[Senate Hearing 117-400]
[From the U.S. Government Publishing Office]


                                                    S. Hrg. 117-400

                        AN UPDATE ON THE ONGOING
                     FEDERAL RESPONSE TO COVID	19:
                   CURRENT STATUS AND FUTURE PLANNING

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

                                 HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             SECOND SESSION

                                   ON

   EXAMINING AN UPDATE ON THE ONGOING FEDERAL RESPONSE TO COVID-19, 
             FOCUSING ON CURRENT STATUS AND FUTURE PLANNING

                               __________

                             JUNE 16, 2022

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT] 


Available via the World Wide Web: http://www.govinfo.gov
                                
                                __________

                                
                    U.S. GOVERNMENT PUBLISHING OFFICE                    
48-911 PDF                  WASHINGTON : 2023                    
          
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          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

                        THURSDAY, JUNE 16, 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...........................     5

                               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.............................................................    13
    Prepared statement...........................................    14
Califf, Robert, M.D., Commissioner, United States Food and Drug 
  Administration, Silver Spring, MD..............................    18
    Prepared statement...........................................    20
O'Connell, Dawn, Assistant Secretary for Preparedness and 
  Response, United States Department of Health and Human 
  Services, Washington, DC.......................................    39
    Prepared statement...........................................    40

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Romney, Hon. Mitt:
    ``Fact Sheet: Consequences of Lack of Funding for Efforts to 
      Combat COVID-19 if Congress Does Not Act'', Submitted for 
      the Record.................................................    81
    Letter from various organizations in response to the VALID 
      Act........................................................    83

                         QUESTIONS AND ANSWERS

Response by Rochelle Walensky to questions of:
    Sen. Burr....................................................    87
    Sen. Murkowski...............................................    88
    Sen. Scott...................................................    93
Response by Anthony Fauci to questions of:
    Sen. Burr....................................................    94
    Sen. Murkowski...............................................    95
Response by Robert Califf to questions of:
    Sen. Burr....................................................    97
    Sen. Cassidy.................................................    98
    Sen. Murkowski...............................................    99
Response by Dawn O'Connell to questions of:
    Sen. Kaine...................................................   100
    Sen. Burr....................................................   100
    Sen. Murkowski...............................................   102
    Sen. Tuberville..............................................   103

 
                        AN UPDATE ON THE ONGOING
                     FEDERAL RESPONSE TO COVID-19:
                   CURRENT STATUS AND FUTURE PLANNING

                              ----------                              


                        Thursday, June 16, 2022

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

    The Committee met, pursuant to notice, at 9:32 a.m., in 
room 106, Dirksen Senate Office Building, Hon. Patty Murray, 
Chair of the Committee, presiding.

    Present: Senators Murray [presiding], Sanders, Casey, 
Baldwin, Kaine, Hassan, Rosen, Lujan, Hickenlooper [presiding], 
Smith, Burr, Paul, Collins, Cassidy, Braun, Marshall, and 
Romney.

                  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 having a hearing on the ongoing Federal response to the 
COVID-19 pandemic. I will have an opening statement followed by 
Ranking Member Burr, and then we will introduce our witnesses.

    After they give their testimony, Senators will each have 5 
minutes for a round of questions. Today, we will be having one 
of our witnesses, Dr. Fauci, testify remotely by video 
following a positive COVID test.

    I appreciate the work of our Committee staff to make it 
possible for us to accommodate this so that we can hear from 
Dr. Fauci while he isolates and recovers. 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.

    If anyone needs accommodations including closed captioning, 
please reach out to the Committee or the Office of 
Congressional Accessibility Services. Before we do get started 
on this hearing, there is another issue we are all extremely 
focused on, the formula crisis. Dr. Califf, I understand 
flooding from the storms has forced Abbott's infant formula 
manufacturing facility in Sturgis offline once again.

    Ranking Member Burr and I agreed, and I would like to give 
you a moment before we begin to update the Committee on the 
latest with the plant. I hope you can speak directly to the 
families in Washington State and across the country about what 
happened, and how you are taking action to get them formula and 
making sure this doesn't worsen the crisis or delay our work to 
get formula back on the shelves as soon as possible.

    Dr. Califf, I want to return to you for that before we 
begin the rest of the hearing.

    Dr. Califf. There we go. Thanks, Senator Murray and Senator 
Burr for giving me a minute to speak about this. You know, we 
have twice daily intensive calls about all the work streams 
working on the infant formula issue.

    At the end of the call yesterday, I commented it was one of 
the first days that we hadn't had any surprises, 20 minutes 
later the email came across about the flood in Sturgis, which 
has forced the facility to temporarily shut down. This is an 
unfortunate setback and a reminder that natural weather events 
can cause unforeseen disruptions in supply chains. I had a call 
with the CEO last night.

    He is sharing our desire to get the facility up and running 
again as quickly as possible. Abbott is working to assess 
damage today and we will be talking daily, and we have our 
people in the facility to help get it up as quickly as we 
possibly can.

    To your main question, which I know is of utmost importance 
and we are all, certainly all of us are very concerned about 
parents trying to get a formula for their infants, I do want to 
reassure parents and caregivers that the all the Government 
work to increase supply means will have more than enough 
product to meet current demand and FDA is committed to working 
closely with Abbott so that Sturgis can restart producing safe 
and quality formula products quickly.

    Thanks to the collaboration of all of the players in the 
market, we now for the first time are getting production 
numbers from them about how much formula each company is 
producing, including Abbott, which has ramped up its other 
plants and is currently meeting the supply production quotas 
that they were using before the shutdown.

    All the other manufacturers have increased their production 
and of course we have flying formula in full swing now. I have 
good numbers to indicate there will be adequate supply. We had 
hoped to have a super supply so that we get the shelves 
completely restocked.

    The estimate is perhaps 2 weeks, but it is too early to 
give an exact estimate of what the delay will be in the Sturgis 
plant.

    The Chair. Well, thank you, Dr. Califf. I assure you that 
this Committee and all Americans will be following this very 
closely. We want to be kept updated and apprized as closely as 
possible as you learn the facts and make sure that parents 
across this country are getting what they need.

    Dr. Califf. I understand. Thank you.

    The Chair. Thank you. With that, we will turn to the 
hearing at hand. And let me just begin by saying that we have 
made a lot of progress in the fight against this pandemic. It 
is much easier to get tests. Schools have safely return to in-
person learning. Businesses have reopened.

    There are new life saving treatments for people with COVID, 
and multiple safe, effective vaccines. And there is encouraging 
news to suggest vaccines for kids under age five will be 
available soon. Something I know that parents across my state 
and the country are eagerly awaiting.

    Across the country, we have gotten over half a billion 
shots in arms. Three in four people have gotten their first 
COVID vaccination. Two-thirds of people are fully vaccinated. 
This is really remarkable progress,. But we have to remember 
the hardships of this pandemic, especially the early days and 
the hard work it took us to get to where we are today. COVID-19 
has killed over 1 million people in our Country.

    That is an unthinkable loss. It closed businesses, shifted 
schools online, and as we all know a lot more. We cannot afford 
to get caught off guard by this virus again. We cannot afford 
to go back. That is why I am shocked I still have to remind my 
colleagues the progress we have made so far was not guaranteed. 
It was accomplished through congressional action and through 
robust investments.

    What happens next is not a given either. It is up to us to 
stay the course in our support and investments if we are going 
to protect our families and communities from whatever this 
pandemic throws at us next. That is why passing emergency 
funding to continue our response has to be a top priority for 
every single one of us.

    Because make no mistake, it is not a matter of if this 
pandemic will throw us another curveball, it is a matter of 
when. That is why emergency COVID funding is not something that 
would be nice to have.

    It is something that we desperately need. Because if we 
wait until there is already a new dangerous variant, or until 
we are in the middle of a fall or winter surge, which some 
experts are predicting will happen, we will have missed the 
boat. We need to be doing everything we can now to get ready. 
That is what people back in Washington State and across the 
country are depending on Congress to do.

    It is why I want to hear more about--that is what I want to 
hear more about from all of our witnesses today, what do we 
need to do right now so we are not caught off guard later? 
Because one thing we already know is when it comes to 
pandemics, when it comes to public health, an ounce of 
prevention is worth a pound of cure.

    We need to be investing in prevention now. We need to be 
ordering the treatments we need for a fall surge now, 
especially when it can take 6 months, by the way, to 
manufacture paxlovid. We need to be ordering the vaccines we 
will need now. We need to be combating misinformation that is 
already far too prevalent and damaging now.

    We need to be getting the testing, PPE we will need lined 
up, especially for our schools and health care facilities, now. 
And let's be clear, we can't just keep buying the same tests, 
treatments, and vaccines, especially when this virus is getting 
more effective at evading them.

    As important as they continue to be to our progress, we 
cannot continue acting as though the vaccines and therapeutics 
we have now are the end all, be all. We have got to support the 
next generation, keep several irons in the fire, and avoid 
getting caught in a situation where our tools or options are 
limited to just a few companies.

    After all, we know this virus will not play favorites. That 
is why it is critical we invest in the research and development 
of the next generation tests, vaccines, and treatments that are 
more effective or easier to store or transport or administer.

    Because once there is a variant that cannot be detected by 
our current tests, that does not respond to current treatments, 
that is not stopped by our current vaccines, we have got to be 
ready. And the research and development of these critical tools 
can take time. And let's be clear, none of that would be 
unprecedented, in fact, it is to be expected.

    When it happens, time is of the essence to save lives, and 
families are counting on us right now to act like it. The 
reality is we are already running out of resources to prepare 
for the fall, and we are running out of time to fix that.

    Democrats have been hammering this home for months. We have 
been yelling from the rooftops, warning what is at risk if we 
do not get this done. I am at a loss as to how I can possibly 
make the urgency of this moment more clear to all of our 
Republican colleagues. The fact that the Administration has had 
to resort to allocating resources from our long term needs to 
keep our short term response afloat, that is not a solution.

    That is a stopgap, and it should be a clear sign of how 
urgent it is that Congress take action. We need to continue to 
support a full, robust response. This is simply too important 
to scramble again on short notice or shortchange our 
communities.

    In addition to more resources, we need to make sure we are 
getting our communities the guidance and technical assistance 
they need to get ready as well. This is especially critical for 
our schools.

    School officials and educators want to do everything they 
can to keep our students safely in the classroom. In fact, 
everyone wants that. But we can't leave them waiting until back 
to school season if we are going to make it happen. Schools 
back in my state want to know what they can be doing right now 
to get ready for the next school year.

    How can they best position themselves to make sure if we 
have a fall surge, they have the resources and a plan in place 
that protects students and educators and keeps them safely in 
the classroom. I want to hear more from our witnesses about how 
they are working with the Department of Education to get 
schools the support they need.

    Of course, in addition to making sure we prepare for what 
is next in the course of this pandemic, we need to make sure we 
are ready for whatever public health threat we face next, 
period. That means making sustained annual investments in our 
public health system like I have proposed, so we can end the 
cycle of crisis and complacency.

    It means making bold investments in pandemic preparedness. 
It means strengthening our Federal policies and processes like 
Senator Burr and I are working to do in our bipartisan Prevent 
Pandemics Act. I know I have said it already, but I will say it 
again and again until we get this done.

    It means passing the emergency COVID funding. We need to 
make sure our communities are able to continue getting back to 
normal, not back to the darkest days of this pandemic, when we 
couldn't get tests, when we didn't have effective treatments, 
when we didn't have vaccines.

    After everything we have been through, it should be clear 
this is not the time to settle for doing too little or acting 
too late. I can tell you that it is clear to me, and it is 
certainly clear to the families I am hearing from back in 
Washington State. I am going to keep pressing for us to get 
emergency funding passed as soon as possible and get our 
communities everything they need to keep people safe.

    I am asking my Republican colleagues to please consider the 
cost of inaction. Consider what it means for our doctors, for 
our nurses, our small business owners, our high risk families 
and friends, including seniors and immunocompromised people, 
our educators, our students, if we let COVID get the better of 
us because we failed to make a modest investment right now.

    I hope we can work together and find a path forward here. 
Senator Burr, I will turn it over to you.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Thank you, Madam Chairman. I welcome our 
guest. Tony, I hope you are having a mild case. To our 
witnesses, thank you for coming back to the HELP Committee. 
When we were last together in January, the country was in the 
throes of the original Omicron surge.

    At that time, I asked you one basic question, what is the 
plan? I hope in your opening statements or maybe when I ask 
this question in the question around somebody or give me an 
answer. The Chair just did a fabulous job of painting 
Republicans into the obstacle for there not being enough 
emergency funding.

    I remind my colleagues, we spent $1.9 billion just on COVID 
a year ago. Where is that money gone? How is it being spent? 
Where is it obligated? No plan has been presented, but on 
multiple occasions, the Chair has been in the room when I have 
said, here is a condition, present us a plan.

    Now in early May, this plan went out. It just tells me what 
you would buy if you got $10 million and what you would buy if 
you got $17.5 billion. And it says confidential. This isn't a 
plan. When is somebody going to share with the American people 
the destination we are trying to get to and how we are going to 
get to that destination?

    We are still in crisis management, and we are two and a 
half years into this. I am really sympathetic of Dr. Fauci's 
position, because Tony, more than anybody understands, we are 
dealing with a virus that continues to evolve and change. But 
since the time we last got together, we have seen Omicron 
subvariants take hold.

    Right now, cases of BA.4 and BA.5 are creeping up around 
the country. In January, I asked yet again how this 
Administration was looking to other countries that have already 
experienced new surges so that we can prepare for the impacts 
of new variants in the U.S. and inform our response.

    BA.4 and BA.5, for example, caused a new wave of infections 
in countries where they are dominant, like South Africa and 
Portugal. 22 percent of the cases in the United States are 
currently BA.4 or BA.5, a number that continues to increase 
daily. We are learning from other countries and regions that 
are ahead of us, like Israel and Europe.

    What do we need to be doing today to ensure that we are 
prepared for what we face in the weeks and the months to come? 
I have asked you repeatedly about studies out of Israel and 
other countries. I have been frustrated by the lack of detail 
about what you are learning from other countries and how it 
informs our COVID response.

    Quite frankly, I sent my staff to Israel over the Memorial 
Day recess. It is my understanding that we meet regularly, 
either by phone or in person, with our Israeli counterparts. 
During these meetings, they share the latest COVID trends in 
Israel and any updated data on the vaccine clinical trials and 
studies. If you are getting the information regularly, why is 
it taking so long for us to act on it?

    In January, Israel became the first country to offer a 
fourth vaccine dose to individuals over 6,0 and health care 
workers that were at least 4 months past their first dose--
their third dose. Israeli health ministers announced new data 
at the end of January, demonstrating additional protections 
from a fourth vaccine dose for those 60 and over.

    It took CDC 3 months to take similar steps. I will say it 
again, 3 months. Israel has also taken steps to appropriately 
target the use of limited COVID-19 countermeasures. Israel 
targeted its supply of oral antivirals to treat those with the 
greatest risk of severe illness to keep them out of the 
hospital and to keep them alive.

    Meanwhile, the Biden administration developed a new plan, 
Test and Treat, a strategy to provide therapeutics to anybody 
who presented infected and came up positive. The terms of the 
emergency use authorization are that Pfizer drugs should be 
given to high risk patients, not everyone who tests positive. 
There is the Israeli data influence.

    But the way we have applied the EUA instructions from FDA 
is hand it out to anybody who walks in and tests positive. 
Tests positive, get an antiviral. The terms of the emergency 
use authorization, I said, but I will quote this, people can--
this was the President, ``people can get tested at a pharmacy 
and if they are positive, receive anti-viral pills on the spot 
at no cost.''

    Either the President was confused about his own 
announcement, or you are deliberately giving these pills to too 
many patients, violating the terms of the EUA, putting people 
at risk, and wasting treatments and taxpayer dollars. I am 
puzzled by the wide gap in our approaches when so much data is 
regularly being shared between health leaders in both 
countries.

    Before you say our countries are of different sizes, I will 
remind you that we can approve drugs and devices based on 
samples of just a few thousand patients. The virus is the same 
in Israel and in the United States. And we have seen Israel get 
hit by new variants every--between six and 8 weeks before the 
United States.

    Israel's quick and decisive actions in early December 
delayed the onset of the Omicron wave by 5 weeks. They had a 
clear path and clear leadership. Meanwhile, we have discarded 
over 82 million COVID vaccine doses in the United States, and 
this Administration assumes that at least 50 percent of booster 
doses we purchase this fall will go to waste.

    My God, folks, let's figure out a different plan for 
inoculating these people. Why don't we keep falling further 
behind? Why aren't we trying to do better? Why aren't we 
learning from our mistakes? It doesn't seem like we are 
striving for anything other than mediocrity. Have we given up? 
Let me highlight just a few of the more glaring 
inconsistencies.

    In April, CDC released data indicating that nearly 60 
percent of the Americans and about 75 percent of American 
people and 75 percent of children had at least one COVID-19 
infection by the end of February. Though more recent data has 
not been released, I imagine the infection rate is even higher 
today given the recent spikes in cases.

    We know the majority of Americans aged five and over are 
vaccinated. So the majority of Americans have some degree of 
protection against the virus, yet we only removed our pre-
departure testing requirements for travelers entering the 
United States legally this past Sunday. Many EU countries 
lifted their pre-entry testing requirements for fully 
vaccinated travelers in February and March.

    Canada followed suit in April. This is not an isolated 
example of where we lag behind because we either don't believe 
the data that they are providing, or it doesn't fit with the 
narrative that we are trying to carry out. In response to a 
letter I wrote about my concerns with CDC termination of Title 
42 order, you wrote, ``the COVID-19 risk for U.S. communities 
is greatly reduced for most people compared to earlier in the 
pandemic.''

    Why are we still in an urgent state of emergency and taking 
months to remove restrictions that other countries have been 
removing since February? American people are fed up with 
confusing messaging and inconsistent response.

    Let me ask again, what is the plan? More than 2 years ago--
two years into this pandemic, the American people are going 
back to work in person, attending weddings, events, traveling 
for work and leisure, and Government still allows its employees 
even at the FDA, CDC, and within HHS platform to work remotely.

    Individuals who are at higher risk of severe illness or 
those who live in communities with higher levels of circulating 
virus know the precautions they need to take to keep themselves 
and their family safe. And if they get sick, we have tests and 
treatments to help them recover. We know more now than we did 2 
years ago.

    We have more tools today to save more lives. Do we know 
everything? No. It is past time to think about the future. I 
have asked you in over and over and over again for a plan. The 
plan for gaining back the trust of the American people and 
moving our Country forward. Six months later, I still haven't 
received an adequate response to what plan--the plan actually 
is.

    Since I am having trouble getting a response to my initial 
question, let me end with asking each of you a slightly 
different one. Every good plan is crafted around an intended 
outcome. I hope all of you can answer this. What is your 
endgame? Maybe I will respond differently to the Chair about 
the attacks that we are standing, Republicans in the way of 
funding emergency money.

    But CDC says it is not an emergency anymore. That is why 
they are ending Title 42. I can go through a litany of things 
that suggest this has transformed to somewhere. We are in a 
period that there needs to be an accountability for how we 
spent the $1.9 trillion devoted to COVID. I think any country 
in the world laughs at the way we are spending our money 
relative to this crisis and this virus.

    I will continue to ask you for a plan until we get one, and 
I will continue to be a roadblock for those who believe that we 
can blindly just appropriate emergency money, borrow it from 
the Chinese, and spend it on something that none of us have a 
clue as to what the plan is. I thank the Chair. I yield back.

    The Chair. Thank you, Senator Burr. I 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 in President Biden's COVID-19 response team. Dr. Fauci, 
we do appreciate you joining us virtually following your 
positive COVID test. And of course, we all do wish you a very 
speedy recovery.

    Dr. Robert Califf is the Commissioner of the Food and Drug 
Administration. Dawn O'Connell is the Assistant Secretary for 
Preparedness and Response. Director Walensky, Director Fauci, 
Commissioner Califf, Assistant Secretary O'Connell, thank you 
all so much for joining us today. We look forward to your 
testimony. We will begin with Dr. Walensky.

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

    Dr. Walensky. Chair Murray, Ranking Member Burr, Members of 
the Senate HELP Committee, I appreciate the opportunity to join 
you once again to provide an update on the COVID-19 pandemic 
and the work CDC continues to do to help Americans live safer, 
healthier lives. It was just over a month ago that we surpassed 
1 million COVID deaths in the United States.

    To many, that numbers seemed unthinkable when the pandemic 
began, but it is a sobering reality that so many of us have 
experienced great loss over the past 2 years. We recently 
experienced another increase in COVID cases, which was 
accompanied by an increase in hospitalizations and deaths.

    Through this, we continue to see that immunity through 
vaccination and infection has resulted in fewer 
hospitalizations and deaths from COVID surges prior to Omicron. 
At this time, 67 percent of our population live in counties at 
medium or high COVID community levels, twice as many as people 
1 month ago.

    CDC's COVID community levels have been an important tool to 
empower localities and jurisdictions to decide where and when 
to use proven prevention strategies to limit the impact of 
COVID-19. Our ability to manage this virus today is in large 
part due to the tools we have, vaccines, tests, treatments, and 
masks.

    We continue to work hard to increase access to these 
important tools every day so that Americans can better protect 
themselves. For example, we have recently expanded the 
eligibility of COVID vaccine boosters for children ages 5 to 
11. And just this week, we are coordinating with our colleagues 
at FDA to consider recommendations for those 6 months to 4 
years to receive their first COVID shots.

    Since the start of this pandemic, nearly 8 million 
children, 11 and younger, have been diagnosed with COVID. Over 
50,000 have been hospitalized and over 600 have died. I know 
that many parents are anxiously waiting to vaccinate their 
children under five, and we are committed to carefully 
reviewing the data so that these vaccines are recommended only 
if they have both safe and effective profiles.

    As I look toward the future of CDC's COVID response, thanks 
to congressional support, CDC will be awarding $3 billion to 
your states to recruit, hire, and train public health workers 
to face current and emerging public health threats.

    While this is an exciting opportunity to help address a 
long standing gap, I am deeply concerned that a lack of 
additional funding for other response activities will end or 
substantially scale back critical COVID response work. Congress 
and the American people expect that CDC will continue 
nationwide studies to evaluate immunity, to conduct long term 
surveillance on COVID, including on post COVID conditions, and 
to support future vaccination efforts both globally and 
domestically.

    We need additional funding to do this work. As we continue 
to support our COVID-19 response effort, we must not forget 
that this will not be our last public health challenge and we 
continue to face future public health threats. Just this past 
month, we have seen outbreaks of monkeypox in non-endemic 
countries, including here in the United States.

    CDC's swift action has supported testing and case 
identification. However, as threats like monkeypox emerge, we 
run the risk of again being constrained by incomplete data from 
our fragmented public health data reporting system. We need to 
work together to support new authority for CDC to receive 
timely, standardized, and uniform data.

    This pandemic has highlighted the need for disease agnostic 
investments to address the long standing vulnerabilities in our 
public health system. The Fiscal Year 2023 budget request 
proposes $28 billion for CDC over 5 years to enhance early 
warning and situational awareness capabilities, to support 
workforce programs, to bolster public health infrastructure, to 
invest in data modernization, and to prioritize global health 
security initiatives.

    The budget also proposes a vaccine for adults program 
modeled on the successful vaccine for children's program. This 
program highlights my and the Administration's commitment to 
health equity by creating a mandatory funding stream through 
which uninsured adults would have increased access to 
vaccinations, sustaining the infrastructure built during the 
COVID pandemic. Congressional support for these initiatives, 
accompanied by additional authorities to collect and coordinate 
public health data, will strengthen our Nation's ability to 
prepare for and respond to emerging public health and 
biosecurity threats.

    I am committed to working with each and every one of you to 
find common ground, to support public health and make 
meaningful strides toward achieving health security for all 
Americans, both now and into the future. Thank you, and I look 
forward to your questions.

    [The prepared statement of Dr. Walensky follows:]

               prepared statement of rochelle p. 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 over 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 our work to provide 
science-based guidance about how we can best protect ourselves and our 
communities as the virus and the pandemic evolve.
                         State of the Pandemic
    Last month, we reached a tragic milestone: 1 million reported 
deaths from COVID-19 in the United States, a heartbreaking reminder 
that COVID-19 is still with us. While we mourn the overwhelming loss 
that these numbers represent, and we honor each of the individuals who 
have passed, there are many reasons for hope. We have learned an 
incredible amount about this virus in a short period of time. We have 
increased access to the tools we need to protect ourselves and those 
around us.

    Over the past 2 months we have seen increases in cases and 
hospitalizations on the national level. Cases are beginning to level 
off on the national level, although we continue to see increases in 
some regions of the country. And, while the 7-day average of daily 
deaths continues to decrease, there are still tragically too many 
deaths each day from this disease. Although COVID-19 continues to 
circulate, we now have vaccines, tests, and treatments that work to 
prevent severe disease and death. Most Americans have some immunity due 
to receipt of vaccines, past infection, or both. In February, CDC 
transitioned to using COVID-19 Community Levels, leveraging community 
level data to offer guidance to local jurisdictions and to empower them 
to decide when and where to implement prevention measures. CDC looks at 
the combination of three metrics--new COVID-19 admissions per 100,000 
population in the past 7 days, the percent of staffed inpatient beds 
occupied by COVID-19 patients, and total new COVID-19 cases per 100,000 
population in the past 7 days--to determine the COVID-19 community 
level. New COVID-19 admissions and the percent of staffed inpatient 
beds occupied represent the current potential for strain on the health 
system. Data on new cases acts as an early warning indicator of 
potential increases in health system strain in the event of a COVID-19 
surge. Jurisdictions can use these data to prioritize efforts to 
minimize the impact COVID-19 has on our health, our healthcare systems, 
and our society, while focusing efforts on protecting those who are 
most at risk of severe illness. As of June 9, 2022, nearly 78 percent 
of the U.S. population is in a location with low or medium COVID-19 
Community Level.

    The pandemic is not over, and we must continue to do all we can to 
decrease severe disease and death. Despite widespread availability of 
vaccines, including booster doses, we know that some parts of the 
country continue to see their healthcare systems stretched thin by the 
pandemic. In addition, there are many Americans who have a compromised 
immune system, one or more disabilities, other serious medical 
conditions, or who continue to be at elevated risk because of their age 
or other factors. We must continue to use the prevention tools in our 
toolbox to limit the impact COVID-19 has on those who are most 
vulnerable and our communities.
                  Genomic Sequencing and Surveillance
    CDC continuously monitors and analyzes the evolution of SARS-CoV-2 
and the emergence of variants domestically and internationally, and our 
national genomic surveillance system can reliably detect variants, 
including those circulating at low levels. CDC's National Genomic 
Surveillance System employs critically important and comprehensive 
strategies to detect and track variants.

    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. CDC also augments sequencing capacity through 
contracts with commercial diagnostic laboratories to support the 
national genomic surveillance system and the sequencing of thousands of 
specimens per week.

    The rapid detection of emerging variants, including Omicron and its 
subvariants, 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. In 
addition, CDC and other Federal agencies continue to work with 
international partners to learn more about variants circulating 
globally; CDC will continue to monitor all data sources closely to 
identify cases of COVID-19 from emerging variants across the world.

    As the pandemic and the virus evolve, we at CDC are working quickly 
to adapt with it, including identifying new strategies to understand 
what is happening in real time to better inform our decisionmaking and 
guidance. For example, in early February 2022, CDC unveiled new 
National Wastewater Surveillance data. We are tracking more than 995 
testing sites nationwide, covering over 110 million Americans. Of 
these, 773 sites are currently represented on COVID Data Tracker. This 
empowers local and state officials to detect increases in SARS-CoV-2 
infection 4-6 days before traditional sentinel signals like test 
positivity, case counts, and hospitalizations.
                          Vaccination Efforts
    Since December 2020, more than 591 million doses of COVID-19 
vaccine have been administered in the U.S. Overall, as of June 13, 
2022, over 221 million people in the U.S. have received their primary 
vaccine series and over 104 million people have received at least one 
booster dose. Approximately 71 percent of the U.S. population 5 years 
of age and above have completed a primary vaccination series and 48.8 
percent of the population 12 years of age and above have received their 
booster dose. While progress is being made, these numbers indicate 
there is still more work to be done. Vaccination remains the best 
public health measure to protect from severe disease. CDC recommends 
that everyone who is eligible protect themselves from COVID-19 by 
getting vaccinated and staying up to date on their vaccinations. This 
includes CDC's recommendation for boosters for anyone 5 years and older 
and a second booster of an mRNA vaccine for adults ages 50 years and 
older and for people aged 12 and older who are moderately or severely 
immunocompromised.

    Strong confidence in COVID-19 vaccines within communities leads to 
more adults, adolescents, and children getting vaccinated, which in 
turn can lead to fewer SARS-CoV-2 related hospitalizations and deaths. 
CDC is employing a variety of approaches to improve vaccine uptake, 
including developing training materials for healthcare providers, 
funding a number of on-the-ground social mobilization efforts, offering 
communication materials to the public, and distributing the COVID-19 
State of Vaccine Confidence Insights Reports, which identify the 
public's questions, concerns, frustrations, and misinformation they are 
encountering while providing readers ways they can act on the findings.

    Furthermore, the Federal Retail Pharmacy Program continues to be an 
important component in our commitment to address the disproportionate 
and severe impact of COVID-19 on communities of color and other 
underserved populations. CDC partnered with 21 national pharmacy 
organizations and independent pharmacy networks that represent over 
41,000 locations nationwide--to ensure that the public has access to 
COVID-19 vaccines in a familiar setting. Almost 90 percent of Americans 
live within five miles of a retail pharmacy. As of June 8, 2022, more 
than 254 million doses have been administered and reported by retail 
pharmacies across programs in the U.S., which includes approximately 8 
million doses administered onsite in long-term care facilities in the 
early days of the vaccination program. As of June 8, 2022, 42 percent 
of the cumulative doses administered through these pharmacy programs 
have gone to a person from a racial or ethnic minority group. CDC 
continues to identify and engage in opportunities that align with the 
guiding principles of the CDC COVID-19 Response Health Equity Strategy, 
and CDC works to accelerate and strengthen efforts to reduce the 
disproportionate burden of the pandemic on communities of color and 
other populations of focus.
                             Global Efforts
    CDC global health experts have worked tirelessly with partners and 
public health officials globally to respond to the COVID-19 pandemic, 
leveraging and adapting our global health investments, systems, and 
programs for the global COVID-19 response. CDC has worked hand-in-hand 
with Ministries of Health in dozens of countries to provide critical 
support during the COVID-19 pandemic. CDC's ability to leverage core 
public health capacities overseas for the global COVID-19 response is 
built on longstanding investments in surveillance, laboratory networks, 
emergency management, and workforce development. For example, CDC has 
supported the development and strengthening of over 30 national 
Emergency Operations Centers worldwide, and CDC's PEPFAR-supported 
investments in laboratory networks and systems have been critical to 
COVID-19 diagnosis and surveillance, with 73 percent of PEPFAR-
supported centralized labs implementing SARS-CoV-2 testing.

    Just as in all our work at CDC, advancing health equity is a core 
tenet of CDC's global health work. CDC supports over 70 countries to 
receive and administer COVID-19 vaccines.

    Around the world, CDC is committed to widespread and equitable 
access to safe and effective COVID-19 vaccines, while continuing to 
build capacity for essential immunization systems. CDC's approach to 
global health prioritizes host country ownership, investment in local 
partnerships, development of sustainable capabilities, and sharing of 
technical expertise. CDC works to identify, partner with, and reach 
underserved populations around the globe.
                             Looking Ahead
    When looking ahead, the fiscal year 2023 Budget Request for CDC and 
ATSDR, provides an important framework to establish future investments 
in public health. This includes $10.7 billion in program funding for 
ongoing and expanded efforts to support our mission--protecting America 
from health, safety, and security threats, at home and abroad. The 
fiscal year 2023 Budget also outlines transformative mandatory 
proposals, building upon the lessons learned through our experience 
with COVID-19 and emphasizing recovery and revitalization of the 
Nation's public health system. The proposed new Vaccines for Adults 
program highlights my and the Administration's commitment to health 
equity by creating a structure and mandatory funding stream through 
which uninsured adults would have access to all vaccines that have been 
recommended by CDC's Advisory Committee on Immunization Practices and 
CDC. In addition, that program will help sustain the adult vaccine 
infrastructure built with investments during the COVID-19 pandemic, and 
it will be a critical step toward being prepared for the next pandemic. 
The Budget also proposes $81.7 billion for pandemic preparedness at the 
Department of Health and Human Services, of which $28 billion would be 
allocated to CDC. This will provide early warning and situational 
awareness, strengthen core capabilities, and strengthen public health 
systems including workforce and global health security.

    Congressional support for these initiatives, accompanied by 
additional authorities to collect public health data, will make the 
Nation better prepared for future pandemics, but there are still 
additional COVID-19 problems to solve here at home and abroad. To 
continue essential COVID-19 response activities, as delineated in the 
Administration's $22.5 billion supplemental request to Congress on 
March 2, 2022, CDC needs additional funds to support infrastructure for 
surveillance and laboratory capacity, as well as to support ongoing 
global response needs, including to accelerate vaccine uptake through 
the U.S. Initiative for Global Vaccine Access, to limit the spread of 
variants and protect lives here and globally.

    In April 2022, CDC announced the launch of the new Center for 
Forecasting and Outbreak Analytics (CFA). CFA seeks to enhance the 
Nation's ability to use data, models, and analytics to enable timely, 
effective decisionmaking in response to public health threats for CDC 
and its public health partners. CFA's work will focus on three main 
goals: to predict, inform, and innovate. CFA has begun to build a 
world-class outbreak analytics team with experts across several 
disciplines to develop faster, richer evidence to predict trends and 
guide decisionmaking during emergencies. CFA will also continue to 
advance the state of the science of outbreak data, models and analytics 
to improve the Nation's ability to respond to health emergencies.
                               Conclusion
    While we have come a long way since the beginning of the pandemic, 
there is still much work to be done, and we all have a role to play. I 
continue to encourage everyone who is eligible to get vaccinated and 
boosted to protect both themselves and their fellow community members 
from COVID-19. We must bolster our public health infrastructure by 
supporting new authorities to enable us to be better prepared, and 
resources like those in the fiscal year 2023 President's Budget to 
support pandemic preparedness, data modernization, public health 
laboratories, domestic and global disease surveillance, and state, 
territorial, and local public health partners. We must also continue to 
make investments now to make sure we address the long-standing 
vulnerabilities in our public health system. I am committed to working 
with Congress to find common ground to equitably support our public 
health system and make meaningful strides toward achieving health 
security for all Americans now and into the future.

    Thank you, and I look forward to your questions.
                                 ______
                                 
    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 conducting and supporting research 
addressing our Nation's response to COVID-19.

    In a prior hearing before this Committee on January the 
11th, I discussed the research efforts by NIH to address the 
Omicron variant. This variant has evolved with multiple 
mutations that are associated with an increased efficiency of 
transmission and immune evasion.

    Fortunately, our current vaccines have maintained their 
effectiveness in preventing severe COVID-19. However, 
individuals who have received only their primary vaccine 
regimen have a greater likelihood of getting infected with the 
Omicron variant than with previous variants.

    Importantly, booster shots have been shown to significantly 
reconstitute and enhance the level of antibodies that 
neutralize the Omicron variant and its sub-lineages. Since I 
last appeared before this Committee, NIAID launched the COVAIL 
trial to learn whether various fourth dose booster regimens can 
further increase the breadth and the durability of immune 
responses in adults who have received a primary COVID-19 
vaccination plus a single boost.

    We remain concerned that most children eligible to receive 
a COVID-19 vaccine have not been vaccinated. NIAID and BARDA 
have collaborated with Moderna on the KidCOVE study to evaluate 
the safety and efficacy of Moderna's mRNA vaccine in children, 
including those under 5 years of age.

    Initial results from the KidCOVE study have helped inform 
the FDA's VRBPAC Advisory Committee and their recommendations 
to the FDA concerning potential emergency use authorization for 
their vaccine in this population, and also ultimately to inform 
the CDC in their recommendations.

    Looking ahead to the anticipated emergence of new variants, 
the importance of developing the next generation of coronavirus 
vaccines is paramount. I referred to a vaccine that would be 
effective against all SARS-CoV-2 variants and ultimately run 
effective against all coronaviruses.

    NIAID has issued new awards to fund research focused on 
designing and developing such pan-coronavirus vaccines. NIAID 
and other involved entities also have made significant progress 
in the development of COVID-19 therapeutics. We now have the 
toolkit, the therapeutics that remain effective against the 
Omicron variant, and its currently circulating sub-lineage 
variants.

    These therapeutics include the oral antiviral drugs 
paxlovid and molnupiravir, as well as remdesivir and the 
monoclonal antibody bebtelovimab, all of which have NIAID 
fingerprints on their development.

    In addition, NIAID is funding nine antiviral drug discovery 
centers for pathogens of pandemic concern that will develop 
oral antivirals for use in outpatient settings that target 
SARS-CoV-2 and other viruses with high potential to cause a 
pandemic.

    We know that even after people recover from an infection 
with SARS-CoV-2, some will experience ongoing symptoms or other 
negative health effects after the acute infection has resolved. 
The NIH Recovery Initiative complements ongoing NIAID studies 
to better understand the various post-acute manifestations of 
COVID-19.

    The recovered team is building a diverse national study 
cohort and supporting large scale studies on the long term 
effects of COVID-19. NIAID also is participating in caring for 
children with COVID, a trans NIH effort to better understand 
the rare but extremely serious multisystem inflammatory 
syndrome or MIS-C that has been associated with SARS-CoV-2 
infection in children and adolescents.

    NIAID will play an important role in the all of Government 
plan for pandemic preparedness that aims to develop and 
implement a range of countermeasures against important 
prototype pathogen families of viruses that threaten the health 
and safety not only of our Nation, but the entire world.

    Thank you for your attention. I would be happy to answer 
your questions following the presentations of my colleagues.

    [The prepared statement of Dr. Fauci follows:]

                 prepared statement of anthony s. 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 research addressing this once-in-a-lifetime infectious 
disease pandemic.

    The public health response to COVID-19 has required an 
unprecedented global public-private research effort. NIAID has played a 
central role in this response by capitalizing on decades of basic, 
clinical, and applied research to facilitate the rapid development of 
COVID-19 vaccines, which continue to be important tools to reduce the 
threat of COVID-19 in the United States and worldwide. NIAID also 
initiated clinical trials with creative and adaptive designs to 
evaluate multiple new and existing therapeutics for the treatment of 
COVID-19.
             Responding to Emerging Variants of SARS-CoV-2
    The emergence of SARS-CoV-2 variants--some of which demonstrate 
increased transmissibility and an ability to partially evade the immune 
response from previous infection and/or vaccination--makes it critical 
that all eligible individuals remain up to date on their COVID-19 
vaccines, including recommended booster doses, to ensure the highest 
possible level of protection. NIAID has launched collaborative research 
to rapidly assess the effectiveness of vaccines, monoclonal antibodies, 
and antiviral drugs against SARS-CoV-2 variants. NIAID also is 
exploring ways to enhance protection afforded by COVID-19 vaccines and 
supports and conducts research to understand the impact of SARS-CoV-2 
variants on infection-and vaccine-induced immunity. NIH, including 
NIAID, participates in the HHS-established SARS-CoV-2 Interagency Group 
(SIG) along with the Centers for Disease Control and Prevention (CDC), 
U.S. Food and Drug Administration (FDA), Biomedical Advanced Research 
and Development Authority (BARDA), Department of Defense (DOD), and 
U.S. Department of Agriculture. The SIG tracks variants in real time to 
address the potential impact of emerging variants on critical SARS-CoV-
2 countermeasures.

    NIAID also facilitates the use of cutting-edge tools such as 
disease modeling and structural biology to understand how SARS-CoV-2 
variants may potentially evade the immune system and/or COVID-19 
therapeutics. In addition, NIAID supports the development of next-
generation COVID-19 vaccines that could provide protection against 
disease caused by emerging SARS-CoV-2 variants. Strategies for next-
generation COVID-19 vaccines include targeting viral antigens that are 
highly conserved among SARS-CoV-2 strains and utilizing alternative 
routes of inoculation, such as intranasal vaccine approaches. NIAID 
also is conducting research on pan-coronavirus vaccines designed to 
provide broad protective immunity against emerging SARS-CoV-2 variants 
and other coronaviruses with pandemic potential. In 2021, NIAID 
announced awards to four academic institutions to conduct research to 
develop pan-coronavirus vaccines.
                Developing Vaccines to Prevent COVID-19
    Sustained research investments by NIAID over decades prior to the 
emergence of SARS-CoV-2 allowed the unprecedented pace of COVID-19 
vaccine development. Longstanding NIAID support enabled the development 
of versatile vaccine platforms and the use of structural biology tools 
including cryo-electron microscopy to design specific proteins--called 
immunogens--that powerfully stimulate the immune system. Prior to the 
COVID-19 pandemic, scientists at the NIAID Vaccine Research Center 
(VRC) and their collaborators made the critical scientific discovery of 
how to mutationally stabilize--in a highly immunogenic form--viral 
proteins that SARS-CoV-2 uses to infect human cells. This strategy 
facilitated the design of vaccine candidates that generate robust 
protective immune responses. As soon as the sequence of SARS-CoV-2 was 
made available in early January 2020, NIAID 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 of which are now authorized or approved by 
the FDA, built upon across a range of vaccine platforms including the 
highly successful mRNA platform.

    Through sustained support for fundamental research underlying the 
vaccine concepts and the establishment and utilization of an extensive 
clinical trials network, NIAID helped advance the development of six 
candidate COVID-19 vaccines. NIAID supported the Phase 3 clinical 
trials for two vaccines that are currently available for use in the 
United States: the mRNA-1273 vaccine, developed through a collaboration 
between the NIAID VRC and Moderna, Inc., and the Ad26.COV2.S vaccine 
candidate from Johnson & Johnson/Janssen. NIAID also is supporting 
Phase 3 clinical trials of investigational COVID-19 vaccine candidates 
from AstraZeneca (AZD1222), Novavax (NVX-CoV2373), and Sanofi/GSK 
(SARS-CoV-2 adjuvanted recombinant protein vaccine).

    In addition, NIAID supports research on COVID-19 vaccines in 
special populations, such as children and individuals who are pregnant 
or lactating. NIAID and BARDA are collaborating with Moderna on the 
Phase 2/3 KidCOVE study to evaluate the safety and efficacy of mRNA-
1273 in children ages 6 months to less than 12 years. KidCOVE 
investigators recently reported positive initial results, and Moderna 
has submitted to FDA a request for an Emergency Use Authorization of 
the vaccine in this population. NIAID will continue to explore 
opportunities to support additional trials to test vaccine candidates 
in children, adolescents, and other special populations.
      Ensuring Protection by the use of COVID-19 Vaccine Boosters
    FDA-authorized and FDA-approved COVID-19 vaccines have maintained 
their effectiveness in preventing severe COVID-19. However, we have 
seen with both the Delta and Omicron variants that protection against 
mild and moderate disease begins to decrease over time following the 
primary vaccine series. NIAID quickly established that boosting with 
the same vaccine that was used for the primary vaccine series could 
significantly increase levels of antibodies against all current 
variants, compared to levels in individuals who received the primary 
regimen alone. This ``homologous'' boosting has translated into 
increased protection against severe disease as well as mild infection. 
In addition, an NIAID-led study showed that boosting with a COVID-19 
vaccine different than the one used for the primary vaccine series 
(``mix and match'') was safe and prompted a robust immune response. 
Data from this study were evaluated by FDA in their decisionmaking to 
authorize the use of a ``mix and match'' approach to boosters for FDA-
authorized or approved COVID-19 vaccines.

    As SARS-CoV-2 variants have emerged, NIAID moved rapidly to 
investigate the potential of targeted boosters to enhance immune 
responses to emerging variants. Shortly after the Omicron variant was 
first described, the NIAID VRC began conducting preclinical testing of 
an Omicron-specific booster candidate. NIAID scientists showed in 
animals that boosting with either the existing mRNA-1273 vaccine or an 
Omicron-specific vaccine enhanced antibodies against Omicron and 
increased protection following challenge with the Omicron variant. 
NIAID now will examine whether people who received boosters--either 
mRNA-1273 or variant-specific COVID-19 boosters--generate antibodies 
that can bind to and neutralize the Omicron variant and its 
sublineages.

    NIAID also 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. In 2021, 
NIAID launched multiple trials assessing the response to COVID-19 
vaccination in people with immune systems weakened due to a variety of 
diseases or organ transplantation. Additionally, NIAID recently 
launched the Phase 2 COVID-19 Variant Immunologic Landscape (COVAIL) 
trial to learn whether different vaccine booster regimens can broaden 
and increase the durability of immune responses in adults who already 
have received a primary vaccination series and a first booster shot.
               Identifying Therapeutics to Treat COVID-19
    Additional 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.

    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. Data from ACTT were critical 
for FDA approval of the antiviral drug remdesivir and the anti-
inflammatory drug baricitinib for treatment of COVID-19. NIAID, in 
collaboration with other NIH Institutes, also launched the Accelerating 
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private 
partnership, which is focused on late-stage clinical trials 
investigating candidate drugs for outpatient and inpatient settings. 
ACTIV uses flexible master protocols for clinical trials, allowing the 
inclusion of additional investigational therapeutics as the trials 
continue.

    The widespread availability of highly effective oral antivirals 
that can be taken at home early in the course of infection could help 
prevent SARS-CoV-2 transmission, mitigate overwhelming surges in 
hospitalizations, and save lives. In collaboration with the DOD Defense 
Threat Reduction Agency, NIAID supported basic research and product 
development for the oral antiviral drug molnupiravir (Lagevrio), which 
the FDA authorized for the treatment of mild-to-moderate COVID-19 in 
certain populations and situations. NIAID also provided expert advice 
for clinical trials of Pfizer's oral antiviral Paxlovid, which the FDA 
authorized for the treatment of mild-to-moderate COVID-19 in certain 
populations. Paxlovid is now the leading antiviral drug for the 
treatment of COVID-19, with an almost 90 percent efficacy in preventing 
severe disease resulting in hospitalization if administered early in 
the course of infection.

    NIH has prioritized and accelerated the development of oral 
antivirals against potential pandemic pathogens by collaborating with 
BARDA to launch the Antiviral Program for Pandemics (APP). APP aims to 
develop safe and effective oral antivirals for broad use in outpatient 
settings to treat and prevent infection with RNA viruses of pandemic 
potential. The program will build sustainable approaches for targeted 
antiviral discovery and development. As part of APP, NIAID recently 
established nine multidisciplinary Antiviral Drug Discovery (AViDD) 
Centers for Pathogens of Pandemic Concern with the goal of creating 
platforms that will target RNA viruses with pandemic potential, helping 
to better prepare the Nation for future viral threats.

    NIAID also conducts and supports research to determine the impact 
of SARS-CoV-2 variants on the effectiveness of monoclonal antibodies 
and other therapeutics. For example, research suggests that although 
effectiveness of certain monoclonal antibodies against Omicron is 
markedly diminished, the monoclonal antibody bebtelovimab, discovered 
by AbCellera in collaboration with the NIAID VRC, is active in vitro 
against all circulating Omicron subvariants. In addition, NIAID is 
working to develop new drugs, including therapeutics that inhibit 
essential processes in the virus replication cycle or that address the 
host response to COVID-19, with an eye toward agents that maintain 
their effectiveness against emerging variants.

    NIH also 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. Each Treatment 
Guidelines section consists of recommendations 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 
meets regularly to evaluate possible treatment options for COVID-19 and 
update the Treatment Guidelines as new clinical evidence emerges.
            Understanding COVID-19 Immunity and Pathogenesis
    Data on immunity induced by infection with SARS-CoV-2, including 
studies by NIAID scientists and NIAID-supported researchers, clearly 
demonstrate that following infection most people generate a protective 
immune response. NIAID continues to support research to understand 
immune responses to SARS-CoV-2 infection and COVID-19 vaccination, 
including projects investigating the durability of immune responses; 
whether immunity differs in certain populations; and how SARS-CoV-2 
variants may evade immunity. These studies include research across the 
range of immune components, including the role of memory T and B cell 
responses in preventing progression of disease during SARS-CoV-2 
infection.

    In addition, NIAID 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 is supporting multiple studies to evaluate acute 
and long-term clinical and immunological aspects of MIS-C and SARS-CoV-
2 infection in children. NIAID also is participating in a trans-NIH 
effort to coordinate MIS-C research, the Collaboration to Assess Risk 
and Identify Long-term Outcomes for Children with COVID (CARING for 
Children with COVID). This effort supports data sharing across studies 
funded by multiple NIH Institutes to determine the spectrum of illness 
and predict long-term consequences of infection in children.
              Addressing the Long-term Effects of COVID-19
    While most people recover quickly and fully from infection with 
SARS-CoV-2, some experience ongoing or new symptoms or other health 
effects after the acute infection has resolved; this syndrome is 
referred to as post-acute sequelae of SARS-CoV-2 infection (PASC). NIH 
supports research to inform estimates of PASC prevalence as well as to 
understand the pathogenic mechanisms underlying the wide range of 
observed symptoms and the risk factors for developing PASC. NIH also 
launched the Researching COVID to Enhance Recovery (RECOVER) 
Initiative, a trans-NIH effort that includes targeted funding for 
research in this critical area. The NIH RECOVER Initiative complements 
ongoing NIAID studies to better understand the various post-acute 
manifestations of COVID-19 and will engage 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.
                               Conclusion
    NIAID continues to expand efforts to elucidate the biology, 
pathogenesis, and clinical manifestations of SARS-CoV-2 infection, 
including with variants of concern such as Delta and Omicron, and to 
apply this knowledge to develop safe and effective interventions to 
diagnose, treat, and prevent SARS-CoV-2 infection and/or COVID-19. 
NIAID also supports early stage research on candidate vaccines that 
could protect against multiple strains of coronaviruses. These efforts 
will improve our response to the current pandemic and bolster our 
preparedness for the next inevitable emerging infectious disease 
outbreak.
                                 ______
                                 
    The Chair. Thank you, Dr. Fauci.

    Dr. Califf.

 STATEMENT OF ROBERT CALIFF, M.D., COMMISSIONER, UNITED STATES 
        FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD

    Dr. Califf. Chair Murray, Ranking Member Burr, and Members 
of the Committee, thanks for the opportunity to provide an 
update on FDA's ongoing work related to the COVID-19 pandemic.

    FDA's thousands of employees remain steadfast in their 
commitment to fighting the pandemic, and we will continue to 
use every tool in our toolbox to arm ourselves with the best 
available diagnostics, lifesaving therapeutics, and vaccines to 
fight the virus.

    Since our last update to this Committee, FDA has approved a 
second vaccine, the Moderna vaccine, for individuals 18 and 
older, authorized a second booster dose of Pfizer-BioNTech and 
Moderna vaccines for older people and certain immunocompromised 
individuals, and expanded eligibility for the Pfizer-BioNTech 
vaccine booster dose to children 5 to 11 years.

    We have also held advisory committee meetings this month 
related to the emergency use requests for the Novavax vaccine 
to prevent COVID-19 in individuals 18 years of age and older, 
for the Moderna vaccine for 6 years to 17 years of age, and 
just yesterday, for both the Moderna vaccine for 6 months 
through 5 years of age and the Pfizer-BioNTech vaccine for 6 
months through 4 years of age.

    In each case, without a dissenting vote, the committee 
agreed that the benefits outweigh the risks in the intended 
population. The agency is working diligently to complete our 
evaluation of the data for these submissions, including taking 
into account the advisory committee's recommendations and we 
will make a determination as quickly as we can. Authorizing a 
vaccine with adequate evidence for safety and efficacy for 
young children in particular remains a top agency priority.

    In addition, on June 28, the Advisory Committee will meet 
to discuss whether the strain composition of COVID-19 vaccines 
should be modified, and which strains should be selected for 
the fall. We also continue to employ our Iowa authorities to 
facilitate availability of tests, including at home diagnostic 
tests, molecular antigen and serology tests.

    For treatments, as of May 31st, 2022, there are more than 
700 drug development programs in the planning stages, and we 
have reviewed more than 460 trials for potential COVID-19 
therapies. These include antivirals, immunomodulators, 
neutralizing antibodies, and combinations of these products, as 
well as cell and gene therapies.

    Regarding treatments for COVID-19, in February, FDA issued 
an EUA for bebtelovimab for the treatment of mild to moderate 
COVID-19 in certain adults and pediatric patients. And in May 
approved olumiant, baricitinib for treatment of COVID-19 in 
certain hospitalized adults. I am a cardiologist.

    I am accustomed to dealing directly with life and death. 
The best way to avoid dying or getting critically ill requiring 
hospitalization from COVID is to be up to date on your 
vaccinations. And if you then get infected and you are high 
risk, these new therapies offer additional protection against 
being dead or in the hospital.

    Just like heart attack patients who die without proper 
treatment to open the blocked artery, a person who dies of 
COVID without appropriate vaccination and treatment is an 
unnecessary loss of life. I have evaluated therapies for four 
decades now, and this is among the most robust data for saving 
lives that I have ever seen. It is not too late to get 
vaccinated or boosted so that you are up to date with your 
vaccinations.

    More than 2 years into this pandemic, we continue to work 
around the clock while not compromising our scientific 
standards. We also continue to monitor changes in the pandemic. 
Using our finite resources, we are supporting the expansion of 
the country's arsenal of safe and effective vaccines and 
treatments and accurate and reliable tests that will protect 
the American people as the virus continues to evolve.

    We continue to face challenges, particularly in the area of 
access to the data we need to make the best decisions. It is 
imperative that we have access to complete data in order to 
prevent shortages, track adverse events, and evaluate the 
safety and effectiveness of medical products that are critical 
to our response efforts, particularly since the virus continues 
to change, leading to ongoing questions about the pertinence of 
initial data that leads to the EUA.

    We are constantly working to get the data we need together 
with our partners in a very collaborative ecosystem. But the 
fragmentation of our health system makes it difficult for us to 
access the complete data needed to monitor key parameters, so 
we can do better.

    I hope we can continue to work together to address issues 
like these and learn from the COVID-19 response efforts. Thank 
you, and I look forward to your questions.

    [The prepared statement of Dr. Califf follows:]

                 prepared statement of robert m. califf
                              Introduction
    Chair Murray, Ranking Member Burr, distinguished Members of the 
Committee, thank you for the opportunity to testify before you today to 
describe the Food and Drug Administration's (FDA's or the Agency'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 intra-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 
new variants. FDA continues to evaluate the potential impact of new 
variants on the currently available diagnostics, therapeutics and 
vaccines. We are closely monitoring changes to the virus and are 
committed to communicating with the public as we learn more. In 
response to the omicron variant, we updated the SARS-CoV-2 Viral 
Mutations: Impact on COVID-19 Tests web page \1\ to share new 
information on the variants and their 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, life-saving therapeutics 
and vaccines to fight this virus.
---------------------------------------------------------------------------
    \1\  https://www.fda.gov/medical-devices/coronavirus-covid--19-and-
medical-devices/sars-cov-2-viral-mutations-impact-covid--19-tests
---------------------------------------------------------------------------
    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. Data also suggest a second 
booster dose of either the Pfizer-BioNTech Vaccine or Moderna COVID-19 
Vaccine could help increase protection levels for certain higher-risk 
individuals.

    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: the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 
years of age and older; the Moderna COVID-19 Vaccine for use in 
individuals 18 years of age and older; and the Janssen COVID-19 Vaccine 
for use in certain individuals 18 years of age and older.

    FDA has also approved Comirnaty (known as Pfizer-BioNTech COVID-19 
Vaccine under the EUA) for use in individuals 16 years of age and older 
and Spikevax (known as the Moderna COVID-19 Vaccine under the EUA) for 
use in individuals 18 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 vaccines, 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. 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.

    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 vaccines 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, \3\ patients, 
        parents and other members of the public; combined with
---------------------------------------------------------------------------
    \3\  Providers in the CDC COVID-19 Vaccination Program are required 
to report certain adverse events following COVID-19 vaccination to 
VAERS
---------------------------------------------------------------------------
          (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 marketed as Comirnaty for the prevention of 
COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech 
COVID-19 Vaccine has continued to be available under an EUA and is 
currently authorized as a:

          Two-dose primary series for individuals 5 years of 
        age and older; third primary series dose for individuals 5 
        years of age and older with certain immunocompromising 
        conditions;

          homologous first booster dose (matching the primary 
        vaccination) administered at least 5 months after completion of 
        primary vaccination to individuals 5 years of age and older;

          heterologous first booster dose (not matching the 
        primary vaccination) administered after completion of primary 
        vaccination to individuals 18 years of age and older (the 
        dosing interval is the same as that authorized for a booster 
        dose of the vaccine used for primary vaccination);

          homologous second booster dose administered at least 
        4 months after a first booster dose to individuals 50 years of 
        age and older and individuals 12 years of age and older with 
        certain immunocompromising conditions; and

          heterologous second booster dose administered at 
        least 4 months after a first booster dose to individuals 50 
        years of age and older and individuals 18 years of age and 
        older with certain immunocompromising conditions.

    On January 31, 2022, FDA approved a second COVID-19 vaccine. The 
vaccine has been known as the Moderna COVID-19 Vaccine; the approved 
vaccine is marketed as Spikevax for the prevention of COVID-19 in 
individuals 18 years of age and older. The Moderna COVID-19 Vaccine has 
continued to be available under an EUA and is currently authorized as 
a:

          Two-dose primary series for individuals 18 years of 
        age and older;

          third primary series dose for individuals 18 years of 
        age and older with certain immunocompromising conditions;

          homologous or heterologous first booster dose 
        administered after completion of primary vaccination to 
        individuals 18 years of age and older (the authorized dosing 
        interval for a homologous booster is at least 5 months after 
        completion of a primary series, and the authorized interval for 
        a heterologous booster is the same as that authorized for a 
        booster dose of the vaccine used for primary vaccination); and

          a homologous or heterologous second booster dose 
        administered at least 4 months after the first booster dose to 
        individuals 50 years of age and older and individuals 18 years 
        of age and older with certain immunocompromising conditions.

    The Janssen COVID-19 Vaccine was originally authorized on February 
27, 2021. On May 5, 2022, FDA limited the authorized use of the Janssen 
COVID-19 Vaccine to individuals 18 years of age and older for whom 
other authorized or approved COVID-19 vaccines are not accessible or 
clinically appropriate, and to individuals 18 years of age and older 
who elect to receive the Janssen COVID-19 Vaccine because they would 
otherwise not receive a COVID-19 vaccine.

    At this time FDA is closely monitoring the emergence of new 
variants 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. \4\
---------------------------------------------------------------------------
    \4\  Emergency Use Authorization for Vaccines to Prevent COVID-19, 
updated March 31, 2022: https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/emergency-use-authorization-vaccines-
prevent-covid--19

    FDA recently held the following virtual meetings of its Vaccines 
and Related Biological Products Advisory Committee (VRBPAC) related to 
emergency use requests that have been publicly announced by COVID-19 
---------------------------------------------------------------------------
vaccine manufacturers.

          On June 7, FDA convened VRBPAC to discuss an EUA 
        request for a COVID-19 vaccine manufactured by Novavax to 
        prevent COVID-19 in individuals 18 years of age and older.

          On June 14, FDA and its advisory committee of 
        external experts met to discuss Moderna's EUA request for 6 
        years through 17 years of age.

          On June 15, FDA and its advisory committee of 
        external experts met to discuss the Moderna EUA request for 6 
        months through 5 years of age and the Pfizer-BioNTech EUA 
        request for 6 months through 4 years of age.

    On June 28, FDA plans to convene the VRBPAC to discuss whether the 
SARS-CoV-2 strain composition of COVID-19 vaccines should be modified, 
and if so, which strain(s) should be selected for Fall 2022. This 
meeting is a follow-up to the April 6 VRBPAC meeting that discussed 
general considerations for future COVID-19 vaccine booster doses and 
the strain composition of COVID-19 vaccines to further meet public 
health needs.
                                Figure 1


    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 booster doses, 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 severe disease 
caused by variants circulating in the United States.

    To date, having three authorized vaccines and two approved vaccines 
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, 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, FDA created an emergency review and development program 
for possible therapies for COVID-19, the Coronavirus Treatment 
Acceleration Program, or ``CTAP.'' 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 May 31, 2022, there are more than 700 drug development 
programs in the planning stages and the Agency has reviewed more than 
460 trials of potential therapies for COVID-19. These therapies include 
antivirals, immunomodulators, neutralizing antibodies, and combinations 
of these products, as well as cell and gene therapies regulated by 
CBER. The diversity of therapeutic approaches being investigated is 
important because it rapidly expands our understanding of the effect of 
different categories of potential treatments.

                                Figure 2


    As of May 31, 2022, FDA has approved two drugs to treat COVID-19 
and currently there are 13 authorized therapeutics 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. In the large clinical 
trial that was conducted among high-risk patients, Paxlovid reduced the 
risk of hospitalization or death by nearly 90 percent compared to 
placebo.

    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 FDA are not accessible or clinically appropriate.

    On February 11, 2022, FDA issued an EUA for bebtelovimab, 
manufactured by Eli Lilly and Company. Bebtelovimab 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 kg or about 88 pounds) 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.

    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 when used as proposed 
outweigh the known and potential risks of such product.

    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. \6\
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    \6\  https://www.fda.gov/news-events/press-announcements/covid-19-
update-fdas-ongoing-commitment-transparency-covid-19-euas
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    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 work to support access to devices for the COVID-19 response 
began in January 2020--before the public health emergency 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), ventilators, and 
other devices. The need for medical devices to respond to the COVID-19 
pandemic has far exceeded what we experienced in any prior public 
health emergency. The first EUAs issued for the COVID-19 public health 
emergency were for medical devices, and the volume of EUA requests 
quickly surpassed (by two orders of magnitude) that of any prior public 
health emergency or other situation. To help combat the COVID-19 
pandemic, FDA and the staff of the Center for Devices and Radiological 
Health (CDRH) have continued to go well beyond normal operating 
procedures to help ensure the availability of appropriately safe and 
effective COVID-19-related devices as quickly as possible.

    From early in the pandemic, CDRH has actively reached out to and 
engaged other government agencies, medical device developers and 
international regulatory agencies, among other stakeholders. CDRH 
continues to hold weekly virtual town halls with industry to address 
COVID-19 test development and validation, as well as additional 
webinars and town halls addressing other policies and questions 
including PPE, 3D-printed swabs and manufacturing disruptions during 
the public health emergency.

    CDRH staff have also interacted frequently with test developers and 
manufacturers through the Pre-Emergency Use Authorization (pre-EUA) 
process, including rolling reviews of information that helped to 
further expedite EUA of critical medical devices for patients and 
health care professionals on the front lines. Since January 2020, FDA 
has received more than 8,000 EUA requests and Pre-EUA submissions for 
devices (including more than 1,000 so far in fiscal year 2022).

    The emergency use requests included submissions for devices that 
CDRH had never received EUA requests for during prior public health 
emergencies. 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. CDRH 
continues to receive nearly 120 EUA requests and pre-EUA submissions 
each month, the majority for in vitro diagnostic (IVD) tests, and has 
begun receiving conventional submissions from firms intending to 
transition their products beyond emergency use.

    Since the start of the pandemic, FDA has issued EUAs or granted 
marketing authorization to nearly 2,300 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 14 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 tests work through the EUA 
review. The EUA process expedites access to appropriately accurate 
diagnostic tests during emergencies, when, without such access, 
information gaps and false results could 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 public health emergencies, 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 April 13, 2022, these 
templates have received over 618,543 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 86 virtual town halls for test developers.

    FDA has prioritized review of EUA requests for at-home tests since 
Spring 2020--almost a year before other countries pursued expansive use 
of home tests--and has consistently actively engaged with test 
developers to support their development. To date, FDA has authorized 19 
distinct over-the-counter (OTC) COVID-19 tests, 11 of which were 
authorized in 4 weeks or less, with five authorized within a week.

    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 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 a 
National Institutes of Health (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. As of June 1, 2022, the 19 authorized OTC at-home tests have a 
combined manufacturing capacity of hundreds of millions of tests per 
month based on data provided to FDA by the manufacturers, and we 
understand many have scaled beyond their initial estimated capacity 
with additional government support.

    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. 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. In that update, FDA stated that going forward, the Agency 
generally intends to focus its review on EUA requests for the following 
types of tests:

          At-home and point-of-care (POC) diagnostic tests 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 NIH'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 partnered with the NIH to establish the Independent Test 
Assessment Program (ITAP), \7\ which streamlines validation and 
authorization of at-home antigen tests with potential for large-scale 
manufacturing. This program is an extension of the NIH RADx program 
which has already supported development of several authorized tests, 
including the first OTC COVID-19 test. ITAP also supports studies on 
OTC tests and works with companies to provide complete, high-quality 
submissions for FDA review. 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. FDA has authorized 
five OTC, at-home COVID-19 tests that participated in this program 
through this accelerated pathway--one manufactured by SD Biosensor and 
distributed by Roche, one manufactured by Siemens, a third manufactured 
by Maxim Biomedical, a fourth manufactured by Osang, LLC, and a fifth 
manufactured by Xiamen Boson Biotech Co., Ltd. \8\ We are already 
seeing shorter review times for such EUA requests due to our 
partnership with ITAP in establishing the evaluation program that 
provides high quality data. The average FDA review time for a test 
evaluated under ITAP is just over a week, and can be as short as 1 day, 
after receipt of a complete data package.
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    \7\  https://www.hhs.gov/about/news/2021/10/25/new-hhs-actions-add-
biden-administration-efforts-increase-access-easy-use-over-counter-
covid--19-tests.html
    \8\  https://www.nibib.nih.gov/covid--19/radx-tech-program/ITAP
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    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.

    To date, FDA has engaged with over 1,000 developers and authorized 
more than 475 tests and sample collection devices that provide a wide 
array of test options. In addition to at-home diagnostic tests, these 
include other types of molecular and antigen tests, as well as serology 
tests; POC tests, home collection tests, multi-analyte tests that can 
detect both COVID-19 and flu; tests using various sample types, 
including saliva tests; and tests for pooling, screening, and serial 
testing. \9\ Most recently, FDA issued an EUA for the first COVID-19 
diagnostic test that detects chemical compounds in breath samples 
associated with a SARS-CoV-2 infection. \10\
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    \9\  https://www.fda.gov/medical-devices/coronavirus-disease-2019-
covid--19-emergency-use-authorizations-medical-devices/in-vitro-
diagnostics-euas
    \10\  https://www.fda.gov/news-events/press-announcements/
coronavirus-covid--19-update-fda-authorizes-first-covid--19-diagnostic-
test-using-breath-samples
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    As noted in Figure 3 below, as part of this effort, FDA has 
authorized 302 molecular tests and sample collection devices, 84 
antibody and other immune response tests, and 49 antigen tests. We have 
also authorized 34 tests for serial screening programs (27 antigen and 
seven 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 3


    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 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. \11\ 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.
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    \11\  https://www.fda.gov/medical-devices/coronavirus-covid-19-and-
medical-devices/sars-cov--2-viral-mutations-impact-covid--19-tests
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    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 May 31, 2022, FDA authorized 274 
PPE devices, including 56 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 4. In 
addition to issuing EUAs, CDRH has reviewed 510(k)'s for and cleared 
over 1,400 devices that can be used for COVID-19 and certain similar 
diseases, including in future pandemics, with over 500 devices in 
fiscal year 2022 to date.
                                Figure 4


    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 outlining policies to help 
expand the availability of medical devices needed in response to COVID-
19.

    For example, to help quickly increase availability of tests in the 
early stages of the pandemic, FDA outlined a policy for developers of 
certain tests who offered their tests, upon validation and notification 
to FDA, while Agency review of the EUA request was pending. 
Additionally, FDA outlined flexible approaches for manufacturers of 
certain cleared and approved devices (e.g., remote monitoring systems, 
ventilators, infusion pumps) regarding certain limited modifications 
made to devices without submitting a premarket submission.

    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.

    For medical devices, review times have increased over time as the 
number of EUA requests and Pre-EUA 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.
                                Figure 5


                                Figure 6


    FDA has significantly improved IVD EUA review times. The average 
total time to decision (TTD) for Original IVD EUAs received in CY 2021 
is 54 days, with 91 percent of the 2021 submissions closed.

    Given the magnitude of the COVID-19 public health emergency, 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 return to normal operations, including a 
proposed phased-in transition period and recommendations relating to 
submitting marketing submissions.

    As proposed, FDA would announce the Advance Notice of Termination 
(ANT) in the Federal Register, which would give manufacturers 180 days 
to come into compliance with regulatory requirements and submit a 
conventional marketing submission (e.g., 510(k) or PMA). Provided that 
the submission is accepted by FDA by this time (180 days after the 
ANT), FDA does not intend to object to these devices to continue to be 
distributed and used while the submission is pending review.

    FDA is working to address stakeholder feedback and timely finalize 
this guidance and a companion guidance for devices that fall within 
COVID-19-related enforcement policies. The transition plan for device 
EUAs and other actions FDA is undertaking are intended to provide 
transparency to our stakeholders and to avoid market disruptions and 
shortages as the Agency and broader device ecosystem transition back to 
normal operations.

    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, 
   Center for Veterinary Medicine, and the Office of Food Policy and 
                               Response)
    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 humans 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 and apply 
mitigation strategies for products for which availability has been 
impacted in part by pandemic-related issues.

    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.

    As highlighted in the U.S. Department of Agriculture's (USDA's) 
Agri-Food Supply Chain Assessment report, developed in response to 
Executive Order 14017 on America's Supply Chains with input from FDA, a 
dynamic, interconnected, supply chain monitoring platform and robust 
data sets are necessary to be most effective in monitoring food supply 
chains, managing risks, and identifying and quickly addressing supply 
chain disruptions to reduce impacts on consumers.

    FDA also recognizes that food supply chain stability and workers' 
safety are two sides of the same coin. Thus, a stable and 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 to workers in the food and 
agriculture sectors, including migratory and seasonal agricultural 
workers. 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 (CVM) 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 continued to conduct mission-critical inspections 
domestically and abroad, including inspections and investigations in 
response to foodborne outbreaks, throughout the pandemic. FDA resumed 
standard operations for domestic surveillance inspections in July 2021, 
and since March 2022 has been conducting prioritized foreign 
inspectional work, including surveillance and other inspections. FDA 
continues to screen every line of every imported food shipment entering 
the U.S. utilizing our Predictive Risk-Based Evaluation for Dynamic 
Import Compliance Targeting (PREDICT) tool.

    We continually adjust 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 review 
importer records for information showing that foreign suppliers are 
using processes and procedures consistent with FDA Food Safety 
Modernization Act (FSMA) requirements. The shift to remote FSVP 
inspections, along with other tools utilized by the foods program, was 
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 3,423 FSVP 
inspections. 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 15,324 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. Last year, FDA 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.
  Imports, 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 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 
refused and destroyed more than 119,000 products, totaling over 
21,232,063 capsules, tablets, and other dosage forms of violative drugs 
shipped via international mail.

    Since March 2020, FDA has maintained the same level of screening 
for products offered for import as pre-pandemic and refused 
approximately 160,464 lines violative medical products offered for 
import. FDA has focused examinations on COVID-19 relief supplies to 
ensure that reviews of compliant products are expedited while 
maintaining our commitment to refusing medical products that appear to 
be unsafe, misbranded, unapproved, counterfeit, or may cause serious 
illness or injury to the public. Import investigators have evaluated 
donations of shipments destined for the Federal Emergency Management 
Agency (FEMA) and have been instrumental in expediting the importation 
of vaccines and related shipments and other COVID-19 necessities 
starting with the first vaccines (Pfizer Belgium) shipped into the 
United States in December 2020.

    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 and to do other prioritized domestic inspectional work when 
possible, to ensure FDA-regulated industries were meeting applicable 
FDA requirements. 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,'' \12\ 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. \13\
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    \12\  https://www.fda.gov/media/148197/download
    \13\  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 as well as remote 
interactive evaluations that include remote livestreaming video of 
operations), teleconferences, or screen sharing, and leveraging 
information from trusted regulatory partners.

    For example, ORA made over 2,100 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 350 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 200 remote assessments that were directly used in application 
decisions. \14\ 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 inspections, and that there are 
situations where only an inspection is appropriate, based on risk and 
history of compliance with FDA regulations.
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    \14\  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 intended to prioritize domestic and 
foreign inspections that could not be performed during the pandemic. 
FDA began to transition back to standard operations for domestic 
surveillance inspections and other prioritized operational work on July 
1, 2021, and exceeded the goals 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).

    Since October 1, 2021, FDA has been performing domestic inspections 
at normal operational levels and recently began to conduct foreign 
facility inspections, including surveillance and other inspectional 
work, as well. As FDA works through the inventory of postponed 
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-known 
inspectional and compliance history that is making 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 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 treatments, 
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 285 warning letters to 
sellers of unproven products claiming to treat, prevent, or cure COVID-
19.

    Working with the Department of Justice (DOJ), FDA has sought and 
obtained preliminary and permanent 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 22 warning 
letters to owners and/or operators of illicit internet pharmacy 
websites that offer unapproved and misbranded drugs purporting to treat 
COVID-19 for sale 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 May 2022, the 
physician was sentenced to 30 days' imprisonment and 1 year of home 
confinement after pleading 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 was fined and sentenced 
to 36 months of probation in October 2021 after pleading 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, we help prevent 
illegal, dangerous, and fraudulent products from getting 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 sentenced to 10 
months of confinement after pleading guilty to 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 70 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.

    In addition to the use of compliance and enforcement tools, FDA 
also used targeted communication to alert the public and address 
misinformation about the efficacy of products purported to treat COVID.
                      Medical Product Supply Chain
    FDA monitors and responds to worldwide demand and supply chain 
disruptions for medical products caused by the COVID-19 pandemic. \15\ 
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 we 
are working to better position the Agency and our health care system to 
assure a strong domestic supply chain in future emergencies.
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    \15\  https://www.whitehouse.gov/wp-content/uploads/2021/06/100-
day-supply chain-review-report.pdf
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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.

    The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), 
signed into law on March 27, 2020, included authorities intended to 
enhance FDA's ability to identify, prevent, and mitigate possible drug 
shortages by, among other things, enhancing FDA's visibility into drug 
supply chains. The CARES Act expanded the requirement for manufacturers 
of certain drugs to provide information on permanent discontinuances 
and interruptions in manufacturing that may lead to a meaningful 
disruption in supply to FDA, and required FDA to prioritize and 
expedite, as appropriate, the review of certain applications and 
inspections that could help mitigate or prevent a shortage of a drug 
covered by section 506C(a) of the FD&C Act.

    Our experience with COVID-19 only reemphasized that a strong 
domestic supply chain depends on a resilient supply chain for medical 
devices. Even before the pandemic hit the U.S., there were disruptions 
in the medical device 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 public health emergency 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 medical device 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.

    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. \16\ Throughout COVID, FDA has dealt with 
hundreds of thousands of device units that have been in shortage. FDA 
used the information it received from its CARES Act authorities to 
prevent or mitigate shortages including diagnostic testing supplies 
such as swabs and viral transport media; blood collection tubes; PPE 
(respirators, surgical masks, gowns, gloves); ventilators; pediatric 
trach tubes; dialysis products; infusion pumps and accessories; saline 
flush syringes, sharps containers, needles and syringes.
---------------------------------------------------------------------------
    \16\  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.
---------------------------------------------------------------------------
    Specifically, FDA uses the information it receives from the CARES 
Act to:

          Expedite review of devices and changes to devices;

          Allow/expedite importation;

          Grant enforcement discretion, including outlining 
        flexible approaches for manufacturers of certain cleared and 
        approved devices (e.g., remote monitoring systems, ventilators, 
        infusion pumps) regarding certain limited modifications made to 
        devices without submitting a premarket submission;

          Provide clinical impact assessments to the Assistant 
        Secretary for Preparedness and Response (ASPR) and the White 
        House supply chain coordinator to support informed 
        decisionmaking regarding shortages;

          Authorize EUAs;

          Communicate with healthcare providers about devices 
        in shortage;

          Inform conservation strategies; and

          Provide assessments that allow for informed 
        decisionmaking on medical device shortages across the U.S. 
        Government.

    FDA is using this information to develop shortage assessments that 
inform potential mitigations. This work has helped to protect patients 
and health care providers around the Nation from critical shortages of 
devices.

    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 and other critical medical devices. 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 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 has also worked across the medical device ecosystem to address 
systemic challenges to our supply chain due to sterilization issues and 
resin shortages. The impacts of supply chain disruptions caused by a 
natural disaster (Texas Winter Storms) have significantly impacted our 
most vulnerable populations. Most recently, devices used to compound 
total parental nutrition for critically ill neonates were impacted by 
the lack of availability of resins. FDA has worked with manufacturers 
and suppliers to help mitigate this disruption.

    FDA continues to work to implement and operationalize the new 
device shortage authority, as well as utilize one time funding from 
COVID supplementals and $5 million in the first annual appropriations 
it received in fiscal year 2022 to stand up a new state-of-the-art 
Resilient Supply chain Program (RSCP). Medical device shortages not 
only put patients in harm's way but also jeopardize our health care 
workers on the front lines, during public health emergencies 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, and why the Agency has requested additional authorities and 
funding in fiscal year 2023 to improve our device supply chain 
readiness going forward 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. FDA recognizes that this will 
take resources and expanded authority. The pandemic has demonstrated 
that by the time a public health emergency is declared, it is often too 
late to effectively prevent or mitigate device shortages.

    Moreover, there are situations that occur frequently that do not 
rise to the level of a public health emergency--such as cybersecurity 
attacks, natural disasters, recalls and spot shortages that may impact 
one region of the country or one particular hospital system, but for 
which device shortages could significantly impact patient care. After 
the COVID-19 emergency ends, these authorities remain tied to a public 
health emergency--that is, during or in advance of a public health 
emergency.

    This limits FDA's ability to identify supply chain vulnerabilities 
and work with the industry to respond to early signs of supply 
constraints or a potential shortage situation. One need only look at 
the ongoing resin supply chain issue, noted above, to see the wide-
spread impacts that have lasted for over a year and resulted in 
shortages of multiple devices to include pediatric trach tubes, blood 
collection tubes, diagnostic tests, and catheters.

    Most recently, a critical device component was impacted by this 
shortage which resulted in an inability to delivery total parental 
nutrition for neonates \17\ Unfortunately, FDA will be very limited in 
our ability to proactively identify and address device shortages after 
the COVID-19 emergency ends while its device shortages authorities 
remain tied to a public health emergency--that is, during or in advance 
of a public health emergency.
---------------------------------------------------------------------------
    \17\  https://www.childrenshospitals.org/content/public-policy/
letter/critical-shortages-fda-letter
---------------------------------------------------------------------------
                               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 COVID-19 pandemic.

    The Administration continues to apply a whole of Government 
approach to protecting Americans from COVID-19, and ASPR leads 
the operational response with responsibilities for procuring 
and distributing many of the tools needed to fight the virus, 
including vaccines, therapeutics, and tests.

    Thanks to the collaboration across HHS and with partners at 
DOD and with private industry, ASPR has delivered more than 750 
million doses of safe, effective, and free vaccine to 90,000 
vaccinationsites around the country, contributing to 221 
million people being fully vaccinated.

    We continue to allocate vaccine and boosters to sites 
nationwide. We are now preparing to support the distribution of 
vaccine for kids under five, should FDA authorize, and CDC 
recommend a vaccine for that population. We have made 10 
million doses available to states, pharmacies, community health 
centers, and Federal entities to order initially with more 
doses becoming available soon after.

    We are also preparing for the distribution of Novavax's 
protein based vaccine should it receive authorization and 
recommendation. This would provide those who are allergic to 
mRNA vaccine or prefer a non-MRA vaccine, the option to get 
vaccinated.

    While vaccines remain the best way to prevent severe 
illness caused by COVID-19, we continue to have therapeutics 
available to prevent and treat infection. Today, ASPR allocates 
four different products, two oral antivirals, one monoclonal 
antibody for treatment, and one monoclonal antibody for pre-
exposure prophylaxis for immunocompromised people.

    We remain focused on making sure that providers and 
patients know these products are available, that they are free, 
and they can be found at approximately 50,000 locations 
nationwide. Testing continues to be an important part of our 
COVID response.

    We have made significant progress in increasing testing 
supply availability and affordability over the past year. In 
fact, we went from zero over-the-counter tests in January 2021 
to approximately 300 million tests available this winter.

    ASPR has secured more than 900 million at home tests for 
distribution for free to American households through the U.S. 
Postal Service. So far, we have delivered nearly 500 million 
tests to more than 70 million American households via the 
covidtest.gov program. And we have just opened our third round 
of ordering.

    Since May 2021, ASPR has also shipped over 149 rapid 
antigen tests and 8.1 million point of care PCR tests to our 
most vulnerable populations, including nursing homes, federally 
qualified health centers, and long term care facilities. 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.

    ASPR continues to stock the Strategic National Stockpile, 
or SNS inventory to at or above pre-covid-19 levels to ensure 
that we are prepared for the next wave of cases. We are doing 
so to the extent possible with domestically manufactured 
supplies and equipment.

    The SNS currently has 42 times the number of N95 
respirators, 8.5 times the number of surgical and procedural 
face masks, 12.5 times the number of gowns and coveralls, 272 
times the number of gloves, and 10 times the number of 
ventilators than we had prior to the start of the pandemic.

    While COVID has been anything but predictable today, we are 
in a much better position to respond than we were a year ago. A 
big reason is because Congress, on a bipartisan basis, provided 
the resources needed to make sure Americans had these free and 
widely available tools to protect themselves.

    Unfortunately, without additional funding, our ability to 
prepare for whatever comes next is severely limited. Last week, 
the Administration notified Congress that in the absence of new 
funding, it was repurposing $10.2 billion in COVID supplemental 
funding, taking it from critical programs in order to secure 
more of our most important tools, lifesaving vaccines and 
therapeutics.

    The difficult decision was made to divert funds from our 
testing program and the SNS at a time when both programs are 
finally better positioned and better prepared than they have 
been at any point in this response, and they require funding to 
be maintained and strengthened in order to stay that way.

    Without additional supplemental funds, we are at a point 
where each spending decision comes with the difficult tradeoff, 
tradeoffs that none of us want to make. I look forward to 
working with you on these difficult funding decisions as we 
continue to respond to COVID and prepare the country for 
whatever this virus might bring next.

    Thank you for your support 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 751.4 million doses of vaccine and 11.3 
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 vaccines 
and boosters. 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 10.3 million first doses 
delivered for this population. We are also preparing to support the 
distribution of vaccine for kids under five, if and when FDA 
authorizes, and CDC recommends, a vaccine for that population. We have 
plenty of supply of both Pfizer and Moderna vaccines appropriate for 
this population, and we are making 10 million doses available to 
states, pharmacies, community health centers, and Federal entities to 
order initially. Meanwhile, we are also preparing for the potential 
emergency use authorization of Novavax's protein-based vaccine that, if 
authorized, would provide those who are allergic to mRNA vaccine or 
prefer non-mRNA an option to get vaccinated.

    In addition to vaccines, HCORE continues to purchase and distribute 
to states and jurisdictions a variety of treatments including 
monoclonal antibodies and oral antivirals.

    Today we allocate four different products--two oral antivirals, 
Pfizer's Paxlovid and Merck's Lagevrio; the monoclonal antibody 
treatment Bebtelovimab from Eli Lilly; and AstraZeneca's Evusheld for 
pre-exposure prophylaxis for immunocompromised people. We are focused 
on making sure that providers and patients know these products are 
available, that they're free and that they are available at 
approximately 50,000 locations nationwide.

    In March, we launched the Test-to-Treat initiative that gives 
individuals an opportunity to rapidly access free treatments at 
approximately 2,600 pharmacy-based clinics, federally qualified health 
centers, and community-based sites. Under this program, people are able 
to get tested and if they are positive and treatments are recommended 
for them, receive a prescription from a health care provider (either 
onsite or via telehealth) and have their prescriptions filled all in 
one location. In coordination with FEMA, we have also added a federally 
supported Test to Treat initiative which allows us to partner with 
states and territories to support additional Test to Treat sites around 
the country. We currently have sites in Rhode Island and Minnesota and 
are evaluating additional proposals from several states.
         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 81 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 18 therapeutics, 56 
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 11.1 
million treatment courses of monoclonal antibodies and antivirals, and 
shipped more than 243 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, 
monoclonal antibodies are administered by infusion, which must be done 
in clinical settings, placing a high burden on patients and healthcare 
staff. BARDA's collaboration with industry on developing oral 
antivirals offers an important therapeutic option other than monoclonal 
antibodies. As a result, there are now two oral antivirals available 
under EUA for the prehospital treatment of patients at high risk for 
progression to severe COVID-19. In fact, the administration of oral 
antivirals has increased sixfold in recent weeks.

    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 tests for use in both point-of-care and home use settings and 
for two molecular and five antigen tests for use specifically in point-
of-care settings. BARDA has also expanded its portfolio to include 
development of respiratory panel tests that, at a minimum, can detect 
SARS-CoV-2 (the virus that causes COVID-19) plus Influenza, but often 
can detect for other respiratory viruses. BARDA is funding development 
of an Omicron-specific molecular test for use in informing monoclonal 
antibody therapy. Last, 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 in 
the spring of 2021. 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 610 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 January that ASPR continues to 
work to replenish SNS inventory to levels at or above pre-COVID-19 
amounts to ensure that 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 June 2, 2022, 
the SNS has utilized approximately $12 billion from COVID-19 
supplemental appropriations provided by Congress to have in its 
inventory approximately: 541 million N95 respirators (42 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); 4.8 billion gloves (272 times pre-pandemic levels); 
and 158,000 ventilators (10 times pre-pandemic levels). SNS has also 
made investments to ensure that there is capacity to make these 
critical supplies.

    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.

    In response to the COVID-19 pandemic, ASPR has leveraged the 
authorities delegated to the Secretary under the Defense Production Act 
(DPA) to issue 70 priority ratings. Priority ratings were issued on 54 
U.S. Government (USG) contracts to support the development, production, 
and/or procurement of critical COVID-19 countermeasures such as 
vaccines, therapeutics, diagnostics, personal protective equipment, 
ventilators, and ancillary medical supplies. Additionally, priority 
ratings were issued on 10 USG contracts to support manufacturing 
expansion for vaccines, diagnostics, N95s, and glass vials as well as 
for vaccine distribution. In six circumstances, the HHS Secretary 
authorized a private sector partner to apply priority ratings on select 
purchase orders to ensure continued production of medical devices that 
were essential in the COVID-19 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.
                                Testing
    In addition to the Industrial Base Expansion efforts I mentioned 
previously, ASPR continues to support COVID-19 testing for the Nation. 
We've made significant progress in increasing testing supply, 
availability, and affordability over the past year. We went from zero 
over-the-counter tests in January 2021 to approximately 300 million 
tests available for use in December 2021. HHS has invested billions of 
dollars in domestic testing manufacturers to accelerate production of 
rapid tests and expand manufacturing capacity. At ASPR, we know 
partnership with industry is critical to ensuring that success 
continues, which is why I visited an Abbott BinaxNOW manufacturing 
facility in Illinois to meet with company leadership, visit with the 
employees on the production floor, and see the manufacturing process 
up-close. The advances we have made in testing are reflective of a 
broader effort within ASPR to bolster our industrial base expansion and 
supply chain efforts.

    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. In partnership with the U.S. Postal 
Service, we have delivered hundreds of millions of tests, and recently 
opened up a third round of ordering. We are also creating a Federal 
stockpile of COVID-19 tests to rapidly distribute in the event of a 
surge.

    Since May 2021, ASPR has also shipped over 149 million rapid 
antigen tests and 8.1 million point-of-care PCR tests to our most 
vulnerable populations, including nursing homes, federally qualified 
health centers, and long-term care facilities. 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 this morning. 
We will now begin a round of 5 minute questions. I ask my 
colleagues, please keep track of your clock and stay within the 
5-minutes.

    We are quickly running out of resources to prepare for 
another COVID surge. I am talking about vaccines that can keep 
us safe from the new COVID variants, more accurate tests, new 
treatments that work against new variants to prevent serious 
illness and death.

    Developing those products is essential, but it takes 
funding, and it takes time. If we don't provide more funding 
now, the vaccines and treatments we need in the fall may not be 
available. I don't want to be in a situation again where 
schools and childcare centers are closed, or hospitals and 
health care workers are overwhelmed. I want to make sure 
everyone who wants a vaccine gets one in the fall.

    I want to ask each one of you individually this morning, 
why are additional investments in our COVID response needed 
now, and how will our ability to prepare for and respond to 
COVID change if we do not provide additional support? Dr. 
Walensky, I will begin with you.

    Dr. Walensky. Thank you, Chair Murray. We have numerous 
ongoing studies that will not be able to continue, studies that 
I believe the American people are interested in and need to 
see, including two nationwide seroprevalence studies that need 
to end in December 2022. These include the national burden and 
incidence of infections, immunity and correlates of protection.

    We are unable to continue our long term surveillance and 
that includes comprehensive monitoring of post-COVID 
conditions. We will be unable to continue our mother to baby 
surveillance, and that includes mothers with COVID. We have 
learned a lot about how the impact--they impact on their 
babies, as well as the vaccine impact of pregnant women and on 
their babies.

    But we won't be able to do those studies for things like 
paxlovid and other therapeutics, including monoclonal 
antibodies. And then finally, CDC will not be able to continue 
its global vaccine efforts and in the future, its domestic 
vaccine efforts support as well. Thank you.

    The Chair. Dr. Califf.

    Dr. Califf. To me, the most important thing that will 
happen is people will die or be hospitalized or experience long 
COVID for days to months to maybe a lifetime unnecessarily if 
they don't have access to the latest vaccines and antivirals. 
Within the FDA, we have to keep track of all this and adapt to 
this rapidly changing virus and the environment that it is in.

    I want to add one more component we haven't talked about, 
the supply chains of all of this. I have learned a lot about 
the food supply chain in the last few months, and it is not 
just infant formula. We have multiple areas of agricultural 
supply that are tenuous if workers get sick and can't--and we 
all remember the early days of the pandemic in that regard.

    The Chair. Ms. O'Connell.

    Ms. O'Connell. Thank you. Without additional funds, we have 
already seen that we are going to be limited in our ability to 
maintain domestic manufacturing of tests. We have been able to 
support that over the last several months and keep it ramped up 
to meet the demand the American people have had for over the 
counter tests. We are now having to divert funds away from 
that.

    We are also not going to be able to expand our domestic 
manufacturing of mRNA vaccines. This was one of the things that 
we think is important for our current response and future 
preparedness.

    In addition, the Strategic National Stockpile is not going 
to be able to purchase domestically manufactured surgical gowns 
as we anticipated being able to do and will struggle to be able 
to maintain the current PPA--PPE levels that I just walked 
through. We also are unable to invest in the research and 
advanced research and development for next generation vaccines 
and therapeutics.

    The Chair. Dr. Fauci.

    Dr. Fauci. Yes, Madam Chair. As you know, the role of the 
NIH is to do the basic clinical and translational research, to 
develop the countermeasures that we have so successfully been 
part of that process, to get us the vaccines, therapeutics, and 
diagnostics.

    As you mentioned in your opening statement, this virus is 
changing, and we need to keep up with it. In order to do that, 
we have got to do better with new vaccine platforms such as 
nanoparticle vaccines. We cannot proceed with that unless we 
get additional funding. Importantly, we need to both prevent 
infection and transmission.

    We know that we cannot do that unless we get a highly 
effective, mucosal or intranasal vaccine. We have a number of 
projects that will not be able to be funded unless we do get 
new resources to continue this funding. These are challenges 
that we have that I believe we will be letting the American 
people down if we do not use our scientific capabilities to 
meet the next challenge of this ever changing virus. Thank you.

    The Chair. Thank you. You know, COVID-19 vaccines have done 
incredible job keeping people from getting severely ill. COVID 
treatments have, as we know, saved thousands of lives. However, 
we only have a limited number of treatments and vaccines, and 
they are produced by a small number of companies.

    I think everyone in this room is worried we are over 
reliant on current products and not doing enough to get ahead 
with the next generation vaccines or treatments or tests. I am 
worried we are not investing in that research and development 
of products that we will need this winter.

    In our conversations, Dr. Fauci and Ms. O'Connell, it is 
clear that NIH and ASPR do not have sufficient resources to 
invest in that necessary research and development work. Dr. 
Fauci, you alluded to this a little bit, but talk about what 
you are doing to ensure this next generation research is the 
top priority for NIH.

    What can NIH due to bring these products further along in 
the process with its existing funding?

    Dr. Fauci. Thank you, Madam Chair. Two examples of what we 
are doing with regard to therapeutics is the antiviral program 
for pandemics, where we are using both development and 
discovery very similar to the paradigm that was used for the 
highly successful development and discovery of drugs for HIV, 
namely the antiviral drugs. We will absolutely need more 
resources to get that done effectively.

    In addition, we have just awarded nine centers that are 
centers for it is called AViDD, the Antiviral Drug Discovery 
Centers. We have very good investigators throughout this 
country. We could fund many more and that would hasten the 
capability that we have of developing new drugs.

    How we can continue to further that is to do what we have 
been doing all along, is to partner with our industrial 
partners, to be able to do the fundamental, basic concept 
development. And then together with BARDA, which we have been 
very successful with in that partnership, to continue to 
develop these new drugs as well as diagnostics.

    The Chair. Thank you. Senator Burr.

    Senator Burr. I will turn to each of you for a yes or no 
answer. You have just described programs that you said would be 
devastating if emergency funding was not made available. Did 
the Administration request funding in their `23 budget for the 
programs you just listed?

    Dr. Walensky.

    Dr. Walensky. I would have to get back with you and----

    Senator Burr. Dr. Califf.

    Dr. Califf. I am certain that parts of it were requested, 
but not the full amount.

    Senator Burr. Ms. O'Connell.

    Ms. O'Connell. We are beginning the process of figuring out 
how to absorb these costs into our annual budgets moving 
forward.

    Senator Burr. I asked, did they make a request? You came 
with the very specific things that are not or are going to be 
disastrous if emergency spending is not--now we are doing the 
`23 budget, the budget request coming from the Administration. 
Did they request these things?

    Ms. O'Connell. It has been over a year since we have 
received COVID specific funding. A lot has changed----

    Senator Burr. In fact, Administration just took money from 
the Strategic National Stockpile. They didn't ask for more. 
They took it. They asked for less. Dr. Fauci, are all the 
things that you just listed, are they in the `23 budget 
Administration request of Congress to fund?

    Dr. Fauci. Some of them are, Senator, but not all of them, 
because at the time that we put in that request, the 
opportunities to do some of the things we done were not 
absolutely apparent to us. So the direct answer to your 
question is not all of it is in the request.

    Senator Burr. Are you beginning to see the pattern as to 
why a plan is important? This has been a well-orchestrated 
event up to this point. It has done you damage. It really has. 
Dr. Califf, we have hit the point in public health response 
where there is a commercial market for COVID vaccines, 
treatments, and diagnostics, yet FDA is still limiting who can 
purchase vaccines and treatment under the EUA.

    Limit and nothing in the law requires that the purchaser of 
an authorized or EUA vaccine or treatment must be Government. 
Does FDA have a plan to allow states or health care providers, 
including payers, to purchase vaccines and treatments to help 
put purchasing decisions back in the hands of Americans rather 
than Government?

    Dr. Califf. Senator Burr, each of our major product areas, 
drugs, devices, biologics is working with the industry to be 
transitioning. A number of them already have transitioned to 
full----

    Senator Burr. You understood what I read in the statement 
was, you actually write into the EUA, only Government can 
purchase these.

    Dr. Califf. That is correct.

    Senator Burr. The law does not restrict anybody else from 
purchasing under an EUA. It is the limitation you put in the 
EUA, correct?

    Dr. Califf. Yes, that is correct.

    Senator Burr. All right. Let's talk about EUAs a little bit 
further. The EUA on antivirals. Did I misstate anything that 
the antiviral EUA states that it should only be prescribed to 
individuals that are at risk?

    Dr. Califf. Right. Pfizer did a robust clinical trial and 
that included people at risk, at higher risk by certain 
factors. We looked at the data. The data were compelling. That 
was the basis for the EUA.

    Senator Burr. The in the EUA says to be prescribed to 
individuals at risk?

    Dr. Califf. Those at high risk. Yes.

    Senator Burr. So does Test and Treat violate the 
restrictions in the EUA if individuals who show up are not at 
risk, test positive, or are given an antiviral?

    Dr. Califf. My interpretation of Test and Treat is it is 
still prescribing paxlovid that is still within the EUA. And so 
only those who meet the risk criteria would be prescribed it.

    Senator Burr. Anybody that does not reach the risk criteria 
would be in violation of the EUA?

    Dr. Califf. I think prescribing, as you know, is a 
complicated area of medical practice. So when you say in 
violation, I am not sure what the legal meaning of that in the 
context of medical practice. But people who are low risk, like 
a 25 year old with COVID and no co-morbidities, would not be 
expected to get benefited and so it wouldn't make sense to 
prescribe it.

    Senator Burr. Was the vice President high risk when she 
took the antiviral?

    Dr. Califf. I am not aware of the vice President's clinical 
status, and as a physician, I wouldn't discuss a person's 
medical history.

    Senator Burr. Ms. O'Connell, just last week, HHS announced 
that it had found $10 billion in the couch. Out of those funds 
previously provided for COVID responses, I was surprised and 
frustrated to hear that these funds were overwhelmingly 
repurposed from within ASPR, including the stockpile.

    It is my understanding that over $1 billion will be taken 
from the Strategic National Stockpile. What are we giving up in 
the stockpile so that that $1 billion can be spread across the 
rest of the response?

    Ms. O'Connell. Thank you, Senator. Without additional 
funding, we have been forced to make very difficult decisions, 
make tradeoffs that none of us want to make. And that included 
finding an additional $1 billion from the Strategic National 
Stockpile. That funding would have gone to securing the 
purchase of domestically manufactured surgical gowns in order 
to meet the requirement that the national stockpile has for 
surgical gowns, so we are going to be short there. We also are 
jeopardizing our ability to maintain the PPE at the levels that 
we currently are. Every piece of equipment we have is 
warehoused. The warehousing costs money.

    Senator Burr. Ms. O'Connell, you are the ASPR, and by 
statute, you are supposed to lead a pandemic. I am going to 
turn to you. Tell me what the plan is.

    Ms. O'Connell. Well, the Administration put forward a plan 
on March 3rd with how it would spend the additional funds that 
it was repurposing----

    Senator Burr. I understand how you would spend it. Tell me 
what the plan is to get to some endgame in COVID.

    Ms. O'Connell. Our plan involves short term, providing, 
making sure all Americans have access to the critical tools 
needed to protect themselves. Medium term, making sure that we 
have access to supplies moving forward. Investing in domestic 
manufacturing so we are not caught short footed like we were in 
March 2020.

    Then long term, this research and development that we have 
talked about to get us to the next generation of vaccines that 
won't require multiple boosts, to get us to therapies that can 
be prescribed for everybody. That is where we need to go.

    Senator Burr. If you can take the outline you just 
presented to me and get somebody from the Administration to 
fill in in between the action steps that are going to be taken, 
you might have a plan. Thank you, Madam Chair.

    The Chair. Senator Paul.

    Senator Paul. Dr. Fauci, the Government recommends 
everybody take a booster over age five. Are you aware of any 
studies that show a reduction in hospitalization or death for 
children who take a booster?

    Dr. Fauci. Right now, there is not enough data that has 
been accumulated, Senator Paul, to indicate that that is the 
case. The--I believe that the recommendation that was made was 
based on the assumption that if you look at the morbidity and 
mortality of children within each of the age groups, 0 to 5, 5 
to 11----

    Senator Paul. Right. So there are no studies, and Americans 
should all know this, there are no studies on children showing 
a reduction in hospitalization or death with taking a booster. 
The only studies that were permitted, the only studies that 
were presented were antibody studies.

    They say if we give you a booster, you make antibodies. 
Now, a lot of scientists would question whether or not that is 
proof of efficacy of a vaccine. If I give you 10 or if I give a 
patient 10 mRNA vaccines and they make protein each time or 
they make antibody each time, is that proves that we should 
give ten boosters, Dr. Fauci?

    Dr. Fauci. No, I think that is somewhat of an absurd 
exaggeration, Senator Paul.

    Senator Paul. Well that is the proof that you use. Your 
committees use that. That is the only proof you have to tell 
children to take a booster so that they make antibodies. So it 
is not an absurdity. You are already at like five boosters for 
people. You have had two or three boosters. It is like, where 
is the proof?

    Now, I think there is probably some indication for older 
folks that have some risk factors. For younger folks, there is 
not. But here is the other thing. There are some risk factors 
for the vaccine. So the risk of myocarditis with a second dose 
for adolescent boys, 12 to 24, is about 80 and 1 million.

    This is both from the CDC and from the Israeli study. It is 
also in the VAERS study, remarkably similar, for boys, much 
higher from boys than girls, and much higher than the 
background. The background is about 2 per 1 million. So there 
is risk and there are risk. And you are telling everybody in 
America just blindly go out there because we made antibodies. 
So it is not an absurd corollary to say if you have 10.

    In fact, you probably make antibodies if you get a 100 
boosters, all right. That is not science. That is conjecture. 
And we should not be making public policy on it.

    Dr. Fauci. So, Senator Paul, if I might respond to that, we 
just heard in his opening statement, Ranking Member Burr talk 
about his staff who went to Israel. And if you look at the data 
from Israel, the boosts, both the third shot boost and the 
fourth shot boost, was associated with a clear cut clinical 
effect, mostly in elderly people, but also as they gathered 
more data, even in people in the 40's and the 50's. So there is 
clinical data----

    Senator Paul. But not in children. Well, see, here is the 
thing is, you are not willing to be honest with the American 
people. So, for example, 75 percent of kids have had the 
disease. Why is the CDC not including this in the data? You can 
ask the question. You can do laboratory tests to find out who 
has had it and who hasn't had the disease.

    What is the incidence of hospitalization and death for 
children who have been infected with COVID subsequently going 
to the hospital and dying? What is the possibility if your kid 
has had COVID, which is 75 percent of the country has had 
COVID, what is the chance that my child is going to the 
hospital or dying?

    Dr. Fauci. If you look at the number of deaths in 
pediatrics, Senator, you can see that there are more deaths----

    Senator Paul. Of people who have had it--of people who have 
had the disease.

    Dr. Fauci. Senator, we also know from other studies that 
the optimal degree of protection when you get infection is to 
get vaccinated after infection. And in fact, showing 
reinfection in the era of Omicron and the sub-lineages, that 
vaccinated----

    Senator Paul. But you can't answer the question I asked. 
The question I asked is how many kids are dying and how many 
kids are going to the hospital who have already had COVID? The 
answer may be zero, but you are not even giving us the data 
because you have so much wanted to protect everybody from all 
the data because we are not smart enough to look at the data.

    When you released data earlier, when the CDC released the 
data, they left out the category of 18 to 49 on whether or not 
there was a health benefit for adults 18 to 49. Why was it left 
out? When critics finally complained, it was finally included 
because there was no health benefit from taking a booster 
between the 18 to 49 in the CDC study. Another question for 
you.

    The NIH continues to refuse to voluntarily divulge the 
names of scientists who receive royalties and from which 
companies. Over the period of time, from 2010 to 2016, 27,000 
royalty payments were paid to 1,800 NIH employees. We know that 
not because you told us, but because we forced you to tell us 
through the Freedom of Information Act.

    Over $193 million was given to these 1,800 employees. Can 
you tell me that you have not received a royalty from any 
entity that you ever oversaw the distribution of money in 
research grants?

    Dr. Fauci. Well, first of all, let's talk about royalties.

    Senator Paul. That is the question. No, that is the 
question. Have you ever overseen or received a royalty payment 
from a company that you later oversaw money going to that 
company?

    Dr. Fauci. You know, I don't know as a fact, but I doubt 
it.

    Senator Paul. Well, here is the thing is, why don't you let 
us know? Why don't you reveal how much you have gotten and from 
what entities? The NIH refuses. We ask them. We ask them. The 
NIH--we ask them whether or not who got it and how much. They 
refused to tell us. They send it redacted. Here is what I want 
to know. It is not just about you.

    Everybody on the vaccine committee. Have any of them ever 
received money from the people who make vaccines? Can you tell 
me? Can you tell me if anybody on the vaccine approval 
committees ever received any money--vaccines--?

    Dr. Fauci. Are you going to let me answer the question? 
Sound bite No. 1. Are you going to let me answer a question? 
Okay. So let me give you some information. First of all, 
according to the regulations, people who receive royalties are 
not required to divulge them even on their financial statement, 
according to the Bayh-Dole Act.

    Let me give you some example. From 2015 to 2020, I--the 
only royalties I have was my lab and I made a monoclonal 
antibody for use in vitro reagent that had nothing to do with 
patients. And during that period of time, my royalties ranged 
from $21 a year to $17,700 a year, and the average per year was 
$191.46.

    Senator Paul. It is all redacted, and you can't get any 
information on the NIH----

    The Chair. Senator Paul, your time----

    Senator Paul. We want to know whether or not people got 
money from the people who made the manufacturing----

    The Chair. Senator Paul, your time is long over expired. I 
gave you an additional two and a half minutes. The witness has 
responded. We are going to move on.

    Senator Sanders.

    Senator Sanders. Thank you all very much for being here. 
One of the concerns that I have in terms of where we are now 
and where we might be in the future, is that the American 
people do not have ready access to the information they need as 
to how they can receive the best treatment available of a 
COVID.

    An example of a 60 year old gentleman wakes up in the 
morning, has bad symptoms, tests positive for COVID. I worry 
that that person and millions of them may not even know that 
there are therapeutics out there that can help them, that they 
may have 5 days, only five--that they have to take it within 
the first 5 days of symptoms.

    Or can you tell us, Dr. Walensky, what we can do to make it 
easier for people to get the therapeutics that they need?

    Dr. Walensky. Thank you, Senator Sanders. This is key in 
terms of our distributing and equitably distributing not only 
our therapeutics, but in fact, even before therapeutics, 
communities and at risk people need to understand to do a test 
because that is the gateway into getting these therapeutics.

    We need to have testing available, accessible. A lot of 
what the ASPR has done in distributing home tests. We need to 
have therapeutics available in at risk communities across the 
country and then we need to do public health campaigns so that 
people understand that a test should be done and that they have 
access to these therapeutics.

    Senator Sanders. But the concern is that in some of them, 
at least, you should take the drug within five--the first 5 
days. Are you confident that we have a system that if somebody 
wakes up, they are going to have to get a prescription from a 
doctor, do they have a doctor that they can get a prescription 
from within the first few days? Do they know where to get the 
drug, or--and do they have the money to pay for that drug?

    Dr. Walensky. The drugs are free. The tests are free. But I 
am not sure that everybody knows that. And we have expanded our 
rollout and accessibility of paxlovid. But I will also say that 
just like early in our vaccine work, we have seen inequities in 
how that paxlovid has been used.

    We will have more data forthcoming from the CDC soon on 
that. But we have a lot of work to do in the equitable 
distribution of paxlovid and to getting the education to the 
communities, to community health centers, to physicians in 
rural areas.

    Senator Sanders. Should our goal be, it seems to me, to 
make it nice and simple that if somebody is feeling ill, if 
somebody has COVID, they can dial a 1-800 number and get the 
drug as quickly as possible. Is that the goal that we striving 
for?

    Dr. Walensky. Yes, we need to do that under the EUA and 
with the caveat that there are some things like renal 
insufficiency or drug interactions that need to be assessed. We 
need to make sure that those assessments are complete as well.

    Senator Sanders. Okay. I want to change course a little bit 
here and touch on a subject that I don't think we talk about 
enough as a Nation, and that is that we have a significant 
shortage of doctors, nurses, pharmacists, dentists, other 
health care providers.

    That shortage has only been exacerbated as a result of 
burnout related to COVID. I know that is not necessarily within 
your jurisdiction, but you can give us--can you give us some 
thoughts about how serious that shortage of medical personnel 
is and what we might want to do to address it?

    Dr. Walensky. Yes, I think it is key. Not only medical 
personnel, but public health personnel. The Beaumont Foundation 
surveyed demonstrated that we are about 80,000 public health 
workers in deficit right now and that we need to not only 
retain the ones who have stepped up to the plate during the 
COVID-19 pandemic, but we need to foster and invest in future 
public health workers as well as health care workers.

    That includes loan repayment and includes investing in the 
time and making sure we are competitive from salary standpoint 
so that we can retain the best of the best in these fields.

    Senator Sanders. Okay. Let me ask Dr. Califf a question. 
Senator Paul raised the issue about money and so forth. I look 
at it, his questions are valid, but I look at it a slightly 
different way. I am concerned, and you correct me if I am wrong 
here, Moderna, who helped create one of the important vaccines 
that is saving lives, received, as I recall, about $2.5 
billion, I think, during the Trump administration.

    My understanding, and you correct me if I am wrong, is that 
the gentleman who is the head or was the head of Moderna 
recently received a golden parachute of some $800 million, $2.5 
billion of Federal funding to develop the drug, Moderna makes 
huge amounts of money, this guy receives $800 million a golden 
parachute. Am I right about that?

    Dr. Califf. I am not aware of that. It is not something I 
would keep up with, particularly in this job.

    Senator Sanders. Not something you would keep up with. The 
Head of the Food and Drug Administration, you would not be 
concerned that a guy--when we are producing and trying to get 
vaccines out to people, it was--I am corrected, it is $926 
million golden parachute. If that is true, if the Federal 
Government gives a company $2.5 billion and a short time later 
the head of the company gets a $900 million golden parachute, 
that is not a concern to you?

    Dr. Califf. No, I didn't say it was not a concern. I said 
it is not something I keep up with in daily life. What I am 
very concerned about is the equitable distribution of vaccines 
that save lives and antivirals that save lives. we are not 
reaching the goals that we need.

    Senator Sanders. Well, maybe, I think we need, I would hope 
everybody agrees that we need the financial resources to make 
sure that everybody has the vaccines. But if one guy ends up 
with $900 million, rather than using that money to get out the 
medicine we need, the vaccines we need, out to the people, 
doesn't make a whole lot of sense to me. Thank you very much, 
Madam Chair.

    The Chair. Senator Romney.

    Senator Romney. Thank you, Madam Chair. Senator Sanders, I 
am one of those that doesn't understand why golden parachutes 
are provided by boards ever. Doesn't make any sense to me to 
pay someone to leave a ton of money. Not that you change the 
law. I am just saying I can't figure out why a board would do 
such a thing. Worth looking into.

    I appreciate the work that each of you do and the effort 
that you make to help the people of our Country have healthier 
lives and have long lives. I realize that science is not all 
knowing. And from time to time, there are mistakes. That is the 
nature of humankind. But I appreciate very much the work that 
you do and want to express my appreciation personally for that.

    I do have an issue that is tangentially related to what you 
do but related to the Administration of which you are you are 
part of. And that is that back in March, I had a number of 
other Members of this Committee sent a letter to the 
Administration asking for an accounting of how the prior COVID 
relief money had been spent, and then also how new money that 
was being requested for emergency supplemental would be spent.

    As part of that response to that letter, the Administration 
released a statement regarding the lack of potential funding 
for--going forward. I want to read a couple of excerpts from 
that letter. One is, ``the Federal Government is unable to 
purchase additional lifesaving monoclonal antibody treatments 
and will run out of supply to send to states as soon as late 
May.

    The Federal Government cannot purchase sufficient 
quantities of treatments for immunocompromised individuals, and 
the Federal Government will be unable to sustain the testing 
capacity we built over the last 14 months.'' And then 
continuing, ``ending the purchase of monoclonal antibody 
treatment, scaling back state and territorial allocations, 
inability to purchase additional oral antiviral pills, 
inability to purchase new antivirals, scaling back planned 
purchases of preventative treatments.''

    Again, what the Administration provided to us in Congress 
in response to our letter was that the Administration would be 
unable to purchase therapeutics and monoclonal antibodies, 
unable to purchase. Madam Chair, I would ask unanimous consent 
that this release from the Administration be entered into the 
record.

    The Chair. Without objection, so ordered.

    [The following information can be found on page 81 in the 
Additional Material:]

    Senator Romney. Now, in good faith, I and a number of other 
people worked over a number of months with Members of this 
party and across the aisle to develop a supplemental bill 
providing that $10 billion to address this inability to 
purchase these things without the $10 billion.

    But you can imagine my surprise when I find out that on 
June 8th, the Federal Government did, in fact prioritize $5 
billion for the purchase of additional vaccines, $4.9 billion 
for therapeutics, and $300 million for additional monoclonal 
antibodies. But it choose not to do so in February, March, 
April, or May, again saying they had inability to do so. So the 
Administration has recklessly and unilaterally spent taxpayers' 
money. We have runaway inflation.

    But instead of taking a real inventory of funds they had at 
their disposal, they said, hey, we need more money. Now, 
Washington operates on a relationship of trust between the 
respective parties, the Administration, and Congress. For the 
Administration to provide information to us that was patently 
false is something which dramatically attacks that trust, which 
I have, Members of my party have, Members of both parties have.

    I hope that there is an appreciation that for the 
Administration to say they could not purchase these things and 
then after several months divert some funds and then purchase 
them is unacceptable and makes our ability to work together and 
have confidence in what we are being told very much shaken to 
the core.

    I would ask this question. If the Administration knew in 
March that it was feasible to buy these things, do you know why 
they waited to actually do so? Any one of you can respond. Dr. 
Fauci, you are on the hot seat on the camera, so we will give 
it to you. I hope you feel better, by the way.

    Dr. Fauci. Yes. Thank you very much. Senator. I think that 
question is probably best given to the Assistant Secretary Dawn 
O'Connell.

    Ms. O'Connell. Thank you, Dr. Fauci. Thank you, Senator 
Romney. And thank you for your support in trying to get 
additional funds freed for us to manage the COVID response.

    Senator Romney. Yes, I didn't realize that they weren't 
needed. I wouldn't have worked as hard with Leader Schumer and 
with others over many weeks and intensive negotiations and gone 
to my colleagues and told them these moneys were necessary had 
I been told that, in fact, they weren't necessary.

    It is--and I know money is--you are going to tell me that, 
hey, we needed to spend money and other things, we had to 
divert it, but that we could have been told. But we weren't 
told that. We were told, we could not purchase therapeutics or 
monoclonal antibodies. And now you have.

    Ms. O'Connell. We had to do so with significant tradeoffs. 
Tradeoffs that we--none of us wanted to make as----

    Senator Romney. But we should have been--we are part of 
Congress. When you are asking us for $10 billion, we should be 
apprised of what those tradeoffs are and have that discussion 
and help make that decision together. You shouldn't be able to 
say, hey, we are looking at tradeoffs, we are not going to tell 
you about them, just give us some more money. Isn't that not 
unacceptable in a relationship between the Administration and 
Congress?

    Ms. O'Connell. We have worked hard to be transparent with 
our funding needs. And again, I have appreciated the support 
you have given us in trying to unlock additional funds. Making 
the decision to spend this money, taking it away from critical 
programs is absolutely difficult, and it is something we didn't 
think was acceptable. We are now at a point, because Congress 
has not given us additional funding, that we have had to do 
these things that are unacceptable.

    Senator Romney. Well we--my time is up. I will just say we 
agreed on one word and that is, unacceptable. Thank you.

    Madam Chair.

    The Chair. Senator Lujan.

    Senator Lujan. Thank you, Madam Chair. Now, as New Mexico 
continues to battle the COVID-19 pandemic, we are now also 
battling the largest wildfires the state has ever seen. 
Wildfires that were started as a controlled burn by the Federal 
Government and two fires that got out of control.

    While I very much respect that people keep telling me 99.8 
percent of control burns are always under control, I am more 
interested in the 0.2 percent that destroyed our state. These 
dual crises have stretched the resources of the state to the 
breaking point.

    As New Mexicans flee natural disaster, in many cases taking 
only the belongings they can carry, they face increased 
exposure to COVID-19 virus, which has run rampant in the 
congregate settings being used to house evacuees. Assistant 
Secretary O'Connell, how are you coordinating to support New 
Mexico's COVID-19 response in light of the wildfires?

    Ms. O'Connell. Thank you, Senator Lujan. And we continue to 
keep the people of New Mexico who are currently experiencing 
these two tragedies in our minds. The Secretary on May 9th, 
realizing the extent of what was happening in New Mexico, 
declared a public health emergency, and that public health 
emergency freed up flexibilities for the health care system 
there in order to respond in the emergent condition, including 
providing telehealth for Medicare beneficiaries, freezing the 
Medicaid rolls so no one would be--would lose insurance during 
this time of tragedy.

    At ASPR, we continue to support through our hospital 
preparedness program, New Mexico's Coalition, a healthcare 
coalition, which was responsible for evacuating many of the 
hospitals and long term care facilities, nursing homes. And so 
we continue to work closely with our colleagues there to make 
sure that everybody is safe and accounted for. We also run the 
Medical Reserve Corps, and the Medical Reserve Corps in New 
Mexico has been activated in order to respond to the wildfires.

    We continue to support our colleagues out there through 
that effort. And we have been in close contact with FEMA. We 
have offered virtual support to FEMA out in New Mexico. And 
wherever we can be helpful, we are trying to be. And we have 
not stopped our COVID response. We are continuing to make 
vaccines and therapeutics and tests available to those in New 
Mexico that need them.

    Senator Lujan. Assistant Secretary O'Connell, this is a 
follow-up to the solid answer with programs that have been made 
available. The follow-up is, how is HHS ensuring that these 
resources are being communicated to those impacted, especially 
given the current lack of cellular and broadband service in 
many regions of the state, which is nonexistent in these 
communities?

    Ms. O'Connell. Thank you, Senator. We continue to have 
boots on the ground in New Mexico. We have got regional 
emergency coordinators in the state that continue to 
communicate with city and local leaders. We also have our CMS 
representatives who are making sure that the Medicare and 
Medicaid provisions are being well communicated to those 
beneficiaries, and everything we can. We have got several 
regional representatives leading this effort for us in New 
Mexico and continue to rely on their ability to communicate on 
the ground.

    Senator Lujan. Now, I said earlier that many families were 
forced to evacuate. They were living in congregate settings. 
But they were not eligible for the fourth COVID-19 vaccine. Dr. 
Walensky, will you commit to reconsidering CDC guidelines for 
the fourth COVID-19 shot to account for the risks of people 
fleeing from natural disasters who are forced into compact 
living conditions?

    Dr. Walensky. Thank you, Senator Lujan. And let me add my 
support and strength to the people of New Mexico who are 
experiencing these natural disasters. Maybe if I could just 
back up and let you know some of the things that CDC has been 
doing in including drafting recommendations and documents like 
wildfire smoke and COVID-19, public health strategies to reduce 
exposure to wildfire smoke during the COVID-19 pandemic.

    Going to a public health--a public disaster shelter during 
COVID-19. We have documents. We are providing technical 
assistance on the ground, as well as public health 
communication, exposure, assessment, and epidemiologic data in 
order to support the efforts ongoing there. And we have been 
working in our National Center for Environmental Health over 
the last decade to support health Departments to prepare for, 
respond to, and recover from wildfire disasters.

    Specifically to your question about booster shots for this 
population, CDC is committed to continuously reviewing the data 
on the safety and efficacy and need for booster shots. We do so 
all the time. We did--we strengthened our recommendation for 
those--for fourths shots for those over the age of 50.

    Should we see a need, safety and efficacy, we will continue 
to expand, but we certainly want to follow the data as we do 
so.

    Senator Lujan. I appreciate that, Dr. Walensky. Madam 
Chair, as my time expires, I have a couple of questions also 
made into the record. But I am hoping that that is a long way 
of saying yes definitively to making these changes. Not all of 
us are over 50. There were a lot of--and I just turned 50 so I 
can say--there are a lot of young families and children and 
grandchildren who are in these settings above the age of five, 
where we had them all in one place.

    When we would get scares of spread or those that are tested 
positive, it is a perfect place to help provide additional 
support in a community where it is hard to get to and we don't 
always have the availability.

    This is an area that I will continue to push, and I am 
hopeful we can find a positive remedy here because New Mexico 
is not going to be the only state facing natural disasters.

    We are in that season right now. I am hopeful that there 
will be some positive direction in how we can take care of more 
people. I thank you very much. Madam Chair, yield back.

    The Chair. Senator Cassidy.

    Senator Cassidy. Thank you all for being here. Thank you 
for your efforts on part of our Country. And, of course, what 
we are hearing is that there has to be more money appropriated 
and dire consequences if not allocated. But that begs the 
question of the stewardship of the current dollars being 
allocated. Now, and so I personally think, and I think others 
agree that physically showing up to work is important. So, Ms. 
O'Connell, how many days in the last month were you physically 
in your office?

    Ms. O'Connell. The vast majority of those days.

    Senator Cassidy. Can you give me a number? I mean, it is so 
frustrating. I have never been able to get a straight answer 
from one of you as to how many days you are in the office and 
what is the return to work policy. So just give me--how many 
days is past week? And if it is five, I am pleased. How many 
days in the last week?

    Ms. O'Connell. The HHS has continued its return to work 
starting in April. We are bringing everybody back.

    Senator Cassidy. No. How many days have you personally been 
in your office this last week?

    Ms. O'Connell. Multiple days, of course.

    Senator Cassidy. Okay, this is not hard to remember. It is 
only 5 days. And if you dissemble, it makes me think that you 
have not been in the office, and you don't want to give me a 
straight answer. I am speaking on behalf of the American people 
who are paying taxes and a lot of salaries, and they think 
people aren't showing up to work. How many days in the last 
five were you physically in your office?

    Ms. O'Connell. We continue to work----

    Senator Cassidy. Okay, Dr. Califf. How many days in the 
last five were you physically in your office?

    Dr. Califf. I was down in North Carolina Monday and Tuesday 
because the 18 year olds that you met at my confirmation are 
graduating from high school----

    Senator Cassidy [continuing]. give me 5 days. When there 
wasn't a family issue, did you go the previous week?

    Dr. Califf. I--five, every day. When I have been in 
Washington and not on business travel, I go into the office at 
White Oak.

    Senator Cassidy. Okay, I get that. Every day you are in 
Washington does not mean that when you are--that you are here. 
So are you either doing business travel as part of FDA, and but 
if not, you are physically in your office?

    Dr. Califf. Yes. Except for family events like----

    Senator Cassidy. Dr. Walensky, how many days in the last 
five were you physically in your office?

    Dr. Walensky. I am not in my office today, but I feel like 
I am working on----

    Senator Cassidy. No, no, not feel like, how many----

    Dr. Walensky. I am working onsite. I have been in--I have 
been traveling, so I have been in my office two, and I have 
been traveling for two. One of them I was, in fact, in your----

    Senator Cassidy. So, in the last month, do you typically 
work out of Washington, or do you work out of your home in the 
Northeast?

    Dr. Walensky. We are an agency at CDC----

    Senator Cassidy. Boy, it is really hard to get a straight 
answer.

    Dr. Walensky [continuing]. work--on the job work. And in 
fact, some of our work is in your state when you ask us to 
deploy.

    Senator Cassidy. I get that. I get that. But let me read 
something from Elon Musk, who is asking Tesla workers to go 
back to 40 hours a week. ``The more senior you are, the more 
visible you must be. That is why I have lived in the factory. 
There are companies that don't require this. When was the last 
time they shipped a great product? You don't ship great 
products by phoning it in.''

    There is a perception that your agencies are 
underperforming. Now, if you are underperforming and you are 
not showing up, that is not good stewardship. Now, let me ask, 
because I understand that HHS has a policy which is allowing 
people to come back every 2 weeks for 8 hours a day.

    Now, do any of you have a policy in your agency which is 
different than this pilot program of only requesting 8 hours in 
the office every 2 weeks? Ms. O'Connell, yes, no.

    Ms. O'Connell. We require more than that in the office. 
Thank you.

    Senator Cassidy. Dr. Califf.

    Dr. Califf. Yes. I mean, we have talked a lot--we have a 
pilot program, which adjusts every individual to the optimal 
working situation for them to be productive.

    Senator Cassidy. Yes, so that tells me that it is really up 
to the individual to decide----

    Dr. Califf. No. It is up to the individual, their 
supervisor----

    Senator Cassidy. In your laboratories, does every 
laboratory worker show up every day physically? Because in a 
laboratory you got to be there.

    Dr. Califf. Well, Senator Cassidy, we are both doctors. You 
know, everyone who has a job to do in the laboratory that 
requires them to be there is there every day. But you also know 
that when you analyze data----

    Senator Cassidy. Analyze data. If you have got a lab tech, 
the lab tech has to be there.

    Dr. Califf. Absolutely.

    Senator Cassidy. Is the lab tech there every day?

    Dr. Califf. Yes.

    Senator Cassidy. I am sorry to be insistent, but it is hard 
to get an answer.

    Dr. Walensky.

    Dr. Walensky. Yes. Laboratory. The people who need to be in 
our labs are working in our labs. But I will also say that----

    Senator Cassidy. Are they are working full time, 40 hours a 
week?

    Dr. Walensky. When I have a data need at midnight on a 
Saturday night, people are working. There are not necessarily 
in the workplace, but they are working.

    Senator Cassidy. I get that. But as a lab employee who is 
only productive if they are in a lab, are they working 40 hours 
a week?

    Dr. Walensky. People who need to be onsite in the lab or 
onsite in the lab, people who are deployed to the field, 
deployed nationally, they are working outside the workplace.

    Senator Cassidy. Yes, but I think there is a lot--I have 
got 18,000 employees and I can't believe they are all deployed. 
You know, I want to finish with this. You are asking for more 
money. Ms. O'Connell, you suggested that there is tough 
tradeoffs that have to be made.

    That, by golly, if you don't give us the money, something 
is going to be sacrificed. I suspect you haven't laid off a 
single person. I also know that you have the ability to monitor 
the at homework history as to whether or not they are actually 
logging on. I would be interested in seeing that data.

    But you have got maintenance people who haven't been 
employed for two and a half years, and I suspect they have not 
been laid off. But you are asking for more taxpayer dollars, 
asking tough choices for that family at home trying to make 
their balance work, and yet it seems as if there is not a tight 
ship being run. I am over. I apologize. I yield.

    The Chair. Senator Hassan.

    Senator Hassan. Thank you, Madam Chair, and Ranking Member 
Burr, for this hearing. And thank you to all of our witnesses 
today for being here and for your service. Dr. Califf, I want 
to start with a question to you about the infant formula 
shortage. I want to follow-up on comments that you made at 
start of today's hearing.

    When you testified in front of this Committee 3 weeks ago, 
you told me that within 2 months we should be, ``beyond normal 
and with a plethora'' of infant formula. Then, as Chair Murray 
noted, Abbott announced last night that its formula production 
plant in Sturgis, Michigan, had flooded, which will, ``likely 
delay production and distribution of new product for a few 
weeks.''

    But despite that setback, as I understood your answer to 
Chair Murray earlier, you still hope to have a ``super-supply'' 
of baby formula on shelves in the next 2 to 3 weeks, which I 
take to mean more formula available than was typical prior to 
the Sturgis plant shutting down. So is that correct?

    If so, how do you expect to achieve that goal with Abbott 
saying that the Sturgis plant will remain shut down for another 
few weeks?

    Dr. Califf. Yes, that is correct, with two assumptions. One 
is that the company stuck to the production data that they have 
given us, which they have already demonstrated they can do. The 
second is there is no other natural disaster like the 
unexpected one last night.

    But we have--one thing that has happened is we now get 
production data from all the companies involved. It adds up to 
a surplus relative to the needs that are demonstrated by the 
number of babies using formula over the last several years. So 
we should be over that number easily, and that doesn't count 
the fly formula coming in.

    Senator Hassan. What you are indicating to me is that other 
producers have been increasing their production.

    Dr. Califf. Absolutely. All of the manufacturers in the 
U.S.--remember there were only four, which is another issue. 
They have all stepped up and are running their plants 24 by 7 
and the numbers show it.

    Senator Hassan. Okay. During the last hearing, you 
indicated that an interagency committee has developed a 
comprehensive plan to get this super supply on the shelves. 
Will you provide that written comprehensive plan to my office 
after this hearing?

    Dr. Califf. Well, we will provide our plan, yes.

    Senator Hassan. Thank you. And will your--and once we have 
looked at the plan, we may want to follow-up with you all for a 
brief. That work for you.

    Dr. Califf. I understand.

    Senator Hassan. Okay. Second question is to Dr. Fauci and 
Assistant Secretary O'Connell. Dr. Fauci, for nearly 2 years I 
have been asking you when a COVID-19 vaccine for children under 
age five would be ready and they are now nearly there.

    While vaccines have been available for older individuals 
for quite some time, the infant and toddler vaccine has been 
much slower, leaving many families with young children in a 
precarious position as they try to keep their kids safe.

    Do you anticipate that children ages 6 months to 5 years 
will be able to get their first dose by the end of this month?

    Dr. Fauci. Well, again, Senator, thank you for that 
question. But I do not want to get ahead of the advisory 
committee. You heard from my opening statement and that of 
Commissioner Califf that in fact, the VRBPAC, which is the 
advisory committee to the FDA, made a recommendation, a 
positive recommendation for an emergency use authorization.

    The next step would be the CDC, in which Dr. Walensky's 
advisory committee will likely--in fact, likely, I am sure they 
will, look at the data and make a recommendation. And then at 
the end of the day, it will be the Director of the CDC's 
obligation and duty to make a recommendation. I hope it does.

    But we never want to get ahead of the data. The data looked 
very, very good, Senator. I mean, as you heard from 
Commissioner Califf, the data looked really quite good. I 
anticipate that that is going to happen, but it would not be 
appropriate for me to get ahead of my CDC colleagues.

    Senator Hassan. Got it. And just briefly, Dr. Walensky, 
what does the timeline look like for that review?

    Dr. Walensky. We are going to review tomorrow and working 
on Saturday as well, because we understand the urgency of this 
for American parents and recognize that even on a holiday 
weekend, we need to be doing this to get it to American 
parents.

    Senator Hassan. Right. Thank you. Assistant Secretary 
O'Connell, how will the Administration work to educate parents 
on the safety of this vaccine and help as many families as 
possible to get their youngest children vaccinated?

    Ms. O'Connell. Absolutely. Assuming that the decisions come 
through, as we may expect the approval and recommendation, we 
have made available 10 million doses for states to order, and 
the vast majority of them have placed those orders that will 
allow us to ship out as soon as an EUA, should it come, comes 
with the expectation that parents can begin getting their 
children vaccinated next week. That is our intention.

    Senator Hassan. Thank you very much. Thank you, Chair 
Murray.

    The Chair. Senator Collins.

    Senator Collins. Thank you. Dr. Califf, we know that the 
baby formula crisis was exacerbated by the fact that people 
weren't working in the mailroom and that inspectors were not 
working a normal schedule in the baby formula plants. In 
response to a question from Dr. Cassidy, you referred to a 
return to work pilot program.

    How many FDA employees are part of that pilot program as 
opposed to working full time right now in the office or in the 
field?

    Dr. Califf. Well, of course, as you allude to, they are all 
working full time. I will have to get back to you on the exact 
number. But it is a majority are in the pilot program in one 
way or another. The goal is to adjust to the maximum 
productivity and job satisfaction.

    Senator Collins. But they can't do their work if they are 
not present.

    Dr. Califf. Well, if it is a job that they will do their 
work best. If they are present, they will be--they are required 
to be there.

    Senator Collins. Well, I would really appreciate getting 
the data on that.

    Dr. Califf. I look forward to bringing the data to you. I 
think it is going to be interesting. I will just say I was at 
Google before this. As opposed to Elon Musk, I think Google is 
doing pretty well with their hybrid program.

    Senator Collins. Let me switch to another issue. I am very 
alarmed by the response that I heard to Senator Sanders' 
question, where he said you should be able to just dial 1-800 
to get a prescription.

    The Administration has pushed very hard on the Test and 
Treat program so that you test positive, you get paxlovid right 
off. And here is why I am concerned. The first is that paxlovid 
interacts in a negative way with a lot of commonly taken 
medications, including blood thinners, for example.

    Second, just on Tuesday, Pfizer announced it was halting 
enrollment in a trial for paxlovid in standard risk patients, 
both vaccinated and unvaccinated, after its study revealed that 
the treatment was not effective in reducing symptoms in that 
group.

    What we heard today and what the Administration seems to be 
pushing is this notion that paxlovid is going to be the answer 
if you have a positive COVID test. Do you really calling 1-800 
is a good way to handle the prescription of a drug that has 
been found to not be effective for standard risk patients and 
has interactions with a lot of medications?

    Dr. Califf. Thank you for asking that question. The place I 
agree with Senator Sanders is that we have a vastly inequitable 
distribution of lifesaving vaccines and antivirals. Now, 
particularly, I know you are from a predominantly rural state. 
Particularly rural people are suffering because they have lower 
vaccination rates and less access.

    I don't agree that an individual just calling a 1-800 
number with no clinician involved is a good idea. First of all, 
because the drug is not indicated except in people who are at 
higher risk. It is not that it is totally ineffective in lower 
risk. If you look at those data, I love to go over those with 
you later, but it is not worth the prescription. In that case, 
the benefits are minimal.

    I think there does need to be an intermediary, either a 
pharmacist or a physician, who can look at the risks and the 
drug interactions and make a good judgment. But the concept is 
right that having to find a physician, get an appointment, can 
take over 5 days for many Americans. We have to have a system 
that deals with that issue.

    Senator Collins. Dr. Walensky, David Leonhart recently 
wrote in The New York Times that while masks can work, the 
evidence suggests that broad mask mandates have not much to 
reduce COVID caseloads over the past 2 years. And in fact, he 
says that daily average cases per capita during last winter's 
surge were practically the same in counties and states that had 
mask mandates and those that did not.

    We have seen that Hong Kong, despite almost universal mask 
wearing, recently endured one of the world's worst COVID 
outbreaks. There are proven ways to lower hospitalizations and 
deaths.

    We know that vaccinations, therapeutics, but mask mandates 
have contributed to a breakdown of trust in public health 
officials given the scant evidence that they actually lower 
caseloads. What specific data has the CDC examined that 
demonstrate that broad based mask mandates lead to lowered 
caseloads, because I can't find any.

    Dr. Walensky. Thank you, Senator Collins. I actually 
believe that that is a piece that has undergone substantial 
criticism for moving forward.

    But I will say that there are numerous studies that have 
demonstrated--and we have to look at this over time, because 
there are secular trends as to when these mask mandates have 
occurred, there are population and aggregate anonymized data 
that have demonstrated decreased rates of disease when mask 
mandates have been put in place earlier in the pandemic.

    We have to control for all of the things as to what has 
been open, what interventions have been available. But there 
have been other studies for certain to refute those data. Thank 
you.

    The Chair. Senator Smith.

    Senator Smith. Thank you very much, Chair Murray, and 
thanks to all of our panelists for being here today. I am going 
to focus my questions on--questions of data and data sharing 
and how that risks--how that reflects our ability to respond to 
the pandemic. But I just want to, before I do that, I want to 
reinforce the comments that Chair Murray made at the beginning 
of this hearing, that we are making progress on the pandemic, 
and we are in a much better position than we have been.

    But it is essential that we have got sustained resources so 
that we are ready as we look to whatever comes next with this 
pandemic. I just want to associate myself with Chair Murray in 
urging my colleagues to support the funding that we need so 
that our COVID response can continue.

    I appreciate very much my colleagues, Senator Cassidy and 
Senator Collins and their work on accountability, but I just 
want to ask you all a simple yes or no question. Has the work 
of your agency been hampered in any way by people not being in 
the office? Could you just say just yes or no?

    Dr. Walensky. No.

    Dr. Califf. No.

    Ms. O'Connell. No.

    Senator Smith. Dr. Fauci.

    Dr. Fauci. No.

    Senator Smith. Okay. Thank you very much. Dr. Walensky, I 
want to bring up something that you and I have talked about. 
This has to do with the resolving the issues around sharing 
public health data with tribes. So this is a challenge that I 
think we both are aware of and have been talking about.

    For folks who aren't paying close attention to this, tribal 
epidemiology centers were created by Congress as an essential 
public health authority in Indian Country, and since the 
beginning of the pandemic, they faced real challenges accessing 
public health data through the CDC. I have introduced a bill to 
resolve this issue. I am grateful for the work of my colleagues 
as well on this, especially Senator Lujan.

    Dr. Walensky, as you know, the GAO has issued a report 
outlining recommendations to resolve the issues. I would just 
appreciate knowing--and I know you appreciate the challenges of 
this.

    Can you commit to working with us to make sure that those 
GAO recommendations for the CDC, the report back on that is 
August 31st, 2022, could you please commit us to following 
through on those recommendations?

    Dr. Walensky. Thank you, Senator Smith. I have appreciated 
the conversations I have had with you as well. We are working 
with our tribal epidemiology consortium and meeting with--
Center Consortium, a meeting with them later this month, as 
well as through the summer meeting with the tribes, 
specifically about how best to work for data sharing.

    We are aware of the GAO report and that we have two 
specific items to address, and we are on a track to provide 
timely response to those. But I do want to just comment that 
this is not just a data issue with tribes, but a larger data 
issue at hand. The CDC does not have the authority to request, 
receive, share data in a way that gives us a comprehensive 
overview, not only through CDC and a national forecast, but to 
tribes, to localities, from one county to another.

    We do not have the authority to do so. We have gotten some 
of that through the public health emergency, through the CARES 
Act, where we were able to receive lab data through CMS 
authorities, where we have been able to receive hospital data. 
But it has been really challenging during this pandemic that we 
still have holes in the data that we are able to receive.

    Now as we look to monkeypox and the outbreaks of monkeypox, 
we are again revisiting the challenges that are--that we are 
not able to see all of the data that would be necessary to 
receive and to share so that we can have a coherent response. 
Thank you.

    Senator Smith. Well, Dr. Walensky, you have anticipated my 
next question. I appreciate that. I want to get to that in a 
minute. Just to close out on the tribal data sharing, I would 
just ask that we stay in close touch on this as we approach 
January 20--excuse me, August 31st, so that we can resolve 
this, and those tribal epidemiology centers can have access to 
the data that they are legally required to have.

    Looking more broadly, I am aware that the CDC does have 
challenges with data, and I just want to try to help to tease 
this out a little bit in the few seconds that I have left. For 
example, does the CDC have the authority to require hospitals 
to report their COVID data? And if they do, is that authority 
permanent or is it temporary?

    Dr. Walensky. It is temporary through the public health 
emergency, and it is not CDC's. It is through CMS.

    Senator Smith. Have hospitals been reporting the data 
that--I mean, do we have all the data that we need at this 
moment?

    Dr. Walensky. We do not. We receive the data that CMS has 
the authority to request, but we don't receive all the data 
that we would like to receive.

    Senator Smith. I want to just acknowledge that Senator 
Kaine has a bill which I co-sponsor, the Improving Data in 
Public Health, which would make the crucial improvements that I 
have come to understand we really need to make to strengthen 
data sharing between public health authorities and the CDC and 
the Federal Government more broadly.

    Let's make sure that this data sharing isn't temporary but 
that it is permanent so that we can continue to be responsive 
at the Federal level and have the data so that we all can make 
good decisions about how best to respond to the public health 
challenges that we will continue to have.

    Dr. Walensky. We are very grateful for your support and 
Senator Kaine on that bill. Thank you very much.

    Senator Smith. I look forward to working with my colleagues 
and with Senator Kaine on that as well. Thank you very much.

    The Chair. Senator Braun.

    Senator Braun. Thank you, Madam Chair. Dr. Walensky, it was 
about a month ago in an Appropriations hearing I asked Dr. 
Fauci about lockdowns, and it was based upon the Johns Hopkins 
study that said that tactic basically was neutral on mortality.

    I don't think it got into maybe what mortality might have 
been caused due to the fact that we were locked down in other 
areas. But would you agree with Dr. Fauci on that, that we 
probably won't ever need to use lockdowns again on COVID as we 
currently know it?

    Dr. Walensky. I certainly hope not, Senator Braun. I know 
that that Hopkins study had some flaws and that there have been 
other studies that have refuted that. We would be happy to get 
you more details on that. But certainly we are doing everything 
in our power to prevent that from happening. But COVID has sent 
us numerous curveballs, so I will never say never.

    Senator Braun. I might also add that in everything I 
observed and keeping in touch with the business community who 
took it pretty seriously, they did not think that transmission 
was occurring at work. It was mostly elsewhere. And that 
locking those businesses down, of course, I think we are 
dealing with those consequences currently.

    Another question, when it comes to vaccine mandates, 
Supreme Court finally weighed in and said that did not make 
sense when we were going to try to force businesses down to 100 
employees to either have their employees get a vaccine or lose 
their job. That seemed like the ultimate heavy hand of 
Government.

    Would you ever recommend doing that again? Because the 
Administration seemed to err on the side of vaccine mandates 
and lockdowns, which I talked about earlier.

    Dr. Walensky. Mandates are generally, vaccine mandates are 
generally a local decision. And what I will say is, we at CDC 
are for promoting more people to get vaccinated because those 
who are vaccinated and boosted have decreased risk of severe 
disease and death. Generally, we would support getting more 
people vaccinated.

    Senator Braun. Well, I would like to cite the fact that the 
Administration has forced it through all Federal employees, and 
I believe that initiation of what would have been the biggest 
mandate for getting vaccinated came from the Biden 
administration, so through an Executive Order. I agree with you 
that local prerogative should come into play. But this was not 
that. Do you care to comment further on that?

    Dr. Walensky. CDC stand is that the more people who are 
vaccinated and boosted, the decreased risk of severe outcomes 
and death.

    Senator Braun. So, we have now gone a couple of years. We 
have learned a lot. I think the data has shown that this has 
ravaged, in a disproportionate way, in the elderly with co-
morbidities.

    I would like your kind of assessment, going forward, with 
the general dynamics of what we know about COVID, does it make 
sense that we protect better where the data has shown that we 
have had the most issues with? And also parallel this to the 
flu. I know it is more transmissible.

    But the flu generally has a broader fatality rate. In here, 
as Senator Paul talked about it a little earlier, we know that 
it has really hit one category very hard. And do you think we 
are protecting them well enough, and you think it makes sense 
to take the broad approaches for so much of the country that 
was either asymptomatic or had mild symptoms?

    Dr. Walensky. I think we need to do both. Certainly, our 
elder community has been among those that have been the highest 
risk, highest risk of severe disease and death. But I will also 
say that COVID is one of the top leading killers of children 
right now. Deaths among children during the COVID pandemic have 
been higher than we generally see--from COVID have been higher 
than we have seen for flu.

    I actually think we need to protect young children as well 
as protect everyone with the vaccine and especially protect 
elders. I will say that we have recently endorsed and 
recommended boosters for all those over the age of 50, a second 
booster for all those over the age of 50, and we will have 
forthcoming data later this week that will demonstrate, 
compared to a third booster, that those over the age of 50 who 
have gotten a fourth have a seven fold decreased risk of death.

    We are actually doing both of those simultaneously, and 
that is what I think we need to be doing.

    Senator Braun. Thank you. And then finally for Dr. Fauci, 
of course, we read this week after 675 years, we finally found 
the origins of the Black Plague. Care to give us an update on 
where we are at on tracking down the origins of COVID-19?

    Dr. Fauci. Thank you for that question, Senator. There have 
been a number of papers that have come out from highly 
qualified virologists and viral file geneticists that indicate 
that this is very, very likely a jumping species from an animal 
host, perhaps through an intermediate host into a human 
species, which then spread throughout the human population, 
certainly, and almost certainly originating in China, in Wuhan.

    We still open up and keep always an open mind as to whether 
or not this had to do with a virus that was isolated out in the 
environment and that came into a lab and then had what most 
people refer to as a lab leak.

    I believe that is less likely that that is the case. But I 
also believe we need to keep an open mind and have all 
possibilities be investigated. But the evidence from the 
virology community point strongly toward a natural occurrence.

    Senator Braun. Very quickly, do you think the Chinese will 
cooperate with you to try to get to the thorough bottom of it?

    Dr. Fauci. Senator, I certainly hope so, because we are not 
going to get an answer that is a definitive answer--I mean, 
even if they do cooperate, we may not do that. But certainly, 
for example, if we want to continue surveillance among bat 
populations and other wild animals that might serve as an 
intermediary host, as well as understanding what was going on 
in some of the laboratories, I believe it is essential to have 
cooperation and collaboration with the Chinese.

    The Chair. Thank you.

    Senator Braun. Thank you.

    The Chair. Senator Hickenlooper.

    Senator Hickenlooper. Thank you, Madam Chair. I want to 
just first thank all of you again. You have been here 
repeatedly. I often wonder watching these, the back and forth 
in these hearings, what message it sends to young people 
deciding whether they want to get into public service.

    It doesn't always look pleasant, but I appreciate your 
maintenance of good spirits as you go through obviously 
difficult, but I think important discussions. Dr. Califf, I am 
going to start--I am going to try and look a little more 
forward just because I am worried about the future equally as 
much as trying to review the mistakes we made in the past.

    You know, the unprecedented COVID-19 clinical trial 
landscape has allowed for timely availability of vaccines and 
therapies that have been essential to fighting this pandemic. 
In this increasingly global world, we can, and I think really 
have to work closely with our allied partners to advance 
scientific and research efforts.

    My question to you is, should we be thinking about multi 
regional clinical trials as a way to expand volume and scope of 
clinical trial data? And if so, how do we get there? And that 
is, I know we have talked about it before, but I just keep 
coming back to this as well.

    Dr. Califf. Well, thanks for giving me a chance to talk 
about my favorite thing. That is what I have done for a living 
my entire career is multi-regional clinical trials in 
cardiovascular disease, and that is what we need to do.

    We are all very focused on diversity in clinical trials 
within the United States, but we are only 4 percent of the 
world's population. So if we really believe that we need to be 
doing trials that are relevant to the populations all over the 
world. I will point out, again, as Dr. Walensky pointed out, we 
have a fragmented system in the U.S. So, yes, we depend on 
Israel for data.

    The fourth dose decision by the FDA was made based on 
Israeli data. For, in many cases we depend on the UK for a 
clinical trial results that are critical to us. With all the 
technology and prowess we have in this country, we have got to 
do better, and it is going to be a focus.

    The CDC needs to have the authority to get the data it 
needs so that we can be as good as the Israelis in producing 
just in time data that is needed.

    Senator Hickenlooper. Yes. When I was a kid, Marshall 
McLuhan wrote a book and one of the key elements was 
information is power. I think that is more true today than 
ever. Dr. Fauci, many of us here, I have been beating the drum 
loudly on pandemic preparedness and pandemic prevention. I 
think it is imperative that we make investments today that will 
help us better understand and prepare for viruses tomorrow.

    You know this has been--we have watched some of the 
discussion on this already. The President has put out a 
pandemic preparedness plan and submitted a mandatory 5 year 
funding request to Congress to truly stay ahead of the curve.

    What progress do you think we have lost due to the 
inability of Congress to significantly invest in the pandemic 
preparedness and pandemic prevention?

    Dr. Fauci. Yes. Well, thank you for that question, Senator. 
Pandemic preparedness involves multiple buckets. Basic clinical 
and translational science to develop the products such as the 
vaccines and the antivirals that have helped us so dramatically 
during the current outbreak, as well as a number of public 
health issues involving, for example, the CDC, the FDA, BARDA, 
ASPR, and others.

    When you look at what has not been available from the 
standpoint of resources, we have a pandemic preparedness plan 
that is based on what we call the prototype pathogen approach, 
which was to look at various families of viruses particularly, 
and to develop commonalities among them, so that we will be 
able, in the next challenged with an emerging microbe, mostly 
likely a virus, that we will have enough back lot experience 
that will be able to do it in the timeframe that we did with 
coronavirus, which, as you know, was 65 days from the 
recognition of the virus to a phase one trial.

    Senator Hickenlooper. Right, so, let me interrupt you just 
because I am going to run out of time here. The real question, 
though, is how much do we lose by delaying the appropriate 
investments to complete that preparedness work?

    Dr. Fauci. Yes. You lose a significant amount. I mean, 
every time you pull back on resources, the pace and the cadence 
of the work slows down. Sometimes you can't even start a new 
project. But the projects that are ongoing, if you don't get 
the resources to fully implement them, you will delay the 
development of interventions.

    Senator Hickenlooper. Or have to take money from one other 
pool that gets sidelined, and you interrupt something else. 
Right. I follow that. Okay. I am out of time. I yield back to 
the Chair. But I again want to thank each of you for your 
public service. I realize science is not perfect, it is not 
binary, and you have difficult, complicated jobs. I am 
grateful.

    The Chair. Thank you.

    Senator Marshall.

    Senator Marshall. Thank you, Madam Chair. Just yesterday we 
learned that in the month of May, our Border Patrol encountered 
an unprecedented 239,000 migrants at the Southern border, the 
highest monthly total in DHS history. And now, thanks to our 
inhumane open border policies, every state is now a border 
state.

    In my home State of Kansas, a person dies most every day 
from fentanyl poisoning. Nationwide, over 200 people are dying 
daily from fentanyl. The number is on the rise, and this is now 
an epidemic. Just last week in Kansas City, authorities seized 
15,000 counterfeit pills laced with fentanyl.

    Chair Murray, in your State of Washington, five people are 
dying per day from drug overdose. Ranking Member Burr in your 
state, nine North Carolinians are dying every day from drug 
overdose. I don't have to remind people on this Committee or 
panel that fentanyl precursors are made in China.

    Then the Chinese work with the cartels to process that into 
a lethal fentanyl, often lacing other opioids, marijuana, meth, 
Adderall, xanax, among others. And all across the Nation, a 
counterfeit oxycodone pills like the ones behind me are now 
actually laced with fentanyl.

    Unfortunately, just one pill can kill. And in the case of 
one young student in Shawnee, Kansas, it only took half of a 
fake Percocet pill to take his life. Dr. Walensky, my 
colleague, Senator Hagerty from the great State of Tennessee, 
has introduced a bill that would expand Title 42 expedited 
removal authority to combat the drug overdose epidemic 
resulting from drug smuggling across our Southern border.

    Dr. Walensky, I would like to ask you, yes or no, would you 
commit to expanding the Title 42 authority to turn back 
migrants to combat this prolific drug smuggling across the 
U.S.-Mexico border in an effort to stop the flow and the 
epidemic of fentanyl that is killing Americans every day?

    Dr. Walensky. Thank you, Senator. I would like to just back 
up and say that CDC is a public health agency, not an 
immigration agency. And the question of Title 42 is a public 
health policy. The question of Title 42 that was posed to me 
is, is there a public health emergency that should bar people 
from coming into the United States?

    We now have, as of April 1st, when I commented on this, we 
now have the tools, the tests, the vaccines, and the 
therapeutics that are available. Our hospitals are not full. 
Everyone and most people in this room are not wearing a mask. 
There is no longer a public health emergency----

    Senator Marshall. So, Dr. Walensky, I appreciate that. But 
I hope you realize that fentanyl poisoning is killing more 
individuals ages 18 to 45 than COVID-19. So for the same 
reasons that you instituted Title 42 for COVID, why wouldn't 
you consider instituting it for fentanyl poisoning, as well as 
would you commit yes or no to tracking this similarly to the 
way you did for COVID?

    Dr. Walensky. To the larger immigration question, I turn 
things back to you and Congress to address the larger 
immigration question. As a public health emergency for COVID, 
which is what Title 42 was put up to do, there was no longer 
need----

    Senator Marshall. Do you deny that there an epidemic of 
fentanyl poisoning across this country?

    Dr. Walensky. I do not.

    Senator Marshall. Thank you. Secretary O'Connell, I have a 
question I am going to submit for the record for the sake of 
time. It has to do with, we are going to be giving some 300 
million more doses of Moderna, more for Pfizer.

    From by understanding of the marketplace, there is still a 
substantial supply chain challenges for our medical products. 
And to Ranking Member Burr's point, I hope that the 
Administration can give us a plan to provide the ancillary 
medical products to support the vaccine Administration, and we 
would appreciate some type of a plan in writing. Thank you. My 
last question for Dr. Fauci.

    Dr. Fauci, the NIH is still funding research in China, at 
least some $8 million since 2020. In the intelligence 
community's 2022 annual threat assessment, the Chinese 
Communist Party is presented as one of the top threats to the 
United States, along with Russia, Iran, Syria, and North Korea.

    To my knowledge, only China is receiving U.S. research 
dollars. The CCP controls their scientists and controls the 
release of research results they work on. However, NIH grants 
policies requires a grantees to maintain supporting research 
records, which they cannot do when those records are under 
control of the Chinese Communist Party. When were you as 
Director of NIAID stop funding research in China?

    Dr. Fauci. Now, thank you for that question, Senator 
Marshall. We have at the NIH and in other agencies in the 
Federal Government, have very productive, peer reviewed, highly 
regarded research projects with our Chinese colleagues that 
have led to some major advances in biomedical research.

    I don't think I would be able to tell you that we are going 
to stop funding Chinese. We obviously need to be careful and 
make sure that when we do fund them, we have the proper peer 
review, and we go through all the established guidelines.

    I might point out that grants that go to foreign countries, 
including China, have State Department clearance. So any time 
that we do fund anything in China or any other country, it has 
to go through a clearance with the State Department.

    Senator Marshall. But you would not deny that the research 
done through EcoHealth, that the records, the studies from 
there, that we still do not have access to them. Is that 
correct?

    Dr. Fauci. We have--no, Senator Marshall, we have access to 
an extraordinary amount of information that has gone there. 
There is a question that people raise with things going on 
there that we didn't have access to.

    But if you look at the grant, the $120,000 to $130,000 a 
year grant that was given from EcoHealth as a sub award in 
China to ask a very relevant, high priority question. We have 
received from them published literature with data that shows 
that they have done what they were given the grant for.

    Now, obviously, none of us know everything that is going on 
in China. But if the question at hand is that we have a small 
grant, peer reviewed, high priority grant that was given from 
Eco to China in a sub award, we have a lot of good information 
that is in the public----

    Senator Marshall. Do you have all the information that you 
think that we should--?

    The Chair. Senator Marshall, at this point, I am going to 
move on. We have a number Senators. We have three votes that 
have been called. I am going to move on to the next person. I 
am going to turn this the Chair over to Senator Hickenlooper 
while I go vote. This next Senator, I will call on as I do 
that, is Senator Baldwin. Senator Hickenlooper, thank you for 
coming up to Chair.

    Senator Baldwin. Thank you, Madam Chair. I have been 
encouraged by the work of this Committee and those of you on 
the panel who have helped make more COVID-19 treatments 
available. Unfortunately, local health Departments in Wisconsin 
have experienced some obstacles when it comes to getting 
paxlovid to those in need.

    Dane County public health officials recently contacted my 
office to raise their concerns about the lack of a clear policy 
guidance and reimbursement for this critical treatment. So, Ms. 
O'Connell, how is ASPR working with states to ensure that local 
public health Departments have the information that they need 
to make paxlovid available through the Administration's Test 
and Treat initiative?

    How can folks who are uninsured receive treatment, and what 
additional resources might the Administration need to make 
treatment available to everyone who needs it?

    Ms. O'Connell. Thank you so much, Senator Baldwin. I will 
take that in two parts. First of all, as far as communicating 
with state public health Departments to make sure they know 
that this treatment is available and how to access it, we do 
weekly stakeholder calls and regular engagements with state 
health officials. We also know it is on us to be--we need to 
take responsibility for communicating very clearly the 
importance of this therapy and its availability.

    We have taken that on in numerous ways with various 
outreach efforts. But, and we continue to work with states to 
make sure that they are positioning these therapies in places 
where folks are the most high risk. So that continues to be an 
ongoing pursuit of ours, and we will continue to work at it. 
Thank you for the feedback on Wisconsin.

    We will reach out and make sure that we have closed that 
loop and that they have the information they need. And then 
part two of your question is about access for the uninsured. 
So, one of the impacts of not getting additional supplemental 
funding is we have had to shut down the uninsured fund.

    The uninsured fund was one of the easiest ways for those 
without insurance to get coverage during the COVID response, to 
be able in this once in a lifetime pandemic get the care that 
they need. We continue to make paxlovid even without the 
uninsured fund. The paxlovid is available for free.

    Pharmacies are not allowed to charge a dispensing fee, so 
those that are uninsured should be able to access it. We 
understand an important component of receiving paxlovid is also 
having a health care assessment, and we know that that comes 
with a fee.

    We encourage those that are uninsured to go to the 
federally qualified health centers, which provide these 
services on a sliding scale and acknowledge whether you are 
uninsured or not, or to seek care at their public health 
Departments or now these new federally run test or treat sites.

    But this is a challenge, and it is one that we are 
continuing to overcome in light of the shutdown of the 
uninsured fund.

    Senator Baldwin. Thank you. I have heard also from state 
health officials about declines in vaccination coverage for 
routine immunization, such as the measles, mumps, and rubella, 
that vaccine.

    Dr. Walensky, how is the CDC working to ensure that any 
forthcoming recommendation on the COVID-19 vaccine for kids 
gives parents the information that they need to feel confident 
about getting not just this vaccine, but as well as all other 
routine immunizations? And is there an opportunity to up the 
rate of vaccination for these other conditions at the same time 
as you are vaccinating kids?

    Dr. Walensky. Yes. Thank you so much, Senator Baldwin. So 
we recently reported data that demonstrated a decrease of about 
1 percent of all incoming kindergartners are completely 
vaccinated for all of the recommended vaccines.

    That is 35,000 children across this country who are no 
longer up to date on all of their other vaccines, even before 
COVID. We have a lot of make-up work to do there in addition to 
what we need to do with COVID. As we roll out our pediatric 
vaccines for children between the ages of 6 months to 5 years, 
and in fact, as we continue to enforce the importance of 
vaccination for our 5 to 18 year olds, we are seeing 
differences in vaccine confidence and differences in rates and 
vaccination.

    We are doing a lot of work in terms of vaccine confidence, 
putting these vaccines in pediatricians' offices and federally 
qualified health care centers, in pharmacies, places where 
parents trust, where they normally get this information. We are 
also canvasing and understanding the vaccine confidence around 
these areas so that we can focus our attention in areas where 
confidence might be lacking.

    We also, importantly, are starting to see really critical 
data that show that much of this confidence is lacking in 
areas--in rural areas. That we have about two times the 
vaccination rate in urban areas compared to rural areas of our 
children. So areas that we really need to focus, and we are 
aware of that and are doing those activities as well.

    Senator Baldwin. Thank you. I yield back, Mr. Chair.

    Senator Hickenlooper. Thank you.

    Senator Casey.

    Senator Casey. Mr. Chairman, thank you very much. I want to 
thank members of the panel for their public service and for 
being here today. I just have, in the interest of time, I think 
everybody--I just have got one question for Dr. Fauci. Doctor, 
I want to wish you a speedy recovery, as well as congratulate 
you on the naming of the science complex at Holy Cross College 
in your honor.

    I wanted to ask you a question, though, about our parents. 
So many parents across the country right now are unsure about 
whether to get their kids vaccinated. Uptake of the vaccine has 
been relatively low for kids who are already eligible. I am 
told that under something, like under 30 percent of children 
ages 5 to 11 are fully vaccinated.

    When the vaccine becomes available for children under five, 
we will need to meet parents where they are and with the 
information that they need to make informed decisions about 
that vaccination.

    Dr. Fauci, can you expand upon how the Administration is 
working with trusted messengers in our society, whether they 
are physicians or community leaders or others, to get accurate 
information about the vaccinations to parents?

    Dr. Fauci. Yes. Thank you for that very important question, 
Senator Casey. Certainly, now that we have the data, which 
looks very favorable, we really want to get these children 
vaccinated because we know vaccinations prevent infection, but 
to a greater extent prevent severe disease.

    As you have heard from a number of us, including and 
particularly Dr. Walensky, that there are more deaths and 
serious consequences of COVID among children than there are in 
influenza.

    The Department, HHS, has a very comprehensive rollout plan, 
which they have been literally preparing now for several weeks, 
2 months in anticipation of if we do, and we did, get favorable 
results on the clinical trials from Moderna and from Pfizer, 
that we would be able to get children and get parents to 
understand where these vaccines are available in pediatrician 
offices and pharmacies and clinics.

    This is something that the Department has taken very 
seriously and hopefully we will do a very high uptake of 
vaccines, because many parents, as we all know, have been 
waiting some time now to get their children vaccinated. And 
hopefully the program that HHS is rolling out will facilitate 
that. Thank you.

    Senator Casey. Doctor, thanks very much. Thank you, Mr. 
Chairman.

    Senator Hickenlooper. Great.

    Senator Kaine.

    Senator Kaine. Thank you, Senator Hickenlooper. And thanks 
to our witnesses, I want to echo comments that I know Chair 
Murray made earlier about the importance of more law--more 
COVID funding in a variety of ways. We are--thankfully, we are 
seeing hospitalizations come down dramatically in Virginia. It 
was about 4,000 a day in January, about 500 a day now. That is 
very, very positive.

    I am looking at hospitalization and death data a lot more 
intensely than the case data, because I think cases continue to 
be high. But the--because transmissibility is high, but the 
severity is dropping, which is what we would want. But I do 
think we still need more funding to deal with COVID issues, 
especially for low income people.

    I would also say that U.S. vaccine diplomacy around the 
world has been a real positive investment that has both helped 
our own public health, helped the health of others around the 
world, but built up goodwill. I am strongly for it. I do want 
to just quibble with one thing.

    Senator Smith asked you all the questions about whether you 
are equally as effective, if you are working virtually or in 
the office. And you said, yes, as effective. I am going to be 
honest. There is one area, and it is in the FDA space, Dr. 
Califf, where it is not as effective, and that is inspections.

    The AP had a story that was out earlier this week that said 
during the period largely from March 2020 till June 2021, you 
were not at the FDA then, but during that period the FDA missed 
15,000 inspections that would normally have done.

    The FDA is racing to catch up, has cleared a backlog of 
about 5,000 of those. But there is no substitute for an 
inspection. There is just no substitute for it. And what 
troubled me about that is, the folks working at plants that 
need inspection like an infant formula plant, they are 
essentially essential workers.

    We can't stop producing formula, so they have to be there. 
If they have to be there to do something that the public needs, 
then the inspectors should be there, too. I recognize that 
poses health challenges. But, and again, you were not at the 
FDA during this period when the inspections were stopped.

    But I frankly worry a little bit about, are there other 
surprises around the corner for us in these spaces where we 
weren't doing inspections? I am not even going to ask you about 
it because I know you take it seriously and you are trying to 
catch up on the backlog and----

    Dr. Califf. Can I just comment that I agree? I was asked 
about the office. So if you asked about--definitely, we had 
inspections that were put on hold and there has been a price to 
pay for that.

    Senator Kaine. Yes. I would say an inspector is every bit 
as essential a worker as the worker that we require to go to 
the plant to produce medicine, to produce infant formula, 
etcetera. I want to ask a question that I always ask of Dr. 
Fauci. Dr. Fauci, I hope you are feeling well, and I am glad 
you are able to join us virtually.

    I started to share my own experiences with long COVID nerve 
tingling symptoms about a year ago because, hey, I was having 
them, and they are exactly the same as they were when I got 
COVID in March 2020. But b, I was running into a lot of people 
who were experiencing more serious symptoms and weren't being 
believed. I felt like sharing from this podium that, yes, no, I 
believe you because I am dealing with nerve tingling that I 
would never felt in 62 years, might open up a discussion and 
make people feel like they were being heard.

    As I expected when I started to talk about this, my office 
has become a real nerve center for people who want to share 
their experiences with long COVID and ask for help. So what I 
want to ask you to know, given that we have put in some 
significant funding for long COVID research, what is the 
current status of the NIH Recover Project?

    Dr. Fauci. Yes. Thank you for that very important question, 
Senator Kaine. Let me assure you that from the patients that we 
have seen and the input we have seen from so many people, this 
is a real syndrome. It is a real problem, and it is something 
we really need to get to the bottom of. There are two tracks 
that are going on.

    One is a broad cohort track, which many people referred to 
as the recovery program, where launch cohorts of individuals 
are now being followed in long range to determine the 
incidence, the prevalence, and hopefully learn about the 
pathogenesis of this real syndrome. They are now accumulating 
very large numbers of individuals.

    One of the problems, Senator, is that there is no yet 
identifiable pathogenic process. So people ask, why aren't you 
treating it, what are you doing for it, is very, very difficult 
to do that because this is a heterogeneous syndrome, as you 
probably know from the people that now are essentially 
addressing your own office because of your own personal 
involvement.

    But there are other things that are going on 
simultaneously. For example, there's a pediatric research 
immune network called PRISM, which is looking at this in 
children, particularly children that might have the multisystem 
inflammatory syndrome of children. There is the, what we call 
immuno phenotyping to determine is there anything that relates 
to a hyperactivity or an aberrant triggering of immune response 
that is triggering some of the things that you might be 
feeling, including the tingling in your nerves.

    There is the broader cohort project and a number of 
individual projects. I do hope, and I say that sincerely, 
because there are so many people now, when you talk about the 
tens and tens of millions of people who have COVID in this 
country, that even a small percentage, and I am not so sure it 
is that small, who wind up with varying degrees of long-covid--
we have to address this problem, find out the underlying 
mechanism, and do something about it. Thank you.

    Senator Kaine. Dr. Fauci, thank you so much. I yield back, 
Senator Hickenlooper.

    Senator Hickenlooper. Thank you.

    Senator Rosen.

    Senator Rosen. Well, thank you, Chair Hickenlooper. Dr. 
Fauci, I know we all hope you are feeling all right. Thank you 
for being here. And thank you to all of you for your continued 
presence, your work, and your commitment to doing that good 
work going forward. I want to talk about the vaccines and 
booster shots just a little bit, because we know the COVID 
virus, the COVID-19 virus, is going to continue to mutate.

    It is critical that we use our best defense, we all know 
this, it is vaccines, to keep our most vulnerable populations 
safe. We are going to protect lives and livelihoods. I just 
want to focus for 1 second on one of our highly vulnerable 
populations, our seniors. Many of them may have unique 
challenges because of their mobility or a variety of other 
issues. So, Dr. Walensky, we know more than 90 percent of 
seniors are fully vaccinated.

    Nearly 70 percent have received their first booster dose. 
But only a little over 30 percent of our seniors have received 
their recommended second booster. So what are you doing to I 
would say, just not just improve outreach, but what about those 
access barriers that may--we may have with seniors in assisted 
living, or nursing homes, memory care, and the like?

    Dr. Walensky. Yes. Thank you, Senator Rosen. So several 
weeks ago, we increased our recommendation--strengthen our 
recommendation for a second booster shot. And that is in the 
context of this increased number of infections for our elderly. 
What I will tell you is we have data forthcoming later this 
week that will demonstrate that that fourth dose compared to 
the third dose has decreased the risk of death by seven fold.

    We now have actually data from the United States that has 
demonstrated the value of this booster dose, especially among 
the elderly and the most frail. We are--we now have vaccine in 
tens of thousands of sites. We have vaccines in pharmacies. We 
have vaccines in providers, physicians' offices. We have 
vaccine throughout the country and in our long term care 
facilities.

    We are continually looking at vaccine confidence and 
canvasing our states to understand where we have challenges in 
vaccine confidence. One of the areas, as I indicated earlier 
for pediatrics. But also true for adults, is in our rural, 
urban divide that we actually have challenges in reaching our 
rural communities, both for vaccine confidence, but actually to 
get folks boosted--for their first shot as well as their 
second.

    We are continuing outreach there through media, through 
social media. I have done media with our collaborations through 
the U.S. DEA and through Rural Public Health Association. So we 
are continuing that outreach. Once we can understand where the 
data are and where the challenges are, we focus on those areas 
so that we can do more in those areas.

    Senator Rosen. Well, maybe that is where our mobile health, 
rural mobile health clinics can make a difference. But would 
you follow-up on that really for our general population. You 
said the updated guidance is going to come out in a few weeks 
for access to the second booster dose for general population, 
because we know it keeps people out of the hospital and from 
suffering more severe disease.

    Dr. Walensky. Yes. So we continue at CDC to follow the data 
with regard to how our vaccines are performing. And so far, the 
data on decreases of severe disease, hospitalizations, and 
death have been limited--and the waning has been limited to the 
elderly population. But we are continuing to follow the data 
for the younger population to see if and when there is waning 
in that population as well, and if and when we should bring 
another booster dose to that population as well.

    Senator Rosen. Thank you. I want to keep a little bit on 
seniors, because we know that the pandemic has had real mental 
health challenges for, of course, our children--for all of us 
but I am going to focus on seniors today because ARP, as really 
noted, that is critical to find a balance between patient 
health and caregiving.

    How the absence of caregivers or if the caregivers 
themselves are vaccinated. It really makes a difference. I just 
would like to know what lessons the CDC has learned from the 
pandemic about caring for seniors and addressing the social 
isolation that we felt prior to the vaccine. What can we do 
there, do you think?

    Dr. Walensky. We have learned really--hard learned lessons, 
I would say, through the last two and a half years with regard 
to mental health, not just in our seniors, but across the aged 
demographic, in our in our students and in our seniors and 
across the age demographic.

    We at CDC are doing a lot of work across the country with 
the VA, with NGO's, with community based organizations, within 
our tribes to strengthen mental health resources, to decrease 
suicide, to allow children to get back to school, to allow 
parents and caregivers get the mental health resources that 
they need so that they can combat the challenges of mental 
health right now.

    Senator Rosen. Thank you. I know my time is up. I 
appreciate that going forward. For the K-through-12 population, 
Senator Murkowski and I introduced bipartisan legislation to 
bring mental health down. That was funding for health grants 
that normally go to universities and colleges, but to bring it 
down K through 12, because we have seen increased suicide, 
increased mental health challenges.

    Nevada, at one point, our Clark County School District was 
the highest of youth suicide, I believe in the year 2020, a 
list no one wants to top. I look forward to working with all of 
you and trying to do what we can to promote good mental health 
services and suicide prevention. Thank you.

    Senator Hickenlooper. Thank you, Senator Rosen. I am going 
to take just a moment of privilege. I want to ask one last 
question to Dr. Walensky, just because I don't think the people 
of America really understand how interconnected we are. I want 
to just take a moment to--I mean, we have seen from the current 
COVID pandemic that viral pathogens don't pay any attention to 
national borders.

    The reality is, I think it creates real danger for the 
probability that new COVID variants or other pathogens like 
monkeypox can emerge and spread quickly undetected in our 
interconnected world. The number I have is 62 percent of the 
global population is fully vaccinated against COVID, and 
clearly there are significant disparities between countries.

    Many countries just do not have the resources to get to a 
significant part of their population. The more vaccines and 
therapeutics we can distribute around the world, the less 
chance we give variants to spread. I think that is the--we 
don't really have a number on that yet in terms of what is 
the--how are we increasing the probability of some new variant? 
How serious is this danger by us allowing these large 
populations in isolation to almost incubate new pathogens or 
more importantly, new variants?

    Dr. Walensky, how has the CDC tracking of viral threats 
globally changed with the launch of the Center for Forecasting 
and Outbreak Analytics? And what more do we need to do now to 
address this global reality that we face in terms of public 
health threats? And again, how do we--I will take 
responsibility for how we spread that information to the 
public, but it is something most people are not aware of.

    Dr. Walensky. Thank you. Senator Hickenlooper. So we 
launched the Center for Forecasting in Outbreak Analytics. This 
is a Center that will be able, is currently able to scale up 
and look at forecasting to inform local jurisdictions as well 
as global jurisdictions to understand where the pathogens are 
in their risk of coming to us, as well as to innovate and to 
think about new ways that we might be able to forecast and 
understand pathogens headed on our direction.

    That Center has been really helpful in understanding the 
importance of new variants, the Omicron variant. They have 
stood up and in forecasting and understanding where we need to 
put our resources at the local level. I do want to take one 
moment to say, I think you are exactly right. We know through 
this pandemic that no one is safe until everyone is safe. The 
disparities that we have in vaccination coverage around this 
world are likely to potentially lead to new variants.

    If we don't control these new variants, they will likely 
reach our shores again. I am concerned that with the lack of 
supplemental funding that we at CDC will not be able to 
continue our global vaccine efforts that we have in terms of 
our technical assistance on the ground, our surveillance, our 
genomic sequencing, and our ability to do vaccine surveillance 
and vaccine safety surveillance within countries that we 
support. So thank you very much for noting that.

    Senator Hickenlooper. Thank you.

    Senator Burr.

    Senator Burr. Thanks, Senator Hickenlooper. I am going to 
wrap up. I guess the Chair is not coming back. Couple of quick 
questions. Dr. Walensky, public health emergency. It expires 
July 15th. Do you intend to extend that?

    Dr. Walensky. I am not the one who would extend it, 
actually. Thank you, Senator Burr. That is for the Secretary.

    Senator Burr. But you will make the recommendation, won't 
you?

    Dr. Walensky. I think it will be an all of HHS 
recommendation.

    Senator Burr. Okay, well, let me just say, we have removed 
the mask requirement. We have eliminated the testing 
requirements to reenter the country. Title 42 is a CDC 
decision, and you said in your response to a letter to me that 
you were lifting it because--and I will refer to how you, I 
think, address Senator Marshall. You said, we have--you said we 
have the tools, test and vaccinations, therefore, there is no 
longer a public health emergency.

    Dr. Walensky. Yes. I misspoke. We have the tools, tests, 
and vaccinations, therefore, there is no longer a public health 
reason to bar people from entering this country. Thank you. I 
appreciate the opportunity to correct that.

    Senator Burr. But there is a public health emergency still?

    Dr. Walensky. I think the question of a public health 
emergency is a different question for then, is there a public 
health reason to bar people from entering into the country. I 
would like to make that distinction.

    Senator Burr. Well, it is already in the record, I think 
what you wrote to me, which I think basically said we don't 
have a public health concern. Let me ask you, what are you 
looking forward to end the public health emergency?

    Dr. Walensky. Maybe if I could defer that question to the 
ASPR, that might--I think as part of HHS, that would be 
helpful. Thank you.

    Ms. O'Connell. Sure. Thank you, Dr. Walensky. And thank 
you, Senator Burr. So the Secretary does have this authority, 
and he did, the Secretary declared it in January 2020, previous 
Secretary, and it has been extended multiple times.

    One of the commitments we have made in this Administration 
is that we are going to give states and local Governments 60 
days' notice before we take it down in deciding whether to take 
it down, we are in daily communication with our clinicians, our 
scientists, the folks on the ground.

    With the public health emergency unlocks, is health care 
system flexibilities, that is something that CMS relies on 
significantly. It extends Medicaid coverage for folks during 
times of an emergency. It extends to health coverage to those 
on Medicare. And it allows hospitals and nursing homes and 
other health care facilities some flexibilities in responding 
to the situation at hand.

    We continue to be in touch to understand whether these are 
still necessary. And as Dr. Walensky said, the Department will 
come together and make that decision or recommendation to the 
Secretary for him to decide. But we will give 60 days' notice 
before it comes down.

    Senator Burr. You have answered the question that I asked, 
which was will it be extended? Yes, it will be extended because 
60 days from now is past July 15th, right? So no notification 
has been made to the state, so it will be extended past there. 
I will write the Secretary and ask him what the criteria is to 
end the state of emergency--the public health emergency, excuse 
me.

    I would only point out that the guidance that we currently 
have going out does not suggest that there is a public health 
emergency. We are beginning to dismantle everything. I am not 
sure it is for any reason other than the fact that everybody 
around the world is doing it, because we are 60 or 90 or 120 
days behind them.

    Now, all of you just told Senator Smith that remote work 
hasn't hampered your agency's response efforts. Okay. FDA 
failed to identify a crisis with baby formula. CDC, I think, 
failed to lead as it relates to monkeypox. Secretary Becerra, 
when I wrote him and asked him about HHS staffing and were they 
actually at work when--were they actually working when not at 
the office, wouldn't provide me anything.

    Now, none of you seem to know how many people in your 
complex--and Tony, I will leave NIH out of this because of the 
unique nature of the work there. How many of you can tell me 
how many people aren't at work? Pilot programs. Executive 
declarations. That makes me wonder how you measure whether 
people are actually working when at home. And then I come to 
today.

    I always like to bring things back to the present because I 
have a tremendous amount of respect for all four of you. Some I 
have dealt with longer than others. I supported where there was 
public acknowledgment of it. Everybody--Tony outdates me. He 
was here before I got here 28 years ago. Because I believed you 
had the capacity, the intelligence, the education, and the 
independence to serve in the role you are in. And for two of 
you, I asked when you were confirmed.

    Would you provide me with all the questions I ask as the 
Minority Ranking Member? The answer was yes. Now we come to 
today. This has been the most well-orchestrated event that I 
have seen in the 28 years that I have been here. And for most 
of you, you have been willing participants in it. This was 
designed to pressure Republicans to open a checkbook, sign the 
check, and let the Administration fill in the balance. With no 
detail on how, when, for what that was being asked for.

    I have never in 28 years seen an attempt to get an outcome 
without answering questions. I leave today extremely 
disappointed that maybe my judgment's been flawed. But I will 
say this to each and every one of you. Nobody has worked harder 
on this issue, I think, on the Hill than I have. Nobody has 
gone to bat for emergency money with no strings attached than I 
have.

    But there is a point in time where my patience runs out, 
where the requirement I have for my constituents in North 
Carolina, my colleagues in the minority, which are 50, exactly 
which are in the majority, requires a degree of detail. That 
you and this Administration are not willing to share.

    I personally believe that if the Federal Government doesn't 
lead by forcing employees back to work--and Rob, Google is a 
hell of a lot different than the FDA. Google can pull it off. 
But the Federal Government has to set the example for the rest 
of the country that it is time to leave your house.

    I hate to see what the healthcare cost is going to be to 
our Country for mental health now on the adult side. Husbands 
and wives aren't used to spending all day together. Just like 
kids need the interaction of school. Folks let's get back to 
running your agencies. Let's bring the employees back into the 
office.

    Let's answer the questions that every Member of Congress 
has for you and not just the ones the Administration wants to 
do. You serve in a uniquely special capacity. And when you 
address public health, it is not for some, it is for all. I 
hope you will look at this dais in these Members and realize 
there is no difference between one that sits on this side or 
that side.

    They are on this Committee because they are passionate 
about the issues that we take up. I thank the Chair for his 
indulgence. I thank the witnesses for their expertise and their 
willingness to be here today. I yield back.

    Senator Hickenlooper. Thank you, Senator Burr. I echo his 
appreciation for all of your hard work. I realize that science 
and especially medical sciences, is some of the most daunting--
present some of the most daunting challenges that we face.

    I remember when I was a small business, the times that 
caused me greatest anxiety and serious mental health challenges 
was when I didn't have enough information to make important 
decisions that were going to affect the lives of my employees 
or sometimes even my customers.

    That that challenge of having to deal with the facts we 
have and not the facts that we would like, having to make 
decisions that affect people's, well, their lives, is some of 
the hardest decisions you can make when you don't have all--one 
size doesn't give you all the answers or enough information to 
know that you have got the answer. And yet you have all stood 
up and continued your work and dealt with this evolving 
situation.

    I am very grateful. I would like to thank all my colleagues 
on the Senate side of this, but also all of our witnesses, Dr. 
Walensky, Dr. Fauci, Dr. Califf, Assistant Secretary O'Connell. 
This is an important conversation. I hope after this discussion 
it is clear, how critical it is that we pass emergency funding 
and make sure that we can protect our communities from what 
this pandemic throws next, which, again, we can't be certain 
of.

    For any Senators who wish to ask additional questions, 
questions for the record will be due in ten business days, July 
1st at 5.00 p.m.
    This Committee stands adjourned.
                                ------                                


                          ADDITIONAL MATERIAL

   FACT SHEET: Consequences of Lack of Funding for Efforts to Combat 
                   COVID-19 if Congress Does Not Act

    The U.S. has made tremendous progress in our fight against COVID-
19. Over the past 14 months, the Biden Administration has made vital 
investments--using resources Congress provided on a bipartisan basis--
to make sure the American people have free and widely available access 
to lifesaving tools: vaccines, booster shots, treatments, tests, and 
high-quality masks. As we enter a new moment in the pandemic, Congress 
has not provided us with the f4nding we need to continue the COVID-19 
response and minimize the pandemic's impact to tie Nation and our 
economy. With cases rising abroad, scientific and medical experts have 
been dear that in the next couple of months there could be increasing 
cases of COVID-19 here in the U.S. as well. As the Administration has 
warned, failure to fund these efforts now will have severe consequences 
as we will not be equipped to deal with a future surge. Waiting to 
provide finding once we're in a surge will be too late.

    Without funding, the United States will not have enough additional 
boosters or variant specific vaccines, if needed, for all Americans. 
The Federal Government is unable to purchase additional life-saving 
monoclonal antibody treatments and will run out of supply to send to 
states as soon as late May. The Federal Government cannot purchase 
sufficient quantities of treatments for immunocompromised individuals. 
And, the Federal Government will be unable to sustain the testing 
capacity we built over the last 14 months, as we head into the second 
half of the year.

    Earlier this month, President Biden laid out a comprehensive plan 
to ensure that the country can continue to move forward safely and 
remain prepared to fight new variants and future surges of the virus. 
And the Administration has been clear that we need Congress to provide 
additional resources, including $22.5 billion in immediate emergency 
funding. Inaction will set us back in this fight, leave us less 
prepared, and cost us more lives.

    Consequences of lack of critical funding include:

          Inability to Secure Sufficient Booster Doses and 
        Variant Specific Vaccines, If Needed:

        The Federal Government does not have adequate resources to 
        purchase enough booster vaccine doses for all Americans, if 
        additional doses are needed. The shortages will be even more 
        acute if we need a variant-specific booster vaccine, since we 
        will not have any existing supply.

          Providers No Longer Able to Submit Claims for 
        Testing, Treating, and Vaccinating the Uninsured:

        The fund that reimburses doctors and other medical providers 
        for caring for uninsured individuals will start to be scaled 
        back this month and end completely in early April. 
        Specifically, 1 week from today--March 22--the Uninsured 
        Program will stop accepting new claims for testing and 
        treatment due to lack of sufficient funds. Providers will no 
        longer be able to submit claims for providing these services to 
        uninsured individuals, forcing providers to either absorb the 
        cost or turn away people who are uninsured, increasing the 
        disparity in access to critically needed health care and 
        putting additional burdens on safety net providers. Three weeks 
        from today-April 5-the Uninsured Program will also stop 
        accepting vaccination claims due to a lack of sufficient funds.

          Ending the Purchase of Monoclonal Antibody 
        Treatments, Scaling Back State/Territory Allocations:

        The Federal Government has no more funding for additional 
        monoclonals, including a planned order for March 25. To date, 
        the Federal Government has been able to provide these life-
        saving treatments free of charge to Americans and work with 
        states to make sure they get to as many people as possible who 
        need them. In order to keep these treatments free and available 
        to the American people for as long as possible, the 
        Administration will now have to stretch our current supply and, 
        starting next week, will be forced to cut state allocations of 
        our limited existing supply of life-saving monoclonal antibody 
        treatments by more than 30 percent.

          Halting Critical Testing, Vaccine, Treatment Efforts:

        The President's National Preparedness Plan was clear that the 
        Federal Government must invest in next-generation vaccines and 
        treatments and maintain our testing capacity in order to fight 
        COVID-19 in the future. Now, without additional funding, we do 
        not have the ability to:

                Y  Purchase additional oral antiviral pills beyond the 
                20 million already secured.

                Y  Pre-purchase promising new antivirals. The reason 
                why the Administration has been able to secure more 
                oral antiviral pills than any other country is because 
                we committed to purchasing them early, even prior to an 
                Emergency Use Authorization (EUA). As even more 
                effective pills potentially become available, the 
                Federal Government is no longer able to make advance 
                purchase commitments to ensure America is one of the 
                first countries in line.

                Y  Accelerate the creation of a next-generation, pan-
                COVID vaccine that would provide broad protection 
                against a range of variants. Vaccines are the most 
                effective tool to prevent COVID-19, and the 
                Administration does not have the funding for necessary 
                investments in research and to support the development 
                of promising new vaccine candidates. Such next-
                generation vaccines hold potential to broaden 
                protection against known and future variants, reduce 
                dosing through single-dose primary regimens with 
                extended duration of protection (i.e., longer interval 
                between boosters or possible elimination of boosters 
                altogether), and reduce costs by increasing 
                manufacturing yields and extending shelf life.

                Y  Maintain our domestic testing capacity beyond June. 
                After spending the last year building up our testing 
                capacity, that progress will be squandered, the 
                Administration will be unable to help keep domestic 
                manufacturers online starting in June. That means, 
                heading into the second half of the year, there will be 
                significantly diminished domestic testing capacity and 
                we may be unprepared for surges.

          Scaling Back Planned Purchases of Preventive 
        Treatments for Immunocompromised:

        The Federal Government has been planning to move forward with a 
        purchase of preventative treatments for the immunocompromised 
        as soon as March 31 that would begin delivery in September, 
        once the treatments are manufactured. However, absent 
        additional funding the Federal Government will now be forced to 
        scale back that purchase of treatments for our most vulnerable. 
        Because these treatments take more than 6 months to 
        manufacture, the United States will likely not have enough of 
        these treatments by the end of the year. And being unable to 
        make additional purchase commitments now likely means that 
        fewer treatments will be available next year as well.

          Reducing Ability to Rapidly Identify and Assess 
        Emerging Variants.

        Robust surveillance and research are critical to identify, 
        understand and monitor emerging variants. With reduced 
        capability to perform adequate surveillance, the country will 
        be prone to being ``blindsided'' by future variants. In the 
        absence of funding to immediately assess lab-based efficacy and 
        real-world effectiveness of existing vaccines and treatments as 
        new variants emerge, health care professionals will be forced 
        to make insufficiently informed treatment decisions. The 
        Administration will need to wind down some COVID surveillance 
        investments, leaving us less able to detect the next variant.

          Damage to Global Vaccination and COVID-19 Treatment 
        Efforts:

        Without additional funding to support getting shots into arms, 
        USAID and interagency partners will have to cut short efforts 
        to turn vaccines into vaccinations across the globe. Leaving 
        large unvaccinated populations worldwide will increase the risk 
        of new deadly variants emerging that could evade our current 
        vaccines and treatments. Without additional funds, the 
        Administration would be unable to extend Global VAX surge 
        support to 20 plus additional under-vaccinated countries that 
        will need intensive support this year to get shots in arms. 
        This will devastate our ability to ensure those countries can 
        effectively deploy safe and effective vaccines. USAID will also 
        be unable to provide life-saving supplies, tests, therapeutics, 
        oxygen, and humanitarian aid to countries still struggling to 
        manage a continuing COVID disease burden.

    In addition to the immediate need for funding, in order to 
facilitate a smooth transition to insurance coverage of life-savings 
COVID treatments the Administration is requesting that Congress 
provides authority to ensure seamless access to Medicare and insurance 
coverage for treatments under an Emergency Use Authorization (EUA).
                                 ______
                                 
                          Hon. Patty Murray, Chair,
                  Hon. Richard Burr, Ranking Member
U.S. Senate Committee on Health,
Education, Labor, and Pensions,
Washington, DC 20510.
    Dear Chair Murray and Ranking Member Burr:

    Thank you for the opportunity to provide this feedback on the 
discussion draft of the Food and Drug Administration Safety and 
Landmark Advancements (FDASLA) Act and in particular, Subtitle C of 
Title VIII which includes the Verifying Accurate Leading-edge IVCT 
Development (VALID) Act of 2022. The undersigned organizations 
represent a diverse and broad community of healthcare professionals, 
patient advocates, industry organizations, medical institutions, and 
pathology departments who practice laboratory medicine, provide 
clinical testing services, and deliver high quality care to patients 
throughout the U.S..

    We write to you today to express our significant concerns with the 
VALID Act of 2022 and request that you provide additional and 
sufficient time to resolve these concerns prior to advancing this 
legislation. We recognize that the user fee reauthorization offers a 
fast moving legislative vehicle; however, since this proposal 
dramatically modifies the current regulatory framework for an entire 
category of medical services, it's critical that this is done right to 
protect patient access to innovative diagnostics. As such, we 
respectfully request that you allow time for further refinement of the 
VALID Act and do not rush this very flawed, problematic legislation 
through the user fee reauthorization legislative process.

    In 2019, bipartisan, bicameral sponsors of the VALID Act in concert 
with staff from your Committee and the Energy and Commerce Committee 
held a series of 2 hour roundtable discussions with stakeholders and 
officials from the Food and Drug Administration (FDA) on draft 
legislative language that was ultimately introduced as the VALID Act of 
2020. Since then, stakeholders, including many on this letter, have 
provided extensive written comments on each iteration of the 
legislation, met with your offices and the bill's sponsors numerous 
times, participated in staff briefings, and most recently, responded to 
dozens of written questions from your staff circulated to stakeholders 
this past winter. Given this immense and active engagement over the 
past 4 years, we were very dismayed to see that the VALID Act of 2022 
failed to incorporate most of our recommendations, even the most 
significant.

    To illustrate our concerns, the current discussion draft failed to 
resolve these key areas:
    1. Stifling Innovation and Constricting Patient Access to Care.
    While each of our organizations hold specific positions, we are 
unified in our view that the VALID Act of 2022 creates an onerous and 
complex system that would radically alter the way that laboratory 
testing is regulated to the detriment of patient care. The VALID 
framework would be costly as laboratories would be subject to user fees 
and need to finance the internal FDA compliance activities that would 
be required. This would force many laboratories, especially community 
laboratories, to consolidate their testing menu which would disrupt 
localized patient care and minimize the innovative efforts at our most 
prestigious institutions. While we appreciate that the laboratory 
developed testing services offered today would be grandfathered, the 
utility of these tests would diminish over time as the VALID Act puts 
overly restrictive constraints on how they can be modified. Further, 
testing consolidation away from academic and other laboratories would 
result in a reduction in training opportunities for an already strained 
laboratory workforce. Unfortunately, the laboratory workforce shortages 
were a significant barrier for this country's ability to respond to the 
COVID-19 pandemic and we are greatly concerned about the potential 
impact the VALID Act would have on patient care in the decades to come.
     2. Duplication With and Lack of Modernization of the Clinical 
               Laboratory Improvement Amendments (CLIA).
    The VALID Act's provisions on quality systems, adverse event 
reporting, and laboratory inspections duplicate requirements that 
laboratories already comply with under the federally administered CLIA 
program. The bill also references terms and aspects of the current 
medical device regulations that are not translatable to laboratory 
developed testing services. Simply directing the Secretary to avoid 
duplication as is written in the VALID Act of 2022 is insufficient, 
especially when other aspects of the legislation call for requirements 
and activities that lead to duplicative and unnecessary regulatory 
burden. Further, many stakeholders acknowledged the need to modernize 
the CLIA program implemented more than thirty years ago. Any update to 
the oversight of laboratory testing is incomplete and potentially 
duplicative without considering updates to CLIA.
                  3. Preemption of State Requirements.
    Many stakeholders actively participate in validity and quality 
review programs such as those administered by the New York State 
Department of Health (NYSDOH). The NYSDOH program in particular has 
successfully incorporated the concept of reviewing certain testing 
services into their assessment of the quality of a laboratory's 
operations and its personnel which has resulted in a harmonious and 
effective approach to regulating laboratory practice. As such, 
stakeholders have encouraged the Committee to recognize the value of 
such programs, prevent duplication with state efforts, and apply 
lessons learned. The VALID Act of 2022 fails to incorporate any of 
these recommendations and instead allows states with programs in place 
prior to 2022 to continue their programs only if their requirements 
match those of the FDA. Further, as developers will still need to 
comply with both the FDA requirements and those state requirements, 
this will create unavoidable duplication as drafted.
     4. Lack of Clarity in the Risk Categorizations, Definitions, 
Eligibility Criteria for Technical Certification, and Other Key Aspects 
                          of the Legislation.
    Lack of clarity in key aspects of the VALID Act of 2022 including 
the definitions of high, moderate, and low risk, create ambiguities 
that make it impossible to understand the implications of various 
provisions on laboratory medicine and patient care. For instance, the 
newly created definition of moderate risk appears to overlap with the 
definition of high risk. Further, the criteria for the technical 
certification program are unclear as to the types of tests eligible for 
authorization under such an order. Even more concerning, terms 
previously defined in an earlier version of the VALID Act such as 
``well characterized'' and ``adverse event'' have been removed from 
this version yet are still referenced in the legislation.
5. Unpredictable Regulatory Process Due to Significant Discretion Given 
                           to the Secretary.
    Throughout the legislation, the text grants discretion to the 
Secretary creating an unpredictable regulatory process and ambiguities 
in the significance of the policy. This is especially problematic as 
stakeholders try to understand the implications for their laboratories 
and practices. For example, in the section on an abbreviated premarket 
review, the legislation says that developers will not need to provide 
raw data as part of their submission unless requested by the FDA. The 
requirement of providing raw data is a meaningful distinction between 
full premarket review and abbreviated premarket review, and yet the 
Secretary has the discretion in any instance to require that data. 
Additionally, in the grandfathering provision, the Secretary has the 
discretion to direct any grandfathered test for premarket review. This 
further creates confusion as laboratories determine which of their 
tests will be subject to review. There are dozens of instances in the 
legislation similar to these examples. We strongly urge the Committee 
to narrow the discretion so that stakeholders may better evaluate and 
understand the implications of this legislation.
6. Subject Matter Experts, i.e. Test Developers, are Unable to Actively 
               Participate in the Accreditation Process.
    The VALID Act of 2022 prohibits test developers from becoming 
accredited third-party reviewers unless FDA waives this requirement, 
which is in sharp contrast to how the medical and scientific community 
usually act. These professionals are the subject matter experts most 
qualified to assess the validity of a diagnostic test and as such, 
their participation in these processes should not be left to the 
discretion of the Secretary or agency. This country has a long history 
of understanding the merits of and thus supporting scientific peer 
review and without such a system, FDA will greatly lack access 
expertise needed to regulate the tens of thousands laboratory developed 
testing services that are used in clinical care.
       7. FDA Lacks Adequate Resources to Meet These Obligations.
    During the COVID-19 pandemic, the FDA was quickly overwhelmed by 
the volume of applications submitted for the emergency use 
authorization, so much so that they had to pause review of all other 
non-EUA applications. This meant delays to the review and subsequent 
access to potentially lifesaving tests such as for oncology 
indications. Even with the funding infusion from user fees, based on 
the experience during the pandemic, we are very much concerned that FDA 
will be unable to handle implementing and administering the VALID Act. 
In 2021, there were more than 160,000 individual genetic tests on the 
market and FDA could not handle the influx of 2133 emergency use 
authorization requests for COVID-19 from March 2020--April 2021.
   8. The Emergency Use Authorization (EUA) Provision Will Create a 
         Similar Crisis Experienced in Winter and Spring 2020.
    At the onset of the pandemic, a contaminant in the only EUA-
authorized test kit plus restrictions on clinical laboratories that 
prevented them from offering laboratory developed testing services 
without FDA review, led to a crisis in the United States in which we 
had no testing for COVID-19 for over 1 month. Guidance published on 
February 29, 2020 allowing the use of tests while laboratories awaited 
an EUA decision was critical for the country's response. Recognizing 
the importance of this guidance, the VALID Act of 2020 and the VALID 
Act of 2021 included EUA language that allowed a similar approach. It's 
unclear why this was removed in the VALID Act of 2022, and we encourage 
the Committee to allow for similar approach in which laboratories can 
quickly mobilize during a public health emergency.

    These are just eight examples of instances in the VALID Act that 
need major overhaul to address the concerns stakeholders have shared 
countless times in writing and in meetings with the bill's sponsors and 
with Committee staff. Before advancing this legislation, we implore you 
to modify the legislation to reflect stakeholders' input and to do so 
in a timeframe that ensures that policy fosters patient safety and 
innovation instead of creating barriers and delays to access novel 
diagnostics.

    For these reasons, the undersigned organizations request that you 
do not advance the VALID Act as part of the Food and Drug 
Administration Safety and Landmark Advancements Act and instead work 
with stakeholders to refine this legislation.

            Sincerely,
                                    20/20 GeneSystems, Inc.
   Academy of Clinical Laboratory Physicians and Scientists
                                               AdventHealth
                                  Akron Children's Hospital
                                             Alphadera Labs
                American Association for Clinical Chemistry
          American College of Medical Genetics and Genomics
                    American Society for Clinical Pathology
American Society for Histocompatibility and Immunogenetics 
                                                     (ASHI)
                             American Society of Hematology
                        American Society of Transplantation
                                                 Amerimmune
                                          ARUP Laboratories
                        Association for Molecular Pathology
                      Association for Pathology Informatics
                   Association of American Medical Colleges
             Association of Organ Procurement Organizations
                            Association of Pathology Chairs
                                              Atrium Health
                                Baylor Scott & White Health
                           Cancer Genomics Consortium (CGC)
                                               Cedars-Sinai
                            Children's Hospital Los Angeles
                          Clinical Immunology Society (CIS)
                Coalition for Innovative Laboratory Testing
                  Columbia University Irving Medical Center
                                           Dartmouth Health
 Department of Pathology & Laboratory Medicine, University 
                                      of California, Irvine
 Department of Pathology & Laboratory Medicine, University 
                                of Miami School of Medicine
 Department of Pathology and Laboratory Medicine, Hartford 
                                                   Hospital
Department of Pathology and Laboratory Medicine, Northwell 
                                                     Health
 Department of Pathology and Laboratory Medicine, Perelman 
             School of Medicine, University of Pennsylvania
Department of Pathology and Laboratory Medicine, University 
                                   of Florida--Jacksonville
Department of Pathology and Laboratory Medicine, University 
                                              of Louisville
Department of Pathology and Laboratory Medicine, University 
                       of North Carolina School of Medicine
                   Department of Pathology, Duke University
   Department of Pathology, East Carolina University Brody 
                                         School of Medicine
     Department of Pathology, Texas Tech University Health 
                            Sciences Center, El Paso, Texas
 Department of Pathology, University of Arizona College of 
                                           Medicine Phoenix
 Department of Pathology, University of Illinois at Chicago
 Department of Pathology, University of Pittsburgh Medical 
                                                     Center
         Department of Pathology. University of Alabama at 
                                                 Birmingham
                                           Diaceutics, Inc.
                               Diamond Medical Laboratories
                                           Emory Healthcare
                               Entvantage Diagnostics, Inc.
                                              Everly Health
                                               Gene By Gene
                                                GeneMatters
                                       Genome Medical, Inc.
                                                   Genomind
                            GenXys Health Care Systems Inc.
                                                 GoDx, Inc.
                                        Gravity Diagnostics
                                 Harbor-UCLA Medical Center
                                           Helix Op Co, LLC
                                        Invitae Corporation
                                             IVD Logix, LLC
                                Johns Hopkins Health System
                                          Kaiser Permanente
                                               KRAS Kickers
                   Laboratory Access and Benefits Coalition
                                    Lighthouse Lab Services
   Mass Spectrometry & Advances in the Clinical Lab (MSACL)
                       Medical Group Management Association
                                            My Gene Counsel
                             Nationwide Children's Hospital
                                          Nebraska Medicine
                         NorthShore University HealthSystem
                                  Northwest Pathology, P.S.
                                         NYU Langone Health
                             Olive View-UCLA Medical Center
                         Oregon Health & Science University
         Pan-American Society for Clinical Virology (PASCV)
                                                  PathGroup
                                              Premier, Inc.
                                Progentec Diagnostics, Inc.
                                Pulmonary Pathology Society
                                                 Sapere Bio
                                           Sema4 and GeneDx
                             TriCore Reference Laboratories
                                            UC Davis Health
                                        UC San Diego Health
                                                 UCI Health
                                                UCLA Health
                            University of California Health
                     University of California San Francisco
                       University of Chicago Medical Center
                            University of Cincinnati Health
               University of Nebraska Medical Center (UNMC)
                                   University of New Mexico
                                    University of Rochester
                       University of Vermont Health Network
                                                 UVA Health
                                                  UW Health
                                                UW Medicine
                       Vanderbilt University Medical Center
                           Virginia Commonwealth University
                                     Weill Cornell Medicine
                     West Virginia University Health System
                                 ______
                                 

                        QUESTIONS FOR THE RECORD

  Response by Rochelle Walensky to Questions of Senator Burr, Senator 
                      Murkowski, and Senator Scott
                              senator burr
    Question 1. I want to talk about CDC's COVID-19 community levels 
metrics. For those who are not familiar, CDC uses green, yellow, and 
red to represent the impact of COVID-19 in each county, which you have 
said is based on the health system's capacity to deal with the virus. 
The color is determined by looking at the number of new cases in the 
county, COVID hospital admissions, and the percent of inpatient beds 
occupied by COVID patients.

    I have heard that states are not using this tool at all, because it 
does not accurately reflect the level of severe disease and ability to 
surge. You can have one county in the green with COVID hospital 
admissions well above another county that is in the yellow.

    In North Carolina, for example, CDC identifies Rockingham County as 
a green county, meaning low impact of COVID-19, Wake County as yellow, 
and Durham County as red. Despite the color ratings, the number of 
COVID hospital admissions is actually higher in Rockingham--a green 
county--than it is in Wake--a yellow county--and the percent of 
inpatient beds occupied by COVID patients in each of these three 
counties hovers around 5 percent.

    What outreach have you conducted to states and local public health 
authorities to see if this tool is accurate and even helpful at all?

    Answer 1. CDC Response: The Centers for Disease Control and 
Prevention (CDC) has held calls with jurisdictions about the COVID-19 
Community Levels (CCLs) and used the feedback shared as we continue to 
evaluate and assess ways to improve the tool. Jurisdictions have 
indicated they find the CCLs a useful informational tool. CDC has also 
held over 20 meetings with public health partners regarding CCLs. 
Topics included community levels data and technical assistance, CCL 
report feedback and updates, and CCL Report Mockup/Pre-decisional 
discussions. Attendees were jurisdictional and tribal partners 
including State, Territorial, and Local Health Officials; state 
epidemiologists; senior leadership from the Association of State and 
Territorial Health Officials (ASTHO), the National Association of 
County and City Health Officials (NACCHO), the Association of Public 
Health Laboratories (APHL), the Big Cities Health Coalition (BCHC), and 
the Council of State and Territorial Epidemiologists (CSTE); and the 
CDC Foundation.

    Question 2. CDC is encouraging doctors to test for monkeypox. 
However, the only way to currently test for monkeypox in the United 
States is through public health laboratories. Has CDC started working 
with commercial and other private sector labs to develop tests for 
monkeypox? If so, what is the timeline for their availability? If not, 
why not? Why haven't you learned the lessons of CDC's failure at the 
beginning of the COVID pandemic?

    Answer 2. At this time, available testing capacity through public 
health capacity is far greater than demand. 69 U.S. public health 
laboratories are able to test for orthopoxvirus, producing a throughput 
capacity between 6,000-8,000 specimen weekly. Orthopoxvirus testing is 
utilizing approximately 2 percent of Laboratory Response Network 
capacity as of June 16, 2022.

    CDC is working with the Food and Drug Administration (FDA), the 
Centers for Medicare & Medicaid Services (CMS), and other Federal 
partners to explore options for expanding testing convenience and 
options into the commercial space. CDC is working with commercial, 
hospital, and academic laboratories to be prepared to expand testing 
capacity. In particular, CDC began engaging with key commercial 
laboratory partners about expanding orthopoxvirus testing capacity on 
May 23, less than a week after the first detected U.S. case of 
monkeypox was confirmed.

    Unlike the currently circulating monkeypox virus, COVID-19 is a 
novel pathogen that required development of an entirely new diagnostic 
test. The United States is better positioned to respond to the 
monkeypox outbreak, having a historic scientific basis of information 
on the nature and effective medical counter measures for orthopox 
viruses. Investments made in the Smallpox Research Agenda have 
contributed to the availability of an FDA-cleared non-variola 
orthopoxvirus test, therapeutic measures including the anti-viral 
tecovirimat, and a deployable vaccine, JYNNEOS. Investments in the 
Laboratory Response Network have helped build testing capacity, which 
at this point have provided capacity far greater than current testing 
demand.

                           senator murkowski
    Question 1. Dr. Walensky, as you are aware by now the Alaskan 
tourism economy took the largest hit from the COVID-19 pandemic in the 
country, with a 33 percent loss in revenue to the state. We are hearing 
that cruises this year are operating at around 70 percent capacity on 
average. This past December, as we were looking ahead to the upcoming 
cruise season in Alaska and safely rebuilding our economy, the Centers 
for Disease Control elevated their Travel Risk Advisory for cruise 
ships to a Level 3 Risk Advisory, which at the time was the same risk 
as traveling to Ukraine.

    The cruise industry was the only industry targeted by the travel 
advisory during the COVID Pandemic, as all other risk advisories were 
for geographic regions. At the time of this announcement, the U.S. was 
seeing a surge in positive cases due to the Omicron variant; however, 
vaccination rates onboard a cruise ship were typically upwards of 95 
percent--significantly higher than the overall U.S. population which 
was at about 60 percent.

    Question 1(a). Why did CDC issue the Travel Advisory on cruise 
ships when they had the highest level of safety precautions in place?

    Answer 1. CDC has historically used Travel Health Notices (THNs) to 
alert travelers and other audiences about current health issues that 
impact travelers' health, like disease outbreaks, special events or 
gatherings, and natural disasters, in destinations around the world. 
These range from a watch level 1 to a warning level 3.

    CDC issued a separate COVID-19 THN for cruise ships because the 
risk of COVID-19 transmission on cruise ships is different from that of 
shoreside travel and entertainment settings (such as U.S. resorts, 
restaurants, bars, and theme parks). Specifically, cruise ships are 
congregate residential settings with high risk of COVID-19 transmission 
among travelers (passengers and crew). They have thousands of travelers 
living for multiple days (or months for crew) on the same ship--eating, 
sleeping, and participating in activities together in one location. 
Data from the pandemic suggest COVID-19 spreads quickly in group 
settings, including on cruise ships.

    During the first 2 years of the pandemic, large outbreaks were 
identified on many cruise ships during periods that coincided with 
major pandemic waves. These outbreaks posed a health risk to travelers 
on board by exposing them to the virus. In addition, on many affected 
ships, COVID-19 cases overwhelmed onboard medical facilities, which led 
to reduced access to healthcare services for travelers on board who 
needed to seek medical care for COVID-19 or other health conditions. 
Hence, CDC developed COVID-19 THN levels and criteria specific to 
cruise ships to inform the public regarding COVID-19 conditions on 
board. CDC used COVID-19 data reported by cruise ships and relevant 
public health authorities to make determinations about the cruise ship 
THN level. Additional information such as new variants of concern, 
vaccination rates, severity of disease (such as hospitalizations, 
medical evacuations, and deaths for crew or passengers) were considered 
when determining the cruise ship THN level. Furthermore, CDC worked 
with the cruise industry and public health authorities to gather 
additional data as appropriate.

    CDC removed the COVID-19 Cruise Ship Travel Health Notice on March 
30, 2022. While cruising continues to pose some risk of COVID-19 
transmission, travelers can make their own risk assessment when 
choosing to cruise, much like they do in other travel settings, based 
on factors such as their health and vaccination status, and personal 
risk tolerance.
    Question 1(b). Will CDC commit to ending COVID related travel 
advisories that single out U.S. destinations?

    Answer 1(b). CDC remains committed to leading with science and 
protecting the American public during this pandemic. CDC issued a THN 
for cruise ships to notify travelers and other audiences about a major 
health issue that impacted cruise ship travelers (passengers and crew) 
at the time. The cruise ship THN was not designed to single out any 
U.S. or international destinations.

    Question 1(c). When will CDC cease ending COVID related travel 
advisories for the cruise industry?

    Answer 1(c). CDC removed the COVID-19 Cruise Ship THN on March 30, 
2022. While cruising continues to pose some risk of COVID-19 
transmission, travelers can make their own risk assessment when 
choosing to cruise, much like they do in other travel settings, based 
on factors such as their health and vaccination status, and personal 
risk tolerance.

    Question 2. Dr. Walensky, I continue to be concerned about the 
impacts of COVID-19 on the well-being of children and youth in Alaska. 
We know that there have been devastating affects to our children and 
youth's mental health, as we have seen a wave of emotional health 
needs. Alaska continues to have the second highest rates of suicide in 
the Nation, and suicide is the second leading cause of death for 
individuals ages 25-44. And we have seen an alarming increase in mental 
and behavioral health issues and suicide attempts by children.

    Additionally, I am concerned about the well-being of our children 
and youth due to the disrupted school years. There has been documented 
learning loss due to the shift to virtual learning, and this is not 
accounting for the social-emotional impacts. An analysis by McKinsey 
suggests that students were (on average) 5 months behind mathematics 
and 4 months behind in reading by the end of the 2021 school year.

    In Alaska, I have heard from programs caring for young children, 
that there have been significant increases in developmental delays 
amongst babies' speech and language development--possibly attributed to 
mask wearing.

    Question 2(a). Has the CDC evaluated the negative impacts of the 
COVID-19 pandemic, not just the mental health of children and youth, 
but the effects on developmental delays and learning loss?

    Answer 2(a). CDC remains committed to working with our state and 
local partners to improve access to mental health resources as we 
continue to address the long-term impacts of the pandemic. CDC is 
analyzing data to understand the trends associated with students' 
mental health during COVID. Data were collected as part of the 
Monitoring School COVID-19 Mitigation Strategies Project, a project 
funded by the CDC Foundation to inform CDC's Operational Strategy for 
K-12 Schools through Phased Prevention COVID-19 recommendations. Data 
were also collected as part of the Adolescent Behaviors and Experiences 
Survey (ABES), a project funded through the CARES Act to assess the 
impact of COVID-19 on behaviors and experiences of U.S. high school 
students. ABES provides a nationally representative sample of high 
school students experiences during the COVID-19 pandemic. According to 
the new data, in 2021, more than a third (37 percent) of high school 
students reported they experienced poor mental health during the COVID-
19 pandemic, and 44 percent reported they persistently felt sad or 
hopeless during the past year.

    CDC's Study to Explore Early Development (SEED) conducted a COVID-
19 Impact Assessment (January through June 2021) with over 1,000 
parents of children 5-9 years of age who were already enrolled in SEED. 
Study findings showed disruptions to regular health services were 
common across all study groups (58 percent-65 percent) and disruption 
to specialty services were more common for children with autism 
spectrum disorder (76 percent) versus children with other developmental 
disabilities (58 percent) and the general population (23 percent). 
Between 70 percent-81 percent of children who received developmental 
services through telehealth had a worse response compared to in person 
visits. Ongoing analyses will address changes in daily living skills 
and behavior problems, factors associated with childhood resiliency, 
response to mitigation strategies and infection, and impact of pandemic 
on parental mental health.

    With COVID funding, CDC expanded its Act Early Ambassador program 
to further support families with young children in high need 
communities across the country by bolstering collaboration among early 
childhood programs to identify and support children with developmental 
delays and disabilities, and to promote resiliency skills among 
families during the pandemic. Forty-three state and territorial 
``COVID-19 Act Early Response Teams,'' including a team in Alaska, 
completed a national needs assessment that described the impact of 
COVID-19 on early identification of developmental disabilities across 
early childhood system.

    Question 3. I have had several conversations with Alaskan public 
health officials, on lessons learned from the Federal response to the 
COVID-19 pandemic. I am disappointed that CMS and IHS are not 
testifying today, as we know they were pivotal in the response to 
COVID-19. This pandemic was not only a public health crisis, but a 
crisis affecting our health systems and the delivery of healthcare. I 
believe that we must apply lessons learnt, to address new public health 
epidemics, such as the drug overdose crisis that many of our 
communities are experiencing. The Federal Government has to improve 
transparency and integrate Federal services, to allow states to respond 
to future public health crisis that arise. An example of this is the 
drug overdose epidemic that many of our states are now experiencing. 
The Federal Government has a responsibility to promote data-sharing 
throughout all health systems. For example, we did not see a 
significant improvement in the surveillance of COVID-19 until CMS 
required hospitals to share data on bed capacity with ASPR. Sharing 
data between hospital systems and state lines, is essential in 
addressing future public health issues and most notably, the drug 
overdose epidemic.

    Question 3(a). How can HHS continue to work internally and with 
other Federal agencies, such as the VA and DOD to integrate Federal 
services and promote data-sharing throughout healthcare systems?

    Answer 3(a). CDC participated in the VA/DOD hosted COVID-19 Data 
Collaboratory during the week of May 16, 2022. The focus of the 
Collaboratory was to discuss efforts at developing further coordination 
across a host of areas, including common ways to collect, analyze, and 
share data findings to track the burden of disease and the 
effectiveness of prevention and treatment efforts. Engagement is 
ongoing with the VA/DOD with a follow-up large group meeting schedule 
in Fall 2022. Additionally, CDC is working with HHS leadership, such as 
the Office of the National Coordinator for Health IT (ONC), as well as 
other HHS OpDivs such as CMS, to better understand and coordinate the 
way data is collected, shared, and analyzed. These efforts also support 
ongoing work to update the HHS data strategy and ensure that data is 
available, accessible, timely, equitable, meaningfully usable, 
protected--and being actively used by HHS, our partners, and the public 
to realize HHS' mission.

    CDC currently lacks the authority to coordinate and require the 
reporting of public health data from state and local health departments 
and healthcare facilities. The result is a fragmented approach to 
public health reporting that is hindered by a patchwork of policies 
which vary from jurisdiction to jurisdiction and prohibits CDC from 
developing the clear national picture of disease burden across the 
country. The lack of a consistent, comprehensive reporting framework is 
burdensome on healthcare providers, who must attempt to meet many and 
varied requirements, and leaves large gaps in the Federal Government's 
ability to prepare for and respond to disease outbreaks. This 
discordance also reduces the quality of data that can be shared back 
with jurisdictions and with interagency partners, such as the VA and 
DOD.

    Providing CDC with a modernized public health authority could 
improve CDC's ability to share high quality data with our interagency 
partners, like the VA and DOD, on a wide array of public health issues, 
including the overdose epidemic. For example, the ability to require 
emergency department data would help CDC and states to more rapidly 
detect unusual spikes in visits related to overdoses, facilitating a 
more rapid response.

    Question 3(b). What can the CDC and ASPR do to continue to 
streamline healthcare workforce efficiency and improve data 
modernization?

    Answer 3(b). The National Healthcare Safety Network (NHSN) is the 
most comprehensive USG data collection and quality improvement system 
for healthcare and is currently in use in more than 38,000 healthcare 
facilities in the U.S., with more than 136,000 individual users 
tracking and identifying emerging and enduring threats across 
healthcare. At the outset of the COVID-19 pandemic, CDC rapidly 
leveraged the reach that NHSN has into thousands of healthcare 
facilities to collect urgently needed COVID-19 data from hospitals, 
nursing homes, dialysis clinics, and other facilities. With support 
from COVID supplemental funding, CDC now collects and analyzes COVID-19 
data from every nursing home in the country (?15,400), including 
vaccination coverage of their 1.2 million residents and 1.8 million 
staff, as well as hospital staff COVID-19 vaccination from more than 
7.6 million healthcare personnel.

    CMS also relies on NHSN for regulatory functions, public reporting, 
and incentive payment programs, including mandatory COVID-19 reporting 
from all U.S. nursing homes and mandatory COVID-19 staff vaccination 
reporting from all U.S. hospitals. CDC has consistently worked with CMS 
to provide data from healthcare settings that is reported in NHSN and 
other systems, including CMS public reporting of facility level COVID 
data from NHSN. CDC has coordinated with VA and IHS to improve 
reporting of COVID and other healthcare data by relevant facilities and 
share data as appropriate to assist these agencies with their 
prevention efforts. CDC has also worked with health departments 
throughout the pandemic to provide access to NHSN reports and data to 
inform their efforts.

    CDC is working with other agencies, public health partners, and 
industry to increase the automation of data reporting to NHSN and 
modernize user interface and support. The goal is to accelerate the 
integration of electronic healthcare records and other emerging data 
standards to NHSN and provide a modern, flexible platform that can 
serve as the hub of USG healthcare data for CDC, CMS, ASPR, and HHS to 
identify and to respond to emerging and enduring health threats in 
healthcare facilities. CDC is also exploring additional capabilities to 
address future health emergencies as described in CMS's recently 
proposed rule requiring ongoing reporting of COVID-19 data from 
hospitals; reporting of pathogens of pandemic or epidemic potential 
during future public health emergencies; as well as CMS' recently 
finalized rule which extends nursing home COVID-19 reporting for 
several years beyond the end of the current Public Health Emergency. 
CDC will also work with health departments and other public health 
partners to continue to expand and improve provision of analytic 
reports and electronic data provided from NHSN to state and local 
health departments, other Federal Government agencies--such as CMS and 
ASPR--and public health partners to support infection control and 
prevention activities and improve patient safety.

    CDC, the Association of Public Health Laboratories (APHL), and the 
Council of State and Territorial Epidemiologists (CSTE) are working 
with healthcare organizations and their EHR vendors to automate the 
reporting of conditions of significance to public health agencies that 
is required of healthcare providers. Electronic case reporting (eCR) 
modernizes the reporting by using data entered in electronic health 
records as part of care delivery by healthcare providers. The 
automation of this reporting reduces the burden on the providers to 
submit reports in a manual process, typically by filling out a paper 
form and faxing it to public health.

    Question 4. We talk a lot about the importance of health equity, 
and focusing on populations that have documented inequities. I have 
been a vocal advocate for addressing health equity issues, particularly 
the issues affecting Alaska Native and American Indian populations to 
die at higher rates than other Americans in many categories, including 
chronic liver disease and cirrhosis, diabetes mellitus, unintentional 
injuries, assault/homicide, intentional self-harm/suicide, and chronic 
lower respiratory diseases.

    However, I want to discuss a different type of equity today, which 
is an important part of the health equity discussion. When we are 
evaluating our Federal response to COVID-19, we fail to discuss state 
equity. States with larger populations, tend to have more purchasing 
power for therapeutics, testing, and other medical supplies, leaving 
many rural states (the majority Western states) behind. We saw this 
during the COVID-19 pandemic, when Alaska was unable to compete with 
New York City, California, or private investors in purchasing PPE, 
therapeutics, and testing supplies.

    Question 4(a). As we move to toward a new phase of COVID-19, how 
are we going to ensure there is state equity when accessing these 
supplies on the private market?

    Answer 4(a). CDC defers to ASPR.

    Question 4(b). What is HHS going to do to address these issue of 
unequal purchasing power to ensure equal access?

    Answer (b). Please see the answer from ASPR.

    Question 4(c). What is HHS doing to continue to conduct 
surveillance of COVID-19, to ensure states can plan appropriately for 
different waves to come?

    Answer 4(c). CDC has been sharing with Americans and the rest of 
the world what we've learned about COVID-19. COVID Data Tracker 
contains a wealth of numbers and tools to analyze COVID-19 cases, 
deaths, and trends at the local, state, and national levels. Data 
Tracker tool contains total cases; average number of daily cases during 
the previous 7 days; total number of deaths; and total number of 
vaccinations. The information, which is updated daily, is both big-
picture (with national data) and granular (down to the county level).

    CDC is also working to detect and characterize new variants of the 
virus that causes COVID-19. As CDC has learned new information about 
the variants, the agency has been providing updates to the public and 
our partners around the world. CDC's COVID-NET program collects data on 
laboratory-confirmed, COVID-19-associated hospitalizations among 
children and adults through a network of over 250 acute-care hospitals 
in 14 states.

    Question 5. The impacts of COVID-19 have exacerbated mental health 
issues across the country and within the military. We've seen this 
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service 
members and their families face difficult and unique circumstances 
living in an austere and remote location, and COVID protocols increased 
their isolation without providing enough access to resources such as 
mental health providers. Just last week, Senator Sullivan and I 
introduced the Don Young Arctic Warrior Act, which focuses increasing 
the help and assistance they need and deserve.

    Question 5(a). Is HHS working on any long-term solutions to address 
the rise in military suicides, as exacerbated by the isolation brought 
on by COVID?

    Answer 5(a). CDC uses data to understand the contributors to 
suicide, including its scope and magnitude, who is most impacted, and 
to track trends over time to inform prevention and response efforts. 
For almost 20 years, CDC has collected data on suicide deaths through 
the National Violent Death Reporting System (NVDRS). CDC has ongoing 
collaborations with the Departments of Defense (DoD) and the Department 
of Veterans Affairs (VA) to strengthen suicide-related data to better 
tailor prevention efforts for veterans and active-military. CDC and the 
Department of Defense link and analyze data from the DoD's Suicide 
Event Report (DoDSER) and NVDRS. DoD collects information on active-
duty service members while NVDRS collects data on people who have ever 
served in the military, and civilian populations. Combining NVDRS and 
DoDSER provides the opportunity to examine and better understand 
suicides among, civilians, veterans, and active-duty military to inform 
upstream prevention, tailor effective strategies, and identify hotspots 
and gaps to target efforts. For example, this project creates detailed 
mapping of suicide burden by county, as well as a thorough description 
of the characteristics of veteran and active-duty suicides in areas 
with the highest incidence. These maps are overlaid with military 
installations, mental health clinics, and suicide prevention programs 
to see which hotspots may lack infrastructure to address suicide burden 
and to highlight areas in need of suicide prevention resources, 
including upstream prevention. Additionally, CDC works with the VA to 
link mortality data from CDC's National Death Index to VA data to 
improve understanding of veteran suicide.

    In addition, CDC is funding approaches to primary prevention of 
suicide. CDC's Comprehensive Suicide Prevention (CSP) program funds 
states and communities to implement multiple strategies and approaches 
with attention to populations disproportionately affected by suicide, 
including military and rural populations. These strategies are 
discussed in further detail in the response below.

    Question 5(b). Are there any lessons the military could learn from 
the CDC or NIH on what strategies work in reducing suicides in highly 
isolated populations?

    Answer 5(b). While anyone can experience suicide risks, certain 
groups have substantially higher rates of suicide than the general U.S. 
population, and CDC recognizes that active-military and veterans bear a 
disproportionate burden. Suicide is preventable, and the same scalable 
prevention and protective strategies CDC has demonstrated effective for 
individuals, families, and communities work for veterans and active 
military too. CDC's Preventing Suicide: A Technical Package of 
Policies, Programs, and Practices (https://www.cdc.gov/suicide/pdf/
suicideTechnicalPackage.pdf) highlights strategies based on the best 
available evidence to prevent suicide including strategies that address 
isolation such as. promoting connectedness, teaching coping and 
problem-solving skills, and identifying and supporting people at risk.

    A comprehensive approach to suicide prevention that includes 
multiple strategies tailored to population needs (including military 
and rural populations) can help reduce suicide and suicide risk. CDC's 
Comprehensive Suicide Prevention (CSP) program funds states and 
communities to implement multiple strategies and approaches from the 
technical package with attention to populations disproportionately 
affected by suicide, including military and rural populations. The 
program seeks to reduce suicide and suicide attempts by 10 percent over 
the course of the 5-year program. CDC also funds the Veteran Suicide 
Prevention Evaluation Demonstration Project (VSPE) to improve the 
evaluation capacity of veteran serving organizations (VSOs) to measure 
the impact of their upstream suicide prevention programs (e.g. those 
focused on improving connectedness). This project just completed its 
fourth year. We know firsthand from working with VSOs participating in 
this project that social connectedness is crucial in supporting 
veterans in their communities and in reducing suicide risk.

    To address isolation and reduce access barriers, some of our funded 
partners are exploring the use of technology to reach and connect 
veterans. For example, CDC funded Objective Zero Foundation (a VSO) to 
develop a mobile app that helps veterans and community members 1) 
independently access wellness tools, trainings, and resources; 2) seek 
support through a crisis hotline or Ambassador; and 3) provide support 
and resources to Ambassadors. The program is currently evaluating 
outcomes, including social connectedness, awareness, and user intent to 
access mental health and other resources and skills to help others. 
Other CDC funded projects, such as Zero Suicide, are exploring 
telehealth to reach at-risk populations to implement evidence-based 
practices that engage and retain individuals at increased risk for 
suicide in care services. Telehealth is a strategy that has been found 
to be effective in reaching veterans and rural populations at risk of 
suicide. Relaxed state laws allowing use of telehealth services enacted 
during the COVID-19 pandemic helped reduce transportation barriers and 
increase access through use of Medicaid funds to reimburse providers 
for telehealth visits.

                           from senator scott
    Question 1. Dr. Walensky--South Carolina had the 5th highest 
prevalence of diabetes among adults in the U.S. in 2017 and it is the 
7th leading cause of death in my state. I have a bill with Senator 
Warner, the PREVENT DIABETES Act (S. 2173), which would align Medicare 
coverage for diabetes prevention programs with the existing and highly 
successful CDC recognition of these programs to simplify compliance and 
expand patient access by allowing virtual suppliers of these services. 
I was pleased to see that the National Clinical Care Commission, a 
panel of national diabetes care experts recently made a similar 
recommendation to HHS--recommending that the Medicare program better 
align its coverage of these services with the CDC's national program by 
allowing virtual access to diabetes prevention programs.

    Can you discuss the public health and wellness opportunity that 
would be created by expanding access to diabetes prevention programs 
for seniors? Specifically, can you discuss the opportunity virtual 
Diabetes Prevention Programs create to effectively help address the 
increased rates of pre-diabetes--particularly rural areas without in-
person providers--as a result of the pandemic?

    Answer 1. Approximately 26 million American adults 65 years and 
older have prediabetes. Expanding Medicare beneficiaries' access to the 
Medicare Diabetes Prevention Program (MDPP) can be critically important 
to the health and well-being of this population. CMS offered greater 
flexibility to provide virtual delivery of MDPP services during the 
COVID-19 public health emergency (PHE) to ensure continuity of services 
when in-person classes are not safe or feasible.

    The MDPP expanded model was originally intended to provide 
primarily in-person MDPP services and does not include a ``virtual 
only'' option. CMS has not permitted virtual-only suppliers to furnish 
MDPP services while the Public Health Emergency Policy is in effect. 
This is because MDPP suppliers must remain prepared to resume delivery 
of MDPP services in-person to start new cohorts and to serve 
beneficiaries who wish to return to in-person services when the PHE has 
concluded. At this time, CMS does not have a path for continuing 
virtual delivery of MDPP post PHE except for the limited virtual 
options that existed prior to the PHE.

    A 2017 study in rural communities found that for the National 
Diabetes Prevention Program (National DPP) lifestyle change program, 
which the MDPP is modeled after, participants who participated through 
telehealth videoconferencing had similar participation rates and 
achieved similar weight loss outcomes as participants who attended in 
person.1 More than 300,000 (. 60 percent) enrollees in the National DPP 
lifestyle change program have participated in a virtual program, making 
it the most popular delivery method. It seems virtual participation 
could improve access while improving health care outcomes. The National 
DPP lifestyle change program is cost effective and can contribute to 
cost savings.
                                 ______
                                 
  Response by Anthony Fauci to Questions of Senator Burr and Senator 
                               Murkowski
                              senator burr
    Question 1. Dr. Fauci, we have seen evidence that BA.4 and BA.5 are 
more transmissible than other Omicron subvariants and are likely to 
evade immunity from vaccines. A recent study from Israel indicates that 
individuals who were vaccinated and recovered from Omicron may have 
some more protection. What do we know about BA.4 and BA.5 so far and 
what questions are we still asking-or what should we be asking?

    Answer 1. Initial data indicate that the BA.4 and BA.5 variants of 
SARS-CoV-2 are more transmissible than previous variants and may 
partially evade the immune response from previous infection and/or 
vaccination. The continued emergence of SARS-CoV-2 variants with such 
attributes is a cause for concern. The National Institute of Allergy 
and Infectious Diseases (NIAID) has launched collaborative research to 
help answer key scientific questions related to BA.4, BA.5, and other 
SARS-CoV-2 variants, namely the effectiveness of vaccines, monoclonal 
antibodies, and antiviral drugs.

    The National Institutes of Health (NIH), including NIAID, 
participates in the Department of Health and Human Services-established 
SARS-CoV-2 Interagency Group (SIG) along with the Centers for Disease 
Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), 
Biomedical Advanced Research and Development Authority (BARDA), 
Department of Defense (DOD), and U.S. Department of Agriculture. The 
SIG tracks variants in real time to address the potential impact of 
emerging variants on critical SARS-CoV-2 countermeasures. As part of 
SIG, NIAID leads the SARS-CoV-2 Assessment of Viral Evolution (SAVE) 
program to rapidly prioritize variants for studies to characterize 
their properties, including whether immunity is maintained against 
these variants. Through the SAVE program, NIAID-supported scientists 
have generated in vitro neutralization data with post-vaccination sera 
that show a reduction in neutralization titers for BA.5 compared to 
earlier Omicron subvariants (BA.1). Studies are ongoing to assess how 
sera from people who experienced a breakthrough BA.1 or BA.2 infection 
are able to neutralize BA.4 or BA.5. NIH continues to assess this 
phenomenon as other emerging variants may be able to further escape 
immunity.

    With both the Delta and Omicron variants, protection against mild 
and moderate disease begins to decrease over time following the primary 
vaccine series. As SARS-CoV-2 variants have emerged, NIAID moved 
rapidly to investigate the potential of targeted boosters to enhance 
immune responses to emerging variants. NIAID now will examine whether 
people who received boosters--either mRNA-1273 or variant-specific 
COVID-19 boosters--generate antibodies that can bind to and neutralize 
the Omicron variant and its sublineages, including BA.4 and BA.5. NIAID 
also 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. NIAID recently launched the 
Phase 2 COVID-19 Variant Immunologic Landscape (COVAIL) trial to learn 
whether different vaccine booster regimens can broaden and increase the 
durability of immune responses in adults who already have received a 
primary vaccination series and a first booster shot.

    NIAID also conducts and supports research to determine the impact 
of SARS-CoV-2 variants on the effectiveness of monoclonal antibodies 
and other therapeutics. For example, research suggests that although 
the activity of certain monoclonal antibodies against Omicron is 
markedly diminished, the monoclonal antibody bebtelovimab, discovered 
by the NIAID VRC in collaboration with AbCellera, is active in vitro 
against all circulating Omicron subvariants, including BA.4 and BA.5. 
In addition, NIAID is working to develop new drugs, including 
therapeutics that inhibit essential processes in the virus replication 
cycle or that address the host response to COVID-19, with an eye toward 
agents that maintain their effectiveness against emerging variants.

    Additional SARS-CoV-2 variants can be expected to arise and NIAID 
is supporting the development of next-generation COVID-19 vaccines that 
could provide additional protection against disease caused by emerging 
SARS-CoV-2 variants. Strategies for next-generation COVID-19 vaccines 
include targeting viral antigens that are highly conserved among SARS-
CoV-2 strains, testing innovative antigen presentations, and utilizing 
alternative routes of inoculation, such as intranasal vaccine 
approaches to generate better mucosal immunity to potentially limit 
infection and transmission. NIAID also is conducting research on pan-
coronavirus vaccines designed to provide broad protective immunity 
against emerging SARS-CoV-2 variants, such as BA.4 and BA.5, and other 
coronaviruses with pandemic potential.
                           senator murkowski
    Question 1. I have had several conversations with Alaskan public 
health officials, on lessons learnt from the Federal response to the 
COVID-19 pandemic. I am disappointed that CMS and IHS are not 
testifying today, as we know they were pivotal in the response to 
COVID-19. This pandemic was not only a public health crisis, but a 
crisis affecting our health systems and the delivery of healthcare. I 
believe that we must apply lessons learnt, to address new public health 
epidemics, such as the drug overdose crisis that many of our 
communities are experiencing. The Federal Government has to improve 
transparency and integrate Federal services, to allow states to respond 
to future public health crisis that arise. An example of this is the 
drug overdose epidemic that many of our states are now experiencing. 
The Federal Government has a responsibility to promote data-sharing 
throughout all health systems. For example, we did not see a 
significant improvement in the surveillance of COVID-19 until CMS 
required hospitals to share data on bed capacity with ASPR. Sharing 
data between hospital systems and state lines, is essential in 
addressing future public health issues and most notably, the drug 
overdose epidemic. How can HHS continue to work internally and with 
other Federal agencies, such as the VA and DOD to integrate Federal 
services and promote data-sharing throughout healthcare systems?
    Question 1(a). What can the CDC and ASPR do to continue to 
streamline healthcare workforce efficiency and improve data 
modernization?

    Answer 1(a). NIAID defers to CDC and ASPR on the above questions.
    Question 2. We talk a lot about the importance of health equity, 
and focusing on populations that have documented inequities. I have 
been a vocal advocate for addressing health equity issues, particularly 
the issues affecting Alaska Native and American Indian populations to 
die at higher rates than other Americans in many categories, including 
chronic liver disease and cirrhosis, diabetes mellitus, unintentional 
injuries, assault/homicide, intentional self-harm/suicide, and chronic 
lower respiratory diseases.

    However, I want to discuss a different type of equity today, which 
is an important part of the health equity discussion. When we are 
evaluating our Federal response to COVID-19, we fail to discuss state 
equity. States with larger populations, tend to have more purchasing 
power for therapeutics, testing, and other medical supplies, leaving 
many rural states (the majority Western states) behind. We saw this 
during the COVID-19 pandemic, when Alaska was unable to compete with 
New York City, California, or private investors in purchasing PPE, 
therapeutics, and testing supplies.

    Question 2(a). As we move to toward a new phase of COVID-19, how 
are we going to ensure there is state equity when accessing these 
supplies on the private market?

    Question 2(b). What is HHS going to do to address these issue of 
unequal purchasing power to ensure equal access?

    Question 2(c).What is HHS doing to continue to conduct surveillance 
of COVID-19, to ensure states can plan appropriately for different 
waves to come?

    Answer 2. NIAID defers to CDC and ASPR on the above questions.

    Question 3. The impacts of COVID-19 have exacerbated mental health 
issues across the country and within the military. We've seen this 
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service 
members and their families face difficult and unique circumstances 
living in an austere and remote location, and COVID protocols increased 
their isolation without providing enough access to resources such as 
mental health providers. Just last week, Senator Sullivan and I 
introduced the Don Young Arctic Warrior Act, which focuses increasing 
the help and assistance they need and deserve.

    Question 3(a). Is HHS working on any long-term solutions to address 
the rise in military suicides, as exacerbated by the isolation brought 
on by COVID?

    Question 3(b). Are there any lessons the military could learn from 
the CDC or NIH on what strategies work in reducing suicides in highly 
isolated populations?

    Answer 3. NIAID defers to CDC on the first question above.

    The National Institute of Mental Health (NIMH) works with the 
Department of Veterans Affairs (VA), the Department of Defense (DoD), 
and clinicians and researchers to address the mental health needs of 
active duty, National Guard, and Reserve service personnel, as well as 
veterans and their families. NIMH-supported suicide prevention research 
focuses on understanding risk factors, identifying effective prediction 
and screening approaches, and developing effective, evidence-based 
interventions. Additionally, the NIMH Office of Rural Mental Health 
helps to ensure that such efforts positively impact highly isolated 
populations, by supporting research to improve the delivery of services 
for residents of rural areas.

    NIMH funds research on coordinated services for individuals at 
elevated risk of suicide across the health care system. This approach 
is often referred to as the Zero Suicide framework, which emphasizes 
the role of leadership, training, and continuous quality improvement to 
optimize delivery of evidence-based strategies to identify, engage, 
treat, and assist with transitions of care across clinical settings. 
\1\ NIMH-funded research has shown that implementation of Zero Suicide 
preventive practices is effective at decreasing suicide risk. 1A\2\ In 
line with this approach, NIMH staff and grantees have published a 
clinical pathway for suicide risk identification in adult primary care 
settings, which emphasizes the importance of pairing screening with 
evidence-based assessment and intervention strategies associated with 
suicide risk reduction. 1A\3\ Provider training in suicide prevention 
is important for ensuring that evidence-based clinical care is 
delivered with high quality, and that care is appropriately tailored to 
the level of risk. For example, for lower risk individuals, early 
detection and intervention, with a focus on recovery and stress 
management, can help reduce concerns about negative impact on 
employment.
---------------------------------------------------------------------------
    \1\  https://www.sprc.org/zero-suicide
    \2\  Layman et al. (2021), https://doi.org/10.1176/
appi.ps.202000525
    \3\  https://www.nimh.nih.gov/news/research-highlights/2022/a--
clinical-pathway-for-suicide-risk-screening-in-adult-primary-care

    Other strategies that complement the Zero Suicide approach can also 
help to create safer, healthier environments. For example, NIMH-
supported research has demonstrated that safe storage of lethal means 
is an effective strategy for reducing suicide deaths. 1A\4\ 
Interventions to build cohesion, shared purpose, and the capacity to 
manage career and personal stressors have also proven effective at 
improving healthy behaviors and reducing psychiatric symptoms, 
including suicide ideation. 1A\5\ Creating multi-level strategies for 
suicide prevention is consistent with previous efforts by the military 
that were associated with reduced suicide rates. 1A\6\
---------------------------------------------------------------------------
    \4\  Shenassa et al. (2004), https://doi.org/10.1136/
jech.2003.017343
    \5\  Wyman et al. (2022), https://doi.org/10.1016/
j.socscimed.2022.114737
    \6\  Knox et al. (2010), https://doi.org/10.2105/ajph.2009.159871

    Understanding risk associated with specific deployment contexts is 
also important. As one example of ongoing research in this area, NIMH-
supported researchers aim to identify risk factors for suicide by 
analyzing data from the Substance Use and Psychological Injury Combat 
Study (SUPIC), a longitudinal data base of over 865,000 Army Active 
Duty and National Guard/Reserve Soldiers returning from Operation 
Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn 
deployments, along with clinical and administrative data from the 
Veterans Health Administration. 1A\7\ Findings from this study could 
substantially improve suicide risk assessment and intervention 
strategies.
---------------------------------------------------------------------------
    \7\  reporter.nih.gov/project-details/10437762

    Beyond the military context, implementation of evidence-based 
approaches in isolated settings requires additional considerations. 
Prior to the COVID-19 pandemic, telehealth had already been found to be 
as effective as in-person treatments for mental illnesses, including 
PTSD. 1A\8\ Expansion of telehealth services during the COVID-19 
pandemic has provided further evidence that mental health care can 
successfully be delivered to individuals in remote areas. The National 
Action Alliance for Suicide Prevention issued guidance on screening for 
suicide risk during telehealth visits. 1A\9\ Ensuring that individuals 
maintain continuous access to their healthcare providers, regardless of 
where they are physically located, remains a challenge for the mental 
health field, with several notable efforts to solve this problem 
underway. 1A\10\, 1A\11\ Finally, efforts to embed mental healthcare in 
the primary care setting, known as behavioral health integration, can 
help address shortages in the behavioral health workforce in rural 
communities. One such approach, the Collaborative Care model, has been 
shown to reduce the severity of suicidal ideation in a recent meta-
analysis. 1A\12\
---------------------------------------------------------------------------
    \8\  Marchand et al. (2011), https://doi.org/10.1080--
percent2F10926771.2011.562479
    \9\  https://theactionalliance.org/resource/covid-guidance-
screening-suicide-risk-during-telehealth-visits
    \10\  https://psypact.site-ym.com/
    \11\  https://www.imlcc.org/
    \12\  Grigoroglou et al. (2021), https://doi.org/10.1016/
j.genhosppsych.2021.04.004

    The NIMH Suicide Prevention website contains additional examples of 
effective suicide prevention strategies, as well as resources for 
people in suicidal crisis or emotional distress. \13\
---------------------------------------------------------------------------
    \13\  www.nimh.nih.gov/health/topics/suicide-prevention
---------------------------------------------------------------------------
                                 ______
                                 
    Response by Robert Califf to Questions of Senator Burr, Senator 
                     Cassidy, and Senator Murkowski
                              senator burr
    Question 1. We have heard concerns from some parents about the 
delay between Moderna's EUA submission and the advisory committee 
meeting. I've seen reporting that one of the reasons for the delay was 
so that parents would not confuse the two different vaccines as each 
has different doses and timelines. It's this kind of continued nanny 
state approach that raises questions about what exactly FDA is doing, 
as it seems FDA is evaluating other factors in addition to its role of 
reviewing safety and efficacy.

    Question 1(a). Can you provide any clarity regarding the reason for 
the delay of authorizing one vaccine for children under 5?

    Question 1(b). Did FDA consider waiting until the other vaccine was 
submitted to make its decision about the first? If so, why?

    Answer 1. On May 23, FDA revised the dates of the Vaccines and 
Related Biological Products Advisory Committee (VRBPAC) meetings due to 
new data from sponsors and expected submissions of emergency use 
authorization (EUA) amendment requests. June 15 was the new meeting 
date for the Moderna EUA amendment request for 6 months through 5 years 
of age and Pfizer-BioNTech EUA amendment request for 6 months through 4 
years of age, based on expected completion of an EUA submission to FDA. 
FDA noted its plans to hold the VRBPAC meetings in anticipation of 
complete submissions of EUA requests that had been publicly announced 
by COVID-19 vaccine manufacturers. FDA also noted that the dates were 
tentative as none of the submissions were complete.

    FDA recognized that many parents and caregivers of children under 
the age of 5 were eager to get their children vaccinated. The agency 
proceeded with holding a 2-day VRBPAC meeting to present the safety and 
effectiveness data for both vaccines to our committee of outside 
experts. We believed that this was the best approach to solicit the 
most informed advice from the VRBPAC because the committee had the 
comprehensive analyses for both vaccines in the youngest pediatric 
populations before them and did not have to wonder about results that 
were mentioned only in a press release. Our top priority was ensuring 
that the relevant data pertaining to the safety and effectiveness of 
both vaccines were available for public consideration before we decided 
whether to authorize these COVID-19 vaccines for pediatric populations.
                            senator cassidy
    Question 1. When do you expect your respective workforces to return 
to pre pandemic levels of in-office or field work on a full-time basis?

    Answer 1. Throughout COVID-19, FDA staff have never stopped working 
and continue to work extremely hard to successfully fulfill our public 
health mission--regardless of whether work is performed from a FDA 
office, or from an alternative work location. FDA initiated a Workplace 
Flexibilities Pilot in April 2022 and will evaluate the best approach 
for FDA's work environment moving forward, informed by how we can best 
accomplish our mission and attract and retain highly qualified talent, 
supported by our personnel policies.

    FDA's reentry process is completely consistent with Government-wide 
guidance. It is important to note that FDA must recruit highly skilled 
and talented staff, often with specialized technical expertise, to keep 
up with the innovative industries we regulate. To meet our mission, the 
Agency must compete with industry for the most qualified staff and that 
will require us to continue to leverage workplace flexibilities as 
appropriate.

    Question 2. What percent of your respective workforces, including 
headquarters, agency, regional office, and field office employees are 
currently working full or part time remotely?

    Answer 2. As of June 2022, approximately 5,000 employees regularly 
come into facilities or to work sites to perform non-portable work. 
Other FDA employees are participating in the Workplace Flexibilities 
Pilot, which provides remote-and telework-eligible options for 
employees who receive supervisory approval for a period of 6 months.

    Question 3. What agency-wide data have you collected regarding 
remote work productivity levels that will help advise any agency plans 
for increased telework in the future?

    Answer 3. FDA initiated a Workplace Flexibilities Pilot in April 
2022 for a limited time, after which time we will evaluate the best 
approach for FDA's work environment moving forward, informed by how we 
can best accomplish our mission and attract and retain highly qualified 
talent, supported by our personnel policies.

    Question 4. I hear that there are some companies that are trying to 
bring new competitors on to the market relevant for COVID response but 
are having difficulty getting samples of the products from the original 
manufacturers, and thus don't have the supplies necessary to carry out 
appropriate trials. They haven't been able to get good answers from the 
Administration about what to do. I'm told that when a product is under 
an EUA, the FDA cannot compel the that company to share samples. Dr. 
Califf, is this something you've heard about and is this something that 
the FDA could address through regulatory action?

    Answer 4. As a general matter, if companies are blocking access to 
product samples needed by competing product developers, there are 
multiple pathways for addressing this. The law widely known as the 
CREATES Act creates a pathway for eligible developers of generic, 
505(b)(2) and biosimilar products to obtain needed samples of drug 
products approved under sections 505(c) or (j) of the FD&C Act or 
biological products licensed under sections 351(a) or (k) of the Public 
Health Service Act. The CREATES Act establishes a private right of 
action that allows eligible product developers to sue companies that 
refuse to sell them samples of these products needed to support their 
applications. If the product developer prevails, the court will order 
the sale of samples, award attorneys' fees and litigation costs to the 
product developer and may impose a monetary penalty on the company 
withholding samples.

    We note that, as a general matter, we also understand that the 
Federal Trade Commission (FTC) takes enforcement action to address the 
anticompetitive blocking of access to samples and other materials 
needed for drug product development. While outside of FDA's purview, it 
is our understanding that this action may result in, among other 
things, issuance of an order requiring a company to make samples of 
their product available to competing developers. While the CREATES 
pathway is limited to obtaining samples of approved drug or biological 
products, to the extent companies are engaging in the blocking of 
access to other products or materials needed for product development, 
we recommend that the matter be raised with the FTC so that they can 
consider appropriate enforcement action.

    In terms of issues that may be occurring in the COVID-19 vaccine 
space, FDA intends to work with the Biomedical Advanced Research 
Development Authority (BARDA) on making U.S. Government owned supply 
available to developers.

    Question 5. Dr. Califf, a Politico article published on May 19th 
described the chaos and disarray of the foods program at FDA, which was 
driven by lack of clear leadership over the program between CFSAN 
Director Susan Mayne and Deputy Commissioner Yiannes. How do you think 
that this lack of clear leadership contributed to the infant formula 
crisis? May 19 article: https://www.politico.com/news/2022/05/19/
infant-formula-fallout-fda-woodcock--00033699

    Answer 5. Deputy Commissioner Yiannas and Dr. Mayne are leaders 
with tremendous experience in their respective fields. FDA's response 
to the infant formula crisis required their vast array of skills. I am 
committed to taking a close look at the foods program to determine what 
investments, changes, and authorities may be needed to better position 
the program for the future. I have asked Dr. Steve Solomon, Director of 
the Center for Veterinary Medicine, to conduct a top-down review of the 
events and activities that led up to the current situation involving 
infant formula. Dr. Solomon has been with FDA for more than 30 years, 
runs one of FDA's most efficient centers, and has familiarity with 
Foods and Field-based issues, having previously worked in our Office of 
Regulatory Affairs. I am confident that that review will provide even 
more detail that will support our ability to implement the processes 
and changes needed to prevent this situation from happening in the 
future.
                           senator murkowski
    Question 1. I have had several conversations with Alaskan public 
health officials, on lessons learnt from the Federal response to the 
COVID-19 pandemic. I am disappointed that CMS and IHS are not 
testifying today, as we know they were pivotal in the response to 
COVID-19. This pandemic was not only a public health crisis, but a 
crisis affecting our health systems and the delivery of healthcare. I 
believe that we must apply lessons learnt, to address new public health 
epidemics, such as the drug overdose crisis that many of our 
communities are experiencing. The Federal Government has to improve 
transparency and integrate Federal services, to allow states to respond 
to future public health crisis that arise. An example of this is the 
drug overdose epidemic that many of our states are now experiencing. 
The Federal Government has a responsibility to promote data-sharing 
throughout all health systems. For example, we did not see a 
significant improvement in the surveillance of COVID-19 until CMS 
required hospitals to share data on bed capacity with ASPR. Sharing 
data between hospital systems and state lines, is essential in 
addressing future public health issues and most notably, the drug 
overdose epidemic.

    Question 1(a). How can HHS continue to work internally and with 
other Federal agencies, such as the VA and DOD to integrate Federal 
services and promote data-sharing throughout healthcare systems?

    Question 1(b). What can the CDC and ASPR do to continue to 
streamline healthcare workforce efficiency and improve data 
modernization?

    Answer 1. FDA defers to CDC and ASPR for a response to these 
questions.

    Question 2. We talk a lot about the importance of health equity, 
and focusing on populations that have documented inequities. I have 
been a vocal advocate for addressing health equity issues, particularly 
the issues affecting Alaska Native and American Indian populations to 
die at higher rates than other Americans in many categories, including 
chronic liver disease and cirrhosis, diabetes mellitus, unintentional 
injuries, assault/homicide, intentional self-harm/suicide, and chronic 
lower respiratory diseases.

    However, I want to discuss a different type of equity today, which 
is an important part of the health equity discussion. When we are 
evaluating our Federal response to COVID-19, we fail to discuss state 
equity. States with larger populations, tend to have more purchasing 
power for therapeutics, testing, and other medical supplies, leaving 
many rural states (the majority Western states) behind. We saw this 
during the COVID-19 pandemic, when Alaska was unable to compete with 
New York City, California, or private investors in purchasing PPE, 
therapeutics, and testing supplies.

    Question 2(a). As we move to toward a new phase of COVID-19, how 
are we going to ensure there is state equity when accessing these 
supplies on the private market?

    Question 2(b)1. What is HHS going to do to address these issue of 
unequal purchasing power to ensure equal access?

    Question 2(c)1. What is HHS doing to continue to conduct 
surveillance of COVID-19, to ensure states can plan appropriately for 
different waves to come?

    FDA defers to CDC and ASPR for a response to these questions.

    Question 3. The impacts of COVID-19 have exacerbated mental health 
issues across the country and within the military. We've seen this 
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service 
members and their families face difficult and unique circumstances 
living in an austere and remote location, and COVID protocols increased 
their isolation without providing enough access to resources such as 
mental health providers. Just last week, Senator Sullivan and I 
introduced the Don Young Arctic Warrior Act, which focuses increasing 
the help and assistance they need and deserve.

    Question 3(a)1. Is HHS working on any long-term solutions to 
address the rise in military suicides, as exacerbated by the isolation 
brought on by COVID?

    Question 3(b)1. Are there any lessons the military could learn from 
the CDC or NIH on what strategies work in reducing suicides in highly 
isolated populations?

    FDA defers to CDC and NIH for a response to these questions.
                                 ______
                                 
Response by Dawn O'Connell to Questions of Senator Kaine, Senator Burr, 
               Senator Murkowski, and Senator Tuberville
                             senator kaine
    Assistant Secretary O'Connell, at a recent HELP hearing on the 
ongoing Federal response to COVID-19, we discussed the importance of 
next generation vaccines. I first want to acknowledge the success of 
the important government and private sector partnerships that have 
taken place over the last 2 years. BARDA, in coordination with other 
government agencies, has led the way in working with researchers and 
other entities on the development of several effective vaccines against 
COVID-19. Yet COVID-19 has shown us that it can change. As new variants 
emerge, we need vaccines that offer universal coverage against emerging 
variants.

    Question 1. Assistant Secretary O'Connell, what is the current 
state of research on next generation vaccines and how has delayed 
COVID-19 funding impacted BARDA's timeline?

    Answer 1. Response: At this time, any investment in next generation 
COVID-19 vaccines by the Biomedical Advanced Research and Development 
Authority (BARDA) has been put on hold given the lack of supplemental 
funding for such efforts. However, BARDA, in collaboration with 
partners at the National Institutes of Health (NIH) as well as other 
interagency partners, continues to assess the pipeline of vaccine 
candidates and has put out Requests for Information to make sure that 
the Federal Government is poised to act quickly, should funding be made 
available. Since additional funding has not been provided, BARDA does 
not have the resources to invest in next-generation vaccine candidates 
that may offer key improvements in technical performance. Every day 
that additional COVID-19 funding is delayed is a day lost in terms of 
applying invaluable government resources, both financial and technical, 
to such programs. With any current remaining funds, BARDA is exploring 
whether it can--in partnership with NIH--establish a scientific 
framework for consideration of next generation vaccines (assays, etc.) 
so should next generation funding come available both teams can move 
out quickly.

    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.
                              senator burr
    Question 1. The recently released ASPR strategic plan is silent on 
status or plan for National Disaster Medical System (NDMS). Can you 
please provide your priorities, plans and intentions for NDMS?

    Answer 1. ASPR has not released a new strategic plan. Rest assured, 
ASPR continues to view the National Disaster Medical System (NDMS) as a 
critical tool to aid and support response to public health emergencies 
with communities are overwhelmed by disaster. As included in the fiscal 
year 2023 President's Budget request, an additional $50 million was 
requested for NDMS to support the recruitment, hiring, and training of 
NDMS intermittent staff. If appropriated, funding would ensure that 
NDMS is best positioned and resourced to aid communities in need. The 
fiscal year 2023 request also includes an additional $13 million to 
maintain NDMS caches and equipment that support the deployment of 
personnel during response operations. It is critical that additional 
funding be provided to support continued operation of NDMS. The system 
remains a priority for me as the ASPR and is recognized as a national 
tool that has been successful in bridging the gap when communities are 
overwhelmed during a public health emergency or disaster.

    Question 2. ASPR has created new models to predict potential 
scenarios for the trajectory of COVID in our Country over the next few 
months. While these models have been around for a few weeks and 
supposedly have some important predictions for the next few months, the 
American people have yet to get a read-out.

    Question 2(a). What are these models predicting for the next 30, 
60, and 90 days?

    Answer 2. Response: ASPR's models support internal, operational 
planning and are not intended or appropriate for public release. ASPR 
defers to CDC's Center for Forecasting and Outbreak Analytics (CFA) on 
the release of available public models.
    Question 2(b). Should I expect to see different numbers and 
predictions out of CDC's new forecasting center?

    Answer 2(b). The CDC and ASPR models have different purposes. The 
CDC forecasting ensemble CFA is focused on short-term projections over 
the next 4 weeks. This is built on a `wisdom of the crowds' approach 
that incorporates multiple academic and external models and are 
validated during seasonal influenza before the pandemic.

    ASPR Modeling is focused on actionable decision and planning 
support that require longer-term timelines, providing scenarios that 
capture key uncertainties and show how those might play out over the 
next few months. The purpose of ASPR modeling is for planning of ASPR-
specific operational activities like procurement of Therapeutics, PPE, 
tests etc. and is not targeted for general consumption or forecasting.

    Despite these intentionally different purposes, the CDC forecasting 
has projections for hospitalization and deaths 4 weeks out and the ASPR 
models include scenarios consistent with these estimates.

    Question 3. As new COVID variants emerge, they have learned to 
evade some of our available treatments. We need to stay ahead of the 
curve by maintaining a strong pipeline of new antivirals and 
treatments. What is ASPR's plan to invest in the next generation of 
COVID countermeasures for the long term, and your plan to balance this 
important work with the other very real threats on your radar?

    Answer 3. BARDA continues to closely monitor for the emergence of 
new COVID-19 variants, evaluate potential impacts to the portfolio of 
available products to determine which of the currently available 
treatments would be most effective. The COVID-19 therapeutics team 
continues to monitor the development of novel medical countermeasures 
(MCMs) and next generation therapeutics for the treatment of COVID-19. 
BARDA's TechWatch program affords companies an opportunity to present 
their capabilities to BARDA and other interagency partners. Industry 
partners are encouraged to request a TechWatch meeting to discuss their 
products and explore the potential for future partnering opportunities.

    There are no existing funds at this time to support the research 
and advanced development of any new antivirals or treatments for COVID-
19. This spring, the Administration requested $22.5 billion to support 
immediate needs to avoid disruption of ongoing response to COVID-19. 
Funding would support additional investments in developing, procuring, 
deploying and administering vaccines and therapeutics, including oral 
antivirals, to aid this response and expand the COVID-19 therapeutics 
portfolio and ensure we have effective MCMs available for use in the 
future.

    Question 4. Our current availability of vaccines and antivirals 
that work against monkeypox is due to the successes of Project 
BioShield and the efforts of the U.S. Government to prepare for 
smallpox, but that means we have less smallpox vaccine to deploy from 
the stockpile should we need it for its intended purpose--smallpox. I 
hope that we will never have to use it for this purpose, but it is 
still a threat, and on the material threat list. What modeling has ASPR 
conducted on the depletion of our smallpox vaccine supply as a result 
of the monkeypox outbreak? How quickly can we backfill our doses?

    Answer 4. To ensure we are prepared for a potential smallpox 
incident, the SNS currently holds a significant number of doses of 
ACAM2000 and a much smaller stockpile of JYNNEOS vaccine. In the event 
of a smallpox incident, JYNNEOS would be made available to special 
populations who should not take ACAM2000 (immunocompromised, pregnant, 
heart condition, etc.). Ultimately, all JYNNEOS and ACAM2000 that will 
be deployed from the stockpile as part of the monkeypox response will 
need to be replenished to ensure there is some product available in the 
SNS to protect against a potential subsequent public health emergency 
caused by smallpox or monkeypox. The cost to replace those doses is 
more than replacing costs to fill/finish for the monkeypox outbreak--it 
is replacing the previously purchased bulk vaccine that is being 
utilized. As of the date of this hearing, ASPR estimated the cost to 
replace vaccine used for the monkeypox outbreak will be $382M.
                           senator murkowski
    Question 1. I have had several conversations with Alaskan public 
health officials, on lessons learnt from the Federal response to the 
COVID-19 pandemic. I am disappointed that CMS and IHS are not 
testifying today, as we know they were pivotal in the response to 
COVID-19. This pandemic was not only a public health crisis, but a 
crisis affecting our health systems and the delivery of healthcare. I 
believe that we must apply lessons learnt, to address new public health 
epidemics, such as the drug overdose crisis that many of our 
communities are experiencing. The Federal Government has to improve 
transparency and integrate Federal services, to allow states to respond 
to future public health crisis that arise. An example of this is the 
drug overdose epidemic that many of our states are now experiencing. 
The Federal Government has a responsibility to promote data-sharing 
throughout all health systems. For example, we did not see a 
significant improvement in the surveillance of COVID-19 until CMS 
required hospitals to share data on bed capacity with ASPR. Sharing 
data between hospital systems and state lines, is essential in 
addressing future public health issues and most notably, the drug 
overdose epidemic.

    Question 1(a). How can HHS continue to work internally and with 
other Federal agencies, such as the VA and DOD to integrate Federal 
services and promote data-sharing throughout healthcare systems?

    Answer 1. 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). ASPR, CDC, CMS, and ONC are also closely coordinating 
on all hazards healthcare information sharing together with government 
and healthcare partners.

    Question 1(b). What can the CDC and ASPR do to continue to 
streamline healthcare workforce efficiency and improve data 
modernization?
    Answer 1(b). ASPR, CDC, CMS, and ONC are working together on all 
hazards healthcare situational awareness, leveraging ongoing 
initiatives and work to improve pathways for data collection. Access to 
private sector data, capabilities, guidance and participation are 
critical to successful government engagement on supply chain 
challenges, to include deployment of stockpiled resources, strategic 
investment in production capacity, or coordinated allocation of scarce 
resources during shortages or supply chain disruptions.

    Question 2. We talk a lot about the importance of health equity and 
focusing on populations that have documented inequities. I have been a 
vocal advocate for addressing health equity issues, particularly the 
issues affecting Alaska Native and American Indian populations to die 
at higher rates than other Americans in many categories, including 
chronic liver disease and cirrhosis, diabetes mellitus, unintentional 
injuries, assault/homicide, intentional self-harm/suicide, and chronic 
lower respiratory diseases.

    However, I want to discuss a different type of equity today, which 
is an important part of the health equity discussion. When we are 
evaluating our Federal response to COVID-19, we fail to discuss state 
equity. States with larger populations, tend to have more purchasing 
power for therapeutics, testing, and other medical supplies, leaving 
many rural states (the majority Western states) behind. We saw this 
during the COVID-19 pandemic, when Alaska was unable to compete with 
New York City, California, or private investors in purchasing PPE, 
therapeutics, and testing supplies.

    Question 2(a). As we move to toward a new phase of COVID-19, how 
are we going to ensure there is state equity when accessing these 
supplies on the private market?
    Answer 2(a). Equitable access to life-saving products is one of the 
most challenging and critical aspects we are working through as we 
transition COVID-19 vaccines and therapeutics to the commercial market. 
We must ensure that vaccines and therapeutics continue to be available 
to anyone who needs them. I commit to keeping you updated as we 
finalize plans for commercialization. We also continue to invest in 
industrial base expansion efforts to bolster domestic manufacturing of 
PPE and tests. Increased domestic manufacturing will increase the 
supplies in the commercial market and support states' access to these 
needed tools.

    Question 2(b). What is HHS going to do to address these issues of 
unequal purchasing power to ensure equal access?
    Answer 2(b) HHS would be happy to provide your staff a briefing to 
discuss the ongoing efforts for COVID-19 product commercialization. In 
short, we hope that a transition to a commercial market will rely less 
on state purchases and more on the existing health care infrastructure. 
However, we recognize that this presents challenges, especially for the 
un-and-under insured. As noted in the prior response, we are also 
supporting efforts to invest in industrial base expansion to ensure 
needed products are available commercially, as and when needed.

    Question 2(c). What is HHS doing to continue to conduct 
surveillance of COVID-19, to ensure states can plan appropriately for 
different waves to come?
    Answer 2(c). I defer to my CDC colleagues who are responsible for 
this function.

    Question 3. The impacts of COVID-19 have exacerbated mental health 
issues across the country and within the military. We've seen this 
first hand in Alaska where 17 soldiers died in 2021 by suicide. Service 
members and their families face difficult and unique circumstances 
living in an austere and remote location, and COVID protocols increased 
their isolation without providing enough access to resources such as 
mental health providers. Just last week, Senator Sullivan and I 
introduced the Don Young Arctic Warrior Act, which focuses increasing 
the help and assistance they need and deserve.

    Question 3(a). Is HHS working on any long-term solutions to address 
the rise in military suicides, as exacerbated by the isolation brought 
on by COVID?

    Answer 3. This is a critical issue and is best addressed by 
colleagues at the Departments of Defense and Veterans Affairs.

    Question 3(b). Are there any lessons the military could learn from 
the CDC or NIH on what strategies work in reducing suicides in highly 
isolated populations?

    Answer 3(b). I defer to my CDC colleagues on such strategies and 
whether they are applicable.
                           senator tuberville
                     Monoclonal Antibody Treatments
    Question 1. Much has been made lately about the administration's 
desire for more money to combat the ongoing pandemic. I have been a big 
supporter of common sense pandemic response efforts since the outset. 
However, every time I have asked HHS questions about its COVID spending 
decisions, I have been met with silence. For example, Ms. O'Connell, at 
a hearing on November 4 of last year, I asked you why HHS wasted 
$142million on a contract with accounting firm KPMG to promote a 
monoclonal that HHS had stopped buying months before. You responded 
that you were, ``expecting a memo any day with the team's 
recommendations'' on whether the program should be kept going.

    Two weeks later and you had not shared that decision with me. As a 
result, I and six of my colleagues on this Committee sent Secretary 
Becerra a letter asking about the purpose of the KPMG contract and who 
conjured it up. No explanations were provided. Weeks of failed efforts 
to receive any information from your staff led us to write another 
letter on March 8. To date, more than 3 months later, your office has 
provided no information. I am asking you to explain $142 million spent 
at an accounting firm to administer medicine to sick Americans but you 
can't justify your decisions. And now, you want more money.

    Question 1(a). If you can't answer questions about past money 
spent, how do you expect our support to provide you with more?

    Question 1(b). Will you commit right now that you will personally 
work with your staff to respond to our multiple letters about the KPMG 
contract so this Committee can implement guardrails on additional 
funding so it isn't similarly wasted on sham contracts?

    Question 1(c). As part of that commitment, will you--at a minimum--
provide the Committee with a copy of the decision memo you alluded to 
in your November 4 testimony, where you stated you were the 
decisionmaker for funding this program?
    Answer 1. HHS is committed to ensuring fair and equitable 
distribution of COVID-19 therapeutics across the country. We partnered 
with KPMG earlier this year to help improve use and increase access of 
monoclonal antibody therapeutics in vulnerable communities. As part of 
its agreement with DoD, KPMG facilitated onsite support in communities 
across the country to help expand and/or establish capacity to 
administer monoclonal antibody treatments.

    The current COVID-19 therapeutics landscape is different with 
different requirements than at the start of the pandemic. As such, the 
specific support KPMG provided is no longer required. Overall use of 
these therapies has improved across the country, and treatment and 
provider options have expanded.

    This contract has been terminated.

    I commit to working with you and your staff to address and respond 
to any pending correspondence.

    Question 2. I understand that roughly 20-30 percent of high risk 
COVID-19 patients cannot take oral antiviral treatments due to drug-to-
drug interactions and the 40 percent shorter treatment window.

    Question 2(a). If this is the case, why is ASPR buying 10 million 
more doses of the oral antivirals and only a small quantity of the 
treatment monoclonal antibodies?

    Answer 2. One of the benefits of the oral antivirals Paxlovid and 
Legevrio is that they have not been impacted by SARS-CoV-2 variants. In 
fact, both Paxlovid and Legevrio have retained activity against all 
circulating SARS-CoV-2 variants to date. The mechanism of action of the 
monoclonal antibodies, which depends on binding to the virus, is a 
distinct disadvantage as new viral variants arise. Looking to the 
future , 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.

    Question 2(b). Without additional COVID-19 appropriations, 
shouldn't ASPR increase the purchase of treatment mAbs and decrease the 
purchase of the orals, so that hundreds of thousands of high-risk 
patients who cannot take the orals are not left without a treatment 
option in the fall?

    Answer 2(b). COVID-19 therapeutics can be used to prevent or treat 
eligible non-hospitalized patients who have tested positive for COVID-
19 and have mild to moderate symptoms and are at high risk for disease 
progression. Prevention and early treatment for eligible patients can 
help improve patient outcomes, reduce stress on healthcare facilities, 
and even save lives. When it comes to COVID-19 therapeutics, we have 
approached it like filling a medicine cabinet--we are not relying on 
one type, or one brand, or one treatment. We ensured that we would 
invest in and buy a broad variety of monoclonal antibody and oral 
antiviral treatments. To date, over the course of the COVID-19 
response, the U.S. Government (USG) has purchased the following 
therapeutic products: Bebtelovimab, Evusheld, Lagevrio (molnupiravir), 
Paxlovid, sotrovimab, REGEN-COV, bamlanivimab/etesevimab; and 
bamlanivimab. Due to the high frequency of the Omicron variant, REGEN-
COV (casirivimab and imdevimab), bamlanivimab and etesevimab, and 
sotrovimab are not currently authorized for use in any U.S. region. In 
addition, the U.S. Food and Drug Administration revoked the emergency 
use authorization (EUA) that allowed for the investigational monoclonal 
antibody therapy bamlanivimab, when administered alone, to be used for 
the treatment of mild-to-moderate COVID-19.

    Currently the USG allocates Bebtelovimab, Lagevrio, Paxlovid, and 
renal-Paxlovid on a weekly basis to states, territories, Federal 
entities, and pharmacy partners. Evusheld is allocated monthly. Current 
estimates (based on case counts and utilization rates) estimate that 
the federally purchased supply of Bebtelovimab will be exhausted later 
this summer; that the federally purchased supply of Evusheld will be 
exhausted by the end of the year or in the first quarter of 2023; that 
the federally purchased supply of Paxlovid will be exhausted in the 
first or second quarter of 2023; and that the federally purchased 
supply of Lagevrio will be exhausted in calendar year 2023. Our focus 
remains working with state and territorial health departments as well 
as national healthcare and medical organizations and associations to 
get COVID-19 therapeutic products into the hands of healthcare 
providers quickly, with a focus on areas of the country hardest hit by 
the pandemic. However, unless Congress provides additional 
appropriations, we will not have funding to purchase additional COVID-
19 therapeutics.
                                 ______
                                 
    [Whereupon, at 12:14 p.m., the hearing was adjourned.]

                                   [all]