LEADING THE WAY FORWARD: BIDEN ADMINISTRATION ACTIONS TO INCREASE COVID-19 VACCINATIONS
Summary
Serial No. 117-12 prints the virtual hearing of the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce titled "Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations," dated Wednesday, March 17, 2021. Opening statements are listed for Hon. Diana DeGette, Hon. H. Morgan Griffith, Hon. Frank Pallone, Jr., and Hon. Cathy McMorris Rodgers. The witnesses are Rochelle P. Walensky, M.D., Director of the Centers for Disease Control and Prevention, Anthony S. Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases, and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research, Food and Drug Administration. The record includes answers to submitted questions from each witness.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
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[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:]
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