Dr. Woodcock. What FDA did was to recommend if, you know 
that people at high risk would be candidates for these 
products.

    Senator Marshall. Did you do a multiple regression analysis 
on this independent factor?

    Dr. Woodcock. We did not.

    Senator Marshall. Okay.

    Dr. Woodcock. We did not. We don't make those kind of 
recommendations. We make----

    Senator Marshall. But you can do studies, right? The FDA 
and CDC can do studies to see if it is truly an independent 
factor, or if not truly that the issue should be about your 
comorbidities and your age. So Dr. Fauci, according to Forbes, 
you have an annual salary in 2020 was $430,000.

    You oversee over $5 billion in Federal research grants. As 
the highest paid employee in the entire Federal Government, yes 
or no, would you be willing to submit to Congress and the 
public a financial disclosure that includes your past and 
current investments?

    After all, your colleague, Dr. Walensky, and every Member 
of Congress submits a financial disclosure that includes their 
investments.

    [Technical problems.]

    Dr. Fauci. I don't understand why you are asking me that 
question. My financial disclosure is public knowledge and has 
been so for the last 37 years or so, 35 years----

    Senator Marshall. The big tech giants are doing an 
incredible job of keeping it from being public. We will 
continue to look for it. Where would we find it?

    Dr. Fauci. All you have to do is ask for it. You are so 
misinformed, it is extraordinary.

    Senator Marshall. Why am I misinformed? This is a huge 
issue. Wouldn't you agree with me that you have a--you see 
things before Members of Congress would see them, so that there 
is an air of appearance that maybe some shenanigans are going 
on. You know, I don't think that is--I assume that is not the 
case.

    Dr. Fauci [continuing]. are you talking about the case? My 
financial disclosures are public knowledge and have been so. 
You are getting amazingly wrong information.

    Senator Marshall. So what--I cannot find them. Our office 
cannot find them. Where would they be if they are public 
knowledge, where?

    Dr. Fauci. It is totally accessible to you if you want it.

    Senator Marshall. For the public, is it accessible for the 
public?

    Dr. Fauci. Through the public to the public. You are 
totally incorrect.

    Senator Marshall. Well, we look forward to reviewing it.

    The Chair. Senator Marshall, Dr. Fauci has answered you it 
is public information, and he is happy to give it to you if you 
were to ask.

    Senator Moran.

    Senator Moran. Chairwoman, thank you. I know this has been 
talked about, I have watched a bit of the hearing from my 
office this morning and into this afternoon, but would you 
highlight for me--I suppose this is for Dr. Woodcock. Lots of 
funding. I think adequate funding. Certainly knowledge about 
winter months would bring an increase in cases. What is the 
challenge in not being better prepared for access to testing, 
in home and elsewhere? And how soon will that change?

    Dr. Woodcock. I don't think that is--I think that is a 
question for Assistant Secretary O'Connell. But I would tell 
you, FDA has approved or authorized over 400 tests or 
collection systems just for COVID. We have approved, authorized 
15 over-the-counter tests, but it is capacity that we are 
talking about here, production capacity.

    Senator Moran. So there is no--what you were telling me, 
Dr. Woodcock, is there is no problem with the FDA approval of 
tests, it is the manufacturing process and the supply chain?

    Dr. Woodcock. We could do more with more resources. We have 
authorized over 2,000 different device products, including the 
400 test related products in 2 years. So that is an incredible 
increase in the workload, and we really appreciate the funding 
that Congress has provided.

    However, the test manufacturers, many of them give us 
incomplete results. We have to go back and forth with them. The 
ITAP program that we are doing with NIH for home testing, I 
think we will improve that tremendously. That is a big advance 
forward. But there is also the matter of production capacity 
with this huge surge and so many more people becoming infected.

    Senator Moran. Is there a separate FDA results process in 
which the test is read and determine positive or negative, 
there is no challenges there in that process?

    Dr. Woodcock. That is what the ITAP program over--NIH is 
doing. They are actually doing the laboratory and clinical 
testing for the manufacturers, and then they send us the data. 
And so it is standardized, and it is a panel and that really 
accelerates our ability to get these authorized very quickly.

    As I said earlier, we have authorized them within 2 days of 
getting the data from the ITAP program. So it is that--that is 
a tremendous set up that I think is really beneficial where we 
have standardized testing by scientists in the Government and 
that enables the manufacturers to get their products through 
very fast.

    Senator Moran. Thank you.

    Ms. O'Connell.

    Ms. O'Connell. Thank you, Senator. And just to pick up 
where Dr. Woodcock left off, once those tests are authorized, 
ASPR reaches out to the manufacturers to make sure that we are 
optimizing the manufacturing capability.

    That part is sort of a seamless process that we have. But 
all of the work we are doing and testing in this Administration 
is in service of four priorities. One, to expand the number of 
testing sites that are available.

    Two, to expand the number of tests that are available, that 
is the part that I am working on, to increase capacity. Three, 
the kinds of tests that are available. That is the part Dr. 
Woodcock just discussed. And then to help lower the cost of 
tests.

    Senator Moran. Is there is there a problem--I don't know 
whether the testing devices are manufactured domestically. Do 
we have another challenge of the importation of tests, as we 
did with masks, gowns, and gloves?

    Ms. O'Connell. We continue to look for tests wherever we 
can find them, and we have encouraged actually some test 
manufacturers that are approved in Europe to apply for FDA 
approval here in the United States. So I do anticipate we will 
have some importation of tests at some point. But we have used 
the Defense Production Act authorities 12 times to support the 
domestic manufacture of tests and to priority rate those orders 
so we can increase the supplies and manufacturing capacity here 
in the U.S..

    Senator Moran. In the third of a minute that I have left, 
we have changed, I think, our view on masks recently and we are 
emphasizing N95s. Is there any intentions to--is there a plan 
to manufacture additional 95 masks so there are more available? 
Is there a way to make them more comfortable? I will leave 
that--that is the crux of my question.

    Ms. O'Connell. We continue to support the manufacture of 
N95 masks. We have 737 million in the Strategic National 
Stockpile, all sourced from 12 domestic manufacturers. So we 
are continuing to support that. We are also in the process of 
putting out an agreement for warm based manufacturing.

    We are able to keep this capacity that we currently have 
going even when demand diminishes. So that is all underway 
right now. As far as fit and style and how they work, I am sure 
colleagues at the table are probably have various pieces of 
their programs that might be participating to that effort and 
consulting with the manufacturers on how that will work. Thank 
you.

    The Chair. Thank you.

    Senator Tuberville.

    Senator Tuberville. Thank you very much. Just very quickly 
I know there is plenty of misinformation on both sides when it 
comes to COVID but I would say the fear mongering on the left 
is and I will give you a couple of questions here about this, 
has made matters much worse.

    Dr. Fauci, I just want to ask you this from my constituents 
back in Alabama. Ivermectin. Forty year drug. Now my 
constituents read this, they hear about it. This 40 year drug, 
they call it a wonder drug. It is about a nickel of tablet. It 
has done wonders, supposedly in India and several other places.

    Then you have this new antiviral pill that were coming out 
and my constituents think, this thing is going to cost about 
$500, $600, $700 each. Could you give me a rundown on the 
difference in those two, what you think about them?

    Get it on record here, so I can tell my people back home, 
this is what Dr. Fauci says.

    Dr. Fauci. Yes. So Paxlovid, the drug from Pfizer has shown 
in a randomized, placebo controlled trial to be highly 
effective to the point of 89 percent, almost 90 percent.

    Senator Tuberville. What is it called?

    Dr. Fauci. Paxlovid.

    Senator Tuberville. Okay.

    Dr. Fauci. It is made by Pfizer and has been shown in a 
very well controlled, randomized, placebo controlled trial that 
if you take that drug compared to the placebo within the first 
three to 5 days within the first 3 days, you have about an 89 
percent chance of preventing you from going to the hospital or 
dying. There were no deaths in the Paxlovid group, and there 
were several deaths in the placebo group. That is Paxlovid.

    Ivermectin has had non-controlled trials suggesting that it 
might be effective, mostly anecdotal. The CDC--excuse me, the 
NIH guidelines panel have looked at that data and felt is not 
sufficient evidence to say that it works, or it doesn't. The 
WHO recommends strongly against it and suggests that it might 
actually be harmful.

    The NIH active studies are doing a whole bunch of studies 
with ivermectin, as well as others to try and settle it once 
and for all, to prevent people from taking it if it doesn't 
work, because it could be toxic. So there is a world of 
difference between ivermectin and Paxlovid.

    Senator Tuberville. But this is a 40 year drug. And we are 
talking about one that is just now coming on the market. So we 
actually know that much about this Pfizer drug. I wish they 
would come up with a lot easier names----

    Dr. Fauci. Yes, they always do that. They fool me too with 
the names, coach. But it is what it is. The fact is, I think it 
is kind of a mis comparison to say one is a 40 year drug and 
one is a drug that was just discovered.

    It was just discovered, but it was shown in a very well 
controlled clinical trial to be highly effective. Even though 
ivermectin is a good drug for some parasites, it has not been 
shown in a well-controlled, placebo controlled trial to be 
effective in COVID.

    Senator Tuberville. Okay. Thank you. Dr. Walensky, I don't 
know if anybody has asked this question. I just want to get 
cleared up. Our Supreme Court justice last week, looking into 
the situation with the mandate, Justice Sotomayor said there is 
100,000 children that are sick as we speak with Omicron, and a 
lot of them are serious and in the hospital. Is that true or 
false?

    Dr. Walensky. I don't have the number of children in the 
hospital right now. It is likely less than 100,000.

    Senator Tuberville. Yes. And Justice Breyer said that if we 
continue to delay this ruling, that we are going to have 
750,000 more that are not vaccinated infected a day. I mean, 
does that make sense to you?

    Dr. Walensky. What I can't tell you is our children between 
the ages of zero and four, one of the only places where our 
hospitalization rates are currently rising, and that children 
who are in the hospital are generally unvaccinated, not 
uniformly, but generally unvaccinated. And that is true for not 
just our 0 to 4 who are obviously ineligible, but also true for 
5 to 11 year olds, as well as our 12 to 17 year olds.

    Senator Tuberville. Thank you. Well, thank you all for 
being here today. Thank you very much. Thank you, Madam Chair.

    The Chair. Thank you so much. I have one final question for 
Ms. O'Connell and Dr. Walensky, and that is regarding 
education. In the past, we have seen school districts that 
serve a significant number of students of color or those in low 
income or rural areas that are facing great challenges in 
accessing resources they need to serve our students.

    How is the Federal Government working now to make sure that 
States are equitably distributing tests and necessary resources 
like masks to all school districts, particularly those that 
serve predominantly students from families with low income, 
students of color, or rural students? And Ms. O'Connell, I will 
start with you.

    Ms. O'Connell. Thank you, Chair Murray. Equity is woven 
into all of the work that we are doing in this response. It is 
something that we remain focused on, including making sure that 
schools across all States are able to access the tools and 
resources that they need. We gave $10 billion, as you know, 
from the American Rescue Plan, for schools to be able to set up 
their funding programs--we are also--testing programs.

    We have also made it possible through Operation Expanded 
Testing, which Dr. Walensky can talk more about, where we have 
regional hubs, where schools can contract directly with labs to 
run their programs for them. That was designed for schools that 
might not otherwise have resources to be able to manage a 
testing program on their own. In addition, we are making tests 
available through the federally qualified health centers and 
rural health centers. And we have done that with masks as well 
earlier in the year.

    The Chair. Thank you.

    Dr. Walensky.

    Dr. Walensky. Yes, and maybe I will just pick up exactly 
where ASPR O'Connell has put down. So our ICATT program, our 
increase community access to testing program, does place tests 
in pharmacies in socially vulnerable--social vulnerability 
indices that are high. That is by design.

    Tests in federally qualified health care centers and 
community centers, just as the Assistant Secretary mentioned. 
We also continue to support screening tests at no cost to 
childcare centers, K-12 schools, and congregate settings 
through exactly the program that the ASPR mentioned, Operation 
Expanded Testing.

    We prioritized high schools that have and all schools that 
have high social vulnerability, and we have own website now 
that is active where you can enroll.

    The Chair. Okay, thank you. Senator Burr, I understand you 
have two additional questions.

    Senator Burr [continuing]. questions, if I could, Madam 
Chair. This is for Dr. Woodcock and Ms. O'Connell. It is my 
understanding that prior to Omicron, BARDA informed some 
therapeutic manufacturers that they would no longer be 
supporting additional work on new therapies because there is no 
longer an unmet need which may impact whether and how FDA 
prioritizes reviewing such therapies. Did BARDA and FDA change 
course on this policy once the Omicron variant was discovered 
in November?

    Ms. O'Connell. BARDA's decision to put that notification 
out was in light of the fact that the therapeutics development 
was moved over to Operation Warp Speed and BARDA was supporting 
the therapies that were being developed through the Warp Speed 
effort. So it was a way of combining the funding that was 
available to be able to move the therapies through faster. 
BARDA never stopped supporting therapy work. But I will let Dr. 
Woodcock----

    Dr. Woodcock. Yes, there is--we still regard, there is an 
extreme unmet medical need for therapeutics at most stages of 
the disease, particularly the late stages where we still don't 
have interventions and so people are dying in the late stage of 
disease, getting into the ICU, going on the ventilator.

    Of course, we have had have 670 INDs that we have been--
clinical protocols that are ongoing, to my knowledge. So robust 
development is still ongoing in the therapeutic area.

    Senator Burr. So how much--how much funding has BARDA 
allocated to therapeutics this year and how much is left to 
spend?

    Ms. O'Connell. I will have to go back and check that. On 
the actual development, we have spent a lot of funds this year 
on the procurement of the therapeutics that have already been 
developed but would be more than happy to bring that number to 
you and your staff.

    Senator Burr. And this is, I am talking about the 
development end of it. There is a firm belief out there that 
BARDA went to the industry and said, we are not supporting this 
anymore. They didn't say this got moved over to Operation Warp 
Speed, which by the way doesn't exist anymore.

    But they said, BARDA said we are not supporting 
therapeutics because there is not an unmet need. That is what 
the industry heard. I would love for you to clarify that for 
me. Last thing, Dr. Woodcock, since we did discuss the point of 
care and at home testing. I just had them come up with the 
chart that FDA put out not long ago. So let me just, and you 
are probably familiar with it, one is molecular, one is 
antigen, and one is serology.

    For the molecular and the antigen point, if you test yes 
for point of care or at home, that kicks you to the right. The 
next box is high manufacturing capacity. If your answer is no 
there, it kicks you down to an FDA intends to decline box. 
There is no option. So if you are not a high manufacturing 
test, then FDA is going to decline to review. Boy, I got to 
tell you, I think this is a huge mistake.

    Now if you tell me that you have got a couple of hundred 
tests that fall into the high manufacturing capacity right now 
at the FDA, where you have got the luxury of being able to kick 
out new innovative companies that haven't solved their 
manufacturing yet, by all means, tell me that is the case, that 
there are a couple hundred.

    Right now, Ms. O' Connell was struggling to buy 500 million 
test, where 47, maybe 50 million there, that leaves another 450 
million to purchase. And we are going to distributors trying to 
buy their inventory, not to manufacturers trying to buy their 
capacity. Something is not right here, guys, on testing. And I 
will tell you, the current Administration's Chief of Staff got 
it right in 2020 March, and he said testing is broken, testing 
is broken, testing is broken. I just say to all of you right 
now, testing is broken.

    Ms. O'Connell, I think the responsibility falls to the 
ASPR. I wrote the law. If--in the case of CDC, they were the 
delay to begin with, but to acquire testing, that falls in your 
lane. And I, for the life of me can't figure out after $82 
billion, except for somebody sitting down and saying, well, we 
just don't need those tests, we don't need to buy them, how you 
could let Abbott close two lines because there wasn't any 
business.

    These are some of the most premier manufacturers in the 
world that we have let get out of the mass manufacturing of 
home test business. If I am wrong, tell me I am. I respect all 
four of you in a huge way. But I also express my disapproval 
very quickly and that is what I am doing today. Anything you 
want to add to that? Ms. O'Connell.

    Ms. O'Connell. Please. Thank you, Ranking Member Burr. Let 
me just clarify, of course, that the initial contracts you are 
speaking of toward the 500 million were the available inventory 
that these distributors had. These the distributor contracts.

    The manufacturer contracts are currently being worked. You 
will see that capacity come on quickly. We just haven't been 
able to land the contracts, to draft the contracts as quickly 
as the distributors, but they are coming.

    Senator Burr. My suggestion in the future is that when you 
guys huddle inside the COVID team, try to get the 
Administration to refrain from making these proclamations until 
we have got the product, until we know who we are negotiating 
with. We are now 3 weeks since the President said we are going 
to buy 500 million test.

    We have 50 million currently contracted. I don't know how 
long it is going to take to get the rest of the contracts. This 
is not dissimilar to when we went out and said we are going to 
booster everybody in America, yet we rolled it out with just 
people over 60 to start with and then we started moving down. 
And now we are begging people to get boosted, which is where we 
should have been on day one because we had the product 
available.

    But listen, you guys have a tough job. And I don't know of 
anything else Congress can do than try to create the statutory 
framework that you can work in to do your job, which exists, or 
provide the funding to allow you to acquire. Those are the only 
two things we can do other than bitch and gripe when it doesn't 
happen as quickly as we would like. But Tony, I really respect 
you and I am sorry you and your family went through what you 
are going through.

    But please understand, we go through that every time we go 
home with millions of people in North Carolina, millions that 
believe the bad information that is out there, millions of 
people that have a loved one in the hospital but there is no 
monoclonal form to take, millions of people who are 
unvaccinated, probably wish today they had gotten vaccinated, 
probably wish they had gotten boosted. But they are now in the 
ICU and their wife or husband, or daughter is calling us and 
saying, what do I do?

    We are here to support. What you need, tell us. But don't 
think that we are just going to sit here and print money 
without a full accountability of where it has gone. And I hope 
the Secretary is listening to that conversation today. Senator 
Blunt and I said give us a full audited accounting of the $82 
billion and will entertain additional funding for testing. That 
was 10 days ago.

    I am not sure when we are going to get it or if we are 
going to get it, but it is conditional, and this is the most 
powerful person on the other side of the Appropriations, and I 
think she knows I am serious on this one.

    There has got to be accountability on the money and the way 
it is spent. Thank you for being here. Thank you, Madam Chair.

    The Chair. Thank you. I want to thank, truly thank all of 
our witnesses today, Dr. Walensky. Dr. Fauci, Dr. Woodcock, 
Assistant Secretary O'Connell. We all know this is a very 
difficult, challenging, changing time and you have all been 
through it for a long time. I think you do understand the 
frustration.

    I am sure you all have it as well as where we are. We all 
want to find solutions and we stand at your back to be able to 
provide those. But thank you so much for answering all our 
questions. This is a really important conversation about the 
threat of the new COVID variant, or whatever the next one is, 
and about the path forward for our pandemic response, and we 
really do appreciate all the work you and all the people in 
your agencies do.

    For any Senators who wish to ask additional questions, 
questions for the record will be due in 10 business days, 
January 26 at 5.00 p.m.
    With that, the Committee does stand adjourned.

                         QUESTIONS AND ANSWERS

 Response by Rochelle Walensky to Questions of Senator Casey, Senator 
 Hassan, Senator Lujan, Senator Cassidy, Senator Braun, Senator Scott, 
                         and Senator Tuberville

                             SENATOR CASEY

    Question 1. At the hearing, I asked how the Federal 
Government is working with vaccine manufacturers to speed the 
development of a safe and effective vaccine for children under 
age five. Understanding that the Pfizer trial for children 24 
months to 5 years old did not meet its endpoint, my follow-up 
questions are, how did we get here and what's next? Please 
describe, generally, the following----

    Question 1(a). How vaccine developers make decisions about 
dose size, quantity and spacing in age deescalation trials;

    Answer 1. CDC defers to FDA.

    Question 2. What type of indicators a vaccine manufacturer 
might consider when determining whether and how to change the 
dose size, quantity or spacing if primary endpoints are not 
met; and

    Answer 2. CDC defers to FDA.

    Question 3. Whether the emergence of a viral variant could 
affect the efficacy of a vaccine in children differently than 
it would affect the efficacy of the same vaccine in adults.

    Answer 3. CDC defers to FDA.

    Question 4. Furthermore, could you please provide an update 
on current Federal goals and investments relating to the 
development of vaccines to protect children under age five from 
COVID-19, including grants, contracts or other funding awarded 
to vaccine developers; and what information is currently being 
provided to vaccine developers regarding current or planned 
opportunities for collaboration between the Federal Government 
and vaccine developers, including the extent to which BARDA 
will conduct TechWatch/CoronaWatch meetings and the extent to 
which FDA will accept applications for emergency use 
authorization.

    Answer 4. CDC defers to FDA and ASPR.

    Question 5. Finally, could you describe current thinking 
across your agencies regarding the circumstances under which 
your efforts would expand to include the development of 
additional or next generation vaccines and therapeutics for 
COVID-19?

    Answer 5. CDC defers to NIH and ASPR.

                             SENATOR HASSAN

    Question 1. Individuals with autoimmune diseases are at 
higher risk of severe COVID-19 symptoms and death. 
Additionally, some of the medicines these patients may take can 
alter vaccine effectiveness. Does the CDC plan to put out 
guidance regarding the interaction between COVID-19 vaccines 
and treatments and immunosuppressant medications to help 
patients with autoimmune diseases and their providers?

    Answer 1. Some people with immunocompromising conditions or 
people who take immunosuppressive medications or therapies are 
at increased risk for severe COVID-19. CDC's Interim Clinical 
Considerations for Use of COVID-19 Vaccines includes 
information for healthcare providers regarding COVID-19 
vaccination in moderately or severely immunocompromised people. 
Immunocompromised people ages 5 years and older should receive 
a primary COVID-19 vaccine series as soon as possible; for 
those 18 years and older, mRNA COVID-19 vaccines are preferred 
over the Janssen COVID-19 Vaccine. The current Food and Drug 
Administration (FDA) approved or FDA authorized COVID-19 
vaccines are not live vaccines and therefore can be safely 
administered to immunocompromised people. Moderately or 
severely immunocompromised people may not mount a protective 
immune response after initial vaccination and, furthermore, 
their protection by primary vaccination may wane over time 
making them susceptible to severe SARS-CoV-2 infection. The 
Advisory Committee on Immunization Practices (ACIP) and CDC 
have made age-specific recommendations for an additional 
primary dose and a booster dose for this population. Evusheld 
is a combination of two long-acting monoclonal antibodies that 
is authorized for emergency use as pre-exposure prophylaxis for 
persons who are moderately to severely immunocompromised or 
unable to get vaccinated.

                             SENATOR LUJAN

    Question 1. Americans are confused about how to best 
protect themselves and their communities from the spread of 
COVID. In New Mexico, trusted health messengers such as 
hospitals are struggling to convey updated guidance to the 
patients they serve. As new guidance comes out, the burden 
falls on providers to disseminate this information in a way 
that reflects the diversity of racial and ethnic, regional, and 
political identities present in the state of New Mexico. 
Hospitals, already stretched thin, still have non-urgent, non-
symptomatic people showing up because these patients simply do 
not know where to turn. The American people need clear 
guidance, presented in a format that leave no doubt as to the 
official recommendations. What can you do in your role as a 
public health official to ensure that public health guidance is 
communicated clearly and effectively?

    Answer 1. CDC recognizes that we can always make 
improvements as an agency and are committed to ensuring that 
our public health messaging and communication efforts are 
effective and accessible to providers and patients alike. As 
the science and our understanding of COVID-19 evolves, we are 
actively working to disseminate the latest public health data 
and guidance as quickly as possible. CDC continues to reach out 
to healthcare providers and has hosted over 50 Clinician 
Outreach and Communication Activity (COCA) calls and sent over 
20 Health Alert Network notices. CDC has connected with 
numerous partner organizations, working with them to better 
understand the needs of the people they serve, including 
organizations serving people at increased risk of serious 
illness or death from COVID-19. These audience-specific 
outreach efforts are in addition to providing accessible 
information via the web, social media, and news media briefings 
and interviews. Since the emergence of the virus, CDC has 
worked very closely with state, tribal, local, and territorial 
(STLT) health departments and public health partner 
organizations. We have heard that people want to hear from us 
directly, to that end we have instituted CDC briefings with CDC 
scientists and subject matter experts in order to convey the 
latest recommendations to the public. In addition, I have 
personally conducted over 80 White House press briefings on 
COVID-19 in just this past year, as part of our engagement 
efforts.

    CDC is working to ensure the agency is communicating across 
government, the scientific community, and the medical community 
in order to provide real-time updates and guidance that are 
both feasible and realistic to implement. As we strive to move 
us forward on this path out of the pandemic, we see it as our 
mission to restore public trust in science.

    Question 2. We know that this virus mutates and presents 
new challenges, that our understanding of the virus continues 
to grow, and that sometimes new information can alter 
recommendations or even change the public's understanding of 
the virus in terms of public health messaging. What lessons 
have you learned from the most recent guidance change? How can 
the CDC improve?

    Answer 2. Our scientific understanding has changed 
frequently during this pandemic it has evolved and even with 2 
years of data, research, and experience, there are things we do 
not know or do not understand completely. Despite this, we 
continue to work to communicate what we know, what we recommend 
based on what we know, and what steps we are taking to learn 
more.

    Because science is continually evolving, we are committed 
to bringing that information to the public in real time. That 
means we must update our guidance to ensure that 
recommendations are understandable and actionable so that 
people can implement them.

    When we communicate guidance during a dynamic, evolving 
public health situation, we need to be clear that our guidance 
is based on our best understanding at the time and that, as we 
learn more, our recommendations may change.

    Question 3. Studies have found that minds are most changed 
during personal conversations with trusted sources like 
clinicians or loved ones. Among the CDC's recommended 
strategies are developing a corps of vaccine Ambassadors. How 
do we scale up our ability to engage in conversations in a 
supportive, empathetic, and non-judgmental way?

    Answer 3. Vaccinate with Confidence is the strategic 
framework of the CDC to strengthen vaccine confidence and 
prevent outbreaks of vaccine-preventable diseases in the United 
States. Strong confidence in COVID-19 vaccines within 
communities leads to more adults, adolescents, and children 
getting vaccinated. High vaccine coverage rates reduce the 
number of COVID-19 illnesses, hospitalizations, and deaths. One 
of CDC's strategies within the Vaccinate with Confidence 
framework focuses on engaging communities and individuals in a 
sustainable, equitable, and inclusive way--using two-way 
communication to listen, build trust, and increase 
collaboration. CDC works with health departments and national 
partners to engage communities around vaccine confidence and 
service delivery strategies to meet community needs. Also, CDC 
collaborates with trusted messengers within the community to 
tailor and share culturally relevant messages and materials. 
CDC provides information on how to tailor COVID-19 vaccine 
information to help those, including vaccine Ambassadors, 
understand their audience and create messages that resonate.

    Question 4. How can a corps of vaccine Ambassadors combat 
public health misinformation that proliferates on social media?

    Answer 4. Vaccine Ambassadors play a key role for public 
health in validating the credibility of messages and 
effectively delivering messages and strategies within their 
community. They can address mis-and disinformation by working 
with jurisdictional communications staff to take questions on 
social media, share accurate information, and post shareable 
graphics and content. Many of the tools are available on CDC 
and HHS websites.

    Question 5. How can we be prepared to counteract 
misinformation and vaccine hesitancy early in future pandemics 
or other public health emergencies that require vaccinations?

    Answer 5. Monitoring misinformation through social 
listening is a key strategy to quickly identify and address 
misinformation about COVID-19 vaccines. This includes 
identifying trending inaccurate information, which, if not 
addressed, can lead to the spread of misinformation.

    Catching misinformation early can help develop and get out 
accurate information to address concerns and questions ahead of 
time and close information gaps before they are filled with 
inaccurate information.

    CDC created the Insights Unit to use an evidence-based 
approach, leverage socio-behavioral and epidemiological 
insights, and execute a plan to reduce and prevent the spread 
and harm of misinformation and promote accurate, credible 
information. Limited tools exist to address misinformation and 
traditional risk communication and social media outreach 
approaches are not sufficient because they are inherently 
reactive approaches.

    Identifying misinformation before it spreads and developing 
programmatic and communications approaches to address it is 
critical to prevent and manage misinformation in future 
pandemics and public health emergencies.

    The Insights Unit generates the COVID-19 State of Vaccine 
Confidence Insights Reports which identify the public's 
questions, concerns, frustrations and circulating 
misinformation. The results are used to identify how CDC and 
partners can take action against the information gaps and 
misinformation.

    Misinformation is not unique to COVID-19, and as technology 
makes communication easier, misinformation will continue to be 
a problem. The lessons learned from the COVID-19 pandemic can 
be expanded to other disease areas of vaccine hesitancy.

    Question 6. In thinking about education and messaging, what 
changes would you all advise for these same leaders on the 
media platforms to use to make vaccination messages resonate 
with those who may still be hesitant about taking the COVID-19 
vaccine?

    Answer 6. Vaccinate with Confidence is the strategic 
framework of the CDC to strengthen vaccine confidence and 
prevent outbreaks of vaccine-preventable diseases in the United 
States. Strong confidence in COVID-19 vaccines within 
communities leads to more adults, adolescents, and children 
getting vaccinated--which leads to fewer COVID-19 illnesses, 
hospitalizations, and deaths.

    CDC's Vaccinate with Confidence strategy is built on three 
pillars:

    Answer 1. Build trust: Share clear, complete, and accurate 
messages about COVID-19 vaccines, and take visible actions to 
build trust in the vaccine, the vaccinator, and the vaccination 
system.

    Answer 2. Empower healthcare personnel: Promote confidence 
among healthcare personnel in their decision to get vaccinated 
and to recommend vaccination to their patients.

    Answer 3. Engage communities and individuals: Engage 
communities in a sustainable, equitable, and inclusive way-
using two-way communication to listen, build trust, and 
increase collaboration.

    Answer 4. CDC is working in coordination with national, 
state, and local governmental and non-governmental partners 
using strategies to build trust in the vaccine, the vaccinator, 
and the vaccination system.

                            SENATOR CASSIDY

    Question 1. The U.S. is in the middle of flu season, which 
has the potential to add additional burden to already-stressed 
health care systems due to the ongoing pandemic.

         LWhat steps is HHS taking to ensure the 
        availability of appropriate diagnostics and treatment 
        options to address the potential dual threats of COVID 
        and influenza, including through shoring up the 
        Strategic National Stockpile?

    Answer 1. CDC defers to ASPR.

         LBeyond testing and preventative steps like 
        vaccination, what steps has HHS taken to proactively 
        treat vulnerable populations like the elderly or others 
        who may be at risk for and are likely to spread 
        communicable diseases like COVID and the flu?

    Answer 1(a) The COVID-19 pandemic has reinforced the 
importance of healthcare infection prevention and control in 
keeping Americans-especially our most vulnerable populations in 
nursing homes and hospitals safe and healthy. CDC has worked 
with the Healthcare Infection Control Practices Advisory 
Committee (HICPAC), a Federal advisory committee appointed to 
provide advice and guidance to HHS and CDC regarding the 
practice of infection prevention and control (IPC) and 
strategies for surveillance, prevention, and control of 
healthcare-associated infections, antimicrobial resistance and 
related events in United States healthcare settings, to develop 
general guidelines for preventing transmission of infectious 
diseases, including respiratory diseases like influenza.

    In addition to those guidelines developed with HICPAC, CDC 
works closely with the Centers for Medicare & Medicaid Services 
and the long-term care (LTC) community to support 
implementation of best practices and provides tools and 
resources to protect residents and staff from infectious 
diseases, including COVID-19 and influenza. In order to monitor 
and track infections including healthcare-associated infections 
(HAI) and COVID-19 activities in LTC settings, CDC has utilized 
the National Healthcare Safety Network (NHSN) LTC Facilities 
Component (LTCFC) to track infections and infection prevention 
process measures and also to identify problems and improve 
care. This includes tracking healthcare personnel (HCP) 
influenza vaccination status, COVID-19 vaccination status for 
both residents and HCP. Additionally, CDC funds state HAI 
programs that work directly with LTC facilities to keep 
residents and staff safe. It was the relationships that these 
programs had built over many years that allowed for quick 
responses and support to many outbreaks in LTCFs.

    CDC has also developed educational materials for LTCFs, 
including trainings such as the National Nursing Home Training 
Series and the Nursing Home Infection Preventionist Training 
Course. While the use of CDC's Infection Control Assessment and 
Response Program (ICAR) infection control assessment tools has 
been recently used mostly to improve IPC activities as part of 
the COVID-19 response, these tools were developed for use in 
assessing IPC programs at healthcare facilities for any 
infectious disease. CDC has developed setting specific guidance 
and assessment tools, including for long term care facilities, 
in both English and Spanish.

    CDC is using American Rescue Plan (ARP) funding to expand 
efforts that protect Americans from COVID-19 infections and 
other emerging infectious diseases across healthcare settings, 
specifically long-term care facilities and nursing homes. For 
example, over the next 3 years, CDC will issue awards totaling 
$1.25 billion to 64 state, local, and territorial health 
departments to support this work. Initial awards totaling $885 
million were made in October 2021 to 64 health department 
jurisdictions, including $500 million to support state-based 
COVID-19 nursing home and other long-term care strike teams. 
The state-based nursing home and other long-term care strike 
teams will allow state, local, and territorial jurisdictions to 
provide surge capacity to facilities for clinical services; 
address staffing shortages at facilities; and strengthen 
infection prevention and control activities to prevent, detect, 
and contain outbreaks of COVID-19, including support for COVID-
19 vaccine boosters. This builds on previous CDC investments in 
health departments to improve patient safety through the 
Antibiotic Resistance (AR) Solutions Initiative and Prevention 
and Public Health Fund established by the Patient Protection 
and Affordable Care Act of 2010 (ACA).

    HHS is working with other Federal agencies, health 
departments, healthcare providers, professional organizations, 
and public health partners to increase vaccine uptake and 
promote the use of boosters in residents and staff in LTCFs. 
The Federal Government is committed to ensuring that residents 
and staff in these facilities have access to COVID-19 vaccines 
to receive primary series and booster shots. All LTC settings 
that request assistance accessing COVID-19 vaccines for their 
residents and staff will receive the support they need. Many 
LTC providers have already identified strategies and 
partnerships to obtain and administer COVID-19 vaccines for 
residents and staff. These include working with established LTC 
partners and retail pharmacy partners and coordinating with 
state and local health departments.

    Question 2. Health systems in Louisiana have been 
overwhelmed by successive waves of COVID variants. These health 
systems could have been better prepared for these growing 
variant trends if they had access to better national and 
regional dashboards monitoring variants of concern. What are 
you all at the CDC, FDA, NIH, and HHS doing to make sure health 
providers are armed with the best data to respond appropriately 
to the next COVID variant or pandemic? Second, how are you all 
harnessing the speed and innovation of the private sector to 
help predict, prevent, and mitigate future COVID-19 variants or 
other pathogens of concern?

    Answer 2. CDC is building on lessons learned from 
responding to COVID-19 variants to determine how to gather and 
report data on variants of concern, particularly the 
application of genomic sequencing. CDC is evaluating sources 
from the data pipeline to determine which prove most useful in 
responding to an emerging variant of concern. These findings 
will inform response to future variants.

    National SARS-CoV-2 Strain Surveillance (NS3) is 
implemented in partnership with state and local public health 
laboratories and the Association of Public Health Laboratories 
(APHL). State public health laboratories provide to CDC, on a 
weekly basis, confirmed, de-identified, diagnostic specimens 
that, ideally, represent a variety of demographic and clinical 
characteristics and geographic locations. The program provides 
a comprehensive and population-based surveillance system for 
national monitoring to track virus evolution over time and 
identify emerging variants that may affect the performance of 
diagnostics, therapeutics, or vaccines, or that impact the 
transmissibility of SARS-CoV-2 or severity of COVID-19.

    In addition to the NS3 program, CDC contracted with large 
commercial diagnostic laboratories to sequence specimens from 
across the United States. These contracts provide consistent 
access to SARS-CoV-2 sequence data across the country to 
supplement existing public health sequencing efforts. The 
proportion of variants in a population are calculated 
nationally, by HHS region, and by jurisdiction and are 
available on CDC's COVID Data Tracker.

                             SENATOR BRAUN

    Question 1. Over 62 percent of Americans are fully 
vaccinated against COVID-19. Yet, the rate of positive COVID-19 
cases reported in the U.S. has increased six fold from early 
December to early January. The spike in cases is likely due to 
the contagious nature of the variant.

         LWhy is the CDC not tracking the number of 
        individuals who have been diagnosed with a breakthrough 
        infections after having received a COVID-19 vaccine?

    Answer 1. As part of ongoing efforts to understand how 
COVID-19 vaccines are working, CDC monitors rates of COVID-19 
cases, hospitalizations, and deaths in vaccinated 
(breakthroughs) and unvaccinated persons. CDC now monitors 
rates of COVID-19 cases and deaths using data from 
jurisdictions that routinely link case surveillance data with 
records from immunization information systems (IIS) to identify 
the vaccination status of all reported COVID-19 cases. This 
approach provides more complete information on breakthrough 
cases and a better understanding of the impact of vaccines than 
was available previously. These data are updated monthly on the 
COVID Data Tracker.

    As of December 2021, 27 jurisdictions, representing all 10 
HHS regions and more than 50 percent of the United States, can 
link their case, death, and vaccine data and are voluntarily 
sharing these data with CDC. Jurisdictions report these 
breakthrough data to CDC in multiple ways. Interoperable 
information systems that enable linkage of data is a core goal 
of CDC's Data Modernization Initiative.

    CDC uses COVID-NET, a population-based surveillance system 
of COVID-19-associated hospitalizations from a network of 250 
acute-care hospitals in 14 states, to monitor rates of COVID-
19-associated hospitalizations by vaccination status. These 
data are also updated monthly and shared with the public on the 
COVID Data Tracker. Previous data on breakthrough cases were 
reported in an MMWR that summarized data from January--April, 
2021. Follow-up analysis of breakthrough surveillance data on 
hospitalizations and deaths reported during January-September 
2021 has shown that characteristics of people with severe 
COVID-19 following vaccination were similar to people at risk 
for severe COVID-19 in general, including older age. Notably, 
historical breakthrough data were reported as case counts which 
was useful during initial vaccine introduction, but challenging 
to interpret because of limited completeness and 
representativeness, as well as a lack of denominator data for 
calculating rates and making direct comparisons with 
unvaccinated persons to contextualize trends.

    Additionally of note, the Federal Government lacks the 
authority to compel reporting of key hospital and case data 
elements, including vaccination status. While robust systems 
have been set up to capture and analyze voluntary reporting of 
breakthrough cases as described above, significant gaps remain 
in the data that is needed to detect adverse events and monitor 
vaccine effectiveness for COVID-19. This has been particularly 
challenging for real-world observational vaccine effectiveness 
studies because it is not possible to identify a cohort of 
individuals that we know are unvaccinated. It is challenging to 
directly compare vaccinated individuals and unvaccinated 
individuals. Therefore, Federal authority to require reporting 
of public health data, such as vaccination status associated 
with case and hospital data, would provide a more complete 
national picture of the COVID-19 outbreak and allow for better 
tracking of breakthrough infections. A Federal public health 
authority would benefit all levels of public health and provide 
better data to inform decisionmakers.

                             SENATOR SCOTT

                             Omicron Status

    Question 1. Dr. Walensky--Of omicron hospitalizations, what 
percentage are ICU cases and what percentage are on 
ventilators? How do those percentages compare to the previous 2 
variants?

    Answer 1. CDC is currently working to determine this 
information and expects to publish an upcoming paper in CDC's 
Morbidity and Mortality Weekly Report.

    Question 1(a). Doesn't this and other available data 
suggest that the omicron variant is less severe than the 
previous 2 variants?

    Answer 1(a) Omicron infection generally causes less severe 
disease than infection with prior variants. Preliminary data 
suggest that Omicron may cause more mild disease, although some 
people may still have severe disease, need hospitalization, and 
could die from the infection with this variant. Even if only a 
small percentage of people with Omicron infection need 
hospitalization, the large volume of cases could overwhelm the 
healthcare system.

    Question 2. Dr. Walensky--What is the difference between 
someone hospitalized with COVID and someone hospitalized 
because of COVID?

    Answer 2. Some data sources of hospitalization allow us to 
distinguish when patients are hospitalized with COVID, and when 
they are hospitalized for (or because) of COVID. However, 
making this distinction with the data may not always be clear. 
We are currently exploring the available data, including 
primary and secondary diagnoses codes, as well as data on 
medications such as remdesivir and dexamethasone, to determine 
how to make this distinction.

    In the Coronavirus Disease 2019-Associated Hospitalization 
Surveillance Network (COVID-NET), we have the ability to 
examine primary reason for admission on a sample of 
hospitalized cases. In an analysis (on a preprint server and 
not yet peer-reviewed) among adults aged 18 years who were 
hospitalized with laboratory-confirmed SARS-CoV-2 infection 
from January-July 2021, 716 (11.7 percent) of 6,115 
hospitalizations had a primary reason for admission other than 
COVID-19 related illness. In a recent study of children aged 18 
years hospitalized with laboratory-confirmed SARS-CoV-2 
infection during July 1-December 1, 2021, 81.3 percent of 1,703 
COVID-19-associated hospitalizations in children were likely 
related to COVID-19. This proportion is similar to a prior 
published analysis using the same data source that found 
children aged 18 years hospitalized with laboratory-confirmed 
SARS-CoV-2 infection during March 2020-May 2021, approximately 
718 (23 percent) of 3,106 had a primary reason for admission of 
Ob/labor and delivery, inpatient surgery or procedures, 
psychiatric admission needing acute medical care, trauma or had 
``other'' reason for admission with no symptoms of COVID-19 on 
admission. The remaining 77 percent had a primary reason for 
admission likely related to COVID-19.

    We have historically avoided making strong claims that 
these hospitalizations are not related to COVID-19, as COVID-
NET was designed to conduct rapid surveillance of COVID-19-
associated hospitalizations and not to carefully adjudicate the 
reason for admission for each hospitalization. Determining the 
primary reason for admission to a hospital can be complex, and 
multiple factors can influence the decision to seek care or be 
admitted, including COVID-19 status. Levels of community 
incidence of COVID-19 and population vaccination coverage can 
also have an impact. Additionally, patients who test positive 
for SARS-CoV-2 infection may develop symptomatic illness after 
admission, which may influence the course of their 
hospitalization, and this would not necessarily be captured in 
the patient's primary reason for admission.

    Question 2(a)1. Is the data currently being collected 
sophisticated enough to differentiate?

    Answer 2(a) CDC Response: Data used to examine this 
question do not include distinguishing details needed to 
differentiate between patients being hospitalized with COVID-19 
or because of COVID-19. To examine this question other 
accompanying information from the discharge, claim or 
electronic health record must be leveraged. CDC continues to 
examine data from multiple hospitalization data sources, to 
better understand trends in COVID-19 related hospitalizations.

    Question 2(b)1. How long does it take to publish this 
differential?

    Answer 2(b) CDC Response: Data available for 
hospitalizations come from multiple sources; some of which 
cannot distinguish ``with'' and ``for''. Analysis of the 
various datasets is ongoing.

    The process of identifying claims where hospitalization 
occurred ``with'' COVID-19 is not readily available or apparent 
through query of available data. Data are reported by the 
process of utilizing electronic health record data to identify 
an incidental COVID-19 case is complex.

    Question 2(c). Given continuous updates to guidance, is 
this lag in reporting problematic when crafting guidance that 
is commensurate with the actual risk posed by a variant of 
concern?

    Answer 2(c) CDC Response: CDC guidance is based on the best 
available data at the time. CDC uses a combination of available 
sources including hospital data and epidemiological studies to 
inform guidance during fluctuating conditions of a response. 
Prevalent Hospitalizations of Patients with Confirmed COVID-19 
are published on COVID Data Tracker within a 2-3-day lag. CDC 
has also published Disease Severity Among Hospitalized Patients 
on COVID Data Tracker. The disease severity metrics are the 
percentage of hospitalized COVID-19 patients who were admitted 
to the intensive care unit (ICU), received invasive mechanical 
ventilation (IMV), or died. These data, from three healthcare 
data sources, show downward trends in ICU admission, invasive 
mechanical ventilation, and mortality among hospitalized 
patients over the course of the pandemic.

                                Testing

    Question 1. Dr. Walensky--Can T-cell testing be used to 
measure the U.S.' progress toward herd immunity?

    Answer 1. CDC defers to FDA.

         LCan T-cell testing complement antibody 
        testing to inform efforts against COVID-19 variants 
        that might evade vaccines or allow for reinfection?

    Answer 1(a) CDC defers to FDA.

         LIf so, how can we ensure physicians have 
        access to tools-like T-cell testing-they need to make 
        appropriate clinical decisions in treating patients?

    Answer 1(b) CDC defers to FDA.

                       Vaccinations & Treatments

    Question 1. Dr. Walensky--Can monoclonal antibody 
treatments be used to prevent COVID infection?

    Answer 1. CDC Response: Anti-SARS-CoV-2 monoclonal 
antibodies (mAbs) have shown evidence of clinical benefit in 
treating SARS-CoV-2 infection, however, some have reduced 
effectiveness against Omicron. Some anti-SARS-CoV-2 mAbs have 
shown evidence of clinical benefit as post-exposure prophylaxis 
after a potential exposure to SARS-CoV-2, like in a household 
setting or during SARS-CoV-2 outbreaks in skilled nursing or 
other long term care facilities. Other anti-SARS-CoV-2 mAbs 
have shown evidence of reducing the risk of infection when used 
as pre-exposure prophylaxis. The FDA has issued an emergency 
use authorization for tixagevimab plus cilgavimab (Evusheld), 
an investigational medicine used in adults and children ages 12 
years and older. Evusheld consists of 2 monoclonal antibodies 
provided together to help prevent infection with the virus that 
causes COVID-19. A healthcare provider gives Evusheld as two 
separate consecutive intramuscular (IM) injections at a 
doctor's office or healthcare facility. If an individual is 
moderately or severely immunocompromised or severely allergic 
to COVID-19 vaccines, they may be eligible for Evusheld.

                            School Closures

    Question 1. When discussing children and the omicron case 
surge on MSNBC, President Biden's chief medical advisor, Dr. 
Fauci, pointed out that pediatric hospitalizations are much 
lower on a percentage basis than adults, especially when 
compared with the elderly. He went on to state: ``But the other 
important thing is that if you look at the children who are 
hospitalized, many of them are hospitalized with COVID as 
opposed to because of COVID. And what we mean by that--if a 
child goes into the hospital, they automatically get tested for 
COVID and they get counted as a COVID-hospitalized individual 
when, in fact, they may go in for a broken leg or appendicitis 
or something like that. So it's over-counting the number of 
children who are, quote, `hospitalized with COVID,' as opposed 
to because of COVID.''

    Question 1(a). Dr. Walensky--Do you agree with Dr. Fauci's 
assessment?

    Answer 1. In the Coronavirus Disease 2019-Associated 
Hospitalization Surveillance Network (COVID-NET), we have the 
ability to examine primary reason for admission on a sample of 
hospitalized cases.

    In an analysis (on a preprint server and not yet peer-
reviewed) among adults aged 18 years who were hospitalized with 
laboratory-confirmed SARS-CoV-2 infection from January-July 
2021, 716 (11.7 percent) of 6,115 hospitalizations had a 
primary reason for admission other than COVID-19 related 
illness. In a recent study of children aged 18 years 
hospitalized with laboratory-confirmed SARS-CoV-2 infection 
during July 1-December 1, 2021, 81.3 percent of 1,703 COVID-19-
associated hospitalizations in children were likely related to 
COVID-19. This proportion is similar to a prior published 
analysis using the same data source that found children aged 18 
years hospitalized with laboratory-confirmed SARS-CoV-2 
infection during March 2020-May 2021, approximately 718 (23 
percent) of 3,106 had a primary reason for admission of Ob/
labor and delivery, inpatient surgery or procedures, 
psychiatric admission needing acute medical care, trauma or had 
``other'' reason for admission with no symptoms of COVID-19 on 
admission. The remaining 77 percent had a primary reason for 
admission likely related to COVID-19.

    We have historically avoided making strong claims that 
these hospitalizations are not related to COVID-19, as COVID-
NET was designed to conduct rapid surveillance of COVID-19-
associated hospitalizations and not to carefully adjudicate the 
reason for admission for each hospitalization. Determining the 
primary reason for admission to a hospital can be complex, and 
multiple factors can influence the decision to seek care or be 
admitted, including COVID-19 status. Levels of community 
incidence of COVID-19 and population vaccination coverage can 
also have an impact. Additionally, patients who test positive 
for SARS-CoV-2 infection may develop symptomatic illness after 
admission, which may influence the course of their 
hospitalization, and this would not necessarily be captured in 
the patient's primary reason for admission.

    Question 2. CDC published in its March 19, 2021 Morbidity 
and Mortality Weekly Report that ``changes in modes of 
instruction have presented psychosocial stressors to children 
and parents that can increase risks to mental health and well-
being and might exacerbate educational and health 
disparities.''

    Question 2(a). Dr. Walensky--Does virtual learning present 
more risks than in-person learning related to child and 
parental mental and emotional health in addition to healthy 
behaviors like physical activity which can impact individuals 
over a lifespan?

    Answer 2. Findings from a nationwide study of 1,290 parents 
of children ages 5-12 conducted from October 8-November 13, 
2020 and published in March 19, 2021 MMWR ``Association of 
Children's Mode of School Instruction with Child and Parent 
Experiences and Well-Being During the COVID-19 Pandemic--COVID 
Experiences Survey, United States, October 8-November 13, 
2020'', suggest children not receiving full-time, in-person 
instruction and their parents might experience increased risk 
for negative mental/emotional and physical health outcomes.

    Specifically:

         LParents of children receiving virtual-only or 
        combined instruction more frequently reported that 
        their child's mental/emotional health worsened during 
        the pandemic and that their time outside, time in-
        person with friends, and physical activity decreased.

         LParents of children receiving virtual-only 
        instruction more frequently reported their own 
        distress, difficulty sleeping, loss of work, concern 
        about job stability, conflict between work and 
        providing childcare, and childcare challenges than did 
        parents whose children were receiving in-person only 
        instruction.

         LChildren receiving in-person instruction and 
        their parents reported the lowest prevalence of 
        negative indicators of child and parent well-being.

         LParents whose children attended school in-
        person only were less likely to report challenges with 
        employment and childcare.

    Answer 1. CDC recognizes the need for a comprehensive, 
coordinated, multidisciplinary approach to promoting student 
mental health and well-being, especially given the potentially 
broad impact of school closures on student mental health.

    Schools have the infrastructure to provide critical support 
to youth and families, including opportunities to engage in 
academic, social, mental health, and physical health services, 
and mental health promotion activities, all of which can buffer 
stress and lessen negative outcomes. Many students and staff 
have been adversely impacted by the pandemic. While mental 
health services are necessary, this alone is not sufficient to 
promote mental health and well-being.

    Question 2. We have witnessed the damaging impacts school 
closures have had on student achievement, mental health, and 
even physical health. I believe parents, in consultation with 
their child's doctor, not teachers' unions know what's best for 
their child.

         LDr. Walensky--Should teachers' unions have a 
        role in crafting health guidance?

    Question 2(a). Should teachers' unions be pushing policies 
that directly contradict CDC guidance on in-person learning and 
have damaging impacts on child development?

    Answer 2. When developing guidance and recommendations, CDC 
often engages with organizations and groups that are impacted. 
The agency does so to ensure recommendations are comprehensive, 
address the stakeholder needs and concerns, and are feasible to 
implement. These informative and helpful interactions result in 
beneficial feedback for final revisions to promote clarity, 
completeness, and usability.

    For the development of the school guidance, CDC had close 
engagement with the U.S. Department of Education and sought 
input from a variety of organizations and stakeholders-
including public health and education organizations to discuss 
experiences, challenges, and lessons learned in implementing 
prevention strategies for infectious diseases in K-12 schools

                              CDC Guidance

    Question 1. The CDC in 2018 published a Crisis and 
Emergency Risk Communications pamphlet which stresses the need 
to ``be first, be right, be credible.'' Unfortunately, we've 
seen anything but. We've seen statements made anonymously or on 
background. We've seen pronouncements made in anger and 
frustration regarding factors outside of the Administration's 
control. We need timely, accurate, clear guidance instead of 
mixed messages and paternalistic attitudes.

         LDr. Walensky--How is CDC working to restore 
        and broaden public trust?

    Answer 1. CDC's mission is to protect the American public 
from threats to their health. The American public should know 
that CDC is comprised of dedicated and compassionate scientific 
professionals who are working long hours every day to serve and 
protect them. At CDC, we are striving to advance science and 
communicate our findings and recommendations in the least 
confusing and most effective manner.

    The dedicated experts at CDC have been responding to this 
pandemic since the early days of 2020 and have done their best 
to communicate with the American people openly and clearly 
about this public health emergency. When we haven't met our own 
standards for clear and open communication, we've worked to 
provide additional information quickly. And when we have heard 
from scientific colleagues, policymakers, and the public that 
we can do better, we have listened and made changes. President 
Biden's commitment to leading with science and truth and 
treating each other with respect and kindness can help CDC 
regain its reputation and credibility, but we have a lot of 
ground to make up and restoring public trust is going to take 
time.

    The virus that causes COVID-19 has challenged and humbled 
us, teaching us even more about modern threats to the public's 
health-like global interconnectedness and the spread of 
misinformation. These threats compound the risks posed by novel 
infectious diseases. And while everyone has worked as hard as 
they can with the best of intentions, there have been missteps 
and the spotlight has been shone on the weaknesses in our 
country's public health system. CDC alone cannot strengthen 
this system, prepare for future emergencies, and rebuild trust 
in public health. Our success in doing these things-which are 
critical to our health and safety as a nation-depends on state 
and local public health, governments, businesses, communities, 
and many others working together.

    Question 2T1. What is the Agency doing to address a process 
that has, so far, produced confusing and sometimes conflicting 
guidance that appears to be consistently behind the curve 
instead of ahead of it?

    Answer 2. As the science and our understanding of COVID-19 
evolves, CDC is actively working to disseminate the latest 
public health data and guidance as quickly as possible. To 
provide unified guidance, CDC is collaborating across 
government and across the scientific and medical community to 
stay ahead of the virus, stop the spread of infection, keep 
people out of the hospital, and save as many lives as possible.

                           SENATOR TUBERVILLE

                         COVID and Vaccinations

    Question 1. In March 2021, you stated ``vaccinated people 
do not carry the virus, don't get sick.'' Do you stand by this 
statement?

    Answer 1. The immunity provided by vaccine and prior 
infection are both high but not complete. Multiple studies have 
shown that antibody titers correlate with protection at a 
population level, but protective titers at the individual level 
remain unknown. As described in greater detail in CDC's COVID-
19 Vaccine and Vaccination Science Brief, studies have 
demonstrated waning of both antibody titers and vaccine 
effectiveness against infection over time, especially among 
older populations. Decreased vaccine effectiveness may reflect 
a combination of waning antibody titers and decreased 
neutralizing capacity in the setting of widespread circulation 
of variants with partial immune escape.

    Question 2. In July 2021, you stated ``99.5 percent of 
deaths from COVID-19 in the United States were in unvaccinated 
people'' and Dr. Fauci also stated 99.2 percent of deaths in 
June were unvaccinated. Is this still accurate?

    Answer 2. As part of ongoing efforts to understand how 
COVID-19 vaccines are working, CDC monitors rates of COVID-19 
cases, hospitalizations, and deaths in vaccinated 
(breakthroughs) and unvaccinated persons. CDC monitors rates of 
COVID-19 cases and deaths using data from 30 jurisdictions 
representing all 10 HHS regions and 70 percent of the U.S. 
population that routinely link case surveillance data with 
records from immunization information systems (IIS) and vital 
registration to identify the vaccination status of all reported 
COVID-19 cases and deaths. This approach provides more complete 
information on breakthrough cases and deaths and a better 
understanding of the impact of vaccines than was available 
previously. These data are updated monthly on the COVID Data 
Tracker.

    CDC also uses COVID-NET, a population-based surveillance 
system of COVID-19-associated hospitalizations from a network 
of 250 acute-care hospitals in 14 states, to monitor rates of 
COVID-19-associated hospitalizations by vaccination status. 
These data are also updated monthly and shared with the public 
on the COVID Data Tracker.

    While people had become accustomed to following counts of 
breakthrough infections, the public health impact of case 
counts is difficult to interpret without knowing the underlying 
burden of community transmission or the proportion of the 
population that has been vaccinated. Reporting rates based on 
comprehensive capture of information on vaccination status 
provides more accurate information about breakthrough 
infections, including patterns over time and across age groups, 
vaccine types, and receipt of booster doses and direct 
comparisons with unvaccinated persons to contextualize trends.

    An MMWR published in September 2021 demonstrated that 
incidence rate ratios are more stable and directly related to 
vaccine effectiveness (VE), while the percentage of vaccinated 
people among COVID-19 cases rises with either increasing 
vaccination coverage or decreasing VE, complicating 
interpretation of this metric. Interpretation of the proportion 
of vaccinated people among hospitalized and fatal cases may be 
further complicated by older people and people with 
comorbidities having higher risks of severe COVID-19 outcomes 
and higher vaccination coverage.

    Question 3. Dr. Walensky, you have stated this is a 
pandemic of the unvaccinated. Is that still accurate?

    Answer 3. Vaccines greatly reduce the risk of the most 
severe outcomes for those who are sickened with COVID-19, 
including the risk of severe illness and death among people who 
are fully vaccinated. Vaccine effectiveness against 
hospitalizations has remained relatively high over time, 
although it tends to be slightly lower forder adultsd 
for people with weakened immune systems.

    Question 4. Many countries as well as cities like San 
Francisco and New York City have high vaccination rates and 
mask and vaccine mandates but have recorded some of the highest 
levels of COVID-19 infections ever in December 2021 and January 
2022.

        Question 4(a). Why are these cities experiencing COVID-
        19 outbreaks?

    Answer 4. The Omicron variant was first clinically 
identified in the United States on December 1, 2021 and spread 
rapidly. By late December, it became the predominant strain, 
and by mid-January it represented 99.5 percent of sequenced 
specimens in the United States (1). The Omicron variant has 
been shown to be more transmissible and less virulent than 
previously circulating variants.

        Question 4(b). Please provide data to confirm that mask 
        and vaccine mandates are effective at reducing the 
        spread of COVID-19.

    Answer 4(b) COVID-19 vaccination helps protect adults and 
children ages 5 years and older from getting sick or severely 
ill with COVID-19 and helps protect those around them. CDC 
tracks state-issued vaccination requirements by requirement 
type (e.g., a vaccination requirement with no test-out option 
versus those that allow recurring testing in lieu of 
vaccination), exemption types allowed, documentation required 
to apply for an exemption, and groups to which the vaccination 
requirement applies (e.g., school workers, government workers, 
healthcare workers, as well as others).

    Vaccination requirements have increased vaccination rates 
by 20+ percentage points to over 90 percent in many 
organizations. An analysis of health care systems, educational 
institutions, public-sector agencies, and private businesses 
shows that organizations with vaccination requirements have 
seen their vaccination rates increase by more than 20 percent 
and have routinely seen their share of fully vaccinated workers 
rise above 90 percent. That is substantially higher than 
broader working-age vaccination rates for Americans aged 18 to 
64.

    Question 5. What percentage of Americans have had COVID-19?

    Answer 5. As of January 11, 2022, more than 62.6 million 
cases of COVID-19 have been reported in the U.S. However, case 
surveillance data do not represent the true burden of COVID-19 
in the United States. The number of cases also includes 
reinfections and therefore does not equal the number of people 
who have had COVID-19. Many people infected, even if 
symptomatic, do not seek medical care or get tested. In these 
situations, data cannot be extracted from medical records. Data 
can also be limited if people are unavailable or unwilling to 
provide information.

    Most of the case reports captured by health departments are 
based on laboratory reports that might contain limited patient 
information. Because of the volume of cases, most health 
departments are unable to obtain additional information on 
every case. As a result, many case reports are missing data on 
patient demographics, symptoms, underlying health conditions, 
characteristics of hospitalizations such as ventilator use, and 
other factors such as travel history. Because of missing data, 
analyses of these data elements are likely an underestimate of 
the true occurrence.

    Question 6. What percentage of children under 18 have had 
COVID-19?

    Answer 6. As of January 11, 2022, there are 8,968,092 
cumulative COVID-19 cases among children aged 0-17 years, as 
shown on the CDC COVID Data Tracker Note that this number does 
not represent the number of unique individuals with infection 
as it also includes reinfections. Case based surveillance of 
SARS-COV-2 also likely underestimates the prevalence of 
infections.

    Question 7. For the most recent week, what percentage of 
COVID-19 infections are breakthrough cases in vaccinated and 
boosted individuals?

    Answer 7. As part of ongoing efforts to understand how 
COVID-19 vaccines are working, CDC monitors rates of COVID-19 
cases, hospitalizations, and deaths in unvaccinated and 
vaccinated persons, including people who received booster 
doses. Data are published monthly on CDC's COVID Data Tracker. 
Unvaccinated adults had 5 times the risk of testing positive 
for COVID-19 in December 2021, compared to fully vaccinated 
adults with additional or booster doses. Although changes 
occurred in December related to the emergence of the Omicron 
variant, monthly rate ratios are more stable than weekly and 
are therefore preferred for monitoring.

    Question 8. For the most recent week, what percentage of 
hospitalizations and deaths are vaccinated/boosted individuals?

    Answer 8. As part of ongoing efforts to understand how 
COVID-19 vaccines are working, CDC monitors rates of COVID-19 
cases, hospitalizations, and deaths in unvaccinated and 
vaccinated persons, including people who received booster 
doses. On a monthly basis, CDC publishes rates of 
hospitalizations and deaths by vaccination status on COVID Data 
Tracker. During December 2021, unvaccinated adults had 41 times 
the risk of dying from COVID-19-associated death compared to 
fully vaccinated persons with additional or booster doses. 
COVID-19-associated hospitalizations were 45 times higher in 
unvaccinated adults ages 50-64 years and 51 time higher in 
unvaccinated adults ages 65 years and older, compared with 
fully vaccinated persons with additional or booster doses in 
each age group during December 2021.

    Question 9. Has the Federal response to COVID-19 been 
successful?

         L(a) Please explain.

         L(b) If not, please explain what should have 
        been done differently.

    Answer 9. As of January 2022, more than 900,000 people have 
died in this country alone from COVID-19. Others have been 
sickened, lost time with their family and loved ones, missed 
work and school, and developed post-COVID conditions. These 
losses are an incalculable tragedy, for every person who has 
personally experienced them and for our country and our world.

    The entire Federal Government is committed to preventing as 
many deaths as we can while minimizing the negative effects 
COVID-19 has on the health and well-being of our society. We 
have developed safe, effective vaccines and administered more 
than 545 million doses as of January 2022. The Federal response 
has developed treatments for COVID-19 and are working to ensure 
everyone, particularly those at highest risk of severe illness, 
has access to these treatments. We have enhanced existing 
public health data and surveillance systems and stood up new 
ones to monitor the spread of this virus, so that we can more 
quickly detect and respond to case surges, increased healthcare 
system burden, and the emergence of new variants. We've worked 
to reopen schools safely and to keep them open because schools 
are so critical to the well-being of children, families, and 
communities. Most recently, we have further scaled up testing 
capacity, making millions of at-home self-tests available to 
America households free of charge, and we've worked with 
pharmacy and health center partners to distribute free masks 
across the country.

    Question 10. Will you commit to doing a cost-benefit 
analysis of the COVID-19 response?

    Answer 10. An effective public health response requires 
global, Federal, state, territorial, tribal, and local public 
health partners to be independently strong, yet closely 
coordinated. This pandemic has continued to reinforce how 
interconnected we all are and why it is critical to support 
surveillance and response capacity abroad, as we make public 
health investments at home.

    I will continue to prioritize support for the improvement 
of core public health capabilities across public health 
partners through flexible and consistent funding to support 
surveillance capabilities, data modernization, laboratory 
capacity, and workforce development.

    Question 11. Please provide specific examples where your 
agency has utilized real world evidence in regards to COVID-19 
or treatments for COVID-19.

    Answer 11. The clinical spectrum of SARS-CoV-2 infection 
includes asymptomatic or pre-symptomatic infection and mild, 
moderate, severe, and critical illness. CDC provides 
considerations for healthcare providers regarding the clinical 
management and treatment of COVID-19 stratified by whether the 
patient has mild or moderate illness that often can be managed 
in the outpatient setting, or severe or critical illness that 
requires hospitalization. CDC recommends clinicians refer to 
the recommendations in the National Institutes of Health (NIH) 
COVID-19 Treatment Guidelines, recommendations and information 
contained within FDA websites and EUAs for treatment, and the 
Infectious Diseases Society of America Guidelines on the 
Treatment and Management of Patients with COVID-19. These 
recommendations and those from CDC are based on scientific 
evidence and expert opinion and are regularly updated as more 
data become available. CDC defers additional questions on 
treatments available to FDA and NIH.

    Question 12. Do you believe schools and universities should 
be requiring students to be vaccinated and boosted in order to 
be enrolled or attend school?

    Answer 12. Ensuring students can safely attend school in-
person is a priority and being up to date on vaccines is the 
most effective way to do so. CDC is working with state public 
health partners to reach school districts and universities 
across the country to continue to demonstrate the importance of 
implementing layered prevention strategies in schools, 
including vaccination and screening testing.

             Vaccine Adverse Event Reporting System (VAERS)

    Question 1. It's been reported by some virologists and 
scientists that this year, around 170 people died from taking 
the flu vaccine. The Vaccine Adverse Event Reporting System 
(VAERS) reports that the number of people dying after taking 
the COVID vaccine is actually in the thousands--maybe as many 
as 20,000 people. I understand that VAERS reports deaths 
``after taking'' the vaccine as opposed to ``from'' the 
vaccine, however, these numbers are startling.

        Question 1(a) What do we know about how many people 
        might have died as a direct relation to taking the 
        COVID vaccine?

    Answer 1. CDC scientists have conducted detailed reviews of 
Thrombosis with thrombocytopenia syndrome (TTS) cases following 
receipt of the J&J/Janssen COVID-19 vaccine and have identified 
nine deaths causally associated with J&J/Janssen COVID-19 
vaccination. CDC and FDA continue to review deaths following 
COVID-19 vaccination reported to VAERS--including death 
certificates, autopsy reports, and available medical records--
and provide updated information to healthcare providers and the 
public as it becomes available. With the exception of the nine 
deaths from TTS following the J&J Janssen COVID-19 vaccine, 
there is no evidence to suggest that COVID-19 vaccines are 
causing or contributing to deaths. In fact, CDC published an 
analysis that showed that during December 2020-July 2021, 
COVID-19 vaccine recipients had lower rates of non-COVID-19 
mortality than did unvaccinated persons after adjusting for 
age, sex, race and ethnicity, and study site: (https://
www.cdc.gov/mmwr/volumes/70/wr/mm7043e2.htm).

    Reports of death after COVID-19 vaccination are rare. FDA 
requires healthcare providers to report any death after COVID-
19 vaccination to VAERS, even if it is unclear whether the 
vaccine was the cause. Reports of adverse events to VAERS 
following vaccination, including deaths, do not necessarily 
mean that a vaccine caused a health problem. More than 539 
million doses of COVID-19 vaccines were administered in the 
United States from December 14, 2020, through December 14, 
2021. During this time, VAERS received 10,688 preliminary 
reports of death (0.0022 percent) among people who received a 
COVID-19 vaccine.

        Question 1(b) Why does VAERS report data this way?

    Answer 1(b) CDC Response: VAERS serves as the Nation's 
early warning system to monitor vaccine adverse events and 
detect potential safety problems. As a passive surveillance 
system, it relies on individuals to send in reports of their 
experiences to CDC and FDA. CDC accepts all reports of adverse 
events after vaccination from healthcare providers and 
individuals to assess possible safety concerns related to 
vaccines, including COVID-19 vaccines. FDA also requires 
vaccine manufacturers to submit reports for any adverse events 
following vaccinations to VAERS. These data are especially 
useful for quickly detecting unusual or unexpected patterns of 
adverse event reporting that might indicate a possible safety 
concern (or ``signal'') with a vaccine.

    When VAERS reports are received, they are reviewed, 
processed, and coded. To better understand the circumstances 
around a particular adverse event, VAERS staff from CDC and FDA 
request follow-up medical records for reports that are 
classified as ``serious.'' This includes adverse events 
resulting in death, life-threatening illness, hospitalization 
or prolongation of hospitalization, permanent disability, or 
congenital anomaly/birth defect. FDA requires all healthcare 
providers to report any death following COVID-19 vaccination to 
VAERS and all reports of deaths are reviewed by CDC and FDA. 
All adverse events reported in VAERS are then publicly posted 
to the CDC WONDER data base, except for in very rare and 
specific instances.

    Question 1. Where can Americans find data about the actual 
number of deaths from the COVID vaccine, as opposed to ``after 
taking'' it?

    Answer 1. This information is reported publicly on CDC's 
website at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/
safety/adverse-events.html.

                             SENATOR HASSAN

    Question 1. Children under age five are still not eligible 
for a COVID-19 vaccine. Moderna reported earlier this month 
that it expects to report trial data on its COVID-19 vaccine in 
children ages 2 to 5 by March.

    Question 1(a). Meanwhile, the number of children with 
COVID-19 is surging in New Hampshire and across the country. As 
of January 1, the hospitalization rate for children under age 5 
reached 4 in 100,000 children-3 times higher than the same time 
last year.

    Question 1(b). What guidance are you providing to parents 
of young children to keep them safe in the interim?

    Answer 1. CDC recommends that all family members above the 
age of 5 years old be vaccinated to help protect younger 
children who are not yet eligible to be vaccinated. In 
addition, CDC recommends the following strategies on our 
website to help protect yourself and others from getting sick 
with COVID-19: https://www.cdc.gov/coronavirus/2019-ncov/
prevent-getting-sick/prevention.html

                           SENATOR TUBERVILLE

    Question 1. Does science still support a 90-day period 
after an infection during which a person should be exempt from 
testing requirements?

    Answer 1. CDC continues to recommend that people who have 
had a laboratory-confirmed SARS-CoV-2 infection within the past 
90 days who have subsequently recovered and no longer have 
COVID-19 symptoms do not need to quarantine following an 
exposure. In addition, CDC continues to recommend that people 
who develop symptoms consistent with COVID-19 isolate 
immediately and get tested.

    Currently, there are not enough data to support a change in 
this recommendation. CDC will continue to monitor relevant data 
and update public health recommendations and guidance on 
quarantine and isolation for the general population as more 
information becomes available.

    Question 2. Why does our Federal Government not currently 
recognize natural immunity, as other countries do?

    Answer 2. Available evidence shows that fully vaccinated 
individuals and those previously infected with SARS-CoV-2 each 
have a low risk of subsequent infection for at least 6 months. 
Data are presently insufficient to determine an antibody titer 
threshold that indicates when an individual is protected from 
infection. At this time, there is no FDA-authorized or approved 
test that providers or the public can use to reliably determine 
whether a person is protected from infection.

    Multiple studies have shown that antibody titers correlate 
with protection at a population level, but protective titers at 
the individual level remain unknown. Whereas there is a wide 
range in antibody titers in response to infection with SARS-
CoV-2, vaccination typically leads to a more consistent and 
higher-titer initial antibody response. Substantial immunologic 
evidence and a growing body of epidemiologic evidence indicate 
that vaccination after infection significantly enhances 
protection and further reduces risk of reinfection, which lays 
the foundation for CDC recommendations.
                                ------                                


   Response by Anthony Fauci to Questions of Senator Casey, Senator 
 Hassan, Senator Lujan, Senator Paul, Senator Cassidy, Senator Braun, 
                 Senator Scott, and Senator Tuberville

                             SENATOR CASEY

    Question 1. At the hearing, I asked how the Federal 
Government is working with vaccine manufacturers to speed the 
development of a safe and effective vaccine for children under 
age five. Understanding that the Pfizer trial for children 24 
months to 5 years old did not meet its endpoint, my follow-up 
questions are, how did we get here and what's next? Please 
describe, generally, the following:

        Question 1(a). How vaccine developers make decisions 
        about dose size, quantity and spacing in age de-
        escalation trials;

        Question 1(b). What type of indicators a vaccine 
        manufacturer might consider when determining whether 
        and how to change the dose size, quantity or spacing if 
        primary endpoints are not met; and

        Question 1(c). Whether the emergence of a viral variant 
        could affect the efficacy of a vaccine in children 
        differently than it would affect the efficacy of the 
        same vaccine in adults.

    Answer 1(a)(b)(c). NIAID defers to FDA and ASPR on the 
above questions.

        Question 1(d). Furthermore, could you please provide an 
        update on current Federal goals and investments 
        relating to the development of vaccines to protect 
        children under age five from COVID-19, including 
        grants, contracts or other funding awarded to vaccine 
        developers; and what information is currently being 
        provided to vaccine developers regarding current or 
        planned opportunities for collaboration between the 
        Federal Government and vaccine developers, including 
        the extent to which BARDA will conduct TechWatch/
        CoronaWatch meetings and the extent to which FDA will 
        accept applications for emergency use authorization.

    Answer 1(d). NIAID currently is supporting the evaluation 
of existing coronavirus disease 2019 (COVID-19) vaccines and 
novel COVID-19 vaccine approaches for potential use in young 
children. Researchers supported by the National Institute of 
Allergy and Infectious Diseases (NIAID), in collaboration with 
the Biomedical Advanced Research and Development Authority 
(BARDA) and Moderna, Inc., are evaluating the mRNA-1273 vaccine 
in children 6 months to less than 12 years of age in a Phase 2/
3 clinical trial called KidCOVE. There are multiple trial sites 
at the NIAID-supported Vaccine and Treatment Evaluation Units 
(VTEUs). Moderna has indicated that it expects to report data 
in March 2022 for children 2 years of age to less than 6 years 
of age. In addition to the clinical evaluation of mRNA-1273, 
NIAID intramural scientists are conducting early stage research 
on an intranasal live-attenuated parainfluenza virus-vectored 
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 
vaccine approach, which is designed to protect infants and 
young children against both human parainfluenza virus 3 and 
SARS-CoV-2. NIAID also is supporting a study to identify 
adjuvants that improve vaccine efficacy in very young children.
    NIAID notes that the Pfizer-BioNTech COVID-19 Vaccine also 
is being evaluated in children under 5 years of age; however, 
NIAID is not involved in the trial. NIAID would defer to the 
vaccine manufacturer to provide an update on the status of the 
trial.

        Question 1(e). Finally, could you describe current 
        thinking across your agencies regarding the 
        circumstances under which your efforts would expand to 
        include the development of additional or next-
        generation vaccines and therapeutics for COVID-19?

    Answer 1(e). NIAID is supporting research on next-
generation COVID-19 vaccines. On March 25, 2021, NIAID launched 
a Phase 1 clinical trial in healthy adults to assess the safety 
and immunogenicity of second-generation COVID-19 vaccine 
candidates developed by Gritstone Oncology, Inc. Gritstone's 
COVID-19 vaccine candidates utilize a strategy aimed at 
inducing both neutralizing antibodies and T cell responses to 
elicit a broad immune response. This approach could provide 
protection against emerging SARS-CoV-2 variants by targeting 
several viral antigens, all of which are highly conserved among 
viral strains. In addition, NIAID is pursuing the development 
of mucosal vaccine approaches that may stimulate greater 
immunity in the upper respiratory tract. These candidates could 
result in a much lower rate of breakthrough infection, broader 
and more durable protection, and stronger reduction in disease 
transmission than that observed with currently available COVID-
19 vaccines. One of these mucosal vaccine approaches is an 
Adenovirus type 4 (Ad4)-based intranasal SARS-CoV-2 vaccine 
candidate developed by NIAID researchers that currently is 
undergoing preclinical testing.

    Current COVID-19 vaccines approved or authorized by the 
U.S. Food and Drug Administration (FDA) elicit robust immune 
responses to the spike protein of SARS-CoV-2. NIAID Vaccine 
Research Center investigators have created a nanoparticle-based 
pan-coronavirus vaccine candidate designed to elicit antibodies 
targeted to the spike protein of multiple different 
coronaviruses. This mosaic nanoparticle-based approach--based 
on the universal influenza vaccine concept known as FluMos--is 
currently undergoing preclinical testing in an animal model. 
NIAID-supported scientists also provided proof of principle 
that self-assembling mosaic nanoparticles displaying receptor 
binding domains of multiple coronaviruses in the Sarbecovirus 
subgroup (including SARS-CoV-2) can induce protection in mice 
when challenged with another Sarbecovirus. In addition, NIAID 
intramural investigators are evaluating inactivated whole virus 
vaccine candidates for a broadly protective beta-coronavirus 
vaccine based on related efforts to develop a universal 
influenza vaccine. NIAID also is supporting studies through its 
vaccine adjuvant program to compare different classes of 
adjuvants and identify the most efficacious vaccine 
formulations. The identification of vaccine adjuvants that 
promote cross-protective and durable immunity in vulnerable 
populations would complement ongoing efforts to develop next-
generation coronavirus vaccines.

    In late 2021, NIAID announced four awards to fund 
multidisciplinary, collaborative teams that had submitted 
highly meritorious applications to conduct research on 
universal coronavirus vaccine candidates and help accelerate 
pan-coronavirus vaccine development. The teams will incorporate 
advances in coronavirus biology and immunology; immunogen 
design; and innovative vaccine and adjuvant technologies to 
discover, design, and develop vaccine candidates to protect 
against multiple types of coronaviruses and viral variants. The 
four awards are funded under the auspices of the Emergency 
Awards Notice of Special Interest (NOSI) on Pan-Coronavirus 
Vaccine Development Program Projects. A key goal of this NIAID 
initiative is to develop multivalent vaccine platforms and 
strategies suitable for use in vulnerable populations and to 
understand vaccine-induced immune responses and efficacy 
related to a person's age or sex. NIAID currently expects 
additional awards will be issued in 2022 to highly meritorious 
applications to support pan-coronavirus vaccine research from 
additional institutions submitted in response to the NOSI.

    The National Institutes of Health (NIH) also is supporting 
research to identify and develop additional COVID-19 
therapeutics. The NIH Accelerating COVID-19 Therapeutic 
Interventions and Vaccines (ACTIV) public-private partnership 
coordinates research strategies for prioritizing and speeding 
development of the most promising treatments. The ACTIV public-
private partnership has evaluated hundreds of available 
therapeutic agents with potential application for COVID-19, 
prioritized the most promising candidates, designed and 
harmonized adaptive master protocols for ACTIV clinical trials, 
and selected numerous NIH-supported networks to launch these 
clinical trials to test prioritized therapeutic candidates.

    On a particular note, NIAID launched the ACTIV-5/Big Effect 
Trial (BET), which is designed to streamline the identification 
of experimental COVID-19 therapeutics that demonstrate the most 
promise. BET, an adaptive Phase 2 clinical trial, compares 
different investigational therapeutics to a common control arm 
to identify treatments with relatively large effects as 
promising candidates for further study in large-scale trials. 
In addition, NIH has launched the Antiviral Program for 
Pandemics, an NIH-BARDA collaboration that aims to develop safe 
and effective antivirals to treat and prevent SARS-CoV-2 
infection. The program will build sustainable platforms for 
targeted drug discovery and development of antivirals directly 
targeting viruses with pandemic potential. As part of this 
effort, NIAID will establish Antiviral Drug Discovery Centers 
for Pathogens of Pandemic Concern. These multidisciplinary 
research centers will create platforms that will target 
coronaviruses and additional RNA viruses with pandemic 
potential, helping to better prepare the Nation for future 
viral threats. Oral drug candidates for broad use in outpatient 
settings are the primary focus of this effort.

    NIAID will continue to conduct and support research to 
identify and develop next-generation COVID-19 vaccines and 
therapeutics. These efforts will improve our response to the 
current pandemic and bolster our preparedness for the next 
viral disease outbreak.

                             SENATOR HASSAN

    Question 1. Children under age five are still not eligible 
for a COVID-19 vaccine. Moderna reported earlier this month 
that it expects to report trial data on its COVID-19 vaccine in 
children ages 2 to 5 by March.

    Meanwhile, the number of children with COVID-19 is surging 
in New Hampshire and across the country. As of January 1, the 
hospitalization rate for children under age 5 reached 4 in 
100,000 children--3 times higher than the same time last year.

        Question 1. At this point, when do you expect that 
        vaccinations will be available to children under age 5?

        Answer 1. NIH defers to FDA.

        Question 2. What guidance are you providing to parents 
        of young children to keep them safe in the interim?

        Answer 2. NIH defers to CDC.

                             SENATOR LUJAN

    Question 1. You stated recently in an interview that, 
``scientists tend to talk in a different language than regular 
people can understand. It's kind of a mismatch between those 
who communicate and those who want to be communicated with not 
talking the same language.'' What is the consequence of 
scientists and regular people not speaking the same language? 
How do you overcome that?

    Answer 1. NIAID notes that the statements in Question 1 
were not made by Dr. Fauci. The BuzzFeed News article 
containing these quotes appears to cite a ``prominent scientist 
who spoke with BuzzFeed News--but asked to remain anonymous due 
to the sensitive nature of the questions''. NIAID does 
appreciate the opportunity to reaffirm the importance of 
conveying complex and rapidly evolving public health 
information and research findings in a manner that is 
accessible to non-scientists. The NIAID Director frequently 
answers questions from non-scientists and has the opportunity 
to assess where there may be confusion around the latest 
research on COVID-19. One effort to overcome such confusion is 
through the White House COVID-19 Response Team's public 
briefings in which Administration officials help translate and 
contextualize the latest research advances for non-scientists.

    Question 2. There are differences between PCR and antigen 
testing and the appropriate use for both. How has the public 
been educated about the differences and appropriate uses? How 
can it be done better?

    Answer 2. The Centers for Disease Control and Prevention 
(CDC) would be the most appropriate agency to elaborate upon 
efforts to educate the public about COVID-19 testing.

    The National Institute of Biomedical Imaging and 
Bioengineering (NIBIB) at the NIH has overseen the Rapid 
Acceleration of Diagnostics (RADx) Tech and Advanced Technology 
Platforms programs, part of the overall RADx initiative. These 
programs have supported development of technologies to increase 
lab capacity for PCR tests, development of test supplies, and 
development of new lab, point-of-care, and over-the-counter 
test devices, including both PCR and antigen technologies. 
NIBIB's focus is on the research and development of testing 
technologies and information about the different types of tests 
in development has been provided through the NIBIB website. 
This includes descriptions of the tests and a list of tests 
authorized for use by the FDA organized by type of test.

    NIBIB also supported development of the When to Test 
website to help guide individuals and families on COVID-19 
testing. The Testing Impact Calculator also includes tools to 
help organizations plan for and develop testing strategies. 
This site includes additional resources on testing strategies 
and obtaining supplies.

    Additionally, NIBIB has issued press releases about the 
awarding of contracts for development of tests and the NIBIB 
Director has participated in numerous media interviews about 
this project and the tests that were developed. Press releases 
are listed on the news section of the NIBIB website.

    NIBIB uses social media and e-newsletters to disseminate 
this information to the public.

        Question 3. Given the increased demand for N95 and KN95 
        masks, we have seen an increase in costs to the 
        consumer. New Mexicans hoping to protect themselves 
        face costs as steep as $6 per mask--a cost that is 
        simply out of reach for some of our most vulnerable 
        populations. What barriers are preventing the Federal 
        Government from providing N95 or KN95 masks to the 
        public free of charge?

        Answer 1. NIH defers to ASPR.

                              SENATOR PAUL

    Question 1. Did the NIH award a grant (available at https:/
/reporter.nih.gov/search/6Io2KK8sZEefzzm WqkIOyg/project-
details/8674931) on bat SARS-related coronaviruses to EcoHealth 
Alliance with a subcontract to the Wuhan Institute of Virology? 
Please answer yes or no.

    Answer 1. Yes, the NIH award to EcoHealth Alliance (EHA) 
included funds for a subaward to the Wuhan Institute of 
Virology (WIV) and EHA then entered into an agreement with WIV.

    Question 2. Was the NIH informed in a grant progress report 
submitted in 2016 that the researchers constructed new SARS-
related coronaviruses (so-called ``chimeric SARS-related 
coronaviruses'') that combined the spike gene of one SARS-
related coronavirus with the rest of the genetic information of 
another SARS-related coronavirus, and that the resulting new 
viruses infected human cells? Please answer yes or no.

    Answer 2. No, NIH received a progress report in 2017 
describing research testing whether spike proteins from 
naturally occurring bat coronaviruses in China were capable of 
binding to cultured human cells (HeLa) genetically engineered 
to express the human ACE2 receptor. The presence of the human 
receptor alone is not sufficient to drive human infection.

    Question 3. Did the NlH inform EcoHealth Alliance in a 
letter dated May 28, 2016, that ``[a]s per the funding pause 
announcement, new USG funding may not be released for Gain of 
Function (GoF) research projects that may be reasonably 
anticipated to confer attributes to influenza, MERS, or SARS, 
viruses such that the virus would have enhanced pathogenicity 
and/or transmissibility in mammals via the respiratory route'' 
and that the grant ``appears to involve research covered under 
the pause''? Please answer yes or no.

    Answer 3. While the NIH did send a letter to EHA dated May 
28, 2016; the language quoted above in Question 3 differs from 
the language in the letter.

    The relevant section from the May 28, 2016, letter is 
included below. In particular, please note the letter to EHA 
states ``new USG funding will not be released'' while Question 
3 states ``new USG funding may not be released''

    ``Based upon information in the most recent progress 
report, NIAID has determined that the above referenced grant 
may include Gain of Function (GoF) research that is subject to 
the U.S. Government funding pause (http://www.phe.gov/s3/
dualuse/Documents/gain-of-function.pdf), issued on October 17, 
2014. The following specific aims appear to involve research 
covered under the pause:

    Aim 3: Testing predictions of CoV inter-species 
transmission

    As per the funding pause announcement, new USG funding will 
not be released for GoF research projects that may be 
reasonably anticipated to confer attributes to influenza, MERS, 
or SARS viruses such that the virus would have enhanced 
pathogenicity and/or transmissibility in mammals via the 
respiratory route.''.

    In addition, the letter clearly states that such a 
determination of whether the research included projects subject 
to the funding pause had not yet been made: ``Therefore, the 
next non-competing segment of the award that starts June 1, 
2016 cannot be released until a determination is reached based 
on the receipt and review of the information requested below.''

    Question 4. Did the NIH inform EcoHealth in 2016, under 
``Special Terms and Conditions'' for continuation of the grant, 
that ``should any of the MERS-like or SARS-like chimeras 
generated under this grant show evidence of enhanced virus 
growth greater than 1 log [10 times] over the parental backbone 
strain you must stop all experiments with these viruses and 
provide the NIAID Program Officer and Grants Management 
Specialist, and Wuhan Institute of Virology Institutional 
Biosafety Committee with the relevant data and information''? 
Please answer yes or no.

    Answer 4. Yes, in an abundance of caution and as an 
appropriate biosafety measure, additional language was included 
in the terms and conditions of the grant award to EHA. The 
Special Terms and Conditions of the award state:

    ``No funds are provided and no funds can be used to support 
gain-of-function research covered under the October 17, 2014 
White House Announcement (NIH Guide Notice NOT-OD-15-011). Per 
the letter dated July 7, 2016 to Mr. Aleksei Chmura at 
EcoHealth Alliance, should any of the MERS-like or SARS-like 
chimeras generated under this grant show evidence of enhanced 
virus growth greater than 1 log over the parental backbone 
strain you must stop all experiments with these viruses and 
provide the NIAID Program Officer and Grants Management 
Specialist, and Wuhan Institute of Virology Institutional 
Biosafety Committee with the relevant data and information 
related to these unanticipated outcomes.''

    These measures would prompt a secondary review to determine 
whether the research aims should be re-evaluated to determine 
whether new biosafety measures should be enacted.

    Question 5. Was the NIH informed in a progress report 
submitted in 2018 that the researchers had found that their 
novel, laboratory-generated chimeric SARS-related coronaviruses 
exhibited increased pathogenicity and greater than 4-log 
(greater than 10,000 times) enhanced viral growth in lungs of 
so-called ``humanized mice'' (i.e., mice engineered to display 
human receptors on lung cells)? Please answer yes or no.

    Answer 5. NIH received a progress report in 2018 that 
showed a figure presenting transient differences in weight loss 
and viral load within the lungs of transgenic mice infected 
with chimeric bat severe acute respiratory syndrome-related 
coronaviruses (SARSr-CoVs). Note, however, that these findings 
were not reported to be statistically significant in comparison 
to mice infected with the parental backbone virus.

    Question 6. Did the NIH continue to fund the grant, despite 
the violation of the terms and conditions outlined on page S of 
the 2016 grant Notice of Award (specifically, for failing 
immediately to ``stop all experiments with these viruses and 
provide the NIAID Program Officer and Grants Management 
Specialist. .. with the relevant data and information'')? 
Please answer yes or no.

    Answer 6. NIH did not conclude that there was non-
compliance with the Special Terms and Conditions of the award 
based on the figures presented in the 2018 progress report.

    Question 7. Did the NIH award another 5-year grant in 2019 
to EcoHealth Alliance with a subcontract to the Wuhan Institute 
of Virology (available at https://reporter.nih.gov/search/
6lo2KK8sZEefzzmWqkIOyg/project-details/9819304) for research on 
bat SARS-related coronaviruses, which proposed to continue and 
expand the construction of new chimeric SARS-related 
coronaviruses? Please answer yes or no.

    Answer 7. NIH renewed the EHA grant in 2019 after the 
renewal application underwent peer review and was found to be 
highly meritorious. EHA has reported that no subcontract or 
subaward agreement was reached with WIV under the renewal award 
and EHA has reported that no funds from the renewal award were 
sent to WIV.

    Question 8. Did the NIH award the second 5-year grant 
despite the fact that the 2018 grant proposal disclosed the 
greater-than-I 0,000-times enhanced viral growth and enhanced 
viral pathogenicity of the laboratory-generated chimeric SARS-
related coronaviruses? Please answer yes or no.

    Answer 8. Please see answers to Questions 5 through 7.

    Question 9. Did the NIH award the second 5-year grant 
despite not having forwarded the grant proposal to the HHS 
Potential Pandemic Pathogen Care and Oversight (P3CO) Committee 
for risk-benefit review? Please answer yes or no.

    Answer 9. NIAID awarded the grant after reviewing it in 
accordance with the U.S. Department of Health and Human 
Services Framework for Guiding Funding Decisions about Proposed 
Research Involving Enhanced Potential Pandemic Pathogens (HHS 
P3CO Framework). Only proposed research being considered for 
funding and that has been determined by the funding agency as 
reasonably anticipated to create, transfer, or use enhanced 
potential pandemic pathogens (ePPPs) is subject to additional 
HHS department-level review.

    Question 10. Did Sections I and II of the HHS P3CO 
Framework (available at https://www.phe.gov/s3/dualuse/
documents/p3co.pdf) require that NIH forward grant proposals to 
the HHS Potential Pandemic Pathogen Care and Oversight (P3CO) 
Committee for risk-benefit review whenever ``proposed research 
is reasonably anticipated to create, transfer, or use enhanced 
PPPs,'' where ``enhanced PPP is defined as a PPP resulting from 
the enhancement of the transmissibility and/or virulence of a 
pathogen''? Please answer yes or no.

    Answer 10. Yes, Section II of the HHS P3CO Framework states 
that ``proposed intramural and extramural life sciences 
research that is being considered for funding and that has been 
determined by the funding agency as reasonably anticipated to 
create, transfer, or use enhanced PPPs is subject to additional 
HHS department-level review.'' The HHS P3CO Framework defines a 
PPP as:

        ``a pathogen that satisfies both of the following: 1. 
        It is likely highly transmissible and likely capable of 
        wide and uncontrollable spread in human populations; 
        and 2. It is likely highly virulent and likely to cause 
        significant morbidity and/or mortality in humans.''

    NIAID, as the funding agency, reviewed the EHA grant in 
accordance with the HHS P3CO Framework and determined that the 
experiments to generate SARS-like or MERS-like chimeric 
coronaviruses were not reasonably anticipated to create, 
transfer, or use ePPPs and, therefore, were not subject to 
additional HHS department-level review as delineated in the HHS 
P3CO Framework.

    Question 11. If you answered yes to any of the questions 
above, are you prepared to retract your previous false 
testimony before the U.S. Senate Committee on Health, 
Education, Labor, and Pensions?

    Answer 11. None of the responses to Questions 1 through 10 
contradict testimony before the U.S. Senate Committee on 
Health, Education, Labor, and Pensions.

                            SENATOR CASSIDY

    Question 1. The U.S. is in the middle of flu season, which 
has the potential to add additional burden to already-stressed 
health care systems due to the ongoing pandemic.

        Question 1(a). What steps is HHS taking to ensure the 
        availability of appropriate diagnostics and treatment 
        options to address the potential dual threats of COVID 
        and influenza, including through shoring up the 
        Strategic National Stockpile?

        Question 1(b). Beyond testing and preventative steps 
        like vaccination, what steps has HHS taken to 
        proactively treat vulnerable populations like the 
        elderly or others who may be at risk for and are likely 
        to spread communicable diseases like COVID and the flu?

        Answer 1. NIH defers to CDC.

    Question 2. Health systems in Louisiana have been 
overwhelmed by successive waves of COVID variants. These health 
systems could have been better prepared for these growing 
variant trends if they had access to better national and 
regional dashboards monitoring variants of concern.

        Question 2(a). What are you all at the CDC, FDA, NIH, 
        and HHS doing to make sure health providers are armed 
        with the best data to respond appropriately to the next 
        COVID variant or pandemic?

        Answer 2. NIH defers to CDC.

        Question 2(b). Second, how are you all harnessing the 
        speed and innovation of the private sector to help 
        predict, prevent, and mitigate future COVID-19 variants 
        or other pathogens of concern?

        Answer 2. NIAID, the National Human Genome Research 
        Institute, and the National Library of Medicine are 
        participating in the SARS-CoV-2 Sequencing for Public 
        Health Emergency Response, Epidemiology, and 
        Surveillance (SPHERES) initiative. SPHERES is a 
        national genomics consortium led by CDC that helps to 
        coordinate SARS-CoV-2 sequencing across the United 
        States. NIAID is working with partners to identify, 
        monitor, and calculate the frequency of current 
        variations in the SARS-CoV-2 genome to help predict 
        emerging variants. NIAID also facilitates the use of 
        cutting-edge modeling and structural biology tools to 
        understand how variants might affect interactions 
        between the virus and the immune system or COVID-19 
        therapeutics. In addition, NIAID-supported scientists 
        are collaborating with vaccine manufacturers to assess 
        the impact of new variants of concern on their products 
        and to design and test new vaccines to help protect 
        against variant viruses. These efforts add to our 
        knowledge about SARS-CoV-2 variants and our ability to 
        combat them.

    Question 3. Dr. Fauci: Many experts have expressed optimism 
regarding how the Omicron variant might leave behind extremely 
high levels of immunity, and the prospect of an end to this 
pandemic is encouraging. However, with each new variant that 
emerges, any gaps in population-level data on how our immune 
systems respond--not just antibodies but also T-cells--limit 
our ability to inform the policies on which public health 
experts, public officials, providers, and patients depend.

        Question 3(a). Given that questions about efficacy of 
        COVID-19 vaccines and the need for boosters can only be 
        answered by understanding both T-cells AND antibodies, 
        how do we ensure that T-cell analysis is fully included 
        in research decisions for vaccines and boosters going 
        forward?

        Question 3(b). How can NIH ensure T-cell data is 
        incorporated into its ongoing research to combat the 
        pandemic, including the effectiveness of vaccines and 
        prior infection against new variants, including Omicron 
        and what might come next?

        Answer 3(a)(b). NIAID continues to conduct and support 
        research to improve understanding of the role of T 
        cells in protection against COVID-19 and COVID-19 
        disease progression. NIAID supported a collaborative 
        longitudinal study by researchers at Emory University 
        and the Fred Hutchinson Cancer Research Center that 
        demonstrated that SARS-CoV-2-specific T cells were 
        detectable for up to 8 months in patients after mild to 
        moderate COVID-19. NIAID also supported two separate 
        studies examining T cell responses in recovered COVID-
        19 patients and individuals vaccinated against COVID-
        19. They found robust immune responses to the original 
        strain as well as multiple variants of SARS-CoV-2 in 
        both groups. Additional work by NIAID researchers and 
        grantees showed that most individuals with existing T 
        cell responses against SARS-CoV-2 should generate a T 
        cell response against the Omicron variant, and that 
        SARS-CoV-2 has thus far not evolved extensive T cell 
        escape mutations. Other work from NIAID-supported 
        investigators has shown that vaccine-induced T cell 
        responses recognize the Omicron variant. In another 
        NIH-supported study, researchers uncovered features of 
        T cells that distinguish fatal from non-fatal cases of 
        severe COVID-19, which could help harness knowledge of 
        T cells to inform new potential treatments for this 
        disease.

        Question 3(c). How can NIH ensure T-cell data is fully 
        integrated into its RECOVER research initiative for 
        those suffering from prolonged symptoms following a 
        COVID infection?

        Answer 3(c). Assessment of T-cell function after SARS-
        CoV-2 infection may provide important clues to disease 
        mechanisms, diagnosis, and treatment of post-acute 
        sequelae of SARS-CoV-2 infection (PASC), including Long 
        COVID. In recognition of this, the NIH Researching 
        COVID to Enhance Recovery (RECOVER) Initiative includes 
        studies of the pathobiologic mechanisms underlying 
        PASC, including studies characterizing the cellular 
        immune response to SARS-CoV-2. Importantly, RECOVER 
        also includes collection, analysis, and biobanking of 
        serum and peripheral blood mononuclear cells (PBMC), 
        including T cells, from adult and pediatric study 
        participants during the course of the project. A 
        RECOVER Consortium group of experts is monitoring the 
        state of the science regarding immunologic responses to 
        SARS-CoV-2 infection and the best technical approaches 
        for characterizing those responses as well as 
        evaluating optimal approaches for cell-based assays for 
        the RECOVER serum and PBMC samples. RECOVER core 
        immunophenotyping laboratories will conduct the 
        recommended T-cell function assays utilizing the 
        biobanked specimens. These analyses will provide a 
        unique resource for correlation of PASC clinical 
        symptoms with deep clinical phenotyping in the RECOVER 
        cohorts as well as for studies by the broader research 
        community.

        Question 3(d). How can NIH support efforts to integrate 
        T-cell data into vaccine, booster, and other public 
        health decisions at FDA and CDC?

        Answer 3(d). NIAID investigators will continue to 
        integrate T cell data into vaccine and booster 
        research, including in clinical studies and pre-
        clinical challenge studies for COVID-19 vaccine 
        candidates. For example, NIAID is supporting a Phase 1 
        clinical trial in healthy adults to assess the safety 
        and immunogenicity of COVID-19 vaccine candidates 
        developed by Gritstone Oncology, Inc., that utilize a 
        strategy aimed at inducing both neutralizing antibodies 
        and T cell responses to elicit a broad immune response 
        against conserved viral antigens. In addition, the 
        NIAID Vaccine Research Center has established the 
        Pandemic Response Repository through Microbial/Immune 
        Surveillance and Epidemiology (PREMISE) program. The 
        program will use data from the measurement of T and B 
        cell immune responses to inform the discovery and 
        development of diagnostic, prophylactic, and 
        therapeutic countermeasures and accelerate the global 
        response to pandemic threats. NIAID anticipates the 
        research conducted by PREMISE will advance our 
        knowledge of immune response to vaccination and 
        infection and help inform the response to future 
        pandemic threats.

        NIAID also is leading a study in fully vaccinated 
        individuals to assess the safety and immune responses 
        (including T cell responses) following boosting with a 
        COVID-19 vaccine different than the one used for the 
        initial vaccination (``mix and match''). NIAID released 
        early data from this trial demonstrating that 
        administering the Pfizer, Moderna, or Johnson & 
        Johnson/Janssen COVID-19 vaccines at least 12 weeks 
        after individuals received a different vaccine regimen 
        effectively enhanced the immune response to SARS-CoV-2. 
        The results of this trial were made available to FDA 
        during FDA's decisionmaking process to authorize the 
        use of heterologous, or ``mix and match,'' booster 
        dosing in eligible individuals following completion of 
        primary vaccination with a different available COVID-19 
        vaccine for persons 18 years of age and older.

                             SENATOR BRAUN

    Question 1. Your administration is explaining to the 
American public that COVID tests will be ``free'' to everyone 
covered by private insurance. Is this true? Will employer and 
individual premiums be impacted by the cost of these tests?

    Question 2. Over the past 2 years, businesses of all sizes 
have faced innumerable challenges and significant disruptions. 
To add to this, inflation is at its highest level since the 
1980's and is having a significant impact on business 
operations. How will adding significant costs to employers' 
healthcare bills through the over-the-counter (OTC) testing 
coverage requirement help bring down the costs of these tests 
and help employers address their workforce and inflation 
concerns?

    Question 3. How does the new OTC testing coverage 
requirement policy solve for the problem of the limited supply 
of tests in the country, particularly with your administration 
seemingly purchasing most of the current supply?

    Answer 1,2,3. Thank you for your questions, these are best 
addressed by the Centers for Medicare & Medicaid Services.

    Question 4. Senior caregivers working across assisted 
living and memory care communities have been instrumental in 
successfully mitigating the spread of COVID-19 among the most 
vulnerable populations in congregate care settings. Without the 
Federal relief that other long-term care options, like nursing 
homes, have received, nearly two-thirds of assisted living 
communities have not experienced a single COVID-19 death due to 
the outstanding efforts of frontline caregivers. However, 
emerging variants mean that seniors in assisted living and 
memory care remain extremely vulnerable despite high 
vaccination rates.

        T3Question 4(a). Dr. Fauci, as new Federal data shows 
        that 85 percent of reported breakthrough deaths were of 
        those 65 and older, and 80 percent of all COVID-19 
        deaths are individuals over age 65, should these 
        assisted living and memory care communities be 
        prioritized in the distribution of rapid tests, PPE, 
        and additional boosters?

        Answer 4. Access to both rapid tests and personal 
        protective equipment is critical for assisted living 
        and memory care communities to carry out infection 
        prevention and control programs and remain vigilant 
        against COVID-19 among residents and staff. Older 
        adults are at high risk of developing severe COVID-19 
        disease and remaining up-to-date with all recommended 
        COVID-19 vaccine doses is essential to protect both 
        staff and residents against developing severe COVID-19. 
        It also is important for any visitors to these 
        facilities remain up to date with all recommended 
        COVID-19 vaccine doses. I continue to urge everyone, 
        especially those who are most vulnerable, to protect 
        themselves by getting vaccinated and boosted.

                             SENATOR SCOTT

                             Omicron Status

    Question 1. Dr. Fauci, should we be employing a ``COVID 
zero'' strategy or should our strategy be to minimize mortality 
and social harm until we reach herd immunity?

    Answer 1. I agree that our strategy should minimize 
mortality and social harm by sustaining and building on the 
progress we have made so far. As therapeutics to prevent 
progression to severe COVID-19 are becoming more widely 
available and a higher percentage of the population is 
vaccinated and boosted, we should be able to return to some 
degree of normality. It is important to note that the emergence 
of new variants capable of evading currently available 
therapeutics and/or vaccines is possible. Therefore, NIAID will 
continue to conduct and support research to develop next-
generation COVID-19 vaccines and therapeutics in order to help 
protect against novel SARS-CoV-2 variants.

                           SENATOR TUBERVILLE

                           Omicron Infection

    Question 1. What information does the administration have 
about the potential for someone to be reinfected with the 
Omicron variant?

    Answer 1. Reinfections with the Omicron variant in 
individuals who already have recovered from an Omicron variant 
infection are rare. If someone mounts a good immune response to 
the initial infection, it is unlikely that they will be re-
infected with the same variant. Most reinfections occur in 
people who have been infected with one variant, such as Delta 
variant, and then are subsequently re-infected with a different 
variant, such as Omicron variant. We also have to be prepared 
for the possibility of another variant emerging that is so 
different from existing variants that it eludes any protection 
that individuals have acquired from vaccinations and/or prior 
infections. NIAID will continue to conduct and support research 
to develop next-generation COVID-19 vaccines and therapeutics 
in order to help protect against novel SARS-CoV-2 variants.

    Question 2. Does science still support a 90-day period 
after an infection during which a person should be exempt from 
testing requirements?

    Answer 2. NIH defers to CDC.

    Question 3. In a CNN appearance on January 11, 2022, you 
said ``What the CDC has said and it gets misinterpreted they're 
saying wearing any mask is better than no mask at all.'' Can 
you provide the data that informed these remarks?

    Answer 3. According to the CDC, loosely woven cloth 
products provide the least protection compared to other types 
of masks, layered finely woven products offer more protection, 
well-fitting disposable surgical masks and KN95s offer even 
more protection, and well-fitting NIOSH-approved respirators 
(including N95s) offer the highest level of protection. For 
additional information on studies informing CDC's public health 
messaging on masks, please see the CDC's Science Brief: 
Community Use of Masks to Control the Spread of SARS-CoV-2 
(https://www.cdc.gov/coronavirus/2019-ncov/science/science-
briefs/masking-science-sars-cov2.html).

                         COVID and Vaccinations

    Question 4. On May 16, 2021, you stated ``So even though 
there are breakthrough questions with vaccinated people, almost 
always the people are asymptomatic and the level of virus is 
much lower in their nasopharynx, the top part of their throat 
that lies behind the nose, than it is in someone who is 
unvaccinated. When you get vaccinated, you not only protect 
your own health and that of the family but also you contribute 
to the community health by preventing the spread of the virus 
throughout the community. In other words, you become a dead end 
to the virus.'' Do you still agree with this statement?

    Answer 4. The statement was accurate at the time it was 
made. Since then, we have seen the emergence of SARS-CoV-2 
variants--such Omicron--that remain highly transmissible even 
in communities with a high level of vaccination. It is 
important to note that COVID-19 vaccines and boosters protect 
against severe disease, hospitalization, and death from known 
variants of concern.

    Question 5. In June 2021, President Biden stated ``[y]ou're 
not going to get COVID if you have these vaccinations,'' and 
``[i]f you're vaccinated, you're not going to be hospitalized, 
you're not going to be in the ICU unit, and you're not going to 
die.'' Do you agree with this statement?

    Answer 5. Most individuals who are vaccinated and boosted 
remain asymptomatic or have only mild symptoms following SARS-
CoV-2 infection. Booster doses remain remarkably effective 
against the Omicron variant. COVID-19 vaccines and booster 
shots can keep you out of the hospital and certainly can save 
your life.

    Question 6. In July 2021, Dr. Walensky stated ``99.5 
percent of deaths from COVID-19 in the United States were in 
unvaccinated people'' and you also stated 99.2 percent of 
deaths in June were unvaccinated. Is this still accurate?

    Answer 5,6. The statements were accurate at the time they 
were made. NIAID would defer to the CDC to provide the most 
recent data on the percentage of deaths from COVID-19 in the 
United States that were unvaccinated people.

    Question 7. In July 2021, former NIH Director Collins 
stated 99 percent of people in a hospital were unvaccinated. Is 
this still accurate?

    Answer 7. Dr. Collins' statement was accurate at the time 
it was made. NIAID would defer to the CDC to provide the most 
recent data on the percentage of COVID-19 hospitalizations who 
were unvaccinated.

    Question 8. In August you stated that ``vaccines prevent 
getting infected, prevent getting sick, prevent your 
hospitalization.'' Is that statement still accurate?

    Answer 8. COVID-19 vaccines and boosters protect against 
severe disease, hospitalization, and death from known variants 
of concern; however, vaccines may not be as effective in 
preventing asymptomatic or mild infection with SARS-CoV-2 
variants.

    Question 9. Has the Federal response to COVID-19 been 
successful?

        Question 9(a). Please explain.

    Answer 9,9(a). The public health response to COVID-19 has 
required an unprecedented global public-private research 
effort. NIAID has played a central and important role in this 
response. NIAID capitalized on decades of fundamental basic 
research, including groundbreaking structure-based vaccine 
design at the NIAID Vaccine Research Center, to facilitate the 
rapid development of COVID-19 vaccines. NIAID also initiated 
clinical trials with creative and adaptive designs, allowing 
the evaluation of the safety and efficacy of multiple new and 
existing therapeutics for the treatment of COVID-19, which has 
helped support authorization of some of these products by FDA. 
In addition, NIAID has engaged domestic and international 
clinical research infrastructure and leveraged highly 
productive partnerships in the public and private sectors to 
support multiple COVID-19 vaccine candidates to progress in 
record time from concept to Emergency Use Authorization by FDA. 
Use of these vaccines throughout the world will continue to 
play a critical role in reducing the threat of COVID-19 in the 
United States and globally.

        Question 9(b)4. Please explain what should have been 
        done differently.
        Answer 9(b). The emergence of novel SARS-CoV-2 
        variants, namely Delta and Omicron, has highlighted the 
        importance of vaccinating the rest of the world. The 
        United States is a world leader in these efforts; 
        however, we should continue to look at ways to 
        buildupon existing efforts to address global vaccine 
        disparities. Improving global COVID-19 vaccination 
        rates is one way that the Federal Government could help 
        limit the impact of additional SARS-CoV-2 variants.

    Question 10. Please provide specific examples where your 
agency has utilized real world evidence in regards to COVID-19 
or treatments for COVID-19.

    Answer 10. Randomized controlled clinical trials are the 
gold standard and continue to be used to determine the safety 
and efficacy of candidate COVID-19 vaccines and therapeutics. 
Real-world evidence also continues to play an important role in 
the public health response to COVID-19. Specifically, real-
world evidence from observational studies was used--when 
available--to help prioritize which repurposed agents to 
evaluate in the ACTIV-6 trial. Real-world evidence also has 
helped inform recommendations of the NIH COVID-19 Treatment 
Guidelines Panel, which aim to provide clinicians with 
evidence-based recommendations on the management of COVID-19. 
In addition, real-world evidence of vaccine effectiveness has 
shown that COVID-19 booster doses reconstitute the waning 
immune protection of the initial vaccine series. Booster doses 
are especially effective in protecting against severe COVID-19 
disease, hospitalization, and death. NIAID will continue to use 
real-world evidence to help inform research on COVID-19 medical 
countermeasures.

    Question 11. A recent Kaiser study found increased 
myocarditis risk in men 18-24 years old who have taken the 
COVID-19 vaccine and some physicians have raised alarm over 
recent sudden deaths in young athletes worldwide, particularly 
soccer players. Yet, the Biden administration is pushing 
booster shots amongst this and younger age groups. Are you 
concerned that this administration's policy could be increasing 
the risk of adverse events like myocarditis in individuals that 
have minimal risk from COVID-19, many of whom are fully 
vaccinated and have protection from a prior COVID infection?

    Answer 11. Reports of myocarditis and pericarditis in 
adolescents and young adults following COVID-19 vaccination are 
rare. Unvaccinated adolescents and young adults are at higher 
risk of developing myocarditis from SARS-CoV-2 infection 
itself. The benefits of COVID-19 vaccination outweigh the 
possible risk of myocarditis or pericarditis as most patients 
who receive care respond well and feel better quickly. Patients 
can usually return to their normal daily activities after their 
symptoms improve. Vaccines and boosters continue to be the best 
way protect individuals from severe COVID-19 disease.

    Question 12. Do you believe schools and universities should 
be requiring students to be vaccinated and boosted in order to 
be enrolled or attend school?

    Answer 12. The decision to require COVID-19 vaccines and 
boosters (and other vaccines) to attend schools and 
universities is made at the local level. I will continue to 
encourage everyone who is eligible to protect themselves from 
COVID-19 by getting vaccinated and boosted.

                            Natural Immunity

    Question 13. In September 2021, when asked whether natural 
immunity provided similar protection as a vaccine, you stated 
you did not have a firm answer on that but needed to discuss 
the durability of the response. In the roughly 4 months since 
you made those comments, have you developed a firm answer?

    Answer 13. Available evidence shows that vaccinated and 
boosted individuals are at much lower risk of hospitalization 
and death from COVID-19. Individuals previously infected with 
SARS-CoV-2 are believed to have a low risk of subsequent 
infection for at least 6 months. At this time, there is no FDA-
authorized or--approved test that health care providers or the 
public can use to reliably determine whether a previously 
infected person is protected from SARS-CoV-2 infection at any 
given time. It also is important to note that the level of 
protection from prior infections may not be the same for all 
viral variants or in all individuals. Further, we now know that 
vaccination enhances the protective immune response in 
previously infected individuals.

    Question 14. Why does our Federal Government not currently 
recognize natural immunity, as other countries do?

    Answer 14. NIH defers to CDC.

                     Early Treatments for COVID-19

    Question 15. Please provide a complete list and funding 
amount of studies funded by the Federal Government that have 
examined early treatments for COVID-19.

    Answer 15. NIH is only able to provide information about 
projects funded by the NIH. You may wish to consult with HHS or 
other agencies for information on studies not funded by NIH.

    NIH sponsored a wide range of research activities during 
Fiscal Year (FY) 2020 and fiscal year 2021 that related to 
investigation of potential early treatments for coronavirus 
disease 2019 (COVID-19) spanning both inpatient and outpatient 
settings as well as early stage research where the modality was 
not yet tested in humans. A total of 201 projects were funded, 
representing a trans-NIH initiative involving multiple 
Institutes, Centers and Offices (ICOs), led by NIAID. The 
portfolio of NIH-funded COVID-19 early treatment projects 
included a diverse range of research.

    Through fiscal year 2021, $389 million in COVID-19 
emergency supplemental and annual appropriations supported 
grants, contracts, and other research agreements related to 
early treatment research projects.

 
------------------------------------------------------------------------
                                               Total FY 2020
Funding IC      FY 2020          FY 2021         & FY 2021      No. of
              Obligations      Obligations      Obligations    Projects
------------------------------------------------------------------------
   NIAID     $193,394,653      $81,080,280    $274,474,933         110
------------------------------------------------------------------------
      NHLBI   $35,890,868      $10,684,487     $46,575,355           7
------------------------------------------------------------------------
   NCATS       $9,921,728      $24,330,995     $34,252,723          28
------------------------------------------------------------------------
     NCI      $13,596,274       $4,231,135     $17,827,409          31
------------------------------------------------------------------------
   NIEHS       $3,206,576       $5,152,543      $8,359,120           7
------------------------------------------------------------------------
   NIBIB       $1,366,290       $2,388,843      $3,755,133           8
------------------------------------------------------------------------
      OD       $2,070,470         $521,426      $2,591,896           6
------------------------------------------------------------------------
   NICHD       $1,079,400                       $1,079,400           4
------------------------------------------------------------------------
   Total     $260,526,259     $128,389,709     $388,915969         201
------------------------------------------------------------------------


    The COVID-19 early treatment-targeted projects examined the 
full spectrum of research opportunities for suppression of 
infection symptoms and improved health outcomes in both 
inpatient and outpatient settings as well as early stage 
research where the modality was not yet tested in humans. These 
projects included investigation of a broad range of therapeutic 
approaches, such as antiviral treatments, anti-inflammatory 
medications, immunotherapeutics, convalescent plasma, dietary 
supplements or vitamins, and repurposed drugs. Other projects 
investigated the use of advanced technologies, such as 
nanobodies.

 
----------------------------------------------------------------------------------------------------------------
                                                                             Total FY 2020 & FY
              Topic               FY 2020 Obligations  FY 2021 Obligations    2021 Obligations   No. of Projects
----------------------------------------------------------------------------------------------------------------
            Chloroquine and            $8,083,110           $1,848,182           $9,931,292               7
          Hydroxychloroquine
----------------------------------------------------------------------------------------------------------------
Other Investigational Products       $149,945,138          $78,958,425         $228,903,564             147
----------------------------------------------------------------------------------------------------------------
                 Remdesivir            $1,703,830             $760,184           $2,464,014               5
----------------------------------------------------------------------------------------------------------------
Vitamins and Other Repuposed          $32,928,856          $11,868,302          $44,797,158              27
                       Drugs
----------------------------------------------------------------------------------------------------------------
Monoclonall Antibody/Biologic         $67,019,048          $30,488,737          $97,507,785              10
----------------------------------------------------------------------------------------------------------------
                   Multiple              $846,277           $4,465,879           $5,312,156               5
----------------------------------------------------------------------------------------------------------------
                      Total          $260,526,259         $128,389,709          $388,915969             201
----------------------------------------------------------------------------------------------------------------


    Projects in the Multiple category displayed in the table 
above include grants for projects in which more than one 
medication or therapeutic was evaluated for treatment 
effectiveness, such as chloroquine, hydroxychloroquine and 
remdesivir.

    Projects in the Other Investigational Products category 
encompassed different lines of inquiry, including the use of 
high throughput screening (HTS) to identify whether metabolic 
changes induced by COVID-19 could be blocked or reversed. Other 
sample efforts include projects that supported development of 
novel therapeutics that target the COVID-19 virus spike protein 
or replication machinery. For example, one project examined 
modified mRNA (modRNA) drugs to target COVID-19. Another 
project identified potential drugs that could target the virus 
spike protein through an approach called protein-catalyzed 
capture (PCCs).

    The projects funded within the Vitamins & Other Repurposed 
Drugs research category involved varied approaches to discover 
existing drugs or vitamins that could effectively block the 
cellular mechanisms required for viral infection or block the 
cellular response to infection that causes disease. One project 
investigated the efficacy and use of dietary supplements sold 
for weight loss, energy, sports performance, and immune 
function in treating COVID-19 infection. For example, a 
prevention study in health care workers evaluated the efficacy 
of low versus moderate to high doses of Vitamin D.

    Question 16. Why does the NIH-funded trial of ivermectin 
not conclude until 2023?

    Answer 16. Ivermectin is being studied in a clinical trial 
known as ACTIV-6 (Accelerating COVID-19 Therapeutic 
Interventions and Vaccines master protocol number 6), which 
began recruiting participants on June 11, 2021. ACTIV-6 is a 
clinical trial to test up to seven existing medications, at 
varying doses, for adults with COVID-19 who have mild-to-
moderate symptoms. The ACTIV-6 study completion date of March 
2023 listed on clinicaltrials.gov reflects when enrollment for 
all ACTIV-6 drugs is anticipated to be complete. The `study 
completion date' on clinicaltrials.gov does not reflect 
completion dates for individual drugs/dosages tested. An 
independent Data Safety and Monitoring Board is responsible for 
periodic assessment of ACTIV-6 data and makes recommendations 
related to the study protocol, individual drugs/dosages, and 
continuation of the trial to the study team and trial sponsors 
to maintain the safety of ACTIV-6 participants.

    Ivermectin is being tested at two different dosages within 
ACTIV-6. A study testing a lower dosage of ivermectin opened 
for enrollment on June 11, 2021, and will close in February 
2022, having met its enrollment goal. Results from the lower 
dose ivermectin study are anticipated later this year, after a 
period of participant follow-up and data analysis. All results 
from ACTIV-6 will be made available to the public and also for 
review by treatment guidelines committees, which span the 
Federal Government, and public health organizations, for 
potential development into guidelines and recommendations for 
healthcare providers. A higher dose ivermectin study is 
anticipated to start in February 2022 and will continue to 
enroll participants over the next six to 8 months until 
enrollment goals are met, with results expected in early 2023.
                                ------                                


   Response by Janet Woodcock to Questions of Senator Casey, Senator 
  Smith, Senator Burr, Senator Cassidy, Senator Braun, Senator Scott, 
                 Senator Tuberville, and Senator Hassan

                             SENATOR CASEY

    Question 1. At the hearing, I asked how the Federal 
Government is working with vaccine manufacturers to speed the 
development of a safe and effective vaccine for children under 
age five. Understanding that the Pfizer trial for children 24 
months to 5 years old did not meet its endpoint, my follow-up 
questions are, how did we get here and what's next? Please 
describe, generally, the following:

        Question 1(a). How vaccine developers make decisions 
        about dose size, quantity and spacing in age de-
        escalation trials;

        Question 1(b). What type of indicators a vaccine 
        manufacturer might consider when determining whether 
        and how to change the dose size, quantity or spacing if 
        primary endpoints are not met; and

        Question 1(c). Whether the emergence of a viral variant 
        could affect the efficacy of a vaccine in children 
        differently than it would affect the efficacy of the 
        same vaccine in adults.

    Question 2. Furthermore, could you please provide an update 
on current Federal goals and investments relating to the 
development of vaccines to protect children under age five from 
COVID-19, including grants, contracts or other funding awarded 
to vaccine developers; and what information is currently being 
provided to vaccine developers regarding current or planned 
opportunities for collaboration between the Federal Government 
and vaccine developers, including the extent to which BARDA 
will conduct TechWatch/CoronaWatch meetings and the extent to 
which FDA will accept applications for emergency use 
authorization.

    Question 3. Finally, could you describe current thinking 
across your agencies regarding the circumstances under which 
your efforts would expand to include the development of 
additional or next-generation vaccines and therapeutics for 
COVID-19?

    Answer 1. As with all vaccines, the FDA requires that 
COVID-19 vaccine developers provide sufficient data to the 
Agency to evaluate the safety and effectiveness of the vaccine 
for its intended use and population. Having a safe and 
effective COVID-19 vaccine available for younger children is a 
priority for FDA. The Agency will ensure the data support 
effectiveness and safety before authorizing or approving a 
COVID-19 vaccine for use in younger pediatric populations.

    As background, dose finding studies are a part of vaccine 
development where various dosages are tested in people in 
randomized-controlled studies. These studies also provide some 
initial safety information on common short-term side effects 
and risks, the safety profile at the different dose levels, and 
examine the relationship between the dose administered and the 
immune response and the ability of a vaccine to generate an 
immune response.

    For some vaccines, including COVID-19 vaccines, age de-
escalation is a step-wise approach that is undertaken for 
vaccine development in pediatric populations. With an age-de-
escalation approach in the pediatric population, clinical 
trials may begin in adults and/or adolescents and proceed 
downward in age, in a step-wise manner, as safety and 
effectiveness data are accrued, sometimes including from post-
marketing use in a much larger number of children than 
evaluated in clinical trials. COVID-19 vaccines may be 
authorized for emergency use in pediatric populations, 
depending on the available safety and effectiveness data and 
benefit/risk considerations, which may be different for various 
age groups.

    Conducting clinical trials to determine an appropriate 
vaccine dose in younger pediatric populations requires 
additional investigation and study over that done in the 
clinical trials for adults, including the evaluation of 
different dosages to ensure that the vaccine dosage and the 
schedule chosen for younger pediatric populations is optimal 
before larger clinical studies in pediatric populations to 
evaluate safety and effectiveness.

    Acknowledging that COVID-19 affects all age groups, but 
that the epidemiology and pathogenesis of COVID-19, and the 
safety and effectiveness of COVID-19 vaccines, may be different 
in children compared with adults, FDA generally expects that 
pediatric trials would be initiated in specific age groups as 
soon as available data support that the vaccine would confer a 
prospect of direct benefit and acceptable risk to trial 
participants (21 CFR 50.52).

    This determination will be made in the context of specific 
vaccine development programs and following discussion of study 
design elements that ensure participant safety and compliance 
with 21 CFR Part 50 Subpart D regulations providing additional 
safeguards for children in clinical investigations. The 
development of COVID-19 vaccines for pediatric populations is 
addressed in our June 2020 Guidance for Industry, Development 
and Licensure of Vaccines to Prevent COVID-19, which reflects 
the advice FDA has been providing to vaccine developers since 
the onset of the pandemic.

    In June 2021, FDA convened its Vaccines and Related 
Biological Products Advisory Committee (VRBPAC) to discuss 
licensure and emergency use authorization of vaccines to 
prevent COVID-19 for use in pediatric populations and 
specifically to discuss approaches to evaluating safety and 
effectiveness to help FDA advise COVID-19 vaccine manufacturers 
to ensure that pediatric trials will be adequately designed to 
support vaccine licensure (or emergency use authorization, when 
relevant statutory criteria are met) in various age groups.

    FDA has been working closely with vaccine manufacturers to 
provide advice as data accrue about safety and effectiveness, 
the latter of which may be comprised of immune response data or 
the number of COVID-19 cases that occur, or a combination of 
both, for their respective COVID-19 clinical trials in 
pediatric populations. These data are accruing as the United 
States experiences SARS-CoV-2 variant surges, such as Delta and 
Omicron.

    For the FDA-authorized COVID-19 vaccines and the 
populations authorized for use, at this time, the available 
evidence supports the effectiveness of the current vaccines, 
including a single booster dose, in preventing COVID-19 and 
serious outcomes that can occur, including hospitalization and 
death.

    With respect to the circumstances that would warrant next-
generation COVID-19 vaccines, the FDA has anticipated the 
emergence of SARS-CoV-2 variants. FDA is prepared to work 
closely with vaccine manufacturers to provide feedback in the 
clinical development and, if applicable, the licensure or EUA 
of vaccines that are tailored to a specific SARS-CoV-2 variant. 
With respect to therapeutics, FDA is committed to working with 
companies to evaluate and expeditiously address the potential 
impact of emerging variants on existing therapies and 
facilitate the development and availability of new therapies 
that retain activity against such variants.

                             SENATOR SMITH

    Question 1. Given the importance of ensuring we have 
sufficient supply of accurate COVID-19 tests, can you explain 
the Administration's plans to develop and increase access to 
broad spectrum diagnostic tests, including molecular tests, to 
increase our ability to detect current and future COVID-19 
variants?

    Answer 1. Since the start of the pandemic, the FDA has 
adapted its regulatory approach to address the public's testing 
needs and has been working closely with test developers to 
adjust as those needs have changed. These efforts have helped 
increase testing capacity and broaden public access to all 
types of COVID-19 tests, including laboratory-based, point-of-
care, and over the counter (OTC) tests.

    FDA sought to facilitate COVID-19 test evaluation and 
authorization through the development and availability of 
templates for EUA requests. The templates provide 
recommendations for test validation and a fill-in-the-blank 
form to streamline the paperwork and make it easier for 
developers to provide information in support of a request for 
an EUA. Since providing the first template in January 2020, FDA 
has been in daily contact with test developers to answer 
questions and help them through the EUA process. This has 
proved to be a helpful tool for many. FDA has had as many as 
ten posted templates and continues to update, add, combine, and 
remove templates as the science evolves and as necessary to 
support developers of COVID-19 tests.

    FDA also supported test developers through establishment of 
a dedicated mailbox, 24-7 toll-free hotline that ran until July 
2020, the posting of over 100 frequently asked questions on our 
website, and by hosting 78 weekly virtual town halls for test 
developers. The Agency has worked with over 1,000 test 
developers since January 2020.

    Since its inception in April 2020, FDA has worked closely 
with NIH on the Rapid Acceleration of Diagnostics (RADx) 
initiative, which aims to speed the development, validation, 
and commercialization of innovative point-of-care and home-
based tests, as well as improve clinical laboratory tests, that 
can directly detect the virus. FDA meets regularly with RADx 
Tech program staff and test developers to answer questions and 
provide feedback on validation plans.

    Additionally, in October 2021, the Administration launched 
and invested in a program called the Independent Test 
Assessment Program (ITAP), an innovative partnership between 
the NIH and FDA, funded with resources from the American Rescue 
Plan to further accelerate new products to market.

    This initiative leverages the clinical and scientific 
expertise of the FDA and the NIH to develop validation 
protocols and the resources of the NIH to perform validation 
testing to establish test performance, which enables FDA to 
accelerate test manufacturers through the FDA review process 
based on data provided by trusted partners through the NIH. The 
first two successful candidates to come through this process 
were authorized by FDA in the last week of 2021, which was 
weeks, if not months, ahead of schedule. The ITAP program and 
the FDA continue to prioritize new OTC test candidates which 
have the potential for large-scale production capacity.

    FDA prioritizes review of tests with the greatest public 
health impact, including those that can be run in high volumes, 
at the point-of-care, and at home. The Administration has also 
proactively reached out to manufacturers with self-tests on the 
international market (e.g., in the United Kingdom or Germany) 
and asked them to submit their tests for FDA review.

    To date, the FDA has authorized over 420 tests and sample 
collection devices that provide a wide array of test options. 
This includes POC tests, rapid at-home tests, multi-analyte 
tests that detect both COVID-19 and flu, antigen, molecular, 
and serology tests as well as tests for pooling, screening, and 
serial screening.

    FDA has been monitoring for viral mutations and their 
impact on authorized molecular and antigen diagnostic tests 
throughout the pandemic. FDA tracks the part of the viral 
genome targeted by each authorized molecular test in a data 
base, monitors global data bases for emerging variants, and 
conducts in silico analyses to evaluate whether any of the 
authorized test probes target a part of the viral genome that 
has mutated.

    If FDA identifies a potential impact on test performance, 
FDA contacts the test developer and communicates with the 
public. The first such communication took place on January 8, 
2021, not long after variants began to emerge. FDA issued a 
safety alert and Letter to Health Care Providers to caution 
that the presence of viral genetic mutations in a patient 
sample can potentially change the performance of a diagnostic 
test.

    At that time, FDA identified three authorized molecular 
tests that may be impacted by genetic variants of SARS-CoV-2, 
though the impact did not appear to be significant. FDA also 
provided recommendations to address possible false negative 
results for clinical laboratory staff and health care providers 
who use molecular tests for the detection of SARS-CoV-2.

    In January 2021, the RADx program established a Variant 
Task Force (VTF) to monitor for emerging variants and study the 
performance of COVID-19 tests with different variants. Most 
recently, the VTF has been evaluating the performance of 
antigen tests with patient samples that have the omicron 
variant.

    On February 22, 2021, FDA issued a guidance to provide test 
developers information on evaluating the potential impact of 
emerging and future viral genetic mutations on COVID-19 tests. 
(See ``Policy for Evaluating Impact of Viral Mutations on 
COVID-19 Tests''.) The guidance describes the FDA's activities 
and provides recommendations to test developers, such as 
considering the potential for future viral genetic mutations 
when designing their test, and conducting their own routine 
monitoring to evaluate the potential impact of new and emerging 
viral genetic mutations, which may be the basis of viral 
variants, on the performance of their tests.

    In March 2021, FDA launched a website with information 
regarding the impact of viral mutations on COVID-19 tests. 
(Please see SARS-CoV-2 Viral Mutations: Impact on COVID-19 
Tests (FDA.) The website includes a list of tests that are 
impacted by viral mutations and provides test-specific analyses 
of the impact on performance as well as recommendations for 
clinical laboratory staff and health care providers using the 
test. The website is updated regularly as new information 
becomes available.

    In September 2021, FDA revised EUAs for most tests to add 
Conditions of Authorization requiring test developers to 
conduct their own monitoring of their test in addition to the 
monitoring done by FDA. These Conditions require test 
developers to notify FDA if any viral mutations are found to 
affect the performance of the test, perform and provide any 
additional analyses requested by the FDA, and update labeling 
with any risk mitigations identified by FDA regarding the 
impact of viral mutations on test performance.

    Question 2. Looking long-term, what steps should Congress 
and the Administration take to improve development and supply 
of broad spectrum diagnostics for future pandemics?

    Answer 2. Ensuring the rapid development of diagnostic 
tests in response to future public health emergencies (PHEs) 
will require a coordinated national response across several 
Federal agencies, as well as dedicated funding. FDA will play 
an important role in these efforts so that it can help to 
ensure tests used in emergencies are appropriately accurate and 
reliable. Based on the Agency's experience, FDA has identified 
the following Federal Government goals:

Establish More Effective Mechanisms for Sample Sharing During Outbreaks 
               to Facilitate Test Development/Validation

    Access to clinical specimens is critical for the validation 
of accurate and reliable tests. At the beginning of the COVID-
19 outbreak, clinical specimens were not available to the U.S. 
Government or laboratories. Although developers could design 
tests based on the published sequence of the virus, the lack of 
clinical specimens made it challenging to validate these tests.

    For example, the developers could use contrived specimens--
including synthetic contrived specimens--for validation, but 
these contrived specimens may not have accurately characterized 
the performance of the test if the test was not done properly. 
Fifty-nine molecular tests for SARS-CoV-2 were authorized based 
on validations with contrived transcripts before clinical 
specimens or viral RNA were readily available. Of note, FDA 
later found that validation with synthetic transcripts had not 
accurately shown test performance. Looking forward, the U.S. 
Government should work with international partners to establish 
a plan for sharing clinical specimens as soon as a public 
health threat emerges. This effort could be aided by having 
appropriate international agreements in place in advance.

Establish Contracts to Pre-Position a Handful of Commercial Developers 
                    Ready to Respond in an Outbreak

    Following the MERS outbreak, South Korea established public 
and private partnerships and invested approximately $25 million 
in infectious disease diagnostic technology. As a result of 
these investments and the expectations created through these 
partnerships, a subset of South Korean commercial manufacturers 
were well positioned to develop and manufacture tests quickly.

    For example, two commercial manufacturers began developing 
COVID-19 tests several weeks prior to the South Korean 
government's request to do so. In the United States, there was 
no such pre-positioning of test developers and manufacturers 
for immediate response. In fact, hesitancy from some U.S. 
commercial manufacturers was expressed based on unfavorable 
experiences with prior outbreaks in which some test 
manufacturers had significantly invested in tests that were not 
ultimately needed.

    Furthermore, the test platform installation base in 
laboratories across the United States is heterogeneous, which 
adds a layer of complexity to a rollout of widespread testing. 
For example, molecular diagnostic tests are validated for use 
only on specific polymerase chain reaction (PCR) machines from 
specific vendors and are generally not interchangeable. The 
laboratories therefore had to wait for an authorized test that 
could be used on the platform they had available. The 
installation base of any given platform is proprietary to the 
vendor, which made it difficult for the U.S. Government to 
ensure laboratories had access to tests they could run.

    FDA reviewed EUA requests from all comers and was soon 
flooded by thousands of requests. With tests for SARS-CoV-2, 
the virus that causes COVID-19, FDA ultimately had to implement 
a triage and prioritization process. In the fall of 2020, FDA 
began to prioritize review of the tests that could either 
increase testing accessibility (e.g., POC tests, home 
collection tests, at-home tests) or significantly increase 
testing capacity (e.g., tests that would reduce reliance on 
test supplies, high throughput tests, widely distributed 
tests). Looking forward, we believe the U.S. Government could 
establish contracts to preposition a handful of commercial 
developers to be ready to respond in an outbreak.

    Ideal candidates would have a good track record with test 
development and be capable of working fast and scaling 
manufacturing operations quickly. These contracts should 
consider the availability of platforms in laboratories across 
the United States and ensure that tests will be available to 
all the laboratories that need them. The government may wish to 
develop test designs that could be implemented by preset 
contract manufacturers, commercial manufacturers, and 
laboratories performing the tests.

    This pre-positioning of commercial developers and 
commercial contract manufacturers would enable the country to 
achieve a greater overall testing capacity with a smaller 
number of tests. In a situation where these contracts were 
prepositioned, FDA would have the enhanced capacity to ensure 
these tests are accurate and reliable before they are used.

   De-Risk Test and Incentivize Product Development, as was Done for 
                           Covid-19 Vaccines

    To encourage the development of diagnostic tests by 
commercial manufacturers, the South Korean government 
guaranteed both purchasing of minimum quantities of tests and 
reimbursement once the tests were authorized for emergency use 
by the MFDS, which is FDA's South Korean counterpart. This 
process eliminated the risk that a test developer might lose 
revenue from shifting manufacturing lines to tests for SARS 
CoV-2. These types of steps to de-risk and incentivize product 
development, although later taken for vaccine development, were 
not taken early on by the U.S. Government for test development. 
Instead, to incentivize development of tests, FDA issued 
policies regarding developers offering certain tests prior to 
an EUA while an EUA request was pending (and for certain 
serology tests, without an EUA or submission of an EUA 
request). These policies had tradeoffs; for example, FDA later 
found that some poorly performing tests were being used. Of 
particular note, FDA's experience with serology tests 
underscores the importance of FDA reviewing tests used in a PHE 
prior to such products entering the market based on sound 
science. In the future, the government should consider de-
risking the financial investment needed to produce accurate and 
reliable tests at scale. This effort could be focused on the 
developers who are pre-positioned to produce tests at scale 
when needed.

          Establish a Centralized Clinical Validation Program

    To complement the flexible policies that FDA put in place 
for serology tests, FDA collaborated with the Centers for 
Disease Control and Prevention (CDC) and the National 
Institutes of Health (NIH) to establish a government capability 
to evaluate the performance of serology tests. This was the 
first time the Federal Government created a capability to 
evaluate tests itself to inform regulatory decisions.

    This was valuable in helping FDA deal with poorly 
performing tests and ultimately for making decisions on EUA 
requests. FDA's research into South Korea's response found that 
the Korea Disease Control and Prevention Agency established a 
testing capability in selected laboratories to conduct a 
clinical evaluation of all molecular tests for which the 
manufacturer sought an EUA. As a result, test developers in 
South Korea did not have to find their own clinical specimens 
or viral material to evaluate their tests, which likely 
shortened the length of time needed to complete validation 
studies to support EUA applications and increased the 
government's confidence in each test's accuracy.

    With respect to molecular tests, the traditional approach 
of test developers conducting their own clinical evaluation of 
their tests continued, as no independent testing capability 
existed in the United States. Establishing the capacity within 
or on behalf of the Federal Government to evaluate test 
performance before outbreaks occur would permit an independent 
evaluation to be quickly performed during an outbreak. This 
established capacity would minimize the need for developers to 
find patient specimens or other clinical samples to validate 
their tests and would conserve specimens for validation. By 
centralizing validation materials and providing this evaluation 
for developers, the government could expedite the validation 
and authorization of tests while increasing confidence in test 
performance. The Federal Government should also consider the 
utility of this approach for technologies used outside an 
outbreak.

Collaborate With Laboratories and Commercial Developers on a Framework 
               for How to Conduct Appropriate Validations

    FDA received thousands of pre-EUA and EUA requests for 
tests for SARS-CoV-2, many of which came from developers 
without prior experience with appropriate test validation. FDA 
created templates to facilitate test validations and EUA 
submissions; however, FDA encountered many cases of poor 
validation and poor-quality submissions, which required the 
Agency to expend even more resources. For example, in an 
analysis of 125 EUA requests from laboratories for molecular 
tests, FDA found that 79 requests had issues with the 
validation. FDA saw similar problems with EUA requests from 
commercial manufacturers, particularly those with less 
experience in test development.

    Going forward, FDA intends to work collaboratively with the 
community on best practices and common approaches to validating 
test design and performance. FDA could proactively create 
validation protocols in collaboration with the test developer 
community for commonly anticipated pathogens and sample types 
before an outbreak; the Agency could then modify them as 
necessary after an outbreak occurs. This proactive approach 
would facilitate appropriate and faster validation. 
Additionally, FDA believes a modern legislative framework for 
all tests, regardless of who makes them, would facilitate a 
more common understanding of validation prior to an outbreak 
and would enhance the developer community's collaboration with 
FDA during an outbreak.

                       Stockpile Testing Supplies

    There were no testing supplies in the Strategic National 
Stockpile, and by March 2020, laboratories were experiencing 
shortages of supplies ranging from extraction reagents, to 
swabs, to transport media. FDA worked to develop shortage 
mitigation measures by seeking alternative products that could 
adequately perform so that end users did not experience a 
depletion of materials. For example, FDA proactively reached 
out to platform developers with PCR instruments, which are used 
to detect and amplify RNA and DNA sequences. FDA requested that 
these developers validate the use of CDC's assay on their PCR 
instruments, leveraging data from a prior authorization of 
CDC's influenza panel to support the use of additional PCR 
instruments and extraction kits.

    In addition, FDA supported manufacturers who do not 
typically produce medical supplies as part of their business 
operations in altering their manufacturing to create products 
usable for U.S. testing. For example, FDA collaborated with 
U.S. Cotton, one of the world's largest manufacturers of cotton 
swabs, to develop and produce a polyester-based Q-tip-type swab 
for testing. FDA also collaborated with laboratories and 
clinical investigators validating potential alternative sources 
of control materials, transport media, and swabs, later posting 
the results of these collaborations on the Agency's website. 
Similarly, as individual developers validated alternative 
components, FDA requested their permission to share their 
findings publicly, on the Agency's website, so that others 
could benefit. In this way, FDA shared scientific information 
that the entire community could leverage to mitigate shortages 
and increase testing capacity. Going forward, the Federal 
Government should either maintain a stockpile of basic testing 
supplies so that it does not need to seek out and validate so 
many alternatives or use less optimal alternatives in a future 
outbreak.

  Provide Continuing Education on the Appropriate Use of Tests as the 
               Situation and Scientific Knowledge Evolve

    During COVID-19, FDA saw examples of when the clinical 
community relied on tests for uses that were outside their 
authorization and not supported by science. For example, many 
members of the community relied on serology tests for 
diagnosis, or as measures of immunity, despite the lack of 
evidence correlating an immune response to immunity from 
infection. In another example, lower sensitivity tests were 
used to screen asymptomatic individuals in whom infection may 
have been harder to detect, if present at all. All members of 
the clinical community should have an understanding of test 
performance and how to use that information in patient care.

    Tests should be accompanied by clear, standardized, and 
comprehensible information on performance for clinicians and 
patients. Training and continuing education can enhance 
physicians' understanding of test performance, selection, 
interpretation, and clinical usefulness. Ongoing education is 
paramount in any PHE response as scientific knowledge evolves, 
particularly given the misuse of serology tests for diagnosis, 
the potential for false positive results when a single test is 
used in populations with a low rate of infection, and the 
perception of immunity. The national approach to testing needs 
to be consistently updated and guided by sound science.

              Invest in Novel Poc and At-Home Technologies

    As the pandemic evolved, FDA saw a growing demand for tests 
that could be performed outside of a traditional laboratory, 
such as at the POC, in homes, in schools, and at other non-
healthcare settings. FDA developed templates for and authorized 
tests that could be performed in these settings; however, most 
such authorizations came many months into the pandemic. The 
Federal Government should invest in the development of truly 
novel technologies that can be used at the POC and in homes and 
for multiple conditions--including potential advances such as 
sequencing to provide mutation detection, breath analyzers, and 
light-based devices--as long as they are accurate.

    In fact, the first POC COVID-19 tests authorized by FDA 
came from developers applying technologies that had already 
been developed prior to COVID-19. Although it may be difficult 
to predict diagnostic needs, it is generally easier to add a 
new, specific target of analysis to an existing platform than 
it is to create, validate, and manufacture an entirely new test 
and testing platform. This especially applies to POC and at-
home tests as they often go through additional validation to 
demonstrate accuracy and reliability in the hands of untrained 
users. The Federal Government could use several mechanisms, 
including competitions with prize awards and grants. FDA 
believes that the establishment NIH's Independent Test 
Assessment Program (ITAP) is critical for supporting these 
efforts.

    The goal of this program is to accelerate the availability 
of more high-quality, accurate, and reliable OTC tests to the 
public, as quickly as possible. If we invest in POC and at-home 
testing technologies now, when a public health threat warrants 
large-scale testing, the government would be able to move 
swiftly to financially support modifications to detect the 
target pathogen, ramp up large-scale production, and provide 
guaranteed reimbursement for use of applicable and already FDA-
approved tests

                              SENATOR BURR

    Question 1. On November 15, FDA issued revised guidance 
stating it would focus its review efforts on at-home and point-
of-care COVID test applications from developers with the 
capacity to manufacture more than 500,000 tests per week within 
3 months of being authorized.

        Question 1(a). How many test developers are able to 
        scale up to manufacture more than 100,000, but less 
        than 500,000 tests per week?

        Question 1(b). Will FDA review their test under the EUA 
        pathway? If not, why not?

        Question 1(c). Is FDA denying applications that cannot 
        meet the 500,000 tests per week manufacturing capacity 
        requirement?

        Question 1(d). How does this policy account for 
        manufacturers developing tests at risk who have the 
        near term potential to reach the 500,000 capacity but 
        cannot scale up without authorization?

    Answer 1. FDA has received over 5,000 EUA and PEUA requests 
for IVDs since January 2020, and continues to receive over 100 
EUA requests a month, mostly for IVDs. It is therefore critical 
that we focus limited resources on those tests that will have 
the greatest impact on the public health. There remains a 
public health need for increased access to testing. This can 
best be addressed by prioritizing review of tests such as at-
home and point-of-care diagnostic tests that can be produced in 
high volumes.

    The priorities outlined in our guidance of November 15, 
2021 are based on our experience working with test developers 
to respond to the pandemic for over 2 years. We took into 
account both our review capacity as well as what we have seen 
developers accomplish with respect to ease of use and 
manufacturing capacity. When considering manufacturing 
capacity, we generally consider the developer's projected 
capabilities within 3 months of authorization. This allows 
manufacturing scale up to take place post-authorization rather 
than prior to authorization. FDA also reviews any EUA requests 
for tests from or supported by a US government stakeholder, 
regardless of the developer's manufacturing capacity. This 
helps to ensure that tests that are part of a coordinated 
response, such as the school and community testing programs, 
are prioritized for review.

    FDA does not have information on the number of test 
developers able to scale up to manufacture more than 100,000, 
but less than 500,000 tests per week. However, any developers 
of tests that have not been prioritized by the Agency for EUA 
may seek marketing authorization through traditional device 
review pathways such as 510(k) notification or De Novo 
classification.

    Question 2. FDA has authorized over 400 COVID tests, and 
has stated that some of these tests may not be as sensitive to 
the Omicron variant. The more this virus shifts and drifts from 
its original strain, the more difficult it may be for our tests 
to detect. What is the FDA doing to work with manufacturers to 
address the challenge that will come along with diagnosing and 
detecting new variants of COVID-19?

    Answer 2. FDA has been monitoring for viral mutations and 
their impact on authorized molecular and antigen diagnostic 
tests throughout the pandemic. FDA tracks the part of the viral 
genome targeted by each authorized molecular test in a data 
base, monitors global data bases for emerging variants, and 
conducts in silico analyses to evaluate whether any of the 
authorized test probes target a part of the viral genome that 
has mutated. If FDA identifies a potential impact on test 
performance, FDA contacts the test developer and communicates 
with the public.

    The first such communication took place on January 8, 2021, 
not long after variants began to emerge. FDA issued a safety 
alert and Letter to Health Care Providers to caution that the 
presence of viral genetic mutations in a patient sample can 
potentially change the performance of a diagnostic test. At 
that time, FDA identified three authorized molecular tests that 
may be impacted by genetic variants of SARS-CoV-2, though the 
impact did not appear to be significant. FDA also provided 
recommendations to address possible false negative results for 
clinical laboratory staff and health care providers who use 
molecular tests for the detection of SARS-CoV-2.

    In January 2021, the RADx program established a Variant 
Task Force (VTF) to monitor for emerging variants and study the 
performance of COVID-19 tests with different variants. Most 
recently, the VTF has been evaluating the performance of 
antigen tests with patient samples that have the omicron 
variant.

    On February 22, 2021, FDA issued a guidance to provide test 
developers information on evaluating the potential impact of 
emerging and future viral genetic mutations on COVID-19 tests. 
(See ``Policy for Evaluating Impact of Viral Mutations on 
COVID-19 Tests''.) The guidance describes the FDA's activities 
and provides recommendations to test developers, such as 
considering the potential for future viral genetic mutations 
when designing their test, and conducting their own routine 
monitoring to evaluate the potential impact of new and emerging 
viral genetic mutations, which may be the basis of viral 
variants, on the performance of their tests.

    In March 2021, FDA launched a website with information 
regarding the impact of viral mutations on COVID-19 tests. 
(Please see SARS-CoV-2 Viral Mutations: Impact on COVID-19 
Tests (FDA.) The website includes a list of tests that are 
impacted by viral mutations and provides test-specific analyses 
of the impact on performance as well as recommendations for 
clinical laboratory staff and health care providers using the 
test. The website is updated regularly as new information 
becomes available.

    In September 2021, FDA revised EUAs for most tests to add 
Conditions of Authorization requiring test developers to 
conduct their own monitoring of their test in addition to the 
monitoring done by FDA. These Conditions require test 
developers to notify FDA if any viral mutations are found to 
affect the performance of the test, perform and provide any 
additional analyses requested by the FDA, and update labeling 
with any risk mitigations identified by FDA regarding the 
impact of viral mutations on test performance.

    Question 3. What is the latest science on boosters for 
recipients of the J&J vaccine? When will you have answers for 
the millions of Americans that received this shot who are 
interested in ensuring they continue to be protected against 
Omicron and future variants?

    Answer 3. FDA has authorized a single-dose primary 
vaccination regimen for the Janssen COVID-19 Vaccine for 
individuals 18 years of age and older. FDA has also authorized 
a single Janssen COVID-19 Vaccine booster dose that may be 
administered at least 2 months after primary vaccination with 
the Janssen COVID-19 Vaccine. Additionally, FDA has authorized 
use of either the Pfizer BioNTech COVID-19 Vaccine or the 
Moderna COVID-19 Vaccine as a heterologous booster dose for 
individuals who have received primary vaccination with the 
Janssen COVID-19 Vaccine. The booster dose of either of the 
mRNA vaccines may be administered at least 2 months after 
completion of primary vaccination with the Janssen COVID-19 
Vaccine.

    Data published in a Morbidity and Mortality Weekly Report 
by the CDC are reassuring in that for the mRNA COVID-19 
vaccines, two doses and one booster dose, and for the Janssen 
COVID-19 Vaccine, one dose and a booster dose, continue to 
provide protection against severe COVID-19 and hospitalization 
and death. Rates of COVID-19 cases were lowest among fully 
vaccinated persons who had received a booster dose, compared 
with fully vaccinated persons who had not received a booster 
dose, and much lower than rates among unvaccinated persons 
during October/November and also December 2021, when the 
Omicron variant was circulating.

    In addition, during December, unvaccinated people had 
approximately 5 times the risk for developing COVID-19 compared 
to vaccinated people who had received a booster dose of a 
COVID-19 vaccine. A similar increase in risk was seen among 
unvaccinated people compared to people who had received a 
booster dose, irrespective of what vaccine people received for 
primary vaccination.

    Question 4. FDA has authorized vaccines for COVID-19 for 
individuals and children ages 5 and up. When does FDA expect 
that a vaccine for ages 2-4 will be available? What challenges 
exist for clinical trials conducted for the 2-4 year old age 
group, and how is FDA working to help address such challenges?

    Answer 4. FDA recognizes the need for a safe and effective 
vaccine for younger children, particularly given the rapid 
spread of the Omicron variant, the notable rise in the number 
of hospitalizations in young children with severe disease, and 
the possibility that future variants could cause severe disease 
in those who are unvaccinated.

    It is important that the public recognize that, because 
children are still growing and developing, it's critical that 
thorough and robust clinical trials of adequate size are 
undertaken to evaluate the safety and effectiveness of a COVID-
19 vaccine in pediatric populations. Children are not small 
adults and issues that may be addressed in pediatric vaccine 
clinical trials can include the appropriate dose and 
administration schedule of vaccines already used for adults.

    Conducting clinical trials to determine an appropriate 
vaccine dose in younger pediatric populations requires 
additional investigation and study over that done in the 
clinical trials for adults including ensuring that the vaccine 
dosage is safe and effective. FDA has been working closely with 
vaccine manufacturers to provide advice as data accrue about 
safety and effectiveness, the latter of which may be comprised 
of immune response data or the number of COVID-19 cases that 
occur, or a combination of both, for their respective COVID-19 
clinical trials in pediatric populations. Once adequate data 
are available, we plan to convene a meeting of our Vaccines and 
Related Biological Products Advisory Committee to publicly 
discuss the data.

                            SENATOR CASSIDY

    Question 1. Second, how are you all harnessing the speed 
and innovation of the private sector to help predict, prevent, 
and mitigate future COVID-19 variants or other pathogens of 
concern?

    Answer 1. FDA continues to work with companies that are 
developing additional medical products, researchers, and 
manufacturers to help expedite the development and availability 
of medical products such as additional vaccines,'monoclonal 
antibodies, and other drugs to prevent or treat COVID-19?

                             SENATOR BRAUN

    Question 1. Dr. Woodcock, we understand that, through the 
National Institutes of Health Rapid Acceleration of 
Diagnostics' Independent Test Assessment Program, companies 
worked closely with the FDA to obtain Emergency Use 
Authorization for rapid antigen tests. Diagnostic manufacturers 
are producing millions of much-needed rapid antigen tests for 
the American people. Can you discuss the future of this 
program?

    Answer 1. The Independent Test Assessment Program (ITAP) 
will continue to be critical to streamlining validation and 
authorization of antigen tests with potential for large-scale 
manufacturing. FDA has already authorized three new OTC, at-
home COVID-19 tests that participated in this program one 
manufactured by SD Biosensor and distributed by Roche, one 
manufactured by Siemens (please see the following release for 
more details: Two New Over-the-Counter At-Home COVID-19 Tests 
Brought to U.S. Market Quickly by Biden-Harris administration 
(HHS.gov), and a third manufactured by Maxim Biomedical.

    This program is an extension of the RADx program which has 
already supported development of dozens of authorized tests, 
including the first over-the-counter COVID-19 test. 
Organizations applying to ITAP will be evaluated for 
participation based on several criteria. \1\ Prior to EUA 
submission, ITAP supports independent laboratory and clinical 
evaluations using protocols developed jointly with FDA.
---------------------------------------------------------------------------
    \1\  https://www.poctrn.org/itap
---------------------------------------------------------------------------
    We plan to continue to use the information from ITAP to 
grant emergency use authorization when the science supports 
doing so. We are already seeing shorter review times for such 
EUA requests due to our partnership with ITAP in establishing 
the evaluation program to address our regulatory needs. The 
average FDA review time for a test evaluated under ITAP is less 
than a week, and can be as short as 1 day.

    This solution is based on our lessons learned earlier in 
the pandemic. Namely, developers unfamiliar with the regulatory 
process often provide incomplete or poor validation data that 
is insufficient to support authorization. FDA interacts with 
such developers to guide them in appropriate validation, but 
this is inefficient for both parties and stretches out review 
times. The establishment of ITAP is a targeted solution that 
will continue to assist developers and streamline the FDA 
review process, and ultimately accelerate the availability of 
more high-quality, accurate and reliable over-the-counter tests 
to the public.

    Our experience with ITAP illustrates the value of an 
independent government testing capability in bringing accurate 
and reliable tests to market quickly. South Korea took this 
approach with molecular diagnostics at the beginning of the 
COVID-19 outbreak and was able to scale their national testing 
capacity very quickly. In the Spring of 2020, we established an 
evaluation program with NCI for serology tests which provided 
valuable data to inform our regulatory decisions. As we have 
noted in our perspective on lessons learned published in NEJM, 
we should establish the capacity within or on behalf of the 
Federal Government to evaluate test performance before 
outbreaks occur so that independent evaluation can be performed 
quickly during an outbreak.

                             SENATOR SCOTT

                               Treatments

    Question 1. Dr. Woodcock what is the status of in-patient 
therapeutics? Do we have effective treatments for those in the 
ICU to prevent ventilator intubation or post-intubation to 
accelerate recovery

        Question 1(a). Are repurposed drugs being considered 
        and approved?

    Answer 1. Currently, the following products are approved or 
authorized for certain patients who are hospitalized:

         LOral Paxlovid (ritonavir-boosted 
        nirmatrelvir) is authorized for the treatment of COVID-
        19 among persons with mild to moderate symptoms who are 
        at high-risk for disease progression. In a clinical 
        trial, Paxlovid reduced the risk of hospitalization and 
        death by 89 percent in unvaccinated outpatients with 
        COVID-19 at higher risk of severe disease. Serious 
        adverse events are uncommon with Paxlovid treatment. 
        Paxlovid is given twice daily for 5 days, starting as 
        soon as possible and within 5 days of symptom onset, 
        and is approved for use in adult and pediatric patients 
        (12 years of age and older weighing at least 40kg).

         LVeklury (remdesivir) is an approved drug 
        product that is indicated for the treatment of 
        coronavirus disease 2019 (COVID-19) in adults and 
        pediatric patients (12 years of age and older and 
        weighing at least 40 kg) with positive results of 
        direct severe acute respiratory syndrome coronavirus 2 
        (SARS-CoV-2) viral testing, who are:

                Y LHospitalized, or

                Y LNot hospitalized and have mild-to-moderate 
                COVID-19, and are at high risk for progression 
                to severe COVID-19, including hospitalization 
                or death;

         LActemra (tocilizumab) is authorized for 
        emergency use for the treatment of COVID-19 in 
        hospitalized adults and pediatric patients (2 years of 
        age and older) who are receiving systemic 
        corticosteroids and require supplemental oxygen, non-
        invasive or invasive mechanical ventilation, or 
        extracorporeal membrane oxygenation (ECMO);

         LOlumiant (baricitinib) is authorized for 
        emergency use to treat COVID-19 in hospitalized adults 
        and pediatric patients 2 years of age or older 
        requiring supplemental oxygen, non-invasive or invasive 
        mechanical ventilation, or ECMO;

         LCOVID-19 convalescent plasma with high titers 
        of anti-SARS-CoV-2 antibodies is authorized for 
        emergency use for the treatment of COVID-19 in patients 
        with immunosuppressive disease or receiving 
        immunosuppressive treatment, in either the outpatient 
        or inpatient setting.

    Since early in the COVID-19 public health emergency, FDA 
recognized the increased demand for certain products and 
prioritized the review of generic drug applications for 
potential treatments and supportive therapies for patients with 
COVID-19, such as for heparin and dexamethasone.

    With respect to additional products, including repurposed 
drugs, being considered for emergency use authorization or 
approval, we note that, consistent with Federal statutes and 
FDA's implementing regulations concerning the confidentiality 
of commercial information, and to protect the integrity of the 
review process, FDA generally cannot disclose information about 
unapproved products. FDA is committed to quickly and thoroughly 
reviewing all submitted applications, including requests for 
emergency use authorization, to speed patient access to 
medicines to prevent or treat COVID-19 provided they meet the 
agency's rigorous standards. Through the Coronavirus Treatment 
Acceleration Program (CTAP), we continue to support research 
and clinical trials that are testing new treatments for COVID-
19, including therapies intended to treat severe forms of the 
disease, so that we gain valuable knowledge about their safety 
and effectiveness.

                           SENATOR TUBERVILLE

                     Antibody Testing & Treatments

    Question 1. On May 19, 2021, the FDA recommended against 
antibody testing to determine a person's level of immunity.

        a. How should people be aware of their level of 
        antibodies or need for a booster?

        b. Do you believe people are receiving a booster when 
        they already have adequate protection from COVID-19?

    Answer 1. The currently authorized SARS-CoV-2 antibody 
tests should not be used to evaluate a person's level of 
immunity or protection from COVID-19 at any time, including 
after the person received a COVID-19 vaccine. Currently 
authorized SARS-CoV-2 antibody tests have not been evaluated to 
determine whether they can predict if a person is protected 
against COVID-19. Furthermore, there is no specific level of a 
particular antibody which has been shown to be associated with 
protection against disease. The available data from the COVID-
19 clinical trials and ongoing assessment of the effectiveness 
of the vaccines provides confidence that the vaccines protect 
against COVID-19, including serious consequences that can occur 
such as hospitalization and death.

    Based on HHS's assessment of currently available data, 
including during the surge of the circulation of Delta and 
Omicron variants, a single booster dose of the currently 
authorized vaccines after completion of primary vaccination is 
recommended to provide protection against COVID-19. With this 
in mind, individuals ages 12 years and older who have completed 
primary vaccination may receive a single booster dose.

    The FDA amended the emergency use authorization for the 
Pfizer-BioNTech COVID-19 Vaccine to allow for a single booster 
dose for people ages 12 years of age and older at least 5 
months after completion of a primary series with the Pfizer-
BioNTech COVID-19 Vaccine or Comirnaty (COVID-19 Vaccine, 
mRNA). Individuals 12 through 17 years of age should receive 
only the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty (COVID-
19 Vaccine, mRNA) as their booster dose.

    Individuals 18 years of age and older who completed a 
primary series with the Pfizer-BioNTech COVID-19 Vaccine, 
Comirnaty (COVID-19 Vaccine, mRNA), or the Moderna COVID-19 
Vaccine, at least 5 months ago, may receive a single booster 
dose of any of the currently authorized or approved COVID-19 
vaccines. Individuals 18 years of age and older who completed 
their primary vaccination with Janssen COVID-19 Vaccine at 
least 2 months ago, may receive a single booster dose of any of 
the currently authorized or approved COVID-19 vaccines.

    Question 2. Please provide specific examples where your 
agency has utilized real world evidence in regards to COVID-19 
or treatments for COVID-19.

    Answer 2. The following is an example of when FDA has 
utilized real world evidence for a COVID-19 vaccine. FDA has 
determined that the known and potential benefits of a single 
booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide 
continued protection against COVID-19 and the associated 
serious consequences that can occur including hospitalization 
and death, outweigh the known and potential risks in 
individuals 12 through 15 years of age when given at least 5 
months following primary series.

    FDA reviewed real-world data from Israel, including safety 
data from more than 6,300 individuals 12 through 15 years of 
age who received a booster dose of the vaccine at least 5 
months following completion of the primary two-dose vaccination 
series. These additional data enabled the FDA to reassess the 
benefits and risks of the use of a single booster dose in this 
age group in the setting of the January 2022 surge in COVID-19 
cases. The data showed that there were no new safety concerns 
following a booster in this population, and in particular, that 
no new cases of myocarditis or pericarditis were reported in 
these individuals.

    (Moved from the NIH set of QFRs)

                             SENATOR HASSAN

    Children under age five are still not eligible for a COVID-
19 vaccine. Moderna reported earlier this month that it expects 
to report trial data on its COVID-19 vaccine in children ages 2 
to 5 by March.

    Meanwhile, the number of children with COVID-19 is surging 
in New Hampshire and across the country. As of January 1, the 
hospitalization rate for children under age 5 reached 4 in 
100,000 children--3 times higher than the same time last year.

    Question 1. At this point, when do you expect that 
vaccinations will be available to children under age 5?

    Answer 1. FDA recognizes the need for a safe and effective 
vaccine for younger children, particularly given the rapid 
spread of the Omicron variant, the notable rise in the number 
of hospitalizations in young children with severe disease, and 
the possibility that future variants could cause severe disease 
in those who are unvaccinated.

    It is important that the public recognize that, because 
children are still growing and developing, it's critical that 
thorough and robust clinical trials of adequate size are 
undertaken to evaluate the safety and effectiveness of a COVID-
19 vaccine in pediatric populations. Children are not small 
adults and issues that may be addressed in pediatric vaccine 
clinical trials can include the appropriate dose and 
administration schedule of vaccines already used for adults.

    Conducting clinical trials to determine an appropriate 
vaccine dose in younger pediatric populations requires 
additional investigation and study over that done in the 
clinical trials for adults including ensuring that the vaccine 
dosage is safe and effective. FDA has been working closely with 
vaccine manufacturers to provide advice as data accrue about 
safety and effectiveness, the latter of which may be comprised 
of immune response data or the number of COVID-19 cases that 
occur, or a combination of both, for their respective COVID-19 
clinical trials in pediatric populations.

    Once adequate data are available, we plan to convene a 
meeting of our Vaccines and Related Biological Products 
Advisory Committee to publicly discuss the data. For the 
Pfizer-BioNTech COVID-19 Vaccine, we will provide an update on 
timing for the advisory committee meeting once we receive and 
evaluate additional data on the results of three doses 
administered to children 6 months through 4 years of age from 
the company's ongoing clinical trial.
                                ------                                


   Response by Dawn O'Connell to Questions of Senator Casey, Senator 
 Baldwin, Senator Hassan, Senator Smith, Senator Lujan, Senator Burr, 
         Senator Cassidy, Senator Scott, and Senator Tuberville

                             SENATOR CASEY

    Question 1. At the hearing, I asked how the Federal 
Government is working with vaccine manufacturers to speed the 
development of a safe and effective vaccine for children under 
age five. Understanding that the Pfizer trial for children 24 
months to 5 years old did not meet its endpoint, my follow-up 
questions are, how did we get here and what's next? Please 
describe, generally, the following:

    Question 1(a). How vaccine developers make decisions about 
dose size, quantity and spacing in age de-escalation trials;

    Answer 1,1(a). In general, vaccine developers typically do 
a small, carefully planned `dose ranging' study for each new 
age range. Based on the adult and non-clinical data, developers 
may select a number of different dose levels to test. 
Typically, the spacing between doses and number of doses is the 
same as in the adult trials, at least initially, to allow for 
bridging between the two populations. The safety and 
immunogenicity data from these small trials is analyzed, 
including comparing immunogenicity results with immunogenicity 
results from the adult population, and based on the data, one 
or two different dose levels may be selected for the larger, 
confirmatory trials. If results from the small trial do not 
identify a dose with a proper safety and immunogenicity 
profile, a second small study might be conducted before moving 
to larger trials. This follow-on study could include looking at 
additional dosing regimens or looking at lower or higher dose 
levels.
        Question 1(b). What type of indicators a vaccine 
        manufacturer might consider when determining whether 
        and how to change the dose size, quantity or spacing if 
        primary endpoints are not met; and

    Answer 1(b). As mentioned above, vaccine developers 
typically do a small, carefully planned `dose ranging' study 
for each new age range. Based on the adult and non-clinical 
data, developers may select a number of different dose levels 
to test. Typically, the spacing between doses and number of 
doses is the same as in the adult trials, at least initially, 
to allow for bridging between the two populations. The safety 
and immunogenicity data from these small trials is analyzed, 
including comparing immunogenicity results with immunogenicity 
results from the adult population, and based on the data, one 
or two different dose levels may be selected for the larger, 
confirmatory trials. If results from the small trial do not 
identify a dose with a proper safety and immunogenicity 
profile, a second small study might be conducted before moving 
to larger trials. This follow-on study could include looking at 
additional dosing regimens or looking at lower or higher dose 
levels.

    Question 1(c). Whether the emergence of a viral variant 
could affect the efficacy of a vaccine in children differently 
than it would affect the efficacy of the same vaccine in 
adults.

    Answer 1(c). Emergence of a variant can potentially impact 
vaccine effectiveness, and a vaccine may not work as well to 
protect against disease caused by the variant for all. In 
addition, it is not uncommon for a vaccine to have a different 
level of efficacy for certain ages/populations as many factors 
can play into this, including decreased immune response to some 
vaccines as individuals age, the health status of the 
individual, and the endpoint being assessed.

    Question 2. Furthermore, could you please provide an update 
on current Federal goals and investments relating to the 
development of vaccines to protect children under age five from 
COVID-19, including grants, contracts or other funding awarded 
to vaccine developers; and what information is currently being 
provided to vaccine developers regarding current or planned 
opportunities for collaboration between the Federal Government 
and vaccine developers, including the extent to which BARDA 
will conduct TechWatch/CoronaWatch meetings and the extent to 
which FDA will accept applications for emergency use 
authorization.

    Answer 2. From the beginning of the COVID-19 response, ASPR 
has been committed to developing safe and effective vaccines 
for all age ranges. When BARDA awarded the initial COVID-19 
vaccine development contracts to Janssen and Moderna in the 
early spring of 2020, funds were included to conduct trials in 
all age ranges down to the youngest populations. Subsequent 
product development and procurement contracts to Novavax, 
Sanofi/GSK, and AstraZeneca included scope and funds to support 
pediatric clinical trials. Similarly, advanced purchase 
agreements with Pfizer included procurement of pediatric doses. 
Over the last 2 years, ASPR/BARDA has and will continue to work 
closely with each product developer to support development of 
their vaccines for pediatric indications as early as is 
appropriate (for example, once efficacy in adults has been 
shown). This includes funding the majority of the Moderna 
pediatric trial that just announced Phase III results, as well 
as advanced purchase agreement of Pfizer pediatric vaccine to 
support their pediatric development efforts, including advanced 
purchase of the Pfizer-BioNTech COVID-19 Vaccine for children 
ages 5 through 11 years that is currently authorized under EUA 
and being widely distributed.

    BARDA's TechWatch program remains open to all threat areas, 
including COVID-19. Industry partners, including those 
developing COVID-19 vaccines, are encouraged to request a 
TechWatch meeting. This program continues to serve as a central 
location for industry to engage interagency government partners 
with potential funding opportunities. At this time, ASPR/BARDA 
does not have sufficient funding to initiate development of 
additional or next generation COVID-19 vaccines. Several 
promising potential candidates and technologies for investment 
have been identified and will be pursued if funding is 
provided, with plans to develop vaccines with broader and/or 
more durable protection.

    Question 3. Finally, could you describe current thinking 
across your agencies regarding the circumstances under which 
your efforts would expand to include the development of 
additional or next-generation vaccines and therapeutics for 
COVID-19?

    Answer 3. BARDA's TechWatch program remains open to all 
threat areas, including COVID-19. Industry partners, including 
those developing COVID-19 vaccines, are encouraged to request a 
TechWatch meeting. This program continues to serve as a central 
location for industry to engage interagency government partners 
with potential funding opportunities. At this time, ASPR/BARDA 
does not have sufficient funding to initiate development of 
additional or next generation COVID-19 vaccines. Several 
promising potential candidates and technologies for investment 
have been identified and will be pursued if funding is 
provided, with plans to develop vaccines with broader and/or 
more durable protection.

    Regarding therapeutics, the oral antivirals are recent 
authorizations and allow for much easier administration and 
improved patient access. One of the benefits of the oral 
antivirals Paxlovid and molnupiravir is that they have much 
broader activity against SARS-CoV-2 and its variants. In fact, 
both Paxlovid and molnupiravir have activity against all SARS-
CoV-2 variants tested as of January 2022. Looking to the future 
and the President's Pandemic Preparedness Plan, focusing on 
broad acting antivirals with activity against many viruses, as 
well as focusing on host-targeted therapeutics that are virus-
agnostic will be high priorities.

                            SENATOR BALDWIN

    Question 1. The Omicron variant has made clear the critical 
need for higher quality masks, such as N95. Further, I applaud 
the Administration's efforts to begin distributing N95 masks to 
the public.

    Question 1(a). Masks that are currently being distributed 
to the public came from the Strategic National Stockpile (SNS). 
How is ASPR working to make sure that masks purchased to 
replenish the stockpile following this distribution are made in 
the United States, using raw materials from American 
manufacturers?

    Answer 1,1(a). The Administration is committed to procuring 
domestically manufactured PPE in accordance with the 
Infrastructure Investment and Jobs Act (IIJA). The Department 
has relied on COVID-19 supplemental resources to support the 
COVID-19 response. ASPR is currently validating COVID-19 PPE 
stockpiling goals and assessing priorities to ensure the best 
use of remaining supplemental funds, possibly including 
investments geared toward creating or expanding domestic 
capabilities to manufacture the raw materials and intermediates 
needed for final manufacture of N95 masks.

    Question 1(b). Please describe how ASPR intends to support 
small domestic manufacturers in the process of replenishing the 
SNS.

    Answer 1(b). The SNS adheres to small business procurement 
regulations. If a small business can meet the requirements of 
the solicitation and is the best offeror for the requirement, 
they will be selected.

    Question 1(c). What is ASPR's plan to invest in domestic 
manufacturers of the raw materials needed to make high-quality 
PPE, including N95s, here in the United States?

    Answer 1(c). ASPR is utilizing funding appropriated by 
Congress via various COVID-19 supplemental appropriations to 
invest in domestic manufacturing of PPE when possible. ASPR has 
stood up an industrial-based expansion office and is working to 
hire staff with specific expertise in this field to award 
contracts to ensure preparedness for future public health 
incidents.

    Question 1(d). How will ASPR work to ensure that any 
contracts for warm-base manufacturing capacity of PPE and its 
raw materials support small businesses?

    Answer 1(d). HHS adheres to small business procurement 
regulations. If a small business can meet the requirements of 
the solicitation and is the best offeror for the requirement, 
they will be selected.

    Question 1(e). Please provide an update on the status of 
the RFI for medical-grade meltblown production.

    Answer 1(e). The U.S. produces approximately 2 percent of 
the man-made fiber (MMF) needed for PPE and other products used 
domestically. During the ongoing COVID-19 response, we have 
invested approximately $20.7 million in meltblown material 
capacity expansion for use in N95 masks, surgical masks, and 
ventilator filters. The chart below captures these investments.

 
----------------------------------------------------------------------------------------------------------------
                                                     Award                               Full Prod     Source
   Vendor        City        State    Award Date    Amount        Capacity Increase        Date        Account
----------------------------------------------------------------------------------------------------------------
Hollingswort      Floyd          VA   5/19/2020       $1.9M            Meltblown 3.1M      20-Dec     DPA Title
    h & Vose                                                            N95s/mo 27.5M                       III
                                                                              Vent/mo
----------------------------------------------------------------------------------------------------------------
     Lydall   Strafford          NH   6/19/2020      $13.5M            Meltblown 100M      21-May          HHS CARES
                                                                      N95s/mo or 192M
                                                                    surgical masks/mo
----------------------------------------------------------------------------------------------------------------
  FyterTech   Green Bay          WI   7/24/2020      $2.75M             Meltblown 60M    Jan 2022          HHS CARES
   Nonwovens                                                          N95s/mo or 170M
                                                                    surgical masks/mo
----------------------------------------------------------------------------------------------------------------
Hollingswort      Floyd          VA   12/2/2020       $2.5M            Meltblown 8.3M      22-Jan          HHS CARES
    h & Vose                                                                  N95s/mo
----------------------------------------------------------------------------------------------------------------

    We currently have a solicitation (https://sam.gov/opp/
0e037509432b491a80d789e5a4f34380/view) and are currently 
reviewing offerors for MMF capacity and research and 
development to support gown manufacturing.

                             SENATOR HASSAN

    I'm grateful that the administration heeded my call to send 
FEMA teams to New Hampshire to help administer COVID-19 
treatments, as this assistance was essential to keeping our 
health system functioning. However, there were delays in the 
teams' arrival and limits to how long they were able to remain 
in the state.

    Question 1. What additional personnel and support is the 
administration planning to provide to New Hampshire and other 
states to help providers overwhelmed by the pandemic?

    Answer 1. The Secretary of HHS, and by delegation the ASPR, 
serves as the lead for Emergency Support Function No. 8 (ESF-8) 
under the National Incident Response Framework. Utilizing an 
established resource request process through the ASPR and FEMA 
Regional Offices, state, local, tribal, and territorial 
requests for Federal medical support for healthcare facilities 
and needs related to the COVID-19 pandemic are evaluated and 
resourced under that construct, to include deployment of 
personnel for medical surge, vaccination, monoclonal antibody 
administration, testing sites, and technical support. To 
support the review of such requests, HHS conducts a call as 
required with the other Federal partners supporting elements of 
the medical response. On this ESF-8 Partner Call, the Federal 
partners including NDMS, DoD, the VA, PHS Commissioned Corps, 
and CDC, gather to discuss, coordinate, and determine 
resourcing support decisions based on requests received from 
states, tribes, and territories. As COVID-19 case counts and 
other considerations change, the requests are reviewed in real-
time to determine the best allocation possible given limited 
Federal resources. We will use this established process to 
determine any additional support the Administration can offer 
to New Hampshire and other states overwhelmed by the pandemic.

                             SENATOR SMITH

    Question 1. Given the importance of ensuring we have 
sufficient supply of accurate COVID-19 tests, can you explain 
the Administration's plans to develop and increase access to 
broad spectrum diagnostic tests, including molecular tests, to 
increase our ability to detect current and future COVID-19 
variants?

    Answer 1. The Administration has been focused on testing 
since day one and has four priority areas:

        Answer 1(a). Increasing the number of testing sites and 
        programs for getting tested in the U.S., for example, 
        through the Increasing Community Access to Testing 
        (ICATT) program and federally Qualified Health Centers 
        (FQHCs);

        Answer 1(b). Increasing the types of tests authorized 
        for use in the U.S., working closely with FDA;

        Answer 1(c). Increasing the overall supply of tests; 
        and

        Answer 1(d). Lowering or eliminating the costs of 
        testing, in coordination with CDC and CMS.

    Advancing equity in access and use of tests is woven 
throughout each of these key goals--from selecting the location 
of Federal, free testing sites to the provision of free tests 
to the uninsured to expanding lower-cost testing options more 
generally. We continue to do everything we can to advance our 
four priority areas, as quickly as we can.

    FDA, in collaboration with other offices in HHS (CDC, 
BARDA, NIBIB), is working to ensure that authorized tests can 
detect all circulating SARS-CoV-2 variants. Most tests can 
detect all high prevalence variants, but several tests have had 
issues detecting specific circulating variants. In those cases, 
FDA works with the manufacturers so that the manufacturers can 
improve their tests quickly or remove them from the market.

    Antigen tests are relatively low cost, are now widely 
available to detect SARS-CoV-2 infections, and are essential to 
ending the ongoing pandemic. However, molecular tests are 
generally much higher performing and can be developed and 
deployed for a new emerging disease much more rapidly than 
antigen tests. Molecular tests can be developed that are 
specific enough to differentiate a particular disease variant 
from other circulating variants. New molecular testing 
technologies that overcome some of the challenges associated 
with centralized laboratory molecular testing have been in 
development over the past 5 or so years and have become 
available for use, with significant Federal investment, during 
the COVID-19 pandemic. These new tests may be appropriate for 
use in non-laboratory settings including doctors' offices and 
nursing homes, and even as self-tests for some diseases like 
COVID-19.

    Question 2. Looking long-term, what steps should Congress 
and the Administration take to improve development and supply 
of broad spectrum diagnostics for the current and future 
pandemics?

    Answer 2. The Administration is working to support efforts 
to make testing available more quickly, both for new emerging 
diseases and emerging SARS-CoV-2 variants. Due to the shorter 
development time for molecular test technologies, the 
Administration is also supporting efforts to support investment 
in domestic capabilities to manufacture newly emerging 
molecular tests that are appropriate for use in non-laboratory 
settings, including homes, making them much more widely 
available. The Administration is also working on a revised 
National Biodefense Strategy that will include broad objectives 
and plans for future investments in this space. There is no 
timeline for release of the revised NBS at this time.

                             SENATOR LUJAN

    Question 1. Throughout the pandemic, state and Federal 
policymakers have asked pharmacists to provide clinical 
services to patients. Every state now authorizes licensed 
pharmacists to order and administer vaccines, tests for COVID-
19 and other infectious diseases, and therapeutics to treat 
COVID-19, but pharmacists' ability to perform these services 
will expire with the public health emergency expiration. The 
Secretary of Health and Human Services even used their 
authority under the Public Readiness and Emergency Preparedness 
(PREP) Act to ensure that all Americans could access these 
services from their pharmacist. At least 38 states have 
expanded their Medicaid coverage of clinical services provided 
by pharmacists during the pandemic, and many commercial payers 
cover clinical services provided by pharmacists. But I 
understand that the Medicare program cannot cover clinical 
services that Medicare beneficiaries want to receive from their 
pharmacist. When Medicare beneficiaries need clinical services 
from their pharmacist, does the Medicare program have the 
authority it needs to pay for those services? If not, what 
legislative change is necessary to ensure Medicare 
beneficiaries have access to clinical services that their 
pharmacist is licensed to provide?

    Answer 1. This response is best addressed by the Centers 
for Medicare & Medicaid Services.

                              SENATOR BURR

    Question 1. The development of the first successful mRNA 
vaccines is a clear success story from the COVID-19 pandemic. 
However, this virus has, and likely will, continue to mutate, 
which means that we must continue to support the development of 
a variety of medical countermeasures, including those that 
utilize different platforms or mechanisms of action. Operation 
Warp Speed recognized this need and supported multiple vaccine 
platforms and therapeutic candidates. In response to Omicron 
and the continued threat of COVID-19, how is ASPR ensuring that 
there are funding opportunities for innovators who have 
products that might work better against the next SARS-CoV-2 
variant or emerging infectious disease than the countermeasures 
we have now?

    Answer 1. Some of the vaccine technologies BARDA has 
invested in during the COVID-19 response are considered readily 
adaptable technologies which means they can be updated easily. 
For example, a change in the sequence of an mRNA vaccine can 
produce a vaccine targeted to a SARS-CoV-2 variant. All the 
investments in the vaccine industrial base capacity expansion 
support not only the current COVID-19 response efforts, but 
also responses to variants as well as other future pandemic 
response and preparedness efforts.

    With respect to therapeutics, one of the benefits of the 
oral antivirals Paxlovid and molnupiravir is that they have 
much broader activity against SARS-CoV-2 and its variants. In 
fact, both Paxlovid and molnupiravir have activity against all 
SARS-CoV-2 variants tested as of January 2022.

    Looking to the future and the American Pandemic 
Preparedness Plan, focusing on broad acting antivirals with 
activity against many viruses as well as focusing on host-
targeted therapeutics that are virus-agnostic will be high 
priorities.

                            SENATOR CASSIDY

    Question 1. The U.S. is in the middle of flu season, which 
has the potential to add additional burden to already-stressed 
health care systems due to the ongoing pandemic.

    Question 1(a). What steps is HHS taking to ensure the 
availability of appropriate diagnostics and treatment options 
to address the potential dual threats of COVID and influenza, 
including through shoring up the Strategic National Stockpile?

    Answer 1,1(a) There are four FDA-approved influenza 
antivirals drugs recommended by CDC for use against recently 
circulating influenza viruses: oseltamivir, baloxavir-marboxil, 
peramivir and zanamivir. Oseltamivir is the most widely used 
oral antiviral for the treatment of influenza and is also 
widely available in generic form with at least 10 different 
manufacturers approved by FDA to provide drug on the U.S. 
market. The broad manufacturing capacity ensures that even 
large waves of influenza infections can be sufficiently covered 
by the commercial market. In the event that demand for 
influenza antivirals exceeds commercial capacity, HHS could 
activate influenza antivirals that are stored in the SNS.

    Early in the COVID-19 outbreak, ASPR/BARDA recognized the 
negative impact that needing influenza testing would have on 
national COVID-19 testing capacity during flu season. As such, 
we began supporting the development of multiplexed panels to 
test for both diseases in one testing operation. BARDA is 
supporting the development and submission for review for 17 
test panels for use in laboratory and limited testing resource 
settings such as homes, nursing facilities, tribal clinics, 
doctors' offices and temporary testing centers. Four of these 
panels have received EUAs so far, with the remaining 13 
awaiting FDA review of their submissions or finalizing test 
development. BARDA is supporting most of these test panel 
developments through the FDA's 510(k) clearance process.

    Question 1(b). Beyond testing and preventative steps like 
vaccination, what steps has HHS taken to proactively treat 
vulnerable populations like the elderly or others who may be at 
risk for and are likely to spread communicable diseases like 
COVID and the flu?

    Answer 1(b). ASPR proactively works with Federal and state, 
local, tribal, and territorial (SLTT) partners to address the 
access and functional needs of at-risk populations, including 
older adults and others who may be more adversely affected by 
or susceptible to infectious diseases such COVID-19 or flu 
through developing tools, guidance, training, and programs to 
support public health emergency preparedness and response 
activities and engaging with Federal and proactively engaging 
with stakeholders to disseminate and implement critical 
information and best practices.

    ASPR's At-Risk Individuals Program continues to monitor 
emerging issues, oversee development of curriculum, and 
disseminate and update promising practices including developing 
a series of web-based trainings and capacity-building guidance 
that address all-hazards planning including infectious disease 
outbreaks. In addition, the HHS emPOWER Program is a mission-
critical partnership between ASPR and CMS. It provides Federal 
data, mapping, and artificial intelligence tools, as well as 
training and resources, to help communities nationwide protect 
the health of at-risk Medicare beneficiaries, including 4.4 
million individuals who live independently and rely on 
electricity-dependent durable medical and assistive equipment 
and devices, and or essential health care services. The HHS 
emPOWER Program continues to grow and innovate, including 
leveraging the program to develop the restricted HHS emPOWER 
Program: COVID-19 At-Risk Medicare Populations suite of 
datasets, geographic information systems, and dashboards tools 
for SLTT partners to use in response and community mitigation 
efforts.

    Question 2. Health systems in Louisiana have been 
overwhelmed by successive waves of COVID variants. These health 
systems could have been better prepared for these growing 
variant trends if they had access to better national and 
regional dashboards monitoring variants of concern. What are 
you all at the CDC, FDA, NIH, and HHS doing to make sure health 
providers are armed with the best data to respond appropriately 
to the next COVID variant or pandemic? Second, how are you all 
harnessing the speed and innovation of the private sector to 
help predict, prevent, and mitigate future COVID-19 variants or 
other pathogens of concern?

    Answer 2. ASPR has supported internal development data 
governance strategies, building out modernized IT systems for 
data sharing (HHS Protect, Tiberius and ASPR Ready), and has 
coordinated closely with CDC and the Office of the National 
Coordinator for Health Information Technology (ONC). Overall, 
the engagement at the state/local level with healthcare 
providers is through CDC.

                             SENATOR SCOTT

    Question 1. Ms. O'Connell--How much COVID funding is still 
left for testing and what is the plan for its investment?

    Answer 1. As of the hearing date, the Federal Government 
has invested $10 billion to support school testing; $8.3 
billion on free community testing, testing for the uninsured, 
rural clinics and hospitals; and $5 billion on test 
procurement, distribution, and materials. As of the hearing 
date, $4.4 billion remains available for future testing 
efforts.

    On efforts related to test procurement and distribution, we 
have quadrupled the amount of at-home tests available since the 
fall and have worked with test manufacturers and FDA to help 
expedite development and review of at-home tests, which will 
directly result in even more tests being available. In the 
near-future, we will announce an initiative in which households 
can place orders for tests, free of charge, and test kits will 
be delivered via USPS. More information will be provided to 
Congress as this initiative goes live.

    We have also supported free testing sites at over 10,000 
pharmacies throughout the country, over 10,000 state-and 
locally run community sites offering free testing generally 
with FEMA or CDC support--for a total of over 20,000 free 
testing sites across the country today. As of the hearing date, 
we are setting up surge testing sites in states to further 
increase access. There are 17 sites up and running in New York 
City, New Jersey, Pennsylvania and Washington, DC, with plans 
for sites in more than a dozen additional states in the coming 
couple of weeks.

    Question 1(a). How many tests does the Federal Government 
currently have and what is the distribution plan?

    Answer 1(a). As of the date of this hearing, the Federal 
Government had begun contracting for the tests to be provided 
to the general public at no cost. As of the date of this 
hearing, over 50 million tests were secured through four 
initial letter contracts, and we will continue to award more in 
the days ahead to get us to a goal of having 1 billion tests 
available. Under the distribution plan, the tests would be 
distributed through the U.S. Postal Service to households who 
place orders in the system. As of the hearing date, final plans 
were being set for the website as well as an automated help 
number.

    Question 1(b). How is distribution determined?

    Answer 1(b). In the near-future, we will announce an 
initiative in which households can place orders for tests, free 
of charge. Under the distribution plan, the tests would be 
distributed through the U.S. Postal Service to households who 
place orders in the system.

    Question 1(c). Given concerns regarding limited accuracy 
and inability to detect early infection with antigen tests, 
what action has the Administration taken to support increased 
production and procurement of rapid, at-home molecular tests? 
If none, why not and does the Administration plan to do so?

    Answer 1(c). Testing continues to be a vital part of our 
response. We've made significant progress in increasing testing 
supply, availability, and affordability. As of the hearing 
date, we went from zero over-the-counter tests in January 2021 
to supporting the manufacturing of approximately 375 million 
tests per month. We invested $3 billion to accelerate 
production of rapid tests and expanded capacity, including 
necessary components such as pipette tips and vials. We're also 
standing up an office within ASPR to focus on making sure we 
have the right mix of products, suppliers, and partnerships to 
respond to public health emergencies and strengthen the 
Nation's overall preparedness.

    In January, President Biden announced a plan to make 1 
billion free at-home tests available to the American people and 
mail them directly to their homes via COVIDTests.gov.

    Question 2. Ms. O'Connell--Recently, President Biden 
mentioned that there is no Federal solution to defeating COVID-
19 and later said Americans need to adjust and prepare for 
COVID to be a part of everyday life.

    Question 2(a). How does the Administration view the role of 
the Federal Government moving forward?

    Answer 2,2(a). The President has been clear that we're 
moving toward a time when COVID won't disrupt our daily lives--
a time when COVID won't be a constant crisis. Rather, it will 
be something we can easily prevent and treat. In doing so, we 
will rely on the powerful tools we've used to protect the 
public from COVID-19--vaccines, treatments, and testing. As we 
move toward that time, we're working closely with state 
Governors, local public health officials, and other subject 
matter experts on steps we should be taking to keep the country 
moving forward.

    Question 2(b). What are the protocols for hospitals 
regarding overloading: what does the trigger look like 
regarding National Guard or other supports?

    Answer 2(b). The Secretary of HHS, and by delegation the 
ASPR, serve as the lead for Emergency Support Function #8 (ESF-
8) under the Incident Response Framework. Requests for medical 
support are evaluated and resourced under that construct. To 
support the review of requests, HHS supports a daily call where 
the other Federal partners supporting elements of the medical 
response, including DoD, the VA, PHS Commissioned Corps, and 
CDC, gather to discuss, coordinate, and determine resourcing 
assignment decisions. As case counts and other considerations 
change, the requests are reviewed in real-time to determine the 
best allocation possible. Using this process, this team will 
decide when to deploy a National Disaster Medical Services team 
or DOD clinical response team to decompress an overwhelmed 
hospital-factors for consideration include the number of cases, 
the available beds, and the available staff in the hospital 
setting.

    Question 3. One of the things that we've learned in this 
pandemic is that we have the best biopharma industry in the 
world. It has been a truly unbelievable feat that America's 
biopharmaceutical companies have been able to respond to an 
unprecedented and evolving pandemic by delivering safe and 
effective vaccines in essentially less than a year's time. 
Additionally, we are seeing continued innovation in the COVID 
space--antivirals, new medications designed to keep people off 
ventilators, as well as continued promising research on 
existing medications, all which will help us to continue to 
expand our COVID-fighting capabilities. As a long term champion 
for the strategic national stockpile and the advanced research 
and preparation conducted by BARDA, I do worry that we may be 
falling behind in our efforts to maintain the most up-to-date 
and innovative repository to respond to the current and future 
pandemics.

    Question 3(a). Ms. O'Connell--What can be done to improve 
partnerships with industry to allow for public-private 
partnerships to manage and to provide certainty for production 
needs and distribution of essential medical countermeasures?

    Answer 3,3(a). HHS is committed to supporting our industry 
partners, providing value-added services, expertise, and 
funding to develop, manufacture and deliver medical 
countermeasures that protect health and save lives in public 
health emergencies. To help the country build manufacturing 
capabilities needed to produce population-scale vaccines and 
therapeutics, we issued a Request for Information (RFI) and 
held a virtual Industry Day as part of our market research into 
the capabilities needed, how those capabilities could be 
sustained over time, and how best to build consortia that 
engage more industry partners with large-scale manufacturing 
experience. In addition, BARDA issued an RFI on domestic 
vaccine manufacturing capabilities utilizing mRNA technology. 
We will leverage all of the legislative authorities at our 
disposal and available funding to build not just the capacity 
but also the capability that the Nation needs. We look forward 
to working with industry on this critical issue for national 
security.

                           SENATOR TUBERVILLE

    Question 1. The administration's declaration on December 
21, 2021 that they would make 500 million test kits available 
to be shipped to people's homes has made it more difficult for 
companies to get shipments to help keep workplaces safe, as 
there have been fewer tests available for private purchase.

    Question 1(a). Can you provide a high-level roadmap to an 
increase in EUA antigen test production?

    Answer 1,1(a). Testing continues to be a vital part of our 
response. We've made significant progress in increasing testing 
supply, availability, and affordability. As of the hearing 
date, we went from zero over-the-counter tests in January 2021 
to supporting the manufacturing of approximately 375 million 
tests per month. We invested $3 billion to accelerate 
production of rapid tests and expanded capacity, including 
necessary components such as pipette tips and vials. We're also 
standing up an office within ASPR to focus on making sure we 
have the right mix of products, suppliers, and partnerships to 
respond to public health emergencies and strengthen the 
Nation's overall preparedness.

    In January, President Biden announced a plan to make 1 
billion free at-home tests available to the American people and 
mail them directly to their homes via COVIDTests.gov.

    Question 1(b). Specifically, how much are vendors 
increasing test manufacturing? In what quantity and by what 
date?

    Answer 1(b). In early 2021, we saw a decline in demand for 
tests following the rollout of COVID vaccines and domestic 
manufacturing capacity for rapid antigen tests significantly 
exceeds current demand. Our industry partners have reached out 
to us with concerns that active manufacturing lines risk being 
shut down without orders from the Federal Government to 
partially offset this imbalance. ASPR recognizes the importance 
of keeping this critical infrastructure active given the large 
supply/demand shifts created by the spread of recent--and 
potentially subsequent--variants. As such, we are working in 
tight coordination with our industry partners as we continue to 
invest in procurement of tests to build a stockpile that will 
be at the ready to respond to rapid demand surges and continue 
to explore ways that we can ``warm base'' existing 
manufacturing capacity so that tests are available if needed.

    Question 2. Across the country, members of the health care 
workforce have been fired for refusing to comply with COVID-19 
vaccine mandates. Do you believe that these mandates have 
contributed to labor shortages in hospitals and other health 
care facilities?

    Answer 2. The Office of the Assistant Secretary for 
Preparedness and Response has worked tirelessly to support the 
development and manufacturing of safe and effective COVID-19 
vaccines. ASPR is committed to ending the pandemic and ensuring 
Americans can live safe and healthy lives. ASPR can provide 
resources, such as personnel from the National Disaster Medical 
System (NDMS), to augment care if and when a medical system or 
systems is in need of additional staff augmentation. The issue 
of labor shortages is something outside of ASPR's role and 
responsibility, but we stand by to support requests if and when 
needed and have done so throughout the ongoing response.

    Question 3. One of the things we've learned during this 
pandemic is that America has the best biopharma industry in the 
world. It was an almost unbelievable feat that America's 
biopharmaceutical companies were able to respond to an 
unprecedented and evolving pandemic by delivering safe and 
effective vaccines in essentially less than a year's time. 
We've also seen continued innovation in the COVID space-
antivirals, new medications designed to keep people off 
ventilators, as well as promising research on existing 
medications. All of these things will help us to further expand 
our COVID-fighting capabilities for all variants. As a 
supporter of the Strategic National Stockpile and the advanced 
research and preparation conducted by BARDA, I worry that we 
may be falling behind in our efforts to maintain the most up-
to-date and innovative repository to respond to the current and 
future pandemics.

    Question 3(a). What can be done to improve partnerships 
with industry to allow public-private partnerships to manage 
and to provide certainty for production needs and distribution 
of essential medical countermeasures?

    Answer 3,3(a). HHS is committed to supporting our industry 
partners, providing value-added services, expertise, and 
funding to develop, manufacture and deliver medical 
countermeasures that protect health and save lives in public 
health emergencies. To help the country build manufacturing 
capabilities needed to produce population-scale vaccines and 
therapeutics, we issued a Request for Information (RFI) and 
held a virtual Industry Day as part of our market research into 
the capabilities needed, how those capabilities could be 
sustained over time, and how best to build consortia that 
engage more industry partners with large-scale manufacturing 
experience. In addition, BARDA issued an RFI on domestic 
vaccine manufacturing capabilities utilizing mRNA technology. 
We will leverage all of the legislative authorities at our 
disposal and available funding to build not just the capacity 
but also the capability that the Nation needs. We look forward 
to working with industry on this critical issue for national 
security.

    (Moved from NIH QFRs)

                             SENATOR LUJAN

    Question 1. Given the increased demand for N95 and KN95 
masks, we have seen an increase in costs to the consumer. New 
Mexicans hoping to protect themselves face costs as steep as $6 
per mask-a cost that is simply out of reach for some of our 
most vulnerable populations. What barriers are preventing the 
Federal Government from providing N95 or KN95 masks to the 
public free of charge?

    Answer 1. In January, 2022, just before we testified before 
this Committee, the Biden administration announced a plan to 
deploy more than 400 million American-made, high-quality N95 
masks from the Strategic National Stockpile (SNS) to retail 
pharmacies and federally qualified health centers (FQHCs) 
across the country. This effort represents the largest 
deployment by the SNS to date, and it is also the largest 
deployment of personal protective equipment (PPE) in U.S. 
history. It will help ensure that Americans have access to 
high-quality masks. Please note these masks were N95s as those 
are the masks manufactured in the U.S.
                                ------                                

    [Whereupon, at 1:55 p.m., the hearing was adjourned.]

                         
                         [all]