[Senate Hearing 117-202]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 117-202

                       NEXT STEPS: THE ROAD AHEAD
                       FOR 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 THE ROAD AHEAD FOR THE COVID-19 RESPONSE, 
                       FOCUSING ON NEXT STEPS

                               __________

                            NOVEMBER 4, 2021

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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                    U.S. GOVERNMENT PUBLISHING OFFICE                    
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

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

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

                              ----------                              

                               STATEMENTS

                       THURSDAY, NOVEMBER 4, 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................     7
    Prepared statement...........................................     8
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.....................    24
    Prepared statement...........................................    27
O'Connell, Dawn, Assistant Secretary for Preparedness and 
  Response, United States Department of Health and Human 
  Services, Washington, DC.......................................    54
    Prepared statement...........................................    55

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Tuberville, Hon. Tommy:
    Alzheimer's Association and Alzheimer's Impact Movement......   101
Burr, Hon. Richard:
    Letter.......................................................   103
    Understanding the Risk of Bat Coronavirus Emergence..........   105
Casey, Hon. Bob:
    Alzheimer's Association and Alzheimer's Impact Movement 
      Statement for the Record...................................   735
Marshall, Hon. Roger:
    CDC COVID-19 Acknowledge Natural Immunity....................   633
    Natural Immunity Questions...................................   637
    A Review and Autopsy of Two COVID Immunity Studies, Dr. 
      Martin Kulldorff...........................................   653
    40 publications..............................................   738
    EcoHealth letter.............................................  1290

                         QUESTIONS AND ANSWERS

Response by Rochelle Walensky to questions of:
    Senator Smith................................................  1295
    Senator Rosen................................................  1296
    Senator Lujan................................................  1298
    Senator Hickenlooper.........................................  1303
    Senator Burr.................................................  1304
    Senator Cassidy..............................................  1304
    Senator Braun................................................  1307
    Senator Marshall.............................................  1308
    Senator Scott................................................  1308
    Senator Tuberville...........................................  1311
Response by Anthony Fauci to questions of:
    Senator Hickenlooper.........................................  1317
    Senator Braun................................................  1318
    Senator Marshall.............................................  1318
    Senator Romney...............................................  1338
    Senator Tuberville...........................................  1342
Response by Janet Woodcock to questions of:
    Senator Hickenlooper.........................................  1348
    Senator Burr.................................................  1348
    Senator Scott................................................  1350
    Senator Tuberville...........................................  1351
Response by Dawn O'Connell, to questions of:
    Senator Smith................................................  1355
    Senator Lujan................................................  1357
    Senator Hickenlooper.........................................  1357
    Senator Braun................................................  1358
    Senator Scott................................................  1359
    Senator Tuberville...........................................  1363

 
                       NEXT STEPS: THE ROAD AHEAD
                       FOR THE COVID-19 RESPONSE

                              ----------                              


                       Thursday, November 4, 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 
G50, 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, 
Collins, Cassidy, Murkowski, Braun, Marshall, Scott, Romney, 
Tuberville, and Moran.

                  OPENING STATEMENT OF SENATOR MURRAY

    The Chair. Good morning. The Senate Health, Education, 
Labor, and Pensions Committee will please come to order.
    Today, we are holding a hearing with members of the 
President's COVID-19 Task Force on the path forward for our 
pandemic response.
    Ranking Member Burr and I will each have an opening 
statement. Then, I will introduce our witnesses. After they 
give their testimony, Senators will have 5 minutes each for a 
round of questions.
    While we are unable to have this hearing fully open to the 
public yet, or media, for in-person attendance, live video is 
available on our Committee website at help.senate.gov. And, if 
you are in need of accommodations, including closed captioning, 
you can reach out to the Committee or to the Office of 
Congressional Accessibility Services.
    A few months ago, President Biden announced his plan to 
respond to the Delta variant, which was surging and 
jeopardizing our hard-won progress against COVID-19. And, while 
our work continues, the President's decisive action and the 
hard work of experts and public health officials across the 
Country have put us in a stronger position to end this 
pandemic.
    Right now, cases, hospitalizations, and deaths are once 
again trending down, and the vaccination rate is continuing to 
go up. Nearly 80 percent of people age 12 and older have gotten 
their first dose of COVID-19 vaccine, nearly 70 percent have 
been fully vaccinated, and inequities in vaccination numbers 
have been narrowing.
    We are also already seeing how requirements for vaccines or 
testing like President Biden has called for, and which a clear 
majority of Americans support, can bring vaccination rates even 
higher. As of last month, vaccine requirements had increased 
vaccination rates by over 20 percent.
    United Airlines has seen their vaccination rate for 
employees go from 57 to 99 percent since they announced their 
vaccine requirement.
    Tyson Foods went from less than half of its workers 
vaccinated to over 96 percent.
    In my home State of Washington, 15 in 16 of our state's 
workers have already complied with Governor Inslee's vaccine 
requirement.
    Across the Country, healthcare facilities, universities, 
and other employers are seeing similar results, and I expect 
that progress to continue now that the Department of Labor has 
put forward an emergency temporary standard on this issue.
    We are also seeing progress on booster shots with three 
different booster shots authorized, and over 13 million already 
administered, and as shots for children younger than 12, with 
the FDA authorizing vaccines for children ages 5 to 11 last 
week and the CDC issuing its decision on this recently.
    But, even with all the progress we have made so far, we 
must not take our foot off the gas. Last winter, we saw this 
virus push our hospitals to the brink. We saw it infect and 
kill hundreds of thousands of people, including essential 
workers and healthcare workers, and we know it led to burnout 
among so many more. Vaccines are one of our best tools for 
making sure that does not happen again, and making sure we can 
build back from this pandemic stronger and fairer.
    In fact, as the White House noted in its report on 
vaccination requirements, an outside economic analysis found 
that increasing vaccination and reaching near full vaccination 
in workplaces could encourage millions of people to return to 
the workforce.
    Tests also continue to serve a critical role in stopping 
the spread by informing our ongoing response, which is why we 
need to plan to scale up testing even more.
    In a larger sense, we must learn the lessons of this 
pandemic, not only so we can prepare for the winter ahead, but 
so we can finally bring an end to this pandemic and be better 
prepared for the next public health crisis, whatever it may be. 
I have been pressing to get that done at every possible 
opportunity, and it is why Senator Burr and I continue to work 
on bipartisan public health and preparedness legislation.
    It is also why I am pushing for critical steps in Build 
Back Better to strengthen our public health infrastructure. 
Among other things, Build Back Better will help public health 
departments across the Country increase their testing and 
tracing capacity, train and retain public health workers, 
upgrade to more modern, inclusive, and interoperable data 
systems, communicate with the public and address misinformation 
about issues like vaccines, and address health inequities and 
build partnerships in hard-to-reach communities.
    It would also help our Federal public health agencies, like 
the FDA, CDC, and the Assistant Secretary for Preparedness and 
Response, to take action to increase lab capacity, so we can 
sequence viruses and identify variants quickly, facilitate the 
development of new treatments and tests and vaccines, and 
improve the supply chain of medical supplies, like syringes, 
ventilators, and personal protective equipment.
    This pandemic has been long, and it has been deadly. It has 
hurt our economy, our communities, and our families beyond 
measure. But, if we continue to take bold action, if we 
continue to follow the science and experts, if we continue to 
get people vaccinated and take steps to keep ourselves and 
those around us safe, we will get through this.
    If we learn from this pandemic, if we finally end the cycle 
of crisis and complacency for public health funding, and ensure 
we have an economy that works for everyone--not just those at 
the top--we can rebuild our Country stronger and fairer, and we 
can make sure we are never in a situation like this again.
    With that, I will turn it over to Ranking Member Burr for 
his opening statement.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Thank you, Madam Chair. To our witnesses, 
welcome back to the HELP Committee.
    I get the feeling that we may need to send smoke signals to 
you. I'm not sure we could have gotten you further away from us 
and everybody, but we are grateful to you and we thank you for 
your service to the American people.
    Each time you have all come before the Committee, I charged 
you to look ahead the next 30, 60, and 90 days and figure out 
where we needed to be and what we needed to do to keep up with 
this virus.
    I will say it again. You are the adults in the room, and 
you need to look forward--look around the corner to anticipate 
what we will need. More than 90 days from our last hearing, and 
we still have much to do to ensure that we are better prepared 
and better at responding than we have been in previous weeks 
and months.
    As we get closer to the 2-year mark of living with COVID-
19, we need to take stock of the current state of our response 
and identify the next critical steps that will lead us out.
    Senator Murray and I have been working closely together to 
develop a pandemic bill. And at some point in the near future, 
Senator Murray and I will release a discussion draft of the 
reform, and we believe this is needed for our Country's future 
response.
    I very much appreciate the ability to work together on an 
issue so important to our national security. We have obviously 
delayed from our previous schedule, but given the intent to 
appear on other big legislation, it is impossible for us to get 
that draft out until that is concluded.
    We need to use all the tools at our disposal to keep pace 
with the virus, which continues to evolve. Recent reports have 
surfaced of a new subvariant that some are calling Delta Plus, 
which has accounted for an increasing portion of cases in the 
U.K. in the past month. I hope to discuss that in person when I 
leave Sunday for the U.K. and spend some time in London next 
week to look at in fact what Delta Plus has done there.
    That mistake--cases and hospitalizations are down in the 
United States, but the Administration cannot declare premature 
victory like we did in the summer. That mistake only brought us 
to a place we are today with shortages of tests, therapeutics, 
and continued lag in extremely important data about the 
disease.
    In September, even CDC warned of shortages in point-of-care 
and over-the-counter tests and to expect increased demand for 
lab-based testing. To state the obvious, we need more rapid 
tests that are available and in stock. North Carolinians are 
calling my office desperate for help in accessing therapeutics. 
And even with new announcements on oral therapeutics, Americans 
are waiting for these drugs.
    This Administration bears 100 percent of the responsibility 
for the lack of testing and the lack of therapies. You got 
complacent. You let your foot off the gas. You did not order 
enough tests. You did not purchase enough therapeutics. And 
now, we are rationing.
    The private sector will respond to purchasing agreements in 
the contracts. They cannot and will not produce things that 
customers are not ordering.
    Congress has given billions of dollars, and billions more 
of dollars. We have demonstrated bipartisan commitment to 
getting you the cover to purchase vaccines, tests, 
therapeutics, even if we do not use them.
    The Administration squandered time and resources you have 
already had available to you, and the American people are 
suffering as a result.
    As we look ahead, we need plans in place to handle COVID as 
an endemic disease that will be part of our lives for the 
foreseeable future.
    My question in the headline for this hearing is simple. 
What is the plan?
    We need to take stock of lessons learned to strengthen our 
ability to be ready for the next threat that we may face, but 
also learn from successful approaches and put those into 
everyday practice.
    We need to identify information gaps and map out how we are 
going to address them so that we can make the best decisions 
based on sound sights and sound data.
    Most importantly, we need strong leadership. We need a 
nominee for the FDA Commissioner, and this Administration 
cannot drag its feet on a new leader at the NIH. Both nominees 
will have challenging missions to complete under difficult 
circumstances and nearly impossible shoes to fill. Qualified, 
non-partisan leadership at these agencies is paramount. Dr. 
Woodcock, I am still rooting for you.
    We must leverage the laboratory community and test 
developers to bring more innovative, rapid, at-home and point-
of-care tests to market. We need not let our guard down as we 
did this summer. We are reaching the time of the year where we 
are all looking forward to spending time with loved ones, and 
access to testing will help this happen safely.
    But, we are still behind. These tests, which we need to 
keep our businesses and schools open and families safe, are 
still far too difficult to find for most Americans. Testing 
shortages and delayed test results are keeping children out of 
school, parents away from the office, and limiting our 
understanding of where virus is circulating in our communities.
    The Administration had to scramble to order 200 million at-
home tests per month, many of which will not even be ready 
until December, and that is not enough.
    In early October, FDA announced that it authorized new 
tests to expand access to reliable, at-home testing. Europe has 
been using these same tests for 7 months.
    Just this past weekend, my 2-year old grandson was notified 
on Friday that his teacher tested positive. Teacher of a pre-
school class, masked 100 percent of the time that they were 
there. They did the appropriate thing. They shut the class down 
for a week.
    The problem was that his siblings could no longer go to 
school. School not only required him to be tested before his 
sister could return to school, but did not accept an at-home 
test for a negative test for the 2-year old. They required a 
PCR test.
    It is confusing. America does not understand the standards 
that we have set. And, in that case, she lost 3 days of school. 
Even though they could afford the PCR test, how many families 
cannot?
    The American people are tired of accepting better late than 
never from our public health agencies. And the testing shortage 
will only get more pronounced if the Department of Labor issues 
its threatening temporary standard, which it did right before 
we came in, which will create an even larger demand for tests 
for those who do not choose to get vaccinated.
    One recent survey found that 59 percent of unvaccinated 
workers are still not likely to get vaccinated, despite the 
mandates from this Administration.
    With a heavy-handed vaccine Federal mandates on employers, 
this Administration completely disregards the legitimate 
question raised by many Americans, and specifically Dr. Paul 
and Marshall. What role does natural immunity play in 
protecting against this virus?
    I have said before that I did not believe that the Federal 
Government mandates will solve our problem. We are seeing cops 
and firefighters quit, and pilots engage in sickouts. The 
Nation's military and contractors worry about our preparedness 
if personnel are fired over these mandates.
    Just this morning, a mandate from CMS to all healthcare 
providers that accept Medicare and Medicaid that if they do not 
mandate to their workforce, they are no longer participants in 
Medicare or Medicaid, will only suggest to doctors not to 
accept Medicare or Medicaid patients if in fact they choose, as 
a medical professional, not to be vaccinated.
    There likely will be controversies over whether to require 
the vaccine for children when even your own experts raise great 
concerns about mandating children get vaccines.
    I urge all of you, back away from mandates, and instead, 
use your platforms to educate, encourage, inform. Do not be 
divisive.
    While more therapeutics and more tests are the tools that 
we need to manage the constant demands of the virus, we also 
need better information to make the best decisions.
    We need real-time data to understand and get ahead of COVID 
today and to detect the next emerging infectious disease or 
public health threat in the future.
    Congress has dedicated $1.1 billion to improve our public 
health data sharing and turn it into actionable information 
through our surveillance system, but we still do not have the 
up-to-date and actionable data we need to answer some of the 
most common questions from the American people.
    Effective communication of information and data is the best 
way for the public health officials to win back the trust of 
the American people. And it is clear to me that the CDC has 
lost the trust of the American people.
    Show Americans the evidence for why the tough choices are 
the right ones, and do not just expect that compliance gets you 
there.
    Use the best information available at the time, even if it 
is not perfect, and update action as the information evolves.
    This is a particular challenge for what is supposed to be 
our leading public health agency, the CDC, an agency that I 
have watched agonize over having perfect, clean data to make 
decisions for Americans. By the time we get their data, it is 
too late.
    We still do not have the answers to basic questions. We 
need real, usable information about masks. How well do 
different types of masks work? When should we use them?
    The CDC continues to change its posture on the collection 
of information on breakthrough cases. How many breakthrough 
cases result in hospitalization? How many do not?
    CDC is not in a place where the Nation looks for real-time 
data, and we need to change that. The CDC is too focused on 
writing academic papers about something that happened weeks or 
months ago.
    When Americans want real data, they are forced to look 
elsewhere, like Johns Hopkins University or HHS Protect. I 
worry the new approach to HHS Protect will not be able to 
overcome the complacent academic culture of CDC without serious 
reforms, so I will be watching very carefully.
    We must all come to terms with the reality that the virus 
is here to stay. It is vital that the four of you sitting here 
today take the initiative to lead, empower Americans with data, 
tools, and clear and actionable guidance needed to get back to 
normal.
    The more people that get vaccinated to protect against 
COVID, the better.
    The more tests available to Americans to detect and 
diagnose COVID, the better.
    The more therapeutics we have to rapidly treat COVID, the 
better.
    The more we can continue to learn from this experience, the 
better prepared we will be.
    I thank the Chair.
    The Chair. Thank you, Senator Burr.
    I will now introduce today's witnesses. Again, thank you 
for joining us today.
    Dr. Rochelle Walensky is the Director of the Centers for 
Disease Control and Prevention and the Administrator of the 
Agency for Toxic Substances and Disease Registry.
    Dr. Anthony Fauci is the Director of the National Institute 
of Allergy and Infectious Diseases and the Chief Medical 
Advisor on President Biden's COVID-19 Response Team.
    Dr. Janet Woodcock is the Acting Commissioner of the Food 
and Drug Administration.
    Dawn O'Connell is the Assistant Secretary for Preparedness 
and Response.
    Dr. Walensky, Director Fauci, Acting Commissioner Woodcock, 
and Assistant Secretary O'Connell, thank you all for joining us 
once again. We look forward to your testimony.
    Dr. Walensky, we will begin with you.

  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 HELP Committee. I am honored to 
join you today to provide an update on the COVID-19 pandemic.
    Since I last testified before this Committee on July 20th, 
we have witnessed a steep increase in COVID-19 cases, 
hospitalizations, and deaths around the Nation, largely fueled 
by the Delta variant. The Delta variant reminded us we need to 
be humble in our response to this virus, and to follow the 
science as we modify guidance and address the pandemic.
    Here are a few things we have learned over the last 4 
months:
    First, the Delta variant is notably more contagious and 
spreads faster than previous variants.
    Second, though breakthrough infections are infrequent, 
vaccinated individuals who are infected with Delta are able to 
transmit the virus.
    Third, while we have seen waning vaccine-induced immunity 
in certain populations, leading us to recommend the rollout of 
booster shots, COVID-19 vaccines are still highly effective and 
provide strong protection, particularly against severe disease, 
hospitalization, and death.
    While we are once again pleased to see downward trends in 
cases, this decline seems to be slowing, and deaths are not 
falling nearly as fast as we would like. On average, we still 
see over a thousand deaths every day, and tragically, there 
have been more than 138,000 deaths since I last spoke here.
    As we look toward the coming weeks and months with some 
optimism, we must remember what the Delta variant did to this 
Country, erasing weeks of prior progress and long, downward 
trends, and reminding us that this novel coronavirus is 
unpredictable.
    In addition, we are entering the winter season where we are 
predicting an increase in influenza and other respiratory 
viruses. We are concerned about this year's flu season has the 
potential to be severe. It is just as important as ever to get 
vaccinated for COVID and for influenza.
    We have made incredible strides in vaccinating the U.S. 
population against COVID-19. As of November 3rd, we have 
vaccinated about 85 percent of the United States population 65 
years and older, 70 percent of those 18 years and older, 68 
percent of those 12 years and older, and nearly 58 percent of 
the entire United States population.
    Some of our latest data only reinforce why vaccination is 
so very important, showing that unvaccinated people have six 
times greater risk of testing positive for COVID-19, and 11 
times greater risk of dying from COVID-19 than people who are 
fully vaccinated.
    Importantly, we now have data showing that the Pfizer 
vaccine is nearly 91 percent effective in preventing COVID-19 
infection in children ages 5 to 11 who did not have COVID-19 
infection previously.
    Why is this such important news? Case surveillance data 
indicate that there have been 9,000 hospitalizations among 
children ages 5 to 11 since the beginning of the pandemic. 
Mortality data have recorded more than 97 deaths in this age 
group.
    There are now well over 5,000 children diagnosed with MIS-C 
and living with complications of this disease. As a mother, I 
know that no parent should have to see their child face long-
term complications of an infection or be hospitalized, and we 
now have a highly effective tool to prevent this disease in our 
children.
    Following FDA's authorization, I endorsed CDC's Advisory 
Committee on Immunization Practices' recommendation that 
children ages 5 and up should receive a COVID-19 vaccine. I 
strongly encourage parents and their children to get 
vaccinated. And if you have any questions about the vaccine, 
please talk to your child's pediatrician, a school nurse, your 
local pharmacist, or a trusted medical professional.
    In addition to the critical work to get out of this 
pandemic through vaccination and other prevention strategies, 
we need to better prepare for future outbreaks and pandemics. 
One of the most important steps we can take to support these 
efforts is to support sustained disease-agnostic funding for 
public health. This is how we will accomplish our goals to 
rebuild our public health workforce, invest in our public 
health laboratory infrastructure, ensure rapid response, 
readiness, and improve our ability to collect and use data.
    I hope these bipartisan goals for Members of this 
Committee, and I look forward to continuing to work with you to 
achieve these investments.
    Before I close, I want to emphasize that the work we have 
done collectively to invest in and distribute vaccines has 
given us our most powerful tool to get out of this pandemic. 
Data show again and again that vaccines work. They are safe, 
and they can save your life.
    Thank you. I look forward to your questions.

    [The prepared statement of Dr. Walensky follows:]
               prepared statement of rochelle p. walensky
    Chair Murray, Ranking Member Burr, and distinguished Members of the 
Committee, it is an honor to appear before you today to discuss the 
Centers for Disease Control and Prevention's (CDC) ongoing response to 
the COVID-19 pandemic. It is my privilege to represent CDC, America's 
health protection agency. 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
    Beginning in July 2021, we witnessed steep increases in COVID-19 
cases, hospitalizations, and deaths around the Nation, due to the 
spread of the Delta variant. However, in recent weeks we have begun to 
see a decrease in the numbers in all three of these indicators in 
nearly all jurisdictions. Yet, as we enter flu season, which has the 
potential to be severe in part due to reduced population immunity from 
decreased flu circulation in the last year and a half, and approach the 
winter holidays, it is as important as ever that we continue to be 
diligent in vaccination for both flu and COVID-19, masking, and other 
mitigation efforts to continue the positive trends of these indicators.

    We have made incredible strides in vaccinating the U.S. population. 
As of November 1, 2021, about 97.4 percent of the United States 
population 65 years and older, 80 percent of those 18 years and older, 
78.1 percent of those 12 years and older, and nearly 66.8 percent of 
the total United States population received at least one dose of a 
COVID-19 vaccine. These gains are thanks to the tireless efforts of 
professionals from across the public health, medical, business, and 
multisectoral levels of government and trusted community leaders who 
have come together across the Country to respond to this pandemic. But 
there is still more work to be done to combat the threat of COVID-19.

    Where people remain unvaccinated, communities remain vulnerable. We 
know that those who are unvaccinated have a more than tenfold greater 
risk of death than those who are vaccinated. With vaccines readily 
available across the Country, the suffering and loss are nearly 
entirely avoidable. These vaccines are safe and effective, and high 
rates of vaccination protect individuals, families, and communities 
from severe disease, hospitalizations, and death from COVID-19.

    While the Delta variant is currently responsible for more than 99 
percent of new cases, CDC continues to monitor all variants circulating 
in the United States to improve our understanding of the evolution of 
SARS-CoV-2 and the impact of emerging variants on critical medical 
countermeasures, including vaccines and treatments. A strong genomic 
surveillance infrastructure enables rapid detection of emerging 
variants and timely sharing of data and information to support public 
health decision-making at all levels. CDC continues to work closely 
with public health laboratories across the United States to strengthen 
genomic sequencing and bioinformatics capacity as an integral component 
of our public health system.
                                Vaccines
    Vaccination remains a safe and highly effective tool in bringing 
this pandemic to an end. CDC is constantly monitoring emerging data on 
the transmission of SARS-CoV-2 and vaccine effectiveness, including 
against hospitalization, severe illness, and death. While breakthrough 
cases are expected to occur, COVID-19 vaccines continue to be highly 
effective, and there is clear evidence that vaccination results in less 
severe illness, fewer hospitalizations, and fewer deaths. In August 
2021, data showed that people who were unvaccinated had 6.1 times 
greater risk of testing positive for COVID-19 and 11.3 times greater 
risk of dying from COVID-19 than people who were fully vaccinated. \1\
---------------------------------------------------------------------------
    \1\  https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-
status.

    CDC closely monitors and regularly updates data on COVID-19 vaccine 
effectiveness for duration of protection, level of protection against 
variants by risk groups, and infection and severe disease or 
hospitalization. With the emergence of Delta as the predominant variant 
circulating in the United States, and as the duration since vaccination 
increases, we have seen some decrease in vaccine effectiveness against 
infection. However, there has been little change in vaccine 
effectiveness against hospitalization and death, for which vaccines 
remain strongly protective. For example, a recent study \2\ found that 
even though COVID-19 vaccines offer less protection against infection 
with the Delta variant than previous variants, people not fully 
vaccinated still had almost five times the risk of getting infected 
when compared to fully vaccinated people.
---------------------------------------------------------------------------
    \2\  Monitoring Incidence of COVID-19 Cases, Hospitalizations, and 
Deaths, by Vaccination Status--13 U.S. Jurisdictions, April 4--July 17, 
2021 MMWR (cdc.gov).

    CDC has a comprehensive strategy for monitoring all aspects of 
breakthrough infections and illness, a strategy that was implemented at 
the time that COVID-19 vaccination began in the United States. 
Immediately after the introduction of the vaccine, national case 
surveillance was an important component of CDC's strategy to rapidly 
identify cases of breakthrough illness. These data continue to be 
monitored to identify signals for unexpected presentations of 
infections or illnesses in vaccinated persons. States continue to 
report these data to CDC; however, this system does not answer all of 
the questions we and our public health partners in the field have about 
vaccine effectiveness. For example, it does not capture many of the 
breakthrough infections that are asymptomatic or mild and that do not 
---------------------------------------------------------------------------
require medical attention.

    In addition, case surveillance alone does not provide enough data 
to understand the clinical spectrum and severity of breakthrough 
disease. To fully monitor and investigate all aspects of breakthrough 
infection, including breakthrough cases that do not lead to 
hospitalization, CDC uses enhanced surveillance and vaccine 
effectiveness study platforms that can more fully detect and describe 
the frequency of mild cases as well as severe cases, and that can track 
whether these variables are changing over time. CDC is collaborating 
with multiple states to link immunization records to case reporting, so 
as to compare the incidence of infections among the vaccinated with the 
incidence among those who are unvaccinated. Both case surveillance and 
these study platforms allow CDC to continuously monitor and provide 
updated information on breakthrough infections and vaccine 
effectiveness on the CDC COVID Data Tracker Website. \3\ In addition to 
monitoring vaccine effectiveness, CDC is reviewing data as they become 
available to compare infection induced immune responses with vaccine 
induced immune responses and their protection against reinfection, 
breakthrough infections, and variants.
---------------------------------------------------------------------------
    \3\  https://covid.cdc.gov/covid-data-tracker/#datatracker-home.

    Having data that show continued vaccine effectiveness is an 
important tool in our efforts to build vaccine confidence. CDC created 
the Vaccinate with Confidence strategic framework to build trust, 
empower healthcare workers, and engage communities and individuals. CDC 
publishes numerous resources online to increase vaccine confidence, 
including information on how to address misinformation and tailor 
messaging for specific audiences. CDC also advances vaccine equity by 
funding a wide variety of partners who vaccine confidence among racial 
---------------------------------------------------------------------------
and ethnic minority groups and in rural communities.

    One example of why CDC's vaccine confidence building work is so 
critical is reflected in our efforts to increase vaccine uptake during 
or prior to pregnancy. The accumulating evidence \4\ has shown that 
infection during pregnancy can be dangerous both to the pregnant person 
and to the child, and that COVID-19 vaccines are safe in those who are 
pregnant or are considering pregnancy. Despite the proven benefits of 
vaccination, as of October 21, 2021, only 34.6 percent of those who are 
pregnant have been fully vaccinated either during pregnancy or prior to 
getting pregnant, and the data are even more alarming in Black and 
Hispanic populations, where only 19.2 and 30 percent of pregnant people 
are vaccinated, respectively. This leaves far too many people at risk 
of severe illness, adverse pregnancy and neonatal outcomes, and death 
from COVID-19. CDC is assessing reasons for vaccine hesitancy in these 
and other disproportionately affected populations, and CDC is 
disseminating safety information rapidly and broadly on our website, 
through social media, and our partners to increase vaccine confidence 
across the United States.
---------------------------------------------------------------------------
    \4\  COVID-19 Vaccination for Pregnant People to Prevent Serious 
Illness, Deaths, and Adverse Pregnancy Outcomes from COVID-19.

    Following the meetings of the Food and Drug Administration's (FDA) 
Vaccines and Related Biological Products Advisory Committee (VRBPAC) 
and of CDC's Advisory Committee on Immunization Practices (ACIP) in 
September and October, CDC recommended booster doses of the Pfizer, 
Moderna, and Janssen vaccines for certain populations. Before making 
these decisions, CDC carefully examined the latest data and conducted 
---------------------------------------------------------------------------
robust discussions around booster shots.

    The data show vaccines generally remain effective in preventing 
hospitalization and severe disease in the United States. Still, recent 
evidence suggests they are less effective in preventing infection or 
milder symptomatic illness due to waning immunity over time, and in the 
setting of the more highly transmissible Delta variant. Emerging 
evidence shows that vaccine effectiveness against COVID-19 infections 
is decreasing over time, including among healthcare and other frontline 
workers. Booster shots will help provide continued protection against 
severe disease in those populations who are especially at risk for 
severe COVID-19. It is important to note, that even with boosters, we 
expect to continue to see some breakthrough cases, and we are well 
equipped to monitor these post-booster vaccination breakthrough cases 
using the same surveillance systems we currently have in place.

    Booster shots are currently available at many local retail 
pharmacies and from other healthcare professionals enrolled in the CDC 
COVID-19 Vaccination Program. In addition, CDC has launched the Federal 
Long-Term Care COVID-19 Vaccine Access Campaign to support any long-
term care setting that requests assistance with accessing COVID-19 
vaccine boosters for their residents and staff.
                          Schools and Children
    Unfortunately, from June to August of this year, the case rate 
among children increased ten-fold, and hospitalization rates among 
children increased almost 400 percent from June 25, 2021, to September 
11, 2021, although it has declined to an increase of 101 percent as of 
October 30, 2021.

    Tragically, hundreds of children have died, including nearly 100 
elementary school aged children 5-11. It is important to recognize that 
even cases that do not result in severe illness or death can be 
devastating, so it remains critical that we continue with our 
prevention efforts and quickly scale up vaccination for eligible 
children.

    The data are clear that vaccination is as effective at protecting 
children as it is at protecting adults. Data from August 2021 showed 
that rates of COVID-19--associated emergency department (ED) visits and 
hospital admissions for children and adolescents with confirmed COVID-
19 were highest in the states with lowest vaccination coverage, whereas 
in the states with the highest coverage, COVID-19 ED visits and the 
rate of hospital admissions among children and adolescents were lowest. 
Vaccinating eligible adults and children against COVID-19 remains the 
most effective prevention strategy to help schools safely maintain 
full-time in-person learning as well as extracurricular activities and 
sports. CDC's ACIP met on November 2, 2021 to review data on safety and 
effectiveness of the Pfizer-BioNTech vaccine for children ages 5 to 11 
years old. I am so pleased to report that CDC now recommends the 
vaccine for this population, and we have been hard at work to plan for 
possible distribution of these childhood vaccines so we will be ready 
to put shots in arms right away.

    Testing is an integral part of our strategy to make schools safe. 
Screening testing identifies infected people, including those without 
symptoms who may be contagious, so that measures can be taken to 
prevent further transmission. A modeling study found that weekly 
screening testing of students, teachers, and staff can reduce in-school 
infection by an estimated 50 percent. \5\ Another study found that, 
among five programs with regular screening testing (at least weekly) of 
most students and staff in the fall of 2020, one-third to two-thirds of 
total COVID-19 cases identified in the schools were found through 
screening. \6\ ``Test to stay'' is a practice comprised of regular 
testing and contact tracing to allow close contacts to remain in the 
classroom, while maintaining other layered prevention strategies, such 
as universal masking, to reduce the spread of COVID-19. CDC views 
``test to stay'' as a promising practice, and we are working with 
multiple jurisdictions to evaluate the effectiveness of this approach. 
When all of this is done in coordination with other prevention 
measures--such as universal and correct indoor masking--the results are 
clear: schools can safely provide in-person learning. To support these 
efforts, in April, CDC provided $10 billion for screening testing to 
help schools reopen safely, and more than $2 billion to scale up 
testing in underserved populations.
---------------------------------------------------------------------------
    \5\  https://www.mathematica.org/news/research-supported-by-the-
rockefeller-foundation-strengthens-the-evidence-base-for-reopening-k-
12.
    \6\  Vohra D, Rowan P, Goyal R, et al. Early Insights and 
Recommendations for Implementing a COVID-19 Antigen Testing Program in 
K-12 Schools: Lessons Learns from Six Pilot Studies. 2021. Oakland, CA: 
Mathematica. Accessed June 30, 2021. https://www.maineaap.org/assets/
docs/US-K12-early recommendations.pdfpdficonexternalicon.
---------------------------------------------------------------------------
    CDC is leading two additional activities to improve testing: (1) 
Operation Expanded Testing is focused on school-based testing for K-12 
students and on supporting testing for students and staff at 
Historically Black Colleges and Universities, and (2) Increased 
Community Access to Testing aims to improve access to testing in 
communities at increased risk of COVID-19 and provide surge capacity 
during times of sudden increase in testing demand.
    On September 24, CDC published three reports highlighting the 
importance of COVID-19 prevention measures in schools to protect 
students, teachers, and staff and keep schools open. The first report 
showed schools without in-school mask requirements were 3.5 times more 
likely to have a COVID-19 outbreak than schools with an in-school mask 
requirement. \7\ The second report showed that while 96 percent of 
schools have offered in-person learning during the 2021-2022 school 
year, COVID-19 continues to cause disruptions (e.g., closures due to 
COVID-19 outbreaks) that have affected more than 900,000 students. \8\ 
The third report showed that counties without school mask requirements 
experienced larger increases in pediatric COVID-19 case rates after the 
start of school compared with counties that had school mask 
requirements. \9\ These findings reinforce the importance of following 
CDC guidance to limit the spread of COVID-19 in K-12 schools, including 
universal mask wearing indoors; vaccinating all eligible students, 
teachers, and staff; improving ventilation; testing; physical 
distancing; and cohorting people into small groups to limit the number 
of students, teachers, and staff that come in contact with each other.
---------------------------------------------------------------------------
    \7\  Jehn M, McCullough JM, Dale AP, et al. Association Between K-
12 School Mask Policies and School-Associated COVID-19 Outbreaks--
Maricopa and Pima Counties, Arizona, July-August 2021. MMWR Morb Mortal 
Wkly Rep 2021;70:1372-1373. DOI: http://dx.doi.org/10.15585/
mmwr.mm7039e1.
    \8\  Parks SE, Zviedrite N, Budzyn SE, Panaggio MJ, Raible E, 
Papazian M, Magid J, Ahmed F, Uzicanin A, Barrios LC. COVID-19-related 
school closures and learning modality changes--United States, August 
1--September 17, 2021. MMWR Morb Moral Wkly Rep, ePub: 24 September 
2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7039e2/.
    \9\  Budzyn SE, Panaggio MJ, Parks SE, Papazian M, Magid J, Barrios 
LC. Pediatric COVID-19 cases in counties with and without school mask 
requirements--United States, July 1--September 4, 2021. MMWR Morb Moral 
Wkly Rep, ePub: 24 September 2021. DOI: http://dx.doi.org/10.15585/
mmwr.mm7039e3/.
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                             Health Equity
    The COVID-19 pandemic has further brought social and racial 
injustice and inequity to the forefront of public health. While in the 
early stages of the pandemic, significant percentages of COVID-19 case 
reports lacked race and ethnicity information, we have since made 
significant progress, and as of early October we now have race 
information for 3 out of 4 COVID-19 cases (75 percent) and ethnicity 
information for 2 out of 3 (67 percent) cases. Our National Vital 
Statistics System captures race and ethnicity data for more than 99 
percent of COVID-19 deaths; CDC's enhanced hospitalization surveillance 
system, COVID-NET, includes these data more than 98 percent of the 
time; and cumulative race and ethnicity completeness in CDC's National 
Syndromic Surveillance Program for emergency departments stands at 92 
percent and 82 percent, respectively. The result is a layered 
surveillance approach that includes robust and dynamic data on multiple 
aspects of the pandemic, yielding actionable information on health 
disparities and equity to inform the Nation's response.

    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, pregnant people, essential and frontline 
workers, people with disabilities, people with substance use disorders, 
people who are incarcerated, and non-U.S.-born persons.
    CDC has released several studies examining vaccination rates in 
certain population groups to monitor disparities and track progress 
toward health equity. The research highlighted the hidden and ongoing 
additional tragedies and disparities that both fueled and are the 
result of the COVID-19 pandemic.

    For example, a study \10\ that used data from CDC's Vaccine Safety 
Datalink (VSD) from December 2020 through May 2021 found that 
vaccination coverage among racial and ethnic groups was highest in non-
Hispanic Asian and non-Hispanic White persons and lowest in Hispanic 
and Black persons. Last month, CDC released a study \11\ that found 
COVID-19 vaccination coverage was lower among United States adults with 
a disability than among those without a disability, even though adults 
with a disability reported less hesitancy to getting vaccinated. 
However, adults with a disability anticipated or experienced more 
difficulty obtaining a COVID-19 vaccination than did those without a 
disability. Further, CDC released a study in October 2021 on COVID-19 
related orphanhood. Approximately 1 out of 500 children in the United 
States has experienced COVID-19-associated orphanhood or death of a 
grandparent caregiver. Children who are members of racial and ethnic 
minority populations accounted for 65 percent of those who lost a 
primary caregiver due to the pandemic, despite being only 39 percent of 
the overall US population. \12\ Collectively, these findings highlight 
the need to continue monitoring demographic and social factors 
affecting vaccine access and to prioritize efforts to ensure equitable 
access to vaccines.
---------------------------------------------------------------------------
    \10\  COVID-19 Vaccination Coverage Among Insured Persons Aged >16 
Years, by Race/Ethnicity and Other Selected Characteristics--Eight 
Integrated Health Care Organizations, United States, December 14, 
2020--May 15, 2021 MMWR (cdc.gov).
    \11\  Disparities in COVID-19 Vaccination Status, Intent, and 
Perceived Access for Noninstitutionalized Adults, by Disability 
Status--National Immunization Survey Adult COVID Module, United States, 
May 30--June 26, 2021 MMWR (cdc.gov).
    \12\  https://pediatrics.aappublications.org/content/early/2021/10/
06/peds.2021-053760.
---------------------------------------------------------------------------
    These data indicate that additional work lies ahead to achieve 
greater and more equitable vaccination rates in certain population 
groups. CDC continues to collaborate closely with state, local, tribal, 
and territorial partners to address these disparities. The Federal 
Retail Pharmacy Program has helped to increase COVID-19 vaccination 
coverage in communities across the Country. As of October 27, 2021, 
more than 152 million doses have been administered and reported by 
retail pharmacies in the United States, which includes approximately 8 
million doses administered through the Pharmacy Partnership for Long 
Term Care Program. Overall, 44 percent of the doses administered 
through the program have gone to a person from a racial or ethnic 
minority group (among people with known race or ethnicity).

    CDC is also partnering with the Health Resources and Services 
Administration (HRSA) to accelerate direct distribution of COVID-19 
vaccines in select HRSA-funded federally qualified health centers 
(FQHCs) to ensure under-resourced communities and disproportionately 
affected groups are equitably vaccinated. As of October 27, 2021, more 
than 21 million doses have been delivered to over 1,400 health centers.

    In addition to publishing and disseminating State of Vaccine 
Confidence Insights Reports biweekly, \13\ CDC is providing financial 
and technical assistance to state, local, territorial and community-
based partners to increase the percentage of all US residents who are 
fully vaccinated regardless of race/ethnicity, income, place of 
residence, or other social factors. To support the work of health 
departments and community organizations across the United States, CDC 
published the COVID-19 Vaccination Field Guide, which outlines selected 
strategies to help increase vaccine confidence and uptake and which 
includes examples from communities currently using these strategies. 
The evidence-based strategies address common barriers to getting a 
COVID-19 vaccine, which are structural, behavioral, or informational.
---------------------------------------------------------------------------
    \13\  Rapid Report--Announcement of Booster Dose Program of mRNA 
COVID-19 Vaccines for U.S. Adults, August 26, 2021 and Report 14, 
September 13, 2021.
---------------------------------------------------------------------------
    CDC continues to add functionality and additional information to 
our COVID Data Tracker. This includes the COVID Data Tracker Health 
Equity Data page, launched earlier this year, which presents CDC's 
health equity-related data relevant to selected populations and place-
based groups identified in the CDC COVID-19 Response Health Equity 
Strategy. \14\ Over the summer of 2021, CDC made updates to the Data 
Tracker to provide more detailed insights related to race, age, gender, 
disability, pregnancy, and more for cases, death, and vaccination 
coverage, including vaccine confidence. CDC remains committed to 
conducting all our work through a lens of health equity.
---------------------------------------------------------------------------
    \14\  https://www.cdc.gov/coronavirus/2019-ncov/community/health-
equity/cdc-strategy.html.
---------------------------------------------------------------------------
                               Conclusion
    In closing, I want to emphasize that despite the current downward 
trend in cases, hospitalizations, and deaths, we must stay diligent 
with our mitigation efforts. As the holidays approach, these strategies 
and tools will allow us to look forward to being with our families and 
to connect with one another safely, but we must all do our part. I urge 
our Nation to prepare for the upcoming flu season by getting the flu 
shot, and if you haven't already, by getting the COVID-19 vaccine. 
Those who are eligible should also get their COVID-19 booster. For 
convenience, people can ask their provider to get both shots, flu and 
COVID-19, at the same time. Vaccination remains one of the best tools 
we have to end this pandemic. It 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 are at 
a critical juncture in the response. If we all commit to sustaining the 
proven mitigation measures that we know work, we can save thousands of 
lives and return to more of a sense of normalcy in our school, work and 
communities.

    Last, we also must continue to focus on how we can better prepare 
for the future. We must make investments now to 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. I am committed to working with Congress to find 
common ground to support our public health system to make meaningful 
strides toward achieving health security for 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. Madam Chair, Ranking Member Burr, Members of the 
Committee, thank you for giving me the opportunity to discuss 
with you the role of the National Institute of Allergy and 
Infectious Diseases and the conduct and support of research 
addressing our Nation's response to COVID-19.
    In previous hearings before this Committee, I have 
discussed the critical role of NIAID in the development of 
COVID-19 vaccines, their testing in clinical trials, as well as 
the proof of their real-world effectiveness.
    Today, I would like to focus my remarks on studies aimed at 
optimizing the degree and durability of protection offered by 
these vaccines. In addition, I will mention our recent work in 
the development of effective therapies to prevent the 
progression of COVID-19 disease. I will close by briefly 
mentioning our involvement in preparedness for future pandemic 
threats.
    It has become apparent as we follow cohorts of vaccinated 
individuals over time that the durability of protection 
afforded by the vaccines both against infection and the 
development of severe disease gradually wanes over time. This 
has led to a considerable amount of activity aimed at 
optimizing protection by boosting with an additional dose of 
vaccine several months after the primary regimen.
    One can gauge the effect of these booster shots by 
measuring the induction of high levels of neutralizing 
antibody, as well as the clinical effect of enhanced 
protection. And in this regard, it has become clear that giving 
a third boost of an mRNA vaccine approximately 6 months or more 
following the original, primary regimen provides a dramatic 
enhancement of protection against infection, as well as severe 
disease. And, in the studies from Israel, this is beginning to 
be seen across all age groups.
    In this regard, certain subsets of individuals who have 
received any of the three vaccines available in this Country 
are now eligible for booster shots. Importantly, to increase 
the flexibility of the administration of boosters, NIAID has 
conducted a critical study, which is called Mix and Match, in 
which individuals are divided into three groups representing 
each of the three available products. These individuals were 
then boosted with a product other than the original one with 
which they were vaccinated.
    Data clearly indicated that boosting with a different 
product than the original was both safe and indeed induced a 
robust immune response. Thus, although we recommend that people 
boost with the original product of their vaccination, this 
study adds a degree of flexibility by allowing a choice of 
booster shots if it is difficult for one reason or another to 
receive the original product.
    Let me now move on to a brief discussion of the NIAID 
research approach to therapeutics, particularly in the context 
of treating an individual early in the course of infection to 
prevent progression to severe disease.
    The NIAID has initiated a program called the Antiviral 
Program for Pandemics, which is aimed at catalyzing the 
development of new medications to combat COVID-19, as well as 
to prepare for future pandemic threats.
    The program has two pillars: One takes existing drugs and 
accelerates their clinical testing and advanced development, 
and the other pursues the discovery of new molecules aimed at 
various vulnerable components of the SARS-CoV-2 replication 
cycle.
    One compound in particular, molnupiravir, developed by 
Merck and Ridgeback Companies, has shown considerable promise 
in a recently conducted clinical trial in which the drug was 
administered early in the course of infection, and it decreased 
hospitalization and death by 50 percent in the treated 
individuals compared to the placebo group.
    I bring this to your attention because the very early work 
on this molecule was the result of NIH grant support to 
academic institutions for the fundamental basic research which 
led to the discovery and the development of this molecule.
    Finally, I would like to close by looking forward to how we 
might best enhance our preparedness for what will be the 
inevitable future pandemics. In this regard, the NIH has 
already initiated its plans for the rapid development and 
implementation of successful countermeasures against several 
prototype pathogen families of viruses that threaten the health 
and safety not only of our Nation, but of the entire world.
    I look forward to describing these plans to you in more 
detail. Thank you for your attention, and I would be happy to 
answer your questions following the presentation.

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

    Thank you for the opportunity to discuss the role of the National 
Institute of Allergy and Infectious Diseases (NIAID) in the research 
response to coronavirus disease 2019 (COVID-19) and its etiologic 
agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 
Within the Department of Health and Human Services (HHS) and the 
National Institutes of Health (NIH), NIAID is responsible for 
conducting and supporting basic and clinical research on emerging and 
re-emerging infectious diseases, including COVID-19. As the Director of 
NIAID and the Chief Medical Advisor to the President, I am pleased to 
discuss NIAID'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. 
In this regard, 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 clinical 
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 clinical trials network 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 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, though challenges remain such as vaccine hesitancy 
and extending the durability and breadth of protection provided by 
COVID-19 vaccination. Currently, more than 69 percent of U.S. adults 
are fully vaccinated against COVID-19, and more than 10 percent of 
adults have received an additional booster dose to bolster and prolong 
vaccine-induced protection, as recommended for key populations by the 
Centers for Disease Control and Prevention (CDC). It is critical that 
we continue to vaccinate as many people as we can, as quickly as 
possible. FDA-authorized and FDA-approved 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 real-world 
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 SARS-CoV-2 
variants that may emerge with increased transmissibility or 
pathogenicity.

    One of the most concerning developments of the ongoing pandemic has 
been the spread of the highly transmissible SARS-CoV-2 Delta variant 
(B.1.617.2). COVID-19 vaccines distributed in the United States under 
FDA Emergency Use Authorizations (EUA), and the FDA-approved COVID-19 
vaccine, continue to be effective against severe disease caused by 
these variants, but we must remain vigilant. NIAID continues to conduct 
research to better understand SARS-CoV-2 variants, how they interact 
with the immune system, and their implications for COVID-19 therapies 
and vaccines.

    We also know that Americans in underserved and minority communities 
have been disproportionally affected by this pandemic. NIAID continues 
to work directly with these communities and has partnered with other 
agencies in the Federal Government, and with industry and academia, to 
ensure that no one in vulnerable communities is left behind as we work 
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, 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 prior to the emergence of 
SARS-CoV-2 enabled the unprecedented pace of COVID-19 vaccine 
development. Two activities in particular predate successful COVID-19 
vaccines: the development of versatile vaccine platforms and the 
adaptation of structural biology tools to design specific proteins 
(immunogens) that powerfully stimulate the immune system. Long before 
the pandemic, NIAID VRC scientists and their collaborators made the 
critical scientific discovery of how to stabilize--in a highly 
immunogenic form--viral proteins that are important for infection. 
These included the spike protein of Middle East respiratory syndrome 
coronavirus (MERS-CoV), which was stabilized using a double mutation 
known as S2P. This strategy facilitated the design of vaccine 
candidates that generate robust immune responses not only against 
coronaviruses but also other viruses of public health importance such 
as respiratory syncytial virus. As soon as the sequence of SARS-CoV-2 
was made available in January 2020, VRC researchers rapidly generated a 
stabilized SARS-CoV-2 spike protein for use in COVID-19 vaccine 
development. This crucial breakthrough in structure-based vaccine 
design led to the development of safe and effective COVID-19 vaccine 
candidates, several now authorized or approved by the FDA, across a 
range of vaccine platforms.

    Six candidate COVID-19 vaccines have been assessed in completed or 
ongoing large-scale Phase 3 clinical trials in the United States. 
Clinical trials assessing COVID-19 vaccine candidates in certain 
pediatric populations have been completed or are still ongoing. On 
August 23, 2021, an investigational vaccine developed by Pfizer and 
BioNTech became the first to be approved by the FDA for the prevention 
of COVID-19 in individuals 16 years of age and older. This approval 
followed a review of a biologics license application based on 
additional data from a Pfizer/BioNTech-supported Phase 3 clinical trial 
and real-world post-authorization safety surveillance data. The 
approved vaccine has the same formulation as the vaccine authorized for 
emergency use in individuals 12 to 15 years of age, and as a third 
primary series dose for individuals 12 years of age and older who have 
been determined to have certain kinds of immunocompromise. On October 
29, 2021, the FDA authorized the emergency use of the Pfizer/BioNTech 
COVID-19 vaccine to include children 5 through 11 years of age. The 
Pfizer/BioNTech vaccine is one of six COVID-19 vaccine candidates NIAID 
has helped advance through support for the fundamental research 
underlying the vaccine concepts, as well as for clinical testing 
through the CoVPN. Two of these vaccine candidates, those from Moderna, 
Inc., and Johnson & Johnson/Janssen, have been authorized for emergency 
use.

    Utilizing the CoVPN, NIAID is implementing 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 more than 
41,000 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 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. CEAL is 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 effectiveness of authorized COVID-19 vaccines.
                          mRNA-1273 (Moderna)
    As part of a longstanding collaboration, the NIAID VRC collaborated 
with the biotechnology company Moderna to develop a vaccine candidate 
designated mRNA-1273, which uses a messenger RNA (mRNA) vaccine 
platform to express the stabilized SARS-CoV-2 spike protein. After 
promising results in early clinical trials, NIAID and BARDA began 
working with Moderna on a Phase 3 clinical trial 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. On August 13, 2021, FDA amended the EUA to allow for a third 
primary series dose for individuals 18 years of age or older who have 
been determined to have certain kinds of immunocompromise.

    On September 22, 2021, NIAID scientists and their collaborators 
published additional results from the Phase 3 trial of mRNA-1273 with a 
longer duration of follow-up. They reported in the New England Journal 
of Medicine that the vaccine had 93.2 percent efficacy in preventing 
COVID-19 illness, 98.2 percent efficacy in preventing severe disease, 
and 63 percent efficacy in preventing asymptomatic infection. 
Importantly, the efficacy of mRNA-1273 in preventing COVID-19 4 months 
or more after the second dose was maintained at greater than 90 
percent. In addition, in observational studies in ``real-world'' 
conditions in broader segments of the population, mRNA-based vaccines 
continue to display high levels of effectiveness.

    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 
experiencing these conditions who received care have responded well to 
treatment and rest and usually can return to their normal daily 
activities after their symptoms improve. Given the significant 
potential health risk of COVID-19, including a substantially higher 
risk of myocarditis than with the COVID-19 vaccine, 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. The vaccine is known as Ad26.COV2.S or JNJ-
78436735. NIAID has supported 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 efficacious overall at preventing moderate to 
severe/critical COVID-19 occurring at least 28 days after vaccination 
and 85 percent efficacy 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. Johnson & Johnson/Janssen 
recently reported that the immune response from vaccination with 
Ad26.COV2.S lasts at least 8 months.
           Ensuring Protection with COVID-19 Vaccine Boosters
    FDA-authorized and FDA-approved COVID-19 vaccines have maintained 
remarkable effectiveness in preventing severe COVID-19. However, 
protection against mild and moderate disease begins to decrease over 
time following the primary vaccine series; this effect is likely 
exacerbated by the SARS-CoV-2 Delta variant which is much more 
transmissible than previous strains of the virus.

    On September 22, 2021, and October 20, 2021, FDA amended the EUAs 
for the Pfizer/BioNTech and Moderna COVID-19 vaccines, respectively, to 
allow for use of a single booster dose at least 6 months after 
completion of the primary series in the following groups: individuals 
65 years of age and older, and those 18-64 years of age at high-risk of 
severe COVID-19 or with frequent institutional or occupational exposure 
to SARS-CoV-2. FDA also amended the Johnson & Johnson/Janssen COVID-19 
vaccine EUA to include the use of a single booster dose administered at 
least 2 months after completion of the single-dose primary regimen to 
individuals 18 years of age and older. In addition, FDA authorized the 
use of heterologous, or ``mix and match,'' booster dosing in eligible 
individuals following completion of primary vaccination with a 
different available COVID-19 vaccine. CDC has made recommendations 
regarding use of these COVID-19 vaccines that are consistent with the 
FDA authorizations.

    NIAID is supporting preclinical and clinical research to assess the 
durability of immunity induced by COVID-19 vaccines and to help 
determine whether boosters will be necessary for additional 
populations. NIAID is leading a study in fully vaccinated individuals 
to assess the safety and immune responses following boosting with a 
COVID-19 vaccine different than the one used for the initial 
vaccination (``mix and match''). On October 13, 2021, NIAID posted a 
preprint outlining the results of the study on medRxiv that showed that 
administering the Pfizer, Moderna, or Johnson & Johnson/Janssen COVID-
19 vaccines at least 12 weeks after individuals received a different 
vaccine regimen effectively enhanced the immune response to SARS-CoV-2. 
Additionally, no safety concerns were identified. The results of this 
trial informed decisions on the use of mixed vaccine schedules for 
additional doses of COVID-19 vaccines, as described above.

    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. In August 2021, NIAID launched multiple additional studies 
to assess and enhance the immune response to COVID-19 vaccines in 
immunocompromised individuals with autoimmune diseases as well as solid 
organ transplant recipients. This effort features a multicenter, 
adaptive design study to assess the immune responses to an additional 
dose of the COVID-19 vaccine in immunocompromised individuals. Data 
from these studies will inform future considerations of additional 
doses of COVID-19 vaccines for these populations. CDC has made a 
recommendation, after review of the available scientific data, that 
people with moderately to severely compromised immune systems receive 
an additional dose of mRNA COVID-19 vaccine at least 28 days after a 
second dose of Pfizer/BioNTech COVID-19 vaccine or Moderna COVID-19 
vaccine.
 Clinical Trials of COVID-19 Vaccine Candidates in Special Populations
    To effectively end the COVID-19 pandemic, it will be important to 
vaccinate as many people as possible, including those in special 
populations, such as pregnant and lactating women, children, and people 
with immune deficiencies. More than 169,000 pregnant and lactating 
women already have received the COVID-19 vaccines under EUAs. Data from 
these individuals demonstrate no safety concerns for pregnant women or 
their babies. In addition, protective antibodies against SARS-CoV-2 
have been detected in babies born to pregnant women who received mRNA 
COVID-19 vaccines. On June 23, 2021, NIAID launched an observational 
study, MOMI-VAX, to evaluate the immune responses generated by COVID-19 
vaccines administered to individuals during pregnancy or up to 2 months 
postpartum. The study also will assess vaccine safety and evaluate the 
transfer of vaccine-induced antibodies to infants across the placenta 
and through breast milk.

    Efforts to evaluate COVID-19 vaccines in pediatric and other 
special populations are ongoing. 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. Pfizer also is evaluating their vaccine 
candidate in children younger than age 5. Other vaccine developers also 
have begun, or are planning to begin, trials to test their vaccine 
candidates in children, adolescents, and other special populations.
                   Other COVID-19 Vaccine Candidates
    In addition to the FDA-authorized and FDA-approved COVID-19 
vaccines described above, 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 100 percent effective 
at preventing severe COVID-19 disease. Novavax's NVX-CoV2373 COVID-19 
vaccine candidate uses a protein nanoparticle vaccine approach. On 
September 23, 2021, Novavax published data in the New England Journal 
of Medicine showing that NVX-CoV2373 demonstrated 89.7 percent 
protection against SARS-CoV-2 infection and 100 percent protection 
against moderate and severe COVID-19 disease. FDA has not yet 
authorized either of these vaccine candidates for emergency use.

    NIAID also is conducting early stage research on pan-coronavirus 
vaccines designed to provide broad protective immunity against multiple 
coronaviruses, especially SARS-CoV-2 and other viruses with pandemic 
potential. On September 28, 2021, NIAID announced awards to three 
academic institutions to conduct research to develop vaccines to 
protect against multiple types of coronaviruses and viral variants.
               Monoclonal Antibodies to Prevent COVID-19
    NIAID, collaborating with Regeneron Pharmaceuticals and Eli Lilly 
and Company, 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. On September 23, 2021, Regeneron reported in the 
New England Journal of Medicine that REGEN-COV prevented symptomatic 
and asymptomatic infection in household contacts of individuals who had 
recently tested positive for SARS-CoV-2. Bamlanivimab also prevented 
symptomatic and asymptomatic infection in residents and staff of 
skilled nursing and assisted living facilities as reported in the 
Journal of the American Medical Association. On August 10, 2021, FDA 
expanded the EUA for REGEN-COV to include post-exposure prophylaxis for 
COVID-19 in certain adults and pediatric individuals (12 years of age 
and older weighing at least 40 kg) who are at high risk for progression 
to severe COVID-19, including hospitalization or death. On September 
16, 2021, FDA expanded the EUA for bamlanivimab and etesevimab, 
administered together, to include post-exposure prophylaxis in these 
same populations. Clinical trials to test the safety and efficacy of 
monoclonal antibody therapies for the treatment of COVID-19 are being 
conducted through the ACTIV partnership, and these are discussed below.
           Understanding the Nature of Immunity to SARS-CoV-2
    NIAID is conducting and supporting research to enhance our 
knowledge of immunity against SARS-CoV-2 and to identify components of 
the immune response that provide protection against COVID-19. NIAID 
also is examining the quality and durability of the immune response to 
SARS-CoV-2, generating information that may be leveraged to develop 
novel SARS-CoV-2 therapeutics or vaccines and inform public health 
measures.

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

    NIAID also is supporting research to improve understanding of the 
role of T cells in protecting against COVID-19 and COVID-19 disease 
progression. For example, NIAID supported a collaborative longitudinal 
study by researchers at Emory University and the Fred Hutchinson Cancer 
Research Center that demonstrated that SARS-CoV-2-specific T cells were 
detectable for up to 8 months in patients after mild to moderate COVID-
19. NIAID also supported two separate studies--one led by researchers 
from NIAID and Johns Hopkins Hospital and another by scientists from 
the La Jolla Institute for Immunology--examining the T cell responses 
in recovered COVID-19 patients and individuals vaccinated against 
COVID-19. They found robust immune responses to the original strain as 
well as multiple variants of SARS-CoV-2 in both groups. In another NIH-
supported study, researchers uncovered features of T cells that 
distinguish fatal from non-fatal cases of severe COVID-19, which could 
lead to new treatments for this disease. However, it is important to 
note that although we are learning important information about T cell 
responses in SARS-CoV-2 infected and vaccinated individuals, we still 
do not know the extent to which T cell responses mediate protection 
against COVID-19.

    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 immune responses to SARS-CoV-2 and suggest that 
these cells also may help protect against emerging variants of concern.

    To help prepare for future pandemic threats, the NIAID VRC has 
established the Pandemic Response Repository through Microbial/Immune 
Surveillance and Epidemiology (PREMISE) program. The program will use 
data from the measurement of T and B cell immune responses to inform 
the discovery and development of diagnostic, prophylactic, and 
therapeutic countermeasures and accelerate the global response to 
pandemic threats. NIAID anticipates the research conducted by PREMISE 
will advance our knowledge of immune response to vaccination and 
infection and help inform the response to future pandemic threats.
               Identifying Therapeutics to Treat COVID-19
    Safe and effective therapeutics are urgently needed to treat 
patients with COVID-19. NIAID has worked quickly from the earliest days 
of the pandemic to evaluate promising therapeutics for COVID-19 in 
rigorous, randomized, controlled clinical trials.
                 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. On July 29, 2021, 
the FDA revised the existing EUA for baricitinib to remove the 
requirement that baricitinib be administered in combination with 
remdesivir. This revision was supported by data from a Lilly supported 
Phase 3 trial. ACTT-3 evaluated the treatment of hospitalized COVID-19 
patients with remdesivir plus interferon beta-1a, which is used to 
treat individuals with multiple sclerosis, and found no clinical 
benefit from the addition of interferon beta-1a. ACTT-4, a study 
assessing baricitinib plus remdesivir versus the glucocorticoid 
dexamethasone plus remdesivir in adults hospitalized with COVID-19 and 
requiring oxygen, showed these two regimens led to similar outcomes.
                  The ACTIV Public-Private Partnership
    NIAID, in collaboration with other NIH Institutes, also launched 
two clinical trials as part of the ACTIV partnership, which utilizes 
master protocols allowing the addition of other investigational 
therapeutics as the trials continue. ACTIV-2 and ACTIV-3 initially 
evaluated the use of the monoclonal antibody bamlanivimab to treat 
COVID-19 in outpatient and inpatient settings, respectively. ACTIV-2, 
which is focused on outpatients, has been expanded and is currently 
evaluating two combination monoclonal antibody therapies--BRII-196 plus 
BRII-198 and BMS-986414 plus BMS-986413--as well as three 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. Brii Biosciences recently announced promising results from 
ACTIV-2 for the treatment of COVID-19. Among patients at high risk of 
clinical progression, those receiving BRII-196 plus BRII-198 had 78 
percent decreased risk in hospitalization and death. On September 24, 
2021, SAB Biotherapeutics announced the graduation of SAB-185 into 
Phase 3 efficacy studies in ACTIV-2.

    ACTIV-3 currently is evaluating the AZD7442 monoclonal antibody 
combination, as well as the small molecules ensovibep and PF-07304814, 
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. PF-07304814 inhibits a critical part of the replication 
process of SARS-CoV-2. 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 to various 
monoclonal antibodies in its fact sheets for health care providers. 
NIAID-supported scientists and collaborators are evaluating the 
potential impact of emerging SARS-CoV-2 variants on the efficacy of 
monoclonal antibodies.
           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.

    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 evaluated 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. Recently, a third therapeutic was added: 
danicopan, an oral drug that inhibits a key inflammatory pathway and 
was originally designed to treat a rare but serious disorder called 
Paroxysmal Nocturnal Hemoglobinuria.

    NIAID, in collaboration with the Department of Defense (DOD) 
Defense Threat Reduction Agency, supported basic research and product 
development for the oral antiviral drug molnupiravir. On October 1, 
2021, Merck and Ridgeback Biotherapeutics announced clinical data from 
their Phase 3 trial which showed that molnupiravir reduced the risk of 
hospitalization or death by approximately 50 percent in at risk, non-
hospitalized adult patients with mild-to-moderate COVID-19. Merck 
announced on October 11, 2021, that they have submitted an EUA for use 
of molnupiravir for the treatment of mild-to-moderate COVID-19 in 
adults who are at risk for progressing to severe COVID-19 and/or 
hospitalization.

    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 target coronaviruses and additional RNA viruses with pandemic 
potential, helping to better prepare the Nation for future viral 
threats. Oral drug candidates for broad use in outpatient settings are 
the primary focus of this effort.

    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 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 11 
professional organizations, academic experts, and treating physicians 
including providers from high COVID-19 incidence areas, and community 
representatives. The Panel meets regularly to evaluate possible 
treatment options for COVID-19 and update the Treatment Guidelines as 
new clinical evidence emerges.
             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, 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 the extent to which 
vaccine-induced immunity, or post-infection immunity, prevent infection 
by 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 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. 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.

    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 Incidence and Pathogenesis of COVID-19
    NIH is supporting studies to understand the incidence of SARS-CoV-2 
infection in specific populations, including children, as well as 
certain aspects of the clinical course of infection, including 
thromboses, strokes, heart attacks, and other sequelae of infection. 
NIAID also is working with partners to delineate biological and immune 
pathways responsible for the varied manifestations of COVID-19.

    Early in the pandemic, the intramural research programs of NIAID, 
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 may have 
exceeded the number of cases medically diagnosed by an additional 16.8 
million infections through mid-July 2020. Continued analysis of the 1-
year follow-up data from the study will be important in better 
understanding mortality rates, prevalence of immunity, and the impact 
SARS-CoV-2 has had on various communities in the United States.

    NIAID scientists are participating in leadership of the COVID Human 
Genetic Effort, an international consortium of hospitals and genetic 
sequencing hubs that aims to discover genetic factors conferring 
resistance to SARS-CoV-2 infection or predisposing to severe COVID-19 
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 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 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. On June 10, 2021, NIH announced awards to New York 
University (NYU) to build the RECOVER research consortium, harmonize 
and coordinate data within the consortium, and develop methods for 
monitoring protocols; and to Massachusetts General Hospital to provide 
statistical analyses and coordinate data standardization, access, and 
sharing among RECOVER projects. On September 15, 2021, NIH announced, 
through NHLBI and the National Institute of Neurological Disorders and 
Stroke, awards to NYU to develop the RECOVER Cohort. This funding, 
supported by the American Rescue Plan Act of 2021 (P.L. 117-2), will 
enable NYU to engage more than 100 researchers at more than 30 
institutions to build a diverse national study population and support 
large-scale studies on the long-term effects of COVID-19.

    NIAID intramural scientists initiated the Longitudinal Study of 
COVID-19 Sequelae and Immunity to better understand PASC and determine 
the extent to which people who have recovered from acute SARS-CoV-2 
infection develop an immune response that provides protection against 
reinfection. NIAID-supported investigators also have established the 
Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) to determine 
how immunological markers correspond to, or may even predict, the 
clinical severity of COVID-19. Since May 1, 2020, IMPACC researchers 
have collected detailed clinical data along with blood and respiratory 
samples from more than 1,200 hospitalized COVID-19 patients of diverse 
race and ethnicity at approximately 20 hospitals nationwide. The cohort 
will be followed during hospitalization and up to 1 year after 
discharge to assess their functional and immunologic recovery.
                               Conclusion
    NIAID continues to expand efforts to elucidate the biology, 
pathogenesis, and clinical manifestations of SARS-CoV-2 infection, 
including emerging variants, 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, BETHESDA, MD

    Dr. Woodcock. Good morning, Chair Murray, Ranking Member 
Burr, and Members of the Committee. Thanks for the opportunity 
to testify here today, and for the continued bipartisan efforts 
of your Committee to address the COVID-19 pandemic. FDA 
appreciates the productive discussions, and we look forward to 
continuing our partnership on these legislative efforts.
    FDA has achieved some of the most impressive scientific-
based regulatory advances I have seen during my higher--entire 
career at the agency during this pandemic, driven by our 
mission to protect the public health.
    I know the American public has been eager to hear about 
getting their children vaccinated, what they can do if they get 
sick with COVID-19, and how they can further protect themselves 
and their loved ones against the virus.
    Let me provide a brief update on the actions the agency has 
taken to protect public health in three key areas since I last 
testified before this Committee.
    First, regarding vaccines, FDA has authorized three COVID-
19 vaccines and approved one vaccine. These have met FDA's 
expectations for safety and effectiveness appropriate either 
for authorization or approval in preventing COVID-19.
    In the last few weeks, the agency has made additional 
critical decisions about the use of these vaccines. FDA 
authorized booster doses for use in certain populations for all 
three authorized vaccines, as you have just heard from our 
other witnesses. As more data became available, the data 
suggested the effectiveness of the initial doses had started to 
wane, meaning that use of a booster dose would be important in 
bolstering protection for these populations.
    The agency also authorized the use of mix and match booster 
doses for COVID-19 using data from NIAID, as was just 
mentioned. This means eligible individuals can get any of the 
three authorized vaccines as their booster dose, and really 
simplifies availability for the public.
    Also, FDA authorized the Pfizer vaccine for use in children 
ages 5 through 11. I know because I have had many messages on 
this. Many parents have been waiting impatiently for months for 
this authorization. And I am happy to say, as we speak here 
today, young children across the Country are starting to get 
vaccinated against COVID-19.
    To be clear, FDA is confident in the safety and 
effectiveness data behind these decisions. The American public 
can and should feel confident in receiving any of these 
vaccines. They will help bring this pandemic to an end. And I 
strongly encourage all eligible Americans to get vaccinated and 
to get their children vaccinated. We all have an important role 
to play here.
    Second, diagnostic tests are key line of defense in the 
pandemic and will become increasingly important, I think. 
Increasing access to accurate, rapid, at-home tests is a 
priority for FDA. We prioritize the review of at-home, rapid 
antigen tests, and we are actively engaging with test 
developers to increase their availability.
    Last month, the agency authorized additional over-the-
counter, at-home tests, which we expect to significantly 
increase the availability of rapid tests to the public. These 
authorizations add to a growing list of tests that can be used 
at home without a prescription in the U.S.
    Additionally, last week, FDA provided recommendations for 
labeling updates to facilitate better over-the-counter, single-
use testing for symptomatic people. In tests currently, they 
are only authorized for serial testing. This change allows 
tests to be sold as single tests, meaning greater availability 
of more individual tests.
    FDA remains focused on speeding the process to get 
appropriately accurate and reliable tests in the hands of all 
Americans who need one.
    Third, there is a need for medical products to treat and 
prevent COVID-19, especially for those unable to get vaccinated 
or who do not develop an immune response. We continue to 
carefully evaluate the data on any promising therapeutics, and 
our priority is to have fast discussions between FDA and drug 
sponsors. We are hoping that we will see more therapeutics 
authorized soon to treat COVID-19 in the future as another 
weapon in our arsenal.
    Finally, I want to stress that all of FDA's work and effort 
is toward the goal of protecting the public. It is a 
responsibility we take seriously, and we rely on science. This 
is what allows us to expedite development and availability of 
medical products to address COVID-19.
    Thank you, and I look forward to your questions.

    [The prepared statement of Dr. Woodcock follows:]
                  prepared statement of janet woodcock
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    The Chair. Thank you.
    Assistant Secretary O'Connell.

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

    Ms. O'Connell. Chair Murray, Ranking Member Burr, and 
distinguished Members of the Committee, it is an honor to 
testify before you today. I am pleased to have this opportunity 
to provide a few key updates that have occurred in ASPR since I 
last testified before you in July. Ensuring the Nation has the 
necessary vaccines, therapeutics, and diagnostics to respond to 
COVID-19 remains a primary focus of ASPR's response.
    To date, BARDA has supported 77 medical countermeasure 
projects. This includes 15 therapeutics, 55 diagnostics, and 7 
vaccine candidates. Notably, as part of the countermeasures 
acceleration group effort with DOD, BARDA has placed 1.5 
billion doses of vaccine under contract, distributed over 4.88 
million doses of monoclonal antibodies, and shipped more than 
144 million diagnostic kits.
    Accelerating the supply of available rapid point-of-care 
and over-the-counter tests has been another important focus of 
ASPR's work. While there is currently enough testing capacity 
across all types of tests, we have seen a growing preference 
for rapid tests, especially those that can be used at home.
    Over the last few months, ASPR has invested over $3 billion 
to bring additional rapid point-of-care and at-home tests to 
market, with $1 billion of that going specifically to at-home 
tests.
    As production has ramped up since September, these 
investments put us on pace to quadruple by December the number 
of at-home tests available each month to nearly 200 million.
    Supporting hospitals and healthcare systems that are 
overwhelmed by COVID-19 patients is another important focus of 
ASPR's response. Since July, 27 National Disaster Medical 
System teams, nearly 600 team members, have deployed to support 
sites in 12 separate states. We currently have teams in 
Wisconsin, New Mexico, and Montana. For these deployments, NDMS 
personnel support a range of functions, including hospital 
augmentation and decompression, setting up medical overflow 
centers for patients, and offering mortuary support.
    Ensuring our healthcare providers and first responders have 
the necessary medical supplies they need remains a focus of 
ASPR's efforts. As of October 1st, the Strategic National 
Stockpile, or SNS, shipped more than 250 million items to aid 
the national response over the course of the pandemic, 
including deploying more than 3,000 ventilators to 17 
jurisdictions since I last testified. And, we continue our work 
to replenish the SNS to levels at or above pre-COVID-19 
amounts.
    Thanks in large part to the supplemental funding Congress 
has provided, the SNS has spent approximately $11.9 billion to 
replenish the inventory, including purchasing from domestic 
manufacturers whenever possible.
    While replenishing the SNS is essential, we continue to 
address the root cause of why public health supply chains were 
so strained in the first place. We are investing critical 
funding in expanding domestic manufacturing, including 
investments of $250 million in PPE manufacturing, $268 million 
in manufacturing of testing consumables, $14.8 million in 
vaccine raw material manufacturing, $160 million in fill finish 
capacity, $65 million in vaccine vial manufacturing, $186 
million in manufacturing capacity for at-home and point-of-care 
tests, and $53.8 million in testing raw materials, with 
additional funds going out the door every day.
    I firmly believe that running all of this from DC without 
the view from the states and regions is unwise, and I have made 
it a priority in my first few months to get out to our regional 
offices to meet with those teams and local leaders and 
understand the unique challenges they face. So far, I have been 
to four out of 10 regions, with plans to get out to all of them 
in the coming months.
    I have met with an NDMS team in New Orleans as it was 
decompressing a pediatric ICU unit this summer, and I have also 
hosted three Tribal consultations to ensure that Tribal nations 
and urban Indian organizations are able to access the SNS.
    I will continue to review, analyze, and adjust our response 
efforts based on what I am seeing and hearing in the field, and 
welcome any feedback you are hearing from your constituents and 
seeing when you are home.
    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, working with the team at 
ASPR, and our colleagues across HHS to end the pandemic.
    Thank you.

    [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.

               Update on ASPR's COVID-19 Response Effort
    The response to the COVID-19 pandemic has required an unprecedented 
whole of government approach. Secretary Becerra continues to direct me, 
in my capacity as the ASPR, to lead the ongoing coordination of the 
COVID-19 response across HHS. In this role I work closely with my 
fellow panelists on all facets of the Department's response, but please 
find here an update on the work for which the ASPR organization is 
chiefly responsible.
                   Countermeasures Acceleration Group
    As you are aware, 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 and continues to play a significant leadership 
and coordination role on behalf of HHS in the effort. This endeavor has 
delivered nearly 500 million vaccine doses, and over a million 
therapeutic doses to protect the American people from COVID-19.

    Over the past few weeks, the CAG has led the rollout and 
distribution of the Pfizer, Moderna, and Johnson & Johnson booster 
vaccines. These booster shots are being administered widely around the 
Country, and ample supply is available in the field to meet the needs 
for both booster and primary series vaccinations. The CAG continues to 
coordinate vaccine ordering and distribution to over 80,000 sites 
nationwide.

    This week, the CAG is in the process of distributing vaccines for 
children ages 5 through 11. 15 million doses have been made available 
for use around the Country in anticipation of high demand for this 
vaccine. Significant work with the states, Federal partners, 
territories, and pharmacy partners continues to ensure that there is 
ample vaccine available at locations where young children are likely to 
receive their vaccines.

    The CAG continues to support efforts to develop and distribute 
therapeutics. As the Delta variant created a summer surge of COVID-19 
cases across the Country, demand for monoclonals increased 20fold from 
the beginning of the surge to its peak. As a result, the CAG supported 
a rapid scale up of monoclonal antibody procurement and distribution to 
meet that rising demand. This included returning to an allocation 
system to ensure that all states had access to and could order the 
monoclonal antibodies they needed to treat COVID-19 patients in their 
jurisdictions. The CAG has also purchased, and continues to prepare 
for, the distribution of new oral antivirals should they obtain 
Emergency Use Authorization from the FDA.

    ASPR continues to prepare for the transition of the CAG into ASPR. 
Teams from HHS and DoD have been meeting for months to identify and 
assign key functions to be transitioned. A permanent Chief Operating 
Officer has been identified and is in the process of being brought on 
board. Individuals for other key positions are being hired. The Deputy 
Secretary of Defense and the Deputy Secretary of HHS meet each month to 
assess progress and will make the ultimate determination on when the 
transition is complete.
         Biomedical Advanced Research and Development Authority
    The Biomedical Advanced Research and Development Authority (BARDA), 
in its work with the CAG, continues to leverage the supplemental 
appropriations provided by Congress to support the development of 
vaccines, therapeutics and diagnostics to end the COVID-19 pandemic. 
BARDA has awarded contracts for 77 medical countermeasure projects to 
aid the COVID-19 response to date. All of these contract awards are 
listed on medicalcountermeasures.gov in detail and include 15 
therapeutics, 55 diagnostics, and seven vaccine candidates. Notably, 
BARDA has placed 1.5 billion doses of vaccine under contract (including 
a combination of adult primary, booster, and pediatric doses), 
distributed over 4.88 million doses of monoclonal antibodies, and 
shipped more than 144 million diagnostic kits.

    BARDA also supports research on expanding eligibility for the 
current authorized and approved vaccines as well as the continued 
development of vaccine candidates in the CAG portfolio that have not 
yet been authorized or approved. This ongoing work on vaccines is 
critical should a variant emerge that is resistant to the current 
authorized and approved vaccines or a new vaccine be developed that is 
easier to store, ship, and administer than the current authorized and 
approved vaccines.

    BARDA's work on therapeutics is critical as we seek to balance the 
ease of administration with the benefits of the treatment. For example, 
many of the currently available monoclonal antibodies are administered 
by infusion which must be done in clinical settings. BARDA's 
collaboration with NIH on developing oral antivirals--single pills that 
can be taken with a sip of water--may offer an important alternative to 
monoclonal antibodies should they be authorized by the FDA.

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

    Over the course of the COVID-19 response, the SNS has worked to 
backstop states' medical supply needs at an accelerated pace. As of 
October 1, 2021, the SNS has deployed more than 250 million items to 
aid the national response including Personal Protective Equipment 
(PPE), ventilators, Federal Medical Stations, and pharmaceuticals. In 
particular, the SNS deployed more than 3,000 ventilators to 17 
jurisdictions since July to respond to the Delta variant case surge. I 
highlighted in my testimony in July that ASPR continues to work to 
replenish SNS inventory to levels at or above pre-COVID-19 amounts to 
ensure we are prepared for any subsequent wave of additional cases and 
to do so--to the extent possible--with domestically manufactured 
supplies and equipment.

    As of October 25, 2021, the SNS has utilized approximately $11.9 
billion from COVID-19 supplemental appropriations provided by Congress 
to have in its inventory approximately: 708 million N95 respirators (56 
times pre-pandemic levels); 274 million surgical and procedure face 
masks (8.5 times pre-pandemic levels); 19.6 million face shields (two 
times pre-pandemic levels); 59.6 million gowns and coveralls (12.5 
times pre-pandemic levels); 3.21 billion gloves (190 times pre-pandemic 
levels); and 167,000 ventilators (10 times pre-pandemic levels). SNS 
has also made investments to ensure there is capacity to make these 
critical supplies.

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

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

    Throughout the COVID-19 response, ASPR has leveraged the 
authorities delegated to the Secretary under the Defense Production Act 
(DPA) to issue 62 priority ratings for U.S. Government (USG) contracts 
for health resources, eight priority ratings for USG contracts for 
industrial expansion, three priority ratings for non-USG contracts to 
support the production of resins for both diagnostics and infusion 
pumps, and the manufacture of closed suction catheters for treatment of 
patients with COVID-19--all to ensure private sector partners making 
life-saving products are able to acquire the raw materials, components, 
and products requisite to deliver for the response.

    Also under the DPA, ASPR is strengthening the industrial base to 
secure and develop domestic capacity, retool and expand industry 
machinery, scale production facilities, train workforces, and 
ultimately infuse the supply chain and marketplace with products the US 
needs to contain further pandemic waves. ASPR continues to invest in 
critical funding in expanding domestic manufacturing including 
investments of: $250M in manufacturing PPE; $268M in manufacturing of 
testing consumables; $14.8M in vaccine raw material manufacturing; 
$160M in fill finish capacity; $65M in vaccine vial manufacturing; 
$168M in manufacturing capacity for at home and point of care tests; 
and, $53.8M in testing raw materials, with additional funds going out 
the door every day. Each of these domestic manufacturing initiatives 
meets current, as well as future COVID-19 needs, and seeks to create or 
sustain high-value domestic jobs.

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

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

    While we wait for the issuance of the HHS IG Report, the National 
Academies has reviewed at our request the Public Health Emergency 
Medical Countermeasures Enterprise (PHEMCE), the interagency group of 
experts that advise, among other things, what should go into the SNS. 
The report is planned for release November 3, 2021. I am currently 
reviewing a final draft of this report and will consider its findings 
and recommendations to fully leverage the PHEMCE when considering what 
should be held in the SNS.

    Restoring and rebuilding the SNS is one of my priorities and I look 
forward to reviewing both of these reports and incorporating their 
findings or recommendations into the strategic work we are undertaking 
to rebuild and restore the stockpile and realign it with the PHEMCE. I 
would be happy to discuss both of these reports with this Committee 
once they are released and made public.
                     Healthcare System Preparedness
    Next, I want to share more about ASPR's work to prepare our 
healthcare system to surge to meet the demands of those being treated 
for COVID-19, without compromising day-to-day healthcare needs.

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

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

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

    Further, if a public health or healthcare system becomes 
overwhelmed with patients, states can request National Disaster Medical 
System (NDMS) personnel to provide additional support. Since July, 24 
NDMS teams--nearly 500 team members--were deployed to ten states in 
support of the Delta surge efforts. For the COVID-19 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.

    Of note, this critical system requires a renewal of its direct 
hiring authority, which was set to expire on September 30, but was 
extended as part of the continuing resolution. NDMS has utilized this 
authority to bring on additional personnel--over 1000 personnel hired 
to date--and will continue to utilize the expedited authority, if 
extended by Congress, to continue to enhance the force.
                                Testing
    In addition to the Industrial Base Expansion efforts I mentioned 
previously, ASPR continues to support COVID-19 testing for the Nation. 
The HHS Testing and Diagnostics Working Group (TDWG) mission was 
established early in the pandemic to increase testing capacity through 
interagency coordination and partnerships with industry and state, 
tribal, local, and territorial public health agencies. TDWG was created 
as part of the Federal response to COVID-19 in March 2020, residing 
with Operation Warp Speed temporarily, and then established under the 
Office of the Assistant Secretary of Health (OASH) leadership and was 
located in the Joint Coordination Cell (JCC) run by the U.S. Coast 
Guard. In March 2021, when the JCC was officially stood down, TDWG's 
administrative and contracting support were moved to ASPR.

    Over the last several months ASPR has worked hand-in-glove with the 
CDC, NIH, FDA, and DoD to make over $3 billion in investments to bring 
additional rapid point of care (POC) and Over-the-counter (OTC) COVID-
19 tests to market. This investment spurred a significant ramp up in 
testing production. Since September, we have been on track to nearly 
quadruple the number of rapid, at home COVID-19 tests available by 
December to nearly 200M tests per month.

    ASPR's TDWG executed two significant testing programs: Increasing 
Community Access to Testing (ICATT) and Operation Expanded Testing 
(OpET). ICATT provides no-cost testing to underserved populations and 
OpET expands testing capacity in Kindergarten through 12th grade 
schools and underserved congregate settings. As a result of these two 
programs, the ASPR TDWG shipped over 40 million rapid antigen tests and 
2.3 million point of care PCR tests to our most vulnerable populations, 
including nursing homes, federally qualified health centers, and long-
term care facilities since May 2021.
                               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 witnesses. We 
will now begin a round of 5-minute questions of our witness. I, 
as always, ask my colleagues, please keep track of your clock 
and stay within those 5 minutes.
    The FDA's Emergency Use Authorization of the Pfizer vaccine 
for children 5 to 11 years old is really a big step in the 
pandemic response. It will make 28 million children eligible to 
receive a vaccine. And given the spread of variants, getting 
kids vaccinated is really critical to protecting them, while 
also protecting our educators and our parents and other 
caregivers.
    Dr. Woodcock, I wanted to ask you, can you describe FDA's 
thorough review of scientific evidence in making this decision, 
as well as your advice to parents who are hesitant to get their 
children vaccinated?
    Dr. Woodcock. Yes, certainly. The FDA first reviewed the 
manufacturing of a new dosage form because the children need a 
lower dose. That was very carefully reviewed, as well as the 
stability of the new dose to make sure that it was appropriate.
    Then, all the data on the children were reviewed at the 
patient level. In other words, we went to the raw data and re-
reviewed that and made sure that the evidence that was 
presented to us accurately reflected both the data on 
effectiveness, on efficacy, on the immune response, and on 
safety. And, we looked at all the adverse events to make sure 
that they were properly reported and that we understood the 
magnitude of those events.
    In this trial of thousands--where thousands of children 
received the vaccine, ages 5 to 11, we saw mostly very mild to 
moderate flu-like symptoms primarily after vaccine, or a sore 
arm, which people can expect after getting a shot.
    But, we did not see any serious adverse events, and the 
vaccine was over 90 percent protective. So, we feel very 
confident, along with all the adolescent data that we have on 
this vaccine and all the data on administration to adults that 
this vaccine is safe and appropriate for children, and it will 
protect them from severe COVID.
    The Chair. Thank you. Dr. Walensky, this morning, OSHA 
released an emergency temporary standard to protect workers 
against COVID-19. This is a critical step to reducing workplace 
transmission and making workplaces safer nationwide, especially 
for our frontline workers who are at high risk of COVID-19.
    Can you just speak to us from a public health perspective 
about the urgent need to get more Americans vaccinated and the 
importance of implementing measures to protect people from 
infection in higher risk settings like our workplaces?
    Dr. Walensky. Yes. Thank you so much. We have had 745,000 
deaths from this disease, and we are continuing to have about 
75,000 cases every single day.
    We know the most destructive thing in a workforce is to 
have a COVID outbreak and to have workers in that workforce 
come down with COVID infection, severe disease, and in some 
cases, death.
    Vaccination, as we have seen, decreases your risk of 
infection by six-fold; decreases your risk of hospitalization 
and death by 10-fold, even during this Delta surgery.
    There is absolutely a public health priority to get people 
vaccinated and to continue the important prevention and 
mitigation strategies, including masking, to keep them safe.
    Thank you.
    The Chair. Thank you. This is a question for the whole 
panel, and I don't have much time left, but I would use my 
Chair prerogative to ask all of you because it is an issue we 
are all concerned about--Senator Burr mentioned it--and that is 
the issue of testing.
    We know diagnostic testing is critical. We have had--but we 
have continued to experience critical challenges with testing: 
shortage of rapid tests, not enough locations to get tested, 
supply chain issues, and more.
    I would like to ask all of you quickly to respond. What is 
your agency doing to make sure our Country is well equipped to 
handle current and future testing needs? And I will begin with 
Dr. Walensky.
    Dr. Walensky. Yes. Thank you so much. So, we are working 
with states and jurisdictions to make sure we can provide 
technical assistance on how best to utilize these tests. This 
is important in the school districts, as well. Ten billion 
dollars in school districts to utilize testing. We provide 
technical assistance as to how to utilize it, and peer-to-peer, 
school-to-school advice on how best to utilize the testing 
program, as well as the hiring of school nurses in order to use 
the testing program.
    The Chair. Thank you.
    Dr. Woodcock.
    Dr. Woodcock. We have streamlined recently our standards 
and approach for over-the-counter tests, so we--as I said in my 
testimony, so that we hope they should get out more quickly.
    We prioritize testing that--where there is a public health 
need, which right now is the over-the-counter tests, and we 
also try to move very quickly those manufacturers that can make 
large supply of tests because there is still an unmet need 
there.
    We think between that, we have authorized 11 over-the-
counter tests and expect more to come. Between that and what 
ASPR is doing, that the supply should increase rapidly.
    The Chair. Ms. O'Connell.
    Ms. O'Connell. Thank you, Chair Murray. We have invested $3 
billion in the last 2 months on increasing production and 
supply of rapid point-of-care and at-home tests. One billion of 
that focused exclusively on at-home tests. So, we continue to 
try to get those out.
    We also, through HRSA, started a pilot program which would 
provide free at-home tests through their federally Qualified 
Health Centers. So, for those families that are not able to 
afford the tests in the pharmacies, this would allow free 
access.
    The Chair. Dr. Fauci.
    Dr. Fauci. Yes, thank you, Madam Chair. The NIH is 
prioritizing the development of affordable, at-home tests 
through a program called the Independent Test Assessment 
Program, or ITAP, which we will provide reliable, independent 
laboratory and clinical tests to the FDA for the manufacturers 
so that they can scale up quickly. And if the tests meet the 
FDA's performance and quality standards, the FDA hopefully will 
then give an Emergency Use Authorization.
    We are providing data for the companies to be able to 
expedite the availability of tests that are rapid, efficient, 
and point-of-care.
    The Chair. Thank you.
    Senator Burr.
    Senator Burr. Thank you, Chair.
    This question is directed to Doctors Fauci and Walensky.
    In January, an NIH study found that 95 percent of people 
who had recovered from COVID had at least three out of five 
components needed to recognize the virus up to 8 months after 
infection.
    In August, Israeli researchers found that the natural 
immunity can confer longer-lasting and stronger protections 
against infection, severe disease, and hospitalization 
resulting from the Delta variant.
    Rockefeller University found that while vaccination induces 
memory B cells to evolve over the course of a few weeks, 
natural infection produces memory B cells that improve for up 
to 1 year after infection. This is likely because remnants of 
the virus remain in the body for longer than a vaccine would, 
which gives the body more time to adapt to it.
    I understand that it is not all Black and white. U.K. 
researchers released study results suggesting that fully 
vaccinated individuals who had COVID-19 have the highest 
immunity.
    Additionally, last week, CDC published a new report that 
found unvaccinated people who had previously been infected were 
five times more likely to test positive for COVID-19 than 
people who were fully vaccinated with an mRNA vaccine.
    My question is simple. What does the science say about the 
durability of natural immunity, and when can we expect answers 
on its benefit?
    Dr. Walensky. Thank you so much, Senator Burr.
    The CDC did publish a 96-page paper review in a scientific 
brief on Friday. I want to be very clear that the CDC continues 
to recommend that people--after review of that scientific 
brief, the CDC continues to recommend that people who have been 
previously infected get their COVID-19 vaccine.
    We know in our vaccine studies, our vaccine effectiveness 
studies, with date certain when people were vaccinated, and we 
can prospectively follow them through our effectiveness studies 
and our effectiveness cohorts. Through that, we can see the 
durability with a date certain in vaccines.
    The data on the infection-induced immunity, some of which 
you quoted, are murkier. They rely on retrospective studies, 
observational studies, and studies where we cannot do a 
prospective study.
    We are following these people. We are following people who 
have been previously infected in our infection cohorts, but the 
data and the science are harder.
    You talked about infection-induced immunity with B cells, 
memory B cells and antibodies, but another arm of the immune 
system, the T cells, are harder to study and harder to evaluate 
in--to try and do this in a commercial type fashion.
    What I would say is the final study that you cited, which 
was the study from the CDC that retrospectively looked at a 
cohort of people who had been previously infected and those who 
had been previously vaccinated. And, as you noted, there was a 
five-and-half-times fold more likely chance of being diagnosed 
with COVID if you had infection-induced rather than vaccine-
induced immunity, and that is among the studies that we 
reviewed that led us to our current recommendations.
    Senator Burr. Dr. Fauci.
    Dr. Fauci. Just to add a little bit to that, Senator Burr, 
the studies you refer to were NIH-funded studies about B cell 
and T cell responses by NIH grantees.
    It is true that, as a matter of fact, both from natural 
infection, as well as from vaccine-induced immunity, you have 
not only antibody responses, but you have the development and 
the maturation of memory B cell responses and T cell responses.
    One of the goals over the next several months, which are 
currently being done by our grantees, is to determine the 
clinical correlation between the development and maturation of 
B cell and T cell responses and clinical effect. And we are 
looking at that both post-vaccination, post-boost, and in 
individuals who have been infected. Hopefully, we will get more 
definitive information over the next several months.
    Senator Burr. Should an individual who has recovered from 
COVID be exempt from the mandate to be vaccinated given that 
they have natural immunity?
    Dr. Walensky. CDC recommendation suggests that you have 
more--both more durable and robust and known immune response if 
you are vaccinated after you have been previously infected, and 
those are our recommendation.
    Senator Burr. Do children 5 to 11 who have recovered from 
COVID, should they be vaccine exempt?
    Dr. Walensky. Our guidance continues to recommend that 
children who have been previously infected actually get 
vaccine. We--as we--data are emerging on the impact of natural 
infection in adults. Our data are still even sparser among 
children.
    Senator Burr. How does the concentration of antibodies in a 
recovered COVID-positive patient compare to an individual 6 
months after they have had a vaccination?
    Dr. Fauci. It really varies from study to study. The one 
thing that we do know that is very important when you talk 
about post-infection immunity is that when you vaccinate a 
person following recovery from infection, the level of 
antibodies are considerably higher than post-infection alone, 
and higher than vaccination alone.
    The best combination of high degree of laboratory-related 
protectiveness is if a person who gets infected and recovers 
ultimately gets vaccinated. That looks like the most powerful 
of the protective responses.
    Senator Burr. Clearly, I understand that from the data. My 
question is on whether a COVID-positive, recovered patient 
should be mandated to take a vaccine.
    If they have not had COVID, then you take a vaccine to 
boost your immunity level to a certain degree. COVID-positive 
patients have already done that, and I am just telling you, it 
is a hard sale to tell people who have had COVID that they are 
now under a mandate--mandate by the Federal Government--to be 
vaccinated.
    I think you have got an extremely tough sale to a 
healthcare professional, doctor, nurse, who had COVID, might 
have a hesitancy about the vaccine. And, I look at what ASPR is 
required to do to fill in for the healthcare vacancies that 
exist out there and surge people to it.
    You start doing this to people, Medicare, Medicaid 
providers, community health centers, we are going to--we are 
not going to have the people to surge, Dawn, from the 
healthcare professionals that make a decision, I had a natural 
immunity, I have got some protection, but I do not yet believe 
I need to be vaccinated. I think we need to think about this.
    Thank you, Chair.
    The Chair. Senator Kaine.
    Senator Kaine. Thank you, Chair Murray, and thank you to 
the witnesses, the Ranking Member.
    I am going to ask about two topics: supporting the mental 
health of our frontline healthcare workers that has been such a 
challenge in this time, and long COVID.
    To Dr. Walensky, I will address you first. We talked about 
this before. The pandemic has taken a huge toll on frontline 
healthcare workers. This Committee has come together in a 
bipartisan way to help pass the Lorna Breen Healthcare Provider 
Protection Act. It passed the Senate in August, and it is 
actually being marked up in the House today, the Health 
Subcommittee. I am happy about that. We are proud to have 
worked together with folks in this body to get $140 million of 
funding for this initiative in the American Rescue Plan.
    Dr. Walensky, we worked closely with Dr. Breen's family for 
over a year to build support for the work, introduce the 
legislation, get funding in the American Rescue Plan, and we 
are encouraged by progress that is being made on this 
bipartisan initiative.
    As the CDC works to implement this bill and use these funds 
to promote education and awareness campaigns, what can those of 
us who have worked on this bill, who care very much about this 
issue, do to help the CDC effectively communicate with our 
frontline healthcare workers that there are resources and help 
available for them?
    Dr. Walensky. Thank you so much, Senator Kaine, and thank 
you so much for your leadership in this very much needed bill 
and these resources.
    First, let me just give you a sense of the scope of the 
challenges and the problems that we face.
    CDC published in an MMWR several weeks ago, not just in 
healthcare, but also in our public health workforce, half of 
the people had--half of the people surveyed had more than one 
mental health challenge in the year prior. One-third reported 
depression. One-third reported anxiety. Eight percent of our 
public health workforce reported suicidal ideation in the past 
year.
    When we talk about our healthcare workers, yes, we are 
hearing about our places that are stressed with COVID surges, 
but we are not hearing about our public--our healthcare workers 
who are left after those surges, who are taking care of people 
where amputations are higher rates than we have ever had 
before. Missed cancer diagnoses because of missed care. This is 
what is impacting our public health--our healthcare workers, 
and these resources are now----
    Some of these resources are now with NIOSH so that we can 
provide them for mental health, for resources for support, 
for--to research what it is that they need so that we can 
provide this healthcare workforce, as well as our public health 
workforce, the resources that they desperately need. I am very 
grateful. Thank you.
    Senator Kaine. Thank you. Dr. Fauci, on long COVID, I have 
had COVID and I am still dealing with nerve tingling issues, 18 
months after having had it. They are mild, thank goodness, but 
others who are dealing with long COVID effects, they are not so 
mild--fatigue, respiratory, cardiac, other issues.
    What updates can you provide about NIH research on efforts 
to better understand the symptoms of long COVID and how to 
expand treatment options for patients who have this condition?
    Dr. Fauci. Yes. Thank you very much for that question, 
Senator. This is a very important problem, which we take very 
seriously at NIH.
    Since our last hearing, when you also brought up that very 
important question, we have now in full implementation of a 
program called RECOVER Program, which is about a $1.5 billion 
program, looking at the formation of large cohorts of 
individuals to be able to study them from the standpoint of the 
incidence, the prevalence, and importantly, what the pathogenic 
mechanisms of symptoms, such as your tingling.
    But even, as you mention correctly, so many people have 
much more severe in the sense of almost incapacitating fatigue, 
sleep abnormalities, a variety of other things.
    There is three components to the program that we have just 
recently awarded. One is a significant amount of resources to 
the NYU Langone Center in New York, which takes the scientific 
lead for the program. The data collection will be led by 
Massachusetts General Hospital and Harvard Medical School, and 
the repository for specimens will be led by Mayo Clinic. Since 
we last spoke, all three of those have now become operable, and 
hopefully, the next time we speak in a situation like this, I 
will be giving--able to give you some scientific data that 
resulted from those studies.
    Thank you.
    Senator Kaine. Thank you very much for that answer.
    I yield back, Chair Murray.
    The Chair. Senator Paul.
    Senator Paul. Dr. Fauci, I do not expect you today to admit 
that you approved of NIH funding for gain-of-function research 
in Wuhan, but your repeated denials have worn thin in a 
majority of Americans, frankly, and do not believe you.
    Even the NIH now admits that EcoHealth Alliance did perform 
experiments in Wuhan that created viruses not found in nature 
that actually did gain in lethality.
    The facts are clear. The NIH did fund gain-of-function 
research in Wuhan, despite your protestations. You can deny it 
all you want, but even the Chinese authors of the paper, in 
their paper, admit that viruses not found in nature were 
created, and yes, they gained in infectivity. Your persistent 
denials, though, are not simply a stain on your reputation, but 
are a clear and present danger to the Country and to the world.
    As Professor Kevin Esvelt of MIT has written, gain-of-
function research looks like a gamble that civilization can't 
afford to risk, and yet, here we are again, with you, steadfast 
in your denials.
    Why does it matter? Because gain-of-function research with 
laboratory-created viruses not found in nature could cause a 
pandemic even worse the next time. We are suffering today from 
one that has a mortality of approximately 1 percent. They are 
experimenting with viruses that have mortalities of between 15 
and 50 percent.
    Yes, our civilization could be at risk from one of these 
viruses. Experiments that combine unknown viruses with known 
pandemic-causing viruses are incredibly risky. Experiments that 
combine unknown viruses with coronaviruses that have as much as 
50 percent mortality could endanger civilization as we know it. 
And here you sit, unwilling to accept any responsibility for 
the current pandemic, and unwilling to take any steps to 
prevent gain-of-function research from possibly unleashing an 
even more deadly virus.
    You mislead the public by saying that the published viruses 
could not be COVID. Well, exactly no one is alleging that. No 
one is alleging that the published viruses by the Chinese are 
COVID.
    What we are saying is that this was risky type of research, 
gain-of-function research. It was risky to share this with the 
Chinese and that COVID may have been created from a not-yet-
revealed virus.
    We do not anticipate the Chinese are going to reveal the 
virus if it came from their lab. You know that, but you 
continue to mislead. You continue to support NIH money going to 
Wuhan. You continue to say you trust the Chinese scientists. 
You appear to have learned nothing from this pandemic.
    Will you today finally take some responsibility for funding 
gain-of-function research in Wuhan?
    Dr. Fauci. Senator, with all due respect, I disagree with 
so many of the things that you have said.
    First of all, gain-of-function is a very nebulous term. We 
have spent--not us, but outside bodies--a considerable amount 
of effort to give a more precise definition to the type of 
research that is of concern that might lead to a dangerous 
situation. You are aware of that. That is called P3CO.
    Senator Paul. We are aware that you deleted gain-of-
function from the NIH website.
    Dr. Fauci. Well, I can get back to that in a moment if we 
have time, but let's get back to the operating framework and 
guiderails of which we operate under, and you have ignored 
them.
    The guidelines are very, very clear that you have to be 
dealing with a pathogen that clearly is shown and very likely 
to be highly transmissible in an uncontrollable way in humans; 
and to have a high degree of morbidity and mortality; and that 
you do experiments to enhance that. Hence, the word EPPP, 
Enhanced Pathogens of Potential Pandemic.
    Senator Paul. When EcoHealth Alliance took the virus----
    Dr. Fauci. Well, can I--I would love to finish.
    Senator Paul [continuing]. SHC014 and combined it with WIV1 
and caused a recombinant virus that does not exist in nature 
and it made mice sicker, mice that had humanized cells, you are 
saying that is not gain-of-function research?
    Dr. Fauci. According to the framework and guidelines of----
    Senator Paul. What you are doing is defining away gain-of-
function.
    Dr. Fauci. No.
    Senator Paul. You are simply saying it does not exist 
because you changed the definition on the NIH website. This is 
terrible, and you are completely trying to escape the idea that 
we should do something about trying to prevent a pandemic from 
leaking from a lab. There is----
    The preponderance of evidence now points toward this coming 
from the lab, and what you have done is change the definition 
on your website to try to cover your ass, basically. That is 
what you have done. You have changed the website to try to have 
a new definition that does not include the risky research that 
is going on.
    Until you admit that it is risky, we are not going to get 
anywhere. You have to admit that this research was risky.
    The NIH has now rebuked them. Your own agency has rebuked 
them.
    Dr. Fauci. That is----
    Senator Paul. But, the thing is, is you are still unwilling 
to admit that they gained in function when they say they became 
sicker. They gained in lethality. It is a new virus. That is 
not gain of function?
    Dr. Fauci. According to the definition that is currently 
operable----
    Senator Paul. (Laughter)
    Dr. Fauci. Senator, the new--let's make it clear for the 
people who are listening.
    The current definition was done over a 2- to 3-year period 
by outside bodies, including the NSABB, two conferences by the 
National Academy of Science, Engineering and Medicine, on 
December 2014, March 2016.
    We commissioned external risk-benefit assessment.
    And then, on January 2017, the Office of Science and 
Technology Policy of the White House issued the current policy.
    Senator Paul. And coincidentally----
    Dr. Fauci. I have not changed----
    Senator Paul [continuing]. The definition appeared----
    Dr. Fauci [continuing]. Any definition.
    Senator Paul [continuing]. On the same day the NIH said 
that yes, there was a gain of function in Wuhan. The same day 
the definition appeared, the new definition, to try to define 
away what is going on in Wuhan.
    Until you accept it, until you expect--accept 
responsibility, we are not going to get anywhere close to 
trying to prevent another lab leak of this dangerous sort of 
experiment. You will not admit----
    Dr. Fauci. Well----
    Senator Paul [continuing]. That it is dangerous, and for 
that lack of judgment, I think it is time that you resign.
    The Chair. Thank you, Senator Paul, and I would like to 
give the time to Dr. Fauci.
    Dr. Fauci. Yes. Well, there were so many things that are 
egregious misrepresentation here, Madam Chair, that I do not 
think I would be able to refute all of them. But, just a couple 
of them for the listeners to hear for.
    You said that I am unwilling to take any responsibility for 
the current pandemic. I have no responsibility for the current 
pandemic. The current pandemic. Okay?
    No. 2. You said the overwhelming amount of evidence 
indicates that is a lab leak. I believe most card-carrying 
viral biologists and molecular virologists would disagree with 
you; that it is much more likely, even though we leave open all 
possibilities, it is much more likely that this was a natural 
occurrence.
    Third. You say we continue----
    Senator Paul. You tested 80,000 animals and no animals----
    The Chair. Senator Paul, please----
    Senator Paul [continuing]. Have been found with COVID.
    The Chair. Senator Paul, the time is for----
    Dr. Fauci. And third.
    The Chair [continuing]. Dr. Fauci to respond.
    Dr. Fauci. You made a statement just a moment ago that is 
completely incorrect when you say we continue to support 
research at the Wuhan Institute of Virology, which----
    Senator Paul. You approved it in August of last year.
    Dr. Fauci. No, no. Your statement says, quote--I wrote it 
down as you were writing--you continue to support research at 
the Wuhan Institute of Virology.
    Senator Paul. You were in Committee a month ago and said--
--
    Dr. Fauci. Which----
    The Chair. Senator Paul.
    Senator Paul [continuing]. You still trust the Chinese 
scientists and you still support the research over there. You 
said it a month ago in Committee.
    The Chair. Senator Paul, I have allowed Dr. Fauci to 
respond. You have had your time. I am going to give him----
    Senator Paul. He is going----
    The Chair [continuing]. One more minute.
    Senator Paul [continuing]. To be dishonest. He ought to be 
challenged.
    The Chair. Senator Paul, we will allow Dr. Fauci to respond 
after you have given accusations like that.
    Dr. Fauci.
    Dr. Fauci. Well, I do not have any more to say except to 
say that, as usual--and I have a great deal of respect for this 
body of the Senate, and it makes me very uncomfortable to have 
to say something, but he is egregiously incorrect in what he 
says. Thank you.
    The Chair. Thank you.
    Senator Paul. History will figure that out on its own.
    The Chair. We will turn to Senator Hassan. Thank you.
    Senator Hassan. Thank you, Madam Chair and Ranking Member 
Burr. I want to thank all the witnesses, too, for being here 
today and for your work. I want to start with a question to 
Assistant Secretary O'Connell.
    Last month, I sent a letter to Health and Human Services 
Secretary Becerra, highlighting the difficulty that some 
Granite Staters have faced in accessing COVID-19 rapid tests 
and urging the Secretary to take action. These tests are 
essential tools to help ensure that people can stay safe, kids 
can stay in school, and we can keep our economy open.
    Assistant Secretary O'Connell, what will the Department do 
to address the issues raised by my constituents in New 
Hampshire about access to COVID-19 rapid tests?
    Ms. O'Connell. Senator Hassan, thank you so much for the 
question, and of course, thank you for the letter.
    Your letter raised two key points: one, the amount of time 
it was taking for some of your constituents to get their 
results, and the other was the lack of the over-the-counter 
tests in New Hampshire.
    We responded to both. The ASPR testing team reached out to 
the state health official to understand the delay and learned 
that the average turnaround time right now is about 1.1 days, 
though it sounds like your constituents had some different 
experiences. We will continue to watch that.
    The second issue was about the lack of over-the-counter 
tests. The team reached out to Abbott, and they have now 
secured the 60,000 tests that New Hampshire has ordered. They 
will come in 10,000 increments for 6 weeks, so you should have 
60,000 tests in New Hampshire by Christmas.
    Senator Hassan. Thank you very much. I appreciate that. I 
know my constituents do, too, especially parents of school-age 
children who want to get those results quickly so the kids can 
get back into the classroom.
    Dr. Fauci, as I think probably some colleagues have already 
noted, but I wanted to talk about the availability of vaccines 
for younger children. I think all families in New Hampshire 
were relieved when the Food and Drug Administration and the 
Centers for Disease Control signed off on Pfizer's COVID 
vaccine for children ages 5 to 11 last week.
    At a hearing earlier this year, I asked when you 
anticipated that vaccines would be available for children of 
all ages, and you told me that you thought vaccines would be 
ready for children of any age by the end of the year. Do you 
still anticipate that vaccines will be available for children 
under age 5 by the end of the year?
    Dr. Fauci. I do not know--when you say available, Senator, 
that is the difference between the clinical studies----
    Senator Hassan. Right.
    Dr. Fauci [continuing]. That are done to show the data. 
Currently, as we are speaking now, the age de-escalation 
studies are part of the spectrum. One of the spectrum was what 
you just heard of, 5 to 11. The data were convincing. You have 
heard of the results from Dr. Woodcock and Dr. Walensky.
    The studies are ongoing now from 6 months up to 2 years, 2 
years to 5 years.
    Senator Hassan. Right.
    Dr. Fauci. I would anticipate, I would have hope that the 
data might be available by the end of the year. I would say--
and again, it is very difficult to make predictions because you 
do not want to get ahead of the data, and you do not want to 
get ahead of the FDA's analysis.
    Senator Hassan. But you are thinking--I am just trying to 
get a sense of timeline.
    Dr. Fauci. Yes. I would think it might be toward the 
beginning of the coming year or the end of this year, I hope.
    Senator Hassan. Thank you very much.
    Dr. Woodcock, I wanted to shift to another issue because, 
of course, while we are dealing with the pandemic, we also 
continue to deal with the opioid epidemic.
    I recently sent you a bipartisan letter about the 
consulting firm McKinsey, which simultaneously worked for both 
opioid manufacturers, such as Purdue Pharma, and for the FDA on 
a variety of projects, including a track-and-trace system to 
monitor dangerous prescription drugs.
    The FDA response to my letter stated that McKinsey never 
disclosed these potential conflicts of interest, and that the 
FDA only learned about them earlier this year, nearly a decade 
later, through media reports.
    McKinsey's work for Purdue Pharma was made public in major 
news--a major new story last year, and McKinsey issued a public 
apology for its actions last year, as well.
    Why wasn't the FDA aware of McKinsey's work for Purdue last 
year when it was front-page news and McKinsey was speaking 
publically about it?
    Dr. Woodcock. Well, at least speaking for myself, I was 
aware of that. At that time, McKinsey was only doing consulting 
work of an administrative nature for the FDA. And, so, the--
there was nothing that had to do with any product or any 
standard or anything like that. It had to do----
    Senator Hassan. Doctor, I am sorry to interrupt, but I am 
almost out of time. I just want to point out that they were 
consulting on a track-and-trace system to monitor dangerous 
prescription drugs; that your response to my letter also says 
that since finding out about McKinsey's work for Purdue, quote, 
no additional contract reviews or outreach to McKinsey has 
occurred.
    I will--because my time is about to--or has expired, I will 
follow-up with you and the FDA. It seems to me we have a major 
conflict of interest between McKinsey's work for McKesson and 
Purdue at the same time it was working for the FDA on track-
and-trace system, and it is something we really have to get to 
the bottom of it because I think it helped fuel the opioid 
epidemic----
    Dr. Woodcock. I would be----
    Senator Hassan [continuing]. Which has devastated my state. 
Thank you, Madam Chair.
    Dr. Woodcock [continuing]. Happy to work with you.
    The Chair. Thank you.
    Senator Collins.
    Senator Collins. Dr. Fauci, first let me make clear that I 
believe in the efficacy of vaccines and have encouraged my 
constituents to become vaccinated, but I am hoping you can 
explain what appears to be a contradiction when I look at the 
data for the State of Maine.
    Maine ranks in the top five states in the number of people, 
the percentage of people, who have been vaccinated. In fact, 95 
percent of those over age 65 have been fully vaccinated, and 
yet, Maine has the 15th highest confirmed deaths from COVID on 
a per-capita basis.
    Our hospitals are overwhelmed. We have seen a 6-percent 
increase in hospitalizations; 18 percent increase in people in 
the ICU; a 37 percent increase in people on ventilators 
recently. And while it is largely individuals who are 
unvaccinated, there are some that are breakthrough cases, and 
all of us know individuals who, despite being fully vaccinated, 
have experienced COVID.
    Can you explain to me why a state that has done a terrific 
job in getting people vaccinated has--is seeing this surge in 
cases that is overwhelming our hospitals and causing great fear 
and pain and loss?
    Dr. Fauci. Well, thank you for that question, Senator.
    Well, first of all, I think you did say something just a 
moment ago that I think is part of the explanation. You said 
that most of them are among people who are unvaccinated. 
However, and it is quite true, that there are breakthrough 
infections because no vaccine is a hundred percent protective, 
and you will always get breakthrough infections.
    In general, for the most part, breakthrough infections for 
people who have been vaccinated, all other things being equal, 
are usually less severe, do not lead as much to 
hospitalizations, and do not lead to as much as death.
    The data, though, in general, as was mentioned I think 
specifically the numbers that were given by Dr. Walensky, are 
incontrovertible, that a vaccinated compared to an unvaccinated 
person has a multifold less likelihood of being infected, a 
multifold less likelihood of being hospitalized or dying.
    I think there are probably confounding multiple factors 
going into the difficult situation that your citizens in your 
state are going through. But, there is no doubt that the 
vaccine is clearly much, much better in the sense of protecting 
you from infection, hospitalizations, or death compared to the 
unvaccinated.
    Senator Collins. Dr. Walensky, parents, teachers, and 
pediatricians have all talked to me about the learning loss, 
the emotional and behavioral health programs--problems, rather, 
that have occurred among children due to their not being in 
school.
    In contrast to the quarantining option, the test-to-stay 
approach allows asymptomatic students who test negative for 
COVID to remain in school rather than quarantining after 
another student or a staff member has tested positive for the 
virus.
    A Lancet study shows that case rates were not significantly 
higher at schools that use the test-and-stay approach versus 
schools that require students to miss school and quarantine at 
home. And, indeed, your home State of Massachusetts has adopted 
a test-to-stay strategy.
    Brown University Professor Emily Oster has expressed great 
frustration with the CDC as being slow to take a stronger 
position in favor of tests to stay, asking what evidence are 
they waiting for. She says school quarantines should end and be 
replaced with tests to stay, or nothing.
    Another public health expert says simply, it is madness to 
quarantine school children. The CDC policies hinder learning 
and provide no meaningful reduction in COVID transmissions.
    My question for you is, why doesn't the CDC issue guidance 
or recommendations to encourage school districts to adopt test 
and stay in order to avoid these highly disruptive quarantines 
of students who are asymptomatic and could be tested?
    Dr. Walensky. Thank you, Senator. Thank you for that 
question. When you and I spoke in this room, or in this venue 
in July, we shared the priority of getting our children back to 
school. I have said it is the first place that should be open 
and the last place--the first place that should be open and the 
last place to close.
    In that context, we have studies just this school year that 
have demonstrated that we have 96 percent of our schools open, 
for which I am very pleased. And still, we have 4 percent of 
schools, over a million children, who have been impacted by 
COVID-related outbreaks and those schools have had to be 
closed.
    Our data also demonstrate that our prevention measures have 
been working, and schools that are practicing their prevention 
measures, including masking, they have been three and a half 
times less likely to close because of a COVID-related outbreak 
than those who have masked.
    But your question is important. These are new data out of 
the U.K. that have demonstrated this new test-to-stay strategy. 
That is a strategy after a child is exposed in a classroom that 
they stay in that classroom with sequential tests every day, 
every other day, to demonstrate that they are negative so that 
they can stay in school.
    We have updated our frequently asked questions that this is 
a promising practice, and we are actually working with local 
jurisdictions now to demonstrate the domestic data here in the 
United States that this practice works, it is safe, it is 
effective, it gets our children back to school.
    Importantly, we recognize that jurisdictions are actually 
doing this, and other jurisdictions may want to. And in that 
context, we are doing peer-to-peer matching of schools that are 
interested in doing the test-to-stay practice and having them 
talk to schools that are also doing it so that they can use the 
implementation strategies that a school has already used.
    We are actively studying this so that we can provide the 
data on it working, and we are actively encouraging it as a 
promising practice. Thank you.
    Senator Collins. Thank you.
    The Chair. Thank you.
    Senator Smith.
    Senator Smith. Thank you, Madam Chair and Ranking Member 
Burr. And thank you so much to our panelists for being with us 
today.
    I just want to start by highlighting that we have made 
major steps forward in getting Americans vaccinated. Vaccine 
requirements are working, I believe, to encourage people to get 
these highly effective vaccines. We are also seeing progress 
with children. It is great news and a big deal that children 
age 5 to 11 can now get their shots. So, clearly, we have more 
work to do, but this is progress.
    I would like to spend my time focusing on the trajectory of 
this pandemic and what normal is going to look like going 
forward.
    Starting out, it seems to me that people thought of COVID-
19 as something like polio, for example, where we could 
quickly--we could develop a vaccine, and then we could control 
or even potentially eradicate this disease.
    Now, it seems that COVID-19 will be more like an influenza, 
an infection that will recur for the foreseeable future, though 
hopefully with less and less severity.
    Dr. Fauci and Dr. Walensky, can you help us understand how 
we should be thinking about the path of this pandemic over the 
next couple of years?
    Dr. Fauci, understanding that we do not have crystal balls 
and this is an unpredictable virus, what do you think the next 
6 months to 2 years----
    Dr. Fauci. Right.
    Senator Smith [continuing]. Are going to look like? And do 
you expect that COVID is going to become more endemic and less 
pandemic as we move forward? And what does this mean for how 
people----
    Dr. Fauci. Sure.
    Senator Smith [continuing]. Are going to be living their 
lives?
    Dr. Fauci. Yes. So, let me just put a very brief 
perspective of it, Senator. When you think about pandemics, you 
are in the pandemic phase, and then you have a deceleration 
phase, then you have a control phase, then hopefully you will 
have elimination and maybe eradication.
    I think eradication is out. We have only eradicated one 
virus in history for humans, and that is smallpox.
    We have eliminated certain infections by very good 
vaccination programs, such as eliminating polio from the United 
States, eliminating measles except for some pockets of under-
vaccinated group.
    What we are really talking about is control, and control 
has a wide bracket. You could have it under control where you 
have enough infections in the community where it is not a 
pandemic phase, but it still is interfering with what we would 
like to get back to, what we used to know as normal.
    What we hope to get at is such a low level that even though 
it is not completely eliminated, it does not have a major 
impact on public health or on the way we run our lives. We 
would hope that as we get people more vaccinated, not only in 
this Country, but throughout the world, that the level of viral 
dynamics will be so low.
    I cannot predict for you today when that will be because, 
as we see, we now have a situation. We are entering the winter. 
The good news is we are continuing to come down, and hopefully 
we will go further and further down.
    But, what happens globally will impact us, so if we get 
more people vaccinated globally, and more people vaccinated 
now, hopefully, within a reasonable period of time, we will get 
to that point where it might occasionally be up and down in the 
background, but it will not dominate us the way it is doing 
right now.
    Senator Smith. Thank you for that. I appreciate you 
bringing in the issue of global vaccination rates and how that 
affects our health here at home.
    I hope, Madam Chair, that this is a topic that we can 
devote a little bit more time to on this Committee because I 
think it is very salient to our work to protect Americans.
    Dr. Walensky, let me turn to the question of data and 
metrics. You and I had a great discussion last week about what 
is the most useful data to track the course of this pandemic as 
it evolves, and how difficult it is for people to assess their 
own relative risk, especially now that we have a vaccine that 
provides such strong protection against serious disease.
    Dr. Walensky, in this phase of the pandemic, what are the 
best metrics for us to pay attention to? For example, should we 
be paying more or less attention to positivity rates, case 
rates, or should we be paying more attention to breakthrough 
infections that cause serious illness and hospitalization? More 
like we track influenza outbreaks, for example.
    Dr. Walensky. Yes. Thank you for that question and for that 
conversation earlier this week.
    I--we have been thinking a lot about what an endemic phase 
looks like and the data that we needed to collect during that 
phase.
    Certainly, right now, we are collecting data on cases, 
hospitalizations, deaths. We know that not all of our case data 
is a hundred percent because not every rapid test is being 
reported.
    Importantly, as we do with flu, we collect death data. We 
collect hospitalization data. We absolutely need to know how 
our healthcare systems are doing, and we absolutely need to 
know how deadly a flu season is.
    We also collect data on influenza-like illness, what is 
presenting, and we are currently presenting--collecting data 
now on COVID-like illness.
    We are working toward those metrics of what we need. Some 
of them we are already--in fact, all of them we are already 
collecting, and the question is, what are going to be our best 
metrics moving forward, and probably modeling it on flu.
    The other metric that I think is critically important is 
vaccination rates. And one thing that we have not really 
touched on just in this conversation, but we are absolutely 
working on and doing much better, is our race and ethnicity 
data, our equity data. Because if we are not following how we 
are doing in these communities with regional and ethnic 
minorities, we are not going to understand the impact of this 
pandemic on all of the communities in this Nation. We have 
actively worked on making sure that those are up to speed, as 
well. Thank you.
    Senator Smith. Well, thank you. Thank you very much.
    As we move forward, I think it is crucial that we are 
tracking the right metrics so that Americans have a useful 
understanding of relative risk and better understand the steps 
that they can take to limit their own risk, just as you say, 
including these vaccines that work, that are safe, and that 
save lives.
    Thank you.
    The Chair. Thank you.
    Senator Braun.
    Senator Braun. Thank you, Madam Chair.
    First question will be for Dr. Fauci. I was watching the 
interchange between you and Senator Paul, and that is always 
entertaining.
    I think what I am interested in today--because it was back 
on May 26, we had a hearing. And what has happened at the Wuhan 
Institute of Virology, there is a debate out there, and it is 
not clear what happened. And the thing I remember, at the tail 
end of our conversation--because the merits of the case either 
way--Senator Paul makes it one way; you make it the other way. 
EcoHealth comes into play in terms of what happened there.
    Transparency. And you were on record as saying you like it, 
you love it, you believe in it. I pressed you that day, well, 
on something I will get to in a moment, but what about 
releasing all the information that you do have under your 
control? Because I think as long as the American public cannot 
see it, with all the mysteries surrounding what happened in 
terms of its origin----
    I think then you said, well, you could maybe suggest it to 
President Biden on declassifying information. When it comes to 
the subject I'm going to get to in a moment, will you agree, 
liking transparency, to get all of the information out there as 
it relates to the origin so we can all see it here in the 
Senate, across the Country?
    Dr. Fauci. I am--thank you for the question, Senator. I 
am--have always been, am now, and will always be very, very 
much for total transparency in everything we do. So, as far as 
I am concerned, what you are saying resonates very strongly 
with me.
    I do want to make one point, because it gets confusing to 
people. One of the things that is very, very clear, 
irrefutable, that the NIH funding of grants in Wuhan and the 
viruses that were discussed, including the viruses that Senator 
Paul mentioned, would be molecularly impossible to have 
resulted in SARS-CoV-2.
    That sometimes gets conflated when they talk about you are 
funding research there where--people can argue about the 
definition of gain of function or not. I gave you the process 
whereby that definition was established. But, what gets 
confused and conflated is that any of the card-carrying 
molecular virologists will tell you that, notwithstanding the 
debates about definitions, the funding by the NIH of the grant 
and the viruses that were worked on could not possibly have 
turned into SARS-CoV-2 because they are evolutionarily so 
distant that nothing anybody could have done, could have done 
that. And I really feel I need to say that.
    But, getting back to your question. I am all for 
transparency.
    Senator Braun. I am talking about--so, has all the 
information, period, been released that pertains to that 
subject? Because that looks like it would be under your control 
to do that. So, is it out there, publically?
    Dr. Fauci. I am not sure exactly what you mean by all the 
information, but I can tell you, anything that is under my 
control that is legally able to be released, I am all for, 100 
percent releasing. I promise you that.
    Senator Braun. Well, we are going to make sure that all of 
that is out there because one of the most difficult things 
about this whole navigation is that there are varying opinions. 
Not everybody is going to agree with you. We would like to see 
it so we can sort through it, where other experts look at it, 
and the American public.
    Now, let's get back to the whole housing that we have 
within our own departments. Josh Hawley and I had a bill that 
passed by unanimous consent through the Senate to declassify 
that information.
    Again, you said you were for transparency. You were 
hesitant about that not being your bailiwick. Is that something 
you would want to go on record with to advise the President to 
get that declassified, so that we can see it, the American 
public can see it? And that was discussed and you thought you 
might be willing to do it back on May 26th. Do you want to 
publically say do it?
    Dr. Fauci. Senator, I--to be quite honest with you, I do 
not really know when you say classified information, what 
information are you referring to? Because the NIH, the 
information that we are involved with, is not classified at 
all. We do not do----
    Senator Braun. No. This would be stuff that we hold within 
our Intelligence departments.
    Dr. Fauci. What----
    Senator Braun. Senators have been able to look at it. It 
has not been released. Department of Homeland Security, that 
is--not what you house within the NIH. And that is you being 
the main advisor to the President on this issue, why would you 
not say declassify it so we can look at it?
    Dr. Fauci. Well, I would have to find out, Senator, when 
you are talking about classified information that is certainly 
above anything that I do. Because I want to reiterate for the 
record that the NIH does not do any classified anything. 
Everything we----
    Senator Braun. All 100 Senators were for doing it. Many of 
us had the ability to look at it. You or others, Dr. Walensky, 
it would be a big deal to do it.
    Real quickly--thank you for those answers.
    I have a question about--and this at--aimed at Dr. 
Walensky. What about the importance of therapeutics? And I 
asked you this back on May 26th. Where is that in the whole 
journey in terms of having another tool in prophylactics, as 
well? Because there is a lot----
    All of us acknowledge that a vaccine was a miracle to get. 
You are seeing where you are running into some that simply will 
not get it. It is hard for me to imagine that you will vaccine 
the rest of the world.
    When do you put the same amount of enthusiasm on the other 
two tripods of the stand to actually put every tool in the tool 
chest aimed at getting rid of this or at least treating it?
    Dr. Walensky. Thank you, Senator. I am absolutely for using 
therapeutics, but I think they should be used after we use 
vaccination because vaccination--certainly, we have seen that 
the therapeutics that are out there, the Remdesivir, the 
dexamethasone, the molnupiravir is a promising new therapeutic 
that Dr. Fauci just mentioned a few minutes ago. All of those 
would be after you are infected. They prevent--they work to 
prevent severe disease and death. They are not foolproof.
    Certainly, my first tool in the toolbox would be for 
vaccination. And then, of course, we would need testing because 
most of these therapeutics actually work best after you have--
especially the oral one, the molnupiravir, worked best if you 
can give them early.
    I do think we need as many tools in this toolbox as 
possible. I would also say that the best public health 
intervention here would be vaccines.
    Senator Braun. You have said that before, and thanks for 
reiterating.
    The Chair. Senator, you are over your time.
    Senator Braun. I just ask you to put that same enthusiasm 
and speed behind the other things that are--or might be out 
there to help us. Thank you.
    The Chair. Thank you. I am going to go vote. As the 
Senators know, a vote is open. The next two Senators will be 
Senator Murphy and Senator Murkowski. I hope to be back by the 
end of that.
    Senator Murphy. Thank you very much, Madam Chair. Thank you 
to all of you for your service to this Country during an 
incredibly trying time.
    I thought that Senator Collins' line of questioning 
deserved a follow-up. She asks a good question. She says we 
have got high vaccination rates in Maine, and so why do we 
still have so many deaths?
    But, I think it is important to sort of step back and look 
at the national data here. I will direct this to you, Dr. 
Walensky.
    I was looking at a survey of national data that was 
published now back in the spring, so it is a few months old. 
But, in it, it suggested that if you look at the 10 states with 
the lowest rates of vaccination versus the 10 states with the 
highest rates of vaccination, it is Black and white.
    You are four times more likely to be hospitalized if you 
live in one of those states with the lowest rates of 
vaccination. You are five times more likely to die if you live 
in those states. And, so, each individual Senator will have 
their own experience.
    But, tell us what the story is now that we have lots of 
variation amongst states when it comes to vaccination rates and 
what that tells us about your likelihood to ultimately end up 
in the hospital or end up dying from COVID.
    Dr. Walensky. Thank you for that question, Senator.
    Yes, we have about 75,000 cases a day right now, and there 
are places, there are states, that are highly vaccinated and 
they are still having cases, as Senator Collins has commented 
on.
    This is going to be very local, very community based. This 
virus is an opportunist. It is rapidly transmissible. And if 
you have communities that are under-vaccinated, even if a state 
averages at 70 percent, this virus is going to go to those 
communities.
    Importantly, we have actually looked during the Delta surge 
at three states with high vaccination rates--Connecticut being 
one of them--and three states with lower vaccination rates. And 
we can see even just in this Delta surge, just since June, that 
the death rates in the under-vaccinated states, in the states 
with vaccination rates that are 10, 20 percent lower than the 
highly vaccinated states, the death rates are 5- to 10-fold 
higher.
    We absolutely can see the impact of this. There are cases 
that occur in vaccinated people. They, for the most part, do 
not lead to death. Sometimes they do, but for the most part, 
they do not. These vaccines are preventing disease. They are 
preventing 10-fold more likely to be hospitalized if you are 
unvaccinated versus vaccinated, 11-fold more likely to die if 
you are unvaccinated versus vaccinated.
    Senator Murphy. Senator Collins' question was a good one, 
and I am glad to get the true story of what the overall 
national data is here because it is compelling.
    But, there are other Senators who are deliberately trading 
in just dangerously false information. It is stunning that the 
misinformation about COVID is not just coming from purveyors of 
propaganda online. It is often coming from our colleagues here 
in the Senate.
    I was on the floor a few weeks ago listening to Senator 
Johnson, who suggested pretty sort of transparently that there 
was a correlation between those who got vaccinated and post-
vaccination deaths, noting that 5,000 deaths that were reported 
on the adverse event system happened 1 or 2 or 3 days following 
a vaccination, suggesting that there was a correlation.
    Doctor--I will ask this of Dr. Walensky. Is there any 
increased risk of death to individuals who get a vaccine? Is 
there any data to back up the claim that Senator Johnson was 
making that there is some correlation between risk of death and 
vaccination? Is it not exactly the opposite?
    Dr. Walensky. It is. For COVID, it is in fact exactly the 
opposite.
    Our vaccine adverse event system collects all deaths after 
vaccination. That means if you are hit in a motor vehicle 
accident and succumb to that event that would be reported in 
our vaccine safety system. Clearly, that is not a causal effect 
from a vaccine.
    Yes, these vaccines are working to prevent death from 
COVID-19.
    What I would just say when--when people ask me all the time 
what they can do, what Congress can do, what Senators can do 
for us as a Country, for me at the CDC, it is to encourage your 
constituents to get vaccinated. Thank you.
    Senator Murphy. One of the things I hope this Committee 
will work on in the middle of this pandemic and following is 
health literacy; is helping Americans understand where good 
sources of medical information are and where the dark spots 
are; where you are listening to political actors who have their 
own agenda, not one based in science.
    I think this is frankly a place where Republicans and 
Democrats can collaborate because I think we have found a 
general lack of health literacy during this pandemic, but it 
was a problem that existed beforehand.
    While it pains me to know that some of our colleagues are 
the purveyors of this misinformation, it is a project that 
probably should be able to be bipartisan moving forward.
    I appreciate you all being here. Thank you, Mr. Chair.
    Senator Burr. [Presiding] Senator Romney.
    Senator Romney. Thank you, Mr. Chairman. I appreciate your 
service and the information you are providing this morning.
    Just following up on Senator Murphy's question, there is a 
perception that side effects, adverse effects from the vaccine, 
are not being gathered, that they are not being made available 
to the public. Are the side effects and adverse effects, Dr. 
Walensky, being captured? Are they available to the public? Is 
there a place we can go to see what the likelihood is of 
various side effects based upon getting a vaccine?
    Dr. Walensky. We have the most robust vaccine safety system 
than we have ever had in this Country in the rollout of this 
vaccine. Our Vaccine Adverse Events Reporting System, as 
Senator Murphy just described, has over 600,000 reports 
publically available.
    We have a new V-safe system, which is developed 
specifically for the COVID-19 vaccine program. It uses a text 
message system, web surveys to get people to provide their 
symptoms after they have been vaccinated. It includes over 9.5 
million people and over 12.5--12 million health surveys.
    We have a pregnancy registry where we survey pregnant 
women. We are getting their information during their vaccine--
after their vaccine in their first trimester. We call them in 
their second trimester, their third trimester, after their baby 
is born, and at 3 months. We have registered over 5,000 women 
in that, and we have over 25--24,000 who have been contacted.
    We have a Vaccine Safety Datalink, which is collaboration 
with our academic institutions, which includes over 7.5 million 
people who initiated vaccination.
    This is the most robust vaccine safety system that has ever 
been documented.
    Senator Romney. Where might the public go to see what the 
probability is of various side effects or adverse effects from 
the vaccination?
    Dr. Walensky. On our CDC website.
    Senator Romney. Thank you. Appreciate that.
    Dr. Fauci, a number of us are concerned about mandates, 
obviously. The question--and I sent you a text just to prep you 
for the question, but the question in this regard is, if we do 
have a mandate--and I am thinking now of the mandate for 
private companies.
    If we do have a mandate, will it save lives? And is there 
an estimate of the number of lives that might be saved by 
virtue of having our private companies that have over 100 
employees either having their employees receive a vaccination 
or get a weekly test?
    If that occurs, will it save lives, and do you have an 
estimate of the number of lives it might save?
    Dr. Fauci. I have a very firm and confident answer to your 
first question, Senator, and I do not have one of your second. 
But, let me just explain very briefly.
    We know that vaccines absolutely save lives, and we know 
that mandates work. If you look at, for example, the percentage 
of people in United Airlines or in the Houston Medical 
Association or in other organizations that have mandated, it 
works 99-plus percent, for example, with United Airlines.
    If you take the fact that mandates work and vaccines 
absolutely save lives, the answer to your question is yes, it 
does save lives. How--what that number is, you would have to do 
modeling, Senator, that I do not have in front of me right now 
to determine when people get vaccinated in a certain area, what 
is the chance of their having gotten infected and given their 
underlying condition, what is the chances of their having died 
or not.
    That information can likely be modeled, but I do not have 
that for you right now.
    Senator Romney. Yes. I would think that given the 
information you do have, if you extrapolate from the 
information you have as to where mandates have been imposed, 
such as United Airlines, and you apply it, you can calculate 
what the number of lives saved might be. I would think that 
would be helpful for me and for others who are concerned about 
mandates. We are also concerned about lives lost and protecting 
human life.
    We also had a question from Senator Kaine about the long-
haulers, if you will, the long COVID. How serious are these 
long-haul cases? And what proportion of those that have COVID, 
do you have a sense?
    Dr. Fauci. Yes.
    Senator Romney. Do we know the number? What proportion of 
those that have receive--that have had COVID are subject to, if 
you will, serious, long COVID conditions?
    Dr. Fauci. A very good question, Senator that we are now 
actually finding out more definitive data. There have been a 
number of published papers from different smaller cohorts. We 
are now putting a massive cohort study, and among the smaller 
cohorts, it ranges from 10 to up to 30, 35 percent of people 
have varying degrees of prolonged symptomatology following the 
so-called resolution of the acute disease.
    Some of them can be relatively minor, but some of them can 
be incapacitating. For example, there are some individuals who 
have truly incapacitating fatigue where they were pretty 
healthy, athletic, and then following COVID, they never get 
back to their baseline. There are sleep disturbances. There is 
a thing called brain fog, which can be very disturbing to 
people, where they cannot focus or concentrate.
    The spectrum is wide. It can go from something that just is 
modestly bearable to something that incapacitates you, and that 
is the reason why we have this study right now, looking at it, 
that is about a $1.5 billion investment to try and sort that 
out.
    Senator Romney. I would just note--I know my time is up, 
but I would just note that it would be helpful for those of us 
that are concerned about our children or grandchildren to have 
a sense not just of the number of deaths associated with COVID 
in children, but also the number of long COVID cases, severe 
long COVID cases, because it would be my estimate that probably 
substantially exceeds the number of deaths among young people. 
And that information, I think, would be helpful for parents and 
grandparents like myself. Thank you.
    The Chair. [Presiding] Senator Hickenlooper.
    Senator Hickenlooper. Once again, I want to thank each of 
you for your--not just for your testimony today, but for all 
the work you have done over this entire--and it is a campaign. 
It is very similar to a war.
    We are seeing a COVID surge right now in Colorado that has 
led to emergency capacity issues in our hospitals, and that is 
not just in certain parts. It is pretty much across the state. 
Just about 80 percent of those in the hospitals are 
unvaccinated.
    Dr. Fauci, I guess--and it is--my question, my first 
question, would be, in a State like Colorado where we have made 
real progress, I mean, great strides in vaccination rates, how 
should we be thinking about this recent surge? Just that it is 
still the tail of the unvaccinated?
    Dr. Fauci. Yes. Yes. That is not unexpected when you get 
into, for example, the situation where the weather starts to 
get colder and people do things more indoor.
    But, as you said quite correctly, when you see surges, they 
are very, very heavily weighted toward the unvaccinated, not 
only in the incidence of infection, but also in the incidence 
of severe disease that might lead to hospitalization. I believe 
that is a pretty obvious type of an explanation for that, which 
is the reason why we continue to push to get as many people 
vaccinated as we possibly can.
    Senator Hickenlooper. All right. And Dr. Walensky, I 
thought that Senator Romney's comments about his children and 
grandchildren--and I think soon, if not already, his great 
grandchildren--that is an issue. That is what we are seeing 
more questions every day.
    This week's vaccine approval for 5- to 11-year olds, I 
think one question we have heard is, how is that going to 
affect this rising, this increase in infection rates? How are 
we going to be--how do we do everything we can to make sure 
these kids get vaccinated, those who want to be vaccinated?
    Dr. Walensky. Yes. So, thank you, Senator. First, let me go 
back to Senator Romney's question on presentive children who 
get long COVID.
    We have had about 1.9 million children between the ages of 
5 to 11. We have seen a long COVID rate in those children of 
about 4.5 percent. It is less than adults, but it is still high 
and it is still--we should note it.
    We have also seen in that demographic 5,000 cases of MIS-
C--that is, multisystem inflammatory syndrome--that can be 
devastating. We have had 46 deaths from MIS-C alone, and nearly 
a hundred children in the demographic between ages 5 to 11.
    We have a lot of work to do to reach out to our 
pediatricians, to reach out to our parents to make sure that we 
have the communication, the education, the information that 
parents need. This is a new vaccine to them. They perhaps 
received the same Pfizer vaccine themselves, but for their 
children, it is a new vaccine.
    One thing I think is really important and is probably worth 
grounding people on is we have a lot of vaccine-preventable 
diseases for our children now: varicella, Hepatitis A, 
meningococcus, just to name a few.
    The death rates from varicella are about 16 per year before 
vaccination. For Hepatitis A, about three per year. For 
meningococcus, about eight per year. The death rate for COVID 
in this age demographic was 66.
    Senator Hickenlooper. Wow. Very sobering. And I am fully 
aware of the high levels of unvaccinated kids in certain--
especially in certain geographic areas.
    My son, Teddy, who is now off to college, but when he was--
had just turned 4 months. He was about to get his second 
whooping cough shot and he got infected by an unvaccinated kid 
who we were--well, it was about the most terrified--it is the 
most terrifying experience I think I have ever been in where 
you just cannot stop him from coughing. And you are in a 
hospital and you have to blow oxygen on his face to try and 
shake him out of the coughing. Absolutely terrifying.
    It was amazing. It took us a long time to get a doctor to 
diagnose it because at that point, we were just beginning to 
see whooping cough again because everyone had gotten--was in 
the habit of getting their children vaccinated, and suddenly 
that changed.
    Ms. O'Connell, I also worry that the recent surge is 
further stretching the situations around our frontline workers 
after already the last couple years tremendously difficult. We 
hear about it in Colorado. Is that happening across the 
Country, as well?
    Ms. O'Connell. Senator, yes. Thank you for that question. 
We have sent 27 different teams out to augment hospitals that 
were overrun by COVID patients. About 600 team members to 12 
different states, so we are seeing that.
    Senator Hickenlooper. Great. And how do we address burnout 
among healthcare workers? How--what advice can you provide?
    Ms. O'Connell. Well, we have been happy, of course, to go 
in and help where we can, but we know that we are not the 
sustainment. And one of the things that the American Rescue 
Plan provided was funding for the public health workforce. And, 
so, we are continuing to look for ways to invest in a long-term 
public health workforce to support these first responders and 
healthcare workers that are burned out and worn out from this 
pandemic.
    Senator Hickenlooper. Again, I will just finish by saying 
thank you to each of you. One of the most amazing things to me 
is, as a scientist who recognizes the importance of data, 
that--your ability and your vision to start collecting data 
from the very beginning. And make sure that we take the lessons 
that we learn in this situation, where so often people are 
making decisions without enough data, is really going to inform 
our pandemic preparedness and help this--not just our Country, 
but the world as we go forward and battle not just this virus, 
but others to come. Thank you.
    The Chair. Thank you.
    Senator Hickenlooper. I yield back.
    The Chair. Senator Tuberville.
    Senator Tuberville. Thank you very much, Madam Chair. Thank 
you for being here today. I know it is hard work and you need 
to get back to work.
    In my former job, I had to win games, and in your business, 
we have got to win, and right now, we are not winning.
    Johns Hopkins University just made a report last week that 
this year, we have lost 353,000 people, and to this point, last 
year, that is how much we lost the entire year. It is a little 
perplexing that, we have got two vaccines, boosters, and we 
have got masks and all that. We have still got to win. We have 
got to win this fight. I mean, I think everybody understands 
that.
    I recently wrote an op ed talking about how we need an all-
above approach. We need every tool in the toolbox to be used.
    I have been talking to doctors all over Alabama. We have 
got a tough problem. They are very upset that they do not have 
the freedom to treat like they should have the freedom to 
treat. They are being told by officials in their hospital that 
they cannot use certain drugs, such as Ivermectin or whatever, 
and they know that it works. That is what they tell me. I am 
not a doctor.
    Monoclonal antibodies, we ran out in Alabama because for 
some reason, we are starting to ration those in the last few 
months. And I think I--I could ask all of you what you think 
about monoclonal antibodies, and I think you would all say 
they--to some degree, they work.
    But, this specific question is for Ms. O'Connell. I want to 
ask you this. Congress gave money through the CARES Act to help 
with the development and production of therapeutics. Within 3 
months of being in office, President Biden's administration 
decided not to buy, or they declined to exercise contract 
options on monoclonal antibodies.
    Now, I know you were not there at the time. They inherited 
these contracts from the Trump administration. Those decisions 
caused a shortage, especially for us in Alabama.
    At the same time, the Biden administration was ramping up 
monoclonal production. As we were trying to get back to it, HHS 
turned and gave $142 million non-compete contract to an 
accounting firm to market these treatments to the public. The 
Administration hired KPMG to promote a therapeutic that the 
Government stopped buying. That makes no sense.
    I looked at the website and I--my son and I could probably 
put it together for $10,000. We paid $142 million.
    I am just asking you, Ms. O'Connell. And I understand that 
HHS is currently reviewing this. I just would hope that you 
would commit to reprogramming some of that money to monoclonals 
if there is any left. Could I get a commitment on you for that?
    Ms. O'Connell. Senator, thank you so much for the question. 
We have seen a change in the monoclonal landscape. When the 
ASPR therapeutics team began looking at the distribution models 
in February, a lot different than we experienced during the 
Delta surge. Twentyfold increase in demand for monoclonals, and 
we went to a state distribution system.
    You are absolutely right. It is time to re-evaluate whether 
we need this distribution help to get to the harder hit 
communities, and that review is under way right now. I am 
expecting a memo any day with the team's recommendations on 
whether to keep that funding going.
    Senator Tuberville. Thank you. And we just need to get more 
of them. I know we are trying to do that and we are all trying 
to do our best, but, we just have got to try to do it the right 
way.
    Dr. Fauci, you have talked a lot about gain of function 
research and whether or not you guys funded it, and I am not a 
doctor, I am not a scientist, so I am not going to--I am just 
going to ask you straightforward here.
    What kind of biological research is China actually 
conducting as we speak, that we know of?
    Dr. Fauci. Yes. Well, right now, when you say China, China 
is well beyond the Wuhan situation. There is research that goes 
on collaboratively with the United States, not only with NIH, 
but with any of a number of organizations, including the CDC 
where we have Chinese researchers.
    The funding that goes on right now that was just mentioned 
with Dr. Paul, we are not funding the Wuhan Institute anymore. 
That is for sure. But, I cannot testify to the scope of 
research that goes on beyond what the NIH----
    Senator Tuberville. The WHO, they do not communicate with 
us? Because we are paying them 4 or $500 million.
    Dr. Fauci. Yes.
    Senator Tuberville. Surely to goodness, they have something 
to do with what----
    Dr. Fauci. Right.
    Senator Tuberville [continuing]. China is doing.
    Dr. Fauci. For the most part, the research that comes out 
of China, if you look at the things over the years, I am 
talking not in this capsule of period where it is all focus on 
China, anti-China. I am talking about decades of collaboration, 
particularly in the arena of influenza and other diseases. 
There is a lot of research going on. I do not think I can tell 
you what all the research is going on because I do not have 
eyes on all the research. The only thing----
    Senator Tuberville. Are we communicating with them, though, 
somehow, some way, with China?
    Dr. Fauci. Well, yes. We communicate a lot with them. 
Certainly, there has been a lot of stress and strain right now 
when you talk about the Wuhan situation, but our colleagues in 
Shanghai, our colleagues in Beijing, we communicate with them 
all the time.
    The Chinese have a very, very fine centers for disease 
control and prevention modeled against our own CDC, and our CDC 
is in very good collaboration and cooperation with them.
    Senator Tuberville. I just think if they had let us in 
early that we may have not been in this situation--maybe the 
world, in this situation that we are in--I hope you would agree 
with that--and they just kind of shut us off.
    Dr. Fauci. No, absolutely. And we want to find all the 
information we can. And the NIH and the entire HHS has been 
very much in favor of all transparency and getting to know all 
the information of what is going on in China. We are all very 
much in favor of that. We want more transparency.
    Senator Tuberville. Thank you.
    The Chair. Thank you.
    Senator Casey.
    Senator Casey. Chair Murray, thank you. I would ask for 
consent, unanimous consent, that the statement from the 
Alzheimer's Association and Alzheimer's Impact Movement be 
submitted for the record.
    The Chair. Without objection.

    [The following information can be found on page 735]

    Senator Casey. Thank you, Chair Murray.
    I wanted to start with Assistant Secretary O'Connell about, 
in particular, the Hospital Preparedness Program. It is a 
program I have long supported aggressively, and so many others 
have, as well. For those listening, this is a program that 
supports hospitals and other healthcare facilities and the 
providers who work at those facilities in preparing for public 
health emergencies.
    As we all know, COVID-19 has taxed the healthcare system 
like never before, and at various points in the pandemic, as 
surges have hit communities across the Nation at different 
times, these hospitals and ICUs have been overrun with 
patients, most recently as a result of the Delta variant.
    Assistant Secretary O'Connell, I have got three questions. 
First, what role have the local healthcare coalitions, which 
are the core element of the program, what have those coalitions 
played in responding to the surges in hospital admissions?
    Ms. O'Connell. Senator, thank you so much for that 
question. And you are absolutely right. The HPP Program that 
you reference is the only federally funded program to help 
healthcare systems and hospitals prepare for emergencies. So, 
it is critical, and we have seen it play a significant role in 
this pandemic response.
    The local coalitions were very important because, as we 
were seeing hospitals overrun with COVID patients, they were 
able to work with their coalition members to move patients to 
ICUs that actually had beds. So, we did see that play a 
significant and important role.
    Senator Casey. Second question is, are you planning any 
after-action review to incorporate lessons learned from the 
pandemic with regard to the Hospital Preparedness Program?
    Ms. O'Connell. Absolutely, Senator. One of the things as I 
have been out in the regions meeting with local leaders and 
coalition leaders, I have seen there has been an uneven use and 
success of the HPP Program based on regional strengths. Based 
on state situations. And, so, I think one of the things I would 
like to do as we look at lessons learned is figure out how to 
have a more uniform successful model for the HPP Program.
    Senator Casey. How about--the third question, how about 
goals for the program in the near term?
    Ms. O'Connell. Well, a couple of things that we have 
learned in the near term: The need to secure PPE within 
healthcare systems and coalitions.
    We have also learned the value of telehealth and how 
important it was for systems to be ready to do some care 
remotely.
    We are going to take these near-term goals and begin 
applying them for longer term preparedness.
    Senator Casey. I appreciate that, those answers.
    I wanted to move to Dr. Walensky on a broader question, I 
guess, about public health infrastructure.
    One of the challenges in the response has been building the 
systems that we need to track information necessary to manage 
everything from hospital capacity and ICU bed availability to 
critical medical supplies, vaccine components. The long list 
that is.
    The concern, of course, is that we are going to reach a 
point where we all start saying the pandemic is over and we 
move on. We have got to finally, at long last, invest in our 
public health infrastructure.
    How would you leverage any tool that we have now, 
especially the existing data systems, that has been created for 
COVID-19 to ensure that we are prepared for the next major 
public health emergency?
    Dr. Walensky. Yes. Thank you so much for that question, 
Senator Casey. My hope, and I am grateful for the support to 
date for long-term disease-agnostic public health 
infrastructure investments that are bipartisan so that we do 
not find ourselves in a situation again. We need to be prepared 
for this--for any pandemic to come, and we need to get out of 
the current pandemic.
    As you note, this is multi-pronged in my view. We need a 
public health workforce that is up-skilled, that is trained, 
that is diverse as the communities they--from which they come. 
We have lost 60,000 jobs in the last decade, and thousands more 
since the pandemic started. So, we not only have to work to 
rebuild that public health workforce, but actually to skill it 
up in ways that can be empowered to prevent the next pandemic.
    Laboratory infrastructure is going to be key. We have built 
up genomic sequencing. Now we are doing tens of thousands a 
week. This was something that we were not even doing much of 
prior to the beginning of this pandemic. But, we, again, need 
the workforce. We need the machinery. We need the tools and the 
collaborations with our public health labs in order to place 
these all across the Country.
    Then, of course, you note data modernization. We absolutely 
need interoperable data. We have been able to scale this up 
enormously over the last year during this pandemic. We have 
tens of thousands of electronic health records that we are now 
accessing in a HIPAA-compliant way, where we were doing just a 
hundred before this pandemic. It needs to be interoperable, and 
we need to invest in it. We----
    To get a full scale hospital system up on EPIC, for 
example, is over a billion dollars for a single health system. 
So, when we scale that nationally to what we need for our 
public health workforces across all of our states and 
territories and tribes and localities, this--the investment is 
so very needed. Thank you.
    Senator Casey. Thank you, Doctor.
    The Chair. Thank you.
    Senator Casey. Thank you, Madam Chair.
    The Chair. Thank you.
    Senator Cassidy.
    Senator Cassidy. Thank you all for being here.
    Dr. Walensky, a couple things. As I walked in--I came in 
late. One of either you or Dr. Fauci were saying that the 
reason that we are not saying that natural immunity is 
protective as is a vaccine--even though there is recent 
publications showing that 6 to 8 months out, 92 percent of 
those with natural immunity have T cells, B cells, and 
antibodies that would be considered adequate to protect, and 
indeed, B cell continues to climb--that we do not have data.
    Now, in your response to Mr. Casey, you just mentioned that 
CDC has access to tens of thousands of EHRs, and I have been 
told that HHS or CDC has access to patient-identifiable data as 
to who tests positive. So, I do that as a prologue.
    If we do not know that natural immunity confers protection 
against future infection, it is because we have decided not to 
look because I have learned that there is a cohort of people 
that we know have been previously infected. We have got the 
bench research showing that the triad of antibodies, T cells 
and B cells are there, and that 92 percent of them are still 
there at age--at 6 months out. So, why don't we--why have we 
not done the research showing that natural immunity confers 
protection against recurrent infection?
    Dr. Walensky. Yes. Thank you so much for allowing me to 
clarify this point because I understand--I understand the 
question.
    First of all, let me just reiterate that our current stand 
after reviewing 96 papers and the scientific brief on this 
issue is that everyone who has been previously infected should 
be vaccinated.
    Senator Cassidy. But that is not my question.
    Dr. Walensky. Agreed. So, and part of the challenge here 
is, as you know, the infection-induced immunity and the biases 
associated with retrospectively looking at the data, several of 
those papers that we reviewed for that brief have demonstrated 
that the kind of disease that you had at the time you had it 
matters.
    Did you have disease a year and a half ago? Did you have--
were you an older person?
    Senator Cassidy. Can I stop you for a second?
    Dr. Walensky. Were you----
    Senator Cassidy. We could do this prospectively because who 
is actually--apparently, I am told, you have patient-
identifiable data, and you would be able to say, Okay, 6 months 
ago, we are going to start everybody infected within the last 6 
months and be able to follow their EHR prospectively to see 
this. I mean, theoretically, CDC has the ability to do this 
right now.
    Dr. Walensky. Yet that too would have its own biases. So, 
one of the things that we have demonstrated in this scientific 
brief is that asymptomatic and mildly symptomatic people, who 
might not present to their providers, might present to an 
urgent care clinic, who might not be recorded in their own EHR, 
likely have less robust protection than those who have been----
    Senator Cassidy. But that could be established 
prospectively if using the data that you have. And you could 
even say, if you had symptomatic infection, you do not need to 
be vaccinated; we would consider you immune; you do not have to 
be subjected to the mandate.
    But, if you had----
    Dr. Walensky. If we had data--if we had data that 
demonstrated a correlation of protection. Dr. Fauci already 
mentioned data that they are working on to look at correlative 
protection not just in antibodies, but as you noted, in T cell 
function, as well. So, if we were able to document a 
correlative protection, we absolutely could prospectively----
    Senator Cassidy. But this paper----
    Dr. Walensky [continuing]. Follow----
    Senator Cassidy [continuing]. That I am reading from CD--
from NIH speaks that there is durable memory of the virus up to 
8 months after infection in 95 percent of the people who 
recovered, including B cells, which continue to climb, T cells, 
and antibody.
    I am also saying you could do it clinically because we have 
data that is patient identifiable, that we could go back and 
look and see if they were exposed. They could be in a hot spot 
like Louisiana where they are being exposed. And then, you 
would see not just by lab data, but empirically.
    I am a--I can tell you, the American people intuitively 
understand this and they feel a little bit like we are being 
willfully blind to it.
    I have limited time. Let me just ask you something else.
    What percent of CDC employees are vaccinated?
    Dr. Walensky. We are actively encouraging vaccination in 
all of our employees and doing a lot of education and outreach 
in order to get our agency fully vaccinated.
    Senator Cassidy. The--but the percent?
    Dr. Walensky. I do not have that for you today.
    Senator Cassidy. I am told that 75 to some north of 75 
percent of CDC employees at headquarters are still working 
remotely. Is that correct?
    Dr. Walensky. We are following regulations through HHS and 
the Federal Government.
    Senator Cassidy. No, that is not my question. I apologize 
to be rude, but I am asking a very straightforward question.
    I have been told that north of 75 percent of employees at 
CDC headquarters are working remotely. Is that correct?
    Dr. Walensky. Senator, I do not actually know the number 
off the top of my head.
    Senator Cassidy. Okay. When you look down the hallway, are 
there empty desks? Are over 50 percent of the desks empty?
    Dr. Walensky. Senator, I do not have the numbers off the 
top of my head. What I will tell you is that we are working 
closely within HHS and the Administration to follow the 
Governmental rules for return to the----
    Senator Cassidy. There is a recent GAO report that shows, 
at least in the last 2 weeks, that there has been no 
coordinated response in the Federal Government to get people 
back into work.
    Now, if there is any agency that--since we have teachers in 
Fulton County are back at work, that the caseload of COVID in 
Fulton County is about 88--at its peak, it was 606.
    If what I have been told by someone who frankly kind of 
knows that people in laboratories are not showing up, I have no 
clue how people--how laboratory workers, who presumably are 
vaccinated, wearing PPE, would consider themselves eligible to 
stay at home.
    I say this because I just want to echo, we have to lead by 
example in the Federal Government. If our public health 
agencies do not have enough confidence in the immunization and 
in the PPE to go back to work fighting infectious diseases, 
there is going to be a lot of undermining of willingness to 
further fund public health.
    Dr. Walensky. We absolutely have our central labs back at 
work conducting their essential research toward this response, 
and we are following the regulations and providing technical 
assistance and technical support to the Federal Government for 
return-to-work policies.
    Senator Cassidy. One more thing. I had asked--Angus King 
and I sent a letter dated February the 25th asking about 
genomic surveillance. We have still not received a response. 
You reference it in your early remarks. Both Senator King and I 
would appreciate a response.
    Dr. Walensky. We will get back to you. Thank you very much.
    Senator Cassidy. Thank you. I yield.
    The Chair. Thank you. I am going to go vote. The next four 
Senators I have in my order are Senator Baldwin, Marshall, 
Rosen, and Murkowski. I will return.
    Senator Baldwin. Thank you, Madam Chair.
    We are here today to discuss the road ahead on the pandemic 
response, and I fear that road will be a rocky one if we forget 
the lessons that we have learned thus far, particularly when it 
comes to our ability to make critical supplies, like PPE, in 
this Country.
    A New York Times headline this summer declared, I quote, A 
Glut of Chinese Masks is Driving U.S. Companies Out of 
Business. In response, I joined several of my colleagues in 
writing to the U.S. Trade Representative, Katherine Tai, to 
urge her to let tariff exclusions on Chinese PPE expire. The 
U.S. Trade Representative is currently weighing that decision.
    One reason these Chinese masks may be so cheap is that they 
are counterfeit, some of them. In fact, the FDA has pulled 
Emergency Use Authorizations from several Chinese mask 
manufacturers, so I am pleased that ASPR plans to use the 
Defense Production Act funds to procure masks and the raw, melt 
blown material needed to make N-95s from domestic sources. I 
worked to include that funding in the American Rescue Plan.
    However, Government procurement can only support so much 
American industry. To retain a strong base of medical supply 
manufacturers and to reduce our reliance on foreign 
manufacturers as a whole, we need to prevent dumped and 
knockoff Chinese PPE from driving American manufacturers out of 
business, as well.
    First, Ms. O'Connell, are you concerned about the practice 
of dumping PPE from China, undermining the ability of domestic 
manufacturers to remain competitive in the U.S.? And if so, 
have you conveyed these concerns to the U.S. Trade 
Representative?
    Ms. O'Connell. Senator Baldwin, thank you so much for this 
important question. We do participate in an interagency process 
where various departments have had the opportunity to share our 
support. So yes, we have conveyed.
    Senator Baldwin. Okay. Dr. Woodcock, the FDA has revoked 
authorizations for certain Chinese masks. Are you concerned 
that increased reliance on Chinese PPE will threaten the safety 
of U.S. healthcare workers? And if so, have you conveyed that 
concern to the U.S. Trade Representative?
    Dr. Woodcock. Yes. Well, I cannot answer the last part of 
your question. I do not know. I will look into the U.S. Trade 
Representative.
    We are concerned about lower quality PPE coming from 
anywhere, and we have of course put in import alerts. We have 
chased down and identified suppliers who have sent in 
counterfeits. We have tried to do recalls throughout the United 
States to get these off the market.
    We are interested in increased authorities because we do 
not have seizure authority for devices, and several other 
authorities that we have been talking to staff about that would 
improve our ability to interdict these counterfeits.
    Senator Baldwin. Thank you. For Dr. Walensky, throughout 
the pandemic, we have heard about how gaps in the clinical and 
public health workforce have significantly hampered our 
response. In particular, we have long faced significant 
recruitment and retention issues among infectious disease 
clinical workforce and with health professionals who conduct 
outbreak preparedness and response activities.
    As this Committee considers policies to better prepare for 
the next pandemic, I am working to introduce the Bio 
Preparedness Workforce Act with Senators Collins, Rosen, and 
Murkowski, which would create a new provider loan repayment 
program focused on encouraging students to pursue careers as 
infectious disease clinicians and bio preparedness 
professionals.
    Dr. Walensky, as an infectious disease physician and public 
health leader, I know that this issue is particularly important 
to you. And can you share your perspective on some of the 
serious workforce challenges I mentioned and how proposals to 
bolster this workforce might make a difference in responding to 
future outbreaks?
    Dr. Walensky. Thank you so much for those efforts, for your 
support, and for that question.
    We know that about 80 percent of people leave medical 
school now with debt. About half of those actually have 
undergraduate debt, as well. And the debt for an average 
medical student is about $215,000.
    In terms of going into the field of infectious diseases, it 
is one of the lowest paying fields for all of medicine, all of 
the subspecialties. In fact, in most hospitals, if you are an 
infectious disease provider versus a generalist, your salary is 
less as an infectious disease provider.
    If we are going to bolster the public health workforce with 
infectious disease physicians, this kind of support will be 
essential. Thank you.
    Senator Burr. [Presiding] Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman, and thank you 
for being here this afternoon, or this morning.
    Eleventh hearing. This is the 11th hearing that this 
Committee has had on the COVID pandemic. We had all, of course, 
hoped that we would be well beyond this, but instead, we are 
well in the middle of it, and we see it changing. I talk to 
folks back home and they really wonder aloud and what is--what 
is the path out of this?
    Right now, my state is--we are four times the national 
average in terms of number of positive cases. Our hospitals are 
still overwhelmed. For the past month, we have been No. 1 in 
the Country. Nobody wants to be No. 1 here, and we are going 
into the winter season, so it is kind of discouraging right 
now.
    We have talked about the strength of the vaccines that have 
been developed through Operation Warp Speed, but I think 
everyone would acknowledge that the pandemic that we 
encountered in March 2020 is different than where we find 
ourselves today with the Delta variant.
    We are talking about vaccine hesitancy--very, very real in 
my state. We still do not have a highly effective vaccine that 
is stable without refrigeration, or a nasal, or an oral 
vaccination option. I am worried that we are prioritizing 
vaccine technology that may not necessarily be feasible to 
bring this pandemic to a close globally. And, so, a question to 
you, Dr. Fauci, and then to you, Dr. Woodcock.
    Do you think, Dr. Fauci, that what we have today, the 
existing vaccine technology that is currently authorized by 
FDA, is truly sufficient to bring us out of this pandemic, not 
just the United States, but globally? And, what then is the 
Administration doing to support and to accelerate development 
of the next phase of vaccines that could offer longer and 
broader immunity to the COVID-19 and, of course, all of its 
variants?
    Dr. Fauci. Thank you for that question, Senator.
    First, the vaccines that are currently available, 
particularly the ease of use of the mRNA and the extraordinary 
effectiveness of both the Moderna and the Pfizer mRNA, if 
properly utilized, we believe would have a much, much better 
control of this outbreak as we have right now.
    But, to your specific question, we are also supporting the 
development of other platforms of vaccines. For example, the 
soluble protein, recombinant protein, together with an 
adjuvant, is something that traditionally has been vaccines 
that have used in other diseases and have much less stringent 
requirements for cold chain and other things that might 
logistically get in the way of getting it more widely 
distributed.
    In specific answer to your question, even though we have 
very effective and very safe vaccines that are being 
implemented now, we are not stopping there. We are making 
investments in the development of other platforms. Some of them 
are already well on their way.
    Senator Murkowski. Well, I think it is important to hear 
that because I think part of what we are dealing with this 
vaccine hesitancy is because people are saying, well, Okay, you 
got your vaccine, and believe me, I got my vaccine and I got my 
second vaccine and I have now gotten my booster. And I am 
hearing from people that are much more hesitant than I say, 
like, well, if you are going to have to keep getting one of 
these every 6 months, how really effective is that?
    Dr. Woodcock, let me ask you. I have spoken to some 
researchers that are working on these next generation of 
vaccines. They have told me that FDA is not prioritizing new 
vaccine technologies now, but rather they are focusing on 
therapeutics and existing vaccines. Is this accurate and can 
you speak to that?
    Dr. Woodcock. Well, the group that regulates therapeutics 
is different than the group that regulates vaccines within the 
FDA, so those--they are not competing with each other, right?
    As far as vaccines, we have been prioritizing the ones we 
could get out immediately because of the public health 
emergency. However, I think there will be new forms of 
vaccines. As Dr. Fauci said, there may be new vaccines that do 
not require the cold chain. They may--manufacturers may be able 
to modify the current vaccines to what are called lyophilized 
formulation that does not require refrigeration. That would be 
good. And people are looking at different types of vaccines, 
such as oral, nasal, and so forth. It is just taking longer.
    I do not think--the FDA is not standing in the way of that 
development. It is the fact that the tried and true platforms 
are easier to get a new vaccine up and running, and we had to 
do that in the middle of this emergency to get things done as 
quickly as possible.
    But, certainly, there is a lot of research going on in 
additional vaccines, and FDA is not impeding that.
    Senator Murkowski. Mr. Chairman, I have additional 
questions that I will submit to the record.
    I would certainly hope that we are going to have an 
opportunity to hear a little bit more from the Administration, 
though, about the mandates that have been put in place, this 
newly released emergency temporary standard from OSHA.
    I think these are areas where, when we are talking about 
vaccine and vaccine hesitancy, we need to be talking to those 
who are putting in place some of these standards that in my 
state are causing an extraordinary issue and problem within our 
workforce.
    Senator Burr. Senator Rosen.
    Senator Rosen. Thank you, Chairman Burr, and of course 
Chair Murray and Ranking Member Burr. Thank you. And I want to 
thank everyone for being here today and for your lifelong 
commitment to saving lives and protecting us. It is something 
that people do not realize as you go into these careers what 
the motivation is, and I thank you for that.
    I want to talk a little bit today about the supply chain 
because, as we have seen throughout the pandemic, American--our 
reliance on just-in-time supply chain for essential goods, 
especially emergency medical supplies, it really leaves us 
vulnerable to critical shortages.
    When we were experiencing acute shortages of essential 
supplies, like masks and gowns, many small manufacturers in the 
United States, well, they stepped up to change what they were 
producing to meet this public need.
    Like Polar Shade, a Las Vegas company that switched from 
making window coverings to PPE during the crisis. My office 
heard from a number of companies looking for Federal guidance 
to receive technical assistance on quality standards where the 
essential goods were needed most, but there was no system in 
place to handle this type of situation.
    That is why I introduced, with Senator Cassidy, the 
bipartisan Strategic Planning for Emergency Medical 
Manufacturing Act. It is going to create a voluntary, domestic 
backup manufacturing network, a process for manufacturers to 
plan ahead, prepare, receive this guidance, and Federal 
contract opportunities before a disaster strikes so they are 
ready to go when needed. And, of course, we heard from Senator 
Baldwin about people dumping supplies that are not quality.
    Ms. O'Connell, how did the gaps in our domestic supply 
chain, how did they hinder COVID-19, the initial response last 
year, and what gaps remain today? And can you--I want to work 
with you on advancing a bipartisan solution to strengthen our 
networks.
    Ms. O'Connell. Senator Rosen, thank you so much for this 
important--for bringing up this important topic, and I would 
really look forward to working with you, as well.
    When the pandemic first started, we experienced something 
where the whole world wanted and needed the same supplies at 
the exact same time, and many of them were being made overseas.
    In that time, thanks to a lot of funding that has come from 
Congress, we have been able to invest a billion dollars in 
various domestic manufacturing efforts. Now, that does not fill 
all the gaps yet, but we are continuing to look at various 
projects and send money out the door.
    One of the things we are doing that I think you will be 
interested in is creating a domestic warm base. We are starting 
to see, and we experienced that even at some phases in the 
pandemic, where demand for certain supplies increased and then 
immediately decreased.
    Senator Rosen. Right.
    Ms. O'Connell. What we need is to have this warm base. So 
we, for example, are putting out a statement of interest in 
having 140 million N-95s capacity to manufacture those per 
month and having that warm base capacity. We are investing $115 
million in that effort.
    We are trying to fill some gaps and we are continuing to 
look for opportunities.
    Senator Rosen. Great. I look forward to working on that 
with you.
    Dr. Fauci, in that same vein, where we have critical supply 
shortages as we think about PPE and other things, what about 
critical supplies of equipment and things for our research 
labs? How does that impact our ability to do the research, to 
advance the latest treatments, and how can we overcome those 
challenges? We had reagents, I know, that we were trying to 
get, a lot of different things.
    Dr. Fauci. Yes, that is an issue in some circumstances, 
Senator, where we have certain reagents, as you mentioned, that 
are not immediately available because of supply chain issues, 
and that is the reason why we get concerned when we have supply 
chain interruptions, which could impact what we do at NIH, 
which is research.
    Senator Rosen. Well, thank you. I look forward to working 
on that.
    Dr. Walensky, testing, testing, testing. It is the key to 
moving forward through a lot of this. Whether you have 
vaccination treatments or not, we need robust testing, and a 
lot of people cannot pay for the out-of-pocket, the turnaround 
can be slow.
    What support is the Federal Government providing to help 
states increase their ability to have fast, reliable, and free 
testing when it comes to labs and staffing? That is critical 
for our economy, people to go back to work.
    Dr. Walensky. Absolutely, and we have been working very 
closely with states and jurisdictions in order to roll out 
testing, free testing, and free testing support. We are working 
closely with states and schools.
    We have rolled out $10 billion thanks to you and the 
American Rescue Plan to provide testing in schools, and 
importantly, personnel, school nurses, as well as the technical 
assistance as to how--and toolkits for our schools as to how we 
use these tests, where best to use which test.
    Then peer-to-peer school advisers. If a school wants to 
roll out a testing program, how you might do that and how they 
might work with another school to understand what the 
challenges are and how to overcome them.
    Senator Rosen. Yes, schools are key. Well, I see that my 
time is expired. Thank you all again. I appreciate it, and 
Madam Chair.
    The Chair. [Presiding] Thank you.
    Senator Marshall.
    Senator Marshall. Thank you, Madam Chair. I want to start 
by asking unanimous consent to submit several documents. The 
first are 40 publications that support natural immunity, 40 
publications.
    The next I want to submit is CDC briefing that Dr. Walensky 
was kind enough to bring to our attention. It was dated October 
29th of this year, Science Brief: SARS-CoV-2 Infection-Induced 
and Vaccine Immunity.
    I want to call to everyone's attention, as the CDC points 
out here, the immunity provided by vaccine and prior infection 
are both high but not complete. The immunity provided by 
vaccine and prior infection are both high but not complete.
    For now, the last--what I would like to submit is 
something--the CDC's MMWR Release Volume 7, October 29, 2021, 
Laboratory Confirmed COVID-19 Among Adults Hospitalized. Along 
with that, a review by a Dr. Martin Kulldorff, as well as some 
comments some--from some 20 physicians. I asked just to look at 
the study just with concerns about that particular study.
    The Chair. Without objection.

    [The following information can be found on pages 735, 633, 
637, 653, 738, and 1290]

    Senator Marshall. This morning, I would like to focus on 
immune versus non-immune as opposed to conflating those who 
have natural immunity plus the vaccination. I will give you, 
there are some studies that would support some benefit to 
giving a vaccine to those who are already immune from natural 
immunity. I give you that, but the issue today I want to really 
lock in on is natural immunity versus vaccination immunity.
    We could have a frank debate, I am sure, all day long about 
the pros and cons, and I would think that if we were giving the 
lecture to our medical students, we would probably say the jury 
is still out, and here is all the information and the data. And 
I think that is why we have physicians to be able to look at 
this data and look at this particular person's medical history 
about do we feel the benefits of this vaccine outweigh the 
risk?
    Dr. Walensky, I just--my question for you is going to be, 
are you so convinced that this data is so much in favor that 
the vaccine by itself is better than natural immunity by 
itself? Are you so inclined to give that advice to the White 
House and separate the Navy Seal that I talked to yesterday 
from the military, a young, healthy Navy Seal?
    He has probably got, oh, my goodness, if he gets COVID, a 
one out of a million chance of having a serious 
hospitalization. At the same time, he has a 50 out of a million 
chance of getting heart swelling, which knocks him out of being 
a Navy Seal at least for 6 months and probably forever.
    Are you so convinced that the data is so compelling that 
natural immunity is not as good as vaccination? Again, do not 
conflate the two together.
    Are you so convinced that the nurses I worked with in 
liberal--when this epidemic was roaring, the union worker at 
Wolf Creek Nuclear Plant that kept the electricity on months 
ago that we held as heroes, that now we are going to punish 
them and separate them from their job? We took an oath to do no 
harm. Are you so convinced? Is the data so compelling that you 
think that is what we should do?
    Dr. Walensky. Thank you, Senator, for that question.
    First, let me just go back to the initial point, which I do 
not want to conflate them, but let me just say, I think the 
studies are uniform that vaccination after----
    Senator Marshall. That is not my question.
    Dr. Walensky. I understand that, but I want to----
    Senator Marshall. That is not my question.
    Dr. Walensky [continuing]. Make sure that we correct the 
record because I do believe that--you said some--I think----
    Senator Marshall. You said that three times. We get that.
    Dr. Walensky. I think the studies are uniform.
    Okay. So, if we are looking at infection-induced immunity 
versus vaccine-induced immunity, and we did transparently put a 
full review of the literature that is out there, 96 studies.
    I think if we were talking to our medical students, we 
would tell them that we do not have a correlative protection. 
We cannot measure whether you are protected or not, and we do 
know by virtue of the fact that our vaccine-induced immunity 
studies know for certain a date that we can follow what those 
correlative protection are in effectiveness studies, and we do 
not have the capacity. Not only do we not have a correlative 
protection at an antibody----
    Senator Marshall. I apologize. I need--I need to move on. I 
apologize.
    Next, I want to submit for the record, ask unanimous 
consent, first of all is an email from Peter Daszak dated July 
11th, 2016.
    It says, Dear Jenny, This is terrific. We are very happy to 
hear that our gain-of-function research funding pause has been 
lifted. Our gain-of-function funding pause has been lifted, 
along with, of course, the studies that go along with that.
    Dr. Fauci, who reviewed the grant proposal? And this is of 
course the one that is in the news, 1R01AI110964, project title 
Understanding the Risk of Bat Coronavirus Emergence. Who 
reviewed the grant proposal? Who made the decision that the 
grant would not be subject to the pause of gain-of-function? 
Who came up with the language allowing exemptions to be made? 
Was it the awardee or EcoHealth?
    Dr. Fauci. Senator, I am not so sure what you are asking. 
Are you saying did I do that?
    Senator Marshall. No. I am asking who. Who would make that 
type of decision?
    Dr. Fauci. As to what?
    Senator Marshall. Who would decide to make a pause in the 
viral gain-of-function decision for this particular research 
policy, this research request, again, from EcoHealth? It is 
dated 5/27/2014, that Peter Daszak would respond, this is 
terrific. We are very happy to hear that our gain-of-function 
research funding pause has been lifted.
    Dr. Fauci. Yes.
    Senator Marshall. Yes. Who would make that decision?
    Dr. Fauci. Okay. So, I think conflating the words gain-of-
function research pause. The question is, it was asked of the 
trained staff at the institute if this research would fall 
under the pause for gain-of-function, and it was determined by 
trained staff that it did not because at that time, there were 
two components of guardrails. There is the guardrail of prior 
to 2017, which is whether or not an experiment is designed to 
enhance the transmissibility or the pathogenesis----
    Senator Marshall. We understand that. We have been through 
the----
    Dr. Fauci. No, no. Well----
    Senator Marshall. That did not rise to your level?
    The Chair. Senator--Senator Marshall, your time has 
expired. We have two additional Senators plus closing remarks 
and----
    Senator Marshall. I think these are very important 
questions that America would like to know the answer to.
    The Chair. If you could submit them for the record, we 
could get a response.
    Senator Marshall. Will you commit, Dr. Fauci, to answering 
our questions that we are going to submit to the--for the 
record?
    Dr. Fauci. We always answer questions that are submitted to 
the record, of course.
    Senator Marshall. Thank you.
    The Chair. Thank you.
    Senator Lujan.
    Senator Lujan. Thank you very much, Chair Murray and 
Ranking Member Burr.
    I very much appreciate my colleagues' comments and 
attention to ensuring maximum vaccination in the United States, 
especially ensuring all American children who are eligible get 
vaccinated. Because of that line of questioning, I am able to 
turn my attention in another area that has been talked about a 
bit today, but I hope we can dig a little deeper.
    Although the United States is making progress vaccinating 
people, I am concerned about the low level of vaccination in 
low-and moderate-income countries. For interconnected border 
States like New Mexico, our physical and economic health 
depends on international cooperation. Much of the world remains 
unvaccinated, and that puts Americans' health and prosperity at 
risk.
    Though 49.6 percent of the world's population has received 
at least one dose of COVID vaccine, only 3.7 percent of people 
in low-income countries have. And yet, in the United States, 50 
million vaccines have been thrown away since March 1.
    Dr. Fauci, I appreciate your comments to Senator Smith on 
this topic, and again, I would like to dig in a little more. 
Dr. Fauci, do low vaccination rates concentrated in parts of 
the world allow COVID to spread unchecked?
    Dr. Fauci. Yes, Senator, and that is the reason why, as I 
have stated publically very often, that a global pandemic 
requires a global response. Because when you have vaccine 
dynamics that are rather robust in countries that are under-
vaccinated, then what could conceivably happen, maybe likely, 
certainly there will be mutations. And sometimes, mutations 
aggregate to the point that they lead to a new variant, which 
would be of concern, particularly if that variant has the 
potential of evading the vaccines that we already have.
    Senator Lujan. Dr. Fauci, you anticipated both of my 
follow-up questions, which were asking about the concerns with 
new variants and evading vaccinations that are currently 
available.
    Now, I open this question up to the panel. Yes or no, do 
low vaccination rates in large swaths of the world put the 
United States' health and economic recovery in jeopardy?
    Dr. Walensky.
    Dr. Walensky. We absolutely need a global response. I think 
that the line is no one is safe until everyone is safe.
    Senator Lujan. Dr. Fauci.
    Dr. Fauci. Definitely, yes.
    Senator Lujan. Dr. Woodcock.
    Dr. Woodcock. Yes.
    Senator Lujan. Ms. O'Connell.
    Ms. O'Connell. Yes.
    Senator Lujan. Dr. Woodcock, the more attention that is 
brought to this area--my question is, what more can be done or 
can we be doing in the United States to ensure countries have 
the data they need to approve vaccinations in country? During a 
recent visit with other colleagues, we found out that some 
countries had not yet approved vaccines that were available 
across the United States and in many parts of the world.
    Dr. Woodcock. Well, we post as much information as we can. 
We post our reviews, which have a large amount of information.
    The material that goes before the advisory committees is 
all posted.
    Also, we participate in an international collaboration 
called ICMRA that for--often, I will be on a call. There will 
be representatives from 90 to 100 different countries. It is 
only regulators, and we talk about the challenges and how we 
can overcome them, and specifically is a vaccine area.
    The FDA is very happy to collaborate to the extent we can 
by law with any country to help them with their regulators and 
getting information that they need.
    Senator Lujan. You said something very key there, that the 
FDA is happy to work with others as long as the law allows. And 
one of the areas that I am very interested in pursuing is what 
is not allowing the United States to fully work with other 
countries in this space.
    The United States is actively engaged in international 
efforts, like COVAX and other regulatory harmonization efforts, 
but the reality is that low-income countries remain largely 
unvaccinated. While the amount of discarded vaccines is a small 
percent of vaccine doses successfully administered, each wasted 
dose represents a missed opportunity to protect the health of a 
person and stop the spread.
    How can we maximize that? And I am very interested in 
pursuing what is standing in its way, how can we increase those 
efforts, what is required for us to work with countries so that 
they have a rapid response, ready to go. I learned that exists 
in Ecuador, even in areas of indigenous communities, where they 
have proven that if they can get the vaccine, they can get into 
people's arms relatively efficiently.
    Madam Chair, I want to be respectful of my other 
colleagues. I will submit the remainder of my questions into 
the record.
    I want to thank each of the experts that are here today, 
and I look forward to working with each and every one of you to 
get more people vaccinated and stop the spread of COVID. Thank 
you so much.
    The Chair. Thank you.
    Senator Moran.
    Senator Moran. Chair, thank you, you and Ranking Member, 
and witnesses; thank you for joining us now this afternoon.
    First, Dr. Walensky, I am interested in learning what the 
Administration's plan may be in regard to vaccination mandate. 
Just days ago, you signed off on the Emergency Use 
Authorization for pediatric COVID-19 vaccine.
    The issue of mandates is roiling across the Country, and 
there are--while there are many parents who are interested and 
willing to get their young children vaccinated, there are also 
other parents who still question the pediatric use Emergency 
Use Authorization and are concerned about a potential Federal 
vaccine mandate.
    I share the concern about Federal vaccine mandate. I urge 
the CDC and the Administration against implementing a vaccine 
mandate for students. Forcing parents to vaccinate their 
children as a requirement to attend public school would be, 
without a doubt, a Federal overreach.
    Federal Government mandates for children to attend school 
that would represent an extreme departure from our educational 
system's historic, long-standing reliance upon local and state 
control. And, in my view, the decision to vaccinate the child 
should be left to the parent and their trusted physician. It is 
a private relationship the Federal Government should not be 
inserting itself into with a mandate.
    Perhaps all that commentary is unnecessary and you can just 
assure me that is not what is the next step in mandates from 
the Biden administration. And if just you can only answer me--
perhaps you cannot answer what the Biden administration is 
going to do, but what is your thoughts and what would your 
recommendation be?
    Dr. Walensky. Thank you, Senator Moran. I am delighted that 
this week we were able to strongly recommend that 28 million 
children receive a COVID-19 vaccine to prevent infection, to 
prevent severe disease, long COVID, multi-system inflammatory 
syndrome, as well as death in the children that we have seen 
between the ages of 5 and 11.
    Those recommendations are strong. They are after 
endorsement of the FDA's Emergency Use Authorization. Vaccine 
requirements are left--for schools are left to the local 
jurisdiction, and so we will leave those to the local 
jurisdiction to make those decisions.
    Senator Moran. Kansas parents who may have concerns about 
whether or not their children will be able to attend school, 
that will not be a decision that is made by--without a vaccine, 
that is not a decision that will be made by the CDC or the 
Biden administration, but remain a local decision to be made by 
a local board of education?
    Dr. Walensky. I will always encourage that parent to get 
their child vaccinated and speak to them about the information 
and communication and education that they need in order to get 
their children vaccinated. Right now, at this moment, those 
decisions are made at the jurisdictional level, as they are for 
vaccination of other all--other vaccine-preventable diseases 
among children.
    Senator Moran. I felt better when you said--before you said 
right now, and that just causes me to, again, ask is there any 
intention to change that long-standing practice?
    Dr. Walensky. Not to my knowledge.
    Senator Moran. Thank you. Let me call on Ms. O'Connell.
    Ms. O'Connell, I have been a supporter and seen the value. 
A long time ago as House member, I offered a Moran 10-Point 
plan on saving healthcare costs, at reducing healthcare costs. 
One of those components is the value of community health 
centers.
    I would like to give you the opportunity to tell me what it 
is that can be done, should be done to continue to include 
those community health centers who have played an integral part 
in combatting COVID-19, that they are capable, more capable, 
and prepared, should there be another pandemic.
    Ms. O'Connell. Well, Senator Moran, thank you. This is one 
of the things that you and I have in common--strong supporter 
of our federally qualified community health centers, our rural 
health centers, and the program that HRSA runs to support both.
    We have seen the FQHCs play a significant role in 
distributing vaccine. We are also running a pilot program right 
now, which allows them to distribute free, at-home rapid tests 
to families, and I think that is another important way in which 
they can contribute to this response. We are hoping to scale 
that up by Thanksgiving. Right now, it is in eight states.
    We have also been able, through the FQHCs and rural health 
centers, distribute masks to families that might need them, 
high-quality masks. And, of course, they continue to provide 
clinical care to families that seek their care there.
    Continue to see them play a significant role, and we are 
always looking for opportunities to increase the impact they 
can have in this pandemic.
    Senator Moran. I thank you for that answer. And I want my 
community health centers to know how valuable they are, not 
just in the time of a pandemic, but throughout daily life of 
lots of Americans.
    I just visited one in Kansas City, Kansas last week. Again, 
reminded that they serve a very valuable purpose and a way for 
those who might not otherwise access the opportunity to have a 
consultation with a healthcare provider to be able to do so and 
to make a decision about how to care for themselves and their 
families. Thank you very much.
    Thank you, Chair.
    The Chair. Thank you.
    Senator Burr, any closing remarks?
    Senator Burr. Thank you, Madam Chair.
    To all four of our witnesses today, thank you for the job 
you do. And more importantly, would you go back to the host of 
people that are behind you in this work and thank them on 
behalf of the Committee.
    Dr. Walensky, I did not have this on my list today, but the 
questions have precipitated it. Do you really not know the 
answer to the number of vaccinated individuals at CDC or did 
you just not want to answer it, Senator Cassidy's question?
    Dr. Walensky. We are still actively working on collecting 
those data, and those data are updated in real-time.
    Senator Burr. Could you provide that for the Committee by 
Monday of next week?
    Dr. Walensky. We are working toward updating those data, 
and I would have to speak with my staff about where we are and 
whether those numbers are going to be available on Monday.
    Senator Burr. Dr. Walensky, I just remind you that there is 
an executive order in place for all Federal agencies that 
vaccinations for Federal workers be concluded by November 22nd, 
and it says that actual date is November 8th, which is next 
Monday, because disciplinary actions have to begin on November 
the 9th. So, if the collection is still in process, how are you 
going to start disciplinary actions based upon the executive 
order?
    Dr. Walensky. We are actively updating those data. I just 
do not know exactly when they will be fully in. But, certainly, 
we will have those data by the appropriate deadlines.
    Senator Burr. Well, if CDC does not have to live by the 
rules, why should employers have to live by the mandate rules?
    Dr. Walensky. As I mentioned, we will actively make sure 
that we are complying with the rules because----
    Senator Burr. Okay. Let me----
    Dr. Walensky [continuing]. We want everybody else, too, as 
well.
    Senator Burr. Let me ask one last question because I think 
what you have heard is a frustration by Members about confusing 
messages that go out.
    It is confusion when somebody has to be vaccinated, though 
they have got natural immunity. It is confusing when this 
policy is in place for masks, and then over here it has 
changed. And I realize this is an evolving thing.
    But, correct me if I am wrong. The CDC website currently 
says that if you have had COVID in the last 90 days and you 
leave the Country and you come back in, you are not required to 
be tested before you come to the United States.
    The website says, ``We recommend that within 3 to 5 days of 
returning to the United States, you should have a COVID test''.
    I leave on Sunday. I have double vaccination. I have a 
booster. Next Thursday in London, I will be required to have a 
COVID test in London before I can fly back into the United 
States. The CDC's own website puts more value on natural 
immunity than they do on two vaccine shots and a booster shot.
    Dr. Walensky. Our guidance is intended--first of all, let 
me just say, I think our guidance is very simple when it comes 
to vaccination and it has nothing to do with whether you have 
been infected or not. We recommend everybody in this Country be 
vaccinated with either two doses of either a Pfizer or Moderna 
vaccine or a single dose of a Johnson & Johnson vaccine. It 
could not be more simple. Everyone should get vaccinated who is 
eligible to be vaccinate.
    With regard to our travel, our travel guidance and our 
travel restrictions are to keep Americans safe, to keep people 
traveling to the United States safe, and to keep our local 
communities safe.
    Senator Burr. Let me repeat what the guidance is, that if I 
leave the Country and I have been infected and recovered from 
COVID in the last 90 days, I can come back in the Country 
without a requirement to be COVID tested before I come in the 
Country. Though, I am recommended once I get in the Country to 
be--to have a test within 3 to 5 days.
    If I am vaccinated and I am boosted, if I leave the 
Country, I have got to physically be tested outside the United 
States before I can return to this Country.
    I am not asking a question. I am making a point. That is so 
confused----
    Dr. Walensky. Senator, may I just----
    Senator Burr. That is so confusing that there is--there is 
every reason to believe that the American people can look at 
this and say, what in the hell are you guys doing? What are you 
judging this based on? It is not common sense and it is 
certainly not sense.
    Dr. Walensky. The scientific ground for these tests is that 
these PCR tests can stay positive up to 12 weeks, and so what 
we are working to prevent is that people who would have a 
persistently positive test from prior infection not be confused 
with people who are newly infected in that Country. They 
actually have to prove that they have been--had a positive test 
so we are not looking and misdiagnosing them as newly infected.
    Senator Burr. Well----
    Dr. Walensky. It is the science that is informing that 
policy.
    Senator Burr. Your stated policy suggests that you put more 
value on natural immunity. It does. It does.
    Dr. Walensky. It is the performance of the diagnostic 
tests, unfortunately.
    Senator Burr. Thank you, Madam Chair.
    Dr. Walensky. Thank you.
    The Chair. That will end our hearing today, and I want to 
thank our panelists--Dr. Walensky, Dr. Fauci, Dr. Woodcock, and 
Assistant Secretary O'Connell. You have all been very patient, 
and we appreciate a very thoughtful discussion about our 
ongoing response to this pandemic and the path forward, and I 
really do appreciate all of you being here today.
    For any Senators who wish to ask additional questions, 
questions for the record will be due in 10 business days, 
November 19th, at 5 p.m. And with that, the Committee stands 
adjourned.

                          ADDITIONAL MATERIAL

 alzheimer's association and alzheimer's impact movement statement for 
                               the record
    The Alzheimer's Association and Alzheimer's Impact Movement (AIM) 
appreciate the opportunity to submit this statement for the record for 
the Senate Committee on Health, Education, Labor, and Pensions (HELP) 
hearing on ``Next Steps: The Road Ahead for the COVID-19 Response''. 
The Association and AIM thank the Committee for its continued 
leadership on issues important to the millions of people living with 
Alzheimer's and other dementia and their caregivers. This statement 
provides an overview of the impact COVID-19 continues to have on the 
Alzheimer's community and policies that help protect this vulnerable 
population, particularly those living in long-term and community-based 
care settings.

    Founded in 1980, the Alzheimer's Association is the world's leading 
voluntary health organization in Alzheimer's care, support, and 
research. Our mission is to eliminate Alzheimer's and other dementia 
through the advancement of research; to provide and enhance care and 
support for all affected; and to reduce the risk of dementia through 
the promotion of brain health. AIM is the Association's advocacy 
affiliate, working in strategic partnership to make Alzheimer's a 
national priority. Together, the Alzheimer's Association and AIM 
advocate for policies to fight Alzheimer's disease, including increased 
investment in research, improved care and support, and development of 
approaches to reduce the risk of developing dementia.
                            COVID-19 Impact
    At least 184,000 residents and employees of nursing homes and long-
term care facilities have died from COVID-19, representing over 30 
percent of the total death toll in the United States. These communities 
are on the frontlines of the COVID-19 crisis, where 48 percent of 
nursing home residents are living with dementia, and 42 percent of 
residents in residential care facilities have Alzheimer's or another 
dementia. Residents with dementia are particularly susceptible to 
COVID-19 due to their typical age, their significantly increased 
likelihood of coexisting chronic conditions, and the community nature 
of long-term care settings.

    These challenges are compounded by the negative consequences of 
social isolation that many older adults already experience. Social 
isolation is an issue within the aging community as a whole, 
exacerbated due to the current pandemic, and acutely impacting those 
living with Alzheimer's and other dementia.
              Long-term and Community-based Care Policies
    To best support individuals living with Alzheimer's and dementia 
during the COVID-19 pandemic, the Alzheimer's Association released a 
comprehensive set of long-term care policy recommendations for Federal 
and state lawmakers, Improving the State and Federal Response to COVID-
19 in Long-Term Care Settings. These recommendations focus on four 
areas: (1) rapid point-of-care testing, (2) reporting, (3) surge 
activation, and (4) providing support.

    Dedicated funding for testing and tracing in nursing homes and 
assisted living communities is crucial. All cases of COVID-19 in these 
settings need to be reported immediately and accurately. These reports 
should be updated upon remission, death, transfer, or other appropriate 
status update. With all appropriate privacy safeguards for individuals, 
this reported data should be freely and immediately accessible to all 
down to the facility level. It is critical that data on race and 
ethnicity are included in this reporting, which will be especially 
important in ensuring targeted support for the entirety of the COVID-19 
pandemic, and preparedness for potential future pandemics.

    As ``hot spots'' occur, they must be dealt with urgently and 
effectively. Any reported COVID-19 cases should trigger careful, 
ongoing monitoring and, if conditions warrant, well-trained and 
equipped strike teams should be deployed to the facility to provide 
needed support until the outbreak is contained and eliminated. All 
nursing homes and assisted living communities must have full access to 
all needed personal protective equipment, testing equipment, training 
and external support to keep them COVID-19-free. It is also important 
to ensure increased access to televisitation technologies to address 
social isolation in long-term care settings, which can have a 
devastating impact, so that people living with dementia are able to 
continue communicating with designated family and friends.

    These policies are designed to create a strong and decisive 
response to the COVID-19 crisis in all long-term care settings and we 
were grateful to see many of them enacted as part of the American 
Rescue Plan Act of 2021 (P.L. 117-2). We thank you for your work to 
ensure these critical provisions were included, as they represent a 
significant step forward in improving care during this pandemic and 
beyond.

    In addition, with the approval of multiple safe and effective 
vaccines and subsequent boosters, we urge the continued prioritization 
of access for Americans over the age of 65, particularly those in long-
term care settings. This is consistent with the Centers for Disease 
Control and Prevention's recommendation that long-term care residents 
be prioritized for access to vaccines, as well as the health care 
workers caring for some of the most vulnerable in our Country and who 
provide an enormous service to society as a whole.

    Finally, expanded access to home-and community-based services 
(HCBS) is crucial, and a strong HCBS workforce is needed to ensure 
quality care. People living with dementia make up a large proportion of 
all elderly people who use these important services. In fact, 31 
percent of individuals using adult day services have dementia. Access 
to these services can help people with dementia live in their homes 
longer and improve quality of life for both themselves and their 
caregivers. For example, in-home care services, such as personal care 
services, companion services, or skilled care can allow those living 
with dementia to stay in familiar environments and be of considerable 
assistance to caregivers. Adult day services can provide social 
engagement and assistance with daily activities. Given the demands on 
and responsibilities of caregivers, respite services are also critical 
to their health and well-being, and may allow people with dementia to 
remain in their homes longer. Strengthening the HCBS workforce through 
increased wages, benefits, and support is also especially important as 
the majority of home care workers are disproportionately women of 
color. We are glad to see the additional HCBS funding included in the 
Build Back Better Act and support swift enactment of those crucial 
provisions.
                               Conclusion
    The Alzheimer's Association and AIM appreciate the steadfast 
support of the Committee and its continued commitment to advancing 
legislation important to the millions of families affected by 
Alzheimer's and other dementia. We look forward to working with the 
Committee in a bipartisan way to strengthen policies to protect those 
living with Alzheimer's and other dementia during the COVID-19 pandemic 
and beyond, particularly in the Committee's forthcoming pandemic 
preparedness package. We welcome the opportunity to be a resource to 
the Committee as that legislation moves forward.
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    [Whereupon, the hearing was adjourned at 12:54 p.m.]

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