[Senate Hearing 117-195]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 117-195
 
                           THE PATH FORWARD: 
                         A FEDERAL PERSPECTIVE
                        ON THE COVID-19 RESPONSE

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             FIRST SESSION

                                   ON

 EXAMINING A FEDERAL PERSPECTIVE ON THE COVID-19 RESPONSE, FOCUSING ON 
THE PATH FORWARD, AFTER RECEIVING TESTIMONY FROM ROCHELLE P. WALENSKY, 
DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION, ANTHONY S. FAUCI, 
   DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, 
 NATIONAL INSTITUTES OF HEALTH, JANET WOODCOCK, ACTING COMMISSIONER OF 
   FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION, AND DAWN O'CONNELL, 
     ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, ALL OF THE 
                DEPARTMENT OF HEALTH AND HUMAN SERVICES.

                               __________

                             JULY 20, 2021

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and Pensions
 
 
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        Available via the World Wide Web: http://www.govinfo.gov
        
        
        
                       ______
 
              U.S. GOVERNMENT PUBLISHING OFFICE 
 46-775PDF          WASHINGTON : 2023
         
        
          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

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

                     Evan T. Schatz, Staff Director
               David P. Cleary, Republican Staff Director
                  John Righter, Deputy Staff Director
                  
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                         TUESDAY, JULY 20, 2021

                                                                   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...........................     3

                               Witnesses

Walensky, Rochelle, M.D., MPH, Director, United States Centers 
  for Disease Control and Prevention, Atlanta, GA................     6
    Prepared statement...........................................     7
Fauci, Anthony, M.D., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health, Bethesda, 
  MD.............................................................    14
    Prepared statement...........................................    15
Woodcock, Janet, M.D., Acting Commissioner, United States Food 
  and Drug Administration, Silver Spring, MD.....................    23
    Prepared statement...........................................    24
O'Connell, Dawn, Assistant Secretary for Preparedness and 
  Response, United States Department of Health and Human 
  Services, Washington, DC.......................................    34
    Prepared statement...........................................    36

                         QUESTIONS AND ANSWERS

Response by Rochelle Walensky, to questions of:
    Senator Casey................................................    70
    Senator Baldwin..............................................    72
    Senator Hassan...............................................    72
    Senator Burr.................................................    73
    Senator Braun................................................    75
    Senator Tuberville...........................................    76
Response by Anthony Fauci, to questions of:
    Senator Burr.................................................    78
    Senator Braun................................................    81
    Senator Tuberville...........................................    82
Response by Janet Woodcock, to questions of:
    Senator Burr.................................................    84
    Senator Braun................................................    86
    Senator Scott................................................    87
    Senator Tuberville...........................................    91
Response by Dawn O'Connell, to questions of:
    Senator Baldwin..............................................    92
    Senator Burr.................................................    93
    Senator Braun................................................    96
    Senator Tuberville...........................................    96


                           THE PATH FORWARD:



                         A FEDERAL PERSPECTIVE



                        ON THE COVID-19 RESPONSE

                              ----------                              


                         Tuesday, July 20, 2021

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10 a.m., in room 
430, Dirksen Senate Office Building, Hon. Patty Murray, Chair 
of the Committee, presiding.
    Present: Senators Murray [presiding], Casey, Baldwin, 
Kaine, Hassan, Smith, Rosen, Lujan, Hickenlooper, Burr, Paul, 
Cassidy, Braun, Marshall, Romney, Tuberville, and Moran.

                  OPENING STATEMENT OF SENATOR MURRAY

    The Chair. Good morning. Senate Health, Education, Labor, 
and Pensions Committee will please come to order. Today we are 
holding a hearing on our Federal response to the COVID-19 
pandemic. Ranking Member Burr and I will each have an opening 
statement and I will introduce our witnesses. After they give 
their testimony, Senators will each have 5 minutes for a round 
of questions.
    While we are yet unable to have the hearing fully open to 
the public or media for in-person attendance, live video is 
available on our Committee website at help.senate.gov. And if 
anyone is in need of accommodations, including closed 
captioning, please reach out to the Committee or the Office of 
Congressional Accessibility Services.
    We are at a point of great promise and peril in the fight 
against COVID-19. While I am encouraged by the fact that two-
thirds of adults in our Country have received their first dose 
of vaccine, I am alarmed by how the rate of vaccination has 
been slowing, and how driven by the delta variant, rates of 
COVID-19 cases and deaths are once again on the rise. Five 
counties in my state currently have high levels of transmission 
according to the Centers for Disease Control and Prevention. 
For example, in Walla Walla County, cases are up in July from 
June, and they were up in June from April and May.
    Even though 99 percent of the COVID deaths nationwide last 
month were among people who had not gotten vaccinated, we are 
still seeing fear and misinformation hold people back, huge 
disparities in vaccination rates among communities of color and 
rural communities, skepticism about vaccines among some 
religious and conservative communities, and slow uptake among 
youth--young adults. Vaccines are safe, effective and free and 
easy to get. We need to make sure people know that. And we also 
need to make sure they understand. Choosing not to get 
vaccinated doesn't just put themselves at risk, it puts the 
people around them at risk and including people who are 
immunocompromised like those fighting cancer and kids who are 
not yet eligible for vaccines.
    We also have to remember vaccinations are just one front of 
this fight. Local health departments need the capacity to track 
emerging outbreaks quickly through contract tracing sequence, 
virus samples to identify variants, help isolate ill people, 
and track vaccination progress. And more experts need to 
evaluate the longevity of immunity, especially in the face of 
new variants and the potential value of booster shots.
    Researchers need to study the long term impacts of this 
disease and how to treat long haul COVID-19 or PASC. And 
perhaps most importantly, we as a Nation need to fully learn 
the lessons of this pandemic and take action so we are never in 
this situation again. That is why Senator Burr and I have been 
working on bipartisan legislation and oversight to build the 
world class public health and preparedness infrastructure our 
people deserve. It is my hope that through this work, we will 
not only address challenges we faced during this pandemic but 
build on progress we saw in some states across the country.
    In my home State of Washington, they worked to overcome 
challenges with sharing critical COVID data among health 
departments, labs, and hospitals to improve how data was used 
to allocate critical medical supplies like respirators and 
develop a more complete dashboard for demographic data that 
broke out numbers, for example, for the Pacific Islander 
community. Michigan created a task force on racial disparities 
early on in the pandemic to ensure they were reaching 
communities of color for testing and contact tracing.
    Alaska literally employed every mode of transportation to 
deliver vaccines to hard-to-reach communities. One of the 
clearest lessons from this crisis is that you should have the 
same protection from a pandemic, chronic disease, or public 
health threat, regardless of where you live, who you are, or 
what your income is. And one of the best ways of providing that 
level of protection is through strong public health 
infrastructure.
    The stronger our health departments are at every level, the 
more effectively they can work to use sequencing technology and 
modern data systems to track the spread of diseases and monitor 
the success of vaccination efforts, stand up testing and 
contact tracing to stop disease outbreaks, develop science 
based guidelines to address local needs, build partnerships in 
hard to reach communities, and build trust as communicators and 
fight misinformation. There is a saying in health care, an 
ounce of prevention is worth a pound of cure. We need to have 
that same mindset when it comes to public health. That is why I 
have pushed for more funding for public health departments 
throughout our COVID response packages.
    It is why earlier this year I reintroduced legislation to 
end the cycle of crisis and complacency in public health 
funding by providing $4.5 billion in dedicated annual funding 
and is why I am going to continue pushing for us to make these 
critical investments. We all want this pandemic to end. And it 
is clear, despite the incredible progress we have made in the 
last few months, we still have a lot more work to do. But even 
after we are through this crisis, our work won't be done. We 
have to make sure we learn from this history and take action, 
so we never repeat it.
    This crisis has cost too much, has taken too many lives for 
us to do anything less. I look forward to hearing from all of 
our witnesses today. Thank you for being here. We want to hear 
about our response to this pandemic so far, the path forward, 
and how we better prepare for threats like this in the future. 
With that, I will turn it over to Ranking Member Burr for his 
opening remarks.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Well, thank you, Madam Chair. I am pleased 
that we are holding this hearing today. Our third panel with 
members of the Administration, this Congress on COVID-19. To 
our witnesses, welcome. Welcome back. Some of you are old hands 
at this now and others are relatively new. Dr. Fauci, Dr. 
Walensky, thank you for returning to the Committee for the 
third time this year to discuss this pressing matter. Ms., 
O'Connell, welcome. This is your first hearing before the 
Committee in your newly confirmed role as the ASPER.
    I am glad that we are able to get you confirmed so quickly. 
You have a lot of work in front of you and all of us, 
Republicans and Democrats, are ready to help you and the fine 
folks at ASPER get the job done. Dr. Woodcock, welcome back to 
the HELP Committee. The FDA has benefited from your leadership, 
and you are the right person at the helm as we continue to 
grapple with the pandemic.
    I hope that we will see you again at another hearing to 
talk about the great things that you are doing at the FDA, 
preferably a confirmation hearing. I look forward to hearing 
from each of you on your perspectives of the current response 
to COVID-19 and what we--where we should go from here. I have 
spent the better part of my career in Congress working to 
prepare our Country for the unthinkable and anticipating what 
we may need to respond to it. These early efforts had the 
support and leadership of many of my colleagues here now, 
including Senator Collins, our Chair, Senator Murray, Senator 
Casey have all been important partners on preparedness with me, 
working to reauthorize PAHPRA and continue to keep a focus on 
these items during peacetime. All of this effort was with the 
hope that we would never have to act on the authorities we 
provided. But it was also with an eye to what may be around the 
corner. Each law we wrote was designed to build on the lessons 
that we learned from each event, Zika, West Nile, SARS and the 
anthrax attacks.
    We tried to anticipate what we didn't think of last time 
around so that we could be better prepared for when the big one 
came. This Committee has been holding hearings on COVID-19 
response since March 2020, at the very first hearing that 
raised concerns with our ability to keep pace with the virus, 
to track its whereabouts, and understand the impact it would 
have on the lives of the American people. We have the 
authorities needed, but we were and still are faced with many 
unknowns.
    Each step of the way, we need to look around the corner and 
ask ourselves, what do we need to do today to keep us up with 
the virus 30, 60, and 90 days from now? CDC estimated in mid-
June the delta virus, the variant accounted for more than 30 
percent of all covered infections. As of mid-July, the cases 
caused by delta variant may be approaching 60 percent of all 
cases. The good news is the cases are down significantly since 
the peak. The bad news is the delta virus--variant is surging 
and vaccines have slowed because of hesitancy of resistance. I 
can tell you that the next few weeks and months will require us 
to answer some very difficult questions, especially as we work 
toward the last few miles of administering the vaccine in this 
country. COVID won't just go away.
    We need all Americans who can get the vaccine to get the 
vaccine. If you won't do it for yourself, do it for your 
friends, your families, for your neighbors, and your local 
community. Do it for your grandchildren so they can go back to 
school. Do it for your grandparents so they can finally go out 
and eat. Not only is a delta variant a concern, but we need to 
look around the corner to the next mutation of the disease.
    I would like to know if we are performing enough sequencing 
to be able to quickly detect the presence of variants. And are 
we tracking the right metrics to understand the shift and drift 
of the virus so that we can see in real time what new variants 
may mean for our response? Last week, one vaccine company 
announced it was ready to file for FDA emergency use for 
booster shot. Do we need booster shots, when do we need them? 
What does this mean for a widely available vaccine? Israel 
started offering booster shots last week.
    I am worried that American leadership is no longer what it 
once was when it comes to public health and other countries are 
outpacing us. We have the same data as Israel. Why aren't we 
making the same decisions? Messages from public health experts 
won't be followed if Americans don't believe in the experts. 
The White House has the power to shape messaging, but it 
doesn't and shouldn't shape science in any administration. The 
last Administration lost the attention and trust of the 
American people with 2 hour press briefings. This 
Administration shouldn't lose theirs for the sake of the 
teachers' union. We need to know what we are being told by 
experts is the unvarnished truth. Don't tell us what you don't 
think we can handle. Don't tell us what the Administration 
thinks we should hear. Level with us.
    As we sit here today, we are just months away from flu 
season. How do we get ready for the colder months ahead of us 
and the flu and cold season that it will bring along with it? 
Are the flu shots ready? Will we have enough? These questions 
should have been thought about weeks ago as they are already on 
our doorstep. The same is true for our legislative efforts and 
the long term changes we need to make now. While lessons 
learned from COVID response are top of our mind, the ASPER must 
play a more prominent role managing the threat landscape in 
peacetime and commanding the public health and medical response 
during the emergencies with better coordination among Federal 
agencies, better availability of data and public health 
surveillance, stronger partnerships with innovators in the 
private sector, building on the good work of BARDA, and 
visibility into our supply chain for critical drug supplies, 
which are also--which also need to be more sustainable.
    The CDC must be reformed to become a more focused, 
accountable, and transparent partner in public health and 
public health preparedness and learn to adopt and leverage 21st 
century technologies. The NIH should build on its ability to 
accelerate basic research, leaning on its long expertise in 
partnering with academia to better understand the pathogens 
that pose the greatest risk and what tools we may have in the 
research bench to combat them. And the FDA should build on the 
great success that we have had, staying the more nimble and 
creative agency it has become during the COVID-19 response.
    This is especially important as the agency works to make 
final its user fee agreements and transmit them to Congress for 
our approval next year. Now is the time to anticipate what is 
next. I encourage each of you, in this critical role that you 
play to engage with this Committee to provide the insight into 
the COVID response as you have over the last 18 months, but 
more importantly, to look ahead. We have a window to update our 
public health and medical preparedness policies, taking into 
account the lessons learned from COVID-19 and this Committee 
intends to act before the attention of Congress turns to other 
matters.
    It is hard to believe, but memories will fade. I have had 
to fight to keep funding for pandemic and threat awareness too 
many times to count. I hope to pass that baton onto one of my 
colleagues to protect these important programs. But before I 
leave, I feel a great responsibility to make things better in 
one final bill.
    I am glad that the Chair is an active and able partner in 
that effort. I appreciate her commitment to this bipartisan 
concern. And I think we have a real opportunity to make 
improvements. This effort will be our focus going into the 
fall.
    We welcome your feedback, your insight, and most 
importantly, your expertise. There is nothing more important 
than the health and security of our Nation. With that, I thank 
the Chair and I yield.
    The Chair. Thank you, Senator. With that, I will introduce 
today's witnesses. We will begin with Dr. Rochelle Walensky. 
She is the Director of the Centers for Disease Control and 
Prevention and the Administrator of the Agency for Toxic 
Substances and Disease Registry. Dr. Walensky, welcome back. 
Thank you for joining us.
    Next, I would like to introduce Dr. Anthony Fauci, who is 
the Director of the National Institute of Allergy and 
Infectious Diseases and the Chief Medical Advisor in President 
Biden's COVID-19 response team. Dr. Fauci, it is good to have 
you back before the Committee. Thank you for joining us.
    Our next witness is Dr. Janet Woodcock, the Acting 
Commissioner of the Food and Drug Administration. Dr. Woodcock, 
thank you for being here. I look forward to your testimony. 
Finally, we have the Assistant Secretary for Preparedness and 
Response, John O'Connell. It is good to see you, Assistant 
Secretary O'Connell.
    Thank you for joining us. I am pleased to welcome you back 
to the Committee following your confirmation to this new role. 
With that. Dr. Walensky, you may begin your opening statement.


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

    Dr. Walensky. Good morning. Chair Murray, Ranking Member 
Burr, Members of the Senate Health Committee. I am honored to 
join you today to provide an update on the COVID-19 pandemic 
and our four priorities of CDC's ongoing response, tracking and 
preventing further spread of COVID, creating access to and 
confidence in vaccines, advancing health equity, and getting 
our children back to school. The current data reveal two 
divergent truths.
    Since the epidemic peaked in January 2021, we have seen 
large reductions in COVID-19 cases, hospitalizations, and 
deaths. And these trends are a testament to the success of our 
vaccination program and the tireless effort of professionals 
from across health, business, and Government sectors who have 
come together to respond.
    On the other hand, our progress across the country is not 
uniform. Vaccine coverage varies by state and by county. 
Communities where people remain unvaccinated, are most 
vulnerable and most likely to experience increase in case 
counts. As of last week, nearly 50 percent of vaccine eligible 
population in this country is now fully vaccinated. 160 million 
people and still nearly two-thirds of counties in the United 
States have vaccine coverage less than 40 percent.
    In areas where vaccine coverage is low, cases and 
hospitalizations are starting to climb again. Over the last 
week, we have averaged 239 deaths per day, an increase of 
nearly 48 percent over the prior week. Each death is tragic and 
even more heartbreaking when we know that the majority of these 
deaths could be prevented with a simple, safe, available 
vaccine. Areas with limited vaccine coverage are allowing for 
the emergence and rapid spread of the highly transmissible 
delta variant. CDC has released estimates of variance across 
the country and predicted the delta variant now represents 83 
percent of sequenced cases.
    This is a dramatic increase, up from 50 percent for the 
week of July 3rd. In some parts of the country, the percentage 
is even higher, particularly in areas of low vaccination rates. 
To date, our data indicates that vaccines are available to 
neutralize but circulating variants in the United States and 
provide protection against severe disease, hospitalization, and 
death. The message from CDC remains clear, the best way to 
prevent the spread of COVID-19 variants is to prevent the 
spread of disease. And vaccination is the most powerful tool we 
have.
    We must continue to expand vaccine coverage by building 
trust and confidence in COVID-19 vaccines. And this is 
particularly important in communities of color, rural 
communities, and other population groups at risk. CDC is 
engaging trusted community leaders to reinforce messages about 
the safety, efficacy, and importance of vaccination. CDC 
remains committed to ensuring all of our work advances health 
equity. Thanks to supplemental resources, CDC has provided 
additional support to health departments to address health 
disparities and improve health equity among historically 
underserved populations at elevated risk. That includes racial 
and ethnic minority groups and people living in rural areas.
    We are training and integrating community health workers 
into care teams, collaborating with partner organizations to 
improve vaccine access, and building vaccine confidence among 
medically underserved communities and disproportionately 
affected populations. As the Director of the CDC, it is my 
priority to get our children back to school for safe in-person 
learning. Earlier this month, the CDC released updated guidance 
to reflect the latest science on COVID-19 and the widespread 
availability of safe and effective vaccines for those ages 12 
and over.
    We continue to recommend that schools implement layered 
prevention strategies to protect those who are not fully 
vaccinated and encourage vaccination for those who are 
eligible. Masks continue to be a critical part of these layered 
prevention strategies. Working together, school administrators 
and public health workers can carefully consider community 
transmission rates, local vaccine coverage, and occurrence of 
outbreaks when deciding what strategies are needed to help 
prevent the spread of COVID-19 and safeguard in-person 
education.
    In summary, the overwhelming majority of deaths from COVID-
19 are now occurring in unvaccinated people. Vaccines are 
widely available across the country, and the suffering and loss 
is simply entirely preventable, nearly.
    For our entire Nation to heal and move forward, we must do 
all our part to get our Country vaccinated. Thank you and I 
look forward to your questions.

    [The prepared statement of Dr. Walensky follows:]
                prepared statement of rochelle walensky
    Chair Murray, Ranking Member Burr, and distinguished Members of the 
Committee. It is an honor to appear before you again 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. We work 24/7 to prevent illness, 
save lives, and protect America from threats to health, safety, and 
security. CDC is proud of its key role in preparedness and response to 
public health concerns here in the United States and abroad.
                          CDC Efforts to Date
    Since we last met, COVID-19 cases have decreased from the spring to 
summer, and we have made tremendous strides in getting people 
vaccinated, which has allowed many people to resume their daily 
activities safely. We are hopeful and have made incredible progress 
toward controlling this pandemic. However, many states and communities 
continue to have low vaccination rates, and the threat of variants is 
growing. We are now witnessing concerning increases in a number of 
jurisdictions and given the threat of variants, including the increased 
prevalence of the hyper-transmissible Delta variant, we must remain 
diligent as we continue to fight this virus.

    On June 23rd we officially passed the heart wrenching milestone of 
over 600,000 deaths from COVID-19 in the United States. This tragic 
reminder is a powerful motivator for us all to continue to push to 
achieve higher vaccination rates and prevent the loss of as many more 
of our loved ones as possible.

    As of July 15, about 89 percent of the U.S. population 65 years and 
older, 68 percent of those 18 years and older, 65 percent of those 12 
years and older, and nearly 56 percent of the total U.S. population 
received at least one dose of a COVID-19 vaccine. This is good news and 
demonstrative of continued progress. These gains are thanks to the 
tireless efforts of professionals from across the public health, 
medical, business, and multisectoral levels of government who have come 
together across the country to respond to this pandemic. However, 
looking state-by-state and county-by-county, it is clear that 
communities where people remain unvaccinated are communities that 
remain vulnerable and, in many cases, are experiencing increased 
numbers of cases. Preliminary data from a collection of states over the 
last several months suggest the overwhelming majority of deaths from 
COVID-19 in the United States have occurred in unvaccinated people. Any 
suffering or death from COVID-19 is tragic. With vaccines available 
across the country, the suffering and loss are nearly entirely 
avoidable.

    Currently, nearly two-thirds of counties in the United States have 
vaccination coverage less than 40 percent. We are seeing increasing 
rates of disease in different areas across the country, primarily in 
counties with low vaccination coverage. As the Delta variant continues 
to spread across the country, we expect to see increased transmission 
in these communities unless we can vaccinate more people. Our 
authorized vaccines provide protection against the variants circulating 
in this country--including Delta. Vaccination is the key to protecting 
these vulnerable individuals, families, and communities and preventing 
severe disease, hospitalizations, and death from COVID-19. The scale of 
this unprecedented public health emergency requires unprecedented 
action--at CDC, 9,300 CDC personnel have been part of our COVID-19 
response, both at CDC headquarters and in the field. About 1,700 staff 
have taken part in over 3,600 deployments to more than 300 locations 
across the United States and around the world.

    As we well know and the world has learned from this pandemic, a 
public health threat anywhere is a threat everywhere. To support the 
prevention of international spread, CDC is working around the world 
with global partners and many low-and middle-income countries to 
support the planning, implementation, and evaluation of COVID-19 
vaccine programs. We will continue working to facilitate lesson sharing 
across countries to increase vaccine access to all, both here and 
abroad. CDC is working to ensure that public health decisions are based 
on the highest-quality scientific information. Since the start of the 
pandemic, over 300 COVID-19 studies have been published in the 
Morbidity and Mortality Weekly Report (MMWR) on topics ranging from 
health disparities exacerbated during the pandemic, to prevention 
strategies, including the safety and effectiveness of COVID-19 
vaccines, to emergence of new variants. CDC has also produced more than 
6,000 documents to provide information and guidance for government 
agencies, businesses, and the public. CDC is actively studying the 
epidemiology of post-COVID conditions (often referred to as long 
COVID), including the prevalence, duration, and severity of symptoms 
following acute SARS-CoV-2 infection, as well as risk factors for 
developing post-COVID conditions. This work will help to establish a 
more complete understanding of the natural history of SARS-CoV-2 
infection and post-COVID conditions, which can inform healthcare 
strategies, clinical decision-making, and the public health response to 
this virus that will be required over the long term. A recent MMWR 
article comparing patients who have had COVID-19 with cancer 
rehabilitation patients and the general adult population found that 
post-COVID patients had poorer physical health, more pain, and greater 
difficulty with physical activities.

    CDC has provided new guidance to assist healthcare professionals in 
evaluating and caring for patients with post-COVID conditions. 
Recognizing and confirming the impact that post-COVID conditions can 
have on quality of life is important. The goal of managing post-COVID 
conditions is to help patients function in the best way possible and 
improve quality of life.

    Now I want to take a moment to give you a more in-depth update on 
some key areas for the COVID-19 response.
                                Variants
    COVID-19 has brought to the forefront how interconnected we are as 
a global community and the importance of our international scientific 
relationships.

    In the fall of 2020, several SARS-CoV-2 variants emerged, some of 
which appear to spread more easily than others. The emergence of 
variants is, of course, concerning, and it underscores the critical 
need for genomic surveillance and increased vigilance in the 
implementation of public health prevention measures.

    We are monitoring dozens of variants and conducting ongoing and 
comprehensive risk assessments through the SARS-CoV-2 Interagency Group 
comprised of CDC, the National Institutes of Health (NIH), the Food and 
Drug Administration (FDA), the Biomedical Advanced Research and 
Development Authority (BARDA), the United States Department of 
Agriculture, and the Department of Defense. We are also in consultation 
with many of our international colleagues. Of the emerging variants, 
four have captured our attention and have the highest risk to public 
health: B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 
(Delta).

    The Alpha variant, originally identified in the United Kingdom, was 
first identified in the United States in December 2020, and quickly 
became the predominant variant. However, based on CDC's most recent 
data, the Delta variant is now predicted to be the predominant lineage 
circulating in the United States. The Delta variant was originally 
detected in India and the earliest known case in the United States was 
in February 2021. According to CDC's Nowcast model for the two-week 
period ending July 3, the national proportion of the Delta variant is 
projected to be 51.7 percent of cases, with the Alpha variant being the 
second-most predominant variant at 28.7 percent. The third most 
prevalent variant in the United States is the Gamma variant, with a 
projected national proportion of 8.9 percent for the two-week period 
ending July 3. The fourth variant of concern, Beta, is projected to be 
well below 1 percent.

    Available data indicate that antibodies elicited shortly after 
vaccination with the currently authorized vaccines are able to 
neutralize the circulating variants, although some have a reduced 
neutralization against the Beta and Gamma variants in laboratory 
studies. A recent study from the United Kingdom indicated that the 
Pfizer vaccine was 93 percent effective at preventing symptomatic 
infection with the Alpha variant and 88 percent effective at preventing 
symptomatic infection with the Delta variant, and a related study 
indicated that the Pfizer vaccine was greater than 95 percent effective 
at preventing hospitalization when infected with either the Alpha or 
Delta variants. Based on preliminary data from a Johnson & Johnson 
vaccine clinical trial in South Africa where the prevalence of the Beta 
variant was estimated to be 95 percent, the vaccine was 64 percent 
effective in preventing infection and 81.7 percent effective in 
preventing severe disease. Additional data from among healthcare 
workers in South Africa vaccinated with the Johnson & Johnson vaccine 
demonstrate that 94 percent of breakthrough infections are mild, in a 
setting with a high prevalence of the Delta variant. Studies are 
currently underway to understand the impact on the real-world 
effectiveness of current vaccines against variants and to better 
understand the impact of the variants on medical countermeasures.

    Since January 2021, CDC has dramatically built up our domestic 
genomic surveillance platforms to monitor circulating variants. While 
the decline in SARS-CoV-2 cases compared to the high peak this past 
winter means that the number of specimens available for sequencing has 
declined, CDC continues to generate enough sequences to detect emerging 
variants through the National SARS-CoV-2 Strain Surveillance (NS3) 
program and contracts with commercial diagnostic laboratories.

    With the funding provided by the American Rescue Plan Act, we are 
further investing in public health infrastructure to strengthen genomic 
sequencing and bioinformatics capacity. We have issued 29 awards, 
totaling approximately $37 million, as part of the SARS-CoV-2 
Sequencing for Public Health Emergency Response, Epidemiology, and 
Surveillance (SPHERES) Initiative. These awards are intended to fill 
knowledge gaps and promote innovation in the U.S. response to the 
COVID-19 pandemic, and will help integrate next-generation genomic 
sequencing technologies with bioinformatics and epidemiology expertise 
across the US public health system.

    On July 1, to address low vaccination coverage and increasing cases 
due to spread of the Delta variant in some communities, CDC, along with 
other Federal partners, intensified our efforts to help states prevent, 
detect, and respond to hotspots among the unvaccinated by launching 
COVID-19 Surge Response Teams. With this interagency initiative, CDC 
will participate in teams at-the-ready to deploy resources and 
personnel to communities at higher risk for--or already experiencing--
outbreaks due to the spread of the Delta variant and under-vaccination. 
In collaboration with state, tribal, local, and territorial health 
department partners, interagency teams will define the needs on the 
ground and work to address these gaps. The most important step we can 
take to prevent these outbreaks is for everyone eligible to get 
vaccinated, and we continue to work with communities across the country 
on that goal.
                             Health Equity
    Data continue to show the disproportionate impact of COVID-19 on 
racial and ethnic minority populations, as well as other population 
groups such as people living in rural or frontier areas, people 
experiencing homelessness, essential and frontline workers, people with 
disabilities, people with substance use disorders, people who are 
incarcerated, and non-U.S.-born persons.

    In June 2021, CDC began providing additional resources to health 
departments to address COVID-19-related health disparities and advance 
health equity among populations that are underserved and facing 
conditions that place them at elevated risk, including racial and 
ethnic minority groups and people living in rural areas. This funding 
represents an investment by CDC--$2.25 billion over 2 years--to support 
communities affected by COVID-19-related health disparities. CDC's new 
National Initiative to Address COVID-19 Health Disparities Among 
Populations at High-Risk and Underserved Communities, Including Racial 
and Ethnic Minority Populations and Rural Communities, is providing 
grants to local and state public health departments to work in 
partnerships with members of the affected communities to improve 
testing and contact tracing capabilities; develop innovative mitigation 
and prevention resources and services; improve data collection and 
reporting; build, leverage, and expand infrastructure support; and 
collaborate with partners to advance health equity and address social 
determinants of health as they relate to COVID-19.

    Community Health Workers (CHW) have a demonstrated impact in the 
communities they serve yet persistent barriers have left them 
underutilized in addressing health disparities. In May 2020, CDC 
announced $332 million dollars in CARES Act funding for a grant program 
and evaluation to support Community Health Workers for COVID Response 
and Resilient Communities. The program will support the training and 
deployment of CHWs to bolster response efforts and strengthen community 
resilience to fight COVID-19 by addressing existing health disparities. 
CHWs are well-positioned to reach communities, especially those 
disproportionately impacted by COVID-19. CHW interventions can improve 
uptake and access to health care services, improve communication 
between community members and health providers, reduce the need for 
emergency and specialty services, and improve adherence to health 
recommendations.

    As of May 2021, CDC has released several publications examining 
vaccination rates in certain population groups to monitor disparities 
and track progress toward health equity. The first study, Demographic 
and Social Factors Associated with COVID-19 Vaccination Initiation 
Among Adults Aged 65 Years--United States, December 14, 2020-April 10, 
2021, found that after the first 3.5 months of the U.S. COVID-19 
vaccination program, 79.1 percent of adults aged 65 years had received 
1 dose, with higher vaccination initiation among men. Counties with 
lower vaccination initiation rates had higher percentages of older 
adults with social vulnerabilities. The second study, Disparities in 
COVID-19 Vaccination Coverage Between Urban and Rural Counties--United 
States, December 14, 2020-April 10, 2021, found that COVID-19 
vaccination coverage was lower in rural counties (38.9 percent) than in 
urban counties (45.7 percent) and that disparities persisted among age 
groups and by sex. A third study, Patterns in COVID-19 Vaccination 
Coverage, by Social Vulnerability and Urbanicity--United States, 
December 14, 2020-May 1, 2021, found disparities in county-level 
vaccination coverage by social vulnerability have increased as vaccine 
eligibility has expanded, especially in large fringe metropolitan 
(areas surrounding large cities, e.g., suburban) and nonmetropolitan 
counties. By May 1, 2021, vaccination coverage among adults was lower 
among those living in counties with lower socioeconomic status and with 
higher percentages of households with children, single parents, and 
persons with disabilities.

    Collectively, these findings highlight the need to continue 
monitoring demographic and social factors affecting COVID-19 vaccine 
access; to prioritize efforts to ensure equitable access to COVID-19 
vaccine; to tailor public health messaging for local populations and 
counties with high social vulnerability; and the need for public health 
practitioners to collaborate with health care providers, pharmacies, 
employers, faith leaders, and other community partners to identify and 
address barriers to COVID-19 vaccination in rural areas.

    While these data indicate additional work that lies ahead to 
achieve greater vaccination rates in certain population groups, we know 
there are communities that have been successful in their vaccination 
efforts. In June 2021, as part of the National Month of Action, CDC 
hosted a webinar as a call to action to increase the number of 
vaccinated people in Black or African American and Hispanic or Latino 
communities. The webinar highlighted organizations that have conducted 
successful mass vaccination activities for Black or African American 
and Hispanic or Latino people. These organizations shared their 
successes, challenges, and strategies used to increase vaccine 
education, awareness, and uptake with the nearly 500 participants from 
public health, healthcare, clinical, and community organization 
leadership. This effort is part of CDC's ongoing work to share best 
practices around the country to help all communities achieve the 
highest rates of vaccination possible.

    To assist decision-makers and researchers, CDC also launched a 
Health Equity page on our COVID Data Tracker. The page catalogs current 
health equity-related data that align with populations and place-based 
focus groups identified in CDC's COVID-19 Response Health Equity 
Strategy.
                                Vaccines
    Vaccination is a critical tool in bringing this unprecedented 
pandemic to an end. As of May 10, every person aged 12 and over in 
every state and territory is eligible to get vaccinated. CDC has 
continued to improve accessibility by increasing distribution of 
vaccines to medical offices. We have increased the number of medical 
practices receiving vaccine by nearly 85 percent since early April and 
now have over 10,000 medical practices served by primary care doctors, 
administering vaccine alongside other routine medical care. The country 
exceeded President Biden's goal of administering 200 million shots in 
the first 100 days of his Administration. A CDC study \1\ reviewing 
data from 2 months of early vaccinations among health care personnel 
found that both Moderna and Pfizer vaccines were 94 percent effective 
in preventing symptomatic SARS-CoV-2 infection, seven or more days 
after the second dose. In addition, another CDC study \2\ found these 
two vaccines were 94 percent effective against hospitalization among 
fully vaccinated adults aged 65 years and older. These findings 
demonstrate the high, real-world effectiveness of these vaccines.
---------------------------------------------------------------------------
    \1\  https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e2.htm's-
cid=mm7020e2-w.
    \2\  https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm's-
cid=mm7018e1-w.

    CDC will continue working with partners to monitor how well COVID-
19 vaccines work in real-word conditions through multiple studies 
looking at vaccine effectiveness in various populations, locations, and 
settings. Through these studies, CDC can obtain more representative, 
scientifically valid, and complete information about vaccine 
---------------------------------------------------------------------------
effectiveness, including factors associated with vaccine breakthrough.

    Vaccinations are highly effective against severe disease including 
hospitalizations and death, thus protecting even the limited number of 
people who are vaccinated but still get COVID-19. A recent analysis led 
by CDC published in the New England Journal of Medicine found that mRNA 
COVID-19 vaccines show secondary benefits of vaccination for people who 
were fully or partially vaccinated and still got COVID-19. Secondary 
benefits included having shorter and milder illness and potentially 
being less likely to spread the virus to others compared to 
unvaccinated people with COVID-19.

    COVID-19 vaccine safety is a top priority for the Federal 
Government, and we take all reports of health problems following COVID-
19 vaccination seriously. Since April 2021, increased cases of 
inflammation of the heart muscle, called myocarditis, or outer lining, 
called pericarditis,--have been reported in the U.S. following mRNA 
COVID-19 vaccination (Pfizer or Moderna). This is a rare condition and 
reported cases have occurred predominantly in male adolescents and 
young adults. Following a thorough safety review and meeting of CDC's 
Advisory Committee on Immunization Practices, which found the benefits 
of mRNA vaccination greatly outweighed the risks, CDC continues to 
recommend COVID-19 vaccination for everyone 12 years of age and older, 
given the risk of COVID-19 illness and related, possibly severe 
complications. FDA and CDC also conducted extensive outreach to 
providers and clinicians to ensure they were made aware of the 
potential for these adverse events.

    CDC and FDA are monitoring reports of Guillain-Barre Syndrome (GBS) 
after receiving Johnson & Johnson's Janssen (J&J/Janssen) COVID-19 
Vaccine. GBS is a neurological disorder in which the body's immune 
system damages nerve cells, causing muscle weakness or in the most 
severe cases paralysis. Reports of GBS after receipt of the J&J/Janssen 
COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) 
are rare, but do likely indicate a small possible risk of this side 
effect following this vaccine. Around 100 preliminary reports of GBS, 
mostly in males, many aged 50 years and older, have been detected in 
VAERS after 12.8 million doses of J&J/Janssen COVID-19 Vaccine 
administered. Available data do not show a similar pattern with mRNA 
vaccines (Pfizer-BioNTech and Moderna). On July 13, the FDA updated the 
label of the Johnson & Johnson vaccine to add a new warning suggesting 
an increased risk of Guillain-Barre Syndrome within 42 days following 
vaccination. This issue will be discussed as part of an upcoming 
meeting of CDC's Advisory Committee on Immunization Practices (ACIP) 
later in July. The detection of rare complications, such as 
myocarditis, thrombosis-thrombocytopenia syndrome (a rare and severe 
type of blood clot), and GBS, is an important validation of the 
sensitivity of vaccine safety monitoring systems to be able to pick up 
even very small numbers of potential vaccine safety concerns.

    Building on long-standing relationships with state and local 
partners, CDC has worked tirelessly to ensure that we are getting 
vaccines to people as quickly, safely, and equitably as possible. As of 
July 16, 2021, about 389 million doses have been delivered, and more 
than 336 million doses of COVID-19 vaccine have been administered. 
About 79 percent of all Americans age 65 years and older were fully 
vaccinated by this date, and about 68 percent of adult Americans had 
received at least one vaccine. This is a whole-of-society effort, and 
it is inspiring to see people across government, business, and 
communities coming together to complete this important lifesaving task.

    Strong confidence in vaccines within communities leads to more 
people getting vaccinated, and to fewer COVID-19 illnesses, 
hospitalizations, and deaths. CDC is working in coordination with 
national, state, tribal, local, and territorial governmental and non-
governmental partners to build trust in the vaccine, the vaccinator, 
and the vaccination system. We will continue to work with these 
critical partners to address barriers to vaccinations, including in 
communities of color and disproportionally affected groups. It is 
important that we continually deliver the message that vaccines are 
rigorously studied during clinical trials, and there is a vast network 
of safety systems that monitor vaccines once they are in use and safety 
protocols to monitor people when they receive the vaccine. In order to 
address vaccine hesitancy, it is crucial to provide accurate scientific 
messaging across all sectors and multiple platforms, using creative 
communications approaches such as enlisting trusted community members 
to help address concerns over COVID-19 vaccines. Listening to, and 
patiently addressing concerns, including on an individual basis, is a 
vital method that should be used to build confidence in vaccines.

    Further supporting efforts to prioritize equity in our vaccine 
strategy, in early April CDC awarded $3.15 billion directly to states, 
territories, and some large cities to support local efforts to increase 
vaccine access, uptake, and equity. The funding focused on reaching 
communities hit hardest by the pandemic, including those with a high 
Social Vulnerability Index, minority communities, and rural areas.

    In order to enhance vaccine uptake among underserved communities of 
color and to build trust and confidence in the authorized COVID-19 
vaccines, CDC has developed a comprehensive program of approximately 20 
national organizations that support hundreds of local and community-
based organizations to improve both COVID-19 and influenza vaccination 
coverage among racial and ethnic groups who have historically had, and 
continue to experience, health disparities. Jurisdictions are also 
encouraged to consider factors such as the Social Vulnerability Index 
and current administration rates in local communities when reaching out 
to enroll providers. Guidance was disseminated to jurisdictions on 
increasing the proportion of vaccines allocated to providers who are 
located in socially vulnerable communities. In July, CDC added a new 
Vaccination Equity tab to display Social Vulnerability Index and 
vaccination coverage maps to the COVID Data Tracker. Improving access 
to underserved communities and populations that have historically 
experienced greater barriers to healthcare access is another critical 
component to prioritizing equity in vaccine distribution. Improving 
access also requires a multi-pronged approach. For example, CDC 
partners with the Health Resources and Services Administration (HRSA) 
to provide COVID-19 vaccinations and technical assistance to interested 
HRSA-funded health centers, with the goal of bringing vaccines to 
communities and improving access for populations disproportionately 
impacted by COVID-19. As of June 29, roughly 7 million doses had been 
distributed to 2,200 HRSA-funded health centers across the Nation.

    The Federal Retail Pharmacy Program is integral to the work CDC is 
doing to maximize access to COVID-19 vaccines in all communities, 
including communities of color and other underserved populations, such 
as rural communities. CDC partnered with 21 national pharmacy 
organizations and independent pharmacy networks that represent over 
40,000 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. These pharmacies continue 
to reach out to communities, administering almost 3 million doses at 
nearly 10,000 mobile pop-up clinics, with 58 percent of people 
vaccinated by pharmacies in the last 2 weeks of June being in a 
minority group.

    On May 13th, CDC released new guidance for fully vaccinated people, 
which said that, anyone who is fully vaccinated can resume activities--
indoor or outdoor--safely without a mask or physical distancing, except 
where required by Federal, state, local, tribal, or territorial laws, 
rules and regulations, including local business and workplace guidance. 
This decision was based on three major scientific developments: (1) Our 
vaccines working in the real world, with studies showing them to be >90 
percent effective in the real-world settings in preventing mild and 
severe disease, hospitalization, and death, (2) Our vaccines proving to 
be effective against the SARS-CoV-2 variants currently circulating in 
the country, and (3) Research showing that if you are vaccinated, you 
are less likely to spread the virus. A growing body of evidence 
suggests that fully vaccinated people are less likely to have 
asymptomatic infection and to be able to transmit SARS-CoV-2 to others. 
While we hope this was encouraging news for the country, we must remain 
vigilant in our efforts to continue increasing vaccination if we want 
to continue returning to normal. At this time, CDC sees no need to 
change our fully vaccinated guidance; however we will continue to 
monitor all indicators and data closely.
                                Schools
    Since becoming the director of CDC, I have stressed the importance 
of getting children back to school for in-person learning. The safest 
way to open schools is to ensure that there is as little disease as 
possible in the community. With the widespread availability of safe and 
effective vaccines, we have seen reductions in COVID-19 cases, 
hospitalizations, and deaths. If vaccination rates continue to increase 
and community transmission rates decrease, the risk in schools is 
expected to decrease as well.

    CDC began working on guidance, resources, and tools for safe school 
reopening in March 2020 when the first schools closed. As CDC learned 
more about COVID-19, we continually updated our guidance, resources, 
and tools for schools, parents, teachers, and other staff. Earlier this 
month, CDC released updated guidance to help prevent the spread of 
COVID-19 and safeguard in-person learning. CDC's Guidance for COVID-19 
Prevention in K-12 Schools is now updated to reflect the latest science 
on COVID-19, lessons learned from schools implementing COVID-19 
prevention strategies, and the widespread availability of safe and 
effective COVID-19 vaccines for those aged 12 years and older. Reports 
suggest that limited in--person instruction during the pandemic may 
have had a negative effect on learning for children and on the mental 
and emotional well-being of both parents and children. In addition, 
many K-12 schools globally implemented layered COVID-19 prevention 
strategies during the 2020-2021 academic year. These schools' 
experiences contributed to our knowledge of the nature of SARS-CoV-2 
transmission in schools and informed updates to the K-12 guidance, 
which emphasizes the importance of offering in-person learning in K-12 
schools.

    CDC recommends schools implement layered prevention strategies to 
protect people who are not fully vaccinated, including students, 
teachers, staff, and other members of their households. These 
strategies include vaccination for children and adults ages 12 and up, 
the correct use of masks, physical distancing, handwashing and 
respiratory etiquette, cleaning and maintaining healthy facilities 
(including proper ventilation), and contact tracing, in combination 
with screening testing, isolation, and quarantine for those exposed and 
not vaccinated. The guidance emphasizes the need for localities to 
monitor community transmission, vaccination coverage, screening 
testing, and occurrence of outbreaks to guide decisions on the level of 
layered prevention strategies.

    Mask use and physical distancing are two key prevention strategies 
for reducing SARS-CoV-2 transmission, but a layered approach that uses 
several strategies will provide the greatest level of protection. 
Schools where not everyone is fully vaccinated should implement 
physical distancing to the extent possible within their structures, in 
addition to masking and other prevention strategies. If it is not 
possible to maintain adequate physical distancing, it is especially 
important that schools layer multiple other prevention strategies, such 
as masking and screening testing, to help ensure that no students need 
be excluded from in-person learning.

    In April, CDC provided $10 billion to states and jurisdictions to 
support COVID-19 screening testing for K-12 teachers, staff, and 
students to assist schools in reopening safely for in-person 
instruction. In May, CDC also awarded $500 million to jurisdictions to 
expand the school-based public health workforce, including nurses and 
other health personnel. Combined, we believe these resources will 
provide substantial help to schools around the Nation as they open in 
the fall.

    SARS-CoV-2 is still a relatively new pathogen, and we are learning 
more about it and how it impacts different people and communities all 
the time. CDC's Guidance for COVID-19 Prevention in K-12 Schools 
presents recommendations based on the best-available evidence at the 
time of release. As science and data on SARS-CoV-2 and COVID-19 
continue to evolve, we will update our guidance and recommendations to 
reflect new evidence. CDC stands committed to providing the best, most 
current data and scientific understanding available to protect the 
health, safety, and well-being of our communities, including our 
students, teachers, and school staff.
                               Conclusion
    In closing, I want to emphasize that with increased vaccinations 
nationwide, we can look forward to seeing more kids in school, more 
families able to connect with one another safely, and our Nation 
beginning to move forward and heal. But we have to ensure that we are 
stamping out COVID-19 in all communities, not just some communities. We 
cannot risk only keeping parts of the U.S. moving forward safely while 
other parts of the country continue to see tragic numbers of cases and 
deaths from COVID-19. This will require sustained efforts from all 
stakeholders and across all levels of government and most importantly 
individuals making the decision to get vaccinated to protect 
themselves, their loved ones, and their communities.

    We also must address the long-standing vulnerabilities in our 
public health system and the conditions that led to disproportionate 
burden of COVID-19 illness and death in some communities. The Fiscal 
Year 2022 President's Budget Request includes an increase of nearly 
$1.7 billion for CDC to invest across the public health system. This is 
an important first step in building back a better public health system 
that can deliver health security to all Americans.
                                 ______
                                 
    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. Thank you very much, Madam Chair, Ranking Member 
Burr, Members of the Committee. Thank you for giving me the 
opportunity to discuss with you again the role of the National 
Institute of Allergy and Infectious Diseases in the research 
response addressing COVID-19. As I have mentioned to this 
Committee on prior hearings, the strategic plan for research 
for NIAID involves research on fundamental basic knowledge 
regarding the virus to development of diagnostics, 
therapeutics, and vaccines.
    For the purposes of today's discussion and my presentation, 
I would like to focus on three vaccines that you know have been 
approved through the emergency use authorization for use in the 
United States, and that is the two mRNA vaccines from Pfizer, 
Biogenetic, and Moderna, and the J&J vaccine, which is a human 
adenovirus vector vaccine. As I mentioned to this Committee on 
prior hearings, the clinical trials that proved the 
extraordinary efficaciousness of these vaccines to the tune of 
93 and 94 percent are very, very clear right now.
    What I would like to emphasize today is what has transpired 
since the last hearing, and that is the accumulation of data on 
the real world effectiveness of these vaccines. In a situation 
we are confronted with a historic pandemic. And that is seen 
not only in the United States, but also in the UK in the form 
of England and Scotland, in Israel, Qatar, and other places.
    When one looks at the data, and one good example is the 
cohort study from Israel in which the mRNA vaccine used in that 
population was highly effective in the real world beyond the 
clinical trial, including among asymptomatic, early symptomatic 
advanced disease, intensive care, and even deaths, and if one 
looked across the cohort, you saw that it was effective in 
essentially every age group from young individuals, middle 
aged, and even the elderly. That is the good news. The sobering 
news that you have already heard of is the fact that we are now 
challenged with a very difficult and problematic variant 
referred to as the delta variant. It has now been detected in 
at least 90 plus countries throughout the world.
    The reason it is so formidable is the fact that it has the 
capability of transmitting efficiently from human to human in 
an extraordinary manner, well beyond any of the other variants 
that we have experienced up to now, which has led to its 
becoming the dominant variant in this country. When I spoke to 
you last time, it was about 1 to 3 percent of the variance in 
the population. Right now it has gone to over 80 percent, and 
in some regions of the country, as high as 90 percent. That is 
the troubling news.
    The fact is that, however, and the importance of 
vaccination is that our vaccines that we are using in this 
country are very effective against this variant, particularly, 
I point out, to the situation regarding advanced disease 
leading to hospitalizations and deaths where it is still well 
in the 90 percent of effectiveness. I would like to close with 
just one or two comments that we have been hearing about 
regarding the situation of booster or an additional third dose 
superimposed upon the double doses of the mRNA and the single 
dose of the J&J.
    Right now, we are doing studies to determine whether or not 
we will need boosters to increase the durability of protection. 
We don't want people to believe that when you are talking about 
boosters, that means that the vaccines are not effective. They 
are highly effective. We are talking about the durability of 
that. And we are doing studies now to determine that.
    In addition, there are individuals who are 
immunosuppressed, people who are on cancer, chemotherapy, a 
variety of other individuals, transplant individuals who may 
actually need a boost as part of their initial regimen in the 
sense of getting them up to the point where they are protected. 
So in closing, I want to underscore what Dr. Walensky just said 
a few moments ago, the extraordinary importance of getting as 
many people vaccinated as we possibly can.
    We have the tools to end this epidemic. It is up to us to 
utilize those tools to the maximum. Thank you very much, Madam 
Chair.

    [The prepared statement of Dr. Fauci follows:]
                  prepared statement of anthony fauci
    Madam Chair, Ranking Member Burr, and Members of the Committee:
    Thank you for the opportunity to discuss the role of the National 
Institute of Allergy and Infectious Diseases (NIAID) in the research 
response to coronavirus disease 2019 (COVID-19) and its etiologic 
agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 
Within the Department of Health and Human Services (HHS) and the 
National Institutes of Health (NIH), NIAID is responsible for 
conducting and supporting basic and clinical research on emerging and 
re-emerging infectious diseases, including COVID-19. As the Director of 
NIAID and the Chief Medical Advisor to the President, I am pleased to 
discuss NIAID's research addressing this pandemic.

    COVID-19 is a once-in-a-lifetime global infectious disease pandemic 
requiring an unprecedented public-private research effort. NIAID plays 
a central and important role in the public health response to COVID-19. 
NIAID has capitalized on decades of investment in fundamental basic 
research, including groundbreaking structure-based vaccine design at 
the NIAID Vaccine Research Center (VRC); engaged domestic and 
international research infrastructure; and leveraged highly productive 
partnerships with industry and longstanding relationships with 
community partners. NIAID utilized its existing domestic and 
international clinical trials infrastructure, originally established to 
conduct research on HIV and influenza, and worked with partners in the 
public and private sectors to establish the COVID-19 Prevention Network 
(CoVPN). The CoVPN has supported multiple COVID-19 vaccine candidates 
to progress in record time from concept to authorization for emergency 
use by the U.S. Food and Drug Administration (FDA). NIAID also has 
built on its longstanding relationships with community partners to 
successfully conduct these crucial clinical trials. NIAID initiated 
clinical trials with creative and adaptive designs, allowing the 
evaluation of multiple new and existing therapeutics for use against 
COVID-19. Several of these trials provided evidence of safety and 
efficacy of COVID-19 therapeutics and helped support authorization by 
the FDA.

    These successes have helped slow the progression of the pandemic in 
the United States. Currently, more than 67 percent of U.S. adults have 
received at least one dose of a COVID-19 vaccine, and we must continue 
to vaccinate as many people as we can, as quickly as possible. FDA-
authorized COVID-19 vaccines meet FDA's rigorous standards for safety 
and efficacy. The high levels of vaccine efficacy observed in the 
carefully controlled conditions of clinical trials have been 
subsequently confirmed by their effectiveness in studies of vaccines 
administered to broad segments of the public in the United States and 
other countries. Vaccination and adherence to public health measures 
are the proven interventions that will be particularly important as we 
work to address the SARS-CoV-2 Delta (or B.1.617.2) variant and other 
variants with increased transmissibility or pathogenicity that may 
emerge.

    While we are cautiously optimistic about the future, we know that 
many challenges remain. One of the most concerning developments of the 
ongoing pandemic is the spread of variants of SARS-CoV-2 such as the 
Delta (B.1.617.2) variant. So far, scientific evidence suggests that 
the COVID-19 vaccines distributed in the United States under FDA 
Emergency Use Authorizations (EUA) continue to be effective against 
severe disease caused by these variants, but we must remain vigilant. 
NIAID is rapidly conducting research to better understand these 
emerging variants, how they interact with the immune system, and their 
implications for COVID-19 therapeutic and vaccine formulations.

    We also know that our fellow Americans in underserved and minority 
communities have been disproportionally affected by this pandemic. 
NIAID is committed to continuing to work directly with these 
communities and partnering with other agencies in the Federal 
Government, and with industry and academia to ensure that nobody in 
vulnerable communities is left behind as we move forward toward 
defeating the COVID-19 pandemic. NIAID also recognizes that while many 
individuals with SARS-CoV-2 infection fully recover after a relatively 
short time period, some individuals suffer longer-term effects after 
the initial phase of illness. NIAID is supporting collaborative efforts 
to study COVID-19 outcomes in patients across all ages, genders, and 
co-morbid conditions. These studies include people who experienced a 
broad range of COVID-19 disease severity so we can identify and 
characterize post-acute sequelae of SARS-CoV-2 infection (PASC) and 
develop effective strategies to address them.
   Developing Vaccines and Monoclonal Antibodies to Prevent COVID-19
    Sustained research investments by NIAID in the years prior to the 
emergence of SARS-CoV-2 enabled the unprecedented pace of COVID-19 
vaccine development. Two activities in particular predate successful 
COVID-19 vaccines: the development of versatile vaccine platforms and 
the adaptation of structural biology tools to design specific proteins 
(immunogens) that powerfully stimulate the immune system. Long before 
the pandemic, NIAID VRC scientists and their collaborators made the 
critical scientific discovery of how to stabilize--in a highly 
immunogenic form--viral proteins that are important for infection. 
These included the spike protein of Middle East respiratory syndrome 
coronavirus (MERS-CoV), which was stabilized using a double mutation 
known as S2P. This key finding facilitated the design of vaccine 
candidates that generate robust immune responses not only against 
coronaviruses but also other viruses of public health importance such 
as respiratory syncytial virus. As soon as the sequence of SARS-CoV-2 
was made available in January 2020, VRC researchers rapidly generated a 
stabilized SARS-CoV-2 spike protein for use in COVID-19 vaccine 
development. This crucial breakthrough in structure-based vaccine 
design for coronaviruses led to the development of safe and effective 
COVID-19 vaccine candidates across a range of vaccine platforms.

    Six candidate COVID-19 vaccines have been or are in the process of 
being assessed in large-scale Phase 3 clinical trials in the United 
States thus far, and three have received EUAs from the FDA. Clinical 
trials to test COVID-19 vaccine candidates in pediatric populations are 
ongoing. On December 11, 2020, based on data from a Pfizer-supported 
Phase 3 clinical trial, an investigational vaccine developed by Pfizer 
and BioNTech became the first to receive an EUA from the FDA for the 
prevention of COVID-19. This vaccine is now authorized for emergency 
use in individuals 12 years of age and older. NIAID has helped to 
advance five additional COVID-19 vaccine candidates through support for 
research on the foundational biology underlying the vaccine concepts, 
as well as for clinical testing through the CoVPN. Two of these vaccine 
candidates, those from Moderna, Inc., and Johnson & Johnson/Janssen, 
have received EUAs.

    Utilizing the CoVPN, NIAID is participating in the implementation 
of harmonized protocols to test investigational vaccines and preventive 
interventions against SARS-CoV-2. These protocols were developed in 
collaboration with the Accelerating COVID-19 Therapeutic Interventions 
and Vaccines (ACTIV) public-private partnership, vaccine manufacturers, 
and the Biomedical Advanced Research and Development Authority (BARDA). 
NIAID also supports the underlying critical infrastructure for these 
clinical trials, such as a common Data and Safety Monitoring Board 
(DSMB), an independent group that periodically reviews data from the 
ongoing trials to ensure the safety of study volunteers and to 
determine whether efficacy has been achieved. The CoVPN has enrolled 
tens of thousands of volunteers across the United States and 
internationally in clinical trials testing multiple investigational 
vaccines and monoclonal antibodies intended to protect people from 
COVID-19. The CoVPN also has developed an extensive community 
engagement framework to reach out to the underserved and minority 
communities disproportionally affected by COVID-19; to better 
understand their interest in, and concerns about, research 
participation; and to partner with them to ensure that their vital 
input is reflected in the conduct of these clinical studies.

    To further address the critical challenges of participation in 
clinical trials as well as vaccine acceptance and vaccine hesitancy, 
NIH established the Community Engagement Alliance Against COVID-19 
Disparities (CEAL) initiative, led by the National Heart, Lung, and 
Blood Institute (NHLBI) and the National Institute on Minority Health 
and Health Disparities. CEAL brings together trusted community leaders 
to serve as champions who share information about the importance of 
participating in COVID-19 research and communicate data on the safety 
and efficacy of authorized COVID-19 vaccines.
                          mRNA-1273 (Moderna)
    As part of a longstanding collaboration, the NIAID VRC worked with 
the biotechnology company Moderna to develop a vaccine candidate 
designated mRNA-1273, which uses a messenger RNA (mRNA) vaccine 
platform to express the stabilized SARS-CoV-2 spike protein. Early 
clinical trials demonstrated that mRNA-1273 was generally well 
tolerated and induced robust immune responses in healthy adults. NIAID 
and BARDA then began working with Moderna on a Phase 3 clinical trial 
through the CoVPN that showed that mRNA-1273 was 94.1 percent 
efficacious in preventing symptomatic COVID-19. On December 18, 2020, 
after a thorough review of comprehensive data on mRNA-1273, the FDA 
issued an EUA for the mRNA-1273 vaccine for prevention of COVID-19 in 
individuals 18 years of age and older. In subsequent observational 
studies under ``real-world'' conditions in broader segments of the 
population, mRNA-based vaccines continue to display high levels of 
effectiveness. For example, in an article published in Morbidity and 
Mortality Weekly Report (MMWR), Centers for Disease Control and 
Prevention (CDC) researchers and their collaborators showed that among 
health care personnel, first responders, and other essential workers, 
the mRNA-1273 and the Pfizer-BioNTech mRNA vaccine were 90 percent 
effective against SARS-CoV-2 infections 14 or more days after receiving 
a second dose. Other MMWR articles reported that these vaccines were 94 
percent effective at preventing symptomatic COVID-19 among health care 
personnel and reduced the risk of COVID-19 hospitalization by 94 
percent among people 65 years of age and older. Recently, NIAID 
scientists and their collaborators demonstrated that anti-SARS-CoV-2 
antibodies persist for at least 6 months after the second dose of mRNA-
1273. On June 26, 2021, FDA updated the EUAs for the Moderna and Pfizer 
COVID-19 vaccines to include information on the potential risks of 
myocarditis and pericarditis, particularly following the second dose. 
According to CDC, reports of myocarditis and pericarditis following 
vaccination with mRNA COVID-19 vaccines are rare. Most patients who 
received care have responded well to treatment and rest, and patients 
usually can return to their normal daily activities after their 
symptoms improve. Given the significant potential health risk of COVID-
19, the CDC continues to recommend that individuals ages 12 and older 
be vaccinated with the relevant FDA-authorized COVID-19 vaccine.
                Ad26.COV2.S (Johnson & Johnson/Janssen)
    Decades of NIAID support for basic, preclinical, and clinical 
research on adenovirus (Ad)-based HIV vaccines underpin the development 
by Johnson & Johnson/Janssen of a coronavirus vaccine candidate based 
on the Ad26-vector, known as Ad26.COV2.S or JNJ-78436735. NIAID is 
supporting a Phase 3 clinical trial of Ad26.COV2.S through the CoVPN 
and has provided immunological testing of the candidate using NIAID-
funded core laboratory infrastructure. As reported in the New England 
Journal of Medicine, the one-dose vaccine candidate was 66 percent 
effective overall at preventing moderate to severe/critical COVID-19 
occurring at least 28 days after vaccination and 85 percent effective 
overall in preventing severe/critical COVID-19 in the Phase 3 trial 
across several geographical regions, including areas where emerging 
viral variants predominate. In the United States, the efficacy against 
moderate to severe/critical disease 28 days after vaccination with 
Ad26.COV2.S was 72 percent. On February 27, 2021, the FDA issued an EUA 
for Ad26.COV2.S for prevention of COVID-19 in individuals 18 years of 
age and older. On April 13, 2021, out of an abundance of caution, the 
FDA and CDC released a joint statement recommending a pause in the use 
of Ad26.COV2.S in order to review extremely rare case reports of blood 
clots in combination with low blood platelets after vaccine 
administration. Medical and scientific teams at the FDA and CDC found 
that available data suggest that the chance of this serious adverse 
event occurring is very low. Following their thorough safety review--
and in accordance with recommendations from the CDC's Advisory 
Committee on Immunization Practices--the FDA and CDC lifted the 
recommended pause on the use of Ad26.COV2.S on April 23, 2021. On July 
12, 2021, FDA announced revisions to the vaccine recipient and 
caregivers and vaccination providers fact sheets for the Johnson & 
Johnson/Janssen COVID-19 vaccine regarding a suggested increased risk 
of Guillain-Barre syndrome during the 42 days following vaccination. 
The chance of this occurring following vaccination appears to be very 
low.
                   Other COVID-19 Vaccine Candidates
    NIAID, through the CoVPN, is supporting Phase 3 clinical trials of 
COVID-19 vaccine candidates from AstraZeneca (AZD1222) and Novavax 
(NVX-CoV2373). AstraZeneca's AZD1222 COVID-19 vaccine candidate uses a 
chimpanzee adenovirus-vectored vaccine approach developed by 
researchers at the University of Oxford in collaboration with 
scientists at NIAID's Rocky Mountain Laboratories. On March 25, 2021, 
AstraZeneca announced an updated interim analysis of AZD1222 reporting 
that the vaccine candidate was 76 percent effective at preventing 
symptomatic COVID-19, including 85 percent effective in participants 
aged 65 years and over. Importantly, the efficacy of AZD1222 against 
severe COVID-19 disease was reported to be 100 percent. Novavax's NVX-
CoV2373 COVID-19 vaccine candidate uses a protein nanoparticle vaccine 
approach. On June 14, 2021, Novavax announced that NVX-CoV2373 
demonstrated 90.4 percent efficacy in preventing symptomatic COVID-19 
and 100 percent protection against moderate and severe disease. In 
addition, the company reported that NVX-CoV2373 showed 91 percent 
efficacy in preventing symptomatic COVID-19 in people 65 years or 
older, as well as those with certain comorbidities or those who were 
identified as being likely to experience regular exposure to SARS-CoV-
2. FDA has not yet authorized either of these vaccine candidates.
 Clinical Trials of COVID-19 Vaccine Candidates in Special Populations
    To effectively end the COVID-19 pandemic, it will be important to 
vaccinate as many people as possible, including those in special 
populations, such as pregnant and lactating women, children, and people 
with immune deficiencies. More than 130,000 pregnant and lactating 
women already have received the COVID-19 vaccines under FDA EUAs, and 
early data are promising. These data do not demonstrate any safety 
concerns for women who are pregnant or their babies. In addition, 
protective antibodies against SARS-CoV-2 have been detected in babies 
born to pregnant women who received mRNA COVID-19 vaccines. On June 23, 
2021, NIAID launched an observational study, MOMI-VAX, to evaluate the 
immune responses generated by COVID-19 vaccines administered to 
individuals during pregnancy or up to 2 months postpartum. The study 
also will assess vaccine safety and evaluate the transfer of vaccine-
induced antibodies to infants across the placenta and through breast 
milk.

    Efforts to evaluate COVID-19 vaccines in pediatric and other 
special populations are ongoing. On March 16, 2021, Moderna, in 
collaboration with NIAID and BARDA, announced the launch of KidCOVE, a 
Phase 2/3 study to evaluate the safety and efficacy of mRNA-1273 in 
children ages 6 months to less than 12 years. This study is in addition 
to Moderna's ongoing TeenCOVE study of mRNA-1273 in adolescents between 
the ages of 12 and 17. On May 10, 2021, the FDA expanded the EUA for 
Pfizer's COVID-19 vaccine to include adolescents ages 12 to 15 years of 
age, and Pfizer also is evaluating their vaccine candidate in younger 
individuals. Other vaccine developers also have begun, or are planning 
to begin, trials to test their vaccine candidates in children, 
adolescents, and other special populations. On April 23, 2021, NIAID 
launched an observational study at the NIH Clinical Center assessing 
how people with immune system deficiencies or dysregulations respond to 
COVID-19 vaccination. NIAID investigators also will gather information 
about COVID-19 illness in these individuals. This study will inform 
decision-making about COVID-19 vaccination in people with immune 
deficiencies and dysregulation conditions.
               Monoclonal Antibodies to Prevent COVID-19
    NIAID, collaborating with Regeneron Pharmaceuticals and Eli Lilly 
and Company, also initiated two Phase 3 clinical trials to evaluate 
whether their investigational monoclonal antibodies, REGEN-COV and 
bamlanivimab respectively, can prevent infection or symptomatic disease 
in people at high risk of exposure due to their living or working 
conditions. Regeneron reported in a preprint publication that REGEN-COV 
prevented symptomatic and asymptomatic infection in household contacts 
of individuals who had recently tested positive for SARS-CoV-2. 
Bamlanivimab also was reported to prevent symptomatic and asymptomatic 
infection in residents and staff of skilled nursing and assisted living 
facilities, and these findings were published in the Journal of the 
American Medical Association. FDA has not yet authorized the use of 
either of these drugs for prevention of COVID-19. Clinical trials to 
test the safety and efficacy of monoclonal antibody therapies for the 
treatment of COVID-19 are being tested through the ACTIV partnership, 
and these are discussed below.
               Identifying Therapeutics to Treat COVID-19
    Safe and effective therapeutics are urgently needed to treat 
patients with COVID-19. NIAID has worked quickly from the earliest days 
of the pandemic to evaluate promising therapeutics for COVID-19 in 
rigorous, randomized, controlled clinical trials.
                 The Adaptive COVID-19 Treatment Trial
    NIAID launched a multicenter, randomized placebo-controlled 
clinical trial, the Adaptive COVID-19 Treatment Trial (ACTT), to 
evaluate the safety and efficacy of multiple investigational 
therapeutics for COVID-19. ACTT-1 examined the antiviral drug 
remdesivir for treatment of severe COVID-19 in hospitalized adults. 
Based on positive data from ACTT-1, the FDA approved the use of 
remdesivir for treatment in adults and children 12 years of age and 
older and weighing at least 40 kg hospitalized due to COVID-19. ACTT-2 
evaluated the anti-inflammatory drug baricitinib in combination with 
remdesivir, and based on favorable data from ACTT-2, the FDA issued an 
EUA for the use of baricitinib in combination with remdesivir for 
treatment of adults and children older than 2 years hospitalized with 
COVID-19 and requiring supplemental oxygen, invasive mechanical 
ventilation, or extracorporeal membrane oxygenation. ACTT-3 currently 
is evaluating treatment of hospitalized COVID-19 patients with 
remdesivir plus interferon beta-1a, which is used to treat individuals 
with multiple sclerosis. ACTT-4, a study assessing baricitinib plus 
remdesivir versus the glucocorticoid dexamethasone plus remdesivir in 
adults hospitalized with COVID-19, has closed to enrollment because the 
study met pre-defined futility criteria.
                  The ACTIV Public-Private Partnership
    NIAID, in collaboration with other NIH Institutes, also launched 
two clinical trials as part of the ACTIV partnership, which utilizes 
master protocols allowing the addition of other investigational 
therapeutics as the trials continue. The two studies, ACTIV-2 and 
ACTIV-3, initially evaluated the use of the monoclonal antibody 
bamlanivimab to treat COVID-19 in outpatient and inpatient settings, 
respectively. ACTIV-2, which is focused on outpatients, has since been 
expanded to evaluate two combination monoclonal antibody therapies--
BRII-196 plus BRII-198 and BMS-986414 plus BMS-986413--as well as four 
additional investigational therapeutics: SAB-185, a fully human 
polyclonal antibody produced in cattle; SNG001, an inhalable beta 
interferon; and AZD7442, an investigational long-acting monoclonal 
antibody combination. Camostat mesilate, an orally administered drug 
that may block SARS-CoV-2 from entering cells, was evaluated but 
ultimately not included in ACTIV-2 efficacy studies, as it failed to 
induce early changes in viral shedding or improvement in symptoms. 
ACTIV-3 currently is evaluating the AZD7442 monoclonal antibody 
combination, as well as the small molecule ensovibep, in hospitalized 
patients. Ensovibep binds to several sites on the SARS-CoV-2 spike 
protein, which may inhibit the virus's ability to infect human cells. 
On April 22, 2021, NIAID and NHLBI launched a new trial, known as 
ACTIV-3 Critical Care, to test Zyesami and remdesivir (alone and in 
combination), for their safety and efficacy in hospitalized COVID-19 
patients who are experiencing acute respiratory distress syndrome, a 
life-threatening condition. Zyesami is a synthetic version of 
vasoactive intestinal peptide, which is made naturally in the human 
body and appears to have lung-protective antiviral and anti-
inflammatory effects.

    Three monoclonal antibody therapies currently have FDA EUAs for the 
treatment of COVID-19 in outpatients. Due to concerns of variant 
resistance to monoclonal antibody therapies, the FDA now includes 
information on the susceptibility of SARS-CoV-2 variants in its fact 
sheets for health care providers for each of these therapies. NIAID-
supported scientists and collaborators are evaluating the potential 
impact of emerging SARS-CoV-2 variants on the efficacy of monoclonal 
antibodies.
           Additional NIAID-Supported Therapeutics Activities
    On April 13, 2021, NIAID announced the launch of the COVID-19 anti-
CD14 Treatment Trial (CaTT) to evaluate the use of a monoclonal 
antibody known as IC14 in adults hospitalized with COVID-19. IC14 works 
by binding to and blocking a human protein called CD14 that is 
associated with the development of severe inflammatory reactions in 
some COVID-19 patients. In addition, NIAID completed a Phase 3 trial 
called, ``Inpatient Treatment with Anti-Coronavirus Immunoglobulin,'' 
or ITAC, to evaluate hyperimmune intravenous immunoglobulin (hIVIG) for 
treatment of COVID-19 in hospitalized adults. The study demonstrated 
that hIVIG plus remdesivir was not superior to remdesivir alone.

    NIAID also launched the ACTIV-5/Big Effect Trial (BET), which is 
designed to streamline the identification of experimental COVID-19 
therapeutics that demonstrate the most promise. BET, an adaptive Phase 
2 clinical trial, compares different investigational therapies to a 
common control arm to identify treatments with relatively large effects 
as promising candidates for further study in large-scale trials. BET 
initially is evaluating two therapeutics: risankizumab, an 
immunomodulatory monoclonal antibody developed by Boehringer Ingelheim 
and AbbVie, which is FDA-approved for the treatment of severe plaque 
psoriasis; and lenzilumab, an investigational immunomodulatory 
monoclonal antibody developed by Humanigen.

    NIH recently launched the Antiviral Program for Pandemics, a 
collaboration between NIH and BARDA that aims to develop safe and 
effective antivirals to treat and prevent SARS-CoV-2 infection. The 
program also will build sustainable platforms for targeted drug 
discovery and development of antivirals directly targeting viruses with 
pandemic potential. As part of this effort, NIAID will establish 
Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern. 
These multidisciplinary research centers will create platforms that 
will initially target coronaviruses, and then could be expanded to 
other viruses with pandemic potential--helping to better prepare the 
Nation for future viral threats.

    The NIH also has established the COVID-19 Treatment Guidelines 
Panel to provide recommendations to health care providers regarding 
specific COVID-19 treatments based on the best available science. The 
Guidelines also address considerations for special populations, 
including pregnant women and children. Each Treatment Guidelines 
section is developed by a working group of Panel members with expertise 
in the area addressed in the specific section; these members conduct 
systematic, comprehensive reviews of relevant information and 
scientific literature. The Panel comprises representatives of NIH and 
five other Federal agencies along with representatives of nine 
professional organizations, academic experts, and treating physicians 
including providers from high COVID-19 incidence areas, and community 
representatives. The Panel meets regularly to evaluate possible 
treatment options for COVID-19 and update the Treatment Guidelines as 
new clinical evidence emerges.
             Responding to Emerging Variants of SARS-CoV-2
    NIAID is fully engaged in efforts to mitigate the potential impact 
of emerging variants of SARS-CoV-2. NIH, including NIAID, participates 
in the HHS-established SARS-CoV-2 Interagency Group, along with CDC, 
FDA, BARDA, the Department of Defense (DOD), and the U.S. Department of 
Agriculture to address the potential impact of emerging variants on 
critical SARS-CoV-2 countermeasures. NIH, CDC, and DOD are assessing 
whether vaccine-induced immunity, or natural immunity from prior 
infection, can be effective in combating the variants. NIH, BARDA, and 
DOD also are determining the efficacy of certain authorized 
therapeutics against emerging variants in cell lines in vitro and in 
animal models.

    NIAID is collaborating with vaccine manufacturers on key areas of 
research to investigate whether vaccines designed for the original 
strain of SARS-CoV-2 can maintain efficacy against emerging variants. 
NIAID also is conducting and supporting comprehensive studies to 
understand the ability of vaccine-induced antibodies to neutralize the 
variant viruses. NIAID researchers have analyzed the immune responses 
of individuals who recovered from COVID-19 prior to the emergence of 
variants and demonstrated that their T cells--a key component of the 
immune response to SARS-CoV-2--also were capable of recognizing the 
three most widespread SARS-CoV-2 variants at the time, Alpha (also 
known as B.1.1.7), Beta (B.1.351), and Gamma (P1). These findings, 
published in Open Forum Infectious Diseases, shed new light on the role 
of T cells in the development of immunity to SARS-CoV-2 and suggest 
that these cells also may help protect against emerging variants of 
concern. On March 25, 2021, NIAID launched a Phase 1 clinical trial in 
healthy adults to assess the safety and immunogenicity of second-
generation COVID-19 vaccine candidates developed by Gritstone Oncology, 
Inc. Gritstone's COVID-19 vaccine candidates utilize a strategy aimed 
at inducing both neutralizing antibodies and T cell responses to elicit 
a broad immune response. This approach could provide protection against 
emerging SARS-CoV-2 variants by targeting several viral antigens, all 
of which are highly conserved among viral strains.

    NIAID also plans to test new vaccine formulations that may protect 
against certain variants that show early indications of reduced 
sensitivity to existing countermeasures. On March 31, 2021, NIAID 
launched a Phase 1 clinical trial of an investigational Moderna vaccine 
based on its FDA-authorized COVID-19 vaccine, designed specifically to 
target the Beta (B.1.351) SARS-CoV-2 variant first detected in South 
Africa. NIAID and Moderna are evaluating this vaccine candidate as a 
precautionary measure as we gain more data to confirm that current 
vaccines provide an adequate degree of protection against currently 
circulating SARS-CoV-2 variants. In addition, NIAID is leading a study 
in fully vaccinated individuals to determine the safety and efficacy of 
boosting with a COVID-19 vaccine different than the one used for the 
initial vaccination. The results of this trial are intended to inform 
public health policy decisions on the potential use of mixed vaccine 
schedules should booster doses be needed.

    NIAID, the National Human Genome Research Institute, and the 
National Library of Medicine are participating in the SARS-CoV-2 
Sequencing for Public Health Emergency Response, Epidemiology, and 
Surveillance (SPHERES) initiative. SPHERES is a national genomics 
consortium led by CDC that helps to coordinate SARS-CoV-2 sequencing 
across the United States. NIAID is working with partners to identify, 
monitor, and calculate the frequency of current variations in the SARS-
CoV-2 genome to help predict emerging variants. NIAID also facilitates 
the use of cutting-edge modeling and structural biology tools to 
understand how variants might affect interactions between the virus and 
the immune system or COVID-19 therapeutics. NIAID scientists are 
helping to inform our understanding of transmissibility of the variants 
by studying their stability in the environment of infected individuals 
and their ability to grow in human lung cells. These efforts add to a 
growing body of knowledge about SARS-CoV-2 variants and our ability to 
combat them.
       Understanding the Immunology and Pathogenesis of COVID-19
    NIH is supporting studies to understand the incidence of SARS-CoV-2 
infection in specific populations, including children, as well as 
certain aspects of the clinical course of infection, including 
thromboses, strokes, heart attacks, and other sequelae of infection. 
NIAID is working with partners to delineate biological and immune 
pathways responsible for the varied manifestations of COVID-19. NIAID 
also will examine the quality and durability of the immune response to 
SARS-CoV-2; this information may be leveraged to develop novel SARS-
CoV-2 therapeutics or vaccines and inform public health measures.

    NIAID, along with FDA, is supporting a National Cancer Institute 
(NCI) effort to determine the sensitivity and specificity of certain 
SARS-CoV-2 serological tests, which can detect antibodies indicative of 
a prior exposure to SARS-CoV-2. NCI and NIAID also are working to 
establish a collaborative network to increase national capacity for 
high-quality serological testing with rapid return-of-results to 
subjects. These efforts include the use of serological testing to 
support clinical trials of convalescent serum and the establishment of 
registries for seroprotection studies.

    Early in the pandemic, the intramural research programs of NIAID, 
NCI, the National Center for Advancing Translational Sciences, and the 
National Institute of Biomedical Imaging and Bioengineering partnered 
to rapidly deploy the SARS-CoV-2 Pandemic Serosurvey. The study 
investigated whether adults in the United States without a confirmed 
history of SARS-CoV-2 infection have antibodies to the virus, thus 
indicating prior infection. Findings from the first time point of this 
longitudinal study suggest that the prevalence of COVID-19 in the 
United States during the spring and summer of 2020 may have far 
exceeded the number of cases medically diagnosed. Extrapolating from 
analyses of blood samples from people who did not have a previously 
diagnosed SARS-CoV-2 infection, along with socioeconomic, health, and 
demographic data, the researchers estimate that there may have been an 
additional 16.8 million undiagnosed SARS-CoV-2 infections through mid-
July 2020. Continued analysis of the one-year follow-up data from the 
study will be very important in better understanding mortality rates, 
prevalence of immunity, and the impact SARS-CoV-2 has had on various 
communities in the United States.

    NIAID scientists are participating in leadership of the COVID Human 
Genetic Effort, an international consortium of hospitals and genetic 
sequencing hubs that aim to discover genetic factors conferring 
resistance to SARS-CoV-2 infection or predisposing to severe COVID-19 
disease. The consortium has identified a subgroup of patients with 
severe COVID-19 that have ineffective immune responses to SARS-CoV-2, 
some of whom have identifiable mutations in key immune pathways. NIAID 
also supports 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 
hosted a virtual workshop on MIS-C with scientists and clinicians from 
academia, NIH, FDA, and industry, and a report of the workshop 
recommendations was published on November 2, 2020. NIAID also supports 
the Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM) 
to evaluate acute and long-term clinical and immunological effects of 
MIS-C and SARS-CoV-2 infection in children. In addition, NIAID is 
collaborating with Children's National Medical Center to follow 1,000 
children with a history of SARS-CoV-2 infection, including those with 
MIS-C, to determine long-term effects of the illness. NIAID is 
participating in a trans-NIH effort to coordinate MIS-C research led by 
NHLBI and the Eunice Kennedy Shriver National Institute of Child Health 
and Human Development. This centralized effort, the Collaboration to 
Assess Risk and Identify Long-term Outcomes for Children with COVID 
(CARING for Children with COVID), will permit data to be shared across 
studies to determine the spectrum of illness and predict long-term 
consequences of infection.
              Monitoring the Long-Term Effects of COVID-19
    Many people who have had COVID-19 experience continued symptoms or 
other sequelae as they transition from the acute to post-acute phases 
of the disease, and we continue to learn more about the duration and 
manifestations of COVID-19 as we hear from these patients. In December 
2020, NIAID hosted a Workshop on Post-Acute Sequelae of COVID-19 with 
clinicians, immunologists, virologists, and members of the patient 
community to present existing data, identify key knowledge gaps, and 
explore different perspectives on this heterogeneous condition. A 
report from this workshop highlighting the key scientific questions and 
knowledge gaps regarding PASC was recently published in the Annals of 
Internal Medicine. NIH has announced the Researching COVID to Enhance 
Recovery (RECOVER) Initiative, a trans-NIH effort to address PASC, 
including targeted funding for research in this critical area. The NIH 
RECOVER Initiative will complement ongoing NIAID studies to better 
understand the various post-acute manifestations of COVID-19 in various 
populations.

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

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

    Dr. Woodcock. Good morning, Chair Murray, Ranking Member 
Burr and Members of the Committee. Thanks for the opportunity 
to be here today. I am going to provide a brief update of what 
the agency has been doing in our COVID-19 response. But first, 
I want to start by recognizing the thousands of FDA employees 
who have really been working nonstop for the past year and a 
half. I really commend their efforts and thank them for their 
service to the country. It has been extraordinary.
    From the earliest days of this public health emergency, 
there was a need for reliable diagnostics, as we all know. We 
began gauging developers in early January 2020. And as of last 
week, FDA has authorized nearly 400 tests and sample collection 
devices that provide a wide range of options for testing beyond 
diagnostics. We have evaluated emergency use requests for 
ventilators and novel devices such as continuous renal 
replacement therapy products. We continue to review additional 
submissions for COVID medical devices and rigorously monitor 
safety signals and reports, including their performance against 
variance for the products on the market.
    This is in addition to addressing numerous device shortages 
that occurred during the pandemic and working with our 
Government partners to prevent counterfeit and substandard PPE 
and other products from entering the United States because, of 
course, people take opportunities to try to get substandard 
products into the country. FDA has also supported development 
and availability of COVID therapeutics as expeditiously as 
possible. On March 31st, we announced the creation of an 
emergency review and development program, the Coronavirus 
Treatment Acceleration Program. We reassigned staff from other 
areas to review the hundreds and hundreds of requests from 
companies, scientists, and doctors who are working to develop 
treatments as of June 30th.
    We have reviewed more than 460 trials for potential COVID 
therapies. These include antivirals, neutralizing antibodies, 
cell and gene therapies, and combinations of these products. 
The diversity of therapeutic approaches that are being 
investigated is really critical to increasing our knowledge of 
this disease in its different stages. And these efforts have 
led to one approved drug therapy to treat COVID-19 and 10 
therapeutics currently authorized for emergency use.
    In addition, FDA issued EUA, as you know, for three COVID-
19 vaccines. These vaccines were authorized without cutting 
corners or sacrificing our rigorous standards. Intensive 
interactions between FDA and manufacturers minimize the time 
between different ordinary phases of the clinical development 
process and allowed for seamless movement through development, 
manufacturing, and our rigorous scientific review.
    Throughout the vaccine authorization process, we took steps 
to facilitate transparency and trust by posting trial data, 
putting out guidances on what our standards would be, key 
decisional memoranda, and we held public advisory committee 
meetings. These vaccines have met the standards and quality to 
support an EUA and are helping, as you have heard, in our fight 
against the pandemic. Our work did not end with the 
authorization of these vaccines, though we have to share as 
much information as we can with the public to help with trust 
and transparency. We are also deeply involved with CDC on the 
safety surveillance for the vaccines as they go into millions 
of healthy people to understand what adverse events might be 
related. And we continue to find that the known and potential 
benefits of these vaccines far outweigh the known risks, even 
as additional rare risks have been discovered.
    All this is in addition to the critical work we do to 
protect the Nation's food supply, which also came into some 
jeopardy during this, and to interdict substandard medical 
products at our ports of entry, courier facilities, and 
international mail facilities. Since March 2020, with 
coordination with Customs and Border Protection colleagues, we 
have intercepted and destroyed almost 60,000 illegal and 
unapproved medical products that were attempting to get into 
the country.
    FDA has also played a major role in investigating the 
numerous shortages of medical products that have occurred 
during the pandemic. Partnering with our sister agencies 
represented here and far beyond, we have responded quickly and 
decisively while maintaining our commitment to protecting the 
health of the American people. We look forward to working with 
the Committee to address further issues. Thank you.

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

    I want to note at the outset that this is just a snapshot of some 
of our recent 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 non-stop for the past year-and-a-half. I want to commend 
and recognize their efforts and thank them for their service.

    From the beginning of this public health emergency, FDA has taken 
an active leadership role in the all-of-government response to the 
COVID-19 pandemic, inspired by the resiliency of the American people 
and our great innovators. FDA stood up an internal cross-agency group 
that continues to ensure we are doing everything possible to protect 
the American public, help ensure the safety, efficacy, and quality of 
FDA-regulated medical products, and provide the industries we regulate 
with the guidance and tools to do the same. We continue to focus on 
facilitating the development and availability of medical 
countermeasures to diagnose, treat, and prevent COVID-19, surveilling 
the medical product and food supply chains for potential shortages or 
disruptions, and helping to mitigate such impacts, as necessary to 
protect the public health.
                         Biologics and Vaccines
    FDA's Center for Biologics Evaluation and Research (CBER) uses 
every tool available to help patients access promising biological 
products while facilitating research to evaluate their safety and 
efficacy as well as manufacturing efforts.

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

          Expediting 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 specific sponsors, and 
        generally through guidance documents;

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

          Expediting the review of Emergency Use Authorization 
        (EUA) requests and Biologics License Applications (BLAs) for 
        critical medical products to address COVID-19;

          Helping to ensure an adequate and safe blood supply; 
        and

          Providing information to healthcare providers and 
        researchers to help them submit expanded access IND requests to 
        permit the use of investigational products for patients with 
        COVID-19.

    Through our transparent scientific review process, FDA has issued 
EUAs for three COVID-19 vaccines. In doing so, we have relied upon the 
Agency's rigorous standards for safety, effectiveness, and 
manufacturing quality. Development of a vaccine generally proceeds 
sequentially through the various stages of clinical development; 
ordinarily this process minimizes scientific and financial risk for the 
manufacturer. Manufacturing scale-up only takes place when the data 
support the safety and effectiveness of a vaccine and it is on track 
for regulatory approval. These three COVID-19 vaccines were developed 
without cutting corners or sacrificing our 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 EUA.

    For the three vaccines authorized to date, our EUA process not only 
included a thorough evaluation of the data by the Agency's career 
staff, but also included input from independent scientific and public 
health experts through our public advisory committee meetings. 
Throughout this process, FDA took additional steps to facilitate 
transparency, such as posting sponsor and FDA briefing documents and 
key decisional memoranda.

    The three authorizations make available COVID-19 vaccines in the 
United States that have shown clear and compelling efficacy in large, 
well-designed phase 3 trials. These vaccines have met rigorous 
standards for safety and effectiveness to support EUA and are helping 
us in the fight against this pandemic. All the COVID-19 vaccines that 
FDA has authorized for emergency use are at least 50 percent effective 
compared to placebo in preventing COVID-19, which is the expectation we 
conveyed in our June 2020 guidance document, Development and Licensure 
of Vaccines to Prevent COVID-19. \1\ A vaccine with at least 50 percent 
efficacy, we noted, would have a significant impact on disease, both at 
the individual and societal level.
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    \1\ https://www.fda.gov/media/139638/download.

    As part of our continued efforts to be transparent and educate the 
public, we have a wealth of information on our website about the 
authorized COVID-19 vaccines. The information includes fact sheets for 
healthcare providers (vaccination providers) and vaccine recipients and 
caregivers, with important information such as dosing instructions; 
information about the benefits and risks of each authorized vaccine; 
and topical Questions and Answers developed by FDA for 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, we are 
requiring the manufacturers and vaccination providers 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).

    These surveillance efforts have led the Agency to take steps to 
proactively address emerging safety signals. In April, out of an 
abundance of caution, FDA and CDC recommended a pause in the use of the 
Janssen COVID-19 vaccine while we investigated reports of thrombosis 
with thrombocytopenia syndrome. Later that month, after careful 
evaluation of the data, FDA announced revisions to the vaccine 
recipient fact sheet to include information about the risk of 
thrombosis with thrombocytopenia, and the vaccination provider fact 
sheet to include a warning about the risk of thrombosis with 
thrombocytopenia syndrome. We concluded that the available data suggest 
that the chance of this serious adverse event occurring is very low. 
FDA and CDC determined that the recommended pause regarding the use of 
the Janssen COVID-19 vaccine in the U.S. should be lifted and use of 
the vaccine should resume. As with all of the COVID-19 vaccines, we 
continue to closely monitor the safety of the Janssen COVID-19 Vaccine.

    On June 25, FDA announced revisions to the vaccine recipient and 
caregivers and vaccination provider fact sheets for the Moderna and 
Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased 
risks of myocarditis and pericarditis following vaccination. The chance 
of these adverse events occurring following administration of either 
the Moderna or Pfizer-BioNTech COVID-19 vaccine appears to be very low, 
but the level of potential risk due to vaccination is still under 
investigation. FDA and CDC are monitoring the reports, collecting more 
information, and will follow-up to assess longer-term outcomes over 
several months.

    On July 12, FDA announced revisions to the vaccine recipient and 
caregivers and vaccination providers fact sheets for the Janssen COVID-
19 vaccine regarding a suggested increased risk of Guillain-Barre 
syndrome during the 42 days following vaccination. The chance of this 
occurring following vaccination appears to be very low.

    At this time, data are not yet available to make a determination 
about how long these authorized vaccines will provide protection, nor 
are we certain that the vaccines prevent transmission of severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2) from person to person. 
Additionally, although we do not yet know the full range of SARS-CoV-2 
variants that each of the authorized vaccines will protect against, 
there is evidence that the current vaccines protect against disease 
caused by variants circulating in the United States.

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

    Having three vaccines authorized to date that meet FDA's 
expectations for safety and effectiveness only 1 year after the 
declaration of the COVID-19 pandemic is a tremendous achievement and a 
testament to the dedication of developers and FDA's career scientists 
and physicians. We are highly engaged in ensuring that all COVID-19 
vaccines meet the high quality that Americans expect and deserve and 
are also actively engaged in ensuring the safety of these vaccines 
following deployment. FDA is also working with international partners 
as part of multinational efforts to end this global pandemic. We have 
provided guidance and technical assistance, and continue to share 
information as we evaluate and release vaccine doses for use in other 
countries. The Agency is very proud of these efforts, and we believe 
that the vaccines will help bring this pandemic to an end.
                              Therapeutics
    Since the beginning of the COVID-19 pandemic, FDA 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 has also accelerated the 
development and publication of guidance and other information for 
industry and researchers on developing COVID-19-related treatments. 
Further, on March 31, 2020, FDA announced the creation of an emergency 
review and development program for possible therapies for COVID-19, the 
Coronavirus Treatment Acceleration Program, or ``CTAP.'' The primary 
goal of CTAP is to help accelerate the development of therapeutics for 
patients and consumers. The Agency has supported the program by 
reassigning staff and working continuously to review requests from 
companies, scientists, and doctors who are working to develop 
therapies. Under CTAP, FDA is using every available authority and 
regulatory flexibility to facilitate the development of safe and 
effective products to treat patients with COVID-19. As of June 30, 
2021, there are more than 630 drug development programs in planning 
stages and the Agency has reviewed more than 460 trials of potential 
therapies for COVID-19. These include antivirals, immunodulators, 
neutralizing antibodies, cell and gene therapies, and combinations of 
these products. The diversity of therapeutic approaches being 
investigated is important because it rapidly expands our understanding 
of the effect of different categories of potential treatments.

    FDA has approved one drug to treat COVID-19 and eleven therapeutics 
are currently authorized for emergency use. 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 Federal Food, Drug and Cosmetic Act (21 U.S.C. 
360bbb-3) or for recommending that an EUA be revised or revoked.

    FDA also continues to work closely with manufacturers to mitigate 
and prevent shortages as the COVID-19 pandemic evolves. For example, 
the Agency has issued three 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 the FDA-approved alternatives to these products were not available 
in sufficient quantities 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 also 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 antibiotics, 
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
    The need for medical devices to respond to the COVID-19 pandemic 
has far exceeded what we experienced in any prior Public Health 
Emergency (PHE). The first EUAs issued for the COVID-19 PHE were for 
medical devices, and the volume of EUA requests quickly surpassed (by 
two orders of magnitude) that of any prior PHE or other situation. 
Further, the emergency use requests included submissions for devices 
that CDRH had never received EUA requests for during prior PHEs. This 
included ventilators and novel devices such as continuous renal 
replacement therapy devices. Since the start of the pandemic, FDA has 
issued EUAs or granted full marketing authorization to almost 1,500 
medical devices for COVID-19-related uses. In addition, FDA rigorously 
monitored safety signals and medical device reports using the 
information to publish 21 letters to healthcare providers and seven 
safety communications, and 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 they work through EUA review. The 
EUA pathway expedites access to accurate diagnostic tests during 
emergencies, when information gaps and false results may adversely 
affect individual patient care and public health decision-making. EUAs 
enable molecular diagnostic tests 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 has employed its EUA authorities to 
facilitate availability of tests in each PHE or threat situation since 
2009, when the Secretary of HHS declared that circumstances exist 
justifying the authorization of emergency use of in vitro diagnostics. 
In PHEs, FDA is generally open to receiving and reviewing EUA request 
for tests from any developer, including commercial kit manufacturers 
and laboratories.

    FDA sought to facilitate COVID-19 test evaluation and authorization 
through the development and availability of templates. 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 emergency use 
authorization. Since providing the first template in January 2020, FDA 
has been in daily contact with test developers to answer questions and 
help them through the EUA process. This has proved to be a helpful tool 
for many. FDA has now made nine templates available for a variety of 
test types. As of July 13, 2021, these nine templates have received 
510,725 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 weekly virtual town 
halls for test developers. The Agency has worked with over 1,000 test 
developers since January 2020.

    Since early 2020, FDA has adopted agile, interactive, and 
innovative approaches to EUA review for all types of devices. For 
example, FDA developed the umbrella EUA approach to efficiently 
authorize multiple devices of the same type meeting the same criteria. 
The Agency has also issued 28 guidance documents (including 17 
revisions) outlining policies to help expand the availability of 
medical devices needed in response to COVID-19. For example, developers 
of certain tests offered their tests, upon validation and notification 
to FDA prior, to issuance of an EUA during Agency review of the EUA 
request. Further, FDA made several improvements to our EUA review 
processes to make the most efficient use of our resources, including 
establishing 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.

    As of July 13, 2021, FDA has authorized 397 tests and sample 
collection devices for SARS-CoV-2. As noted in the graphic below, these 
include 282 molecular tests and sample collection devices, 85 antibody 
and other immune response tests, and 30 antigen tests. Among these are 
11 diagnostic tests that can be run at home (three molecular and eight 
antigen tests), seven of which do not require a prescription. We have 
also authorized 18 tests for serial screening programs (11 antigen and 
seven molecular). The volume and variety of available tests is a 
testament to FDA's support of innovative test design and our commitment 
to public health.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    .epsFDA has authorized a wide variety of other medical devices for 
use in combating the pandemic, including a wide range of personal 
protective equipment (PPE), ventilators, and other therapeutic devices. 
As of July 13, 2021, FDA has authorized 270 PPE devices including 39 
surgical masks, and has authorized 205 filtering facepiece respirators 
(FFRs), 13 systems for PPE decontamination or bioburden reduction at 
the time there was a need for these types of devices due to PPE 
shortages, \3\ and 13 EUAs for face shields and other barriers intended 
to protect the user from bodily fluids, liquid splashes, or potentially 
infectious materials (see related graphic below). In addition to 
granting EUAs, FDA has also cleared, through its premarket notification 
pathway, over 250 PPE 510(k)s.
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    \3\ https://www.fda.gov/news-events/press-announcements/fda-brief-
fda-revokes-emergency-use-authorizations-certain-respirators-and-
decontamination-systems.
[GRAPHIC] [TIFF OMITTED] T6775.002

    .epsFDA 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
    Food security is national security. Thus, throughout the pandemic, 
FDA has worked with Federal, state, and local partners, as well as 
industry, to help ensure a safe and adequate food supply for both 
people and animals.

    While SARS-CoV-2 is not transmitted by food, some components of the 
food system experienced challenges and supply chain imbalances, 
particularly at the outset of the pandemic. Overall, food production 
and manufacturing in the U.S. has remained resilient. We continue to 
monitor the food supply chain systems closely to efficiently and 
promptly identify mitigation strategies when necessary. Early on, the 
pandemic caused a significant shift in where consumers were buying 
food. We took steps to provide temporary guidance to provide 
flexibility in packaging and labeling requirements to help industry 
redirect products manufactured for food service and institutional use 
to retail grocery stores, or if needed to the animal food industry so 
the food does not go to waste.

    FDA also recognizes that food supply chain continuity and worker 
safety are two sides of the same coin. Thus, a robust food supply is 
dependent 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 and now as restaurants and 
other retail establishments resume regular operations.

    In response to the pandemic, FDA's Office of Food Policy and 
Response, Center for Food Safety and Applied Nutrition, Office of 
Regulatory Affairs, and Center for Veterinary Medicine developed 21 
Forward, a food supply chain data management tool, to help identify 
where risks for interruptions in the continuity of the food supply due 
to COVID-19 transmission among workers may be greatest. As part of 21 
Forward, FDA also conducted targeted outreach to the food industry to 
offer additional resources and technical assistance in addressing 
challenges.

    In collaboration with HHS, CDC, and US Department of Agriculture 
(USDA), data from 21 Forward have been made available to assist states 
with their vaccine distribution efforts for workers in the food and 
agriculture sectors, including migratory and seasonal agricultural 
workers.

    FDA's Coordinated Outbreak Response and Evaluation team has been 
working throughout the pandemic, is fully staffed, and on the job 
looking for signs of foodborne illness outbreaks and initiating 
responses as needed. FDA's Center for Veterinary Medicine is also 
monitoring the animal food supply and initiating needed responses, 
working closely with other veterinary diagnostic laboratories in its 
Veterinary Laboratory Investigation and Response Network (VET-LIRN). In 
terms of inspectional work, FDA investigators continue to conduct 
mission-critical inspections domestically and abroad, including 
inspections and investigations in response to foodborne outbreaks 
during the pandemic. FDA transitioned to standard operations for 
domestic surveillance inspections in July 2021. Additionally, our 
import investigators and laboratory analysts continue to work on-site 
by:

          Staffing our ports of entry, helping to ensure the 
        efficient distribution and safety of the Nation's imported food 
        supply; and

          Conducting examinations, sample collections, and 
        laboratory analyses of imported and domestic food to ensure the 
        safety of our Nation's food supply.

    FDA continues to screen every line of every shipment of imported 
food entering the United States utilizing our Predictive Risk-Based 
Evaluation for Dynamic Import Compliance Targeting (PREDICT) tool. We 
adjusted the algorithm in PREDICT to place increased scrutiny on 
shipments from facilities where foreign inspections have been 
postponed. FDA has made greater use of our Foreign Supplier 
Verification Program (FSVP) regulation to oversee compliance with FDA 
Food Safety Modernization Act (FSMA) requirements. The shift to remote 
FSVP inspections, along with other tools utilized by the foods program, 
has been critical to ensuring the safety of human and animal food from 
foreign suppliers during the COVID-19 pandemic. Since March 26, 2020, 
FDA has conducted 1,888 FSVP inspections. Since March 2020, FDA has 
refused approximately 8,469 lines of imported food products. FDA will 
continue to target and refuse human and animal foods that are unsafe, 
misbranded, or may cause a serious health concern for the public.

    FDA continues to closely monitor the overall safety of the Nation's 
food supply, in collaboration with CDC, USDA, U.S. Customs and Border 
Protection (CBP) and our state and local partners, to protect consumers 
from foods contaminated with pathogens.

    One year ago, 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. We have learned from 
our response as an Agency 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, and strengthening food safety infrastructures with 
regulatory partners.
    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. Through continued vigilance, 
FDA has prevented unsafe and unauthorized pharmaceuticals and other 
medical products from entering the country. Since March 2020, with the 
cooperation of and in coordination with CBP, FDA has received and 
destroyed almost 60,000 products, totaling over 11,093,868 capsules, 
pieces, and tablets of illegal or unapproved drugs.

    Since March 2020, FDA has refused approximately 94,725 lines of 
imported violative medical products. We have maintained the same level 
of pre-pandemic screening for imported products. However, FDA has 
focused examinations on COVID-19 relief supplies to ensure compliant 
products are expedited while maintaining our commitment to refusing 
imported medical products that are unsafe, misbranded, unapproved, 
counterfeit, or may cause serious illness or injury to the public. In 
fact, our import and domestic officers have evaluated donations of 
shipments destined for the Federal Emergency Management Agency (FEMA) 
and met the first vaccines (Pfizer Belgium) on their arrival into the 
United States in December 2020 to ensure proper transport, storage, and 
reconciliation of products. Our officers also assisted with expediting 
the importation of other compliant vaccine-related shipments.

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

    On May 5, 2021, FDA issued a report titled, ``Resiliency Roadmap 
for FDA Inspectional Oversight,'' 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 outlines inspections that the Agency was unable to 
complete during the past year 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 outlines 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.

    Of note:

          From March 2020 through March 2021, FDA conducted a 
        total of 821 mission-critical inspections, including 29 in 
        foreign countries.

          Additionally, the Agency conducted a total of 777 
        prioritized domestic inspections since resumption of that work 
        in July 2020.

          Of the more than 13,500 applications for medical 
        product approval or authorization received since March 2020, 
        only approximately 68 applications have been delayed due to the 
        inability to conduct inspections--and a majority of these 
        applications are not deemed mission-critical.

    Additionally, the Resiliency Roadmap Report outlines FDA's 
continued, successful use of alternative tools and approaches where 
inspections were or are not currently feasible, including remote 
interactive evaluations (e.g., remote livestreaming video of 
operations, teleconferences, or screen sharing), making record requests 
to regulated establishments, and leveraging information from trusted 
regulatory partners. For example, FDA made over 1,300 record requests 
to human and animal drug and biological product manufacturers, to 
support on-time regulatory decision actions. In addition, since March 
2020, FDA has added products from 18 firms to import alerts as subject 
to detention without physical examination, based on records requests in 
advance or in lieu of inspection that FDA submitted pursuant to section 
704(a)(4) of the FD&C Act.
    Notably, FDA's bioresearch monitoring program staff have conducted 
more than 130 remote interactive evaluations that were directly used 
for application decisions. \4\ 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.
---------------------------------------------------------------------------
    \4\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/remote-interactive-evaluations-drug-manufacturing-and-
bioresearch-monitoring-facilities-during-covid.

    The Resiliency Roadmap Report further outlines the ongoing steps 
the Agency is taking to resume standard operational levels of 
inspection activities, including how it intends to prioritize domestic 
and foreign inspections that were not performed during the pandemic. 
The plan highlights a variety of possible scenarios given the continued 
uncertainty of the trajectory of the ongoing COVID-19 pandemic. On July 
1, FDA activated the base-case scenario (COVID response continues on 
current trend) to transition to standard operations for domestic 
inspections and other operational work, as detailed in the report. 
Inspections considered critical to FDA's mission will remain the 
primary focus. When planning routine surveillance inspections, the 
Agency will prioritize higher-risk establishments. 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 
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on products that present the greatest risk to public health.

    The Agency will also soon begin a multi-year modernization effort 
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 will include a 
review of inspectional approaches using next-generation assessment 
technologies and improvements. FDA is also establishing an Agency-wide 
Inspectional Affairs Council that will provide for 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 inspectional 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 actions against 
firms and individuals who do not comply with regulatory requirements, 
including those selling 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 Agency expertise and advanced analytics to protect consumers 
from fraudulent medical products, including unproven cures, 
illegitimate test kits, and substandard or counterfeit respirators. FDA 
has sent thousands of abuse complaints to domain name registrars and 
internet marketplaces. The Agency also has sent more than 241 warning 
letters to sellers of unproven COVID-19 products. Working with the 
Department of Justice (DOJ), FDA has sought and obtained preliminary 
injunctions that require defendants to halt the sale of fraudulent 
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, FDA's Office of Criminal Investigations (OCI), working 
with other Federal and local law enforcement agencies, investigated a 
hospital pharmacist who tampered with COVID-19 vaccine doses at a 
Wisconsin hospital where he worked. On two successive overnight shifts 
at the hospital in late December 2020, the pharmacist purposefully 
removed a box of COVID-19 vaccine vials manufactured by Moderna--which 
must be stored at specific temperatures for specific time periods to 
remain viable--from the hospital's refrigeration unit intending to 
render the vaccines inert and no longer effective. The pharmacist 
acknowledged that after leaving the vaccines out for several hours each 
night, he returned them to the refrigerator to be used in the 
hospital's vaccine clinic the following day. Before the full extent of 
his conduct was discovered, 57 people received doses of the vaccine 
from these vials. In January 2021, the pharmacist pled 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 where appropriate. We protect the supply chain 
in two equally critical ways, by helping to ensure that (1) safe 
products are coming in; and (2) illegal, dangerous, and fraudulent 
products do not get into the country. These efforts include partnering 
with CBP in establishing satellite laboratories at selected 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 SARS-CoV-2. As a 
result of this investigation, a British national was charged and 
arrested for shipping mislabeled and unapproved products. Subsequently, 
in April 2020, FDA intercepted a bulk shipment of hydroxychloroquine 
coming from China going to a physician in California. The physician was 
thereafter charged with mail fraud and making a false statement 
stemming from the allegations that he smuggled hydroxychloroquine from 
China to make his own pills and concealed the shipment from CBP by mis-
declaring it as yam extract. In May 2020, FDA worked with CBP to 
intercept several shipments of counterfeit facemasks, with the result 
that they were refused and destroyed before getting into U.S. commerce.

    More recently, FDA 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. Regarding the 
latter, substantial methanol exposure can result in nausea, vomiting, 
headache, blurred vision, permanent blindness, seizures, coma, 
permanent damage to the nervous system or death. Ingesting 1-propanol 
can cause central nervous system depression, which can result in death. 
FDA has tested several hundred products using field-based and 
laboratory-based tools, found more than a hundred violative products, 
issued warnings to consumers not to use contaminated hand sanitizers, 
and has taken steps to help ensure that these dangerous or subpotent 
products do not enter domestic commerce. FDA has coordinated with CBP 
to identify such products, and we have listed products made by more 
than 40 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 United States that appear to be in 
violation until the Agency is able to review the products. That action 
marked the first time the FDA has issued a countrywide import alert for 
any category of drug product.
                      Medical Product Supply Chain
    FDA monitors and responds to worldwide demand and supply chain 
disruptions for medical products caused by the COVID-19 pandemic. We 
work closely with manufacturers to help ensure they continue to notify 
the Agency of any permanent discontinuance or interruption of drug 
(human and animal), biological product, and device manufacturing in a 
timely manner and, as noted in FDA's fiscal year 2022 budget, we are 
working to better position the Agency and our health care system to 
assure a strong domestic supply chain in future emergencies. \5\
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    \5\ https://www.fda.gov/media/149616/download.
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    In addition to our usual communication 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 current or emerging regional shortages of critical care drugs 
used to treat COVID-19.

    FDA understands the significant impact shortages can have on 
patient care and is doing everything within our authorities to help 
prevent and alleviate disruptions. When we identify a shortage, we 
react swiftly to mitigate the impact to U.S. patients and health care 
professionals, and quickly share that information with the public. For 
example, 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 to 
treat hospitalized patients with COVID-19 when approved drugs are not 
available. The Agency has also published guidance to help applicants 
and manufacturers provide FDA with timely and informative notifications 
about changes in the production of certain drugs (including animal 
drugs) and human biological products, and urging the submission of 
these notifications, which may assist in our efforts to prevent or 
mitigate shortages of such products.

    The Agency quickly identified the need to help ensure widespread 
access to hand sanitizers as demand spiked, while also continuing our 
mission to ensure these products are not contaminated by removing 
adulterated products from the market. FDA has published and continues 
to update three guidance documents designed to help facilitate the 
production of alcohol-based hand sanitizer in non-traditional settings 
such as pharmacies or distilleries. The Agency has launched several 
enforcement initiatives and import alerts to help stop adulterated and 
subpotent hand sanitizer products from getting into U.S. distribution 
channels.

    Our experience with COVID-19 demonstrates that a strong domestic 
supply chain depends on a resilient supply chain for medical devices as 
well. Indeed, multiple entities across the public and private sector 
have important parts to play in strengthening the domestic medical 
device supply chain. FDA can play a critical role in identifying and 
preventing shortages for devices, because the Agency not only reviews 
and authorizes these products, but also has unique, collaborative 
relationships that allow direct engagement with device manufacturers, 
patients, distributors, healthcare organizations and other 
stakeholders. Even before the pandemic hit the United States, there 
were already problems in the supply chain due to demand for devices in 
other nations where COVID-19 was already prevalent. As a result, FDA 
began shortage mitigation activities for medical devices in January 
2020 before the PHE was declared in the U.S., and months before a 
pandemic was declared worldwide. The Agency took several actions to 
rapidly respond to supply chain needs, including reassigning 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.

    In addition, FDA has conducted horizon scanning to assess demand 
for devices needed to respond to the pandemic, including PPE, 
ventilators, diagnostic supplies, infusion pumps, and non-contact 
infrared thermometers; and established a rapid response team, working 
with field personnel to address fraudulent imports. The Agency has 
likewise worked to prevent and mitigate shortages of testing supplies. 
For example, FDA collaborated with U.S. Cotton, one of the world's 
largest manufacturers of cotton swabs, to develop and produce a 
polyester-based 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.

    Congress has acknowledged the importance of this work to our health 
care system, and we want to continue working with this Committee and 
others to ensure FDA has the resources and authorities needed to ensure 
U.S. patients and health care providers have the products they need 
each day, and especially during public health emergencies.
                               Conclusion
    FDA continues to advance its mission to protect and promote public 
health by ensuring 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 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, I am honored to testify 
before you today regarding efforts within the Office of the 
Assistant Secretary for Preparedness and Response to support 
the ongoing response to COVID-19. First, let me thank you for 
your support of my confirmation. It was just 6 weeks ago that I 
was before you as a nominee, and it has been just over 3 weeks 
since I was confirmed as the ASPER.
    I am honored that you have entrusted me with this important 
role, and I pledge to do everything I can to maintain your 
trust and confidence in my abilities to lead this Office with 
vision, precision, and transparency. While I continue to assess 
ASPER's work, one thing is abundantly clear. The ASPER team is 
working tirelessly to end this pandemic, and I am pleased to 
share some examples of the work that they are leading. As you 
know, the Strategic National Stockpile, or SNS, worked to 
backstop states' medical supply needs when the pandemic 
strained global supply chains.
    The SNS has deployed more than 200 million items including 
personal protective equipment or PPE, ventilators, Federal 
medical stations, and pharmaceuticals. ASPER has invested 
approximately $10 billion from COVID-19 supplementals to 
replenish the SNS to levels at or above pre-COVID-19 amounts. A 
new mission ASPER has taken on over the course of the pandemic 
is securing the medical supply chain. This work is complex and 
challenging and has forced our organization to stretch in new 
ways. A secure and resilient medical supply chain is not only 
necessary for our current COVID-19 response but will be 
critical for any nationwide response that follows.
    ASPER is investing in industrial base expansion efforts to 
reduce supply chain vulnerabilities and generate a domestic 
warm base for manufacturing that can be leveraged in a crisis. 
So far, ASPER has supported efforts for domestic manufacturing 
of PPE, active pharmaceutical ingredients, COVID-19 tests and 
supplies such as reagents and resins.
    In support of this work, ASPER is also leveraging the 
authorities delegated to the secretary under the Defense 
Production Act to ensure that private sector partners making 
life saving products have the materials they need to deliver 
their product. So far, ASPER has priority rated 55 contracts to 
directly and indirectly support the COVID-19 response effort.
    ASPER will continue to leverage all of the tools we have at 
our disposal to ensure the supply chain is secure and that we 
are never again in this situation we found ourselves in last 
year. The national disaster medical system has completed nearly 
5,400 mission assignments. The teams have brought surge 
capacity to ICU and emergency rooms, established medical 
overflow centers, provided mortuary support in places like New 
York City, established sites to deliver therapeutics, and 
operated Federal vaccination sites. They are currently standing 
by to participate in surge teams being stood up by the 
Administration to respond to recent hotspots.
    The ASPER's Biomedical Advanced Research and Development 
Authority, or BARDA, has supported over 65 medical 
countermeasure projects for the COVID-19 response. Most 
notably, BARDA led the vaccine development work for what was 
then known as Operation Warp Speed and is now known as the 
Countermeasures Acceleration Group and advanced the development 
of the three vaccines currently authorized by the FDA.
    This was done, as you know, at historic speed with less 
than a year between the identification of the virus in the 
authorization of the first vaccine. ASPER is also working with 
HHS leadership and the Department of Defense to transition the 
Countermeasures Acceleration Group to a long term sustainable 
management structure within HHS. Dr. Robert Johnson, a senior 
leader at BARDA, recently assumed the responsibilities as the 
Chief Operating Officer of the mission.
    I look forward to using this transition planning period as 
an opportunity to evaluate gaps and bring in the additional 
logistical capacity needed at ASPER and HHS to sustain the 
enduring mission for as long as it is required. As we move 
forward, I would like to build on this foundation to accelerate 
and recalibrate the work where needed and continue to do all we 
can to bring an end to the pandemic as quickly as possible.
    Thank you again for inviting me to testify and allowing me 
to share these examples of the work ASPER is leading on behalf 
of the Administration wide COVID-19 response effort. 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 support the 
ongoing response to COVID-19. I am grateful for this opportunity to 
address this Committee and appreciate your continued support for the 
ongoing response efforts.

    When I first appeared before the Committee in early June as the 
ASPR nominee, I shared my top three priorities for the office, which 
are reflected in the Fiscal Year 2022 Budget request:

        First, I wanted to ensure that ASPR has the resources and 
        support necessary to continue its critical COVID response work, 
        and help the Nation emerge quickly from the current pandemic. 
        This critical work is in addition to our normal preparedness 
        and response efforts for natural disasters, chemical, 
        biological, radiological, and nuclear incidents, and pandemic 
        influenza PI events.

        Second, I wanted to restore and strengthen capacities that have 
        become strained during the COVID-19 pandemic. Specifically, I 
        wanted to ensure the Strategic National Stockpile (SNS) is 
        appropriately resourced, replenished, and ready to respond to 
        future challenges, and that the medical supply chain is 
        resilient and can support our country's needs.

        Finally, I wanted the organization to increase readiness for 
        future public health emergencies by working with our colleagues 
        both inside the Department and across the interagency to 
        prepare for whatever manmade or naturally occurring threats may 
        come next.

    A month into the job, these remain my top priorities. Every passing 
day I am awed by the hard work and dedication of the ASPR team. It is 
clear to me that they are working as hard now to end the pandemic as 
they did when the outbreak first began. Today, I am pleased to share 
with you an update on the tireless work they have been doing to respond 
to COVID-19.
               Update on ASPR's COVID-19 Response Effort
                   Countermeasures Acceleration Group
    The response to the COVID-19 pandemic has required an unprecedented 
whole of government approach. As you are familiar, HHS and the 
Department of Defense (DoD) forged a partnership formerly called 
Operation Warp Speed (OWS) that is now known as the Countermeasures 
Acceleration Group (CAG). This partnership brought together the two 
Departments to develop, manufacture, and deliver safe and effective 
vaccines and therapeutics to the American people. ASPR has played a 
significant leadership and coordination role on behalf of HHS in the 
effort. This endeavor has delivered nearly 390 million vaccine doses 
and over a million therapeutic doses to protect the American people 
from COVID-19.

    In addition, the President has committed to sharing 580 million 
doses of vaccine with the world. This includes half-a-billion Pfizer 
doses the United States will purchase and donate to 100 countries in 
need--the largest-ever donation of COVID-19 vaccines by a single 
country, and a commitment to share 80 million doses of our own surplus 
U.S. supply. The CAG has delivered nearly 40 million vaccines to 25 
countries, with millions more en route.

    Now, work is underway to transition DoD's role in the CAG to HHS 
for long term sustainability and management. Dr. Robert Johnson, the 
Director of the Influenza and Emerging Infectious Diseases Division of 
ASPR's Biomedical Advanced Research and Development Authority (BARDA), 
assumed the responsibilities as the Chief Operating Officer of the CAG 
earlier this month. Under Dr. Johnson's leadership, ASPR's role in the 
response is more apparent than ever.
         Biomedical Advanced Research and Development Authority
    ASPR's BARDA has supported over 65 medical countermeasure projects 
for the COVID-19 response. All of these contract awards are listed on 
medicalcountermeasures.gov in detail and include 14 therapeutics, 48 
diagnostics, and seven vaccine candidates. Notably, BARDA, as part of 
the then-Operation Warp Speed, accelerated the availability of three 
vaccines--Moderna, Pfizer, and Johnson & Johnson. This was done at 
historic speed, with the novel virus identified and the first vaccine 
authorized in under a year.

    Looking forward, BARDA will leverage the supplemental 
appropriations provided by Congress to continue its work as part of the 
CAG to support the development of additional vaccines and therapeutics 
to end the COVID-19 pandemic. There are still populations--like 
children under the age of 12--that cannot yet receive the vaccine as we 
complete careful clinical testing. It is critical that the work 
continue to develop vaccines and to establish successful treatments for 
those who do become infected. I look forward to working with this 
Committee on specific plans toward this effort.
         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 categories of medical equipment and supplies. 
Many vital products are primarily made overseas, and practices like 
``just in time'' inventory management resulted in difficulty surging 
manufacturing when demand surged last spring. This created significant 
and devastating challenges for states and healthcare systems that 
needed 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. As of 
June 15, 2021, the SNS deployed more than 200 million items to aid the 
national response including Personal Protective Equipment (PPE), 
ventilators, Federal Medical Stations, and pharmaceuticals. Now, ASPR 
is working to replenish the SNS to levels at or above pre-COVID-19 
amounts, so it is prepared for any subsequent wave of additional cases.

    As of July 9, 2021, the SNS has utilized approximately $10 billion 
from COVID-19 supplemental appropriations provided by Congress to 
inventory approximately: 517 million N95 respirators (35 times pre-
pandemic levels); 272.5 million surgical and procedure face masks 
(eight times pre-pandemic levels); 11.9 million face shields (two times 
pre-pandemic levels); 22 million gowns and coveralls (five times pre-
pandemic levels); 524.7 million gloves (17 times pre-pandemic levels); 
and 167,000 ventilators (10 times pre-pandemic levels).

    While replenishing the SNS is essential, it is also critical to 
address the root-causes 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 supply chain for medical materials, ingredients, and 
supplies is critical for any national response to public health 
emergencies.

    To start, ASPR is leveraging the authorities delegated to the 
Secretary under the Defense Production Act (DPA) to ensure that private 
sector partners making life-saving products are able to acquire raw 
materials, retool their machinery, scale their production facilities, 
train their workforces, and ultimately deliver their product. 
Throughout the COVID-19 response, ASPR has used the DPA authority to 
issue 46 priority ratings for U.S. Government (USG) contracts for 
health resources, eight priority ratings for USG contracts for 
industrial expansion, 3 priority ratings for non-USG contracts to 
support the production of resins for both diagnostics and infusion 
pumps, and the manufacture of closed suction catheters for treatment of 
patients with COVID-19. Going forward, ASPR will continue to build 
capacity and partnerships with private industry toward the shared goal 
of ending the COVID-19 pandemic.

    In addition, ASPR is working to steward Congress's investment in 
expanding the domestic industrial base. These industrial base expansion 
(IBx) efforts seek to reduce supply chain vulnerabilities and generate 
a domestic ``warm-base'' for manufacturing that can be leveraged in a 
crisis. So far, ASPR has supported domestic manufacturing of PPE; 
active pharmaceutical ingredient manufacturing capacity; and COVID-19 
testing, including swabs, tests and kits, and supplies such as reagents 
and resins. Each of these domestic manufacturing initatives meet 
current, as well as future COVID-19 needs, and seek to create or 
sustain high-value domestic jobs.
                     Healthcare System Preparedness
    Finally, I want to share more about ASPR's work to prepare our 
healthcare system to surge to meet the demands of those being treated 
for COVID-19, without compromising day-to-day health care needs.

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

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

    Further, if a public health or healthcare system becomes 
overwhelmed with patients, states can request National Disaster Medical 
System (NDMS) personnel to provide additional support. During the 
COVID-19 response, NDMS has completed nearly 5,400 mission assignments 
so far, and counting. For these deployments, NDMS personnel supported 
hospital augmentation including emergency room support; hospital 
decompression; setting up medical overflow centers for patients and 
mortuary support; establishing monoclonal antibody therapy sites; ICU 
augmentation; and, operating Federal vaccine sites. With the aid of 
NDMS personnel and resources, communities were able to continue to 
provide care to those in need of medical assistance and treatment. NDMS 
will continue to support such requests.
                               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 very much to all of our panelists 
today. We will now begin a round of 5 minute questions of our 
witnesses. I ask all of my colleagues, please keep track of 
your clock. Stay within those 5 minutes. We do have votes 
starting at 11:30 a.m. and we have many Members in attendance 
today. My first question is for the whole panel.
    We are at a pivotal point in this pandemic, and after weeks 
of declining rates of cases and deaths, we are now seeing a 
resurgence of COVID-19 in part due, as you mentioned, to the 
circulation of variants. Vaccination rates are plateauing and 
COVID fatigue is setting in around the country. So I want to 
ask each of you, what is the one thing everyone can do to help 
keep us from returning to the early days of this pandemic?
    Dr. Walensky.
    Dr. Walensky. Get vaccinated and get your neighbors 
vaccinated.
    Dr. Fauci.
    [Technical problems.]
    The Chair. Dr. Woodcock.
    Dr. Woodcock. Couldn't say it better.
    The Chair. Ms. O'Connell.
    Ms. O'Connell. Get vaccinated.
    The Chair. Thank you to all of you and I hope everyone 
heard that. Dr. Fauci, the quick development of effective COVID 
vaccines has been a real success story during this pandemic. 
People are getting vaccinated. It is really key to everyone's 
ability to return to normal lives. With the spread of variants, 
as we all talked about, driving and increases in cases and 
deaths now, I am encouraged to see public health experts and 
vaccine developers are now considering the possible need for 
boosters. You mentioned this a bit in your opening remarks, but 
I want to ask you, how do you assess the duration of vaccine 
efficacy and the impact of variants on that efficacy?
    Dr. Fauci. Thank you very much, Madam Chair. There are two 
ways that are actively being used now to assess the answer to 
your question. One is there are correlates of immunity which 
have been established. In other words, you have a level of 
measurable laboratory, for example, neutralizing antibody, 
which is the easiest to measure. There are also areas of 
immunity that are more difficult to measure, like T-cell 
responses. But the one that seems to be very well correlated is 
the antibody level.
    We know from studies, from the clinical trials, as well as 
from animal studies that there is a baseline level below which 
you go, you are much more vulnerable to getting a breakthrough 
infection. So the first is laboratory data. The second is 
watching and following cohorts of people to see if you have an 
increase in breakthrough infections. We know, according to the 
clinical trial, take for an example, the mRNA, they are 93 to 
94 percent effective in preventing clinically recognizable 
disease.
    If you see a fall below that into the 80's or even 
unfortunately hope it never happens into the 70's, then you 
reached the point where the durability needs a boost. Those 
studies are ongoing right now.
    The Chair. We don't have any data about whether or not we 
are seeing that?
    Dr. Fauci. No, we don't. There are some preliminary data 
that we have heard about from Pfizer, which studies that they 
did in Israel and in their own studies, which seem to indicate 
that there is waning immunity. We have a lot of cohorts that we 
are following. The CDC is following at least 20 cohorts that 
will be able to amplify on that data and give us much more of a 
basis of making a decision.
    The Chair. How will the Administration determine if booster 
shots are needed?
    Dr. Fauci. Just by those very studies. Just by the 
following the cohort studies and we are waiting. We will be 
maybe--perhaps Dr. Walensky would like to comment because she 
has in her domain of the CDC a number of cohort studies that 
will inform us. In the meantime, we at NIH are doing studies 
now to determine when you give a booster, how high up do you 
get it and what kind of a cushion do you get for antibody 
responses?
    The Chair. Okay.
    Dr. Walensky.
    Dr. Walensky. Yes. Thank you, Senator. We have numerous 
cohort studies. They represent tens of thousands of people, and 
they are represented across the United States. These include 
data from 14,000 nursing home facilities, long term care 
facilities. We have a heroes cohort that is essential workers 
of over 5,000 people that are actually getting weekly PCR 
testing. We have health care worker cohorts.
    We have cohorts across the country where we are following 
these data and really looking at it every several weeks to 
understand what the vaccine efficacy is. And it is among that, 
and the laboratory data will be the decisions that we use. 
Fortunately, we are anticipating that this will wane and not 
plummet. So as we see that waning, that will be our time for 
action.
    The Chair. Okay, thank you very much. We really appreciate 
it. We will stay in touch on that. I will reserve the balance 
of my time because there are many Members here.
    Senator Burr.
    Senator Burr. Thank you, Madam Chair. I have got to say, 
the last exchange was, oh, my god, we haven't learned anything. 
Let me just make this point. I remember early on in this when 
the question of testing came up, the CDC said we do testing. 
And CDC demanded to do the test and we lost weeks. And I am not 
here to evaluate data. Tony, that is your job and Rochelle and 
others. But to say we are going to make this decision based 
upon the research we have got going on at CDC, based upon the 
information that we have put out and only our research counts, 
and to basically ignore the Israeli data or the Pfizer data--
and I am not suggesting that we are totally doing that.
    I guess my question would be, is Israel giving us 
transparency into their data? If you still lived in a world 
when we didn't accept foreign data for applications, which FDA 
has had the authority to do since 1996 when I changed the law, 
but it took COVID to actually make that happen. So I realized 
that we want accuracy. But do we really have to wait for CDC to 
complete the data? Do you think you are going to come to a 
different conclusion than Israel did? Share with me.
    Dr. Walensky. Thank you for that question, Senator. 
Absolutely not. We have to have collaboration across the globe 
because this is a global problem. So we have already had two 
conversations with Israel. We have data sharing from our 
collaboration--from our cohorts as well as from theirs. We have 
also been in discussions with the UK to see what data they have 
because, of course, they are several weeks ahead of us in the 
delta variants. So we intend to leverage all of the data we 
have around the world to share liberally with other countries 
and the hopes that they will share with us so that we can make 
the proper decisions here in this country and around the world.
    Senator Burr. Is there a reason to believe that the Israeli 
data is flawed?
    Dr. Walensky. I am sorry?
    Senator Burr. Is there reason to believe the Israeli data 
is flawed?
    Dr. Walensky. Flawed, we are in discussions, epidemiologic 
discussions. There are numerous cohorts in Israel, those in the 
Ministry of Health, those in their health care systems. And we 
have seen some of their data. They are actually continuing to 
analyze the data. And so where we are in those active 
epidemiologic conversations.
    Senator Burr. My point is they have made a decision to do 
booster's based upon their data. And we are saying we are still 
going to work out through our research to determine. And that 
is where you begin to lose the trust of the American people in 
our health care experts. In April, the Biden administration 
announced a $1 billion commitment for sequencing at CDC. To 
date, only 844 cases from North Carolina have been sequenced, 
according to CDC website. We had over a million cases. It seems 
there is a major problem again at CDC. Let me just ask you, in 
CDC's recent updated mask guidance for schools, says community 
should use local outbreak data to make decisions.
    Yet I would challenge you that if only 844 cases have been 
sequenced, those local people don't have the data they need to 
make that determination as to what the policies are going to be 
at a local level. Would you agree?
    Dr. Walensky. That discussion is based on cases, not based 
on variance. So we are actually getting data from around the 
country based on variance as well, based from the local health 
departments within North Carolina and with all of the states, 
as well as academic centers, and commercial labs. And the 
recommendations for schools was based on test positivity and 
positive cases, not necessarily based on variance.
    Senator Burr. But shouldn't transparency by the local 
health department about the variant in their community be 
important to their decision as to what they do in the schools?
    Dr. Walensky. Absolutely. And we have data by region for 
variants that are posted on our website. They have been updated 
this morning with 83 percent. So not only are we looking at 
test positivity actually down to the county level, but variants 
that come in as well from each of the individual states, from 
the academic partners, from the labs.
    Senator Burr. Dawn, I know you have only been there 3 
weeks. What are your plans to address the pressure that the flu 
is going to cause on the system?
    Ms. O'Connell. Ranking Member, thank you for that question. 
That has been something that we have been--the ASPER team has 
been considering and planning for over the last several months. 
There is now an interagency process set up by the White House 
Supply Chain Coordinator that ASPER has been actively 
participating in, working with manufacturers of both flu 
vaccines and COVID vaccines to make sure that the supplies are 
there so we have access to both vaccines as we head into the 
fall.
    But it is something that we will continue to monitor and 
recalibrate if needed so we are sure that we can do both at the 
same time. At this point, our planning assumption suggests that 
we can, but I will continue to monitor that.
    Senator Burr. Thank you. Thank you, Chair.
    The Chair. Senator Kaine.
    Senator Kaine. Thank you, Chair Murray and Ranking Member. 
Thank you to the witnesses. I want to say a word about 
disinformation and then have some questions. Former President 
Trump was on television this weekend and he said one of the 
reasons people won't get vaccinated is because, ``they don't 
trust the election results.'' And when I heard that, I sort of 
chuckled at that. I thought that was odd to be connecting a big 
lie about the election to refusal to get vaccinated. But it 
caused me to do something that I hadn't done, which is look at 
the vaccination rates in all 51 states, including the District 
of Columbia.
    The CDC data from yesterday morning shows the following. 
The 21 jurisdictions with the highest vaccination rates all 
vote for Joe Biden. 25 of the 30 jurisdictions with the lowest 
vaccination rates voted for Donald Trump. There is a difference 
between causation and correlation. But possibly what the 
President said on television on Sunday, there may be something 
to it that repeated disinformation about the election is now 
connecting in people's minds with this information about 
willingness to take the vaccine.
    It didn't have to be this way because one of the great 
things about President Trump and the Trump administration 
working with partners and funded by Congress was setting a 
world record in terms of developing really super effective 
vaccines in record time. President Trump had COVID in October. 
He decided to get vaccinated in January. He didn't tout the 
vaccination. It came out months later. But he could still tout 
it, he could still say this is a Trump accomplishment and 
encourage people in these states who are lagging behind the 
national average to get vaccinated.
    That won't solve all of the problem because there are many 
reasons people don't get vaccinated. But I am now convinced, I 
just came back from Latin America. In Latin America, they are 
so thrilled at the U.S. donation of vaccines, and they view our 
vaccines as state-of-the-art compared to the China and Russia 
vaccines. And they appreciate that we are donating them rather 
than charging them, which China and Russia are doing. So around 
the world, people are beating a door down to try to get to U.S. 
vaccines if they can. And here we have near universal 
availability.
    Again, I thought it was sort of comical, the President's 
comments this past weekend. But as I look at the CDC data, 
maybe it is not so comical, but it is incredibly serious. Dr. 
Walensky, I wanted to ask you this question. I think you stated 
in your opening testimony that the overwhelming majority of 
deaths now are people who are not vaccinated. Now, when you say 
overwhelming majority, are you talking about 60 percent, 80 
percent, 95 percent, 99 percent? What is the statistic?
    Ms. O'Connell. In a five-month study from January to May 
and numerous states, five or six states, it was 99.5 percent.
    Senator Kaine. Now, obviously, before the vaccine started, 
it was 100 percent. 100 percent of people who died before we 
were vaccinating were unvaccinated by definition. And since the 
vaccine has begun to be deployed, 99.5 percent of people who 
died are people who are unvaccinated. Those are very, very 
powerful statistics. As the Administration has begun to say 
this is now a pandemic of the unvaccinated. Dr. Walensky, I am 
very concerned with a CDC press release, I guess, from last 
week about overdose deaths in the last calendar year. A 29 
percent increase in overdose deaths.
    It appears to be connected to the isolation. Substance use 
disorders is often a disorder of isolation. It appears to be 
connected to the intense isolation of the last year. Can you 
tell us what CDC and other partners are doing to look at this 
and work together with us to try to combat the resurgence of a 
scourge which we had seen some positive movement on in the last 
few years?
    Dr. Walensky. Yes, thank you, Senator. You know, there have 
been two things in the last decades that have decreased life 
expectancy in this country. One is COVID-19 and the second is 
overdose. And so we are now seeing a collision of those two 
things happening at the same time. And in fact, as you noted, 
the report demonstrated a 29 percent increase in overdose 
deaths a year over year.
    We are actively working to not only study this issue and 
not only study the overdose deaths, but the overdose 
hospitalizations, to look at surveillance, to look at the 
infectious diseases associated with injection drug use, to 
promote certain services programs, naloxone programs, as well 
as to provide services and toolkits around the country for not 
just substance use disorders, but for mental health, Hear Her 
Now campaigns--Hear Her Now campaigns for maternal mortality, 
toolkits for suicide prevention for youth. Parental toolkits.
    We are actively not only doing the surveillance and the 
studying of this, but also the--in the communities for the 
toolkits on the prevention side.
    Senator Kaine. Right, thank you. I yield back, Chair 
Murray.
    The Chair. Thank you.
    Senator Paul.
    Senator Paul. Dr. Fauci, as you are aware, it is a crime to 
lie to Congress. Section 1001 of the U.S. Criminal Code creates 
a felony and a five-year penalty for lying to Congress. On your 
last trip to our Committee on May 11, you stated that the NIH 
has not ever and does not now fund gain of function research in 
the U.S. Institute of Virology. And yet gain of function 
research was done entirely in the Wuhan Institute by Dr. Xi and 
was funded by the NIH.
    I would like to ask unanimous consent to insert into the 
record the human virology paper entitled, Discovery of A Rich 
Gene Pool of Bats SARS Related Coronaviruses. Please deliver a 
copy of the Journal article to Dr. Fauci. In this paper, Dr. Xi 
credits the NIH and lists the actual number of the grant that 
she was given by the NIH. In this paper she took two bat 
coronavirus genes, spiked genes, and combined them with a SARS 
related backbone to create new viruses that are not found in 
nature.
    These lab created viruses were then shown to replicate in 
humans. These experiments combine genetic information from 
different coronaviruses that infect animals but not humans to 
create novel artificial viruses able to infect human cells. 
Viruses that in nature only infect animals were manipulated in 
the Wuhan Lab to gain the function of infecting humans.
    This research fits the definition of the research that the 
NIH said was subject to the pause in 2014 to 2017, a pause in 
funding on gain of function. But the NIH failed to recognize 
this defines in a way, and it never came under any scrutiny. 
Dr. Richard Ebright, a molecular biologist from Rutgers, 
described this research in Wuhan as, ``the Wuhan lab used NIH 
funding to construct novel chimeric SARS related coronaviruses 
able to infect human cells and laboratory animals.
    This is high risk research that creates new potential 
pandemic pathogens--potential pandemic pathogens that exist 
only in the lab, not in nature. This research matches,'' these 
are Dr. Ebright's words, ``this research matches, indeed 
epitomizes the definition of gain of function research done 
entirely in Wuhan,'' for which there was supposed to be a 
Federal pause.
    Dr. Fauci, knowing that it is a crime to lie to Congress, 
do you wish to retract your statement of May 11th where you 
claimed that the NIH never funded gain of function research in 
Wuhan?
    Dr. Fauci. Senator Paul, I have never lied--.
    Senator Burr. Microphone.
    The Chair. The Microphone.
    Dr. Fauci. Senator Paul, I have never lied before the 
Congress, and I do not retract that statement. This paper that 
you were referring to was judged by qualified staff up and down 
the chain as not being gain of function.
    Senator Paul. What does--.
    Dr. Fauci. Let me finish----
    Senator Paul. You take an animal virus, and you increase 
its transmissibility to humans. You are saying that is not gain 
of function?
    Dr. Fauci. That is correct. And Senator Paul, you do not 
know what you are talking about, quite frankly. And I want to 
say that officially. You do not know what you are talking 
about. Okay, you get one person--can I answer your question?
    Senator Paul. From the NIH definition of gain of function--
this is your definition that you guys wrote. It says that 
scientific research that increases the transmissibility among 
mammals is a gain of function. They took animal viruses that 
only occur in animals, and they increased their 
transmissibility to humans. How you can say that is not gain of 
function.
    Dr. Fauci. It is not.
    Senator Paul. It is a dance, and you are dancing around 
this because you are trying to obscure responsibility for 4 
million people dying around the world from a pandemic.
    The Chair. Let's let--Dr. Fauci.
    Dr. Fauci. I have to--well, now you are getting into 
something. If the point that you were making is that the grant 
that was funded as a sub-award from Eco Health to Wuhan created 
SARS-CoV-2, that is where you are getting. Let me finish.
    Senator Paul. We don't know. We don't know if it did--but 
all the evidence is pointing that it came from the lab, and 
there will be responsibility for those who funded the lab, 
including yourself.
    Dr. Fauci. I totally resent--.
    The Chair. This Committee will allow the witness to 
respond.
    Dr. Fauci. I totally resent the lie that you are now 
propagating, Senator, because if you look at the viruses that 
were used in the experiments, that were given in the annual 
reports that were published in the literature, it is 
molecularly impossible--.
    Senator Paul. No one is saying those viruses caused it.
    Dr. Fauci. It is molecularly--.
    Senator Paul. No one is alleging that those viruses caused 
the pandemic. What we are alleging is the gain of function 
research was going on in that lab and NIH funded it.
    Dr. Fauci. That is not----
    Senator Paul. You can't get away from it. It meets your 
definition, and you are obfuscating the truth.
    Dr. Fauci. I am not obfuscating the truth, you are the one.
    The Chair. Senator Paul, your time has expired, but I will 
allow the witness to----
    Dr. Fauci. Let me just finish. I want everyone to 
understand that if you look at those viruses, and that is 
judged by qualified virologists and evolutionary biologists, 
those viruses are molecularly impossible to result in SARS-CoV-
2.
    Senator Paul. No one is saying they are. No one is saying 
those viruses caused the pandemic. We are saying they are going 
to function viruses--.
    Dr. Fauci. They are not--.
    Senator Paul. Because they are animal viruses that became 
more transmissible in human, and you funded it. Why won't you 
admit the truth?
    Dr. Fauci. You are implying----
    The Chair. Senator Paul, your time has expired, and I will 
allow witnesses who come before this Committee to respond.
    Dr. Fauci. You are implying that what we did was 
responsible for the deaths of individual--I totally resent 
that--.
    Senator Paul. It could have.
    Dr. Fauci. If anybody is lying here, Senator, it is you.
    The Chair. Senator Smith.
    Senator Smith. Thank you, Dr. Fauci. And thanks to all of 
our panelists for being here today. And thank you, Chair Murray 
and Ranking Member Burr. I just want to say, Dr. Fauci, is 
there anything more that you would like to say to counteract 
these attacks on your integrity that we have all just 
witnessed?
    Dr. Fauci. Well, Senator, thank you. I don't think I have 
anything further to say. This is a pattern that Senator Paul 
has been doing now at multiple hearings based on no reality. He 
is talking about gain of function. This has been evaluated 
multiple times by qualified people to not fall under the gain 
of function definition. I have not lied before Congress. I have 
never lied, certainly not before Congress. Case closed.
    Senator Smith. Thank you. So we are 6 months into this 
pandemic, and I think we are at a critical moment. Two-thirds 
of adults have received at least one dose of the vaccine. And 
at the same time, we are seeing cases rising to about 41,000 a 
day. As Dr. Walensky has said, we have an epidemic here of the 
unvaccinated. And--but, of course, this continues to affect 
every single one of us. So it seems to me that our actions and 
messages in this moment are going to make a huge difference in 
whether we move forward or backward, not only here in the 
United States, but everywhere in the world.
    Today, as I was walking into this Committee hearing, for 
the first time in months, I saw a line of people waiting 
outside of a pharmacy for testing and vaccines. And it made me 
wonder whether the recent surge of the delta variant is getting 
people's attention and moving them from indecision to action. 
What a terrible way for this to happen. But--so I have a few 
questions just I hope clear up some of the misinformation and 
misunderstandings. Dr. Fauci, the COVID-19 vaccine protects 
against the delta variant, is that correct?
    Dr. Fauci. It protects against the clinically apparent 
disease, and it protects extremely well against hospitalization 
and death.
    Senator Smith. Right. So if you are not vaccinated, given 
how contagious the delta variant is, I mean, it is--would it be 
fair to say you are almost--you are very likely to get this 
variant. To get the COVID-19 variant, would you say?
    Dr. Fauci. Well, certainly when you look at the capability 
of this virus to transmit from people to people. I mean, 
obviously you have to be in an environment in which the virus 
is present. So if you are in it, for example--and I believe Dr. 
Walensky mentioned that in her remarks. If you are in an area, 
be it a state, a city, a county or what have you, well, you 
have a high level of infection in the community and a very low 
level of vaccinated people, the chances in that environment of 
getting infected are reasonably high.
    Senator Smith. Right. And how do you compare, how do you 
think about the risks--the side effect risks of the COVID-19 
vaccine compared to the risks of not being vaccinated? Because 
this is, I think, what people are struggling with.
    Dr. Fauci. Right. It refers to the risk benefit ratio of 
getting a vaccination. And every time this has been evaluated, 
not only with this vaccine, but with so many other vaccines, 
there is no intervention that is without some time getting an 
adverse event. I mean, I don't think I can think of one that 
hasn't.
    When you have that situation, you balance the rarity or the 
uncommonness of a particular adverse event with the advantage 
that you would get from protecting yourself against the actual 
disease against which you are vaccinated. And thus far, 
whenever this has come up about an adverse event, it has been 
evaluated, perhaps even a warning has been given, but it is 
always weighed on the part of saying that the benefit of the 
protection of the vaccine outweighs the risk of the adverse 
event.
    Senator Smith. Thank you. Dr. Walensky I talk with public--
I have spoken with a lot of public health experts in Minnesota 
who tell me that they are still challenged getting especially 
younger adults who are eligible to be vaccinated, getting them 
vaccinated. And part of it is the challenge, this perception 
that COVID is just not that big a deal for younger people, 
people who consider themselves healthy and have got a strong 
immune system and so forth. So let me ask you this. Are there a 
larger number of younger people getting hospitalized today 
versus a year ago or 6 months ago?
    Dr. Walensky. We have seen hospitalizations go up for every 
age bracket recently as cases go up. Proportionally because 
there are more cases now among younger people, we are seeing 
more of those people in the hospital. They still get 
hospitalized at a less frequent rate given unvaccinated than 
elderly patients. But in fact, because there are more of them 
now that we are seeing more of them in the hospital.
    Senator Smith. Okay. So another good piece of advice there 
to have, being aware of the risk, even if you are--even if you 
see yourself as young and healthy.
    Dr. Walensky. Absolutely.
    Senator Smith. Thank you, Madam Chair.
    The Chair. Thank you.
    Senator Moran.
    Senator Moran. Madam Chair, thank you. Thank you and 
Senator Burr for today's hearing. Thank you for the witnesses 
for being here. Let me start with Dr. Walensky, please. Doctor, 
in May, the CDC announced new guidance for fully vaccinated 
individuals, that they could resume activities without wearing 
a mask or staying socially six feet apart.
    At that time, the CDC further said that they would continue 
to update guidance for travel as the science was developing and 
they would need to collaborate with other agencies regarding a 
face mask requirement. A month later, a number--me and a number 
of my colleagues sent a letter to the CDC and the TSA asking 
for an update regarding the mask requirement during travel.
    While we had a response from TSA, we have not had it yet, a 
response from CDC. And I wondered if you would tell me where 
the CDC is in the process of updating the mask requirement for 
fully vaccinated individuals while traveling.
    Dr. Walensky. Thank you for that question, Senator. 
Obviously, as you know, the discussion about masking on Federal 
aviation and ships is an interagency process, not simply with 
CDC. I will say a lot has changed since May 13th. As you heard 
from Dr. Fauci, we now have a variant circulating in this 
country that is at the time was less than 3 percent and is now 
83 percent and much more transmissible.
    We are continuing those conversations, working toward a 
letter back to you. Thank you for your patience. And we will 
continue to revisit that as we learn more about vaccine 
efficacy, as we learn more about transmission in the context of 
vaccination, and as we understand more about the delta variant.
    Senator Moran. Are you expecting a change in the expiration 
date of that continued requirement?
    Dr. Walensky. I think we still have more looking to do with 
that.
    Senator Moran. Let me turn to Ms. O'Connell. Ms. O'Connell, 
you are not the perfect witness from HHS for my statements or 
questions, but you are my only witness from HHS for my 
statements. It is a bit about the future, which you are fully 
engaged in. We need a better response to public health 
emergencies. And I want to talk about--in that regard, I want 
to talk about the parameters of the provider relief fund. HHS, 
in my view, is terribly slow in their release of guidance and 
on how the funds could be utilized.
    There has been a lot of confusion by health care providers. 
They have been reluctant to spend the money. It is--we are 
incapable of solving problems if the resources that we provide 
to those who are in the health care field, they are not 
utilized because they are fearful that they don't know what the 
guidance is and therefore, if they make a mistake, they have 
penalties at a later date.
    I guess the question that could be for you, what is the 
plan to get HHS to perform better or more quickly so that 
providers have the necessary information and comfort level to 
take the steps necessary to prevent the spread of the virus and 
to care for the health care of Americans and others?
    The part that doesn't necessarily involve you, but in hopes 
that HHS is otherwise listening, there is about $24 billion 
left unspent in the Provider Relief Fund and we have been 
anxiously awaiting always with the answer that it is in the 
works about assistance and care for facilities that care for 
our senior populations. And there is still no answer in that 
regard.
    I don't know that you have a comment necessarily on that 
part of my commentary, but again, I would utilize this as an 
opportunity to try to get more certainty at HHS on the spending 
of those dollars.
    Ms. O'Connell. Senator Moran, thank you for your question, 
for both parts of it, and I certainly appreciate how 
frustrating it has probably been not to have the clarity that 
you and your constituents have been seeking.
    We will take the comments that you have made today and 
bring them back to the secretary and other parts of HHS senior 
leadership to make sure that we understand how important it is 
that this money is moving quickly, and that the guidance comes 
out expeditiously and that we can do all we can to support. I 
mean, we really want to do all we can to support your 
constituents.
    It is helpful to know that this has been a problem, and I 
look forward to working with you and your staff on it.
    Senator Moran. If you can accomplish that, the purpose of 
my comment will be satisfied. I would particularly ask that 
someone from HHS respond to us about the provider relief fund 
as it relates to senior care living circumstances.
    Dr. Fauci, in the 24 seconds I have left, I will just ask a 
quick question. What are the necessary steps--you have talked 
about mental health. What are the necessary steps to mitigate a 
mental health and drug overdose crisis? What should Congress 
and American institutions be doing today for a future pandemic?
    Dr. Fauci. Well, first of all, I think the lesson that we 
have learned from this, and we would hope in good preparation 
for what will inevitably be another challenge in the future, 
can't predict when, is to realize the important mental health 
impact that this outbreak has had, not only in the suffering 
from the disease itself, but from the extraordinary disruption 
of our society, which I think we are going to have to realize, 
that even when we get this under control, the mental health 
effects of this are going to be following this for months if 
not years afterwards.
    We can't forget that. When the outbreak is over, the mental 
health effects are not going to be over. They are going to 
linger. And that is what we really need to address.
    The Chair. Thank you.
    Senator Rosen.
    Senator Rosen. Thank you, Chair Murray, Ranking Member 
Burr, for holding this vitally important hearing today. And I 
really want to thank all of the witnesses for helping to get 
our Country vaccinated. It is so important to every person that 
we know and love in our community and our personal lives that 
we do everything we can to save them and protect them, and I 
appreciate your hard work in this regard.
    I just want to speak a little bit about vaccine outreach, 
because our Country--we have made tremendous progress over the 
past several months in making the vaccine available to most 
individuals, to getting shots and arms. I have had the honor of 
going to some of the vaccine sites, of course, clinics in my 
home State of Nevada. Our health care heroes, they are pillars 
of strength in our communities, showing up day after day to be 
sure that everybody that wants a vaccine can get one.
    We just can't lose ground. But unfortunately, Nevada is--
our cases are growing, and we seem to be getting to the top of 
the list nobody wants to be in, in the cases of the delta 
variant. I am extremely concerned about the lag in vaccination 
rates. In fact, last week, especially a nursing home, Senator 
Cortez Masto and I sent a letter to Secretary Basara to raise 
concerns about the low reported vaccination rates in Nevada's 
nursing homes. And we have to find a solution to protect those 
most vulnerable who can't go out to a site and even their loved 
ones couldn't take them.
    Dr. Walensky, are there any plans for the CDC or in 
coordination with other agencies to restart the pharmacy 
partner program that sent teams directly to every nursing home, 
perhaps, or every facility with less than a 90 percent 
vaccination rate for residents and staff and I might even say 
families of staff who they go home to?
    Dr. Walensky. Thank you for that question, Senator Rosen. 
And we recognize this challenge, and we are with you. And that, 
in fact, we have 10 CDC people deployed to Nevada right now 
working to assist. You know, part of the long term plan in 
terms of working to vaccinate our long term care facilities, 
not necessarily these staccato partnerships with the 
pharmacies, but to have a longitudinal plan, because, in fact, 
especially in our long term care facilities, there is quite a 
bit of turnover of the patients.
    We want to make sure that there is always vaccine 
available. Many of these long term care facilities have access 
to pharmacies, and we want to make sure that there is a vaccine 
actually active in the pharmacies so that they can do 
vaccination when patients come in. I agree with you and in fact 
we need to work to get our staff vaccinated as well. In fact, 
staff in some of these long term care facilities are 20 percent 
less coverage than the facility members themselves--the 
residents themselves.
    We are working on confidence in those areas, but 
specifically strike teams in with a long term care facilities 
to assist in getting vaccine to those places that is not 
reliant on a one time mass vaccination, but really has a 
longitudinal plan to make sure vaccine can be available in the 
long term.
    Senator Rosen. Yes, and I would hope that you would include 
the families of the staff, because oftentimes they have a high 
turnover, too. They go home to their community and are just 
going to keep putting out that fire over and over. But I would 
like to switch now and talk a little bit about the research in 
vaccines, because obviously we are discovering more about COVID 
every single day.
    I think for years to come, we are going to continue to 
learn. And so now is the time to take those additional steps to 
say--to see we don't look back and find gaps in data that could 
have been prevented, those gaps could have been prevented if we 
had acted sooner, speaking of longitudinal. And so data like 
this could save lives. That is why I introduced the Ensuring 
Understanding of COVID-19 to Protect Public Health Act. And it 
is bipartisan legislation that requires long term those 
longitudinal studies on a variety of COVID patient population 
with regular public reporting.
    For example, some of the recent research is showing that 
COVID-19 vaccine may actually improve symptoms for some 
patients with long haul COVID. So, Dr. Fauci, how do we--what 
do we know about this so far and how common is the vaccine to 
be a strong prevention tool, but also to work therapeutically 
in this case? And what else should we be studying?
    Dr. Fauci. Very good point, Senator. And there has been 
anecdotal reports of people who have been infected, have 
developed long COVID, and their symptoms have been improved 
upon getting the SARS-CoV-2 vaccine. That has not been proven 
under the scrutiny of a clinical trial.
    Right now, we are looking at individuals who actually have 
recovered and seeing if, in fact, vaccination does improve. 
Right now, although the anecdotal cases suggest that I don't 
think we can say anything definitively from a scientific 
standpoint, but that is something that is being looked at.
    Senator Rosen. Thank you. I see my time is up. Thank you.
    The Chair. Thank you.
    Senator Romney.
    Senator Romney. Thank you, Madam Chair. And thank you to 
the members of our panel today for being here responding to our 
questions. Thank you also to the teams of people that you work 
with. Their tireless work over the last year and a half is 
something which many of us feel a great deal of gratitude for, 
for that effort. As we try and understand vaccine hesitancy, I 
am sure some of that is due to spurious conspiracy theories.
    Perhaps and I don't know this, but social media may be 
populated in part by enemies of our Country that are putting 
out theories to try and get people not to take vaccines. But 
there is also, I believe, another reason why some people who 
are not prone to believe those conspiracies don't get 
vaccinated, and that is because they don't know what the data 
really suggests. And they wonder, Okay, is this really a good 
thing for my 16 year old?
    What are, the serious side effects of this vaccine for a 16 
year old versus the probability of them getting very ill? And I 
wonder, do we provide or is there a place where people can go 
to find out what the data show for the side effects of vaccines 
by age group and how many serious complications there are for 
people of different ages and then compare that perhaps with the 
serious implications of getting COVID? And I will ask first, 
Dr. Walensky.
    Dr. Walensky. Yes. Thank you very much, Senator Romney. In 
fact, that is exactly what we are doing. So, one of the things 
I think that is so important to understand is that when people 
don't want to be vaccinated it's for a whole host of reasons. 
And until you start talking to them about what is their reason, 
is it, I can't take off work tomorrow and I may feel unwell, is 
it because I don't understand these potential side effects for 
my 6 year old?
    We and CDC have what we call vaccine confidence consults. 
So we have state departments, local health departments who can 
call into us and say, these are the things that we are hearing 
on the ground. What is the real data so that we can have 
trusted messengers for providing that real data in real time to 
people and making sure that their answers are--their questions 
are answered and that we can empower the people who are the 
trusted messengers on the ground with exactly those data.
    Senator Romney. Is that information being collected? Are 
doctors and hospitals actually collecting the data that shows 
how many people are getting side effects by age group? Are you 
getting accurate information that people can rely upon? 
Because, again, I see on social media and some broadcasters a 
sense that somehow this is being hidden, that the side effects 
are being underplayed, that you have an incentive not to let 
people know what the kind of side effects might be and the 
seriousness of those side effects.
    Dr. Walensky. The answer is absolutely. We have numerous 
large scale mechanisms by which to collect these data. We have 
the first ever V-safe monitoring program where people are--
given their vaccine, how did they do today? How are they doing 
in a week? We have the Vaccine Adverse Event Reporting System. 
That is a passive reporting system.
    Everything gets reported, is supposed to get reported but 
we recognize it is passive. Things may get missed. And then we 
actually also have the vaccine safety data link, which is a 
link of nine academic centers that were able to get real 
vaccine data as well as their denominators, which is hard to 
get in passive reporting so we can check numerators and 
denominators there and give us real estimates. We are doing--we 
are covering the gamut.
    Senator Romney. The talk that Senator Burr described with 
regards to getting a booster, the suggestion from Israel is it 
makes sense. There are a number of us that would get in line to 
get a booster. How long is it going to take before we are able 
to get sufficient information to allow Americans who want to 
get an additional vaccination to be able to do so? Are we 
talking weeks, are we talking months? I mean, I guess given the 
fact that this is being done overseas, can we not use the data 
that has come from those places to allow people in this country 
to get a third shot if they want to?
    Dr. Woodcock. The agencies represented here are all 
monitoring this extremely carefully. As you have heard, 95-99.5 
percent of all people are being hospitalized now are 
unvaccinated. So at the moment, the people that are getting 
sick are the people who haven't been vaccinated.
    Senator Romney. I understand but I am looking at the data 
that is coming from Israel, and people who have double 
vaccinations are still susceptible to the delta variant for 
serious disease and death. And they are showing that if they 
get a booster, that dramatically is reduced. Why should we not 
allow people who are elderly or have other compromised 
conditions to be able to get that booster?
    Dr. Woodcock. Certainly. We are looking at all that. 
Remember this vaccine right now, the vaccines that are under 
emergency use authorization require an additional authorization 
for a booster.
    Senator Romney. How long is that going to take? That is a 
question. We have people who want to get that booster, and I am 
hearing that from people who are at risk and concerned. They 
want to take that booster. They are willing to take the 
additional risk of something that has not been--they have 
already had two shots of it. They are saying, give me the 
third, because I got this over a year ago. I got the 
vaccination over a year ago. I want to get that protection. Why 
can't they? And if--I understand, you won't let them yet. But 
when will you let them?
    Dr. Woodcock. Well, Pfizer, at least has announced that it 
is going to submit to their EUA data, both Pfizer data and 
Senator Burr's early point, other Israelis--other data that 
they have available to potentially make the case for a booster. 
So the FDA will be looking at that.
    Senator Romney. I am sure you will. I don't like the 
timeframe, frankly, given the fact that this is being done 
elsewhere. My time is up so I will turn back to you, Chair.
    The Chair. Dr. Woodcock, for clarification, Pfizer has not 
requested FDA to approve a booster?
    Dr. Woodcock. Well, of course, I can't talk about that, but 
Pfizer has publicly announced that they are going to submit an 
amendment to their EUA to request--for a booster dose.
    The Chair. Thank you.
    Senator Hassan.
    Senator Hassan. Well, thank you, Chair Murray and Ranking 
Member Burr. And thank you to all of our witnesses today for 
the work you do. I want to just start to talk about a recent 
news item. It is a deeply disturbing report detailing dangerous 
inequities that USA Paralympians are facing at this year's 
Tokyo Paralympics. Becca Myers is a six time Paralympic 
medalist who won three golds in Rio 5 years ago. She is deaf, 
blind, but in the past, that hasn't stopped her from competing 
and winning at the highest levels.
    This year, though, she and other athletes from Team USA who 
experienced disabilities are being denied adequate access to 
personal care assistants, reportedly due to COVID-19 
restrictions. Individuals who experience disabilities should 
not be forced to navigate the Tokyo Olympics without the 
support that they need in the midst of a global pandemic. Becca 
announced on Sunday that she is quitting the team because she 
is being denied a, and this is her quote, ``reasonable and 
essential accommodation'' that would enable her to compete.
    This is an outrage and a preventable situation that should 
never have gotten to this point. So I want the U.S. Olympic and 
Paralympic Committee to work immediately to address this issue, 
and I want them to ensure that all of our athletes are able to 
compete safely at this summer's game, including by providing 
them the basic supports that they need just to navigate the 
world. So I do have a question though, Director Walensky, 
because over the last year and a half, the CDC has provided 
guidance on how to mitigate the risk of COVID-19 in various 
activities, as well as special events, including sports.
    I have a question that you all could answer in writing. You 
can comment on it now if you would like. But what I am 
interested in is your best guidance regarding COVID-19 
mitigation, taking into account the needs of people with 
disabilities. So if you would like to comment now you can or we 
can just do it in writing.
    Dr. Walensky. Maybe I will just comment and say I share 
your concern. We have dedicated resources specifically to 
disabled communities, especially those who are unable to come 
out and get vaccinated. I think probably the details of 
individual sports, which we can do by writing, but I just want 
to echo your concerns.
    Senator Hassan. I just want to be clear that for some 
people with disabilities, the accommodation, the aid they need 
is another human being. And it really needs to be seen as the 
same kind of accommodations we would make in other situations. 
So I appreciate having an ongoing discussion with you about it.
    Now, I would like to turn to you, Ms. O'Connell. Last year, 
many states, hospitals, and First Responders struggled to 
acquire personal protective equipment, and the Federal 
stockpile did not contain the supplies needed to fulfill their 
requests for help. The stockpile also contained many expired 
and unusable products, which further limited its effectiveness.
    I recently introduced bipartisan legislation with Senator 
Cassidy that would improve transparency into the stockpile, 
authorized transfers of expiring products, and assist states in 
establishing and maintaining their own stockpiles in order to 
help avoid the kinds of challenges that we faced last year.
    What steps are you taking to improve the stockpile, and 
will you continue to work with us on this bipartisan 
legislation to make further improvements?
    Ms. O'Connell. Senator Hassan, thank you so much for your 
question. This is a place where I intend to spend a lot of time 
in my new role. I am pleased to report that ASPER has spent and 
invested over $10 billion in supplemental funds to restock the 
stockpile.
    We currently have 35 times the number of N95 respirators we 
had at the beginning of the pandemic. We have 17 times the 
number of gloves, 8 times the number of masks, and of the N95 
masks, all 12 contracts are with domestic manufacturers. So we 
are beginning to see some progress.
    Senator Hassan. Will you work with us on the bipartisan 
legislation that Senator Cassidy and I have introduced?
    Ms. O'Connell. I would look forward to. Thank you, Senator.
    Senator Hassan. Thank you. Dr. Fauci, I have a question for 
you about pediatric vaccines. Many parents and family members 
are understandably eager for updates on the potential 
availability of COVID-19 vaccine authorized for use for 
children under 12. I am encouraged that clinical trials for 
young children are underway, and I am hopeful that we will see 
the same safety and efficacy that we have seen from previously 
authorized COVID-19 vaccines. Doctor, when do you believe 
parents and families can expect trials to yield the type of 
data needed to pursue authorization for use in children under 
12?
    Dr. Fauci. Thank you for that question, Senator. From the 
standpoint of the data that would be required to make a 
decision, that very likely when you do the age de-escalation 
studies, so we have gone from 12 to 9, 9 to 6, 6 to 2, and then 
6 months to 2 years, likely by late fall, early winter, we will 
have enough data. But that doesn't mean that then it is all of 
a sudden going to be allowed to happen. That will be a 
regulatory decision that the FDA will have to make.
    Senator Hassan. Well, thank you. And I see that I am out of 
time. I will follow-up with you in writing because I am also 
interested in what you think we could do now to help boost 
confidence and uptake for the pediatric population once the 
approval is authorized.
    The Chair. Thank you.
    Senator Marshall.
    Senator Marshall. Thank you, Madam Chair. My first question 
for Dr. Walensky. As a physician, we always want to be able to 
know and discuss the benefits and risk of anything that we are 
prescribing, including a vaccine. It is estimated that 40, 
maybe 50 percent of children have already had the COVID virus. 
What are the additional benefits to the vaccine to a child who 
has already had the virus?
    Dr. Walensky. I think it very much depends on what that 
variant that child might have had, whether they could 
potentially be infected or reinfected. And one thing I just 
want to note with the children is I think we fall into this 
flawed thinking of saying that only 400 of these 600,000 deaths 
from COVID-19 have been in children. Children are not supposed 
to die. And so 400 is a huge amount for a respiratory season.
    Senator Marshall. Thank you. Dr. Woodcock, how many 
children under the age of 18 without a preexisting condition, a 
significant health condition, have died from COVID in this 
country?
    Dr. Woodcock. I don't--I don't have that at my fingertips. 
I am sorry.
    Senator Marshall. Dr. Walensky.
    Dr. Walensky. Over 400
    Senator Marshall. Without a pre-existing----
    Dr. Walensky. That, I don't know.
    Senator Marshall. The answer is probably zero. So I think 
if you take a deep dive, most of the children that have died 
had some type of underlying health condition. Dr. Fauci, in my 
hand is a three dimensional printing of the COVID spike, 
something that is certainly a scientific--just baffles me in so 
many ways.
    It is composed of two units, as you know. There is an S2 
subunit and an S1. And I would like for you to talk about the 
S2 subunit for a second. Can you explain the significance of 
the furin cleavage side, the double arginine CGG codon, if you 
would, and how that works clinically for us?
    Dr. Fauci. Yes. Thank you for that question, Senator. The 
furin cleavage site is a site of a set of amino acids, which is 
at the point where the enzyme furin can cleave it so that the 
virus can then bind to the receptor cell and then enter the 
cell. So what is seen on a number of viruses, it has been seen 
on the SARD-CoV-2 and it is also seen on other beta 
coronaviruses. You asked also about the double CGG codon that 
is a codon again, that is unusual, but it is also seen on a 
number of beta coronaviruses. It is not a very common codon for 
the amino acid in question, but it is seen in coronaviruses.
    Senator Marshall. Dr. David Baltimore, a Nobel Laureate, I 
will quote him here, ``when I first saw the furin cleavage side 
in the viral sequence with this arginine codon I said to my 
wife, it was the smoking gun for the origin of the virus. These 
features make a powerful challenge to the idea of a natural 
origin for SARS-2.'' And again, this is Nobel Laureate, Dr. 
David Baltimore saying this. Would you agree or disagree with 
Dr. Baltimore?
    Dr. Fauci. Well, Dr. Baltimore, who is an extraordinarily 
accomplished scientist, has backtracked on that statement, and 
says, I wish I had not used the word smoking gun when it was 
pointed out to him that actually this is seen in a number of 
coronaviruses, including one of the common cold coronaviruses. 
So I believe, if you would ask--.
    Senator Marshall. You disagree with him?
    Dr. Fauci. Well, I agree with his second statement where he 
backtracked and said he wished he had not--.
    Senator Marshall. You disagree with his first statement 
though?
    Dr. Fauci. He disagrees with his first statement.
    Senator Marshall. Okay, not going to answer the question. 
We also have the S1 subunit, and I refer to the timeline behind 
me here that there was a moratorium placed for viral gain of 
function in 2014. And I think you will agree with me that the 
NIH funded research that led to this, an S1 spike that looks 
very similar, if not exactly to what is on the COVID-19 spike.
    Dr. Fauci. What are you referring to, Senator? Can you 
please be more specific?
    Senator Marshall. Yes. So I am talking about the S1 subunit 
of the current COVID-19 spike.
    Dr. Fauci. What about it? I mean, are you talking about an 
experiment or are you talking about a paper that was published?
    Senator Marshall. I am talking about viral research that 
was done using NIH funding with the North Carolina lab and Dr. 
Xi developed this S1 subunit spike that looks exactly like what 
we have on the current COVID-19 spike. Is that not true?
    Dr. Fauci. No, I am not sure exactly what you are referring 
to. Are you referring to the paper of Baric and Xi in Nature 
Immunology? Is that what you are referring--I need to know 
specifically.
    Senator Marshall. Yes, Dr. Baric and Xi printed studies on 
this S1 unit that was basically the development of the key to 
the door that was--specifically took the original SARS virus 
and made it so it would bind to the human lung cells.
    Dr. Fauci. No, there was gain--if you are referring, 
Senator, to gain of function by the definition.
    Senator Marshall. That is not my question. Would you agree 
that the spike that was developed there is was also on the 
current--
    Dr. Fauci. Yes, but that is irrelevant to anything until 
you have a context in which you are putting it. You are talking 
about an S1 and a spike in what context? If you are talking 
about a paper that was written by them.
    Senator Marshall. But would you agree or disagree that it 
is the same spike?
    Dr. Fauci. I am not sure what you are talking about, 
Senator. I am really not sure what you are talking about.
    Senator Marshall. Okay, thank you.
    Dr. Fauci. Alright.
    The Chair. Thank you.
    Senator Casey.
    Senator Casey. Thank you, Chair Murray. And I want to thank 
the panel for being here today and for your public service. A 
challenging time for the country. I just wanted to make a 
couple of statements at the top. Assistant Secretary O'Connell, 
I was--I want to ask you a question, but just wanted to note on 
page four and five of your testimony about the information 
about the inventory that you have built up. We are happy to 
read that. I won't go through it all.
    Also the statement you made about ensuring, ``ensuring a 
safe and consistent supply chain for medical materials, 
ingredients and supplies is critical for any national response 
to public health emergencies.'' I couldn't--we couldn't be, I 
should say, more pleased with that kind of a focus, because we 
are going to need that in the future. Dr. Walensky, there was 
an earlier question, I think, by Senator Hassan talking about 
nursing homes and nursing home workers in particular.
    I want to ask you a question, because I have got a separate 
question. But the lower vaccination rate for nursing home 
workers is of concern. We are told by Federal data that there 
are still 13 states with less than half, less than half of 
nursing home workers have been vaccinated. So the message about 
vaccinations couldn't be more important.
    Last thing I would say, Dr. Fauci, in reference to the 
questions by Senator Paul today and the accusation, I think it 
is a widely shared view in both houses, in both parties that 
the integrity that you bring to your work and the knowledge you 
bring to your work on behalf of the Nation, that I think that 
sentiment is a broad and deep reservoir, and it is very, very 
much bipartisan. I want to ask you to comment on that.
    But I wanted to--I have a question for Dr. Fauci and Dr. 
Walensky about breakthrough infections. We know that even with 
any--even with the great success of the vaccines, there is no 
100 percent effectiveness. So I wanted to ask you about 
breakthrough infections. I haven't seen, maybe it is available, 
but I haven't seen information about either breakthrough 
infections or enough information about cases of long COVID, 
because--I assume because of a lack of data.
    Dr. Walensky, I would ask you, what types of data is CDC 
collecting to track breakthrough infections? And how are both 
CDC and the National Institute of Allergy and Infectious 
Diseases, Dr. Fauci, using data to monitor outcomes in patients 
with breakthrough infections?
    Dr. Walensky. Thank you, Senator. So there are different 
ways that we are capturing these data. And I think all of them 
fit together in a puzzle. One is passive surveillance where 
folks give us data when they break through, the hospital 
systems provide us data. They know that somebody is 
hospitalized and has a history of vaccination. We want to know 
about those cases to the extent possible. We would like to have 
a sample of the virus so that we can understand the viral load, 
so that we can sequence it, we can understand their symptoms 
and their risks that potentially put them in that situation.
    However, that is actually limited because it actually 
doesn't give us the denominator. We don't know who else would 
have been reporting or who we missed in that process. And in 
order to do real effectiveness studies, we need to have both 
the numerator of the cases as well as the denominator. So we 
are doing many of those studies across the Nation. We do have 
them geographically sampled. We have a long term care facility 
study where we are getting data from over 14,000 long term care 
facilities. We have a health worker study.
    We have an essential worker study. That is 5,000 essential 
workers that are being tested by PCR every single week. And we 
have numerous other cohorts in 19 academic medical centers, 187 
hospitals to monitor both the numerator, how many people are 
breaking through, how serious is their infection, as well as 
the denominator, how many people overall were vaccinated, so we 
can get a really good window as to the breakthrough--the 
percentage of people who are breaking through.
    Senator Casey. Thank you.
    Dr. Fauci.
    Dr. Fauci. Well, thank you very much for your prior 
comment, Senator. That is much appreciated. With regard to your 
question, I think people need to appreciate when you talk about 
breakthrough infections, that the original data from the 
clinical trial, the efficacy data, was based on preventing 
clinically apparent disease, not preventing infection such as 
asymptomatic infection.
    When you hear about a breakthrough infection, that doesn't 
necessarily mean the vaccine is failing because it is still 
holding true, particularly with regard to protection against 
severe disease, leading to hospitalization and deaths.
    As per your question, what are we doing? We will be 
following for two-years the people who are in the clinical 
trials, the 30,000 and 44,000 people, to be able to determine 
just what percent now in the context of the delta variant are 
actually breaking through, to determine if it is more than that 
original that we saw or in the context of delta, if it is 
actually much more.
    Senator Casey. Thank you, Doctor. Thank you, Chair Murray.
    The Chair. Thank you.
    Senator Cassidy.
    Senator Cassidy. Thank you all. I will ask--if I cut you 
off, it is not--I am not being rude, I just got 5 minutes. Got 
to hustle. Ms. O'Connell to follow-up on what Senator Hassan 
said, thank you for replenishing the strategic national 
stockpile. The one thing that troubled us is that there was no 
first in, first out. There was no rotation of material before 
it expired which was just dumped. What--just yes or no, have 
inventory management systems been implemented to minimize the 
wastage?
    Ms. O'Connell. Thank you, Senator. Yes, we are looking at 
that.
    Senator Cassidy. Looking is a very vague term. If you are 
one of my medical students on rounds, I would say, what does 
that mean?
    Ms. O'Connell. Well, one of the things we are pursuing is 
the model of the vendor manage.
    Senator Cassidy. Wonderful. Thank you. Second, related to 
that, I am told there is a lot of vaccine that is about to 
expire. So it is 6 months from being expired in a state which 
is not completely using it. Unfortunately, my state, is among 
those.
    Ideally, from my perspective, we rotate that vaccine out to 
the border for those who are coming across as undocumented or 
down to Central America and Mexico, which is having these COVID 
outbreaks. I am told there is contractual issues with that. But 
is there any effort to rotate out soon to expire vaccine that 
doesn't appear as if it is going to be used into a set in which 
it could be used quite rapidly?
    Dr. Woodcock. We have been working on this, and what we 
have been advising the states is where they have repositories 
to hold on to that vaccine because unlike most medical products 
you are used to, we are making these stability determinations 
on the fly.
    Senator Cassidy. Dr. Woodcock, that is the news. You are 
telling me that even if it goes beyond the expiration date, 
that the vaccine can still be used?
    Dr. Woodcock. No, I am saying we are telling people to hold 
on to it, because when the additional stability--because we are 
doing stability--the companies are doing stability on the fly 
because we--
    Senator Cassidy. I understand.
    Dr. Woodcock. Yes, so we have extended the date once 
already for one of the vaccines. We may be able to keep 
extending as more stability--as there is longer stability 
observed.
    Senator Cassidy. But it still seems to me inevitably, 
sooner or later, you are going to decide you have got to toss 
it. Now, just an inventory management system. It seems wise to 
be rotating that to a place where it would be taken up quickly 
as opposed to a place where it is being taken up quite slowly. 
Agree, disagree, and if you agree, any thoughts regarding that?
    Dr. Woodcock. Well, that is really for probably ASPER to 
talk about----
    Senator Cassidy. Maybe for State Department.
    Dr. Woodcock. Yes.
    Senator Cassidy. Are there other contractual obstacles to 
doing that? Because someone told me that the contracts with the 
drug companies would not allow the transfer of the product to 
another setting. We couldn't give it to Mexico, for example, 
because it just has to be tossed. Do you know about that?
    Dr. Woodcock. Well, they aren't FDA's contract so my 
understanding is that it is possible under EUA to do exports 
and that could be possible. So that--but we can get back to you 
on that, because it really isn't an FDA issue.
    Senator Cassidy. Sounds great. Next, as regards Dr. Fauci, 
Walensky, it does seem to me this issue of Dr. Woodcock, of 
whether or not we need a booster would be ascertainable by 
whether or not we can see a response of antibody to re-
challenge within the window period is what, 4 days for the 
virus between exposure and an onset of infection if the 
antibodies after exposure to vaccine, if you will, mimicking an 
infection, shoot up rapidly, we have got protection. Are any 
studies taking place along these lines?
    Dr. Woodcock. Yes, absolutely, both within the Government 
and within the companies. And we certainly are--the Government 
as a whole, the agencies involved are monitoring this very 
carefully and we are sharing all the data. And we have heard 
from----
    Senator Cassidy. Now these are very simply done in very 
short--and don't have a lot of timeframe. Obviously, the window 
period is only 4 days. So, and I have asked about this before, 
but it doesn't seem as if there are any answers. What is the 
delay in knowing this? Because that would answer Senator 
Romney's question as regards whether or not a booster is 
required.
    Dr. Woodcock. Well as Dr. Fauci said, there are two things 
going on here. One is, when does immunity wane to the point 
that you need to give a booster? Our populace is not just going 
to--we can't just boost them all the time, right. We need to 
boost them when it is appropriate.
    Senator Cassidy. But isn't there a subset of people whom 
you are following longitudinally that have negative antibodies? 
Their antibodies are initially positive and now they have gone 
on either very low or zero.
    Dr. Woodcock. They are waning. I wouldn't say they are 
negative. Obviously, Senator, Dr. Cassidy, there are going to 
be people who don't respond to vaccination primarily because of 
some immunocompromise. However, what is being followed is the 
waning of humoral immunity, as Dr. Fauci described, over time. 
But it is waning. It isn't vanished. And that is clear because 
everybody who is getting hospitalized is unvaccinated and they 
are being exposed to the delta variant. So the vaccination is 
holding right now in the U.S.
    Senator Cassidy. Good. I thank you all.
    The Chair. Thank you.
    Senator Lujan.
    Senator Lujan. Thank you so much, Chair Murray, for this 
important hearing, and to all of our witnesses for being here 
today. While I am encouraged that data shows vaccine rates are 
increasing across America, still less than half of Hispanics 
have been vaccinated despite data showing that it is the least 
vaccine hesitant group. Dr. Walensky, Federal investment in 
community health centers increased Hispanic vaccination rates. 
Yes or no, did this investment in this community save lives?
    Dr. Walensky. I am grateful for your collaboration with 
HRSA and the Federal qualified health centers, and I absolutely 
think that being able to reach out to these communities has 
saved their lives, some of their lives.
    Senator Lujan. Dr. Walensky, additionally, when Hispanic 
communities has received outreach in Spanish, it increased 
vaccination rates. What is the plan to build on the success of 
using culturally appropriate outreach and messaging to boost 
Hispanic vaccination rates?
    Dr. Walensky. I think we need to use culturally appropriate 
messaging in all of our vaccination efforts. And not just in 
our vaccination efforts, in all of our health care efforts. We 
have--our vaccination toolkits are available in more than 20 
languages. So it has to work within the vaccination of the 
Hispanic community, but also many of our other harder to reach 
communities.
    Yes, we are continuing to do outreach by trusted messengers 
in their own language and culturally sensitive ways. And in 
fact, we are seeing that is working. We had a recent NWR in 
North Carolina that demonstrated when we did this outreach, we 
were able to reach Hispanic communities, increasing vaccination 
rates from 8 to 19 percent.
    Senator Lujan. Dr. Walensky, the next question I have is 
along those lines. The Administration has enlisted Black owned 
barbershops and beauty salons, as well as faith based community 
outreach to promote the shots and even serve as vaccination 
sites to increase Black vaccine rates. Which is important and I 
applaud. Does the Administration have plans to employ similar 
targeted outreach to the Hispanic community?
    Dr. Walensky. The Administration is working to reach people 
where they are and to understand the community by community, 
what is it that community needs, to understand--to have trusted 
messengers, whether it is in barbershops, whether it is in 
faith based organizations, whether it is in grocery stores, 
that is what we are working to do.
    Senator Lujan. I would be interested if you could submit to 
me or get to me what those plans are for outreach into the 
Hispanic community, similar to the plans I just described. I 
wish I could ask the panel similar questions about Native 
American vaccination rates. IHS is not sharing the data, with 
the exception of the good work that is happening in Alaska, 
where Alaska is not depending on IHS to get vaccination rates.
    We do not have state specific IHS data. Many officials have 
told me they are going to fix this. It has not been fixed. 
Please fix it. Let's get IHS on board. Let me ask each of you a 
yes or no question, has disinformation on tech platforms 
negatively impacted the response to the pandemic, Dr. Walensky?
    Dr. Walensky. Yes. And in fact, it has propagated 70 
percent more often.
    Senator Lujan. Dr. Fauci.
    Dr. Fauci. Yes, it has.
    Senator Lujan. Dr. Woodcock.
    Dr. Woodcock. Yes, absolutely.
    Senator Lujan. Ms. O'Connell.
    Ms. O'Connell. Yes, it has.
    Senator Lujan. Assistant Secretary O'Connell, viruses don't 
respect international borders, and for interconnected border 
states like New Mexico, our physical and economic health 
depends on international cooperation. I very much appreciate 
the line of questioning from Dr. Cassidy. We need to do better 
in this space and look for every available tool that exists to 
make sure we are helping get vaccine out, especially into 
neighboring countries across the Americas. What can the Federal 
Government do to decrease COVID infections in border 
communities?
    Ms. O'Connell. Thank you, Senator, for that question. And, 
I did want to follow-up on what Senator Cassidy asked and Dr. 
Woodcock was responding to. It is a question of liability, 
which is one of the things that we work through in these 
contracts that need to be worked through when vaccines are 
shared with other countries.
    That is the contracting issue that can be an impediment. 
But it is important, I think, that we offer tests and vaccines 
where we can to prevent the spread of COVID in the border 
communities.
    Senator Lujan. I recently joined a CODEL to Latin America, 
and one of the countries we visited in Ecuador, where I found 
out that some of the vaccine formularies and samples have not 
been made available to local regulators to approve the vaccine 
anticipating if the United States can donate more vaccine or 
there is more vaccine purchased.
    Dr. Walensky and Dr. Woodcock--and I know my time is about 
to expire. Maybe submit this into the record. How can the 
Federal Government better coordinate internationally to ensure 
that foreign regulatory bodies have the data and vaccine supply 
so they can be approved locally? If you want to give me a quick 
response so then I can follow-up into the record.
    Dr. Woodcock. We have--we have collaborations with 
regulators around the world through EKRA, which is the 
International Medicines Group, Medicine Regulator Group, as 
well as other ways. So we are actively reaching out to other 
foreign regulatory authorities to give them information about 
what we have done to review vaccines and what we know about 
them.
    Senator Lujan. Thank you. And I want to thank this trusted 
panel. I certainly hope that we can stop the spread of 
misinformation, that we can listen to the experts, and save 
more people across America. Thank you for your commitment to 
saving lives. I yield back.
    The Chair. Thank you.
    Senator Braun.
    Senator Braun. Thank you, Madam Chair. Questions for Dr. 
Fauci. I am a strong believer in First Amendment protections, 
and we have obviously seen coming from the business world as 
well, the tech industry carries so much clout. They are 
monopolies as ones are defined. And when you have markets that 
you control over 70, 80 percent, that is so much not only 
economic power, but it is a lot of other power that goes along 
with it. When you have any case where the Federal Government 
gets in cahoots in any way with big companies like that, that 
is almost unheard of.
    Generally the Government would try to do something about 
that. In February, Facebook included new criteria for removing 
misinformation, and part of it was about the origination of the 
COVID virus, which now has gone from what they were declaring 
is misinformation to maybe the way we think it actually 
occurred.
    Facebook has said that they have made consultations with 
leading health organizations. Was your organization, NIAID, one 
of the leading health organizations Facebook consulted with 
when deciding what speech to filter through?
    Dr. Fauci. To my knowledge, Senator, that is not the case. 
When you say consulting with my agency regarding what speech to 
filter through, I don't ever recall or have ever heard of any 
discussion about filtering speech.
    Senator Braun. Did they consult with you on any topics, not 
necessarily whether you would filter through it or not? Have 
you been in contact with them to give them your personal 
opinion on this or that?
    Dr. Fauci. I don't know what you mean by this or that. 
There was one communication or two perhaps with Mark Zuckerberg 
in which he emailed me and wanted to know if there is anything 
that he could do that I believe it was promoting vaccination or 
making sure people do the right thing, wear a mask. But it was 
mostly propagating a public health message. It had nothing to 
do with the origins of the virus at all.
    Senator Braun. Then do you, on a very frequent basis, 
consult with him, either via email or do you have his cell 
phone number, for instance?
    Dr. Fauci. I have exchanged a few emails. You probably know 
that because you are asking the question. About 10,000 pages of 
my email have been FOIA'd. And in fact, there is an email 
exchange or two between myself and Mr. Zuckerberg. I don't 
recall--I can look it up right now and see if I have a cell 
phone number. I am not sure I do.
    Senator Braun. Well, you can get back to me on that. I am 
guessing you might. My point is an entity like that, and we 
have got 190 million users here in the U.S. and they are 
getting into the fray on so many things. And they are the 
classic example where there is too much concentration within 
one entity. And in years past, we have done something about 
that, not just let it kind of run its course. And we have never 
had any of the big monopolies get involved with filtering or 
censoring speech to boot.
    Another question related to the White House, has recently 
said that they are wanting to flag problematic posts. And 
working for the President, would you be one that would try to 
come up with whatever posts that are out there that need to be 
flagged as misinformation?
    Dr. Fauci. No, I have not at all been involved, even 
indirectly, in that.
    Senator Braun. Do you think there is a risk, even though 
you haven't been involved, to the White House wanting to flag 
stuff that they think is problematic, and then have that same 
type of communication with entities like Facebook? Just your 
opinion on that?
    Dr. Fauci. No, actually, this is beyond my area of 
expertise. I developed vaccines to save people's lives. I don't 
get involved in flagging things, Senator. So, I am sorry.
    Senator Braun. Let's then pivot to speaking of vaccines.
    Dr. Fauci. Yes.
    Senator Braun. When you entered grade school, there are 
many vaccines that are mandated, and I think accepted over 
time. Would you, and I would like Dr. Walensky to ask or answer 
this as well, would you be for mandating ever a vaccine for 
COVID-19 or any other variants as mandatory for getting into 
grade school?
    Dr. Walensky. I think first we need to see the data. I hope 
they are efficacious. But first we need to see the data. 
Understand the risk benefit. So I think that is premature at 
this point.
    Senator Braun. What data would you need beyond what we have 
got to go to that next step of making that a mandate, along 
with some of the others that have been so for a long time?
    Senator Braun. We don't have--we don't have clinical trial 
data in the grade school age population yet.
    Senator Braun. I think that means for you that you might 
considering further down.
    Dr. Walensky. I think we need to see what the clinical 
trial data to see the risk benefit and see the long term data.
    Senator Braun. Dr. Fauci?
    Dr. Fauci. I think the same thing. You have to make 
decisions based on data. We don't have that data right now. 
When we do, then we could address that decision.
    Senator Braun. Thank you.
    The Chair. Thank you.
    Senator Baldwin.
    Senator Baldwin. Thank you, Madam Chair. So I have been 
encouraged by this Administration's use of the Defense 
Production Act to produce more pandemic supplies in the U.S. 
And I was proud to be a part of the effort to secure $10 
billion in the American Rescue Plan to increase the domestic 
supply of PPP and other medical supplies. In 2020, the U.S. was 
overly dependent on China, and we did not have sufficient 
domestic sources of very critical PPE, which was exacerbated by 
a shortage of raw materials.
    When the pandemic hit, there was a bottleneck in the global 
production of medical grade meltblown material that is 
essential for N95 masks. Today, Wisconsin manufacturers have 
the ability to provide the meltblowns to provide surge capacity 
required to produce billions of N95 respirator masks. This type 
of American manufacturing is exactly what we need to be 
supporting.
    Ms. O'Connell, I know that ASPER has used significant 
funding to increase its inventory of supplies, but I am 
concerned that if we don't focus some of our expenditures on 
raw materials, we may remain dependent on China and other 
countries. How is ASPER working to secure supplies of raw 
materials like meltblown to make us better prepared for the 
future?
    Ms. O'Connell. Senator Baldwin, thank you so much for that 
question and thank you for the work that you did to get that 
$10 billion in the American Rescue Plan. We just recently had 
released by OMB $2 billion of that $10, which is going to go 
to, among other things, expanding manufacturing for raw 
materials for vaccines. So that is one of the first efforts 
that is going to--that money will be used for. It will also go 
to make sure that we have enough fill-finish capacity, needles 
and syringes, and it is just the start.
    We are, of course, very anxious to get these contracts 
awarded and moving. But it is the beginning of that $10 billion 
going to exactly what you had hoped it would go to. Of course, 
that is not enough. We have got more to go. But I just wanted 
to share with you, that is where we are right now. We have also 
spent, as I mentioned earlier, other supplemental funds on 
producing, and in the U.S., gowns and other PPE.
    We are continuing to do that domestic manufacturing. But we 
do have this industrial base expansion for vaccine 
manufacturing capacity right now.
    Senator Baldwin. Okay, thank you. During this Committee's 
last COVID-19 hearing, I asked about the Administration's 
approach to reducing waste and better targeting vaccines, 
including by reducing the number of doses in each vial and the 
number of vials in each package. Experts believe that both of 
these steps would significantly aid vaccination efforts as 
doctors' offices and community organizations could more easily 
give interested patient shots without worrying about spoiling 
additional doses.
    In that hearing, Dr. Kessler expressed the Administration's 
strong desire and efforts to move forward on both of those 
goals. But recent reporting suggests that this might no longer 
be the case. Dr. Fauci, can you assure me that the 
Administration is doing all it can to encourage the production 
of smaller vials and smaller batches as soon as possible? And 
what steps are being taken and what is your anticipated 
timeline for changes like this?
    Dr. Fauci. Well, thank you for that question, Senator. That 
is not really in my area of activity. I believe that is more of 
an FDA question.
    Senator Baldwin. Well, Dr. Woodcock, please.
    Dr. Woodcock. Certainly. And between ASPER and FDA, right. 
Basically, to do that, we need to get the manufacturers to 
change how they are manufacturing the drug and what the storage 
conditions might be and things like that. And I think heroic 
efforts are being made to try and get a vaccine--get vaccines 
that don't require deep freezing storage conditions and that 
could be then broken up into smaller groups and stored in, say, 
a pediatrician's office refrigerator.
    I mean, that is the idea here, that--so that pediatricians 
and others could--primary care, at the pharmacy, at the nursing 
home pharmacy, whatever, as new people come in, they could 
vaccinate them without wasting large amounts of vaccine or 
having to break into something in the deep freeze.
    Those efforts are arduously going on. They are highly 
technical, though, and they aren't simple. And I think the 
Government and the manufacturers are both united in realizing 
this is necessary.
    Senator Baldwin. Thank you.
    The Chair. Thank you.
    Senator Tuberville.
    Senator Tuberville. Thank you very much. Thank you for 
being here today, testifying. Dr. Walensky, you have been in 
your current post since January. You are in the top position, 
and you surely have heard critiques of the job the CDC has done 
so far in each--this Administration, even the last, you usually 
learn from some things that happened in the past. What would 
you say to those who look to the CDC and say that change is 
needed, that perhaps the agency needs a bit of restructuring?
    Dr. Walensky. Thank you for that question. Certainly 
during--
    Senator Tuberville. What would you do different?
    Dr. Walensky. What would I do differently? You know, 
certainly during the times of pandemic, I came in on January 
20th. We had our pedal to the metal, shall we say, moving 
forward to try and do everything that we could to get us out of 
the pandemic. We have made a lot of progress. We have had to be 
humble about what this virus can do. And a lot has changed just 
in the last 6 months. We need a public health infrastructure in 
this country that allows CDC and our state and local health 
departments to be prepared for a pandemic.
    In that process of restructuring, we need long term disease 
diagnostic funding that isn't like a roller coaster that comes 
with one pandemic and, or one infectious disease threat and 
disappears when that threat is gone. We are going to be dealing 
with this--when, God willing, everybody is vaccinated and 
people are well and the pandemic is largely behind us, we have 
long COVID, we will have boosters to be thinking about, we will 
be dealing with mental health issues for a very long time to 
come and we need the public health infrastructure to do so. 
That would be my biggest--my biggest task and change.
    Senator Tuberville. Thank you. Dr. Woodcock, FDA currently 
has emergency use authorization for three COVID vaccines, but 
they have not yet received the full FDA seal of approval. What 
would you say to the vaccine hesitant people who don't feel 
comfortable taking a vaccine that hasn't been fully FDA 
approved?
    Dr. Walensky. Well, first of all, I would say we did not 
cut any corners in these 30,000 patient trials and these 44,000 
patient trials and all the surveillance you have been hearing 
about of potential rare side effects. So compared to other 
vaccines they would be looking at, these have really gotten the 
full court press as far as evaluation and study.
    They have gone through the FDA process, and they have gone 
to the ACIP, the CDC's advisory committee, and strongly 
recommended that people take them. That said, it is public that 
one of the companies put a marketing application before us and 
we are going to do everything we can to review that in a timely 
manner. But, of course, I can't say anything more about that.
    Senator Tuberville. What kind of timeline, do you think, 
that we will have full approval?
    Dr. Walensky. That is the kind of thing I can't talk about. 
Thank you.
    Senator Tuberville. Thank you. Dr. Fauci, we have made this 
way too political--this has been tough on the American people. 
We all know that. Everybody has worked hard to try to get 
through this. Politics has played a huge role in this. We have 
all watched it from close and afar.
    But I think people need a unifying message from all of us. 
Because in my State of Alabama, we don't have everybody taking 
a vaccine and we are having outbreaks as we speak. We have had 
Operation Warp Speed General Perna here in a committee 
hearing--not in this Committee, but in other committee. He took 
a beating saying how poorly a job he did. And the American 
people saw that.
    A lot of people voted for Donald Trump and a lot of people 
in the South, a lot of people in my state, and we have to have 
a unified message. We can't be blaming this or that. We have 
got to go North with this. We can't go South. We can't go the 
other direction.
    Dr. Fauci, can you understand unless this Administration 
acknowledges the efforts of the last one, a large part of 
Americans, they are going to continue to feel like nothing is 
positive. They are not going to take the vaccine. You 
understand what I am saying?
    Dr. Fauci. I understand exactly what you are saying, 
Senator. And thank you. That is a very appropriate question 
that I would be pleased to answer. Having been present through 
the last year, which was the year when COVID began, the last 
year of the former Administration, I can tell you that no doubt 
that the former Administration deserves a considerable amount 
of credit for the effort that was put into Operation Warp Speed 
that was able to allow not only the rapid development and 
testing, but also the implementation of the vaccine.
    There is no doubt in my mind, as someone who has been on 
both sides of the fence, to say that is the case. But with 
regard to a unifying message, if I might, sir, I think what we 
need to appreciate is that we are dealing with a common enemy 
and the common enemy is the virus. The virus doesn't know if 
you are a Republican, Democrat or Independent. The virus just 
knows that it makes people ill and it kills people.
    We have an extraordinarily efficient tool against that 
common enemy. And what I would hope the message would be, the 
unifying message is let's all pull together and utilize that 
tool, which is vaccination, to really crush that common enemy. 
I think we have it within our capability to do it. And I would 
hope that would be the message.
    Senator Tuberville. Positive attitude plus effort equals 
performance. And if we keep that positive attitude, we can get 
through this thing. We just need to quit fighting in the media 
and get everybody believing in the same thing. We are all on 
the same team. Thank you very much.
    The Chair. Thank you.
    Senator Hickenlooper.
    Senator Hickenlooper. Thank you, Madam Chair and Ranking 
Member. Thank you, Coach. I appreciate that. The belief in the 
positive attitude. As someone who was a part of many scientific 
debates back in my salad days, it just--it makes--it increases 
my respect beyond what I can say in words of how well you have 
gone through the intense debate, because these are life and 
death decisions you have to make oftentimes where there was 
conflict among the science, and we were trying to get the facts 
assembled and sorted and prioritized as quickly as we could.
    Before I even ask any questions, just let me say that my 
questions are always toward a unified future. But I want to 
make sure I recognized how well you have each served your 
Country under very difficult circumstances. So, and I don't 
know, Dr. Fauci, how many of these types of hearings have you 
been in so far?
    Dr. Fauci.
    [Technical problems.]
    Senator Hickenlooper. Yes. So just to look at the intensity 
by which you focus on the answers is remarkably impressive and 
I want to express my gratitude and our gratitude. I guess first 
with Dr. Walensky and Dr. Fauci together, we saw yesterday the 
Pediatrics Academy talk about kids older than two wearing 
masks. We know that kids 12 and older should be getting 
vaccinated.
    Well, just quickly, just to give you a platform to talk 
about that unified message, what should schools be thinking 
about and who should they be talking to get ready? Obviously, 
the more kids we can get that are over 12 and older, the more 
we get them vaccinated, there can be--they will be fully 
protected by the time they get to school in the fall, if we 
start now.
    What does that message look like--would be a couple of--Dr. 
Walensky why don't you start then Dr. Fauci can fill in.
    Dr. Walensky. Thank you for that question, Senator. First 
of all, I want to lean in and say I think it is critically 
important that our schools be open for full in-person learning 
in the fall. We have learned enough over the last year to 
understand what we need to do to keep our children safe. And we 
believe based on the science, that we can keep them safe in 
those settings. How are we going to keep them safe?
    The first and foremost is the best thing would be to have 
everybody vaccinated who can be vaccinated. Surround 
unvaccinated children who are no longer--who are not yet 
eligible, with people who are vaccinated to protect them. So 
that is the highest and most important thing. For those 
children who are not able to be vaccinated, they can and should 
wear a mask in those school settings. And we have said that in 
our guidance.
    I want to also comment on one other thing, and that is that 
I think is critically important in the school year coming ahead 
and that is the role of testing. Senator Burr has talked about 
the importance of other viral syndromes, flu, influenza. We are 
going to see upper respiratory infections in these schools in 
the fall. These kids have not been in school.
    They have not been with each other. And I am worried about 
the upper respiratory infections. And we are going to have to 
understand what is COVID and what is a simple cold among 
children. So those are among the things that I am thinking 
about. Thank you.
    Senator Hickenlooper. Great. Thank you. Nothing to add?
    Dr. Fauci. Nothing to add. That was a very good 
explanation.
    Senator Hickenlooper. You have become a good--an admirable 
team. Dr. Woodcock, some of the FDA reports on--is it 
pronounced Adulhelm? Biogen's new Alzheimer's drug I think are 
very concerning. Last week, there was an expert panel convened 
by the Institute for Clinical and Economic Review unanimously 
concluded that it wasn't--it wasn't efficacious, it didn't 
provide a benefit for patients with Alzheimer's and certainly 
wasn't worth the price tag. And I know that I saw a couple--I 
was researching or reading my briefs from my remarkable staff 
last night that it could have been handled differently. How 
specifically differently should the FDA have looked at this?
    Dr. Woodcock. Well, a lot of the confusion is in some of 
the controversy is simply what you said, this is an accelerated 
approval. That means it was approved on a surrogate endpoint 
that we believe is reasonably likely to predict clinical 
benefit. So the conclusion that you just referred to is not 
surprising, Okay, because they haven't definitively shown 
benefit.
    Now, Congress has urged us to use the accelerated approval 
pathway for life threatening diseases that don't have any 
effective therapy. Alzheimer's is one. I think part of the 
issue was that it was brought to an advisory committee and 
proposed for traditional approval, not on a surrogate endpoint. 
The advisory committee more or less conclusively shut that 
down. And so the agency went back and looked at all the data on 
the surrogate endpoint, which is clearing out the Alzheimer's 
plaque, the amyloid plaque from the brain.
    They found that correlated with benefit, benefit meaning 
slowing a decline of deterioration of thinking, right. And so 
with Malta looking at other programs with other antibodies to 
do the same thing, they concluded that this clearing out of a 
plaque was reasonably likely to predict clinical benefit, 
right. But not--doesn't definitively mean that there is a 
clinical benefit. So I think with such a prevalence--it is very 
common in cancer. It is well accepted.
    That is how we approved HIV drugs from the very beginning, 
alright. And that was a very big success story. That is how we 
approve many drugs for rare diseases. But this is a common 
disease and almost everyone probably in this room has had a 
relative--.
    The Chair. Dr. Woodcock, thank you. We do have votes called 
and we have got to finish our hearing. So I appreciate the 
response.
    Dr. Woodcock. I am sorry.
    The Chair. Thank you.
    Senator Burr.
    Senator Burr. Thank you, Madam Chair. Let me say, Dr. 
Woodcock, I think the decision that FDA made relative to 
surrogate endpoints is exactly that forward leaning approach 
that we envision when we created that expedited pathway. And I 
applaud the decision. I look back at HIV, who Tony Fauci was 
very involved in, and had we not done similar things then, we 
wouldn't have found the keys that unlock doors that we needed.
    I want to turn to Dr. Walensky for just a second. I just 
want to ask a quick follow-up on breakthrough. And Dr. Fauci, I 
understood what you said about the NIH following the clinical 
trials over a two-year period as it relates to breakthrough. 
That is important. It is not important from a standpoint of 
today and the decisions that we make. It is my understanding 
that CDC is only tracking breakthroughs that result in 
hospitalization. Is that accurate?
    Dr. Walensky. No, it is not. So that is in passive 
surveillance, which is, as I mentioned earlier, not the best 
way to track these breakthroughs and one of the limitations of 
our passive surveillance system, which is why we are collecting 
longitudinal data in tens of thousands of people, some of whom 
are getting PCRs so that we can check each test for 
asymptomatic breakthroughs as well.
    Senator Burr. Okay. I think it is extremely important that 
we be as specific on breakthrough exposures. One of the last 
tools that we have is, yes, you may get vaccinated, but you may 
become infected, and you are going to have to prove the data 
that says you probably won't go to the hospital, and you 
certainly won't die. So without that data, you are in a very 
weak situation. So I would encourage you to build that data 
base. I am going to take a couple of minutes to make an 
editorial, and it really gets to the heart of supply chain.
    Ms. O'Connell, this is going to fall in your lap. And this 
is something that the Chair and I and the Committee are going 
to deal with. You talked about a warm base. I know the target 
for what we want in the strategic national stockpile. Here is 
the reality. Federal purchases are 4 percent of PPE. And for us 
to set up a sustainable supply chain, it means that you have to 
compete with dumping practices of China on N95 masks. You have 
to compete with competition from around the world.
    I think, I know Janet and Tony understand that the memory 
span of a Member of Congress is about 18 to 36 months. After 
that, we sort of forget about the last incident that we went 
through and where we look at it and say, well, why are we 
funding to keep the lights on in this N95 mask facility. We 
don't need any more N95 masks. And the problem is that the 96 
percent of the purchasers providers across the country have now 
turned to the lowest cost competitor, which is probably not the 
warm base facilities that we have got. We have got to come up 
with a solution to this, and I want to work with you.
    I want to work with the White House. Because I have gotten 
to a point through a process of elimination as to what won't 
work, faced with the realities of Congress's inability to 
continue to fund indefinitely things that don't produce 
something tangible. We have had to put BARDA on life support 
three different times because members didn't see a need for it. 
Thank God we were able to keep it resuscitated.
    I am not sure that there is a way to do this without 
creating an America's trading bloc, where we incorporate North 
and South America together, where we incorporate the low cost, 
low labor areas of Central America, where textile companies 
already have a presence, where companies could move automatic 
N95 masks, and not just warm base them, but actually let them 
compete with China in the open marketplace and sell to the rest 
of the world, and invite the EU and invite Australia and invite 
Africa and India to be part of the America's trading bloc where 
we can expand.
    As Janet knows, we have had problems with Brazilians on 
knocking off pharmaceutical manufacturing down there for years. 
Let's turn them into a part of our inventory of assets where we 
can turn to vaccine production down there, pharmaceutical 
production down there, raw materials of South America.
    If not, then show me something that is sustainable without 
the condition of Congress coming in and funding at the tune of 
hundreds of billions of dollars on an annual basis to keep that 
supply chain for us as a purchaser of only 4 percent. Somehow 
we have got to--we have got to present to the other 96 percent 
a domestic manufacturing capability that makes them competitive 
against China even with China's dumping practices.
    I sort of lay that on the table. It won't be the first time 
Tony has looked at me and said, you come up with something 
crazy, but I am in the business of trying to find solutions 
that are sustainable. And it will only happen if we think 
outside the box on this. We thought outside the box with 
surrogate endpoints and Janet, well down the road people don't 
die of HIV. They extend their lives.
    Maybe the keys we find are actually cures in the future, 
mRNA technology platform, Tony. We may be curing cancer off of 
that platform two, three, four years down the road. I wonder 
what the person who didn't like mRNA for the vaccine for COVID 
think when they have got prostate cancer and they have got a 
cure on an mRNA platform? I think they are going to take it.
    Everything is going in our favor, but this is absolutely 
crucial to our assurance to the American people and to the 
American economy and manufacturers that we are going to put 
them somewhere, in a system that is sustainable for the future. 
I thank you for listening to me and I thank the Chair. I yield 
back.
    The Chair. Thank you, Senator Burr. Appreciate that. That 
will end our hearing for today. And I want to thank all of our 
colleagues, our witnesses, Dr. Walensky, Dr. Fauci, Dr. 
Woodcock, Ms. O'Connell, Assistant Secretary O'Connell, for 
such a thoughtful discussion about our ongoing response to this 
pandemic and the path forward.
    With that, for any Senators who wish to ask additional 
questions, questions for the record will be due in 10 business 
days, August 3rd at 5 p.m. The hearing record will also remain 
open until then for Members who wish to submit additional 
material for the record.
    The Committee will next meet tomorrow, July 21st, for an 
executive session to consider the Family Violence Prevention 
and Services Improvement Act of 2021 and the nominations of 
Catherine Lhamon to be Assistant Secretary for Civil Rights at 
the Department of Education, Lisa Brown to be General Counsel 
of the Department of Education, Roberto Rodriguez be Assistant 
Secretary for Planning, Evaluation and Policy Development at 
the Department of Education, David Weil to serve as 
Administrator of the Wage and Hour Division at the Department 
of Labor, and Gwynne Wilcox and David Prouty to serve as 
members of the National Labor Relations Board.
    Again, thank you to all of our witnesses today. With that, 
this Committee does stand adjourned.

                         QUESTIONS AND ANSWERS

   Response by Dr. Rochelle Walensky to questions of Senator Casey, 
   Senator Baldwin, Senator Hassan, Senator Burr, Senator Braun, and 
                           Senator Tuberville

    Responses to the QFRs are accurate as of the date of the hearing.
                             senator casey
    Question 1. Even as the vaccination campaign continues--whether it 
is reaching people who thus far have been reluctant to get vaccinated, 
or hopefully expanding the campaign soon to include younger children--
testing remains an important tool in our fight against COVID-19. 
Especially given that younger children are not yet eligible for 
vaccination, and with the rise of the Delta variant, testing continues 
to be a pressing need to ensure that cases are caught early to break 
the chain of transmission--or to rule out COVID-19 when someone is 
showing symptoms that are common to different illnesses. How is CDC 
working with local public health officials, health care providers, 
employers and schools to support robust testing regimes, and what do 
those recommendations look like currently?

    Answer 1. CDC is actively engaging with our state, tribal, local 
and territorial public health partners and with K-12 schools to support 
implementation of robust testing programs. CDC guidance on testing can 
be found here: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-
overview.html.

    CDC has provided specific technical assistance (TA) on testing and/
or deployed teams to jurisdictions and school districts who have 
requested assistance. Support is provided through technical assistance 
calls, sharing of resources, and creating connections with their state 
or local school testing teams at the health department or referrals to 
other opportunities for Federal testing support, such as the HHS 
Testing and Diagnostics Work Group.

    CDC is also partnering with jurisdictions interested in exploring 
various ways to expand access to testing and incentives to test in 
populations they have identified as likely to benefit from additional 
testing. This includes factors such as current proximity to testing 
sites, area percent test positivity or case burden, and other factors 
such as social vulnerability index scores. Pilot activities have 
explored expanding testing in high density workplaces, using pop-up 
testing in retail sites in the communities, and event-based testing 
where testing is offered in conjunction with previously scheduled or 
well-known events or gatherings. As an example, the Race to End COVID 
project at the Talladega Superspeedway, sponsored by Talladega 
Superspeedway, the Alabama National Guard, the U.S. Department of 
Health and Human Services, the CDC Foundation, and the Alabama 
Department of Public Health, offered an incentive to drive two laps 
around the track behind a pace car to all participants who were tested 
or vaccinated at the pop-up site hosted by the track. The lessons 
learned from these pilots will be disseminated to inform other 
jurisdictions who are seeking ways to expand testing availability and 
desirability within their populations.

    Starting in mid-May, one-on-one TA calls were held with 46 health 
departments to discuss their testing plans for summer schools and 
summer camps as well as their plans to offer screening testing to K-12 
schools in their jurisdiction using CDC Epidemiology and Laboratory 
Capacity (ELC) Reopening Schools cooperative agreement funds.

    Question 2. Earlier this year, I sent a letter with Senator Wyden, 
Senator Tim Scott, and Senator Crapo, calling on CDC to publicly 
release data that have been provided to the Federal Government by CVS 
and Walgreens in relation to the Long-Term Care Partnership (LTC 
Partnership). The LTC Partnership data is the only real time accounting 
of the COVID-19 vaccine rollout from the beginning, and experts have 
testified to Congress that it is critical to understanding how the 
distribution of vaccines proceeded, as well as the racial, economic and 
geographic equity of the COVID-19 vaccine distribution. As the 
bipartisan letter noted, releasing such information retrospectively 
will help researchers and policymakers analyze issues such as the speed 
and equity of vaccine distribution, and the vaccine's role in reducing 
disease and death in nursing homes. One need look no further than your 
agency for proof of the data's usefulness--CDC shared the LTC 
Partnership data with states, and used the data for its own public-
facing research. Please provide me with all facility-level vaccination 
data that has been transmitted to CDC by the LTC Partnership since 
December 2020. Please provide these data no later than August 20, 2021.

    Answer 2. CDC has been in communication with your staff regarding 
this data request.

    Question 3. There is concern that cases of influenza this coming 
winter season will be significantly higher than last year. Is there an 
opportunity to encourage increased uptake of both flu and COVID-19 
vaccines in the coming months, and what would need to occur to make 
that happen, in terms of patient and provider education, vaccine 
distribution plans, etc.?

    Answer 3. This influenza (flu) season, CDC will expand education 
efforts to promote flu vaccination, including among groups of people 
for whom vaccination is especially important, such as people with 
underlying health conditions, pregnant women, children under 3, and 
people within racial and ethnic minority groups, which typically have 
lower vaccine uptake. CDC is investing an additional $150 million to 
continue to build community engagement around COVID-19 and flu 
vaccination among racial and ethnic minority groups.
    In addition, CDC has planned outreach through social media, press 
conferences, web page spotlights, radio media tours, op-eds, and other 
publications. A digital campaign will launch to educate the public and 
people who are at increased risk from influenza and COVID-19 
complications about the importance of vaccination. Finally, CDC will 
support a special campaign to inform the general population, with a 
focus on Black/African American and Hispanic/Latino audiences, about 
the importance of flu vaccination.

                            senator baldwin
    Question 1. The CDC is updating its variant tracker once every 2 
weeks. Please provide additional information regarding CDC's plan to 
increase the frequency of this reporting, improve the granularity of 
data provided, and work with state and local health departments to 
enhance sequencing efforts on the ground.

    Answer 1. CDC reports variant proportion data on two-week time 
intervals with plans to increase frequency in the coming weeks. CDC 
developed guidance for state and local public health laboratories to 
``tag'' sequences submitted to public data bases that were generated 
through state-level baseline genomic surveillance efforts. By tagging 
these sequences, CDC can incorporate these sequence data into the 
national analysis of variants. Integration of surveillance across the 
U.S. maximizes the sequencing capacity, expertise, and available data 
across the U.S. that is available to inform public health decision-
making.

    To improve the detection, monitoring, and mitigation of COVID-19 
variants, the American Rescue Plan invested $1.7 billion to help the 
CDC, states, and other jurisdictions more effectively detect and track 
variants by scaling genomic sequencing efforts. This one-time funding 
is supporting CDC and state and local public health to increase the use 
of sequencing in the U.S. public health system. The information from 
sequencing allows CDC and state and local public health leaders to 
respond to emerging infectious threats more effectively. Sequencing 
technology is used not only to help in the detection and prevention of 
COVID-19, but also with most other infectious disease threats. The CDC 
Advanced Molecular Detection (AMD) program was established in 2014 and 
has been funded by Congress at $30 million per year, to incorporate 
sequencing and relevant technologies into public health and has been 
applied to food safety, emerging infections, biosecurity, antimicrobial 
resistance, and many other pathogens. CDC has also funded 29 
universities to conduct genomic surveillance research in collaboration 
with public health agencies. The studies are meant to provide deeper 
insights into viral genomics and molecular epidemiology within the 
various regions across the country.

                             senator hassan
    Recently, deeply disturbing reports have been published detailing 
dangerous inequities that USA Paralympians are facing at this year's 
Tokyo Paralympics.

    Becca Meyers is a six-time Paralympic medalist who won three golds 
in Rio 5 years ago. She is deaf and blind, but in the past that hasn't 
stopped her from competing--and winning--at the highest levels.

    This year, though, she and other athletes from Team USA who 
experience disabilities are being denied adequate access to personal 
care assistants, reportedly due to COVID-19 restrictions.

    Individuals who experience disabilities should not be forced to 
navigate the Tokyo Olympics without the support they need in the midst 
of a global pandemic.

    Becca announced on Sunday that she is quitting the team because she 
is being denied a, ``reasonable and essential accommodation'' that 
would enable her to compete.

    This is an outrage--and an entirely preventable situation.

    The US Olympic & Paralympic Committee must work immediately to 
address this issue, and ensure that all of our athletes are able to 
compete safely at this summer's games--including by providing them the 
basic supports they need to navigate the world.

    Question 1. Director Walensky, over the last year and a half, the 
CDC has provided guidance on how to mitigate the risk of COVID-19 in 
various activities, as well as special events--including sports. 
Understanding that the CDC does not have jurisdiction over specific 
safety measures taken by the US Olympic & Paralympic Committee, can you 
please explain how COVID-19 mitigation efforts take into account the 
needs of people who experience disabilities?

    Answer 1. We know that most people with disabilities are not more 
likely to become infected with or have severe illness from COVID-19. 
However, some people with disabilities might be more likely to get 
infected or have severe illness because of underlying medical 
conditions, residing in congregate living settings, or systemic health 
and social inequities.

    CDC is currently providing $93 million to the Administration for 
Community Living (ACL) within HHS to administer grants to aging and 
disability networks in every state and territory. These funds are 
providing assistance to older adults and people with disabilities for 
scheduling vaccine appointments, transportation to vaccine sites, 
direct support services needed to attend vaccine appointments, 
connection to in-home vaccination options, and education about the 
importance of receiving the vaccine to older adults and people with 
disabilities. This partnership is also providing an additional $5 
million in funding to stand-up and maintain a new Disability 
Information and Access Line (DIAL) to help people with disabilities 
find vaccination locations in their communities, assist callers with 
making vaccination appointments, and connect callers to local services.

    CDC partners with state, territorial, local, tribal partners, and 
community-serving organizations to support communities at higher risk 
for COVID-19. For example, CDC is partnering with FEMA, CDC Foundation, 
Georgia Tech Center for Inclusive Design and Innovation, University of 
North Carolina Center for Literacy and Disability Studies, DeafLink, 
and National Association of State Directors of Developmental 
Disabilities Services, to provide COVID-19 guidance and resources for 
people with disabilities and care providers. There is a need for 
guidance and resources that are tailored for people with disabilities 
and their care providers. This project aims to compile and develop 
guidance and tools to help people with disabilities and those who 
provide services or care for them make decisions, protect their health, 
and communicate with their communities. The tools and guidance 
developed in this project reflect what CDC has learned about the needs 
of people with disabilities and care providers from partners and 
listening sessions, projects, and research efforts. Following the 
launch of the CDC Toolkit for People with Disabilities web page 
(https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/
people-with-disabilities.html), we gathered feedback from partners 
indicating a need for more information geared toward people with 
disabilities related to vaccine access, accessible vaccination sites, 
and accessible communications products/web resources to develop web 
content, fact sheets and one-pagers, scheduling language, and a 
promising practices document on vaccination access for people who have 
challenges leaving their home. As a result, we began the integration of 
information related to people with disabilities as well as social media 
and web-based graphics that reflect varying disabilities throughout the 
CDC sites instead of just on disability-related webpages.

    Another collaborative project involving CDC Foundation and Georgia 
Tech Center for Inclusive Design and Innovation is developing 
accessible materials and culturally relevant messages for people with 
disabilities. The project focuses on people with disabilities, as well 
as caregivers of people with disabilities, and organizations serving 
people with disabilities to deliver essential COVID-19 information. The 
project helps to ensure that COVID-19 guidance is not only accessible 
to people with disabilities, but also that it is culturally appropriate 
and relevant to the challenges people with disabilities face during 
emergency response situations such as COVID-19.

                              senator burr
    Question 1. Is CDC tracking the number of individuals who got 
vaccinated that were previously infected with COVID-19?

    Answer 1. CDC uses seroprevalence surveys to estimate the 
proportion of the population that has antibodies as a result of 
vaccination, infection, or both. Both vaccination and infection result 
in production of antibodies. By using a combination of antibody tests 
and vaccine history, we can distinguish if someone has been infected, 
vaccinated, or both.

    CDC is working with national blood collection organizations to 
estimate the number of vaccinated persons that were previously infected 
based on vaccine history and antibody testing. We are analyzing these 
data and working to publish soon.

    CDC is modifying its national commercial laboratory survey to 
capture similar information and hopes to implement this during the 
upcoming months.

    Question 2. If not, how is CDC estimating the actual level of 
immunity--both natural immunity from having COVID-19 and the immunity 
provided by vaccination--to get a full picture of the road ahead to 
protect our communities?

    Answer 2. CDC is currently estimating the level of immunity through 
the seroprevalence studies described above. The type of antibodies 
detected can determine if the person has antibodies because of past 
infection or due to vaccination alone. In addition, CDC currently has a 
manuscript in production that assessed SARS-CoV-2 seroprevalence 
related to infection and vaccination in the US population.

    Question 3. Is CDC tracking reinfection rates for those that have 
been previously infected with COVID-19?

    Answer 3. CDC is using several data sources to understand 
reinfections including cohort studies, review of big data from 
electronic health record systems, and by working with local 
jurisdictions as they link cases over time. In terms of surveillance, 
CDC is working closely with public health jurisdictions and the Council 
of State and Territorial Epidemiologists (CSTE) to update the national 
surveillance case definition of COVID-19 and enable states to count 
repeat infections in the same individuals over time. This information 
will be included in the approved position statement 21-ID-01 titled 
``Update to the standardized surveillance case definition and national 
notification for 2019 novel coronavirus disease (COVID-19).'' The rate 
of reinfections depends on both the level of protection by previous 
infection, for which there is increasing evidence, and the general rate 
of infections in the population, which is highly variable. Unlike 
ascertaining vaccine status, ascertaining prior infection status relies 
on data systems linking multiple episodes in local jurisdictions or on 
widespread sequencing.

    Question 4. Can T-cell testing be used to gain better insight in to 
how COVID-19 variants interact with immunity from previous infection or 
vaccine?

    Answer 4. SARS-CoV-2 T cell assays are very complex, and therefore 
are not widely available. Individuals cannot obtain these tests from 
health care providers. T cell studies can be performed in a research 
setting. However, we do know that T cells contribute to immunity. 
Preliminary studies indicate that vaccines generate T-cell immunity, 
and it is maintained against variants. Ongoing studies are being 
performed to understand T-cell immunity better.

    Question 5. According to CDC, 74 percent of hospitalized or fatal 
breakthrough infections occurred in individuals 65 and older. Is CDC 
tracking how many of these individuals have other conditions that may 
make them more susceptible to severe illness from COVID-19?

    Answer 5. The best data for this come from the Coronavirus Disease 
2019 (COVID-19)-Associated Hospitalization Surveillance Network (COVID-
NET), because it has more comprehensive and complete information on 
underlying medical conditions among hospitalized patients.

    COVID-NET is a population-based surveillance system that 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 covering approximately 10 percent of the U.S. population. 
Preliminary data from COVID-NET show, among all COVID-19-associated 
hospitalizations, approximately 29 percent of all vaccinated cases are 
immunocompromised compared to 11 percent of all unvaccinated cases. 
Additionally, approximately 68 percent of vaccinated hospitalized cases 
have 3 or more underlying medical conditions compared to 52 percent of 
unvaccinated cases. For adults ages 65 years, 32 percent of all 
vaccinated hospitalized cases are immunocompromised compared to 13 
percent of unvaccinated hospitalized cases. For adults ages 65 years, 
the proportion of vaccinated hospitalized cases (74 percent) is not 
significantly different from the proportion seen in unvaccinated cases 
(69 percent).

    For national surveillance, 7,525 vaccine breakthrough infections 
among people who were hospitalized or died were reported as of August 
2, 2021. Of those, 2,895 (38 percent) had one or more of the following 
conditions noted: pregnant, diabetes, renal disease, liver disease, 
autoimmune disease, immunocompromised, or immunosuppressive medication. 
However, another 3,352 (45 percent) were missing data regarding one or 
more of these underlying conditions. In addition, national vaccine 
breakthrough surveillance does not collect information on other 
underlying medical conditions (e.g., obesity, cardiovascular disease, 
or pulmonary disease) that have been associated with more severe COVID-
19 disease but are not presumed risk factors for a vaccine breakthrough 
infection.

    Of note, of the 7,525 reported vaccine breakthrough infections 
among people who were hospitalized or died, 5,557 (74 percent) were 
aged 65 years, including 3,704 (49 percent) who were aged 75 years. 
Therefore, a large majority likely have one or more underlying medical 
conditions that might reduce their response to vaccination and/or 
increase their risk for severe COVID-19 disease.

    The number of COVID-19 vaccine breakthrough infections reported to 
CDC through national surveillance likely are an undercount of all SARS-
CoV-2 infections among fully vaccinated persons. National surveillance 
relies on passive and voluntary reporting, and data might not be 
complete or representative. These surveillance data are a snapshot and 
help identify patterns and look for signals among vaccine breakthrough 
cases.

    Question 6. CDC stated that children who are eligible for the 
COVID-19 vaccine can get their routine vaccinations at the same time as 
their COVID-19 vaccine. Looking to the fall and a potential need for 
boosters, can a person receive the flu shot and the COVID-19 shot at 
the same time?

    Answer 6. COVID-19 vaccine and other vaccines may be administered 
on the same day, as well as any interval without respect to timing 
(https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-
clinical-considerations.pdf). However, some additional guidance related 
to co-administration of COVID-19 vaccines and influenza vaccines 
specifically is under consideration for the upcoming Prevention and 
Control of Seasonal Influenza With Vaccines: Recommendations of the 
Advisory Committee on Immunization Practices (ACIP)--United States, 
2021-2022 Influenza Season. CDC will provide a further update when 
available.

                             senator braun
    Question 1. Can you please provide specific updates on your plans 
to ensure that nursing home staff and residents have sufficient point 
of care molecular diagnostics and access to the most appropriate 
prophylactics and treatments?

    Answer 1. Long-term care facilities (LTCF), such as nursing homes, 
are high-risk settings for residents, staff, volunteers, and visitors. 
Case and death rates for LTCF staff and residents have declined sharply 
since mid-December 2020 when vaccine rollout began. Recent outbreaks, 
including those linked to variants and/or breakthrough cases, further 
stress the need to vaccinate residents and staff, including vaccinating 
new residents and staff given relatively high turnover in both 
categories, and continue to implement appropriate infection prevention 
and control (IPC) practices effectively and consistently.

    More than 80 CDC teams have deployed to LTCFs to investigate 
outbreaks, assess staff and supply shortages, and recommend IPC 
measures. Additionally, CDC maintains guidance specifically for nursing 
homes and long-term care facilities around IPC practices and the 
appropriate use of testing which are both essential to quickly detect, 
identify, and prevent the spread of SARS-CoV-2 infections in LTCFs.

    CDC continues to provide resources and information on our website 
and for patients and healthcare providers regarding the availability of 
monoclonal antibody treatments and other COVID-19 therapeutics for 
certain patients at high risk of disease progression.

    CDC is working to rapidly characterize emerging variants to 
understand the potential impacts on critical SARS-CoV-2 medical 
countermeasures (e.g., vaccines, therapeutics, and diagnostics). CDC 
provides updated information on variant classifications and definitions 
as well as the national prevalence of variants of interest and concern. 
These data and other clinical considerations are being used by the 
Office of the Assistant Secretary for Preparedness and Response (ASPR) 
within HHS and other Federal and state partners to inform decisions 
regarding distribution and allocation of testing supplies, therapeutics 
(i.e., monoclonal antibodies), and personal protective equipment (PPE) 
supplies to help jurisdictions and their nursing homes. CDC continues 
to update its information and resources as new science becomes 
available. CDC also continues to work closely with the Centers for 
Medicare & Medicaid Services (CMS) within HHS and jurisdictions to 
provide technical assistance and support to nursing home facilities 
across the U.S. through current CDC programs and those stood up as part 
of the ongoing COVID-19 response. This also includes hosting webinars, 
Clinician Outreach and Communication Activity (COCA) calls, and 
engaging LTCF partners to provide the latest information.

    Question 2. Due to mandatory lockdowns, limited doctor office, 
clinics and emergency room visits, there has been a rapid decline in 
routine health screenings such as HIV/AIDS. Your agency found that at 
just one commercial laboratory system, comparing a six-month period in 
2019 to 2020, they reported nearly 700,000 fewer HIV screening tests 
completed and about 5,000 fewer confirmed HIV diagnoses. This is 
reflective of what has happened across the country: HIV testing is 
greatly reduced due to patients not accessing healthcare and health 
departments moving resources to COVID.
    Question 2(a). This is especially troublesome because as we know, 
early detection and getting patients on a treatment plan is critical to 
limiting the spread of HIV/AIDS. Will you commit to keeping this 
Committee updated on HIV screening levels? Will you commit to 
developing a plan to encourage Americans to visit their local 
healthcare provider for routine screenings?

    Answer 2. Yes, and thank you for asking this important question. 
After an initial interruption of key HIV prevention activities due to 
the pandemic, jurisdictions rapidly prioritized surveillance activities 
and many scaled up self-testing and mobile HIV testing activities. 
These innovations could help overcome longstanding barriers to 
prevention by providing testing in locations beyond traditional testing 
venues. Although overall HIV testing declined in 2020, 2021 HIV testing 
year-to-date is back on track.

    Answer 2(a). CDC will keep the Committee updated on progress 
related to HIV screening and testing in the U.S. Through CDC's core HIV 
programs and our role in the Department of Health and Human Services-
wide initiative, Ending the HIV Epidemic in the U.S., CDC is committed 
to making testing accessible, convenient, and routine by scaling-up 
self-testing, making HIV screening a regular part of health care, and 
increasing testing in non-traditional settings, such as correctional 
facilities and syringe services programs.

    Question 3. Congress has provided a substantial amount of funding 
for COVID testing--nearly $50 billion in the American Rescue Plan 
alone, plus tens of billions of dollars more last year. A significant 
amount of testing money appears to be unspent. This is concerning, 
given that we are hitting a vaccine wall and cases are on the rise due 
to the delta variant. We need to ensure that our capacity for testing 
remains high going into the fall and winter.

    Question 3(a). How much money remains for COVID testing from the 
American Rescue Plan?

    Question 3(b). How much money remains for COVID testing 
appropriated in 2020?

    Question 3(c). What is the Administration's plan for the remainder 
of the COVID testing funds? How and when will this money be spent?

    Answer 3(a), 3(b), 3(c). As of the end of July 2021, of the 
approximately $95 billion identified by Congress across all COVID 
supplemental appropriations for testing-related activities, all but 
$17.5 billion had been allocated to support testing, contact tracing 
and mitigation activities across HHS. HHS is in the process of 
allocating the remaining balance for priority activities such as 
increasing community access to testing and supporting domestic 
manufacturing capacity of tests and enhancing testing capacity in 
congregate settings.

    In particular, as of the end of July 2021, the Centers for Disease 
Control and Prevention awarded approximately $40 billion of the COVID 
supplemental funding appropriated to HHS for broad testing, mitigation 
and related activities, support for school testing and to address 
testing-related health disparities in high-risk and underserved 
communities to state, local, and territorial health departments. In 
addition, CDC had plans in place for additional awards to targeted 
settings. These funds support a range of activities, including: 
enhancing testing and mitigation in targeted settings such as 
correctional facilities, and among homeless populations; expanding the 
Nation's disease intervention specialists; supporting infection 
prevention and control; expanding the Nation's wastewater surveillance 
system; and improving laboratory data and capacity.
                           senator tuberville
    Question 1. What would you say to those who look at the CDC and say 
that change is needed, that perhaps the agency needs restructuring?

    Question 2. What areas or offices specifically do you think could 
be restructured?

    Answer 1 & 2. Thank you for the questions. The ability to respond 
to a public health emergency requires a strong day-to-day public health 
system, supported by infrastructure that is not highly segmented by 
disease, condition, or activity. In addition to the COVID-19 pandemic, 
over the past 24 months, CDC has also responded to diverse public 
health threats from E-cigarette or Vaping Product Use-Associated Lung 
Injuries (EVALI), Ebola, complex multi-state food-borne disease 
outbreaks, wildfires, and hurricanes. Responding to the unique 
characteristics of each of these public health emergencies has required 
deep scientific expertise to deploy a specialized approach and called 
for a robust public health system with world-class infrastructure 
nationwide to stop disease at its source. Unfortunately, this recent 
history has revealed the effects of an inadequate public health 
infrastructure. Ongoing health disparities made us as a nation more 
vulnerable to outbreaks, large-scale public health emergencies, and 
pandemics as well as burdening large segments of our population with 
chronic public health concerns. Additional investments in both domestic 
and global public health and health security infrastructure are needed.

    With investments requested in the fiscal year 2022 Budget, CDC will 
begin to address mission-critical gaps in public health infrastructure 
and capacity nationwide. Transitioning from sporadic influxes of 
supplemental funding tied to a specific emergency to flexible funding 
that can prevent another crisis will strengthen the current public 
health system. Flexible, sustainable investments in infrastructure and 
capacity are critical for saving lives and averting economic losses 
caused by public health emergencies and chronic public health problems. 
In fiscal year 2022, CDC will prioritize funding to rebuild the most 
critical public health infrastructure needed to safeguard the Nation's 
health and economic security.

    Question 3. Isn't it important for CDC to track cases in order to 
determine the effectiveness of the vaccine against COVID?

    Answer 3. CDC has multiple surveillance systems and ongoing 
research studies to monitor the performance of vaccines in preventing 
infection, disease, hospitalization, and death. CDC also collects data 
on breakthrough infections through outbreak investigations. Examples of 
CDC's systems for monitoring performance of vaccines include: The 
National Healthcare Safety Network (NHSN), HEROES/RECOVER, Influenza 
and Other Viruses in the Acutely Ill (IVY), and the Coronavirus Disease 
2019-Associated Hospitalization Surveillance Network (COVID-NET).

    Question 4. Do you consider it misinformation for individuals to 
share their stories of adverse events following vaccination?

    Answer 4. Millions of people in the United States have received 
COVID-19 vaccines under the most intense safety monitoring in U.S. 
history. Communicating timely and transparent information to public 
health officials, healthcare providers, and the public about the safety 
of vaccines, including possible adverse events following vaccination, 
continues to be a top priority for CDC. CDC's communication effort will 
always be based on the scientific evidence and data that we have 
gathered to-date through different sources, including analyzing our 
vaccine safety monitoring data and vaccine safety clinical research.
    CDC recommends that individuals who may have experienced an adverse 
event following vaccination speak to their healthcare providers. CDC 
also encourages anyone experiencing any possible adverse events 
following vaccination to share this information through CDC and FDA's 
vaccine safety monitoring system, Vaccine Adverse Event Reporting 
System (VAERS). When individuals are administered COVID-19 vaccines, 
they are also given information about the opportunity to register with 
CDC's after-vaccination health checker service, called v-safe. Through 
v-safe, vaccine recipients can quickly tell CDC if they have any side 
effects after getting a COVID-19 vaccine.

    Question 5. Can you provide the estimated number of reinfections in 
COVID-recovered individuals, to the best of the CDC's understanding?

    Answer 5. CDC is using several data sources to understand 
reinfections including cohort studies, review of big data from 
electronic health record systems, and by working with local 
jurisdictions as they link cases over time. In terms of surveillance, 
CDC is working closely with public health jurisdictions and the Council 
of State and Territorial Epidemiologists (CSTE) to update the national 
surveillance case definition of COVID-19 and enable states to count 
repeat infections in the same individuals over time. This information 
will be included in the approved position statement 21-ID-01 titled 
``Update to the standardized surveillance case definition and national 
notification for 2019 novel coronavirus disease (COVID-19).'' The rate 
of reinfections depends on both the level of protection by previous 
infection, for which there is increasing evidence, and the general rate 
of infections in the population, which is highly variable. Unlike 
ascertaining vaccine status, ascertaining prior infection status relies 
on data systems linking multiple episodes in local jurisdictions or on 
widespread sequencing.

    Question 6. Can you explain the scientific differences between CDC 
and WHO recommendations for masking children under 5 years old?

    Answer 6. Out of an abundance of caution, CDC recommends masks for 
children older than age two, carefully weighing the risks and benefits 
of masking this age demographic. Conversely, most children older than 2 
years old do not have any anatomic, physiologic, or developmental 
limitations that should preclude them from wearing a mask safely and 
effectively. Masks have been shown to be safe in children older than 
age two. A cohort study among infants and young children in Italy found 
that the use of facial masks was not associated with respiratory 
distress or significant changes in oxygen saturation, including among 
children age 24 months and younger. In addition, studies suggest that 
masks are not likely to impact social development in children.

    Additional research emerged during the ongoing COVID-19 pandemic 
with strong and consistent evidence demonstrating the effectiveness of 
mask use among children age 2 years and older in preventing SARS-CoV-2 
transmission, especially when it is combined with multiple prevention 
strategies.

    Question 7. Can you provide the most recent estimate of the number 
of COVID infections in children under 18 years old?

    Answer 7. There were 3,757,699 cases aged 0-17 years during the 
period, January 21, 2020--August 17, 2021, based on the aggregate case 
surveillance system counts, accessed August 18, 2021.

    Question 8. Are you aware of any ongoing studies into the 
effectiveness of masking in children under 12 years old?

    Answer 8. CDC regularly scans the published and pre-print 
literature as well as other sources for research on this topic. CDC 
uses this information to assess current guidance and whether any 
amendments are warranted based on that new science. There are data from 
studies of children, including children under 12 years old, that 
demonstrate masking provides an additional layer of protection against 
spread of infection in schools. These data are reviewed in this 
document: https://www.cdc.gov/coronavirus/2019-ncov/science/science-
briefs/transmission-k-12-schools.html.

    Question 9. Funds in part from NIH/NIAID helped build the 12 
Regional Biocontainment Laboratories (RBLs) and 2 National 
Biocontainment Laboratories (NBL) to support high consequence 
infectious disease research after 9/11 and the anthrax scares in 2001. 
However, unlike the NBL facilities, the RBL facilities received no 
further direct support until last year when Congress provided enhanced 
investment through NIH/NIAID, targeted specifically to RBL facilities, 
one of which is at the University of Alabama at Birmingham (UAB) in my 
state. Nevertheless, it seems as though the RBL infrastructure, most 
importantly the highly trained staff these facilities maintain and 
produce is something that falls within the purview of the HHS ASPR, 
considering among other things the UAB RBL has had collaborations with 
Altimmune and ImmunityBio for COVID19 vaccine development, and 
supported BARDA contractors. This type of work strongly aligns with 
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and 
Sustaining Robust and Reliable Public Health Security Capabilities. The 
RBL infrastructure and personnel is expensive to maintain and operate, 
and perhaps should not solely rest on either the shoulders of the host 
University or the NIH/NIAID.

    Question 9(a). Therefore, is support from Assistant Secretary for 
Preparedness and Response (ASPR) something under consideration?

    Question 9(b). If not, why not, and if so what is needed to 
facilitate that conversation?

    Answer 9(a) & 9(b). CDC defers to our HHS colleagues from NIH and 
ASPR.
                                 ______
                                 

  Response by Dr. Anthony Fauci to questions of Senator Burr, Senator 
                     Braun, and Senator Tuberville

    Responses to the QFRs are accurate as of the date of the hearing.

                              senator burr
    Question 1. Recent reports from the Administration have indicated 
that, while we don't need a booster for the COVID-19 vaccine just yet, 
we will likely need one in the near future.

    Question 1(a). What does the data show us so far about the 
durability of all three authorized vaccines, particularly against 
circulating variants, such as Delta?

    Answer 1(a). At this time, data indicate that all currently 
authorized COVID-19 vaccines remain effective at preventing severe 
disease and death from COVID-19, including from the Delta variant of 
SARS-CoV-2 (also known as B.1.617.2). The National Institute of Allergy 
and Infectious Diseases (NIAID) is supporting research to assess the 
duration of protection provided by current COVID-19 vaccination 
regimens and further quantify the protective effect of these vaccines 
against variants of SARS-CoV-2. Moderna and Pfizer/BioNTech recently 
reported that immune responses to their respective COVID-19 vaccines 
remained robust 6 months following vaccination. Johnson & Johnson/
Janssen also reported that the durability of immune response from 
vaccination with their COVID-19 vaccine lasts at least 8 months and 
that the average neutralizing antibody levels were greater at 8 months 
than at 29 days post-vaccination. In addition, data from both lab 
studies and clinical effectiveness studies show the effectiveness of 
all three authorized COVID-19 vaccines against the Delta variant, 
particularly against hospitalization.

    Question 1(b). What factors should be considered in determining if 
or when a booster is needed? Should certain populations be considered 
for a booster before others?

    Answer 1(b). The National Institutes of Health (NIH), Centers for 
Disease Control and Prevention (CDC), and U.S. Food and Drug 
Administration (FDA) continue to engage in a science-based, rigorous 
process to help evaluate whether the durability of immune protection 
from currently authorized COVID-19 vaccines is waning and whether a 
booster may become necessary. Current data indicate that all currently 
authorized COVID-19 vaccines remain highly effective at preventing 
severe disease and death from COVID-19, including against the Delta 
variant, and as of the date of the hearing, the CDC and FDA have stated 
that fully vaccinated people do not need a booster shot at this time.

    Whether a booster is needed in the future will depend on multiple 
factors, including the durability of immune protection, the emergence 
of a SARS-CoV-2 variant that evades protection from currently 
authorized vaccines, and the strength of immune responses elicited by 
the initial vaccine regimen in certain populations. For example, data 
indicate that some immunocompromised individuals, including solid organ 
transplant recipients and individuals with cancer, have a weak response 
to the standard vaccine regimen. Emerging data suggest that some of 
these individuals are able to generate immune responses to an 
additional dose of COVID-19 mRNA vaccines. Given these data, 
immunocompromised individuals are likely to be considered for 
additional doses of the COVID-19 vaccine before other populations.

    NIH is conducting and planning studies to measure and enhance the 
immune response to COVID-19 vaccines in immunocompromised individuals. 
In April 2021, NIH scientists began two clinical trials to assess how 
adults and adolescents with certain cancers or immune system 
deficiencies respond to COVID-19 vaccination. These studies will 
provide valuable information about the immune responses to COVID-19 
vaccines in these individuals. NIAID also plans to launch two 
additional trials in August 2021 that will assess immune responses to 
an additional dose of a COVID-19 vaccine in patients taking 
immunosuppressive medications. One of these trials will enroll 
participants with one of five autoimmune diseases, and the other will 
enroll kidney transplant recipients. Each study will enroll 
participants who have absent or weak antibody responses after an 
initial course of COVID-19 vaccination. NIAID also plans to launch an 
additional study that will enroll other solid organ transplant 
recipients who are receiving immunosuppressive medications. Results 
from these studies will help us to better understand the immune 
response to vaccination in immunocompromised individuals and identify 
approaches to safely enhance their responses to vaccination. These 
studies may also lead to evidence-based guidelines for safely enhancing 
responses to COVID-19 vaccination in immunocompromised individuals.

    Question 1(c). What is the status of studies looking at using 
different types of vaccines together, such as administering doses of 
both Moderna and Pfizer to someone or using an mRNA vaccine as a 
potential booster for Johnson & Johnson?

    Answer 1(c). It is possible that the use of mixed vaccine 
regimens--in which an individual receives doses of more than one 
vaccine type--may induce a broader immune response, resulting in 
improved protection against COVID-19. NIAID currently is supporting 
research to determine the effect of mixed vaccine regimens and on June 
1, 2021, launched a study to determine the safety and efficacy of 
boosting with a COVID-19 vaccine different than the one used for the 
initial vaccination, such as the Johnson & Johnson/Janssen vaccine 
followed by one dose of the Moderna COVID-19 vaccine. The study also 
will evaluate immune responses against SARS-CoV-2 variants. Initial 
results from this trial are expected in late summer 2021 and may inform 
public health policy decisions on the potential use of mixed vaccine 
schedules, should booster doses be needed.

    NIH is committed to supporting further research into the use of 
mixed vaccine regimens. NIAID also is studying the currently available 
COVID-19 vaccines--which were designed to target the original strain of 
SARS-CoV-2--to assess the durability of protection they provide against 
SARS-CoV-2 variants.

    Question 2. Given all of the work that we have put into identifying 
and tracking these new variants as they emerge, once a new variant is 
detected, how quickly can we determine--in days or weeks--whether our 
vaccines will continue to protect us from severe illness due to COVID-
19?

    Answer 2. As mentioned in the response to question 1, data indicate 
that all currently authorized COVID-19 vaccines remain effective at 
preventing severe disease and death from COVID-19, including against 
known variants of SARS-CoV-2. Once a new SARS-CoV-2 variant of interest 
or of concern is detected and scientists obtain a sample of the variant 
or the genetic sequence of the variant, they can assess whether 
antibodies from individuals who have recovered from COVID-19, or who 
received a COVID-19 vaccine, can neutralize the variant virus. These 
experiments, which provide an early indication of vaccine efficacy 
against a new variant, can be performed in a matter of days. However, 
the process of definitively determining the impact of a variant can 
take months and can vary based on several factors, including how 
widespread, transmissible, and/or pathogenic the variant is. NIAID is 
fully engaged in efforts to rapidly mitigate the potential impact of 
emerging variants of SARS-CoV-2.

    NIAID, the National Human Genome Research Institute, and the 
National Library of Medicine are participating in the SARS-CoV-2 
Sequencing for Public Health Emergency Response, Epidemiology, and 
Surveillance (SPHERES) initiative. SPHERES is a national genomics 
consortium led by CDC that helps to coordinate SARS-CoV-2 sequencing 
across the United States. NIAID is working with partners to identify, 
monitor, and calculate the frequency of current variations in the SARS-
CoV-2 genome to help predict emerging variants. NIAID also facilitates 
the use of cutting-edge modeling and structural biology tools to 
understand how variants might affect interactions between the virus and 
the immune system. NIAID scientists are helping to inform our 
understanding of transmissibility of the variants by studying their 
stability in the environment and their ability to grow in human lung 
cells. These efforts add to a growing body of knowledge about SARS-CoV-
2 variants and our ability to combat them.

    As part of the ongoing COVID-19 response, NIAID is collaborating 
with vaccine manufacturers on key areas of research to investigate 
whether vaccines designed for the original strain of SARS-CoV-2 
maintain efficacy against emerging variants. NIAID is conducting and 
supporting comprehensive studies to understand the ability of vaccine-
induced antibodies to neutralize the variant viruses. In addition, 
NIAID is supporting the development of additional COVID-19 candidate 
vaccines that seek to induce a broader immune response. On March 25, 
2021, NIAID launched a Phase 1 clinical trial in healthy adults to 
assess the safety and immunogenicity of second-generation COVID-19 
vaccine candidates developed by Gritstone Oncology, Inc. Gritstone's 
COVID-19 vaccine candidates utilize a strategy aimed at inducing both 
neutralizing antibodies and T cell responses to elicit a broad immune 
response. This approach could provide protection against emerging SARS-
CoV-2 variants by targeting several viral antigens, all of which are 
highly conserved among known viral strains.

    Question 3. The Regional and National Biocontainment Laboratories 
were designed to facilitate NIAID-funded research to address 
biothreats, including emerging infectious diseases. As you know, Duke 
University is home to one of these regional biocontainment 
laboratories, and you have previously highlighted some of their 
promising research, including a pan-coronavirus vaccine candidate that 
could potentially provide increased protection against SARS-CoV-2 and a 
variety of other coronavirus infections.

    Question 3(a). Could you expand on the role of the Regional and 
National Biocontainment Laboratories in the development of medical 
countermeasures for COVID-19 and other threats?

    Answer 3(a). NIAID established the U.S. National Biocontainment 
Laboratories (NBLs) and Regional Biocontainment Laboratories (RBLs) to 
conduct research on biodefense and emerging infectious disease agents 
and to be available and prepared to assist national, state, and local 
public health efforts in the event of a bioterrorism or infectious 
disease emergency. Biocontainment laboratories, including the NBLs and 
RBLs, are essential for the development of medical countermeasures for 
emerging and re-emerging infectious diseases.

    The NBLs and RBLs offer unique resources for the research 
community, including animal models, imaging services, and specialized 
equipment. In the case of COVID-19, research that involves the use of 
live SARS-CoV-2 is required to take place in high biocontainment 
laboratories, such as the BSL-3 laboratories within the NBLs and RBLs. 
The NBLs and RBLs were able to utilize their unique BSL-3 capacity to 
assist with basic, translational, and clinical research on SARS-CoV-2 
and COVID-19.

    Over the past year, the NBLs and RBLs played a critical role in 
helping to address the COVID-19 pandemic and have been utilized to 
conduct research with clinical samples containing live SARS-CoV-2 to 
advance the development of COVID-19 medical countermeasures. The NBLs 
and RBLs also have been involved in a variety of pre-clinical research 
activities to test novel vaccines and therapeutics for COVID-19 and to 
explore the pathogenesis of, and immune responses to, SARS-CoV-2. This 
research includes the development of new animal models for COVID-19 
research and the analysis of SARS-CoV-2 variants of concern.

    Question 3(b). How can these biocontainment laboratories be used in 
future preparedness and response efforts?

    Answer 3(b). As noted in the response to question 3(a), the NBLs 
and RBLs facilitate the conduct of research that aims to prevent, 
prepare for, and respond to emerging and re-emerging infectious 
diseases. NIAID recently published a funding opportunity for facility 
and building system upgrades for the RBLs, which will facilitate future 
research efforts in these laboratories. NIAID will continue to support 
highly meritorious biomedical research in biocontainment laboratories, 
including at the NBLs and RBLs, to prepare for and respond to future 
infectious disease threats.
                             senator braun
    Question 1. Dr. Fauci, what steps are your agency taking to prepare 
for the increased exposure to flu, COVID variants, and other 
communicable diseases in nursing homes?

    Answer 1. Older adults, and specifically those in nursing homes and 
long-term care facilities, are often at higher risk for severe outcomes 
from infectious diseases, and the Administration is committed to the 
development and testing of medical countermeasures for this vulnerable 
population. The Centers for Disease Control and Prevention (CDC), the 
lead agency for public health, has released guidance on the prevention 
and management of transmissible diseases in long-term care facilities, 
including nursing homes. This includes specific detailed guidance for 
COVID-19, influenza, and other communicable diseases. The National 
Institute of Allergy and Infectious Diseases (NIAID) conducts and 
supports basic, translational, and clinical research into infectious 
diseases, including research into the prevention of infectious 
diseases. This research encompasses studies in vulnerable populations, 
such as older adults and individuals living in nursing homes.

    Vaccines are the most effective public health tools for preventing 
infectious diseases, and COVID-19 vaccines currently authorized by the 
U.S. Food and Drug Administration (FDA) are well tolerated and 
effective at preventing severe disease and death, including in older 
adults. NIAID has played an integral role in the evaluation of COVID-19 
vaccines. Early in the pandemic, NIAID supported a Phase 1 clinical 
trial of Moderna, Inc.'s COVID-19 vaccine, mRNA-1273, which was 
developed through a collaboration between scientists at the NIAID 
Vaccine Research Center and Moderna. NIAID included individuals aged 55 
and over in this trial to assess the safety and efficacy of mRNA-1273 
in older adults. The data from this trial facilitated progression of 
mRNA-1273 into more advanced clinical trials that ultimately led to the 
emergency use authorization (EUA) of this vaccine by the FDA.

    New viral threats will continue to emerge, and the development of 
universal influenza vaccines and pan-coronavirus vaccines, which would 
protect vaccinated individuals against multiple viruses in one shot, 
can help us be better prepared for future infectious disease threats. 
NIAID is leading efforts to develop universal influenza vaccines to 
protect against multiple strains of seasonal and pandemic influenza 
viruses. NIAID also is conducting early stage research on the 
development of pan-coronavirus vaccines designed to provide broad 
protective immunity against multiple coronaviruses, especially SARS-
CoV-2 and other viruses with pandemic potential. These vaccines 
ultimately would be evaluated for use across the age spectrum, 
including in older adults. NIAID also is investigating the use of 
therapeutics for prevention of COVID-19 in older adults. In 
collaboration with Eli Lilly and Company, NIAID initiated a Phase 3 
clinical trial that demonstrated that the investigational monoclonal 
antibody, bamlanivimab, could prevent symptomatic and asymptomatic 
infection in residents and staff of skilled nursing and assisted living 
facilities. In addition, NIAID is supporting the development of broad-
spectrum therapeutics, including antivirals and antimicrobials, that 
can be used to treat infections, including in older adults.

    NIAID also conducts and supports research into understanding how 
the immune system changes as we age. On October 21, 2020, NIAID 
announced a new funding opportunity announcement (FOA), ``Cohort 
Studies To Improve Our Understanding of Influenza Immunity, Vaccine 
Response and Effectiveness in Older Adults.'' This FOA will support 
research to increase understanding of (1) factors that correlate with 
protection against influenza in older individuals, (2) the impact of 
influenza exposure and vaccination history on protective immune 
responses, and (3) immunological mechanisms associated with vaccine 
failure, including potential intra-seasonal waning of protection. 
Moreover, this research may lead to the identification of risk factors 
for severe outcomes associated with influenza infection. Ultimately, 
this work will inform efforts to develop durable, broadly protective 
influenza vaccines across the age spectrum of adults.

    Question 2. COVID vaccines do not appear to be working as well in 
immunocompromised individuals or individuals taking immunosuppressants. 
Could antibody tests be used to greater effect in this population to 
identify individuals who may need an additional vaccine dose?

    Answer 2. Immunocompromised individuals are at an increased risk 
for poor clinical outcomes from COVID-19. While data indicate that some 
immunocompromised individuals have a weak response to the COVID-19 
vaccines available under FDA EUAs, vaccines remain the most effective 
tool that we have for preventing COVID-19. As of the date of the 
hearing, the FDA does not recommend using currently authorized SARS-
CoV-2 antibody tests to evaluate a person's level of immunity or 
protection from COVID-19, including whether an individual may need an 
additional dose of the COVID-19 vaccine. Antibody tests have not been 
evaluated to assess the level of protection provided by immune 
responses to COVID-19 vaccination, including in immunocompromised 
individuals.

    NIH is conducting and planning studies to assess and enhance the 
immune responses to COVID-19 vaccines in immunocompromised individuals. 
In April 2021, NIH scientists began two clinical trials to assess how 
adults and adolescents with certain cancers or immune system 
deficiencies respond to COVID-19 vaccination. These studies will 
provide valuable information about the immune responses to COVID-19 
vaccines in these individuals. NIAID also plans to launch two 
additional trials in August 2021 that will assess immune responses to 
an additional dose of a COVID-19 vaccine in patients taking 
immunosuppressive medications. One of the trials will enroll 
participants with one of five autoimmune diseases, and the other will 
enroll kidney transplant recipients. Each study will enroll 
participants who have absent or weak antibody responses after an 
initial course of COVID-19 vaccination. NIAID also plans to launch an 
additional study that will enroll other solid organ transplant 
recipients who are receiving immunosuppressive medications. Results 
from these studies will help us to better understand the immune 
responses to vaccination in immunocompromised individuals and identify 
approaches to safely enhance their immune responses to vaccination. 
These studies may lead to evidence-based guidelines for safely 
enhancing responses to COVID-19 vaccination in immunocompromised 
individuals.

    Results from these studies will help us to better understand the 
immune responses to vaccination in immunocompromised individuals and 
may better inform the development of meaningful antibody tests or other 
assessments of immune response to vaccination for this population.
                           senator tuberville
                Vaccination of Children/Parental Consent
    Question 1. Last November, the District of Columbia passed a bill 
allowing children 11 years and older to get vaccinated without their 
parents' consent. It's been proven that this virus has an insignificant 
impact on children under the age of 15 or 16.
    Question 1(a). Do you think minor children should be vaccinated 
without the consent of their parents?

    Answer 1 & 1(a). I cannot comment on legislation passed at the 
local level. While it is true that young children and adolescents are 
less likely to experience severe symptoms from COVID-19, a portion of 
these individuals will still experience severe disease and 
hospitalization. Additionally, children and adolescents who are 
infected with SARS-CoV-2 can experience a rare, but extremely serious, 
multisystem inflammatory syndrome in children (MIS-C). As the Delta 
variant (also known as B.1.617.2), which appears to be more 
transmissible, has become the dominant strain of SARS-CoV-2 in the 
United States, it is critical that as many people as possible are 
vaccinated against COVID-19. The U.S. Food and Drug Administration 
(FDA) has authorized the Pfizer/BioNTech COVID-19 vaccine for use in 
individuals 12 years old and older, and I would encourage everyone who 
is eligible to receive the vaccine to do so as soon as they can.
                            COVID-19 Origins
    Question 2. Did you have knowledge of safety concerns at the Wuhan 
lab?

    Question 2(a). If so, when did you become aware of those concerns?

    Question 2(b). Was it before or after you said in May 2020 that the 
virus was more likely to have emerged naturally?

    Answer 2(a) & (b). NIAID was aware of interest on the part of the 
Wuhan Institute of Virology (WIV) to obtain additional information and 
trained staff as they prepared to begin research in a new 
biocontainment level 4 (BSL-4) facility.

    My own view, based on the studies I have reviewed and my prior 
experience, is that it is most likely that SARS-CoV-2 infections in 
people resulted from zoonotic transmission from animals to humans, 
based on what occurred with two other coronaviruses--Severe Acute 
Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome 
(MERS)--and many other emerging diseases, as well as what is known 
about the molecular makeup of SARS-CoV-2. The available scientific 
evidence, including information about the sequence of the virus, does 
not support the assertion that SARS-CoV-2 was engineered. This view is 
consistent with an emerging consensus from world-renowned experts in 
virology, genetics, and evolutionary biology based on currently 
available data. However, as I have publicly stated, the possibility of 
a laboratory accident exists. A laboratory accident could include 
scenarios where a naturally occurring virus was unintentionally 
released during research activities such as collection of animal 
samples or examination of virus in a laboratory. I am in favor of a 
full investigation into the origins of SARS-CoV-2, and I look forward 
to the findings of the experts in the various disciplines relevant to 
this discussion.

    Question 3. What is your awareness of Dr. Baric's collaboration 
with researchers at the Wuhan lab?

    Answer 3. I am aware of collaborations between Dr. Ralph Baric from 
the University of North Carolina and the WIV. Dr. Baric was listed as a 
collaborator on a 2014 grant ``Understanding Risk of Bat Coronavirus 
Emergence'' submitted by EcoHealth Alliance and also was listed as a 
co-investigator on the corresponding 2019 grant renewal application. 
Prior to the renewal, this grant had included subawards to the WIV. 
Based on results published in peer-reviewed papers that include authors 
from Dr. Baric's lab and the WIV, I also am aware that Dr. Baric has 
collaborated with investigators from the WIV on basic coronavirus 
research.

    Question 4. At what point did you realize that more investigation 
is necessary to determine the origins of the virus?

    Answer 4. Since the beginning of the pandemic, I have been 
supportive of a full investigation into the origins of SARS-CoV-2 by 
qualified experts in the relevant fields.

    Question 5. In May, President Biden asked the Intelligence 
Community to review the origins of Covid-19. Biden also asked that this 
effort include work by our National Labs and other agencies of our 
government to augment the Intelligence Community's efforts. Have you 
participated in this review?

    Answer 5. The National Institutes of Health (NIH) is supporting and 
cooperating with the President's call for a U.S. Intelligence Community 
(IC) investigation and would refer you to the IC for additional 
information about their review.
                               NIH Grants
    Question 6. The HHS Office of Inspector General (OIG) is conducting 
a review of NIH grants.

    Question 6(a). Have you provided documentation to the OIG?

    Question 6(b). Have you been interviewed as part of this review?

    Answer 6(a) & (b). I am unable to specifically comment on any 
ongoing oversight engagements; however, I will note that the NIH is 
fully cooperating with the Department of Health and Human Services 
(HHS) Office of Inspector General.
                    COVID-19 Vaccine Clinical Trials
    Question 7. Members of your staff served as co-investigators on the 
COVID-19 Vaccine clinical trials.

    Question 7(a). Have they investigated every report of an adverse 
event by a trial participant?

    Question 7(b). If so, what does that investigation entail?

    Question 7(c). Do they evaluate each participant reporting an 
adverse event?

    Answer 7(a), (b) & (c). Vaccine clinical trials are designed, in 
part, to assess the safety of candidate vaccines, and all reported 
adverse events are investigated by the trial sponsor. The National 
Institute of Allergy and Infectious Diseases (NIAID) was the trial 
sponsor for the Phase 1 clinical trial for the Moderna vaccine 
candidate, and the study recorded all adverse events among the 120 
enrollees, including capturing any symptoms, new medical conditions, 
and laboratory abnormalities. While NIAID is supporting the underlying 
critical infrastructure for other clinical trials for COVID-19 vaccines 
through the COVID-19 Prevention Network (CoVPN), NIAID is not the trial 
sponsor.

    Clinical trial protocols include information surrounding the 
definition and handling of adverse events. NIAID would note that most 
of the trial sponsors for the Phase 3 clinical trials of the COVID-19 
vaccines tested through the CoVPN have made the protocols for these 
trials available online, including for Moderna's COVE trial, Johnson & 
Johnson/Janssen's ENSEMLE trial, and Novavax's PREVENT-19 trial. The 
protocol for Pfizer/BioNTech's Phase 3 clinical trial also is available 
online. NIAID recommends contacting the trial sponsors for further 
information on COVID-19 vaccine clinical trials.

                             Misinformation

    Question 8. Are you involved in the administrations recently 
revealed efforts to flag ``misinformation'' about COVID-19 for removal 
by social media companies?

    Answer 8. No, I am not involved in the described efforts.

    Question 9. Do you consider it misinformation for individuals to 
share their stories of adverse events following vaccination?

    Answer 9. No. I encourage anyone who has experienced an adverse 
event following vaccination to report it to the Centers for Disease 
Control and Prevention and FDA Vaccine Adverse Event Reporting System 
(VAERS), a national early warning system to detect possible safety 
issues in vaccines.

    Question 10. Funds in part from NIH/NIAID helped build the 12 
Regional Biocontainment Laboratories (RBLs) and 2 National 
Biocontainment Laboratories (NBL) to support high consequence 
infectious disease research after 9/11 and the anthrax scares in 2001. 
However, unlike the NBL facilities, the RBL facilities received no 
further direct support until last year when Congress provided enhanced 
investment through NIH/NIAID, targeted specifically to RBL facilities, 
one of which is at the University of Alabama at Birmingham (UAB) in my 
state. Nevertheless, it seems as though the RBL infrastructure, most 
importantly the highly trained staff these facilities maintain and 
produce is something that falls within the purview of the HHS ASPR, 
considering among other things the UAB RBL has had collaborations with 
Altimmune and ImmunityBio for COVID19 vaccine development, and 
supported BARDA contractors. This type of work strongly aligns with 
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and 
Sustaining Robust and Reliable Public Health Security Capabilities. The 
RBL infrastructure and personnel is expensive to maintain and operate, 
and perhaps should not solely rest on either the shoulders of the host 
University or the NIH/NIAID.

    Question 10(a). Therefore, is support from Assistant Secretary for 
Preparedness and Response (ASPR) something under consideration?

    Question 10(b). If not, why not, and if so what is needed to 
facilitate that conversation?

    Answer 10(a) & (b). NIAID defers to the HHS Office of the Assistant 
Secretary for Preparedness and Response to respond to this question.
                                 ______
                                 

 Response by Dr. Janet Woodcock to questions of Senator Burr, Senator 
              Braun, Senator Scott and Senator Tuberville

    Responses to the QFRs are accurate as of the date of the hearing.
                              senator burr
    Question 1. Pfizer and Moderna have both submitted or begun to 
submit applications for full, standard approval of their vaccines. 
Given FDA's extensive knowledge and understanding of the vaccine data, 
are the agency's review timelines going to be faster than a traditional 
application? If not, why not?

    Answer 1. FDA's review of a Biologics License Application (BLA) is 
among the most comprehensive in the world. When a BLA is submitted, the 
Agency evaluates the information supporting safety and effectiveness as 
well as manufacturing data. FDA also inspects the facilities that are 
involved in the manufacturing of the product to ensure that the 
vaccines that are distributed meet rigorous quality standards.

    FDA scientists are working around the clock and reviewing the 
applications, which include hundreds of thousands of pages of data and 
other information, as expeditiously as possible, in a thorough and 
science-based manner.

    Having safe and effective approved COVID-19 vaccines is a top 
priority for HHS and FDA. We firmly believe that those eligible to 
receive a vaccine under the existing EUAs should get their COVID-19 
vaccine now.

    As you know, FDA first issued an EUA for the use of the Pfizer-
BioNTech COVID-19 Vaccine in individuals 16 years of age and older on 
December 11, 2020. Additionally, two other vaccines are currently 
available under EUA for the prevention of COVID-19. On December 18, 
2020, FDA issued an EUA for the use of the Moderna COVID-19 Vaccine, 
and on February 27, 2021, FDA issued an EUA for the use of the Janssen 
COVID-19 Vaccine. The Moderna and Janssen COVID-19 vaccines are 
authorized for use in individuals 18 and older. For additional 
information on COVID vaccines, please visit: https://www.fda.gov/
emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/
covid-19-vaccines.

    Question 2. FDA has made great strides in supporting innovative 
clinical trial designs. How do you plan to continue to advance 
innovative clinical trial designs to expedite the development of novel 
products, using the creativity and flexibilities exercised during the 
pandemic response as a roadmap?

    Answer 2. FDA has a long-standing commitment to supporting 
innovation in clinical development programs to help bring safe and 
effective drugs to patients more efficiently. Although the COVID-19 
pandemic accelerated the use of innovative trial designs, FDA's policy 
development in this area long preceded the current public health 
emergency. FDA recognizes that there are emerging shifts in how 
diseases are diagnosed, prevented, and treated, and in the development 
of therapeutics. FDA is working on multiple fronts to provide guidance 
on innovative approaches to drug development, such as complex, 
innovative trial designs, master protocols, decentralized trials, 
trials utilizing real world data and evidence (RWD/RWE), modelling, and 
simulation. Our engagements with stakeholders have supported innovative 
trial designs as part of the COVID-19 pandemic response. These designs 
improve clinical trial efficiency and may optimize product development.

    FDA continues to promote innovation in clinical trial design and 
conduct, and to encourage the utilization of advanced technologies. The 
agency is already working in many ways to facilitate pharmaceutical 
development and improve the overall clinical trial enterprise. We are 
also leveraging strong national and global partnerships in collectively 
advancing scientific knowledge to ultimately benefit patients. We are 
invested in advancing innovations, such as decentralized clinical 
trials and the use of digital health tools that have the potential of 
making clinical trials more efficient and may allow for wider 
inclusivity of diverse populations. Further, recognizing the value of 
innovative designs, FDA is committed to continuing the Complex 
Innovative Designs Meeting Program, which provides applicants accepted 
into the program with additional meetings with FDA to discuss proposed 
innovative designs.

    Question 3. What has FDA learned from its review of products made 
using platform technologies, such as the mRNA and viral vector-based 
platforms, during the response? How will FDA support the development of 
products for other disease areas that leverage platform technologies?

    Answer 3. FDA recognizes that, when scientifically appropriate, 
certain products have begun sharing manufacturing platform 
technologies, allowing certain information from one product to be 
applicable to future products with similar production strategies. The 
Agency is interested in finding ways to streamline the development and 
review of such innovative technologies. Toward this end, FDA hopes to 
find ways to best leverage knowledge gained from approved products that 
rely on certain platform technologies and associated manufacturing 
methods to be applied to subsequent products that a sponsor may 
develop. As this is a novel area, FDA continues to work to determine 
how to best leverage such platform technologies and looks forward to 
working with Congress in this area.

    Question 4. On July 8th, the FDA and CDC said that Americans who 
have been fully vaccinated do not need boosters at this time. Pfizer 
announced it would file for authorization of a booster with the FDA, 
and the ACIP has stated that they cannot recommend booster shots for 
specific groups of individuals without FDA action. What is the timeline 
for determining whether to authorize a proposed booster, either for 
certain populations or the general public?

    Answer 4. At the time of the hearing, FDA was closely monitoring 
data as it became available from studies administering a booster dose 
of the authorized COVID-19 vaccines to immunocompromised individuals. 
The Agency is collaborating with the Centers for Disease Control and 
Prevention and continues to evaluate all potential solutions to this 
growing question in the medical community. For more information and 
updates, please see: https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-vaccines.

    FDA understands the potential importance of booster vaccine doses 
for control of this pandemic and will promptly review any data 
submitted to the Agency regarding their use in a thorough and science-
based manner. Due to legal and regulatory restrictions, FDA generally 
cannot discuss product submissions that may be under review, including 
the timing of any potential FDA action to authorize or approve the use 
of additional doses of COVID-19 vaccines. Please contact the vaccine 
manufacturers directly regarding their plans to submit data for their 
individual vaccines and the timing of such submissions.
                             senator braun
    Question 1. FDA has authorized large numbers of COVID tests and 
other products using emergency use authorizations. Without further 
action from FDA, when the public health emergency comes to an end these 
products will no longer be available for use.

    Question 1(a). How does the FDA plan to transition products to full 
approval or clearance? What will happen if the public health emergency 
ends, and critical products have not received approval or clearance 
from FDA?

    Answer 1 & 1(a). On February 4, 2020, the Secretary of the 
Department of Health and Human Services (HHS) determined, pursuant to 
section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, \1\ that 
there is a public health emergency that has a significant potential to 
affect national security or the health and security of United States 
citizens living abroad, and that involves the virus that causes COVID-
19. Pursuant to Section 564 of the FD&C Act, and on the basis of such 
determination, the Secretary of HHS then declared that circumstances 
exist justifying the authorization of emergency use of in vitro 
diagnostics for the detection and/or diagnosis of COVID-19 (February 4, 
2020), personal respiratory protective devices (March 2, 2020), other 
medical devices (March 24, 2020) for use during the COVID-19 outbreak, 
and drugs and biological products during the COVID-19 pandemic (March 
27, 2020). (Please note that a determination under section 319 of the 
Public Health Service Act that a public health emergency exists, such 
as the one issued on January 31, 2020, and subsequently renewed, is 
insufficient to enable FDA to issue EUAs.)
---------------------------------------------------------------------------
    \1\  https://www.fda.gov/regulatory-information/laws-enforced-fda/
Federal-food-drug-and-cosmetic-act-fdc-act.

    The declarations under section 564 have enabled FDA to authorize 
unapproved products and unapproved uses of approved or cleared products 
when, based on the totality of the scientific evidence available, it is 
reasonable to believe that the product may be effective in diagnosing, 
treating, or preventing the disease or condition and the known and 
potential benefits of the product's use outweigh the known and 
potential risks, taking into consideration the material threat posed by 
an emergency situation. Irrespective of the status of the public health 
emergency declaration under section 319 of the Public Health Service 
Act, FDA is empowered to authorize such uses until the Secretary 
terminates the declaration of emergency or threat justifying emergency 
use under section 564(b), the criteria for EUA issuance are no longer 
met, or revocation is otherwise appropriate to protect the public 
health. It may be the case that once the public health emergency 
declaration under section 319 of the Public Health Service Act expires, 
the benefit-risk justification for issuance of any particular EUA are 
no longer met or revoking such use is otherwise appropriate. In some 
instances, manufacturers of certain devices, especially nonconventional 
manufacturers, may no longer wish to market or distribute these 
products. In other instances, manufacturers may desire to transition to 
full approval or clearance and the statute directs FDA to communicate 
---------------------------------------------------------------------------
with manufacturers regarding such transition.

    The Agency is required to periodically review the authorizations 
made under section 564 of the FD&C Act. As part of that review, FDA 
reviews the progress made toward approval, licensure, or clearance of 
the products authorized. See section 564(g) of the FD&C Act and FDA's 
guidance on Emergency Use of Medical Products and Related Authorities. 
\2\ As outlined in FDA's guidance, Emergency Use Authorization for 
Vaccines to Prevent COVID-19, it is FDA's expectation that, following 
submission of an EUA request and issuance of an EUA, a sponsor would 
continue to collect placebo-controlled data in any ongoing trials for 
as long as feasible and would also work toward submission of a 
Biologics License Application (BLA) as soon as possible. FDA's 
recommendations regarding the safety and effectiveness data and 
information are essential to ensure that clinical development of a 
COVID-19 vaccine has progressed far enough that issuance of an EUA for 
the vaccine would not interfere with the ability of an ongoing Phase 3 
trial to demonstrate effectiveness of the vaccine to support licensure 
and to continue safety assessments, including investigating the 
potential for vaccine-associated enhanced respiratory disease (ERD). 
The ability of a sponsor to accrue this information about a COVID-19 
vaccine is critical to ongoing assessment of its benefits and risks.
---------------------------------------------------------------------------
    \2\  https://www.fda.gov/media/97321/download.

    FDA is working on a transition plan for devices that have been 
authorized under EUAs \3\ or that fall within enforcement policies \4\ 
issued during the COVID-19 public health emergency. FDA's intention is 
to issue guidance in draft form and request public comment before 
finalization and implementation. Transition plan draft guidance is on 
CDRH's Fiscal Year 2021 ``A List,'' \5\ meaning that this is a 
prioritized policy that FDA seeks to publish in a timely fashion. FDA 
recognizes that it will take time for device manufacturers, healthcare 
facilities, healthcare providers, patients, consumers, and FDA to adapt 
and adjust from policies adopted and operations implemented during the 
public health emergency to normal operations. One of the goals of 
developing guidance on this topic is to have an orderly transition 
process and to provide transparency around FDA's approach to that 
transition. In addition, FDA is engaging in discussions with individual 
companies that are interested in obtaining marketing clearance or 
approval for their devices, and we encourage companies to initiate 
those discussions. Note that this proactive engagement is an integral 
part of FDA's transition plan. As we shift more resources toward 
working with sponsors pursuing full marketing status and as more 
devices achieve this status, there will be a smoother transition away 
from reliance on products authorized for emergency use or that fall 
within enforcement policies issued during the COVID-19 public health 
emergency.
---------------------------------------------------------------------------
    \3\  https://www.fda.gov/medical-devices/emergency-use-
authorizations-medical-devices/coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-devices.
    \4\  https://www.fda.gov/medical-devices/emergency-situations-
medical-devices/coronavirus-covid19-and-medical-devices#guidance.
    \5\  https://www.fda.gov/medical-devices/guidance-documents-
medical-devices-and-radiation-emitting-products/cdrh-proposed-
guidances-fiscal-year-2021-fy-2021.
---------------------------------------------------------------------------
                             senator scott
    Question 1. Dr. Woodcock, the COVID-19 pandemic has had a 
disproportionate and devastating impact on communities of color. 
Drivers of this disparate impact correlate directly to social 
determinants of health, such as health and financial literacy, 
transportation, housing conditions, employment, safety, and education. 
I have expressed concerns at a number of hearings on the prevalence of 
vaccine hesitancy among Black Americans, with a 2020 survey suggesting 
that only 25 percent of Black adults planned to get vaccinated in the 
event of a COVID-19 vaccine approval. The pandemic has exposed several 
disparities that exist within the U.S. healthcare system. One such area 
is the under-representation of communities of color in clinical trials. 
Improving the diversity of participants in clinical trials continues to 
be a challenge due to a number of obstacles, including a lack of racial 
diversity in clinical trial investigators, community mistrust and 
skepticism due to historic abuses of racial minorities used as test 
subjects, as well as a lack of convenient and affordable transportation 
to clinical trial sites. To improve health outcomes for those most at 
risk, we must diversify our pool of participants. Our goal should be to 
include participants from diverse ethnic backgrounds and income levels. 
It is also imperative investigators make devices and software available 
to participants in addition to allowing enrollees to participate from 
diverse settings such as their home, local clinics, and, potentially, 
skilled nursing facilities.

    Question 1(a). Dr. Woodcock--You have praised the success of the 
innovations made within clinical trial designs. What is your vision to 
expand access to clinical trials and how do we get there?

    Answer 1 & 1(a). Modernizing clinical trials is a priority for FDA 
and the subject of significant policy work in which we are currently 
engaged. We view modernizing clinical trial designs and conduct and 
utilizing innovative technologies as an essential area to improve 
efficiencies and to facilitate the development of drugs, biological 
products, and devices.

    Prior to the pandemic, the Agency was working on these areas, and 
the current public health emergency further catalyzed these efforts. 
There is a wide range of designs, tools, and methods that can be 
utilized in this area. For example, decentralized clinical trials, 
hybrid trials, trials embedded in healthcare settings, trials that 
allow for seamless transition between phases, the use of digital health 
technologies, and supporting efficient, risk-based, approaches to trial 
conduct are all areas that FDA is currently working on or is planning 
on addressing. We have recently announced that the Agency will be 
issuing a draft guidance on the use of digital health technologies in 
clinical investigations and another draft guidance on decentralized 
clinical trial designs.

    Question 1(i). What was done during the pandemic to ensure COVID-19 
treatment and vaccine trials were clinically diverse?

    Answer 1(i). FDA published guidance \6\ to encourage diversity in 
clinical trials and make recommendations on how to help increase 
diversity in trials.
---------------------------------------------------------------------------
    \6\  https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/enhancing-diversityclinical-trial-populations-
eligibility-criteria-enrollment-practices-and-trial.

    Sponsors who have requested an Emergency Use Authorization have 
provided numbers, including enrollment numbers about the diverse 
populations, in the package submitted to FDA for consideration for 
potential Emergency Use Authorization (EUA). We continue to strongly 
encourage the companies to improve their enrollment diversity and we 
provide recommendations on how to do so by leveraging messaging in 
local communities, site selection, and other strategies to raise the 
---------------------------------------------------------------------------
proportion of minorities being enrolled.

    With regard to COVID-19 vaccines, in the June 2020 guidance, 
Development and Licensure of Vaccines to Prevent COVID-19, the Agency 
encourages the inclusion of diverse populations, including those most 
affected by COVID-19, in all phases of vaccine clinical development.

    For the three vaccines that FDA has authorized for emergency use, 
all clinical trials included members of racial or ethnic groups at 
greater risk from COVID-19.

    FDA, vaccine manufacturers, and other scientists are currently 
working to try to understand how long the authorized vaccines will 
provide protection for the prevention of COVID-19. Many studies are 
well underway to evaluate how long protection from a COVID-19 vaccine 
lasts and whether there is any variability based on age, race or 
ethnicity, or comorbidities that disproportionately impact underserved 
communities. These studies are currently being conducted by government 
agencies, academia, and industry partners. Specifically, these studies 
are longitudinal patient follow-up studies, which usually entail 
measuring antibody titers in a cohort of individuals before and at 
multiple times after vaccination, and identifying an association 
between antibody responses below a certain antibody level threshold and 
vaccine failure/infection. These studies may be designed to demonstrate 
differences in various groups based on age, race and ethnicity, or 
comorbidities.

    Question 1. If successful, how can we implement these changes post-
pandemic?

    Answer 1. Advancing innovative and inclusive clinical trials is a 
key part of FDA's ongoing efforts that started prior to the pandemic 
and will continue post-pandemic. FDA will continue to encourage the 
inclusion of diverse populations in clinical trials and is committed to 
continue to work on ensuring that best practices for enhancing 
diversity in COVID-19 treatment and vaccine trials are sustained beyond 
the pandemic. Because clinical trials provide a crucial base of 
evidence for evaluating whether a medical product is safe and 
effective, enrollment in clinical trials should reflect the diversity 
of the population that will ultimately use the product. The opportunity 
to participate in clinical research should be available to all eligible 
patients who are impacted by the disease.

    In November 2020, FDA issued a final guidance for industry titled, 
Enhancing the Diversity of Clinical Trial Populations; Eligibility 
Criteria, Enrollment Practices, and Trial Designs. \7\ This guidance 
recommends approaches that sponsors of clinical trials to support a new 
drug application or a biologics license application can take to broaden 
eligibility criteria, when scientifically and clinically appropriate, 
and to increase enrollment of underrepresented populations in their 
clinical trials. FDA has also published several additional guidances 
supporting clinical trial diversity, including, Collection of Race and 
Ethnicities in Clinical Trials (2016); Pregnant Women: Scientific and 
Ethical Considerations for Inclusion in Clinical Trials (2018); 
Clinical Lactation Studies: Considerations for Study Design (2019); 
Postapproval Pregnancy Safety Studies (2019); and Older Participants-
ICH E7.
---------------------------------------------------------------------------
    \7\  https://www.fda.gov/media/127712/download.

    FDA remains committed to increasing the participation of racial and 
ethnic minorities and other underrepresented populations in clinical 
trials that test new medical products for all diseases and conditions 
through issuing guidance, developing tools, and encouraging the use of 
innovative trial designs. In addition, FDA is working on policies 
pertaining to the use of decentralized trial designs and digital health 
technologies. Decentralized clinical trials have the potential to 
increase diversity of research participants by incorporating, 
telemedicine and mobile/digital technologies to increase access to 
under-represented populations and/or communities--rural or remote--that 
---------------------------------------------------------------------------
may not have access to major medical and research centers.

    Moving forward, FDA will apply lessons learned from COVID-19 to 
help support the participation of people in racial, ethnic, and other 
minority groups in the clinical trials that test new medical products 
through hosting public meetings, developing tools, and issuing guidance 
documents.

    Question 1(ii). What are some of the benefits to providing 
technology to clinical trial participants? For example, mobile glucose 
monitors or tablets and phones equipped with software to transmit 
information back to clinical trial investigators.

    Answer 1(ii). Digital health technologies are among the most 
promising tools we have for advancing clinical trial innovation and 
promoting diversity and inclusion. Including digital health 
technologies in clinical trials may make trial participation less 
burdensome for participants and expand access to trials by enabling 
remote data collection and monitoring from the participant's home 
instead of traveling to a clinical site. Additionally, providing 
digital health technologies to participants may enhance a participant's 
experience in a clinical trial by promoting engagement and more 
seamless information sharing between trial participants and clinical 
investigators. Some of these digital health technologies allow 
continuous collection of data from trial participants, which could 
allow round-the-clock monitoring of drug effects. This may improve our 
ability to understand the safety and efficacy of new drugs in ways that 
were not previously possible.

    When digital health technologies are included in clinical trials, 
however, FDA recognizes the crucial importance of maintaining both the 
safety of trial participants and clinical trial integrity. To promote 
both, the Agency promptly provided guidance during the COVID-19 
pandemic titled Conduct of Clinical Trials of Medical Products during 
COVID-19 Pandemic \8\ that included recommendations regarding the 
remote collection of data in clinical trials.
---------------------------------------------------------------------------
    \8\  http://wcms-internet.fda.gov/media/136238/download.

    In this guidance, FDA explains that sponsors planning to use remote 
electronic assessments as part of a clinical investigation should use 
appropriate technology and develop procedures for provision of 
technology and technical support to trial participants, investigators, 
and/or other trial personnel to facilitate those assessments. For 
example, sponsors could develop a plan to accommodate trial 
participants who are either already enrolled in a trial or may be 
enrolled in a trial in the future, but who do not have access to 
appropriate communication technology (e.g., cell phones or Internet), 
---------------------------------------------------------------------------
by providing trial participants with these services.

    FDA encourages the use of digital health technologies in clinical 
trials that are beneficial to study participants. The Agency issued 
final guidance in November 2020, entitled Enhancing the Diversity of 
Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, 
and Trial Designs Guidance for Industry. \9\ This guidance encourages 
sponsors to think about reducing visit frequency, when appropriate, in 
addition to considering whether flexibility in visit windows is 
possible and whether electronic communications, such as phone, email, 
social media platforms, or other digital health technology tools, can 
replace site visits and provide investigators with real-time data.
---------------------------------------------------------------------------
    \9\  https://www.fda.gov/media/127712/download.

    In the above-referenced guidances, FDA provides a few examples of 
potential approaches, and encourages the development of other 
approaches that can make trial participation less burdensome for 
---------------------------------------------------------------------------
participants and foster retention and inclusiveness.

    Question 1. What statutes need to be changed to allow for this 
exchange?

    Answer 1. At this time, FDA has not identified statutory changes 
that are necessary to facilitate the use of digital health technologies 
in clinical trials. The Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act provide sufficient flexibility to enable use 
of a broad spectrum of technologies when appropriate to a particular 
development program. Sponsors are already utilizing digital health 
technologies in clinical development programs, and FDA is working with 
sponsors to help facilitate such use consistent with applicable 
regulatory requirements.

    Question 2. The role of the Food and Drug Administration (FDA) in 
combatting the COVID-19 pandemic has been critical, and I'd like to 
thank you for the agency's vital work to support the successful 
delivery of three vaccines to the American people. You have testified 
in the past before this Committee that no corners were cut in FDA's 
evaluation of COVID-19 vaccines in authorizing them under Emergency Use 
Authorization (EUA), meaning that the FDA's gold standard review for 
evaluating the safety and efficacy of COVID-19 vaccines was met or 
surpassed for the vaccines authorized in the United States. Looking to 
future pandemic preparedness efforts and other biological threats, 
whether naturally occurring, deliberate, or accidental, I would like to 
better understand the EUA process--not just for vaccines, but also for 
vaccine manufacturing. Vaccine manufacturers moved at unprecedented 
speed to develop a product and its manufacturing process while 
simultaneously scaling-up manufacturing capacity--all at a record-
breaking pace. These efforts took place in the middle of a pandemic in 
an environment with serious supply chain constraints. While not 
unexpected given the circumstances, our understanding is that there 
have been a number of challenges with COVID vaccine and therapeutic 
manufacturers--with media reports focused on a range of companies, 
including some of the largest pharmaceutical companies in the world 
(Merck, Lilly) and some smaller contract manufacturers (Emergent, Texas 
A&M/Fujifilm DioSynth, Catalent). So, I think explaining the EUA 
standard for the authorization of the product and the manufacturing 
process will serve to assure the American public and the world that any 
product authorized during a public health emergency by the FDA is 
appropriate--both for the current pandemic and in preparation for the 
next.

    Question 2(a). Dr. Woodcock--Can you please briefly explain the 
standards for granting an EUA for a vaccine candidate?

    Answer 2 & 2(a). FDA may issue an EUA after FDA has determined that 
the product that is the subject of an EUA request meets the statutory 
requirements under section 564 of the FD&C Act. In determining whether 
to issue an EUA for a vaccine, FDA evaluates the available evidence to 
determine, among other things, whether it is reasonable to believe that 
the vaccine may be effective in preventing COVID-19 and whether the 
known and potential benefits of the vaccine, when used to prevent 
COVID-19, outweigh any known and potential risks of the vaccine. Once a 
manufacturer submits an EUA request for a COVID-19 vaccine, FDA 
evaluates the request and determines whether the relevant statutory 
criteria are met, taking into account the totality of the scientific 
evidence about the vaccine that is available to the Agency. The FDA 
guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19 
\10\ provides more information about FDA's current recommendations 
regarding the data and information needed to support the issuance of an 
EUA under section 564 of the FD&C Act for an investigational vaccine to 
prevent COVID-19, including chemistry, manufacturing, and controls 
information; nonclinical data and information; and clinical data and 
information, as well as administrative and regulatory information. \11\
---------------------------------------------------------------------------
    \10\  https://www.fda.gov/media/142749/download.
    \11\  https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-frequently-asked-
questions#biologics.

    Question 2(i). Can you please explain the standards for authorizing 
a bulk drug substance manufacturing facility as part of a product EUA 
---------------------------------------------------------------------------
in a public health emergency?

    Answer 2(i). As stated in FDA's Guidance for Industry, Emergency 
Use Authorization for Vaccines to Prevent COVID-19, FDA assesses 
current good manufacturing practice (CGMP) compliance for each 
manufacturing site using all available tools and information. FDA 
expects manufacturers to submit sufficient data to ensure the quality 
and consistency of their product, and FDA evaluates the chemistry, 
manufacturing, and controls and facility information for the product. 
FDA uses all available tools and information, including reviews, site 
visits, inspections, EUA investigations, and previous compliance 
history, and has utilized the authority under section 704(a)(4) of the 
FD&C Act to request records and other information from foreign and 
domestic establishments to assess compliance with CGMP requirements of 
facilities that are intended to manufacture vaccines to prevent COVID-
19 under an EUA. FDA has also used establishment inspection information 
from capable foreign regulatory authorities under the Pharmaceutical 
Annex to the U.S. and European Union Mutual Recognition Agreement 
(MRA), and the Pharmaceutical Annex to the U.S. and United Kingdom MRA, 
as well as other confidentiality agreements and commitments.

    FDA takes its responsibility for helping to ensure the quality of 
manufacturing of vaccines and other medical products for use during 
this pandemic very seriously. As outlined above, the Agency is using a 
variety of tools to help ensure that products being produced in 
different facilities meet the high-quality standards that Americans 
have come to expect. It is important to note that even when companies 
use contract manufacturing organizations, it is ultimately the 
responsibility of the company that holds the EUA to ensure that the 
required quality standards are met. No product can be distributed by 
manufacturers until FDA authorizes its distribution from the facility 
that is manufacturing it. FDA will continue to work with companies to 
ensure that the quality standards it expects for products distributed 
under an EUA are met, and will continue to work diligently to help 
bring needed medical products in a timely manner to Americans during 
this public health emergency.

    Question 2(ii). Can you please explain the standards for 
authorizing a fill/finish manufacturing facility as part of a product 
EUA in a public health emergency?

    Answer 2(ii). Please see the response to ``i'' above.

    Question 3. Current data suggests high efficacy rates among the 
vaccines for which Emergency Use Authorization was approved, good news 
for the 85.7 percent of South Carolinian seniors who have received at 
least one dose and the 77 percent of whom are fully vaccinated. 
However, as the Delta variant remains extremely contagious and the 
World Health Organization labeling the Lambda version a ``variant of 
interest,'' the U.S. cannot remain idle as we work to return students 
back into the classroom and more adults come back to work. Recently, 
Pfizer announced it planned to submit COVID-19 booster shot data to the 
FDA by mid-August 2021. American seniors, their families and 
caregivers, and stakeholders remain interested in knowing what the 
Federal Government plans to do regarding the possible authorization and 
distribution of booster vaccines. This information is especially timely 
since the first Americans, including South Carolinian long-term 
facilities residents, received their initial vaccines in December 2020.

    Question 3(a). Dr. Woodcock--What collaborations are occurring 
between the Federal Government, vaccine developers, the states, long-
term care facilities, the senior community, and other interested 
stakeholders regarding information about booster vaccines? When will 
this information be made public?

    Answer 3 & 3(a). The COVID-19 vaccines authorized in the United 
States continue to be remarkably effective in reducing risk of severe 
disease, hospitalization, and death, even against the widely 
circulating Delta variant. Recognizing that many vaccines are 
associated with a reduction in protection over time, and acknowledging 
that additional vaccine doses could be needed to provide long lasting 
protection, we have been analyzing the scientific data closely from the 
United States and around the world to understand how long this 
protection will last and how we might maximize it.

    FDA understands the potential importance of booster vaccine doses 
for control of this pandemic and will promptly review any data 
submitted to the Agency regarding their use in a thorough and science-
based manner. Due to legal and regulatory restrictions, FDA cannot 
discuss product submissions that may be under review, including the 
timing of any potential FDA action to authorize the use of booster 
doses of COVID-19 vaccines. Please contact the vaccine manufacturers 
directly regarding their plans to submit data for their individual 
vaccines and the timing of such submissions.
                           senator tuberville
    Question 1. Funds in part from NIH/NIAID helped build the 12 
Regional Biocontainment Laboratories (RBLs) and 2 National 
Biocontainment Laboratories (NBL) to support high consequence 
infectious disease research after 9/11 and the anthrax scares in 2001. 
However, unlike the NBL facilities, the RBL facilities received no 
further direct support until last year when Congress provided enhanced 
investment through NIH/NIAID, targeted specifically to RBL facilities, 
one of which is at the University of Alabama at Birmingham (UAB) in my 
state. Nevertheless, it seems as though the RBL infrastructure, most 
importantly the highly trained staff these facilities maintain and 
produce is something that falls within the purview of the HHS ASPR, 
considering among other things the UAB RBL has had collaborations with 
Altimmune and ImmunityBio for COVID19 vaccine development, and 
supported BARDA contractors. This type of work strongly aligns with 
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and 
Sustaining Robust and Reliable Public Health Security Capabilities. The 
RBL infrastructure and personnel is expensive to maintain and operate, 
and perhaps should not solely rest on either the shoulders of the host 
University or the NIH/NIAID.

    Question 1(a). Therefore, is support from Assistant Secretary for 
Preparedness and Response (ASPR) something under consideration?

    Question 1(b). If not, why not, and if so what is needed to 
facilitate that conversation?

    Answer 1(a) & (b). FDA defers to ASPR to respond to these 
questions.
                                 ______
                                 

  Response by Dawn O'Connell to questions of Senator Baldwin, Senator 
              Burr, Senator Braun, and Senator Tuberville

    Responses to the QFRs are accurate as of the date of the hearing.

                            senator baldwin
    Question 1. I was encouraged to hear Assistant Secretary 
O'Connell's announcement that $2 billion of the $10 billion that I 
secured in the American Rescue Plan for domestic manufacturing and 
utilization of the DPA would be used to support vaccine industrial base 
expansion for raw materials, consumables, fill/finish capacity, 
needles, vials, and syringes. Please provide additional details on the 
recipients of this funding, as well as any information that can be 
shared regarding future obligations.

    Answer 1. With $10 billion received for industrial base expansion, 
ASPR has been establishing and maintaining domestic capacity for 
vaccine production and administration, in addition to a number of other 
efforts for PPE and pharmaceutical manufacturing. Specifically, ASPR is 
executing an acquisition strategy to expand the capacities and surge 
capabilities for high-speed, reliable sterile filling/packaging 
operations, domestic conversion of bulk biological drug substance into 
drug product for distribution, and investments in manufacturing 
capacities to better avail raw materials and consumables that are 
commonly used across the commercial sterile biologic products industry 
for production, delivery and administration (e.g., nucleoside 
triphosphates (NTPs), enzymes, resins, lipids, and needle and syringe 
sets).

    Question 2. How is the Administration utilizing this funding to 
ensure that American companies that shifted and significantly expanded 
production of raw materials to aid in our pandemic response receive 
support? How is the Administration working to build on our pandemic 
response to develop a public health industrial base with the capacity 
to respond to crises and make us less reliant on China?

    Answer 2. ASPR is leveraging the authorities delegated to the 
Secretary under the Defense Production Act (DPA) to ensure that private 
sector partners making life-saving products are able to acquire raw 
materials, retool their machinery, scale their production facilities, 
train their workforces, and ultimately deliver their product. 
Throughout the COVID-19 response, ASPR has used the DPA authority to 
issue 46 priority ratings for U.S. Government (USG) contracts for 
health resources, 8 priority ratings for USG contracts for industrial 
expansion, and 3 priority ratings of specific purchase orders for 
companies manufacturing critical lifesaving health resources that have 
been impacted by COVID-19 response demands. ASPR is also continuing to 
build capacity and partnerships with private industry toward the shared 
goal of ending the COVID-19 pandemic. ASPR is also working to support 
efforts in expanding the domestic industrial base. These industrial 
base expansion (IBx) efforts seek to reduce supply chain 
vulnerabilities and generate a domestic ``warm-base'' for manufacturing 
that can be leveraged in a crisis.

    Supporting domestic vaccine development and manufacturing efforts, 
BARDA has invested $1.256B in the advanced research and development of 
Moderna's mRNA-1273 vaccine candidate, supporting clinical trials and 
manufacturing scale up and validation. The investments in a mRNA 
vaccine will support new vaccine production platforms in the future 
that will improve the efficiency and reduce the timeline to develop 
vaccines for other biodefense threats and emerging infectious diseases. 
Platform technologies, such as the mRNA approach, can provide flexible 
and rapid response and have many advantages with potential to 
revolutionize the way vaccines and therapeutics are produced for known 
and newly emerging threats.

    Question 3. Will the Administration commit to using some of this 
funding for the raw materials, including medical-grade meltblown, 
needed to produce N95 and N99 masks so that we are not dependent on 
countries like China for this material?

    Answer 3. ASPR has invested over $20.5 million in several companies 
to increase and sustain melt-blown fiber production in the U.S., 
producing enough raw material to manufacture the equivalent of 
approximately 171 million N95 or 400 million surgical masks a month. In 
addition, utilizing the $10 billion received via the American Rescue 
Plan Act to support industrial base expansion, ASPR has been working to 
establish and maintain domestic capacities for N95 manufacturing.
                              senator burr
    Question 1. As we saw during the early stages of the COVID-19 
response, quickly identifying and containing the spread of a new 
pathogen is a significant challenge. In preparing for the next public 
health threat, how is HHS taking into account additional capacity for 
testing in health care facilities as a result of health systems' 
investments in high throughput instruments during the COVID-19 
response?

    Answer 1. HHS monitors the testing supply chain through 
collaboration with diagnostic manufacturers. Ten of the major 
manufacturers send shipment data, install base data, and supply 
projections on a regular basis. HHS integrates this data into HHS 
Protect, a platform that overlays epidemiological data, hospital 
clinical data, COVID-19 testing data, and other public health metrics. 
Of the three main data reports, the install base data gives HHS 
visibility into the locations and quantity and utilization of all the 
high-throughput machines for a specific company. This information 
allows HHS to monitor how additional capacity for testing has increased 
since the beginning of the pandemic.

    Question 2. T-cell testing adds a critical dimension to how we 
measure immune response. How can these tests be used to inform both 
individual clinical decisions and a population-based, public health 
response, and what steps is HHS taking to include T-cell testing in 
planning for future public health threats?

    Answer 2. T cells are an important component of the immune response 
to viruses, including SARS-CoV-2, the virus that causes COVID-19. 
Existing T cell testing technologies available for widespread use can 
be used to aid in identifying individuals with an adaptive T cell 
immune response to a virus, indicating recent or prior infection. For 
example, the T-Detect COVID Test, which was developed by Adaptive 
Biotechnologies and received an emergency use authorization (EUA) from 
the FDA, can help determine if a person previously had COVID-19. This 
test may be useful for people who have exhibited symptoms previously 
but have not tested positive for COVID-19 using a molecular or antigen 
diagnostic test. At this time, the test has only been authorized to 
detect prior infection by SARS-CoV-2, and cannot be used to indicate 
the degree of protection induced by COVID-19 vaccination or infection.

    It is important to note that antibody or serum-based commercial 
assays are readily available to the public and are easier and less 
expensive to perform than T cell assays. Antibody or serum-based tests 
also are generally sufficient to indicate current or previous 
infection/vaccination. Techniques to examine T cells are labor 
intensive, relatively expensive, and require specialized equipment and 
sample collection. Laboratories that perform the T-Detect test for 
commercial purposes also must be specifically designated by the company 
and have obtained specialized certification. For these reasons, 
monitoring of T cell responses to COVID-19--or other infectious disease 
threats--is only possible on a small scale at this time. Nonetheless, 
scientific studies of T cells can provide important insights into 
COVID-19 progression, protection against SARS-CoV-2 variants, and 
durability of immunity. HHS, through the National Institute of Allergy 
and Infectious Diseases (NIAID), is supporting research to improve 
understanding of the role of T cells in protecting against COVID-19 as 
well as in COVID-19 progression. These efforts may lead to improved T 
cell tests and help support the public health response to COVID-19.

    NIAID also conducts and supports basic and clinical immune 
research, including on T cell responses, to improve understanding of 
SARS-CoV-2. NIAID supported a collaborative longitudinal study by 
researchers at Emory University and the Fred Hutchinson Cancer Research 
Center that demonstrated that T cells were detectable for up to 8 
months in patients after mild to moderate COVID-19. NIAID also 
supported two separate studies--one led by researchers from NIAID and 
Johns Hopkins Hospital and another by scientists from the La Jolla 
Institute--that examined the T cell responses in recovered COVID-19 
patients and individuals vaccinated against COVID-19 and found robust 
immune responses to the original strain--as well as multiple variants--
of SARS-CoV-2 in both groups. In another NIH-supported study, 
researchers uncovered features of T cells that distinguish fatal from 
non-fatal cases of severe COVID-19, which could lead to new treatments 
for this disease.

    NIAID also is funding a number of basic research studies that will 
inform how T-cell based approaches could be incorporated into future 
countermeasures. This includes assays that measure the magnitude of T 
cell responses in individuals who receive the currently authorized 
COVID-19 vaccines. Understanding how T cells respond to SARS-CoV-2 
infection and vaccination may help improve protection afforded by 
future vaccines. Additional monitoring of T cell responses to SARS-CoV-
2 may also improve our understanding of the extent and longevity of 
immunological protection against SARS-CoV-2.

    Question 3. Health systems have experienced a spike in cyber-
attacks during the pandemic. For example, Universal Health Services, 
Inc. experienced a cybersecurity attack in September 2020, which forced 
hospital systems offline for weeks. Pursuant to the 2020 National 
Defense Authorization Act Section 9002, the ASPR was designated as the 
sector risk management agency for the health care and public health 
sector.

    Question 3(a). What work does ASPR perform as the sector risk 
management agency? Of this work, what proportion is specific to 
cybersecurity?

    Answer 3 & 3(a). This past year has been full of challenges, and 
HHS has found ourselves responding to increased quantities and new 
types of cyber-attacks against the Healthcare and Public Health Sector. 
In ASPR, the Division of Critical Infrastructure Protection (CIP) 
serves as the hub for HHS as the sector-specific agency. Based on 
authorities included in the 2021 National Defense Authorization Act 
(NDAA), CIP is now the focal point for HHS as the sector risk 
management agency. The goal of sector risk management agencies is to 
look at the entire sector--in this case, health care and public 
health--for all hazards. CIP works closely with government and private 
sector partners through the structure of the Critical Infrastructure 
Partnership Advisory Council to identify and address risks across the 
sector--working with hospitals, pharmacies, manufacturers, 
distributors, health IT providers, insurance plans, and mass fatality 
managers. Over the past 5 years, CIP has been focused on four main 
areas of risks management:

        1. Identifying risks at facilities across the sector in an 
        objective data driven manner through our Risk Identification 
        and Site Criticality Tool (RISC), currently in development of 
        an enhanced, web-based version. The RISC tool identifies cyber 
        risks alongside natural hazard and other manmade risks, unlike 
        many other tools used in the sector, thus promoting 
        conversation between IT security staff and emergency managers. 
        The tool was released 2 years ago and has been downloaded in 
        all 50 states and utilized by at least 1,400 individuals.

        2. Monitoring supply chain challenges in the health sector, 
        including dependence on foreign sourcing and challenges of 
        just-in-time-distribution;

        3. Overall mitigation of risks before, during, and after 
        disasters--with a focus on planning for and communicating 
        during responses, including Hurricane Maria and the WannaCry 
        and Petya/notPetya cyber incidents of 2017, wildfires, 
        hurricanes, and the COVID-19 pandemic; and

        4. Coordinating with the White House, DHS, and the FBI to 
        enhance HHS' ability to identify and share cyber hygiene best 
        practices; promote sharing of cyber incident information; 
        engage in discussion and coordination with the private sector 
        on priority education, policy, and communications activities; 
        and exercise existing and new cyber plans among government and 
        private sector partners.

    As cybersecurity is such a threat to the Healthcare and Public 
Health Sector, CIP makes sure to incorporate that risk into a majority 
of projects to both raise awareness and encourage all those involved in 
the partnership to recognize their potential role in preventing or 
responding to cyber incidents.

    Question 3(b). How has ASPR been executing its cybersecurity 
responsibilities as part of this role and/or how does ASPR plan to 
execute these responsibilities? If the latter, what is ASPR's timeline 
for putting into place this plan?

    Answer 3(b). ASPR led the development of a ``strategy for public 
health preparedness and response to address cybersecurity threats'' 
that was required by section 703(a)(1) of the Pandemic and All-Hazards 
Preparedness and Advancing Innovation Act of 2019. This strategy was 
delivered to the HELP Committee on August 2, 2021 by Secretary Becerra. 
This strategy identifies duties, functions, preparedness and response 
goals for which HHS is responsible for the Healthcare and Public Health 
(HPH) Sector. It also includes strategies to address identified gaps 
and strengthen public health emergency preparedness and response 
capabilities.

    ASPR will direct and monitor implementation of this strategy 
through the CIP Division, relying on expertise and activity from many 
HHS Operating and Staff Divisions, including the FDA for medical 
devices, OCR for privacy and security, ONC for health IT, and OCIO for 
the HC3 and 405d programs. ASPR also manages the Critical 
Infrastructure Partnership Advisory Council Joint Cybersecurity Working 
Group, with hundreds of members. The group bases its work on the 
recommendations of the 2018 Healthcare Industry Cybersecurity Task 
Force and is currently developing CY2022 joint priorities.

    ASPR CIP has led the development of the HPH sector Incident 
Response plan, which will be appended as an annex to the all hazard 
plan. The plan describes the full spectrum of the USG response to HPH 
cyber incidents, including coordination of tactical activities among 
HHS, FBI and CISA; development of an assessment of the effect of cyber 
incidents on delivery of care, on supply chains, and on system 
integrity; engagement of ESF-8 as necessary; and development of post-
incident reporting and of after-action plans.

    Question 3(c). How many FTEs and resources are dedicated to 
cybersecurity at ASPR?

    Answer 3(c). For the management of the Sector Risk management 
Agencies (SRMA) role for external HPH Sector Cybersecurity (which 
excludes internal HHS/ASPR IT security), ASPR has one dedicated staff 
member supporting cybersecurity preparedness across the health care and 
public health (HPH) sector, partial time of a second staffer and two 
contractor positions currently waiting to be filled. In addition, ASPR 
staff greatly leverage external resources of HHS, DHS, and the private 
sector to ensure comprehensive risk management for the HPH Sector. 
Specific activities include:

          Co-chairing the Joint Cybersecurity Working Group 
        comprised of 15 subject-specific Task Groups and over 300 
        organizations represented;

          Leading efforts of Federal, state, local, tribal and 
        territorial entities to develop and disseminate Sector-wide 
        recommendations and guidance to prepare and better secure the 
        sector from Cyber threats, to identify risks from cyber 
        threats, lead response efforts to HPH-wide cyber events, and 
        promote mitigation and resiliency strategies;

          Collaborating with private sector and Federal, state, 
        local, territorial, and tribal partners to establish and lead 
        work groups to address recommendations made by the Healthcare 
        Industry Cybersecurity Task Force Report for improving 
        healthcare cybersecurity, released in June 2017;

          Leading collaborative interagency and other HPH 
        sector efforts to identify emerging cyber risks in HPH, 
        including risks associated with emerging technologies such as 
        artificial intelligence and machine learning-based tools, as 
        well as risks associated with new care delivery models such as 
        telehealth;

          Leading tracking and assessment efforts during the 
        Federal response to Cyber Incidents;

          Developing and implementing mitigation strategies as 
        well as incident and after action reports to inform and advise 
        on future response operations; and,

          Creating a bi-weekly bulletin on cybersecurity topics 
        that reaches approximately 3,000 subscribers. Topics discussed 
        in the bulletin include information pertinent to understanding 
        and mitigating cybersecurity risks across all critical 
        infrastructure sectors, identification and analysis of trends 
        in cyberattacks and vulnerabilities, best practices for general 
        cyberhygiene, and specific recommendations for addressing 
        significant cyber threats.

    Question 3(d). How does ASPR coordinate with the Cybersecurity and 
Infrastructure Security Agency and the Federal Bureau of 
Investigations?

    Response: One of the ways ASPR collaborates with CISA is by 
promoting their tools and resources and sharing info that could help 
our sector partners. ASPR serves as a conduit between the Healthcare 
and Public Health (HPH) Sector and CISA. Confronting cybersecurity 
threats requires contributions from across the Federal Government, 
including CISA, the FBI's National Cyber Investigative Joint Task 
Force, and other stakeholders. ASPR participates in weekly calls with 
CISA colleagues and our health sector partners. ASPR also works closely 
with CISA through the Federal Senior Leadership Council Roles and 
Responsibilities work, through which we have negotiated mechanisms of 
sharing information between SRMAs, CISA, and the FBI.

    Question 3(e). Please describe ASPR's coordination with the health 
care and public health sector specifically related to cybersecurity.

    Answer 3(e). As described above, ASPR holds weekly calls with 
sector partners to discuss cybersecurity threats. During these calls, 
ASPR is able to provide both the specialized knowledge regarding 
cybersecurity as well as sector-specific knowledge to assist partners 
in preventing and responding to incidents like a ransomware attack. 
ASPR is also able to create private sector partnerships that have a 
Federal Advisory Committee Act (FACA) exemption so that we can meet 
with the same private sector partners and request consensus advice and 
recommendations from them in a closed setting. Last, ASPR holds joint 
sector working groups with private sector and government sector 
partners to identify topics to work on, analyze best practices, and 
develop products to release to the private sector.
                             senator braun
    Question 1. Can you please provide specific updates on your plans 
to ensure that nursing home staff and residents have sufficient point 
of care molecular diagnostics and access to the most appropriate 
prophylactics and treatments?

    Answer 1. You should be aware that HHS has and continues to 
distribute approximately 3 million point of care tests to long term 
care facilities on a weekly basis. In addition, HHS monitors the 
testing supply chain through collaboration with diagnostic 
manufacturers. Ten of the major manufacturers send shipment data, 
install base data, and supply projections on a regular basis. HHS 
integrates this data into HHS Protect, a platform that overlays 
epidemiological data, hospital data, testing data, and other public 
health metrics. Of the three main data reports, the install base data 
gives HHS visibility into the locations and quantity of all the high-
throughput machines for a specific company. This information allows HHS 
to monitor how additional capacity for testing has increased since the 
beginning of the pandemic.
                           senator tuberville
    Question 1. Funds in part from NIH/NIAID helped build the 12 
Regional Biocontainment Laboratories (RBLs) and 2 National 
Biocontainment Laboratories (NBL) to support high consequence 
infectious disease research after 9/11 and the anthrax scares in 2001. 
However, unlike the NBL facilities, the RBL facilities received no 
further direct support until last year when Congress provided enhanced 
investment through NIH/NIAID, targeted specifically to RBL facilities, 
one of which is at the University of Alabama at Birmingham (UAB) in my 
state. Nevertheless, it seems as though the RBL infrastructure, most 
importantly the highly trained staff these facilities maintain and 
produce is something that falls within the purview of the HHS ASPR, 
considering among other things the UAB RBL has had collaborations with 
Altimmune and ImmunityBio for COVID19 vaccine development, and 
supported BARDA contractors. This type of work strongly aligns with 
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and 
Sustaining Robust and Reliable Public Health Security Capabilities. The 
RBL infrastructure and personnel is expensive to maintain and operate, 
and perhaps should not solely rest on either the shoulders of the host 
University or the NIH/NIAID.

    Question 1(a). Therefore, is support from Assistant Secretary for 
Preparedness and Response (ASPR) something under consideration?

    Answer 1(a). NIAID provided funding in 2003 and 2005 for the 
construction of National Biocontainment Laboratories (NBLs) and 
Regional Biocontainment Laboratories (RBLs). The NBLs and RBLs are 
designed to complement and support the research activities of NIAID-
funded biodefense and emerging infectious diseases research as well as 
assist national, state, and local public health efforts. The NBLs and 
RBLs achieve this mission by providing safe and secure state-of-the-art 
BSL-3/4 laboratory space to the scientific community to advance 
research on biodefense pathogens and emerging infectious diseases. 
NIAID's mission to support the development of medical products to 
counter bioterrorism and emerging and reemerging infectious diseases is 
part of a larger national strategy that involves many agencies.

    The majority of Federal oversight of U.S. BSL3/4 labs is done on 
those conducting select agent research, and falls under the purview of 
CDC and USDA through the Select Agent Program. Additional certification 
and oversight responsibilities for BSL3/4 labs is handled at the level 
of the institution. As such, NIH and ASPR oversight is generally 
limited to oversight of funded research.

    Question 1(b). If not, why not, and if so what is needed to 
facilitate that conversation?

    Answer 1(b). See response to 1(a).
                                 ______
                                 
    [Whereupon, at 12:24 p.m., the hearing was adjourned.]

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