[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]




   LEADING THE WAY FORWARD: BIDEN ADMINISTRATION ACTIONS TO INCREASE 
                         COVID-19 VACCINATIONS

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

                            VIRTUAL HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 17, 2021

                               __________

                           Serial No. 117-12




                 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]





     Published for the use of the Committee on Energy and Commerce

                   govinfo.gov/committee/house-energy
                        energycommerce.house.gov




                                 ______
                                 

                 U.S. GOVERNMENT PUBLISHING OFFICE

46-138 PDF                WASHINGTON : 2022











                    COMMITTEE ON ENERGY AND COMMERCE

                     FRANK PALLONE, Jr., New Jersey
                                 Chairman

BOBBY L. RUSH, Illinois              CATHY McMORRIS RODGERS, Washington
ANNA G. ESHOO, California              Ranking Member
DIANA DeGETTE, Colorado              FRED UPTON, Michigan
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois             STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina    ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California          BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida                DAVID B. McKINLEY, West Virginia
JOHN P. SARBANES, Maryland           ADAM KINZINGER, Illinois
JERRY McNERNEY, California           H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont                 GUS M. BILIRAKIS, Florida
PAUL TONKO, New York                 BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York           BILLY LONG, Missouri
KURT SCHRADER, Oregon                LARRY BUCSHON, Indiana
TONY CARDENAS, California            MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California                RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California          TIM WALBERG, Michigan
DEBBIE DINGELL, Michigan             EARL L. ``BUDDY'' CARTER, Georgia
MARC A. VEASEY, Texas                JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire         GARY J. PALMER, Alabama
ROBIN L. KELLY, Illinois, Vice       NEAL P. DUNN, Florida
    Chair                            JOHN R. CURTIS, Utah
NANETTE DIAZ BARRAGAN, California    DEBBBIE LESKO, Arizona
A. DONALD McEACHIN, Virginia         GREG PENCE, Indiana
LISA BLUNT ROCHESTER, Delaware       DAN CRENSHAW, Texas
DARREN SOTO, Florida                 JOHN JOYCE, Pennsylvania
TOM O'HALLERAN, Arizona              KELLY ARMSTRONG, North Dakota
KATHLEEN M. RICE, New York
ANGIE CRAIG, Minnesota
KIM SCHRIER, Washington
LORI TRAHAN, Massachusetts
LIZZIE FLETCHER, Texas
                                 ------                                

                           Professional Staff

                   JEFFREY C. CARROLL, Staff Director
                TIFFANY GUARASCIO, Deputy Staff Director
                  NATE HODSON, Minority Staff Director






              Subcommittee on Oversight and Investigations

                        DIANA DeGETTE, Colorado
                                  Chair

ANN M. KUSTER, New Hampshire         H. MORGAN GRIFFITH, Virginia
KATHLEEN M. RICE, New York             Ranking Member
JAN SCHAKOWSKY, Illinois             MICHAEL C. BURGESS, Texas
PAUL TONKO, New York                 DAVID B. McKINLEY, West Virginia
RAUL RUIZ, California                BILLY LONG, Missouri
SCOTT H. PETERS, California, Vice    NEAL P. DUNN, Florida
    Chair                            JOHN JOYCE, Pennsylvania
KIM SCHRIER, Washington              GARY J. PALMER, Alabama
LORI TRAHAN, Massachusetts           CATHY McMORRIS RODGERS, Washington 
TOM O'HALLERAN, Arizona                  (ex officio)
FRANK PALLONE, Jr., New Jersey (ex 
    officio)






                           C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     2
    Prepared statement...........................................     4
Hon. H. Morgan Griffith, a Representative in Congress from the 
  Commonwealth of Virginia, opening statement....................     5
    Prepared statement...........................................     6
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     7
    Prepared statement...........................................     9
Hon. Cathy McMorris Rodgers, a Representative in Congress from 
  the State of Washington, opening statement.....................    10
    Prepared statement...........................................    12

                               Witnesses

Rochelle P. Walensky, M.D., Director, Centers for Disease Control 
  and Prevention, Department of Health and Human Services........    14
    Prepared statement...........................................    16
    Answers to submitted questions...............................    98
Anthony S. Fauci, M.D., Director, National Institute of Allergy 
  and Infectious Diseases, National Institutes of Health.........    31
    Prepared statement...........................................    33
    Answers to submitted questions...............................   110
Peter Marks, M.D., Ph.D., Director, Center for Biologics 
  Evaluation and Research, Food and Drug Administration, 
  Department of Health and Human Services........................    43
    Prepared statement...........................................    46
    Answers to submitted questions...............................   117

                           Submitted Material

Commentary of June 8, 2020, ``Could Trump Turn a Vaccine Into a 
  Campaign Stunt?,'' by Ezekiel J. Emanuel and Paul A. Offit, New 
  York Times, submitted by Mr. Burgess...........................    96






 
   LEADING THE WAY FORWARD: BIDEN ADMINISTRATION ACTIONS TO INCREASE 
                         COVID-19 VACCINATIONS

                              ----------                              


                       WEDNESDAY, MARCH 17, 2021

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m. via 
Cisco Webex online video conferencing, Hon. Diana DeGette 
(chair of the subcommittee) presiding.
    Members present: Representatives DeGette, Kuster, Rice, 
Schakowsky, Tonko, Ruiz, Peters, Schrier, Trahan, O'Halleran, 
Pallone (ex officio), Griffith (subcommittee ranking member), 
Burgess, McKinley, Long, Dunn, Joyce, Palmer, and Rodgers (ex 
officio).
    Also present: Representatives Eshoo, Kelly, Craig, Guthrie, 
Walberg, and Carter.
    Staff present: Kevin Barstow, Chief Oversight Counsel; 
Billy Benjamin, Systems Administrator; Jesseca Boyer, 
Professional Staff Member; Jeffrey C. Carroll, Staff Director; 
Austin Flack, Policy Analyst; Waverly Gordon, General Counsel; 
Tiffany Guarascio, Deputy Staff Director; Perry Hamilton, 
Clerk; Rebekah Jones, Counsel; Zach Kahan, Deputy Director, 
Outreach and Member Service; Chris Knauer, Oversight Staff 
Director; Mackenzie Kuhl, Digital Assistant; Kevin McAloon, 
Professional Staff Member; Aisling McDonough, Policy 
Coordinator; Kaitlyn Peel, Digital Director; Tim Robinson, 
Chief Counsel; Chloe Rodriguez, Clerk; Nikki Roy, Policy 
Coordinator; Benjamin Tabor, Junior Professional Staff Member; 
C.J. Young, Deputy Communications Director; Sarah Burke, 
Minority Deputy Staff Director; William Clutterbuck, Minority 
Staff Assistant; Theresa Gambo, Minority Financial and Office 
Administrator; Marissa Gervasi, Minority Counsel, Oversight and 
Investigations; Brittany Havens, Minority Professional Staff 
Member, Oversight and Investigations; Nate Hodson, Minority 
Staff Director; Peter Kielty, Minority General Counsel; Emily 
King, Minority Member Services Director; Bijan Koohmaraie, 
Minority Chief Counsel; Clare Paoletta, Minority Policy 
Analyst, Health; Olivia Shields, Minority Communications 
Director; Alan Slobodin, Minority Chief Investigative Counsel, 
Oversight and Investigations; Evan Viau, Minority Professional 
Staff Member, Communications and Technology; and Everett 
Winnick, Minority Director of Information Technology.
    Ms. DeGette. The Subcommittee on Oversight and 
Investigations hearing will now come to order.
    Today the committee is holding a hearing entitled ``Leading 
the Way Forward: Biden Administration Actions to Increase 
COVID-19 Vaccinations.'' Today's hearing will examine the 
Federal Government's response to the COVID-19 pandemic and 
vaccination efforts in the United States.
    Due to the COVID-19 public health emergency, today's 
hearing is being held remotely. All Members, witnesses, and 
staff will be participating via video conferencing.
    As part of our proceeding, microphones will be set on mute 
for purposes of eliminating inadvertent background noise. 
Members and witnesses, you will need to unmute your microphone 
each time you wish to speak.
    [Pause.]
    Ms. DeGette. I am having some connection problems here on 
my end, and so I don't know if--I cannot see anybody, but I am 
going to finish my little introduction, then we will try to 
figure out what the problem is. If I can't chair the hearing--
which I hope doesn't happen momentarily--Mr. Peters, the vice 
chair, will serve as chair until I am able to return.
    Documents for the record can be sent to Austin Flack at the 
email address we have provided to staff. All documents will be 
entered into the record at the conclusion of the hearing.
    And the Chair is going to be in recess for 1 minute while I 
determine the technology.
    [Pause.]
    Ms. DeGette. OK, apparently we have resolved our technical 
problems. Thanks to everybody for your patience. We have a new 
saying in our office: ``Technology is our friend.''
    And so, before we start, I want to thank all of the Members 
for participating. This is such an important hearing. And also, 
those who are hoping to waive on to the subcommittee, I want to 
let all of the Members know that our witnesses have a hard stop 
at 12:30 p.m. eastern time today, due to a previous engagement 
at the White House. And so I expect we will be able to be able 
to have the members of the subcommittee ask questions. It is 
unclear whether we will be able to get to the members of the 
full committee who are not on the subcommittee. I just want to 
warn you of that now.
    And with that, the Chair will recognize herself for an 
opening statement.

 OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Today the subcommittee continues its oversight of the 
ongoing COVID-19 pandemic. Since its beginning, we have 
examined many aspects of this crisis, including vital efforts 
to develop, distribute, and to administer COVID-19 vaccines. 
This is part of this committee's ongoing effort to monitor 
pandemics.
    And in fact, we had a hearing in this subcommittee on 
December 4, 2019, just before coronavirus encircled the entire 
world. Dr. Fauci was at that hearing, and others from the 
administration, where we talked about our concerns about being 
ready for any kind of pandemic. And, of course, everything hit 
soon after that.
    We intend to continue on this subcommittee to make sure 
that we address this pandemic, that we come out the other side 
as quickly as possible, and we intend to ensure that we are 
much better prepared for anything that may come at us in the 
future.
    Now, just this year, in that vein, this subcommittee has 
held two hearings already on the pandemic, one with State 
officials and the other one with the vaccine manufacturers, to 
talk about the status of the vaccine production and 
distribution. Today we are so happy to hear, for the first 
time, from the senior members of the Biden administration in 
charge of this effort on exactly where the vaccination campaign 
currently stands.
    As we just passed the 1-year anniversary of the national 
emergency, it is really difficult to fathom the devastating 
loss that we endured. Of course, more than 532 million--
thousand--Americans have lost their jobs. Millions more lost 
their--let me start again--532 million--thousand Americans lost 
their lives, and millions more lost their jobs. Businesses are 
suffering. Every day we have new questions.
    These are the questions that I came up with just yesterday:
    Do we have sufficient doses of the vaccine to distribute?
    When will we be able to distribute them?
    We were all absolutely thrilled to hear from the President 
that he hopes to open this country for July 4th celebrations. 
Is that realistic?
    When are we going to be able to approve new vaccines?
    What are we going to do with the uneven distribution of the 
vaccines to minority communities, low-income communities, and 
rural communities?
    What are we going to do about certain pockets of people 
resisting to get the vaccines, and how can we persuade them 
that we need to do it to make everybody safe?
    What is the status of the vaccine research with children?
    And how do we restore the CDC to its historic place at the 
top of the panoply of the international public health 
community?
    All of those are really important issues that we are going 
to have to answer.
    We have two people here with us today who have been 
extraordinary in helping us develop the vaccine, and also our 
country's response to the pandemic. That is, of course, the 
now-famous Dr. Fauci, and also Dr. Marks, who have appeared in 
front of this subcommittee many times.
    And we want to thank both of you for your efforts.
    And also, we are so happy to have new leadership down at 
the CDC. Dr. Walensky, thank you so much for being with us.
    This is her first time testifying before this committee, 
and I know it won't be the last.
    We look forward to working with you to make sure that the 
CDC is working at its very top and science-based best.
    The American Recovery Act, which was just passed by 
Congress and signed into law last week, further will help us 
boost vaccinations and testing across the country. It provides 
funding to families, States, local governments, and business. 
And so we feel like the veil is lifting on COVID-19, but we 
still must remain vigilant. We can't become complacent now. 
This is a message the administration has been giving out every 
day.
    And in addition, vaccine hesitancy and access disparities 
persist. As I said, we have to work together to address these 
disparities.
    I want to thank the witnesses again for coming. We all look 
forward to hearing from you today about where we are at, where 
we need to go, and how Congress can help, because if we all do 
our part we can end the pandemic. And this committee will 
continue to do its part by continuing our bipartisan oversight 
over this critical subject, which we have aggressively pursued, 
not just since the beginning of the pandemic but for all of the 
24 years that I have been on this committee.
    [The prepared statement of Ms. DeGette follows:]

                Prepared Statement of Hon. Diana DeGette

    Today, the subcommittee continues its oversight of the 
ongoing COVID-19 pandemic. Since its beginning, we have 
examined many aspects of this crisis, including vital efforts 
to develop, distribute, and administer COVID-19 vaccines.
    In previous hearings this year, we heard from State health 
officials who provided their on-the-ground assessments of the 
national vaccination effort and from vaccine manufacturers who 
updated us on efforts to ramp up vaccine production.
    Today, we will hear from the Biden administration on where 
our historic vaccination campaign currently stands and how we 
will get America fully vaccinated.
    As we pass the 1-year anniversary of this national 
emergency, it is difficult to fathom the devastating losses we 
have endured.
    More than 532,000 Americans have lost their lives, millions 
more have lost their jobs, and countless businesses have 
suffered. The long-term effects on our children, our Nation's 
mental health, and the many COVID ``long-haul'' survivors are 
still unknown.
    At the same time, we have also been awed by the resilience 
of the American people and the remarkable progress we have made 
in the fight against the pandemic.
    We are proud of our government scientists--including two of 
them who are here with us today--who worked alongside their 
scientific colleagues in private industry to bring us three 
safe and effective vaccines, with potentially more to come.
    These scientists and many others have worked tirelessly 
throughout the last year, and we thank them for their work. 
Efforts to develop COVID-19 vaccines were possible due to 
investments made by Congress and through extraordinary public-
private partnerships.
    While we celebrate these remarkable successes, we must 
acknowledge the reality that vaccine development was only the 
first step. As we have said time and again, vaccines don't save 
lives, vaccinations do.
    Fortunately, the Biden administration continues to take 
concrete steps to end the pandemic. Weekly vaccine supply has 
more than doubled since President Biden took office, and 
vaccinations have risen to as many as 2.9 million shots a day.
    And President Biden has assured America that, by the end of 
May, we should have enough supply to vaccinate all adults.
    The administration has also worked to ensure wider vaccine 
distribution through community health centers, local 
pharmacies, and FEMA mass vaccination sites, increasing access 
for particularly vulnerable populations and underserved 
Americans.
    In Colorado, we have seen the benefits of working with 
community-based organizations to bring vaccination clinics into 
underserved areas, and we look forward to expanding those 
efforts.
    Thankfully, even more help is on the way. The American 
Rescue Plan, which was passed by Congress and signed into law 
last week by President Biden, will further boost vaccinations 
and testing across the country, provide desperately needed 
funding to support American families, and invests resources to 
help schools reopen for safe in-person instruction.
    While the veil begins to lift on COVID-19, we must remain 
vigilant. Now is not the time to become complacent. We must 
continue to take critical public health measures such as 
masking and social distancing.
    Additionally, vaccine hesitancy and access disparities 
persist across many communities. Federal, State, and local 
leaders must work together to reach these communities, address 
their concerns, and provide access to these lifesaving 
vaccines.
    Today, we are joined by some of our Nation's top public 
health officials. We are pleased to welcome back Dr. Anthony 
Fauci and Dr. Peter Marks to the committee. We are grateful for 
their leadership and steady presence throughout this entire 
pandemic.
    We are also pleased to welcome Dr. Rochelle Walensky, who 
is testifying before Congress for the first time in her new 
role as the Director of the Centers for Disease Control and 
Prevention. For too long, the voices of CDC experts were 
stifled, so I am grateful for her commitment to ensuring that 
science is driving our Nation's pandemic response.
    Thank you to our witnesses for sharing your valuable time 
and for the tireless work of you and your public health 
colleagues across the government.
    I look forward to hearing from you today on how we can 
ensure equitable access, strengthen vaccine confidence, 
increase vaccination rates across the country, and help defeat 
the new variants in the months ahead.
    While the light at the end of the tunnel is visible now, it 
will continue to grow only if we remember what brought us here: 
listening to science and following the guidance from our public 
health experts.
    If we all do our part, we can end this pandemic. And this 
committee will continue to do its part by continuing our 
bipartisan oversight over this critical subject, which we have 
aggressively pursued since the beginning of this pandemic.

    Ms. DeGette. And with that, the Chair is pleased to 
recognize the ranking member of the subcommittee, Mr. Griffith, 
for 5 minutes for an opening statement.

OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE 
         IN CONGRESS FROM THE COMMONWEALTH OF VIRGINIA

    Mr. Griffith. Thank you very much, Chairman DeGette, for 
holding this important hearing on COVID-19 vaccines.
    Just over a year ago, the World Health Organization 
announced that COVID-19 could be characterized as a pandemic. A 
few days later, President Trump declared a national emergency 
in the United States. About a week after that, California 
became the first State to go on lockdown. More States follow 
soon after that, forcing businesses, schools, and restaurants 
to close.
    As of March 16th, we have lost over 50--excuse me--533,000 
Americans to COVID-19. And according to a recent New York Times 
article, one in three Americans have lost a loved one to the 
virus. Tens of millions more have been infected, some of whom 
are experiencing prolonged symptoms.
    However, we have reasons to be hopeful. There is light at 
the end of what has been a very dark tunnel. Because of the 
success of Operation Warp Speed and the unprecedented efforts 
of the private sector, to date we have three safe and effective 
vaccines that have received Emergency Use Authorizations, EUAs, 
from the U.S. Food and Drug Administration, FDA.
    Pfizer, Moderna, and Johnson & Johnson, and more vaccine 
candidates are in clinical trials. Two of our witnesses, Dr. 
Fauci and Dr. Marks, played important roles in this 
achievement. While the vaccine rollout was slow to start, as 
vaccine manufacturers ramped up their production efforts, the 
supply and distribution has continued to improve since the 
first vaccines were authorized, distributed, and administered 
in December.
    According to the Centers for Disease Control and 
Prevention, nearly 22 percent of the U.S. population has 
received at least one dose of a COVID-19 vaccine, and almost 12 
percent of the U.S. population is fully vaccinated. This means 
that more people have been vaccinated than have been infected 
with the virus in the U.S. We still have a ways to go, but we 
are in a remarkable situation given that we are only a little 
over a year out from the start of this global pandemic.
    Recently this subcommittee held two hearings focused on 
COVID-19 vaccines. On February 2nd the subcommittee heard from 
a handful of States about vaccine distribution and 
administration efforts at the State level. The overwhelming 
message was that supply was their biggest issue.
    On February 23rd this subcommittee heard from five COVID-19 
vaccine manufacturers on the status and supply of their 
vaccines. Pfizer and Moderna testified they anticipated 
delivering 300 million doses each of their COVID-19 vaccines by 
the end of July. In addition, Johnson & Johnson testified it 
could deliver 100 million doses by the end of June. Further, 
other companies, including AstraZeneca and Novavax, have been 
manufacturing vaccine doses at risk, so that doses will be 
available to ship, should their vaccines receive authorization 
from the FDA.
    I look forward to hearing from the top Federal officials 
before us about President Biden's recent promise that every 
American adult will be eligible for a COVID-19 vaccine by May 
1, and how soon after that each adult will be able to make an 
appointment and actually get vaccinated.
    I also hope to get an update regarding recent guidance that 
has been issued by the administration, including guidance 
relating to schools, guidance for those who have already been 
vaccinated, and the recent revised guidance for nursing homes.
    Further, I look forward to hearing about research efforts 
over the past year, since what we know now about the virus is 
very different than what we knew 1 year ago. Specifically, I 
hope to hear about the status of the variants, including how 
effective our existing countermeasures are against the new 
variants and what we know about those who continue to 
experience symptoms long after contracting the virus, also 
known as long-haulers.
    Lastly, I hope to get an update from the FDA regarding the 
timing of additional vaccines being authorized and what the 
process will look like when the public health emergency is over 
and we have to transition products that have received EUAs to 
full approvals.
    I look forward to our discussion today to learn more about 
the Federal Government's ongoing response efforts and how we 
can end this pandemic as quickly as possible.
    Thank you again, Madam Chair, and I yield back.
    [The prepared statement of Mr. Griffith follows:]

             Prepared Statement of Hon. H. Morgan Griffith

    Thank you, Chair DeGette, for holding this important 
hearing on COVID-19 vaccines.
    Just over a year ago the World Health Organization 
announced that COVID-19 could be characterized as a pandemic. A 
few days later President Trump declared a national emergency in 
the U.S. About a week after that, California became the first 
State to go on lockdown. More States followed soon after that, 
forcing businesses, schools, and restaurants to close.
    As of March 11, we have lost 527,726 Americans to COVID-19, 
and according to a recent NY Times article, one in three 
Americans have lost a loved one to the virus.1A\1\
---------------------------------------------------------------------------
    \1\ https://covid.cdc.gov/covid-data-tracker/#cases--totaldeaths 
and https://www.nytimes.com/interactive/2021/03/05/us/covid-
deaths.html. Tens of millions more have been infected, some of whom are 
experiencing prolonged symptoms.
---------------------------------------------------------------------------
    However, we have reasons to be hopeful. There is light at 
the end of what has been a very dark tunnel. Because of the 
success of Operation Warp Speed and the unprecedented efforts 
of the private sector, to date we have three safe and effective 
vaccines that have received Emergency Use Authorizations (EUAs) 
from the U.S. Food and Drug Administration (FDA)--Pfizer, 
Moderna, and Johnson & Johnson--and more vaccines candidates 
are in clinical trials. Two of our witnesses, Dr. Fauci and Dr. 
Marks, played important roles in this achievement. While the 
vaccine rollout was slow to start as vaccine manufacturers 
ramped up their production efforts, the supply and distribution 
has continued to improve since the first vaccines were 
authorized, distributed, and administered in December.
    According to the Centers for Disease Control and 
Prevention, over 19 percent of the U.S. population has received 
at least one dose of a COVID-19 vaccine, and over 10 percent of 
the U.S. population is fully vaccinated.1A\2\
---------------------------------------------------------------------------
    \2\ https://covid.cdc.gov/covid-data-tracker/#vaccinations. This 
means that more people have been vaccinated than have been infected 
with the virus in the U.S. We still have a ways to go, but we are in a 
remarkable situation given we are only a little over a year out from 
the start of this global pandemic.
---------------------------------------------------------------------------
    Recently this subcommittee held two hearings focused on 
COVID-19 vaccines. On February 2nd, the subcommittee heard from 
a handful of States about vaccine distribution and 
administration efforts at the State level. The overwhelming 
message was that supply was their biggest issue.
    On February 23rd, the subcommittee heard from five COVID-19 
vaccine manufacturers on the status and supply of their 
vaccines. Pfizer and Moderna both testified that they 
anticipated delivering 300 million doses each of their COVID-19 
vaccines by the end of July. In addition, Johnson & Johnson 
testified it could deliver 100 million doses by the end of 
June. Further, other companies, including AstraZeneca and 
Novavax, have been manufacturing vaccine doses at risk so that 
doses will be available to ship should their vaccines receive 
authorization from the FDA.
    I look forward to hearing from the top Federal officials 
before us about President Biden's recent promise that every 
American adult will be eligible for a COVID-19 vaccine by May 
1, and how soon after that every adult will be able to make an 
appointment and actually get vaccinated. I also hope to get an 
update regarding recent guidance that has been issued by the 
administration, including guidance related to schools; guidance 
for those who have already been vaccinated; and the recently 
revised guidance for nursing homes. Further, I look forward to 
hearing about research efforts over the past year since what we 
now know about the virus is very different than what we knew 1 
year ago. Specifically, I hope to hear about the status of the 
variants, including how effective our existing countermeasures 
are against new variants; and what we know about those who 
continue to experience symptoms long after contracting the 
virus, also known as long-haulers.
    Lastly, I hope to get an update from the FDA regarding the 
timing of additional vaccines being authorized; and what the 
process will look like when the public health emergency is over 
and we have to transition products that have received EUAs to 
full approvals.
    I look forward to our discussion today to learn more about 
the Federal Government's ongoing response efforts and how we 
can end this pandemic as quickly possible.
    Thank you, Madam Chair, I yield back.

    Ms. DeGette. I thank the gentleman. The Chair is now 
pleased to recognize the chairman of the full committee, Mr. 
Pallone, for 5 minutes.

OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Madam Chair. And let me initially 
thank the witnesses who are arranging their schedules so that 
they could testify before the subcommittee this morning.
    I know how busy you all are. And obviously, as Chairwoman 
DeGette said, we are here today to continue our critical 
effort--or oversight of the COVID-19 vaccination campaign in 
the United States, and that has great promise, really, at this 
point, to help us beat the pandemic.
    We have all been working hard in Congress to help expand 
the availability and administration of the three available 
vaccines around the country. Last week President Biden signed 
the American Rescue Plan into law. And this obviously invests 
in the tools and resources needed to crush the virus and 
provide relief to struggling families.
    Specifically, the bill provides more than $20 billion to 
speed up COVID-19 vaccination efforts across the country, 
supports the development of community vaccination centers, and 
provides funding for mobile vaccination units in underserved 
areas.
    Now, many of you know that I have been critical--I was 
critical of the Trump administration for leaving it up to 
States to compete with each other for testing, medical 
supplies, et cetera over the last year. There was no national 
effort, really, on the part of the Trump administration. It was 
pretty much left up to the States. And while the initial 
vaccine rollout under the Trump administration was bogged down 
because of, in my opinion, poor planning and limited State 
resources and supply, the Biden administration has taken 
decisive action to get the COVID-19 vaccination effort back on 
track.
    Since President Biden took office, the weekly vaccine 
supplies sent to States has more than doubled, and States have 
been given more advance notice of their vaccine allocation. We 
are now on track to have enough vaccine supply for all American 
adults by the end of May, 2 months earlier than prior 
projections.
    And the Biden administration also continues to prioritize 
efforts to ensure equitable distribution or access to vaccines 
for marginalized communities and Americans who are more 
vulnerable to severe disease.
    President Biden is also focused on the wellbeing of 
children and families, recognizing the need for students to 
return to in-person school as soon and safely as possible. 
President Biden has encouraged States to expand their 
vaccination eligibility to teachers and school staff, and he 
also expanded the retail pharmacy program to help vaccinate 
educators by providing additional doses and helping educators 
schedule appointments. The American Rescue Plan also provides 
nearly 130 billion to help schools reopen safely and support 
students and staff returning to the classroom.
    And thanks to the Biden administration's efforts, we have 
already seen encouraging results. More than 70 million 
Americans have received at least one dose of COVID-19 vaccine. 
And last week President Biden set the aggressive goal directing 
States to make all American adults eligible for the 
vaccinations by May 1st. And I applaud the President's 
ambitious proposal and look forward to working with the 
administration to achieve this bold benchmark, obviously with 
all of our witnesses.
    Now, despite these tremendous efforts and the progress that 
has been made by all three of our witnesses, we can't be 
complacent. As the President told the American people last 
week--and I know Dr. Fauci keeps saying it, too, I hear him all 
the time in the media--that the government alone cannot defeat 
this pandemic. It is going to take all of us doing our part to 
beat this virus and return to our former lives.
    And the stakes couldn't be higher. The longer it takes to 
vaccinate America, the more we risk further spread of the 
disease and increase the likelihood that new variants will 
continue to spread.
    So I am pleased that we are joined today by the 
distinguished panel of scientists and public health leaders 
from the Biden administration. I look forward to hearing how we 
can continue to make progress and respond to the challenges 
that remain in the battle against the pandemic.
    You know, I know that all of you are constantly out there. 
One of the things that I know that you continue to stress is 
that people should not be afraid to take the vaccine. And I 
don't want to stress that too much in my opening remarks now, 
but I still do worry when I go around. There are many people 
who either will tell me that they are afraid to take the 
vaccine, or won't tell me that directly, but I know that that 
is what is going on in their minds. And so I know that that is 
an important part of the American Rescue Plan, too, is I think 
there is a billion dollars that was part of that Energy and 
Commerce initiative on the bill to basically have a program and 
make people aware that this is something that they should 
participate in.
    So thank you again, Madam Chair. This is a very important 
hearing. I appreciate it.
    [The prepared statement of Mr. Pallone follows:]

             Prepared Statement of Hon. Frank Pallone, Jr.

    We are here today to continue our critical oversight of the 
COVID-19 vaccination campaign in the United States--an effort 
that holds great promise to help us beat this pandemic.
    We are all too aware of the devastation that COVID-19 has 
inflicted on this country and around the world. More than a 
thousand Americans continue to die from COVID-19 every day, 
while new, more contagious strains spread across the Nation.
    Yet there are reasons to hope that brighter days are ahead. 
We know that vaccines are among the most powerful tools to 
combat this virus.
    Currently, there are three extraordinarily safe and 
effective COVID-19 vaccines authorized by the Food and Drug 
Administration.
    Democrats have been working to help expand the availability 
and administration of these vaccines across the country. Last 
week, President Biden signed the American Rescue Plan into 
law--historic legislation that invests in the tools and 
resources needed to crush the virus and provide relief to 
struggling families.
    Critically, it provides more than $20 billion to speed up 
COVID-19 vaccination efforts across the country, supports the 
development of community vaccination centers, and provides 
funding for mobile vaccination units in underserved areas.
    This new law will allow us to get shots in more people's 
arms quickly and equitably, so that we can end this pandemic as 
soon as possible.
    While the initial vaccine rollout under the Trump 
administration was bogged down because of poor planning, 
limited State resources and vaccine supply, and confusion, the 
Biden administration has taken decisive action to get the 
COVID-19 vaccination effort back on track.
    Since President Biden has taken office, the weekly vaccine 
supply sent to States has more than doubled and States have 
been given more advanced notice of their vaccine allocation. We 
are now on track to have enough vaccine supply for all American 
adults by the end of May--two months earlier than prior 
projections.
    The Biden administration also continues to prioritize 
efforts to ensure equitable access to COVID-19 vaccines for 
marginalized communities and Americans who are more vulnerable 
to severe disease.
    President Biden is also focused on the well-being of 
children and families, recognizing the need for students to 
return to in-person school as soon and as safely as possible. 
President Biden has encouraged States to expand their 
vaccination eligibility to teachers and school staff. He also 
expanded the retail pharmacy program to help vaccinate 
educators by providing additional doses and helping educators 
schedule appointments. The American Rescue Plan also provides 
nearly $130 billion to help schools reopen safely and support 
students and staff returning to the classroom.
    Thanks to the Biden administration's efforts, we're already 
seeing encouraging results. More than 70 million Americans have 
received at least one dose of COVID-19 vaccine.
    The work is far from over, but we are entering a new phase 
in the Nation's vaccination efforts.
    Last week, President Biden set an aggressive goal, 
directing States to make all American adults eligible for their 
vaccination by May 1st. I applaud the President's ambitious 
proposal and look forward to working with the administration to 
achieve this bold benchmark.
    Despite these tremendous efforts and the progress that has 
been made, we must not be complacent. As the President told the 
American people last week, the Federal Government alone cannot 
defeat this pandemic--it will take all of us doing our part to 
beat this virus and return to our former lives.
    The stakes could not be higher. The longer it takes to 
vaccinate America, the more we risk further spread of the 
disease and increase the likelihood that new variants will 
continue to spread.
    I am pleased that we are joined today by a distinguished 
panel of scientists and public health leaders from the Biden 
administration. I look forward to hearing how we can continue 
to make progress and respond to the challenges that remain in 
the battle against the pandemic.
    We must work together for this historic vaccination 
campaign to succeed. If we do, I am confident that we will 
defeat COVID-19.

    Ms. DeGette. I thank the gentleman. The Chair now 
recognizes the ranking member of the full committee, Mrs. 
McMorris Rodgers, for 5 minutes.

      OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A 
    REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON

    Mrs. Rodgers. Thank you, Chair DeGette and Republican 
Leader Griffith. Thank you to our distinguished panel.
    First, let's set the record straight. Regarding the COVID-
19 vaccine development and distribution, President Biden 
started on third base. The Democrats and the media suggested 
that he hit a triple. We keep hearing disinformation about what 
President Biden inherited.
    The first false claim is that President Biden had to start 
from scratch. On January 21st CNN reported that anonymous Biden 
administration sources said, ``We are going to have to build 
everything from scratch.'' Three days later, President Biden's 
Chief of Staff, Ron Klain, perpetrated this claim, and Vice 
President Harris repeated it just last month. This is 
disinformation.
    Dr. Fauci, you publicly stated that the Biden 
administration did not start from scratch. The day President 
Biden entered the White House, more than 1.5 million new doses 
were administered.
    Let's not forget the nationally televised 60 Minutes 
segment with General Perna on the Trump administration's 
distribution plan. That was in early November, before we even 
had a COVID-19 vaccine to distribute. The Trump administration 
first outlined their plan in September. In October the 
administration even announced partnerships to administer free 
vaccines.
    Another false claim is that the Trump administration did 
not contract for enough vaccines. On March 2nd President Biden 
claimed that ``the prior administration had contracted for not 
nearly enough vaccine to cover adults in America.'' Again, this 
is disinformation. It is false.
    Last year the Trump administration entered into contracts 
with multiple companies to manufacture hundreds of millions of 
doses of COVID-19 vaccines. To date, between just the three 
companies who have EUAs, we have enough doses to vaccinate 300 
million people, far more than our eligible adult population.
    And that is not to mention the options for purchase of 
additional doses included in those initial agreements, which 
the Biden administration appears to have recently used.
    I am disappointed that President Biden and Democrats refuse 
to acknowledge any successes of Operation Warp Speed. Vaccines 
normally take more than 10 years to develop, yet we have three 
safe and effective vaccines in less than 1 year. Imagine how 
many lives will be saved. Every American, Democrat and 
Republican alike, should be proud and thankful for its success. 
We should not be--we should be looking at this model for 
America to lead a new era of innovation for medical 
breakthroughs, not downplaying its success to underpromise or 
score political points.
    I now want to turn to school closures. Let's be clear: 
School closures are having a devastating effect on our 
children. Dr. Hasan, the division chief of pediatric infectious 
diseases at our RWJBarnabas Health in New Jersey, put it, ``The 
mental health crisis caused by school closing will be worse, a 
worse pandemic than COVID.'' Worse than COVID, yet schools 
remain closed.
    One year ago today, this day, Governor Inslee closed the 
schools in my home State of Washington, and we have been too 
slow to open. Washington ranks 46th in the Nation in getting 
students back into the classrooms. This is unacceptable.
    Why is it taking so long, Governor Inslee? It is time our 
kids returned to the classroom. Schools remain closed because 
of fear and politics, not science.
    Dr. Walensky, on February 3rd you stated, ``Schools can 
safely reopen.''
    Dr. Fauci, for months last year you agreed schools should 
reopen. As you put it last fall, ``Close the bars and keep the 
schools open.'' But unfortunately, the teachers' union 
continues to stand in the way.
    President Biden should be leading to get our schools open. 
But following public backlash from the White House about your 
remarks, Dr. Walensky, the CDC published guidance that kept 
many schools from fully reopening. We now know the CDC 
misinterpreted some of the research it relies on. Four doctors 
wrote in USA Today and confirmed fear, not science, led to 
harmful policy.
    Enough is enough. Our kids are in crisis. Today I call on 
you, Dr. Walensky and Dr. Fauci, to do as this administration 
promised: follow science and truth. Update the CDC guidelines 
to open our schools immediately. Surely that is something that 
we can all agree on.
    Thank you, I yield back.
    [The prepared statement of Mrs. Rodgers follows:]

           Prepared Statement of Hon. Cathy McMorris Rodgers

INTRO
    Thank you, Chair DeGette and Republican Leader Griffith. 
and thank you to our distinguished panel.
SET THE RECORD STRAIGHT
    Let's first set the record straight.
    Regarding the COVID-19 vaccine development and 
distribution....
    ... President Biden started on 3rd base, yet Democrats and 
the media suggest he hit a triple.
    We keep hearing lies about what President Biden inherited.
FIRST CLAIM
    The first false claim is that President Biden had to start 
from scratch.
    On January 21st, CNN reported that anonymous Biden 
administration sources said, quote, ``We are going to have to 
build everything from scratch.''
    Three days later President Biden's Chief of Staff Ron Klain 
perpetuated this claim, and Vice President Harris repeated it 
just last month.
    This is disinformation.
    Dr. Fauci, you publicly stated that the Biden 
administration did NOT start from scratch.
    The day President Biden entered the White House, more than 
1.5 million new doses were administered.
    Let's not forget the nationally televised 60 Minutes 
segment with General Gus Perna on the Trump administration's 
distribution plans.
    That was in early NOVEMBER--before we even had a COVID-19 
vaccine to distribute.
    The Trump administration first outlined their plan in 
September.
    In October, the administration even announced partnerships 
to administer free vaccines.
SECOND CLAIM
    Another false claim is that the Trump administration did 
not contract for enough vaccines.
    On March 2, President Biden claimed that, quote ``the prior 
administration had contracted for not nearly enough vaccine to 
cover adults in America.''
    Again--this is disinformation. It's false.
    Last year, the Trump administration entered into contracts 
with multiple companies to manufacture hundreds of millions of 
doses of COVID-19 vaccines.
    To date--between just the three companies who have EUAs--we 
will have enough doses to vaccinate 300 million people. far 
more than our eligible adult population.
    AND--that's not to mention the options to purchase 
additional doses included in those initial agreements, which 
the Biden administration appears to have recently used.
    I'm disappointed that President Biden and Democrats refuse 
to acknowledge any successes of Operation Warp Speed.
    Vaccines normally take more than 10 YEARS to develop.
    Yet, we have three safe and effective vaccines in less than 
ONE YEAR.
    Imagine how many lives will be saved.
    Every American--Democrat and Republican alike--should be 
proud and thankful for its success.
    We should be looking at this model for America to lead a 
new era of innovation for medical breakthroughs...
    ... not downplaying its success to under promise and score 
political points.
    [pause]
SCHOOL CLOSURES
    I now want to turn to school closures.
    Let's be clear-school closures are having devastating 
effects on our children.
    As Dr. Hasan, the division chief of pediatric infectious 
diseases at RWJBarnabas Health in New Jersey, put it. ``The 
mental health crisis caused by school closing will be a worse 
pandemic than COVID.''
    WORSE than COVID.
    ... yet, schools remain closed.
    One year ago--to this day--Governor Inslee closed schools 
in my home State of Washington. and we have been too slow to 
reopen. Washington ranks 46th in the Nation in getting students 
back to classrooms.
    This is UNACCEPTABLE.
    Governor Inslee, why has it taken you so long to prioritize 
our children? It is time our kids return to the classroom.
    Schools remain closed because of fear and politics, NOT 
science.
    Dr. Walensky, on February 3rd, you stated, ``schools can 
safely reopen.''
    Dr. Fauci for months last year you agreed schools should 
reopen. As you put it last fall, ``Close the bars and keep the 
schools open.''
    But--now teachers' unions have an ally in the Oval.
    President Biden should be LEADING to get our kids back in 
school.
    ... but, following public backlash from the White House 
about your remarks, Dr. Walensky, the CDC published guidance 
that kept many schools from fully reopening.
    We now know the CDC misinterpreted some of the research it 
relied on.
    Four doctors wrote in USA Today and confirmed fear--not 
science--led to harmful policy.
    Enough is enough.
    Our kids are in crisis.
    Today, I call on you Dr. Walensky and you Dr. Fauci to do 
as this administration promised it would.
    ... follow science and truth.
    Update CDC's guidance to open schools immediately.
    Surely, we can all agree that is the right thing to do.
    Thank you. I yield back.

    Ms. DeGette. I thank the gentlelady for yielding back.
    The Chair will now ask unanimous consent that the Members' 
written opening statements be made part of the record.
    And, without objection, so ordered.
    I want to now introduce the witnesses for today's hearing: 
Dr. Rochelle Walensky, the Director of the Centers for Disease 
Control and Prevention; Dr. Anthony Fauci, the Director of the 
National Institute of Allergy and Infectious Diseases; Dr. 
Peter Marks, who is the Director of the Center for Biologics 
Evaluation of Research at the FDA.
    I want to thank--I just can't thank you enough, all of you, 
for the work you have done and for appearing today.
    And I know all of you are aware that this committee is 
holding an investigative hearing. And so, when we do so, we 
have the practice of taking our testimony under oath. Does any 
of you have an objection to testifying under oath today?
    Let the record reflect the witnesses responded no.
    The Chair then advises you, under the rules of the House 
and the rules of the committee, you are entitled to be 
accompanied by counsel. Does any of you wish to be accompanied 
by counsel?
    Let the record reflect that the witnesses have responded 
no.
    If you would, then, please raise your right hand so I may 
swear you in.
    [Witnesses sworn.]
    Ms. DeGette. Let the record reflect the witnesses have 
responded affirmatively.
    And you are now under oath and subject to the penalties set 
forth in Title 18, Section 1001 of the United States Code.
    The Chair will now recognize our witnesses for 5 minutes 
for their summary of their written statements.
    As you can see, there is a timer on the screen that will 
count down your time, and it turns red when your 5 minutes has 
come to an end.
    So first I would like to recognize Dr. Walensky.
    Doctor, you are recognized now for 5 minutes.

STATEMENTS OF ROCHELLE P. WALENSKY, M.D., DIRECTOR, CENTERS FOR 
DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN 
SERVICES; ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE 
  OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
  HEALTH; AND PETER MARKS, M.D., Ph.D., DIRECTOR, CENTER FOR 
       BIOLOGICS EVALUATION AND RESEARCH, FOOD AND DRUG 
    ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

            STATEMENT OF ROCHELLE P. WALENSKY, M.D.

    Dr. Walensky. Good morning and thank you, Chairwoman 
DeGette and Ranking Member Griffith, for your invitation to 
talk with you today, and for your leadership during the U.S. 
response to COVID-19.
    I have had the honor of being the Director of the Centers 
for Disease Control and Prevention for 2 months. Taking on this 
role in the middle of a pandemic has presented no shortage of 
challenges, and I am so grateful for the guidance of the 
dedicated staff at CDC and the deep expertise they bring.
    CDC staff continue to work tirelessly to respond to the 
COVID-19 pandemic, and I am committed to supporting their 
efforts to ensure that science and evidence drive our path 
forward.
    Last week we crossed the 1-year mark since the WHO declared 
COVID-19 a global pandemic. I want to take a moment to 
recognize the more than 500,000 American lives lost during this 
past year. That is half a million mothers, fathers, sisters, 
brothers, grandparents, and children who have died because of 
this virus. Every loss is felt by grieving families, by friends 
unable to say goodbye, and by communities devastated by this 
pandemic.
    While we have recently seen reductions in cases and deaths, 
we must remain cautious. The average daily death rate is, 
tragically, still more than twice that seen last September. We 
are in a race to stop transmission, and the emergence of 
variants that spread more easily has made that even more 
challenging.
    I am committed to closely monitoring the proliferation of 
these variants in our country and around the world. We are 
doing that by rapidly scaling up genomic sequencing, and we are 
well on our way to 25,000 samples per week.
    As we monitor disease transmission and variants, we are 
getting vaccines into arms quickly, safely, and equitably as 
possible. Having three vaccines that are highly effective at 
preventing serious illness, hospitalization, and death will 
help us end this pandemic. As of March 16th, more than 110 
million doses of COVID-19 vaccine have been administered. Over 
72 million people have received at least one dose, including 
more than 39 million people who are fully vaccinated.
    This is a remarkable accomplishment, and yet we have so 
much more work to do. CDC is working in coordination with 
national, State, Tribal, and local governmental and 
nongovernmental partners to build trust in the vaccines, the 
vaccinators, and the vaccination system.
    Instrumental to this work is addressing barriers to 
vaccinations in communities of color and disproportionately 
affected groups. COVID-19 has highlighted longstanding systemic 
health disparities, and health equity must be a cornerstone of 
our public health work. CDC is committed to expanding evidence-
based approaches to reduce disparities and COVID-19 cases, 
hospitalizations, and deaths, prioritizing equity in vaccine 
distribution, and expanding a diverse workforce.
    This is not our first emergency. Since 2009 the U.S. has 
faced four significant emerging infectious disease threats: the 
H1N1 influenza pandemic, Ebola, Zika, and now COVID-19. While 
urgency demanded rapid and unique approaches in response to 
each of these threats, none resulted in the necessary sustained 
investments in public health infrastructure.
    This lack of preparation continues to present significant 
challenges in our ongoing fight to tackle COVID-19. If we don't 
act with permanent fixes, these challenges will continue to 
exist when the next public health threat emerges. I would like 
to leave you with four important points today.
    First, CDC is leading with science and will continue to be 
the public health scientific resource for the American public 
and our international partners.
    Second, we are expanding the reach of lifesaving COVID-19 
vaccines and improving vaccine confidence. To end this pandemic 
we must also maintain proven, effective prevention measures, 
mask and hand hygiene, and physical distance.
    Third, health equity must be at the intersection of 
everything we do in public health, and I am committed to doing 
that as CDC Director.
    And finally, we must work towards sustainable investments 
in public health infrastructure to be better prepared for 
whatever comes next.
    I look forward to working together to address both the 
immediate challenges ahead and addressing the deficiencies in 
our public health infrastructure that left our country 
vulnerable to this pandemic. We will get through this pandemic, 
and I look forward to working with you to support CDC and 
address our public health challenges at home and abroad.
    Thank you again for this invitation to testify today, and I 
look forward to answering your questions.
    [The prepared statement of Dr. Walensky follows:]


    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    Ms. DeGette. Thank you so much, Doctor. Thank you so much, 
Dr. Walensky.
    I am now very pleased to recognize Dr. Fauci for 5 minutes.

              STATEMENT OF ANTHONY S. FAUCI, M.D.

    Dr. Fauci. Thank you very much, Madam Chair, Ranking Member 
Griffith, Chairman Pallone, Madam Chair McMorris Rodgers. Thank 
you for giving me the opportunity to present to you the role of 
the National Institute of Allergy and Infectious Diseases in 
research addressing COVID-19.
    I have some slides there, but we better go without slides. 
I think it will be better, given this virtual nature of it.
    The NIAID's strategic plan includes four major components: 
improving fundamental knowledge, developing diagnostics, 
characterizing therapies, and developing safe and effective 
vaccines.
    Let's start off first with the characterization and the 
testing of therapeutics. There are two major ways of 
approaching this. One, therapeutics for early to moderate 
disease; and two, therapeutics from moderate to advanced 
disease.
    We have made substantial progress in randomized placebo-
controlled trials that have led to the FDA approval of a drug 
called Remdesivir, which is playing a major role in the 
treatment. EUAs have been given for monoclonal antibodies from 
Lilly and from Regeneron. Convalescent plasma has an EUA, and 
other antivirals and hyperimmune globulin are being actively 
tested.
    With regard to therapeutics for moderate to advanced 
disease, dexamethasone is the standard of care and has been 
shown in a randomized placebo-controlled trial to diminish 
significantly the 28-day mortality of people in the hospital on 
respirators or requiring high-flow oxygen.
    In addition, an Emergency Use Authorization has been given 
for Baricitinib plus Remdesivir.
    I want to point out that one of the most important advances 
that we will be pursuing over the coming months is the 
identification of vulnerable targets in the SAR-CoV-2 
replication cycle, very similar to what we did with the highly 
successful development of drugs for HIV and the curative 
therapies for hepatitis C. When you develop and show the 
replication cycle, you can identify vulnerable targets and 
design drugs to inhibit these vulnerable targets.
    And then we have vaccines. Perhaps the most important 
success story in this terrible outbreak that we have been 
experiencing has been the success with vaccines. But this did 
not start in January, when the virus was recognized. It began 
with research decades earlier, particularly within the NIH, and 
particularly within the Vaccine Research Center, where basic 
preclinical and clinical research to develop vaccine platforms 
like MRNA and vector-borne expression of protein.
    In addition, the stabilization of the spike protein at the 
NIH Vaccine Research Center by Dr. Barney Graham and his 
colleagues serves as the basis for five out of the six vaccines 
that have now been either tested or already proven to be 
efficacious.
    In addition, the NIH has utilized and pivoted its extensive 
domestic and international clinical trials network that we set 
up decades ago for HIV and influenza.
    As you well know, and as was mentioned in some of the 
opening remarks, we now have three vaccines that have been 
proven to be highly efficacious and safe. The Moderna, the 
BioNTech Pfizer, and the J&J. And we soon will be getting data 
from AstraZeneca and Novavax.
    One thing to point out about the development of this 
vaccine is that it has been done in record time. The sequence 
of the virus was put on a public database on January 10th, 65 
days later a phase 1 trial started, and on July 27th two of the 
three vaccines, the Moderna and the Pfizer, began a phase 3 
trial. And within a period of a total of 11 months, vaccine was 
going into the arms of individuals. That was highly 
efficacious.
    And it should be pointed out that there was no cutting of 
corners, that this was just the reflection of the extraordinary 
scientific advances.
    And finally, we must deal with viral variants, which are 
mutational changes in the virus, which have been a source of 
discomfort and concern among many nations throughout the world. 
We will address them by enhancing our vaccination programs 
against the wild-type virus by boosting with very specific 
viruses and, as we mentioned over and over again, by 
implementing the public health measures of masks, distancing, 
avoiding congregate settings, and washing of hands.
    I'd be happy to answer questions later. Thank you very 
much, Madam Chair.
    [The prepared statement of Dr. Fauci follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    Ms. DeGette. Thank you so much, Dr. Fauci.
    I am now very pleased to recognize for his--oh, before I 
do, Dr. Fauci, it is never a presentation by you without 
slides. So if you can provide the slides to this committee, we 
will distribute them to all of the members.
    Dr. Fauci. I will do so, Madam Chair. I had them, I just 
thought, by showing them, it could be--but you will get copies 
of them, I assure you.
    Ms. DeGette. Thank you so much.
    Dr. Fauci. Right.
    Ms. DeGette. We look forward to having you back in person 
with your slides later this year.
    Dr. Fauci. Thank you.
    Ms. DeGette. I am now very pleased to recognize Dr. Marks 
for 5 minutes.

             STATEMENT OF PETER MARKS, M.D., Ph.D.

    Dr. Marks. Chair DeGette, Ranking Member Griffith, 
distinguished members of the subcommittee, I am Peter Marks, 
Director of the Center for Biologics Evaluation and Research at 
the U.S. Food and Drug Administration. Thank you for the 
opportunity to testify before you today to describe the [audio 
malfunction] and response efforts.
    All of our efforts are in close coordination and 
collaboration with our partners across the Federal Government 
to help ensure the development, authorization or licensure, and 
availability of safe and effective medical products to address 
the COVID-19 public health emergency.
    While my testimony will focus on FDA's work regarding 
COVID-19 vaccines, I want to note at the outset that this is in 
the context of the breadth of work that we're doing across the 
agency to address the pandemic, including our efforts on 
diagnostics and therapeutics.
    With the urgency called for during this pandemic, FDA, 
through our transparent scientific review process, has provided 
Emergency Use Authorization--or EUA, for short--for three 
COVID-19 vaccines. In doing so, we've relied upon the agency's 
rigorous standards for safety, effectiveness, and manufacturing 
quality.
    Normally, vaccine development is a slower process in order 
to minimize risk. The process proceeds sequentially through the 
various stages of clinical development, and manufacturing 
scaleup only takes place when it is very clear that the vaccine 
has been shown to be safe and effective and on track for 
regulatory approval.
    These vaccines were developed without cutting corners or 
sacrificing our standards by intensive interactions between FDA 
and manufacturers, eliminating the time between different 
studies and the clinical development process, merging together 
different phases of clinical trials, and by simultaneously 
proceeding with manufacturing scaleup at risk before it was 
clear that the vaccines would be shown to be safe and effective 
while the clinical trials were ongoing.
    For the three vaccines authorized to date, our EU process 
not only included a thorough evaluation of the data by the 
agency's career staff but also included input from independent, 
scientific, and public health experts serving on our Vaccine 
Public Advisory Committee.
    Throughout this process, FDA took steps to facilitate 
transparency, including posting briefing documents and key 
decisional memoranda.
    The three authorizations make available COVID-19 vaccines 
in the United States that have been shown to have clear and 
compelling efficacy in large, well-designed phase 3 trials that 
meet FDA's rigorous standards for safety and effectiveness.
    Vaccines will help us in the fight against this pandemic, 
which has claimed over half a million lives here in the U.S. 
alone. All the COVID-19 vaccines authorized by FDA for 
emergency use have surpassed the standard of being at least 50 
percent more effective than placebo in preventing COVID-19, 
which was the standard recommended in our June 2020 guidance 
document on the development and licensure of vaccines to 
prevent COVID-19. All have proved extremely effective at 
preventing hospitalization and death that can result from 
COVID-19 complications.
    Though there may be some differences in the results 
obtained using the three authorized COVID-19 vaccines, it 
should be noted that they were not compared head to head in a 
clinical trial. All three were found by FDA and its external 
advisory committee to exceed the standards for an EUA that we 
articulated in guidance. And importantly, all did an excellent 
job in preventing hospitalization and death from COVID-19.
    FDA also plays an integral role in the monitoring of the 
safety of authorized COVID-19 vaccines. FDA is doing so in 
collaboration with the Centers for Disease Control and 
Prevention, the Centers for Medicare and Medicaid Services, 
Department of Veterans Affairs, and other academic and 
nongovernment health care data systems.
    In addition, FDA actively participates in ongoing 
international pharmacovigilance efforts, including those 
organized by the International Coalition of Medicine Regulatory 
Authorities and the World Health Organization. These efforts 
are in addition to the pharmacovigilance efforts being 
undertaken by the individual manufacturers of the authorized 
vaccines.
    Given the importance of passive and active safety 
monitoring, a coordinated and overlapping approach using state-
of-the-art technology has been implemented. These systems can 
also potentially be leveraged to assess safety and specific 
populations, and to assess vaccine effectiveness, including 
against emergent variants.
    The emergence of such virus variants raises new concerns 
about the performance of the authorized vaccines against these 
variants, as well as for the therapeutics and diagnostics FDA 
has authorized for COVID-19. In February 2021 we issued three 
new guidances and an update to our vaccine EUA guidance to 
address the emergence of SARS coronavirus 2 variants. In 
issuing these, we want the American public to know that we are 
using every tool at our disposal to fight this pandemic, 
including pivoting as the virus adapts. These guidances will 
help manufacturers develop medical products to provide 
healthcare providers with the best available diagnostics, 
therapeutics, and vaccines to fight this virus, even as 
variants emerge.
    We remain committed to getting these lifesaving products to 
people at the front lines. Having three vaccines authorized by 
FDA only 1 year after the declaration of a public health 
emergency is a tremendous scientific achievement and a 
testament to the dedication of a multitude of partners, 
including FDA's career scientists and physicians, many of whom 
have been working tirelessly to conduct comprehensive and 
rigorous evaluations of the data submitted for vaccines to 
prevent COVID-19. All those working at the agencies are 
grateful to be able to contribute measurably toward bringing 
this pandemic to an end.
    Thank you again, and I look forward to responding to your 
questions.
    [The prepared statement of Dr. Marks follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    
    [Pause.]
    Voice. Did we lose Madam----
    Mr. Pallone. This is Congressman Pallone. I don't know if 
we lost Diana again. I mean, I could start. Can you guys all 
hear me?
    Voice. Yes, we can, Chair.
    Mr. Pallone. I mean, do you think I should just proceed and 
ask my questions first, maybe?
    Mr. Peters. Why don't you go ahead, Mr. Chair. As vice 
chair, I will authorize you to do that.
    [Laughter.]
    Mr. Pallone. OK, all right. Let me just say I don't--you 
know, I don't want to prolong this, because I want to ask a 
question of each of our witnesses. But, you know, I wanted to 
stress that, you know, when I am critical of the Trump 
administration, it was based on what I had to deal with. In 
other words, I really felt that they did not see this as a 
national strategy, that they felt that the States were on their 
own.
    And many times, when I had to talk to the people in charge 
of Operation Warp Speed, I would say, ``Well, look, we are 
doing what we--our best to get materials and supplies from 
China or other places.'' But, you know, this is supplemental. 
The States have to do this, and we are just, you know, 
supplementing. We will help them out when we can. And I just 
felt that that was wrong.
    And it is quite clear, when you are dealing with the Biden 
administration, that they see this as a national strategy, 
something that is coordinated nationally, and that is, you 
know, obviously, coordinated with the States. It is their 
responsibility. And that is what I thought was very much 
lacking with the Trump administration and led to a lot of the 
problems in getting things out, whether it was supplies for 
testing, contact tracing, or, ultimately, the vaccine.
    But in any case, let me start with Dr. Walensky.
    As you know, the American Rescue Plan provides more than 20 
billion for vaccine distribution and administration, including 
a billion to strengthen vaccine competence. It also provides 
nearly 130 billion to get students back in the classroom. And 
it also has major money for public health infrastructure, which 
I know you mentioned, as well. So my question is, how will the 
resources provided in the American Rescue Plan help speed up 
vaccination efforts across the country, and particularly help 
schools reopen safely?
    And you have got about a minute, because I want to get to 
the other two witnesses, sorry.
    Dr. Walensky. Thank you so much for that question, Mr. 
Chairman. You know, we are working really closely with the 
States to scale up vaccination efforts. As part of those 
efforts, we're working to mobilize trusted messengers, mobilize 
grants to national organizations, 20 national organizations, to 
work with community-based organizations, with faith-based 
organizations to ensure that those trusted messengers can get 
to people.
    Last month we had a vaccine forum with over 13,000 
participants that really talked about key ways that people are 
reaching those hard-to-reach populations. We are giving 
resources to rural communities, to urban communities, to 
federally qualified healthcare centers, so that they can reach 
the more marginalized communities. So we are really scaling up 
those vaccine efforts, and with a real equity focus.
    With regard to schools, we are working towards distributing 
resources both in how we can give more resources for space, as 
well as for ventilation systems, as well as for testing 
resources. So lots of resources headed in the direction of 
schools as well.
    Mr. Pallone. I would ask Dr. Marks--the American Rescue 
Plan also invests more than 6 billion for research, 
development, production, and purchase of vaccines, 
therapeutics, and supplies, including 500 million for FDA 
activities, such as the evaluation of the vaccines, 
facilitation-related inspections, continuous manufacturing. How 
will this funding support FDA's COVID treatment of vaccine 
efforts, particularly considering the new variants spreading 
across the country?
    Dr. Marks. Thanks very much for that question, Mr. 
Chairman. The--we are going to be using our large database 
surveillance systems, which are able to look at millions and 
millions of lives, to be able to look at the safety and 
effectiveness of these vaccines. We will be able to assess--
besides making sure we have very, very good safety 
surveillance, we should be able to look at how variants may be 
spreading across the country, and that will help us to 
understand how best to interfere with and address this virus.
    We also hope that the--and are very grateful for the 
opportunity to do additional work in advanced manufacturing 
that will help us to prevent being behind the eightball when we 
have to scale up for future pandemics.
    Mr. Pallone. Last, Dr. Fauci, the question that is on the 
top of a lot of parents' minds all around the country is that 
none of the vaccines currently available are authorized for 
adolescents under 16. So when do you anticipate younger teens 
and children will be able to get vaccinated?
    And in the meantime, does the lack of inoculation affect 
our ability to contain the pandemic?
    In other words, could parents have confidence sending their 
kids back to school, knowing that they are not being 
vaccinated?
    Dr. Fauci. Thank you very much, Mr. Chairman. Yes, as a 
matter of fact, there are studies that are ongoing right now, 
both for high-school-age children as well as for elementary-
school-age children. The way these tests are now designed, to 
give safety and what we call comparable immunogenicity, we will 
not have to prove in an efficacy trial that they work. We just 
need to show that it is safe, and that it induces a comparable 
immune response that we know correlates with protection.
    For high school students, it looks like they will be 
available to get vaccinated in the beginning of the fall, very 
likely for the fall term.
    With regard to children, we are doing an age de-escalation 
study in elementary school children from 12 to 9, and 9 to 6, 6 
to 2, and 6 months to 2 years. We anticipate we will have 
enough data to be able to vaccinate these younger children by 
the first quarter of 2022.
    Mr. Pallone. Thank you. I guess we should go to Morgan 
Griffith next, although I see that Diane is back.
    Do you----
    Ms. DeGette. Thank you, Mr. Chairman, and I really do 
apologize. I have got two computers that are--that keep going 
out. So I appreciate everybody working together, and I 
appreciate you, Mr. Chairman.
    We will now recognize the ranking member, Mr. Griffith, for 
5 minutes.
    Mr. Griffith. Thank you very much, Madam Chair.
    As I start, let me say, Dr. Walensky, thank you for getting 
us some questions answered related to school opening that we 
sent you. We got those answers last night. We haven't had time 
to--I haven't had time to go through them fully. I do know 
there is still some outstanding questions, and we will probably 
have some follow-up.
    That being said, President Biden recently announced that he 
will direct States to make every American adult eligible for 
COVID-19 vaccines by May 1. This is exciting. However, 
eligibility is very different than accessibility and shots in 
the arm. What is the administration's projection for when every 
American adult who wishes to be vaccinated will be able to be 
fully vaccinated?
    Dr. Walensky. Thank you so much for that question. You 
know, there are numerous resource constraints that have been a 
challenge, with regard to rolling out vaccines. So among them 
has been resource--money itself, but also the vaccine itself.
    We know now that we will have adequate supply of vaccine 
for every American who is interested by the end of May, which I 
think is a really critical, important resource to know that we 
have. But that is not the only resource we need. We need to 
have, actually, vaccinators. We need to have places where 
people can get vaccinated, and we need to have people who want 
to roll up their sleeves to get vaccinated. So that is a work 
that we have ahead.
    The people who have rolled up their sleeves for the 110 
million doses that have already been given are people who are 
anxious to get vaccinated, but we have a lot more work to do, 
in terms of distribution----
    Mr. Griffith. So you would say some time in June, probably? 
Because if everybody--there is plenty of supply by May 31st, 
then probably everybody should be able to get it in May or 
early June. Is that a fair statement?
    Dr. Walensky. You know, I would be reluctant to put a date 
on exactly when we will have enough of the vaccinators and----
    Mr. Griffith. That is fair, that is fair. Let me move on, 
because I have got limited time, and I know you do too.
    Dr. Fauci and Dr. Marks, recent reports have indicated a 
rift has developed between countries, particularly some in the 
EU, but other countries, as well, which have approved the use 
of the AstraZeneca vaccine, and they are seeking additional 
doses.
    The Biden administration, in the meantime, has been 
stockpiling doses of the AstraZeneca vaccine, waiting for the 
emergency use authorization from the FDA in the United States. 
Now, I am not going to fuss with the FDA, because they got to 
make that decision. That is their job. But I am curious about, 
you know, how old is the AstraZeneca stockpile now, and when 
does it expire? I know it has a 6-month life, so how old is it?
    And when are we going to run into the risk of actually 
throwing some vaccines away that, if we don't want to use them, 
somebody else might want to?
    Dr. Fauci, do you want to start with that, and then, Dr. 
Marks, anything you want to add?
    Dr. Fauci. Yes, let me just, Congressman Griffith, address 
the issue of the AZ, and the issue in Europe. You know, right 
now there is a big conflict in Europe, where many of the 
countries do not want to use the AZ vaccine. We have a 
situation where the European Medicines Agency, the EMA, has 
indicated very, very clearly that they feel that this is not an 
issue with regard to the supposed adverse events of blood 
clotting. So they feel that it should be used, even though many 
of the countries are not using them.
    We in the United States have an ongoing trial that is fully 
enrolled with the AZ product. And, as you mentioned correctly, 
within a reasonable period of time, as we get into April, there 
would likely be enough data to be able to make a determination 
as with regard to the EUA.
    With regard----
    Mr. Griffith. So----
    Dr. Fauci [continuing]. To the expiration, I would have to 
refer that to Dr. Marks because the FDA knows more about that 
than I do.
    Mr. Griffith. All right, and since you brought up the blood 
clotting, before you get there, Dr. Marks, I did some math, and 
somebody correct me if I am wrong. In the UK they have given 
out 17 million doses of the AZ and had, according to my math, 
.002 percent folks with blood-clotting issues. And having had 
coronavirus, and then had blood clotting without having taken 
any vaccine, is that unusual?
    Dr. Fauci. Yes, I think----
    Mr. Griffith. To me that is an unusual amount.
    Dr. Fauci. Yes, I think that is the point, Congressman 
Griffith, that the European Medicines Agency is making, that 
the actual incidence of the clotting is not more than you would 
expect in the population in the absence of vaccine. So that is 
why they are insisting that the concern is not founded on the 
reality of what has gone on.
    Mr. Griffith. My time is almost up. Dr. Marks, can you tell 
me, what are we doing with this stockpile?
    And is it going to go bad?
    And are we going to throw away doses that could be used for 
countries that do want the vaccine, even--whether it be the EU 
or other nations?
    Dr. Marks. So the EU, when they approved this, put an 
expiration date. But we do not necessarily have expiration 
dates on products under investigation, new drug applications, 
when they are maintained on stability studies. And so I do not 
believe at this time we are at risk of throwing that vaccine 
out any time in the near future.
    Mr. Griffith. But you do hope that we will get approval 
soon, or you hope that, if it works out and the FDA 
appropriately approves it, that we would have those vaccines 
for Americans, then?
    Dr. Marks. That is correct.
    Mr. Griffith. All right. Thank you very much.
    I yield back. Thank you, Madam Chair.
    Ms. DeGette. I thank the gentleman. The Chair now 
recognizes herself for 5 minutes.
    As I said in my opening statement, this committee has long 
been concerned about pandemic preparedness. And in fact, we had 
a hearing on December 4, 2019, just before COVID-19 hit. Of 
course, it wasn't about COVID-19, but it was about pandemic 
preparedness. And at that hearing I asked then-HHS Assistant 
Secretary--well, I asked everybody, and one of the witnesses 
said--what keeps them up at night. And one of the witnesses 
said his biggest fear was a pandemic ``that could devastate our 
country through our health and our economy and our social 
institutions.'' That was just shortly before COVID hit.
    Now, Dr. Fauci, you were on that panel that day, as I said, 
and you have testified with your slides at many of our previous 
pandemic hearings. That day you and I discussed the need to 
modernize vaccine development and how Congress could aid in 
those efforts. So I want to go back to that and say, with all 
of the knowledge now that we have gotten in the year-plus since 
that hearing, I want to ask you what is keeping you up at night 
right now, and what can Congress help you and the agency do as 
we move forward in the coming months?
    Dr. Fauci. Thank you for that question. What is keeping me 
up at night is the same thing that I actually also answered 
that question of yours back then, that it was a respiratory-
borne virus that has a high degree of capability of spreading 
and that has the capability of causing a high degree of 
morbidity and mortality.
    We are still in the middle of a serious outbreak. And one 
of the things I get concerned about--both for the present and 
for the future--for the present, it is that we prematurely 
pulled back on our mitigation methods. We now have stabilized 
at a plateau. We had a sharp decline in the decrement of cases 
after that extraordinary spike that we saw, where we were 
seeing anywhere between 300- and 400,000 cases per day, and up 
to 3,000 to 4,000 deaths.
    Well, luckily and happily, it is gone down. However, we 
have plateaued at around 50,000 cases a day, an unacceptably 
high level. My concern is that we prematurely pull back and 
don't give the vaccines time to continue to protect the 
country.
    Ms. DeGette. Thank----
    Dr. Fauci. With regard to the future, and your question 
that you asked, my concern is that we don't have the corporate 
memory of lessons learned, and we don't look at what happened 
to us here and the things that we need to do in the future to 
prevent this from happening again.
    But thank you, because the Congress has been 
extraordinarily supportive of what we've done, and in fact many 
of the successes of the vaccine related to the longstanding 
decades of support that we've received from the Congress.
    Ms. DeGette. Thank you. Thank you so much.
    Dr. Walensky, as CDC Director you lead our public health 
response to COVID-19. As we just saw in the press over the last 
few days, in the last Congress a number of the CDC's 
recommendations were either subverted in the last 
administration or they were influenced by nonscience-based 
principles. What is the CDC doing to restore science back to 
the findings and the recommendations at the agency?
    Dr. Walensky. Thank you so much for that question.
    So my first job, as you have noted, has been to ensure that 
we had a full review of our guidance and to make sure that the 
guidance that stood on the CDC website was science-based, it 
was written by our own scientists. That review was conducted by 
Dr. Anne Schuchat, my principal deputy, and by the incident 
managers who served during this pandemic.
    That guidance we--during that process we have taken down 
some of the things that were previously put up that were not 
authored by CDC personnel, as well--and scientists--as well as 
came up with some recommendations in--moving forward, to ensure 
that our guidance is in--has executive summaries, has end users 
that can understand it, that has scientific briefs that 
accompany it. And we are working towards making sure that all 
of our guidance moving forward will follow those 
recommendations.
    Ms. DeGette. Thank you so much.
    And Dr. Marks, turning to you, as more Americans get 
vaccinated and we get more real-world data about the 
effectiveness of the authorized vaccines, how is that going to 
inform future decisions about use of vaccines, including 
whether we need boosters or changes to address the variants 
that we are seeing crop up all around the world?
    Dr. Marks. Thanks very much.
    So, as we see--as we have real-world evidence that comes 
in, we will be analyzing it. We will be looking to make sure 
that we have continued protection against these viruses that 
are circulating.
    We will also be looking at the trials that continue, and--
to see how long people who were enrolled in the trials are 
maintaining their immune response. So that combination of 
evidence from people who were enrolled in the trials and 
continue to be monitored, plus the real-world evidence, 
together will give us what we need to understand when we may 
need to come out with a booster of some sort.
    Ms. DeGette. And just very briefly, because I know people 
want to know, when do you expect to start getting results from 
that real-world evidence?
    Dr. Marks. So we are already starting to get the first 
readouts from the large databases that we are having for 
safety. Effectiveness data will come later on, but the safety 
data are just starting to come in now.
    Ms. DeGette. So you think the next few months?
    Dr. Marks. Yes----
    Ms. DeGette. OK. Thank you so much.
    The Chair is now delighted to recognize the ranking member 
of the full committee, Mrs. Rodgers, for 5 minutes.
    Mrs. Rodgers. Thank you, Madam Chair.
    Our kids are in crisis. Suicide risks are up. Overdoses are 
up. The mental-health-related visits are up.
    Dr. Hasan, the Division Chief of Pediatric Infectious 
Diseases at RWJBarnabas Health in New Jersey, put it, quote, 
``The mental health crisis caused by school closing will be a 
worse pandemic than COVID.''
    So my first question: Yes or no, Dr. Walensky, do you agree 
that the mental health crisis caused by school closures is a 
public health crisis?
    Dr. Walensky. Thank you for that question.
    I would comment that I too am concerned about the mental 
health of our children, and I am working very hard to get our 
schools open. And I think we will have a lot of work to do to 
address the mental health challenges and the educational 
challenges of this past year.
    Mrs. Rodgers. Is that a yes then?
    Dr. Walensky. I think it would be hard to pit one crisis 
over another. So I would just say I think we have challenges in 
both areas.
    Mrs. Rodgers. So we know that CDC's guidance requires 6 
feet of separation, which is a significant obstacle for schools 
to reopen. I have heard it in eastern Washington, and I know 
others have heard it across the country.
    That guidance does not seem to be weighted on scientific 
evidence. So I would like to ask, Dr. Walensky, in your home 
State already it allows 3 feet. Colorado allows 3 feet. The WHO 
advises one metric, basically 3 feet. The Harvard T.H. Chan 
School of Public Health cites 3 feet. The American Academy of 
Pediatrics says 3 feet is sufficient.
    The CDC even published a study at the end of January that 
showed minimal in-school spread with students not maintaining 3 
feet of distance, and before joining the CDC you yourself 
agreed that 3 feet is safe.
    I have an email here. This is back in 2020, so 2020 that 
you advised your hometown mayor that, quote, ``If people are 
masked, it is quite safe and much more practical to be 3 
feet.''
    So to address what I believe is a mental health crisis, Dr. 
Walensky, our schools need to be opened. The school closures 
are causing a mental health crisis. We need swift action from 
the CDC, and I do not think that we need to wait for more 
studies.
    So yes or no: If people are masked, is it safe and more 
practical to open schools with the 3 feet of distance?
    Dr. Walensky. Thank you for that question.
    I comment that the email that was written in 2020, indeed, 
was during a time when we had very little transmission or about 
40,000 cases.
    The guidance that came out happened in the context of 
around 200- to 300,000 cases and before and after we were 
starting to talk about variants.
    The Wisconsin study that you comment on in the MMWR, which 
is exactly where we were leading into our operational guidance, 
as noted in that study, there were 92 percent of mask wearing 
as well as degasified classrooms with somewhere between 11 to 
20 students in those classrooms.
    So our operational guidance was intended to lean in to do 
exactly what Wisconsin was doing, and in fact we have surveys 
that are reported in the MMWR that said high school students 
are wearing their masks only about 60 percent of the time.
    So our guidance was really intended to lean in so that 
schools could open and act exactly like Wisconsin.
    We also have an MMWR report that I would be happy to get to 
you from Georgia that showed where students were not leaning 
in, where classrooms were dense, There were outbreaks in nine 
elementary schools.
    So our guidance was intended to lean in towards how 
Wisconsin was acting so that we could get our schools back 
safely.
    Now, you raise a really important point, and that is the 
feet, 6-foot versus 3-foot question. As soon as our guidance 
came out, it became very clear that 6 feet was among the things 
that was keeping schools closed, and in that context science 
evolved.
    So there has been one study that was published late last 
week that demonstrated in Massachusetts, where there is 
generally 100 percent mask wearing, that 3 feet was actually 
safe. Student rates and teacher rates of disease were the theme 
in 6 feet versus 3 feet.
    There are several other emerging studies that I am aware 
of. As we look at those studies in the context of 
Massachusetts, this Massachusetts study, we are looking to 
update our guidance.
    Mrs. Rodgers. That is good news. I would urge you to act 
and act now. I do not think that we need to wait for additional 
studies.
    I am a mom of three school-age kids. I am speaking for 
millions of moms across this country that are extremely 
concerned about the mental health of our children, and I hear 
these stories every day, and I know others do too.
    The CDC can update its guidance, and I would just ask when 
are you going to be able to do that?
    Dr. Walensky. We are actively looking at the additional 
studies. We have only one published study to date. We are 
actively looking at those additional studies, and we are 
looking to do it soon.
    I would just articulate, I too am a mother of three, one 
who has been home-schooled the entire year. So I am entirely 
with you that we need to get our children back. We want----
    Mrs. Rodgers. Now is the time. OK. I yield back. Now is the 
time.
    Ms. DeGette. I thank the gentlelady for yielding back.
    The Chair is now pleased to recognize Ms. Kuster for 5 
minutes.
    Ms. Kuster. Thank you very much, Chair DeGette.
    And I just want to say for the record we all want our 
children to get back to school. This is not a partisan issue. 
Everyone wants our children to get back to school, and we just 
want to be safe about it.
    So I am going to turn the attention to the issue of long 
COVID. Some call it ``long-hauler COVID.'' And for months we 
have heard reports about people, Americans across this country 
suffering from COVID-19 for many, many months.
    My own niece, similarly, a world-class ski racer, she was 
on the United States ski team. I am so proud of her. She became 
sick with COVID last April and continues to this day, almost a 
year later, to have trouble with the simplest of daily 
activities. She has to choose between taking a shower or 
cooking dinner. She does not have the energy to do both.
    She is 34 years old and previously extraordinarily not only 
healthy but an amazing athlete. Morella has seen so many 
doctors over the last many months, adding up to thousands of 
dollars of out-of-pocket expenses.
    She has gone through analyst testing and none of which has 
been helpful in identifying exactly what she is suffering from. 
And she is not alone.
    According to the National Institutes of Health, more than 
50 percent of COVID-19 patients experience lingering symptoms 
longer than 90 days after recovering from the initial 
infection.
    Dr. Fauci, I was so pleased to see NIH's announcement last 
month that it had launched a nationwide initiative to identify 
the causes and ways to prevent and treat long COVID.
    What do we know so far about what causes or prevents long 
COVID, how we can treat it, and how long these symptoms might 
last?
    Dr. Fauci. Thank you very much for that question, 
Congresswoman Kuster.
    This is a very important issue that we take very seriously. 
The first thing we can say, this is real. This is not 
imaginary. These are people whose symptoms are real.
    And as you mentioned, it is really variable. Different 
studies say anywhere from 25 to over 35, 40 percent of 
individuals have prolongation of symptoms that measure not only 
in weeks but in months, some of which as your subject that you 
described become completely incapacitating.
    What we need to know first--and that was the study that we 
announced just a short while ago--we need to know the extent of 
this, the percentage of the duration of it.
    Underlying this, it seems to be a commonality of symptoms. 
Just as you mentioned very correctly, profound fatigue, muscle 
aches, temperature dysregulation, unexplainable tachycardia, 
and what people refer to as ``brain fog,'' which is just a 
strange feeling of being unable to focus or concentrate for any 
period of time.
    The NIH has been given an appropriation of $1.15 billion to 
study this disease, and you will be hearing more announcements 
not only to understand the scope of the cohort but the 
underlying cause and what the mechanisms are. We call that 
pathogenesis.
    Once we understand that, then we can start talking about 
designing therapies, but it is a very disconcerting syndrome 
that I believe is going to have effects that will go on well 
beyond the control epidemiologically of this syndrome.
    Thank you.
    Ms. Kuster. Well, thank you.
    And I wondered, just for the record, tachycardia is what 
she gets, tremendous chest pain. Is that the word?
    Dr. Fauci. She gets a rapid beating of her heart that is 
unexplained. Usually, when you exercise, your heartbeat goes 
much quicker. They are lying in bed and their heart rate is 
110, 105, 115, which is distinctly abnormal for someone who is 
sitting down or in bed.
    Ms. Kuster. So I saw the first headlines today that I have 
ever seen that maybe the vaccination might help. She is getting 
her first vaccine this week. Have you heard any connection 
about that?
    And is that anything that will be studied?
    Dr. Fauci. That will be studied, Congresswoman Kuster. The 
issue is thus far that is anecdotal, and the reason I say 
anecdotal is that many people spontaneously get better anyway, 
and if you get vaccinated and you get better, you are not sure 
whether it is the vaccine or the spontaneous recovery.
    So you will have to do a randomized trial in order to 
determine that.
    Ms. Kuster. Great. My time is almost up, but, Dr. Walensky, 
is the CDC also working on this long COVID, and how will you 
coordinate with NIH in that effort?
    Dr. Walensky. We are. Thank you for that question, 
Congresswoman.
    We are actively doing evaluations. We are doing studies. We 
are collecting cohort data, and we will report those data as 
they emerge.
    Ms. Kuster. Well, we will anxiously await it. Thank you for 
all that you are doing. We are very grateful.
    And with that, I yield back, Madam Chair.
    Ms. DeGette. I thank the gentlelady.
    Is Mr. Burgess here? I see his desk, but I do not see him. 
Going once, going twice.
    Mr. Griffith. Madam Chair, we have a conference going on, 
and he may have gone to that. If we could pass him by now and 
come back to him later, I would appreciate it.
    Ms. DeGette. OK. Mr. Long?
    [No response.]
    Ms. DeGette. Mr. Dunn, I know you are here.
    Mr. Dunn. I did not expect to be pushed up. Well, thank you 
very much, Madam Chair.
    So if I could start with this----
    Voice. You surprised me.
    Mr. Dunn. I am proud of the vaccine story here in the 
United States. You know, there is no doubt that the early 
actions taken by the Trump administration to organize Operation 
Warp Speed, invest in manufacturing capacity, plan for vaccine 
distributions led to the success we see today.
    I am also pleased with the current administration following 
through on this success with President Biden's pledge that all 
American adults will be eligible for COVID-19 vaccines by May 
1st.
    As we approach that date, I want to be sure that the 
administration is focused on issuing guidance that will allow 
more sectors of our economy to reopen.
    I also strongly encourage the administration to pursue 
policies that get our teachers and children back in the 
classroom.
    All of the schools in my district are open for in-person 
learning, safely and with great success, and I have serious 
concerns about the near- and long-term effects on the children 
who have been kept out of their school settings for so long.
    Another concern is staying on top of COVID-19 variants and 
exploring countermeasures such as booster shots and 
therapeutics to combat COVID-19 infections. I think we have not 
given enough attention in the past to antiviral therapeutics.
    Voice. They passed over you.
    Mr. Dunn. In that vein, the medical community needs to also 
better understand the COVID-19 immunity, who has it, and for 
how long. We know how to test for T cell that is humoral 
immunity, but the testing is complex and not widely available. 
There has been a lack of emphasis on this type of testing, and 
we have already spent $6 trillion. It seems to me a test for 
immune status needs our attention, honestly.
    So, Dr. Fauci, according to the media reports, two Federal 
health officials at the CDC discussed changing the travel 
recommendations for those who are fully vaccinated against 
COVID-19 but abandoned the idea because there was never a lot 
of momentum behind adjusting it.
    Is that accurate?
    And if so, why is momentum driving these decisions rather 
than science?
    Dr. Fauci. Well, I would leave the answer to that to Dr. 
Walensky, but let me just say that, from my own standpoint, the 
CDC has come out with the first of an installment of 
recommendations related to what vaccinated people can do. That 
was a short while ago talking about in the home type of 
interaction with vaccinated people as well as with unvaccinated 
people.
    But the rollout of further recommendations, I will leave 
that to Dr. Walensky.
    Rochelle?
    Mr. Dunn. Dr. Walensky?
    Dr. Walensky. Thank you very much.
    We had internal conversations as we were rolling out 
guidance for what you can do with vaccinations, about what we 
should say or do about travel. These never hit pen to paper. 
They were conversations among subject matter experts as to what 
should happen, and in fact I never saw a draft of that. I do 
not believe there ever was a draft of that.
    As you may recall, at the time that we released that 
guidance just last week, I believe, just 9 percent of Americans 
were vaccinated, fully vaccinated. We are now up to about 11 
percent.
    We are revisiting the travel question. That is a really----
    Mr. Dunn. Because we are short on time, I am going to 
interrupt you here and ask another question for both Drs. Fauci 
and Walensky.
    I am concerned about the vaccination rate of dialysis 
patients. OK? This is clearly the most vulnerable, vulnerable 
patients, and we know that, and yet somehow they have been 
overlooked in the prioritization. So we have 1.6 million 
dialysis patients and staff across the country that are 
awaiting vaccination.
    It seems to me that they would be pushed to the front of 
the line. Can either of you address that for me and make me 
more comfortable?
    Dr. Walensky. Yes, thank you for that question, 
Congressman.
    CDC is actively working to support the development of a 
vaccination program within dialysis centers. You are right to 
highlight that this is a key high-risk population, among many 
other high-risk populations, and we are working actively to 
ensure that that can happen.
    I am happy to provide you an update.
    Mr. Dunn. This group, by the way, you know, these patients, 
they have enormous penetrants on vaccination. So they typically 
get 95 percent annual flu vaccinations and things like that.
    These doctors are very attentive. They see their patients 
three times a week anyway. I mean, it seems like, you know, 
that would be a group that we could actually focus on.
    Dr. Walensky. And I would add to that a high-risk minority 
population as well. So we have a lot of motivation to try and 
get that group vaccinated.
    Mr. Dunn. So in the last 15 seconds, Dr. Fauci, what 
percentage of people who are eligible, early COVID patients who 
are eligible, for monoclonal antibody therapy actually get it 
now?
    Dr. Fauci. Yes, a very small percentage because, as you 
know, we have about 50,000 new infections per day, and the 
amount of monoclonal antibodies are measured in the hundreds of 
thousands to a million. So when you are talking about relative 
percentage, Congressman Dunn, it is extremely small.
    And we are trying to make sure we can get people early 
enough in the course of their infection to get it. We know now 
that it does not work after they get into the hospital. You 
need to get them early on, and there is a logistic issue there 
because of infusion centers are not readily available for 
people.
    So you want to get somebody early, but you have a technique 
that requires an intravenous infusion, which makes it 
logistically difficult.
    Mr. Dunn. Well, I appreciate you working on that, and I 
yield back, Madam Chair.
    Ms. DeGette. I thank the gentleman.
    The Chair is now pleased to recognize Miss Rice for 5 
minutes.
    Miss Rice. Thank you, Madam Chair.
    And thank you all for being with us here today.
    Dr. Walensky, you mentioned in your opening remarks about 
the deficiencies in our public health infrastructure that all 
of us on this Zoom today have seen in our own districts.
    But I think it is really important, and I would ask you to 
kind of expound on that because what we need to do is make sure 
that, God forbid, if we have a situation like this pandemic 
again, that with all of this major Federal money, taxpayer 
money, going to address this pandemic and improve our 
infrastructure across the board, that the money is going in the 
right place and we are building back smarter and with more of 
an eye towards resiliency.
    So if you could just expound on what you meant by the 
deficiency.
    Dr. Walensky. Thank you so much for that question, 
Congresswoman.
    You know, there has been a study that came out that looked 
through the survey and demonstrated that over 50,000 public 
health jobs have been lost in the last decade, all during the 
time when we have experienced outbreaks of H1N1, Ebola, Zika, 
and now, of course, COVID-19.
    I think part of that public health infrastructure really 
does need to be in the workforce itself. We need to develop a 
workforce. Just in this last year, hundreds more have left the 
workforce because of exhaustion and threats. So we need to 
develop the workforce.
    Secondly, we need to develop the epidemiology and data 
modernization. I have spoken to public health epidemiologists 
in labs who say that they are singlehandedly keeping fax 
machines in business.
    That is not a way that we can effectively address public 
health infrastructure.
    And then, thirdly, we need development of our public health 
labs. We need to have personnel in those labs, work-experienced 
personnel. We need to develop the capacity. We need to have 
machinery so that we can develop our public health labs.
    They are the ones that test the disease. They are the ones 
on the forefront of doing that.
    In that context I believe that, not only do we need one-
time support, but we need longitudinal support in order to be 
able to maintain that infrastructure so that it is ready to go 
for preparedness in future pandemics.
    And then, of course, we need work through global health 
security as well.
    Thank you.
    Miss Rice. Thank you, Doctor.
    Dr. Fauci, one of my colleagues asked you about 
AstraZeneca. You know, one of the big issues that people have 
already mentioned is the whole people not wanting to take the 
vaccine. There was a recent poll done that showed almost 50 
percent of Republicans questioned said that they were not going 
to get the vaccine.
    I am not trying to turn this into a political thing. I 
think it is a good thing that Donald Trump admitted that he got 
the vaccine in January, but my concern is that, when people are 
just kind of loosely hearing about what is going on with AZ 
outside of the U.S., how that is going to contribute to an 
increase in people's fear of taking a vaccine even though it 
has nothing to do with the vaccines that are presently being 
given here in the U.S.
    And how can we address this issue of people having doubts 
about the vaccine once and for all, or is there a way to do 
that?
    Dr. Fauci. Yes, thank you for that question, Congresswoman 
Rice.
    There is a way, and in fact we have been very active in 
outreach to the community to try and get the evidence and the 
data that are correct to individuals, and that is the reason 
why literally all of us on the team, the White House medical 
team, are out one way or another, be it with minority 
populations or just people in general, explaining the facts 
about the vaccine, talking about why and how it was shown to be 
safe and effective.
    Often people don't appreciate that the process of showing 
that a vaccine is safe and effective is really determined, the 
data, by an independent Data and Safety Monitoring Board that 
does not behold to the administration or to the pharmaceutical 
companies, but it is made up of independent scientists, 
vaccinologists, ethicists, and statisticians.
    When they determine that the data show that it's safe and 
effective, then the FDA makes a decision, but they also are 
very closely related to their own advisory committee.
    So the entire process is both transparent and independent, 
and we explain that to people and take the time to address 
their hesitancy without being confrontative.
    We are getting better and better in getting more and more 
people who now are willing to take a vaccine, and we're just 
going to continue to do that.
    Miss Rice. Well, I am glad to hear that, Dr. Fauci, but all 
of this scientific-based information is being heard in an echo 
chamber of mis- and disinformation, which makes your job even 
harder.
    Very quickly, Dr. Fauci, you were asked before about the 
long haulers. My concern--and I think we should all be 
concerned about this--is the long-term health implications.
    So I and everyone knows someone who had this disease. A 
brother of mine had it. His symptoms were pretty mild, but they 
are still there.
    So what are the long-term medical implications and long-
term health implications for people who have COVID, whether 
they had a mild symptom, moderate, or more severe? And what are 
we going to do about that?
    Dr. Fauci. First of all, we've got to determine the extent 
of their--there are two type of long-term concerns. There's an 
individual who might get mild to moderate symptoms, may or may 
not be in the hospital, and winds up getting unexplainable 
symptomology, like fatigue, like some of the symptoms that I 
just mentioned in response to another question.
    But there are also those who get considerable organ system 
damage. I made rounds myself on a patient about 4 days ago at 
the NIH Clinical Center where the extent of disease that person 
has, that even if they do recover, almost certainly they are 
going to have prolongation of dysfunction in multiple organ 
systems.
    So it is not only the long COVID. It's also people who have 
damage to their heart, to their lungs, to their kidneys. Those 
are the things that we are also concerned about.
    Miss Rice. Thank you, Doctor.
    Thank you all.
    Ms. DeGette. The Chair now recognizes Mr. Burgess for 5 
minutes.
    Mr. Burgess. I thank the chair.
    Dr. Fauci, let me just ask you a question in reference to 
comments that Chairman Pallone made during his opening 
statement about the lack of a national effort.
    Would you consider Operation Warp Speed to be a national 
effort?
    Dr. Fauci. Yes, it was a national effort that was started, 
and you know, we're part of it at the NIH. The CDC is part of 
it.
    Mr. Burgess. Sure, sure, right.
    Dr. Fauci. The FDA was part of it. Yes, it was.
    Mr. Burgess. But the long and short of it, there was a 
national effort, and even on the effort on PPE, Operation 
Airbridge was a national effort, was it not?
    You were part of the White House Task Force at the time.
    Dr. Fauci. That attempted to address a very severe shortage 
of PPE, yes.
    Mr. Burgess. But it was a national effort. I mean, you 
would agree with that.
    Dr. Fauci. Yes.
    Mr. Burgess. And you will recall the very first hearing 
when Diana DeGette became chairwoman of this committee, the 
very first or one of the very first hearings we had was on 
vaccine hesitancy. You came and testified to that committee.
    This was a hearing before anyone ever heard of novel 
coronavirus.
    So, in your opinion, what can we best do to help you 
alleviate the problems of vaccine hesitancy?
    Dr. Fauci. Well, you know, I think that there are--there 
are many things that you can do. First of all, we have gotten 
from the Congress as part of the American Rescue Act the 
ability with more resources to be able to promote the 
dissemination and administration of vaccines. So I think that 
is really important, what the Congress has already done.
    But I also think----
    Mr. Burgess. Let me just interrupt you for a minute. But 
even 2 years ago, 3 years ago, the PR side of things both at 
the CDC and the NIH really seemed to be where the gap was.
    Are there things we can help you do on the public service 
announcements or the public relations side?
    Dr. Fauci. Well, Dr. Burgess, I think you just hit on 
something. I think maybe by example if Members of Congress get 
vaccinated, maybe even publicly, that would really be helpful.
    Mr. Burgess. Well, I think a lot of us have and certainly 
made that information public.
    Well, I just want you to know going forward, we stand ready 
to work with you to do whatever is required.
    Yes, I too was grateful the President said on Maria 
Bartiromo's show that he encouraged his supporters to be 
vaccinated. I think it is important.
    Let me just visit with you for a second about the structure 
or the purchasing contracts between the United States and some 
of the vaccine manufacturers. There was an option in those 
contracts. There was an option to purchase additional doses, 
was there not?
    Dr. Fauci. You know, I believe so, Dr. Burgess. I was not 
directly involved in that, but I do believe there was an option 
there, but I am actually speaking on shaky grounds here because 
I was not involved in the purchasing.
    Mr. Burgess. OK. Do you recall just generally when those 
contracts were struck?
    Dr. Fauci. Again, it is not something I was involved with. 
It had to be very early in 2020, right after the operation----
    Mr. Burgess. And that would be my point. It has been some 
time since that occurred.
    Dr. Fauci. Right.
    Mr. Burgess. Dr. Walensky, thank you and congratulations. 
Thank you for making your first appearance before our humble 
subcommittee. As you can see, as I told you, it is nothing but 
sweetness and light when you get in front of this committee.
    I just had a question for you about when you testified 
before the Appropriations Committee, you had a five-page report 
on the coronavirus vaccine distribution strategy and spending 
plan, and this was, I think, earlier this month, in March of 
2021.
    Was any of that drawn from the COVID-19 vaccination 
program, the interim playbook for jurisdiction operations, that 
was--the date I have on this is October 29, 2020. Did you 
reference this background document to provide the data for the 
Appropriations testimony?
    Dr. Walensky. Thank you for that question.
    You know, I am certain that there are similar concepts that 
were considered at CDC in October 2020 as well as what we were 
considering in March 2021.
    You know, can I just go back to the question of vaccine 
hesitancy for one moment, if you don't mind?
    Mr. Burgess. Sure.
    Dr. Walensky. I just want to sort of articulate that I 
think we can't call vaccine hesitancy one thing. I think we 
should sort of acknowledge that there are many different kinds 
of vaccine hesitancy, some related to lack of convenience, some 
related to ``I don't necessarily want to be the one to go 
first,'' some related to, you know, the science might have been 
developed too fast, or ``I'm worried about side effects,'' or 
``Nobody else around me has died, and I don't want to be the 
first one.''
    So I think we have to address all of that hesitancy at its 
roots and understand where it's coming from, who's going to be 
the trusted messenger.
    So I think, you know, among the efforts the CDC is engaged 
in is addressing all of those through vaccine competent 
consults, for example. What is the issue that is leading to 
that hesitancy and how can we help?
    Mr. Burgess. And I thank you for bringing that out, and, 
Madam Chair, in reference to that, I'd like to submit for the 
record a New York Times article from June of 2020 where they 
interviewed Dr. Zeke Emanuel, and his bringing up that the 
vaccine likely would not be able to be trusted because it would 
be delivered as an October surprise by the Trump 
administration.
    I would ask that that be part of the record.
    Ms. DeGette. All document requests will be considered, as 
usual, at the end of the hearing.
    The Chair now recognizes Ms. Schakowsky for 5 minutes.
    Ms. Schakowsky. Well, first let me thank our wonderful 
witnesses. We are all thankful for your work and the Biden 
administration's action to expand supply of COVID-19 vaccine to 
the American people.
    I just went to one of the super sites that is in my 
district, and it was fabulous to see. This is a great 
achievement in a mere 50 days since the President's election.
    But there is a looming crisis that has not been addressed 
sufficiently. The President has likened the battle against the 
virus being a war, and he is right. This is a world war, and as 
long as the virus flourishes anywhere, it is a threat to 
everyone everywhere.
    And recently the U.N. Secretary General, Antonio Guterres, 
has been quoted as saying the progress on vaccination has been 
wildly uneven and unfair, and more than 130 countries, he said, 
have not received a single dose, and that endangers everyone.
    As the great Dr. Fauci recently said, and I quote--it was 
on one on the TV shows--``Unless you equally suppress 
throughout the world, you will always have the danger of a 
variant emerging, getting into your country, and reinvigorating 
another spike.''
    That is why developing countries, led by India and South 
Africa, with hundreds of other countries joining in, have gone 
to the World Trade Organization asking for a waiver of the 
TRIPS Agreement so that they can, during this pandemic only, be 
able to manufacture their own vaccines.
    So to Dr. Fauci and to Dr. Walensky: Even if Americans are 
vaccinated, can we really be protected if other countries 
cannot access a COVID vaccine until 2022 or 2023?
    Dr. Fauci. Well, thank you for that question, Congresswoman 
Schakowsky.
    You're right. I actually stand by what I said, and you 
quoted me correctly that if we have outbreak in viral dynamic 
anywhere in the world, it is a threat to everywhere in the 
world.
    And that is the reason why I was so pleased as one of the 
first things that President Biden did, literally the day after 
his inauguration, was to ask me to make a statement to the 
Executive Board of the World Health Organization that we were 
going back into the World Health Organization. We were going to 
be paying our fair share of our obligations, and we would join 
COVAX, which is a consortium of countries and organizations to 
do just what you're asking, to try and get equity among the 
distribution and the production of vaccines.
    In that regard, you are aware that we are giving $4 billion 
to COVAX, but we also know, once we get our own country 
vaccinated, since we have suffered worse than virtually any 
other country besides Brazil--we are both way up there with 
over 530,000 deaths--that we will make any surplus vaccine 
available to the countries who have not the resources to be 
able to make it themselves.
    Ms. Schakowsky. Well, I am just wondering if that is really 
the answer, just to give our surpluses when so many countries 
have asked for permission to create their own.
    And to Dr. Walensky, I know that you have had experience 
with Third World HIV/AIDS impact, and I wonder if you could 
shed light on the danger to the U.S. health and economy if we 
allow Big Pharma to dictate how and when poor countries receive 
a lifesaving vaccine, and that we focus on protecting, 
unfortunately, I think, intellectual property rights over 
getting the vaccine or allowing other countries to produce it.
    Dr. Walensky. Thank you so much for that question, 
Congresswoman.
    You know, I think we just have to look at the last four 
pandemics and the last four infectious threats of our country 
to know that we are all in this together as a globe. If you 
look at H1N1 or Ebola or Zika or now COVID, anything that 
affects the areas around the world is potentially a threat to 
us.
    Indeed, these variants, the ones that we are most concerned 
about right now, also started in outside countries.
    So I think we have to work as a nation to protect our 
Nation, and then we have to work as a globe to protect the 
globe and to ensure that we can get resources to resource-
limited settings to make sure that we can get vaccines out.
    Ms. Schakowsky. Well, I hope that we in the U.S. could do 
all of those good things plus allow for this TRIPS waiver for 
these poor countries.
    And I yield back.
    Ms. DeGette. I am now pleased to recognize Mr. Long for 5 
minutes.
    Mr. Long. Thank you, Madam Chair.
    And thank you all for being here today.
    Dr. Walensky, the subcommittee held a hearing in February 
with a handful of States regarding COVID-19 vaccine 
distribution at the State level.
    In addition to highlighting the need for more supplies, one 
issue the States noted was the need for additional transparency 
regarding distribution and for better understanding of how the 
dose that their State would receive and when.
    Dr. Walensky, what is the current process to notify States 
about the vaccine allocation and distribution?
    Dr. Walensky. Thank you for that question, Congressman.
    I have been now on eight--I have been on most of eight 
Governors' calls once a week on Tuesday mornings where Jeff 
Zients and I are discussing not only the state of the pandemic, 
but the plans for vaccine distribution.
    Among the things that was promised to the Governors is that 
they would have a 3-week line-of-sight as to how much vaccine 
would be coming so that they were able to plan for the vaccine 
allocation in the weeks ahead.
    So those happen weekly. That allocation happens weekly to 
the Governors.
    I also want to note that there's a supply that goes 
directly to the States, and then there's also allocation that 
goes to FEMA for these community vaccination sites that 
Congresswoman Schakowsky mentioned, to federally qualified 
health centers, as well as to the Federal Pharmacy Program, and 
then, of course, to Federal agencies, such as the VA, the State 
Department, and DoD.
    Mr. Long. I know that, as you mentioned there, President 
Biden said that the States would receive three weeks' notice, 
and did I hear you right that is currently happening?
    Dr. Walensky. Indeed, it is.
    Mr. Long. OK. That was a big step and a huge improvement, 
and I am glad that they are following through on that, because 
I know the States desperately needed that information.
    Now, Dr. Walensky, what can CDC and other parts of the 
Federal Government involved in the distribution process do to 
increase transparency for the States?
    Dr. Walensky. So we are working with the States to ensure 
where that supply goes, to demonstrate what is happening in our 
vaccination supply system through systems like Tiberius that 
show here the Federal pharmacy programs are getting 
distribution, to see where the community vaccination centers 
are going to land, as well as to work with the States towards 
vaccine confidence and to provide resources for health equity 
as well.
    Mr. Long. Again, Dr. Walensky, it is critical that we 
ensure Americans have access to COVID-19 vaccines regardless of 
their geography, regardless of where they live. Dr. Walensky, 
what is the CDC doing to ensure that Americans who live in 
rural areas--such as I represent, a lot of rural areas--in the 
United States have access to the COVID-19 vaccine?
    Dr. Walensky. That is such a key question. Thank you for 
that.
    We have put 10 percent of the initial $3 billion into 
issues related to health equity, as well as to outreach towards 
urban centers as well as rural centers.
    The Federal Pharmacy Program is among those designs. So, as 
you may know, the Federal Pharmacy Program is now distributing 
to 9,000 pharmacies with a goal to scale up more than twice 
that, and those pharmacies are actually placed, with the 
experience that we have from CDC and vaccine distribution.
    The pharmacies have chosen to reach these hard-to-reach 
populations, including rural populations, the community 
pharmacies, small chains, as well as large chains, and you 
know, 90 percent of Americans now live within 5 miles of a 
pharmacy.
    So that's among the ways that we are using that program, as 
well as federally qualified health centers to address, you 
know, marginally housed populations, non-English-speaking 
populations.
    Mr. Long. OK. Well, thank you.
    And about a month ago I set out on a 3-day tour. I just 
cleared my calendar for 3 days and visited the six hospitals, 
two clinics, and one vaccination center in my district, and I 
wanted to sit down with the front-line workers, the doctors, 
nurses, people who had been dealing with COVID patients for a 
year now.
    And back at that time my phone lines were burning up. 
People were concerned where they could get the vaccine. I would 
go to one hospital, and they were supposed to receive the 
vaccine that day, and they did not, and other hospitals got 
Pfizer and then they said they couldn't get the second dose of 
Pfizer.
    But I just want to say, you know, and thank all of you that 
have contributed to this in any way, shape, or form, that my 
phone lines have settled down. People seem to be able to access 
the vaccine a whole lot better than they could 1 month ago.
    And with that, I yield back.
    Ms. DeGette. I thank the gentleman.
    The Chair now recognizes Mr. Tonko for 5 minutes.
    Mr. Tonko. Thank you, Madam Chair.
    In less than 2 months in office, the Biden administration 
has moved swiftly to dramatically expand our vaccine supply, 
but as we all know vaccines sitting in vials do not protect 
people. Vaccines in arms do.
    I am appreciative of the leadership that all of our public 
health experts today offer, those that are here as our 
witnesses.
    When can we expect all American adults to be fully 
vaccinated?
    And when can we hopefully achieve herd immunity?
    So, Dr. Walensky, President Biden will direct States to 
make all adults eligible for the vaccine by May 1st. The Biden 
administration also believes that we will have enough vaccine 
doses for every adult by the end of May, 2 months earlier than 
initially forecasted.
    But it is unclear how long it will take to actually get 
those shots into arms. So we know that States are responsible 
for administering vaccines and for prioritizing vaccine 
allocations.
    What mechanism is the administration using to direct States 
to make all adults eligible for vaccines by May 1st?
    And how will that directive impact States' ability to 
prioritize certain populations?
    Dr. Walensky. Thank you for that question.
    You know, yes, we have a goal of herd immunity, and we are 
working to get there. You know, when will everybody have 
vaccination? It really depends on how interested people are in 
getting vaccinated.
    So there has been a supply constraint until now. We are 
working through that supply constraint, and I think in the 
weeks ahead that supply constraints will diminish, and then we 
are really going to need to do the hard work, as you know, to 
work towards getting vaccine in places that it has not touched 
yet, the places that have been hard-to-reach communities, hard-
to-reach places, Tribes, rural places, urban sites.
    So that is the work that we have ahead. It is hard work 
that we have ahead. We have to cross the digital divide and 
make sure that people are not just able to sign up through 
electronic systems. We need to make sure that people have phone 
banks.
    We need to spend resources, and we are working this space 
with community-based organizations, faith-based organizations.
    We need an educational campaign, and so we have been 
actively working in that area, and that is among the resources 
that we are going to put forward in the American Rescue Plan.
    Mr. Tonko. Thank you.
    Dr. Fauci. If I might just mention one thing, if I could, 
with your permission. We really need to be careful about this 
illusive terminology of herd immunity because we really do not 
know what percentage that really is.
    And I think we should focus on the fact that whatever 
vaccine we can get into people will get us closer and closer to 
the protection of the community, doing between 2 and 3 million 
doses per day rather than concentrate on this arbitrary 
percentage that could be anywhere from 70 to 85 percent.
    We just don't know yet. We should focus on getting as many 
people vaccinated as quickly as we possibly can.
    I just wanted to make that point because people get hung up 
on that terminology, which I think most of the time is not 
helpful.
    Thank you.
    Mr. Tonko. Yes, and, Dr. Fauci, while you have made comment 
to that, what effect do we have on that herd immunity 
achievement when we consider that children under the age of 16 
are not currently eligible to receive any vaccine?
    Dr. Fauci. Yes. Again, it gets back to what percentage do 
you mean as herd immunity. If you subtract the number of 
people, the number of children less than 16 from the population 
and you make an arbitrary percent, you may not reach that 
percent until you get the children vaccinated.
    That is the reason why I say rather than focusing on that, 
let's just keep pushing to get as many people vaccinated as we 
possibly can, and as we do that, you will see the type of 
infection, the dynamics of the outbreak get less and less and 
less.
    So whatever that time is--middle of the summer, end of the 
summer, early fall--we'll be much, much better off than we are 
right now.
    Mr. Tonko. Thank you, Dr. Fauci.
    Dr. Marks, the Biden administration has now purchased more 
vaccine doses than required for vaccinating the entire U.S. 
population. Experts believe we may soon have greater supply 
than demand.
    After every American is fully vaccinated, what are the 
administration's plans for the extra vaccine it has purchased?
    Is there a structured plan to reach out to others?
    Mr. Marks. I'm going to have to defer that to the people 
who are actually distributing the vaccine at FDA. I can say 
that one piece of insight I can give you is that there may be 
some concern that we have enough vaccine and if we need to give 
boosters in the not too distant future, that we have sufficient 
supply to be able to do that because we still only know that 
the vaccine has a certain length of protection, probably at 
least 6 months, but we don't know whether that's a year or 
more.
    So there may be some wisdom to having some supply, but I'd 
have to defer to others in the administration about what will 
happen with additional supply, whether it will go overseas or 
whatnot.
    Mr. Tonko. OK. Thank you.
    Any comments from any others?
    Ms. DeGette. The gentleman's time has expired.
    Mr. Tonko. OK.
    Ms. DeGette. And I am trying to make sure that everybody 
can ask questions----
    Mr. Tonko. I understand.
    Ms. DeGette [continuing]. Before our panel has to leave. So 
thank you.
    Mr. Joyce, you are now recognized for 5 minutes.
    You will need to unmute, Mr. Joyce. Thank you.
    Mr. Joyce. Thank you, Chair, and thank you, Ranking Member 
Griffith, for convening this group today.
    Dr. Fauci, it is great to see you again. Years ago, I sat 
when Dr. Tom Provost, my chairman at Hopkins, brought you there 
to lecture us, and you continued a career that has had impact 
throughout the decades.
    Dr. Fauci, I have two separate questions that I think will 
really have you reach into the skill set of immunology, which 
is one of your many areas of forefront.
    As we continue to see advancements in second-generation 
vaccines, do you believe that innovations such as intranasally 
administered vaccines--those that allow the development of IGA 
or mucosal immunity--do you think that those should be 
considered as we reach to the next step of vaccines?
    Dr. Fauci. The answer to that is yes. I mean, there is a 
lot of interest and always has been about exposing mucosal 
surfaces for vaccines that are essentially transmitted through 
the respiratory route.
    So you're right. This will be the second- and third-
generation vaccine, and there is research already going on that 
we are supporting at the NIH level. So I would imagine that you 
are going to be seeing after we get this under control.
    I don't think--as you probably know, it's not going to be 
ready to essentially get the pandemic under control, but we're 
going to have respiratory illnesses that are essentially 
emerging in pandemic form for years and years to come, and we 
may be having to deal with SARS-CoV-2 for more than just the 
next year or so.
    So you're quite correct, Congressman Joyce, that those type 
of innovative approaches towards vaccine are definitely on the 
table.
    Mr. Joyce. Dr. Fauci, as we look to possibly address the 
lack of adequately immunizing pediatric patients and the risk-
rewards with certain current vaccines, should we be looking at 
less invasive methods of vaccine administration, specifically 
the internasal route?
    I mean, using an analogy, Jonas Salk developed the original 
polio vaccine in my home State of Pennsylvania, but I did not 
receive the Salk vaccine as a child. I received the Sabin, the 
oral vaccine, where we were lined up and taken to school and 
received it on sugar cube.
    So when we address parents' hesitancy to immunize their 
children, is there a role for the internasal route as it 
continues to be developed?
    Dr. Fauci. The answer is yes, the same answer to what you 
had mentioned to your first question. You recall that this is 
something that we faced with influenza when we developed the 
flu mist, which was originally designated for children, 
originally saying that you don't want to give children an 
injection because they may not like it.
    It turns out from an immunological standpoint, it also had 
some value added there.
    So the answer to your question is yes. We will be pursuing 
alternative methods of administration of vaccines both for 
SARS-CoV-2, as well as for other diseases.
    Mr. Joyce. Thank you, Dr. Fauci.
    Dr. Walensky, my next question--and we have addressed this 
at some levels in earlier questions--but we realize that there 
is a vulnerable population, approximately a half a million 
individuals in the United States, who suffer from kidney 
failure and are going to hemodialysis three times a week on a 
regular basis.
    And a lot of these patients--actually I think the estimates 
are close to 90 percent--have multiple comorbidities, like 
diabetes and hypertension, and they face a 20-plus percent 
mortality rate if they contract COVID.
    Unfortunately, they remain largely unvaccinated, and 
considering these are high risk and we want attention to health 
equity, what further steps for bringing these vaccinations to 
these patients who are going to hemodialysis centers three 
times a week, have a great support staff providing that 
hemodialysis?
    What next steps should be taken to allow the immunization 
of these patients who have kidney failure and allow their 
workers, those who participate, the technicians who provide 
that three times a week hemodialysis?
    What steps should be taken? Should that immunization occur 
right at the dialysis centers?
    Dr. Walensky. Thank you for that question, Dr. Joyce.
    Yes. We are actively working now. Of course, we had supply 
constraints early on, so we couldn't roll out all programs that 
we wanted to early on, but right now we are actively working 
with dialysis centers.
    As you note, not only is this a high-risk population, but 
it also is often a minority population, and so this is a key 
place where we could offer vaccine. It's a trusted resource. 
People come three times a week, and, in fact, we're actively 
working with these dialysis centers to roll out a plan for 
vaccination there.
    Mr. Joyce. Thank you. I see my time has expired, and I 
thank you for yours, and I thank you for your presentations.
    Ms. DeGette. I thank the gentleman.
    The Chair now recognizes Mr. Ruiz for 5 minutes.
    Mr. Ruiz. Thank you, Chair.
    We have been talking for months now about the importance of 
making sure that there is an equitable distribution of vaccine, 
that we need to make sure people are prioritized based on level 
of risk for contracting and dying from COVID and not solely 
based on their income or ability to purchase the vaccine.
    And while the guidelines put out by CDC do prioritize the 
higher-risk groups, what we are seeing is that despite these 
efforts we have an access problem in the hardest-hit 
communities that are traditionally underserved.
    Qualifying for a vaccine does not help if you cannot 
actually get one, and targeting populations who are at higher 
risk has not always translated to those populations getting 
vaccinated.
    Underserved communities with higher rates of infections 
have disproportionately low inoculation rates, as do 
individuals of color, despite the fact that they are more 
likely to contract COVID-19, transmit COVID-19, and die from 
COVID-19.
    According to a recent Kaiser Family Foundation report 
examining data from 35 States, the vaccination rates among 
White people was over 2\1/2\ times higher than the rate for 
Hispanics and nearly twice as high as the rate for Black 
individuals.
    And I am seeing this play out in my own district. In 
Riverside County, California, where my district sits, Hispanics 
make up 47 percent of the population but 65 percent of COVID 
cases. Yet Hispanics have only received less than 19 percent of 
the vaccine, which is why I applaud President Biden's focus on 
equity by getting vaccines into the communities that are 
hardest hit.
    First, the Federal Retail Pharmacy Program was a good move 
because they exist in almost every community.
    And, second, providing vaccines to FQACs ensures that 
medically underserved areas have vaccines for their high-risk 
residents.
    But we also need to make sure that the FQACs and the retail 
pharmacies are opening vaccine sites in the underserved 
communities. We need to make sure to address barriers like lack 
of internet to make appointments, lack of transportation to the 
vaccine site, lack of time away from work, lack of information 
in a language people understand.
    Equity does not mean equal. It means providing resources 
proportionate to the need or burden of disease. Equity 
requires, one, prioritizing high-risk individuals and 
communities; two, allocating vaccines proportionate to those 
risks; and three, vaccinating people in the community with 
community partners or at the workforce.
    And because of President Biden's equity initiative, I was 
able to partner with Rite Aid and local community health 
workers or [speaking foreign language] that does a Health Care 
District and the Coachella Valley High School to inoculate over 
700 people in 2 hours for the hardest-hit, highest-risk 
communities at a vaccination site at the high school.
    I also partnered with Eisenhower Health to vaccinate 577 
people at Coachella Senior Center, also a medically underserved 
area.
    Dr. Walensky, the Biden administration has taken steps to 
expand vaccine access through direct distribution to these 
retail pharmacies. What is the plan to ensure that the vaccines 
are mostly being offered in retail pharmacies located in 
communities hardest hit, like medically underserved areas or 
communities of color, and not just in low-risk, affluent cities 
as reward for their higher-consuming customers?
    Dr. Walensky. Thank you so much for that question, Dr. 
Ruiz, and thank you so much for your leadership and the 
inspiring work that you are doing to make sure that this 
vaccine is reaching these hardest-hit communities.
    Our group at the CDC, our Pharmacy Group at the CDC, has 
really wonderful connections with these pharmacies through 
vaccine distribution and flu vaccine as well. They know where 
these pharmacies are, where the local pharmacies are, where the 
hardest-to-reach communities are, and which pharmacies are 
there. And we're collaborating with the administration to make 
sure that it's those pharmacies that are getting vaccines.
    I also want to comment on the community vaccination sites. 
We are collaborating with FEMA, and we pick the sites for these 
community vaccination sites, these 6,000-a-day vaccination 
sites to ensure that they are in areas both of high census as 
well as high social vulnerability index, greater than .7.
    So we are actually specifically selecting these sites for 
exactly those reasons.
    Finally, I want to say that one thing I believe is really 
important is that our efforts here are sticky, and the way that 
I mean that is to say we cannot be one and done as we do this 
outreach because, as soon as we get all of these communities 
vaccinated, we need to make sure and go back and get their 
children vaccinated for their next childhood vaccines, and we 
need to work on hypertension, and we need to do so many other 
things in these communities to address health equity after 
COVID-19.
    Ms. DeGette. I thank the gentleman.
    The Chair is now pleased to recognize Mr. McKinley for 5 
minutes.
    Mr. McKinley. Thank you, Madam Chairman.
    And, Dr. Walensky, speaking of the misinformation being 
disseminated that Cathy McMorris Rodgers brought up earlier, my 
Twitter account has been lit up during this hearing by people 
posting that President Trump killed 500,000 Americans.
    So, Dr. Walensky, would you agree with that statement? Is 
that an accurate statement, that Trump killed 500,000 people?
    Dr. Walensky. Thank you for that question, Representative.
    I came into this office in 2020, and on January 20th, came 
into this administration on----
    Mr. McKinley. It is a yes or no, Dr. Walensky. Did he or 
did he not kill 500,000 people?
    Dr. Walensky. I think the effect of this pandemic is 
multifactorial.
    Mr. McKinley. Oh, I can see where this is going to go.
    So, Dr. Fauci, if I could turn to you since she is not 
going to answer the question, while on the campaign trail we 
heard time and time again that then-candidate Biden, that the 
President's words have consequences.
    Then on Monday, the National Review reported that President 
Biden proclaimed that Americans should wear masks until 
everyone is vaccinated. I am not aware of any healthcare 
professional expecting that 100 percent of the population will 
be vaccinated.
    So, Dr. Fauci, do you agree that Americans should wear 
masks? Do you agree with the President that Americans should 
wear masks until 100 percent are vaccinated?
    Dr. Fauci. You know, I'm sorry, Congressman McKinley. I did 
not hear that statement, and I pretty much follow what the 
President says. I didn't hear him say that everyone should wear 
masks until 100 percent of people are vaccinated. I----
    Mr. McKinley. It says until everyone, everyone is 
vaccinated. He did not say ``100 percent,'' he said ``till 
everyone.''
    Dr. Fauci. Well, everyone is 100 percent.
    Mr. McKinley. That is what I thought so too. So I will tell 
you what, Doctor. I will send you a copy of that. It was on 
several news outlets about that, but it first broke on National 
Review.
    Let's go back to try to get a straight answer from Dr. 
Walensky.
    Dr. Walensky, regrettably, 288 children have died from 
COVID, according to the CDC, and that is a tragedy by any 
measure. But that number actually mirrors the annual death due 
to seasonal flu with children.
    So at the beginning of the pandemic, we closed schools, and 
we understand that. We did not know the effect COVID could have 
on children and teachers.
    But now we know. So the data suggests the spread of the 
virus is minimal in schools. They use safety precautions, even 
in communities with high disease prevalence.
    And teachers are being vaccinated. So college students can 
go on spring break and bars and restaurants can open up at full 
capacity, but children cannot go back to school and people 
cannot attend church services.
    Dr. Walensky, communities and States are looking to the CDC 
for guidelines. Will the CDC be updating their school reopening 
guidance this week, this week regarding giving the new data 
available?
    Dr. Walensky. Thank you very much for the question.
    We recognize the challenges of having children home. I want 
to articulate that, you know, respiratory viruses frequently 
travel in schools, and I think we were cautious when we had a 
respiratory virus and we were worried, like influenza, that 
this virus might behave in the same way.
    We have published operational guidance to get children 
back. In fact, it was intended to have schools lean in to get 
the schools that were closed open, and we very specifically 
said that schools that are doing well should not close.
    And so now we have emerging science that looks at the 3-
feet versus 6-foot rule----
    Mr. McKinley. OK. Thank you.
    So are you going to be--I have got one last question that I 
do not need to be filibustered on.
    Dr. Fauci, last summer while the pandemic was raging, we 
also had social unrest, unfortunately, happening in the 
country. Thousands of people, understandably, were gathering to 
protest racial injustice. The media and some public health 
heralded these protests.
    In fact, 1,200 people--1,200 public health professionals--
signed an open letter arguing that protests against systemic 
racism must be supported, quote, ``even at the cost of 
spreading the virus.''
    Dr. Jennifer Nuzzo of Johns Hopkins stated publicly, quote, 
``Public health risks of not protesting exceed the harms of the 
virus.''
    Dr. Fauci, do you agree with that statement?
    Dr. Fauci. My stance has always been that we should abide 
by the public health measures that we talk about all the time, 
which are avoiding congregate settings, wearing a mask, washing 
your hands.
    Mr. McKinley. So you would think that they maybe were not 
justified?
    Dr. Fauci. I'm not going to get into the justification or 
not of who demonstrates about what. I'm just going to give you 
the public health measures that we talk about all the time and 
not get into the background or basis of a demonstration or not.
    Mr. McKinley. Thank you.
    Ms. DeGette. The gentleman's time has expired.
    Mr. McKinley. I yield back.
    Ms. DeGette. The Chair now recognizes Mr. Peters for 5 
minutes.
    Mr. Peters. Thank you, Madam Chair.
    I wanted to follow up a little bit on my colleague Dr. 
Ruiz's questions about equity. Equity is a key tenet of the 
Biden administration's national COVID-19 strategy, and so I 
know that the Biden administration is taking great strides to 
expand distribution by setting up 20 high-volume vaccination 
sites, which support 600 community vaccination centers, 
increase the number of community health centers and retail 
pharmacies as we were discussing before offering vaccinations 
of underserved communities.
    But I would like to ask Dr. Walensky maybe in a more open-
ended way: Can you explain how the administration determines, 
first, the location of these vaccination centers and, second, 
the number of doses to deliver to each jurisdiction? What are 
the basic factors that go into those determinations?
    Dr. Walensky. Thank you for that question, Congressman.
    You know, the CDC works collaboratively with FEMA to find 
areas of high census and areas of high social vulnerability as 
to the best places to place these vaccination centers, as well 
as what volume they need, whether that area would support a 
6,000-dose-a-day or a 3,000-dose-a-day vaccination site.
    As to how many doses and how that allocation happens, that 
happens at the operation level, and so, you know, I cannot 
speak exactly to how that occurs. We assist in the site 
selection.
    Mr. Peters. OK. Well, I appreciate that.
    I would like to ask you, Dr. Walensky, too, a little bit 
about data. I am very concerned about the quality of data. I 
think all sorts of Federal agencies touch the data that comes 
in that's reported from States, and there is no standardization 
for how you report data from State to State, maybe even from 
hospital to hospital.
    So it makes it very hard for you and for us as policymakers 
to really understand what are the facts on the ground from 
which we can make policy decisions and how you can respond to 
this pandemic and any future health crises like this.
    So I want to know, first of all, what guidance have you 
developed for State and local governments on, like, what data 
to report, where they would standardize that, and how are you 
dealing with the various silos in the Federal Government?
    And then also maybe you could touch on how the Federal 
Government protects the privacy of the data that's reported.
    Dr. Walensky. Thank you for that question.
    I think among the things that you are highlighting is that 
our data on infrastructure was actually not well-supported when 
this all started, and in fact we are working hard on data 
modernization efforts so that we can ensure that data is 
coming.
    We have to provide independence to the States so that they 
can report as they are able, but then also some uniformity of 
data so that we can actually receive that data and report at a 
national level.
    So we are working closely with the States to unify the data 
coming in and as well as data modernization efforts in the 
context of this pandemic.
    I want to articulate that CDC does not receive individual 
line-item data from individual persons. So the privacy is held 
at the State, and we get data on aggregate unidentified.
    Mr. Peters. Sure, but you would agree that, if you do not 
standardize the reporting and we do not have an understanding 
about hospitalizations and preexisting conditions for all the 
various people who are experiencing it, it makes it very hard 
for us to judge what is really going on on the ground with 
accuracy. Is that right?
    Dr. Walensky. I think, you know, a lot of individual States 
have had to develop their individual data systems, and we need 
to provide some independence for them to be able to do that and 
some uniformity in reporting.
    Mr. Peters. Yes. I am trying to help you with the 
uniformity side. We have actually introduced a bill called the 
Health Statistics Act in consultation with a lot of the 
statisticians in Washington who think this is really important. 
I would urge you to ask about it.
    A lot of this can be implemented by the administration 
without Congress, but part of our effort is to provide 
financial support to local and State efforts to report these 
data to the extent they have to change their systems for 
reporting.
    So we would like to help you with this at the committee and 
hope that you will take us up on that.
    I guess finally, just to follow up on one more equity 
issue: Since opening the Health Center Program, has the 
administration observed an increase in the rates of vaccination 
among Black and Hispanic Americans? And how does that look 
going forward?
    Dr. Walensky. Right. We know that the Black and Hispanic 
population had a larger life expectancy loss, a larger or 
higher death rate, and so we are working actively to make sure, 
you know, we have 10 percent of resources, of vaccine 
distribution resources, going to ensure health equity.
    We have worked on vaccine confidence consults. We're 
working with NGOs and community-based organizations to make 
sure that the message gets to trusted messengers. That is 
exactly the hard work that we have ahead.
    Mr. Peters. My time has expired, but I would ask whether 
you have seen the vaccinations go up among those populations.
    Dr. Walensky. Yes, we are dedicating a whole lot of effort 
to that. So I would be surprised if that is not the case. We 
are fully engaged in that activity.
    That is what we need to do.
    Ms. DeGette. I thank the gentleman.
    The Chair now recognizes Mr. Palmer for 5 minutes.
    [Pause.]
    Mr. Palmer, you seem to be muted.
    Let's see if that works.
    [Pause.]
    No. Mr. Palmer, we still can't hear you. I am going to go 
to the next Member, and then we will come back to you.
    So, Ms. Schrier, you are now recognized for 5 minutes.
    Ms. Schrier. Thank you so much, Madam Chair.
    First, thank you to all of our witnesses for your 
tremendous leadership.
    Now, today I am not speaking as a Member of Congress. I am 
speaking as a doctor. I told my own parents that when they go 
for their coronavirus vaccine they should take whichever one is 
offered because they all prevent hospitalization and death 
essentially equally.
    So just to be very clear, Dr. Fauci, doctor to doctor, 
would you agree?
    Dr. Fauci. I would agree totally with what you told your 
parents, absolutely. We have three highly efficacious vaccines, 
and importantly, as you correctly told them, they are all three 
of them superb at preventing hospitalizations and death.
    So whatever you told your parents was correct, Doctor.
    Ms. Schrier. Thank you very much.
    Now, I have a lot of concerns about where we go from here. 
Like as long as this disease is circulating anywhere in the 
world, we remain at risk, and I am worried that with variants 
popping up pretty quickly, this virus could get ahead of our 
vaccines.
    And so far we have been lucky, but we do not want to end up 
playing Whac-a-mole every time there is a new variant.
    And so I want to make sure that we do not get caught off 
guard by some new variant and without the tools we need from a 
public health standpoint. I want to make sure that our return 
to normalcy is sustained and that we do not have to fully close 
down our economy or our schools again.
    So, if COVID is going to be with us for a while, 
vaccination is critical, but I also believe we need a much 
greater ability to test asymptomatic people, test them early, 
catch them early, and prevent outbreaks that could land us 
right back in this same situation.
    So, for example, if we had widely available, inexpensive 
home testing, people could test themselves and stay home if 
they are infected. I am thinking schools, workplaces, and we 
could catch the disease early and prevent outbreaks.
    So, Dr. Fauci, do you agree it would be useful to add some 
degree of routine home testing in addition to vaccinations to 
our public health toolbox?
    Dr. Fauci. I not only agree with that, Dr. Schrier, I 
actually have been saying that for months and months and 
months, that we should be literally flooding the system with 
easily accessible, cheap, not needing a prescription, point of 
care, highly sensitive, and highly specific, that we could do 
just what you are saying.
    And in fact, you're going to be seeing more of that soon.
    Ms. Schrier. That is great. You and me both, Doctor.
    And, Dr. Walensky, our children will not be vaccinated for 
many months. Could you just comment briefly on how home testing 
could help schools not only open safely, but stay open?
    Dr. Walensky. Thank you for that, Dr. Schrier.
    I too have been saying that and writing about it as well. 
You know, we know in schools we know now--that we didn't know 
then--that children, there's less transmission in schools among 
children as there are among adults, between adults.
    And so I do believe once we have teachers vaccinated that 
we can use testing in the schools, serial testing, cadence 
testing to identify potential infections, asymptomatic 
infections, shut down clusters, and be able to keep our schools 
open.
    Ms. Schrier. That is right. I am even imagining that you 
would not have to quarantine a whole classroom. You could just 
test everybody every day and root out the ones who were 
infected.
    So finally, I know there are a lot of these tests that are 
in the pipeline. I saw yesterday that there is a new path for 
evaluating these kinds of tests to use at home, but we have not 
seen the same sort of push to get them produced inexpensively 
and at scale and into everyone's hands the way we saw with 
vaccines.
    And so I would just ask the three of you, you know, one at 
a time: Would the three of you commit to working together in 
kind of a whole of government approach to get these tests into 
every home as quickly as possible?
    Dr. Fauci?
    Dr. Fauci. Absolutely, Dr. Schrier, and in fact, in one of 
those tests that recently came out, we are investing a couple 
hundred million dollars to really scale up the production to do 
just what you are saying.
    But I agree with you we need to do it on a broader scale, 
not just for individual product.
    Ms. Schrier. Right. Dr. Walensky?
    Dr. Walensky. Indeed, and we are working towards imminent 
release of guidance that will facilitate that.
    Ms. Schrier. I love it.
    Dr. Marks?
    Dr. Marks. Indeed, yes. Although I'm not responsible for 
devices, I can tell you that our Center for Devices is doing 
whatever they can to expedite the availability as much as they 
can.
    Ms. Schrier. Fantastic. Well, thank you very much. I really 
appreciate all of you being here.
    And I yield back the rest of my time.
    Ms. DeGette. I thank the gentlelady.
    Mr. Palmer, welcome back, and you are recognized for 5 
minutes.
    Mr. Palmer. Can you hear me now?
    Dr. Fauci. Yes.
    Mr. Palmer. You are nodding. OK. I expected a verbal 
response.
    Dr. Fauci, during Dr. Joyce's comments, the two of you 
discussed the flu mist for young children, and there is 
research that the preclinical trials were done at the 
University of Alabama at Birmingham with a company called 
Altimmune that is developing an internasal delivery that I 
think has tremendous potential because it is not only a 
vaccine, it also prevents transmission, or at least it is in a 
clinical trial to determine whether or not it would prevent 
transmission.
    My question to you is, What do you know about that approach 
and the potential for helping us to reopen our schools, not 
only our schools, but our whole country?
    Dr. Fauci. Well, internasal application of vaccines for 
respiratory illnesses does have an advantage, as I mentioned in 
my answer to a prior question.
    You bring up a very good point. If you induce a high degree 
of mucosal immunity, that since viruses are transmitted from 
the nasal passage and the lung and the mucosal surfaces, that 
could have the advantage.
    We have been investing at the NIH not only in products such 
as you described, but a number of our grantees are working on 
alternative methods of vaccine delivery, and the mucosal 
presentation of the vaccine either through a nasal spray or 
even an oral version of it is being pursued by a number of 
investigators.
    So the answer to your question, Congressman Palmer, it is a 
very favorable and promising area of research.
    Mr. Palmer. I think too, particularly because it does not 
require cold storage, it really helps us with the distribution 
in rural areas and to some of these disadvantaged communities, 
and then there are people out there who are needle adverse.
    Dr. Fauci. Right.
    Mr. Palmer. I resemble that remark. But I think this could 
be a very effective program.
    My question is, and you may not know the answer to this: 
Are these trials a part of Operation Warp Speed?
    Dr. Fauci. The Operation Warp Speed is not one that, in 
essence, is doing additional trials other than the group that 
we put together, the six companies' three platforms. The trial 
that you are talking about would fundamentally be funded at the 
NIH level or the CDC level in certain circumstances.
    Mr. Palmer. I would think, though, given the potential 
efficacy for this drug or preventing the transmission, that it 
ought to be part of some type of Operation Warp Speed program 
to get this done as quickly as possible, and particularly for 
getting kids back in school.
    The last thing that I want to point out, I do appreciate 
the fact that--I do not know if you were a part of the study or 
supported the study that was done in Massachusetts that showed 
that allowing the students to sit 3 feet apart and the staff 3 
feet apart did not increase the rate of transmission.
    And I think that is a very important study. More people 
need to know about it in terms of getting our schools reopened.
    Dr. Fauci. Yes, the CDC is very well aware of that. In 
fact, Dr. Walensky just commented to that a little bit ago.
    So, Rochelle, why don't you repeat that?
    Dr. Walensky. Yes, thank you for that question, 
Congressman.
    You know, when we put out our guidance, one of the hardest 
things that we recognized for schools to be able to do was the 
6-foot distancing, and whenever there are challenges, that's 
when science emerges.
    So right after that guidance came to, then there were 
studies that were ongoing to look exactly at the 6 feet versus 
3-foot question, when people were 100 percent masked as they 
were in Massachusetts.
    That study was released just late last week. I am aware of 
several other studies that are emerging, and when we have 
concise and consistent evidence that we are actively reviewing 
actually right now, we will update our guidance.
    Thank you.
    Mr. Palmer. Thank you.
    I do want to say something. I rarely do this, but I was 
offended and extremely disappointed that you could not give a 
straight yes-or-no answer on whether or not the claims that 
President Trump was responsible for 500,000 COVID deaths when 
you have got over half of the deaths in Pennsylvania are in 
long-term facilities.
    I mean, there are people that would blame Governor Cuomo 
for the 15,000 deaths in long-term facilities.
    I just think that is unfair, and it is, in my opinion, 
beneath the office that you hold, and I would really appreciate 
it if you could give a straight answer yes or no. Is President 
Trump responsible for 500,000 people dying from COVID?
    Ms. DeGette. I am going to intercede right here. I am going 
to let Ms. Walensky answer, but as chair, we are going to let 
her answer that question that has now been asked by two people 
if you can do it quickly because we are running up against your 
time frame.
    Go ahead.
    Mr. Palmer. Thank you, Madam Chair.
    Dr. Walensky. Thank you. Thank you, Congressman.
    I think we have to look back. We will look back at this 
pandemic and recognize that there are many, many reasons why we 
as a country were ill-prepared to tackle this pandemic that 
resulted in over 500,000 deaths.
    Mr. Palmer. That is not an answer.
    Ms. DeGette. OK. That----
    Mr. Palmer. I yield back.
    Ms. DeGette. Thank you so much.
    And we are not going to have any more badgering of the 
witnesses.
    Mrs. Trahan, you are now recognized for 5 minutes.
    Mrs. Trahan. Thank you, Chairwoman DeGette and Chairman 
Pallone, for holding this critically important hearing.
    My thanks to each of the witnesses, for your steadfast 
leadership and dedication in combating this pandemic has been 
critical to our crushing the virus and a comfort to our 
constituents that better days are ahead for our country and for 
the world. I so appreciate you taking the time to appear before 
this committee.
    So, as a mother of 6- and 10-year-old daughters, I would 
like to continue to understand the impacts of COVID on 
America's children. Although they may be less likely to 
experience severe symptoms from COVID, we should not minimize 
the fact that many have suffered very real harm over the past 
12 months.
    And to no one's surprise, the same COVID-related health 
disparity suffered by Black and Hispanic adults have also 
befallen children of color.
    It was indicated earlier in this hearing that high-school-
age children will be able to start getting vaccinations this 
fall, and younger children will get vaccinated by the first 
quarter of 2022. In the meantime, many families across the 
country are anxious to return to pre-pandemic activities, and 
as a goal point that could be a vaccination. They are craving 
guidance on how to live, work, and socialize while we wait for 
our children to get vaccinated.
    Dr. Walensky, let me just start by saying that we are so 
proud back home to have you at the helm of the CDC. Thank you 
for your tremendous service to all of us in Massachusetts and 
the entire Nation during these unprecedented times.
    As the vaccine's clinical trials among children continue, 
more adults become fully vaccinated and States begin to loosen 
restrictions, what do parents need to know about the ongoing 
risks to their kids from the virus?
    Specifically, is there guidance other than mask wearing and 
social distancing that you can give or that might evolve for 
vaccinated parent and grandparent interactions with children 
under 18 awaiting the vaccine?
    Dr. Walensky. Thank you for that, Congresswoman.
    You know, our initial guidance about what can you do when 
you're vaccinated was really a first step into recognizing 
that, in fact, there are going to be relatively low-risk 
children who want to see their vaccinated grandparents, and 
those children are going to be unvaccinated, and our guidance 
actually permits that as long as children don't have a high-
risk condition and the family members don't have a high-risk 
condition.
    Among the things that we really need to recognize is as we 
want to lean into more of our day-to-day activities--school 
sports is a really common one to discuss--that so much of how 
we are able to do that depends on how much disease is in the 
community.
    Because, in fact, that disease comes in from the community 
into the schools. We have numerous MMWRs that have been 
published on football outbreaks, on outbreaks that are 
happening in these extracurricular activities, and they happen 
when there is enough disease in the community and we're not 
taking these mitigation efforts.
    So I think what's going to happen is, as more and more 
adults get vaccinated, we will see, I hope, and as we do it 
quickly, the community rates come down and our ability layered 
on top with screening strategies as was previously noted by Dr. 
Schrier, to be able to engage in some of these day-to-day 
activities in our children.
    Mrs. Trahan. Great. Thank you.
    I also wanted to touch on the mental health of our 
children. Others have mentioned already today that there is an 
urgent need to invest in mental health resources and services 
to our youth, and the pandemic has only exacerbated this.
    The CDC recently found that, compared to 2019, mental-
health-related emergency room visits increased 31 percent for 
children between the ages of 12 and 17 from March to October of 
last year.
    I recently partnered with Congressman Cardenas to introduce 
the Youth Mental Health and Suicide Prevention Act, which sends 
funding directly to school districts to support positive mental 
health promotion and suicide prevention efforts in high 
schools.
    But the numbers show our children need help right now. So, 
Dr. Fauci, with our remaining time, what efforts are firmly 
underway within NIH and across the broader Federal Government 
to understand and respond to youth mental health challenges 
that have been brought on or worsened by the pandemic?
    Dr. Fauci. Yes, thank you for that question.
    In fact, the Infectious Disease Institute that I direct is 
by no means the only institute that's involved in addressing a 
comprehensive response to the pandemic. The National Institute 
of Mental Health is now getting deeply involved not only in 
recognizing this problem but by also trying to study its 
intensity and how we might respond to it.
    Your point is extremely well taken. We consider this one of 
the most serious issues related to spinoffs of the outbreak 
that really were not anticipated when you just think in terms 
of an infectious disease.
    Mrs. Trahan. Well, thank you.
    The effects of the pandemic will be far reaching and long 
lasting, and I appreciate your being with us here today. We 
must be able to not only meet their needs now but also in the 
future.
    Thank you. I yield back.
    Ms. DeGette. I thank the gentlelady.
    The Chair now gives the last word to Congressman 
O'Halleran, who is recognized for 5 minutes.
    Mr. O'Halleran. Thank you, Madam Chair. I appreciate your 
time and the work that went into this, bringing this together.
    And I appreciate the panel not just for coming here today 
but for all the work that they have done over the last year to 
get us to where we are at today.
    The authorization of safe and effective COVID-19 vaccine 
gives America hope, but we must continue to follow the CDC 
guidelines in the United States.
    The variant first identified in the United Kingdom is 
spreading quickly, even as we have seen a reduction in overall 
cases.
    I want to be looking forward in the coming months as to how 
we can be prepared to respond to future variants and future 
diseases with the potential to tear into global pandemics.
    In the American Rescue Plan, Congress allotted $1.75 
billion that will be provided to the CDC for SARS-CoV-2 
genomics sequencing and surveillance. And there is a real 
urgency to this project, and we must become better at attacking 
new COVID variants and assuring that variants that are 
potentially more contagious, deadly and even resistant to 
variants do not spread.
    You know, I have a number of Tribes. They got tremendously 
impacted, and there are a lot of disparities going on both with 
Tribes and throughout our country. We have to also address 
those issues quickly.
    And I want to thank Dr. Walensky on the work that she had 
remarked on on the Navajo Tribal Utility Authority and the 
Navajo Energy and Construction Authority. Permanent solutions 
are needed in these areas.
    I was going to ask a series of questions of different 
folks, but I want to use my time to identify. We have to 
address this issue, but at the same time there are other 
viruses in the world or that may be coming that are not going 
to stop because we are working on just this issue.
    So I want to ask each of the panelists starting with Dr. 
Fauci: What do we need to do as Congress? We cannot afford to 
wait 2 years to start looking to the future. We have to do it 
now.
    So, starting with Dr. Fauci, can you tell me, identify what 
do we need to do, how are we going to get there, and what does 
Congress need to do?
    Dr. Fauci. Well, one of the things that Congress has 
already done, Congressman O'Halleran, with the American Rescue 
Act and the extraordinary generosity of money that was put into 
that is that there are components of that that are directed 
specifically to SARS-CoV-2 but will have spinoffs for long-
term, durable preparedness for pandemics of the future.
    In fact, as you continue to prepare and respond to what's 
going on right now, you're giving the building blocks of what 
we're going to be doing to have the structure and the 
capability of responding in the future.
    So they really are joined. So I want to just express my 
appreciation and all my colleagues at the NIH for the fact that 
this has been done, and this money will be extremely well spent 
looking forward.
    Mr. O'Halleran. Dr. Walensky, can you take that up?
    But I also want to say that is what we expect now, but what 
are we going to be looking for in the future? We just cannot 
afford, just like a military process, we cannot afford to be 
caught the way we were ever again. So how do we get to where we 
need to be?
    Dr. Walensky. Thank you so much.
    So let me echo the gratitude for the resources that we have 
received to jump start things now for the $1.7 billion for the 
variant genomic sequencing, as you know.
    What we need to do is lay the foundation now, and then we 
need longitudinal resources to ensure that we can keep that 
foundation both in the public health infrastructure in 
epidemiology and data modernization as well as in global health 
leadership and global security so that we can support global 
efforts, we can take global leadership, and we can create in-
country capacity for our global health partners.
    Mr. O'Halleran. Thank you.
    And just quickly, how do you feel about the fact of where 
we need to go?
    What is the time issue here as far as how soon do we get 
the World Health Organization to work with us continuously, the 
other countries of the world to do that, and to make sure that 
we recognize the Third World countries and the disparities in 
America and what has to be brought about?
    Dr. Fauci. Yes, sorry. We're doing it already because 
that's the reason why we went right back into the WHO. We're 
going to be giving the resources that had been held back, and 
we're doing COVAX. So we are already doing that.
    Dr. Walensky, you were going to say something.
    Dr. Walensky. I was going to echo, Doctor, what you said.
    We're already working in 60 countries with over 150 
projects. We're actively engaged with the WHO, and we have a 
longstanding partnership with them.
    Mr. O'Halleran. Madam Chair, I would just wish that 
everybody would bring the continuing work back to us, please, 
and on a regular basis.
    Thank you, Madam Chair. Sorry for going over.
    Ms. DeGette. I thank the gentleman. That was the perfect 
ending segment for our questions because it leads me to thank 
all three of our witnesses for being here and your wonderful 
testimony, your leadership on confronting this terrible, 
terrible pandemic in the last year, and your leadership as we 
go forward to vanquishing this foe and also to looking to be 
able to address anything that comes forward.
    So we appreciate it. We know we will see you back again in 
front of this subcommittee.
    I want to remind Members that, pursuant to the committee 
rules, they have 10 days to submit additional questions for the 
record to be answered by witnesses who've appeared before the 
subcommittee.
    And I know all of the witnesses will respond promptly to 
any questions if you receive any.
    We do have one request for unanimous consent on a document. 
That is Mr. Burgess' request to insert an op-ed from the New 
York Times dated June 8, 2020.
    And without objection, it will be ordered.
    [The information appears at the conclusion of the hearing.]
    Ms. DeGette. And with that, thanks again to our witnesses 
and all the Members who stayed, and this subcommittee is 
adjourned.
    [Whereupon, at 12:33 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    


                            [all]