[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
PATHWAY TO A VACCINE: ENSURING A SAFE AND EFFECTIVE VACCINE PEOPLE WILL
TRUST
=======================================================================
VIRTUAL HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
__________
WEDNESDAY, SEPTEMBER 30, 2020
__________
Serial No. 116-128
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
56-467 PDF WASHINGTON : 2024
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois GREG WALDEN, Oregon
ANNA G. ESHOO, California Ranking Member
ELIOT L. ENGEL, New York FRED UPTON, Michigan
DIANA DeGETTE, Colorado JOHN SHIMKUS, Illinois
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 CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland PETE OLSON, Texas
JERRY McNERNEY, California DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice BILL JOHNSON, Ohio
Chair BILLY LONG, Missouri
DAVID LOEBSACK, Iowa LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon BILL FLORES, Texas
JOSEPH P. KENNEDY III, SUSAN W. BROOKS, Indiana
Massachusetts MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California RICHARD HUDSON, North Carolina
RAUL RUIZ, California TIM WALBERG, Michigan
SCOTT H. PETERS, California EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
------
Professional Staff
JEFFREY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
MIKE BLOOMQUIST, Minority Staff Director
Subcommittee on Oversight and Investigations
DIANA DeGETTE, Colorado
Chair
JAN SCHAKOWSKY, Illinois BRETT GUTHRIE, Kentucky
JOSEPH P. KENNEDY III, Ranking Member
Massachusetts, Vice Chair MICHAEL C. BURGESS, Texas
RAUL RUIZ, California DAVID B. McKINLEY, West Virginia
ANN M. KUSTER, New Hampshire H. MORGAN GRIFFITH, Virginia
KATHY CASTOR, Florida SUSAN W. BROOKS, Indiana
JOHN P. SARBANES, Maryland MARKWAYNE MULLIN, Oklahoma
PAUL TONKO, New York JEFF DUNCAN, South Carolina
YVETTE D. CLARKE, New York GREG WALDEN, Oregon (ex officio)
SCOTT H. PETERS, California
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. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, 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. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 10
Prepared statement........................................... 12
Witnesses
Mark McClellan, M.D., Ph.D., Founding Director, Duke-Margolis
Center For Health Policy Duke University....................... 14
Prepared statement........................................... 16
Answers to submitted questions............................... 123
Ali S. Khan, M.D., Dean, College of Public Health University of
Nebraska Medical Center........................................ 26
Prepared statement........................................... 28
Answers to submitted questions............................... 127
Paul A. Offit, M.D., Director, Vaccine Education Center,
Childrens Hospital of Philadelphia............................. 37
Prepared statement........................................... 39
Answers to prepared questions................................ 132
Helene Gayle, M.D., President and CEO, Co-Chair, Committee
Equitable Allocation Oo Vaccine for the Novel Coronavirus,
National Academies of Sciences, Engineering, and Medicine...... 42
Prepared statement........................................... 44
Answers to submitted questions............................... 134
Ashish K. Jha, M.D., Dean, School Of Public Health, Brown
University..................................................... 51
Prepared statement........................................... 53
Answers to submitted questions............................... 138
Submitted Material
Statement of September 29, 2020, ``Following the Science to
Protect Public Health in Pandemic,'' USA Today, submitted by
Ms. DeGette.................................................... 107
Report on July 1, 2020, COVID-19 Second Wave Preparedness Part 2:
Vaccines and Therapeutics, by the Energy and Commerce
Committee's, submitted by Mr. Walden \1\
Study on September 17, 2020, ``A Phase III Randomized, Double-
blind, Placebo-controlled Multicenter Study in Adults to
Determine the Safety, Efficacy, and Immunogenicity of AZD1222,
a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of
COVID-19,'' AstraZeneca AB, submittedd by Mr. Walden \2\
Study of September 15, 2020, ``A Randomized, Double-blind,
Placebo-controlled Phase 3 Study to Assess the Efficacy
andSafety of Ad26.COV2.S for the Prevention of SARS-CoV-2-
mediated COVID-19 in Adults Aged 18 Years and Older,'' Janssen
Vaccine and Prevention B.V., submitted by Mr. Walden \3\
Study of August 20, 2020, ``A Phase 3, Randomized, Stratified,
Observer-Blind, Placebo-Controlled Study to Evaluate the
Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2
Vaccine in Adults Aged 18 Years and Older Clinical Study
Protocol, Moderna,'' submitted by Mr. Walden\4\
Study ``A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-
Blind, Dose-Finding Study to Evaluate the Safety, Tolerability,
Immunogenicity, and Efficacy of SARS-Cov-2 Rna Vaccine
Candidates Against Covid-19 In Healthy Individuals,'' Pfizer,
submitted by Mr. Walden \5\
FDA Guidance of June 2020, ``Development and Licensure of
Vaccines to Prevent COVID-19,'' submitted by Mr. Walden\6\
Report of September 8, 2020, ``Biopharma Leaders Unite to Stand
with Science,'' Moderna, submitted by Mr. Walden............... 110
Washington Post op-ed from 7 former FDA Commissioners on the
Trump Administration undermining the credibility of the FDA
dated September 29, 2020, submitted by Ms. DeGette............. 115
Oxfam report on the world's COVID-19 vaccine supply dated
September 17, 2020, submitted by Ms. Schakowsky................ 118
----------
\1\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF02/
20200930/111063/HHRG-116-IF02-20200930-SD004.pdf.
\2\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF02/
20200930/111063/HHRG-116-IF02-20200930-SD010.pdf.
\3\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF02/
20200930/111063/HHRG-116-IF02-20200930-SD009.pdf.
\4\1AThe information has been retained in committee files and
also is available at https://docs.house.gov/meetings/IF/IF02/
20200930/111063/HHRG-116-IF02-20200930-SD008.pdf.
\5\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF02/
20200930/111063/HHRG-116-IF02-20200930-SD007.pdf.
\6\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF02/
20200930/111063/HHRG-116-IF02-20200930-SD005.pdf.
PATHWAY TO A VACCINE: ENSURING A SAFE AND EFFECTIVE VACCINE PEOPLE WILL
TRUST
----------
WEDNESDAY, SEPTEMBER 30, 2020
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:34 a.m., via
Cisco Webex online video conferencing, Hon. Diana DeGette
(chairman of the subcommittee) presiding.
Members present: Representatives DeGette, Schakowsky,
Kennedy, Ruiz, Kuster, Castor, Sarbanes, Tonko, Clarke, Peters,
Pallone (ex officio), Guthrie, McKinley, Griffith, Brooks,
Mullin, Duncan, and Walden (ex officio).
Also present: Representatives O'Halleran, Dingell, Bucshon,
Carter, and Bilirakis.
Staff present: Kevin Barstow, Chief Oversight Counsel;
Jesseca Boyer, Professional Staff Member; Jeffrey C. Carroll,
Staff Director; Austin Flack, Staff Assistant; Waverly Gordon,
Deputy Chief Counsel; Perry Hamilton, Deputy Clerk; Chris
Knauer, Oversight Staff Director; Joe Orlando, Policy Analyst;
Kaitlyn Peel, Digital Director; Tim Robinson, Chief Counsel;
Benjamin Tabor, Policy Analyst; C.J. Young, Press Secretary;
Mike Bloomquist, Minority Staff Director; S.K. Bowen, Minority
Press Secretary; Brittany Havens, Minority Professional Staff,
Oversight and Investigations; Peter Kielty, Minority General
Counsel; Ryan Long, Minority Deputy Staff Director; Clare
Paoletta, Minority Policy Analyst, Health; Alan Slobodin,
Minority Chief Investigative Counsel, Oversight and
Investigations and Everett Winnick, Minority Director of
Information Technology.
Ms. DeGette. The Subcommittee on Oversight and
Investigations hearing will now come to order.
Today, the Subcommittee on Oversight and Investigations is
holding a hearing entitled, Pathway to a Vaccine: Ensuring a
Safe and Effective Vaccine People Will Trust. The purpose of
today's hearing is to examine the safety, efficacy, and
accessibility of prospective COVID-19 vaccines.
Due to the COVID-19 vaccine emergency, today's hearing is
being held remotely. All members and staff will be
participating via video conferencing, and as part of our
proceeding, microphones will be set on mute for the purposes of
eliminating inadvertent background noise. Members and
witnesses, you will need to unmute your microphone any time you
speak.
If at any time during the hearing, I'm unable to chair the
hearing, the chairman of the full committee, Chairman Pallone,
or the vice chairman of the committee, Congressman Kennedy,
will serve as chair until I'm able to return.
Documents for the record can be sent to Benjamin Tabor at
the email address we've provided to staff. All documents will
be entered into the record at the conclusion of the hearing.
The Chair will now recognize herself for an opening
statement.
OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Today, the Energy and Commerce Committee continues its
oversight of the Nation's COVID-19 pandemic response, examining
the pursuit of a safe and effective COVID-19 vaccine that the
American people can trust.
In the eight months that we've battled COVID-19, over 7
million Americans have had the virus, and, tragically, over
200,000 of them have lost their lives. Millions of people face
unemployment and have lost their health insurance, and families
are still juggling childcare and virtual classrooms.
The list of those most vulnerable to COVID-19 is
especially--especially on the line as the virus continues to
spread around the country. We know that a safe and effective
and trusted COVID-19 vaccine will be a critical tool to stem
this pandemic. I believe that I am joined by everybody in this
hearing and everybody in this country in hoping that a vaccine
is available as quickly as possible.
This summer, we held a hearing with five of the leading
companies who are working to develop a COVID-19 vaccine. The
companies assured us that while the pace of the vaccine is
really unprecedented, safety and science are not going to be
sacrificed for speed.
Last month, these companies joined four other manufacturers
in a rare joint pledge, stating that they would stand with
science and not put forward a vaccine until it had been
thoroughly vetted. Honoring this commitment will be critical as
the future success of a COVID-19 vaccine depends on the
American public's confidence that it will be safe and
effective.
Alarmingly, the public's trust in a future COVID-19 vaccine
has declined dramatically in just a few months. Nearly two-
thirds of Americans worry that political pressure will rush
approval of a COVID-19 vaccine, and more than half say that
even if it were free, they would not get vaccinated before
election day.
One does not have to search far to find the source of the
public's distrust. Time and again throughout the pandemic, the
Trump administration has politicized science, undermining its
own public health experts at every turn. And in fact, just last
night in yesterday's Presidential debate meltdown, President
Trump called the process a, quote, very political thing.
The White House and the HHS leadership have interfered with
CDC guidance and other scientific publications for political
purpose. The White House has publicly pressured FDA to issue
emergency use authorizations for prospective COVID-19
treatments, despite objections from FDA scientists.
And the President, unfortunately, has attacked the
credibility of his own public health leaders. For example, just
hours after CDC Director Redfield testified on the
effectiveness of wearing face coverings and the potential
timeline for a vaccine, President Trump told the press that Dr.
Redfield was, quote, confused, and had made, quote, a mistake.
The President has politicized the pursuit of a COVID-19
vaccine repeatedly by claiming it will be available in October
before a, quote, special day, obviously referring to election
day, and he did that again last night. The President has even
accused his own FDA of being part of the, quote, Deep State,
suggesting it was slow-walking a vaccine to hurt his political
prospects. And just last week, following that--reports that the
FDA would be publishing additional standards for emergency use
authorization of a COVID-19 vaccine, President Trump falsely
claimed that the guidance was politically driven. The reported
guidance was praised by external experts, but it may not ever
see the light of the day because of the President's political
whims.
The committee, this committee, the Oversight Subcommittee,
has been sounding the alarm on the administration's dangerous
politicization of science for months. And frankly, we're not
alone in our concern.
Last week, the National Academy of Medicines and Sciences
took the unusual step of issuing a statement warning that the
repeated politicization of science, quote, undermines the
credibility of public health agencies and the public's
confidence in them at a time when we need most.
Fortunately, as we will hear from our witnesses, there are
ample reasons to be optimistic. The search for a COVID-19
vaccine is, and will continue to be, driven by science, and I
believe there are steps that we can take to restore the
American public's confidence.
Namely, the administration must allow the career scientists
at the FDA to do their jobs free from political interference,
such as allowing the time necessary to conduct robust review of
clinical trial findings. And it must let FDA release the
additional standards for emergency use authorization of a
COVID-19 vaccine once it's developed.
All of us on this committee, Democrats and Republicans, are
rooting for a safe, effective, and trusted COVID-19 vaccine,
accessible to all Americans, and we will continue our oversight
until these goals are met. We will also continue to call for a
comprehensive COVID-19 vaccine plan.
I look forward to hearing from the panel today. Hopefully,
our wonderful experts can help guide us on ways to ensure that
the public has full confidence in a COVID-19 vaccine once it's
made available. I also hope that they can provide additional
solutions and suggest guardrails that will ensure that science
and not politics guides the way, because the health of our
Nation depends on it.
[The prepared statement of Ms. DeGette follows:]
Prepared Statement of Hon. Diana DeGette
Today, the Energy and Commerce Committee continues its
oversight of the nation's COVID-19 pandemic response, examining
the pursuit of a safe and effective COVID-19 vaccine that the
American people can trust.
In the eight months we have battled COVID-19, over seven
million Americans have had the virus and more than 200,000 of
them have lost their lives.
Millions of people face unemployment and have lost their
health insurance, and families are juggling childcare and
virtual classrooms. The lives of those more vulnerable to
COVID-19 are especially on the line as the virus continues to
spread around the country.
We know a safe, effective, and trusted COVID-19 vaccine
will be a critical tool to contain this pandemic. I believe I
am joined by everyone in hoping that such a vaccine is
available as soon as feasible.
This summer, we held a hearing with five of the leading
companies who are working to develop a COVID-19 vaccine.The
companies assured us that, while the pace of vaccine
development is unprecedented, safety and science are not being
sacrificed for speed.
Last month, these companies joined four other manufacturers
in a rare joint pledge stating they would ``stand with
science'' and not put forward a vaccine until it had been
thoroughly vetted. Honoring this commitment will be crucial as
the future success of a COVID-19 vaccine depends on the
American people having confidence that it is safe and
effective.
Alarmingly, the public's trust in a future COVID-19 vaccine
has declined dramatically in just a few months.
Nearly two-thirds of Americans worry that political
pressure will rush approval of a COVID-19 vaccine and more than
half say that even if it were free, they would not get
vaccinated before Election Day.
One doesn't have to search far to find the source of the
public's distrust. Time and again throughout the pandemic, the
Trump Administration has politicized science, undermining its
own public health experts at every turn.
The White House and HHS leadership have reportedly
interfered with CDC guidance and other scientific publications
for political purposes. The White House has publicly pressured
FDA to issue emergency use authorizations for prospective
COVID-19 treatments, despite objections from FDA scientists.
And, the President has attacked the credibility of his own
public health leaders. For example, just hours after CDC
Director Redfield testified on the effectiveness of wearing
face coverings and the potential timeline for a vaccine,
President Trump told the press that Dr. Redfield was
``confused'' and had made ``a mistake.''
The President has politicized the pursuit of a COVID-19
vaccine by repeatedly claiming it will be available in October,
before, a ``special date,'' obviously referring to Election
Day.
The President has even accused his own FDA of being part of
the [quote] ``deep state'' suggesting it was slow walking a
vaccine to hurt his political prospects.
And, just last week, following reports that FDA would be
publishing additional standards for emergency use authorization
of a COVID-19 vaccine, President Trump falsely claimed that the
guidance was politically driven. The reported guidance was
praised by external experts, but it may never see the light of
day-all because of President Trump's political whims.
The Committee has been sounding the alarm on the
Administration's dangerous politicization of science for
months, and we are not alone in our concern.
Last week, the National Academies of Medicine and Sciences
took the unusual step of issuing a statement warning that the
repeated politicization of science ``undermines the credibility
of public health agencies and the public's confidence in them
when we need it most.''
Fortunately, as we'll hear from our witnesses, there are
reasons to be optimistic that the search for a COVID-19 vaccine
is, and will continue to be, driven by science. And, there are
steps we can take to restore the American people's trust in a
COVID-19 vaccine.
Namely, this Administration must allow career scientists at
FDA do their jobs free from political interference--such as
allowing the time necessary to conduct robust review of
clinical trial findings. And it must let FDA release the
additional standards for emergency use authorization of a
COVID-19 vaccine it has already developed.
The Committee is rooting for a safe, effective, and trusted
COVID-19 vaccine that is accessible to all Americans, and we
will continue to conduct oversight to ensure these goals are
met. We will also continue to call for a comprehensive COVID-19
vaccine plan--something the Trump Administration has failed to
develop in the four months since this Committee first urged
them to do so.
I look forward to hearing from our panel today. Hopefully,
these experts can help guide us on ways to ensure that the
public has full confidence in a COVID-19 vaccine once it is
made available. I hope they can also provide additional
solutions and suggest guardrails that will ensure that science,
and not politics, guide the way.
The health of our nation depends on it.
Ms. DeGette.And now I'm very pleased to recognize our
ranking member, Mr. Guthrie, for 5 minutes, for the purposes of
an opening statement.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEATH OF KENTUCKY
Mr. Guthrie. Thank you, Chair DeGette, for holding this
important hearing about the COVID-19 vaccine pathway.
Ultimately, it will be a vaccine that offers us the best
chance to finally end this pandemic, allowing our Nation to
fully reopen. But it is not just the vaccine itself. In
addition to an improved or authorized vaccine, we will need
widespread acceptance, distribution, and immunization to
successfully combat this virus.
The purpose of this bipartisan hearing should be to
increase public confidence in the Food and Drug Administration
and its processes for authorizing and approving vaccines
through science-based decisions that are there--that there is
greater vaccine acceptance and confidence among Americans.
Congress, through this committee, created the emergency use
authorization pathway as part of Project BioShield Act in 2004,
and later expanded that pathway in the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 on a bipartisan basis.
Through those efforts, we provided special authority to the FDA
to be used in a public health emergency prior to a full
approval when the scientific evidence is available to support
such use.
To receive an emergency use authorization, or EUA, a drug
company must demonstrate that based on the total totality of
scientific evidence, the drug's known or unknown potential
benefits outweigh the known and potential risks. The FDA can
apply that standard appropriately to different settings, such
as requiring more rigorous evidence for treatments used on
healthier populations than for seriously ill, hospitalized
patients.
For COVID-19 vaccines, the FDA has announced it is using an
``EUA-plus approach'' through a guidance setting, a much more
stringent standard than for other EUAs. Unfortunately, I have
grave concerns that some are trying to score political points
by irresponsibly criticizing the FDA and its vaccine review and
approval process, potentially undermining trust in the FDA-
authorized vaccine, especially during this global pandemic and
national health emergency.
It is understandable in this politicized environment that
many in the public would be concerned or confused about the
vaccine development and approval process, whether the corners
are being cut and whether these unfounded--with these unfounded
criticisms circulating.
The truth of the matter is that the review and approval
stages of the vaccine will be controlled throughout the process
by nonpolitical, independent, scientific experts, not
politicians. The data produced during the vaccine clinical
trials are reviewed and evaluated by a Data Safety Monitoring
Board, which is composed of independent scientific experts. In
addition, there is an FDA Vaccines and Related Biological
Products Advisory Committee, composed of independent leading
medical experts, who are expected to review and evaluate data
on the vaccines in public meetings.
Indeed, even Congress has contributed getting assurances on
a scientific decision from the FDA. It was this committee's
full committee hearing in June and other committee hearings
over the past few months where Congress and the American people
received assurances from FDA Commissioner Stephen Hahn that he
would support his career scientists and the FDA would not cut
corners on the safety or efficacy of COVID-19 vaccines.
The intense scrutiny has led to other extraordinary pledges
from the highly respected public health officials. Dr. Peter
Marks, the director of FDA's Center for Biologics, said he will
resign his position if the FDA were to green-light an unproven
coronavirus vaccine. In addition, the director of National
Institutes of Health, Dr. Francis Collins, and the director of
National Institute of Allergy and Infectious Diseases, Dr.
Anthony Fauci, have said they will only back a vaccine that has
science behind it.
Further, nine drug companies have already pledged they will
not submit vaccine candidates for FDA review until their safety
and efficacy is shown in large clinical trials. In addition,
each of the four companies who are now in Phase 3 clinical
trials have published their clinical trial protocols.
For vaccine distribution, two independent committees will
provide guidance: the National Academies of Science and
Engineering and Medicine, and CDC's Advisory Committee on
Immunization Practices.
I urge each of us to put politics aside--I know we're a few
weeks from election, but put politics aside in order to deliver
one unified, life-saving message, that Americans can trust the
FDA's vaccine approval process, and it will be driven by the
science and will result in science-based decisions.
And, lastly, a reminder for everybody to get your flu shot.
It has been--this year, it will be more important than ever.
I've already received my flu shot.
I look forward to the testimony from these esteemed
witnesses and welcome them to this hearing. And I yield back.
[The prepared statement of Mr. Guthrie follows:]
Prepared Statement of Hon. Brett Guthrie
Thank you, Chair DeGette, for holding this important
hearing about the COVID-19 vaccine pathway.
Ultimately, it will be a vaccine that offers us the best
chance to finally end this pandemic, allowing our nation to
fully reopen. But it is not just the vaccine itself. In
addition to an approved or authorized vaccine, we will need
widespread acceptance, distribution, and immunization to
successfully combat this virus.
The purpose of this bipartisan hearing should be to
increase public confidence in the U.S. Food and Drug
Administration (FDA) and its process for authorizing and
approving vaccines through science-based decisions so that
there is greater vaccine acceptance and confidence among
Americans.
Congress, through this Committee, created the emergency-use
authorization pathway as part of the Project BioShield Act in
2004, and later expanded that pathway in the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013 on a
bipartisan basis. Through those efforts, we provided special
authority to FDA to be used in a public health emergency prior
to a full approval, when the scientific evidence is available
to support such a use.
To receive an Emergency Use Authorization (EUA), a drug
company must demonstrate, that based on the totality of
scientific evidence the drug's known or potential benefits
outweigh the known and potential risks. The FDA can apply that
standard appropriately to different settings, such as requiring
more-rigorous evidence for treatments used on healthier
populations than for seriously ill hospitalized patients. For
COVID-19 vaccines, the FDA has announced it is using an ``EUA
plus approach,'' through a guidance setting a much more
stringent standard than for other EUAs.
Unfortunately, I have grave concerns that some are trying
to score political points by irresponsibly criticizing the FDA
and its vaccine review and approval process, potentially
undermining trust in an FDA-authorized vaccine, especially
during this global pandemic and national health emergency. It
is understandable in this politicized environment that many in
the public would be concerned or confused about the vaccine
development and approval process and whether corners are being
cut with these unfounded criticisms circulating.
The truth of the matter is that the review and approval
stages of the vaccine will be controlled throughout the process
by non-political, independent, scientific experts, not
politicians. The data produced during the vaccine clinical
trials are reviewed and evaluated by a Data Safety Monitoring
Board, which is composed of independent scientific experts.
In addition, there is an FDA Vaccines and Related
Biological Products Advisory Committee composed of independent,
leading medical experts who are expected to review and evaluate
data on the vaccines in public meetings.
Indeed, even Congress has contributed to getting assurances
on a science-based decision from the FDA. It was this
Committee's full Committee hearing in June, and other Committee
hearings over the past few months, where Congress and the
American people received assurances from FDA Commissioner
Stephen Hahn that he would support his career scientists and
that FDA would not cut corners on the safety or efficacy of
COVID-19 vaccines.
The intense scrutiny has led to other extraordinary pledges
from highly respected public health officials. Dr. Peter Marks,
the Director of FDA's Center for Biologics, said that he will
resign his position if the FDA were to green light an unproven
coronavirus vaccine. In addition, the Director of the National
Institutes of Health, Dr. Francis Collins, and the Director of
the National Institute of Allergy and Infectious Diseases, Dr.
Anthony Fauci, have said they will only back a vaccine that has
the science behind it.
Further, nine drug companies have already pledged that they
will not submit vaccine candidates for FDA review until their
safety and efficacy is shown in large clinical trials. In
addition, each of the four companies who are now in Phase 3
clinical trials have published their clinical trial protocols.
For vaccine distribution, two independent committees will
provide guidance: The National Academies of Sciences,
Engineering and Medicine; and CDC's Advisory Committee on
Immunization Practices.
I urge each of us to put politics aside in order to deliver
one unified, life-saving message that Americans can trust that
the FDA's vaccine approval process and that it will be driven
by the science and will result in a science-based decision.
And lastly, a reminder for everybody to get your flu shot.
It has never been more important.
I look forward to the testimony from these esteemed
witnesses and welcome them to this hearing. I yield back.
Ms. DeGette. I thank the gentleman.
I got my flu shot too, and I echo what you say, everybody
should get their flu shot.
The Chair will now 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, Chairwoman DeGette.
Today we're going to hear from some of the Nation's leading
public health experts on one tool that could help put an end to
the pandemic and the suffering, and that's a safe, effective,
and trusted COVID-19 vaccine. And I'm pleased that you're all
with us today so that expertise and science have their rightful
place in these discussions.
We all want a COVID-19 vaccine to be developed as soon as
possible, but first and foremost, we must confirm that it's
safe and effective, and we must ensure it is trusted and
accessible to all who need it. But as I said in our July
hearing with vaccine manufacturers, my fear is that the Trump
administration might force the FDA to approve a vaccine before
proven to be safe and effective in an effort to boost the
President's political fortunes. I hope that doesn't happen, and
I'm grateful that career FDA officials have repeatedly stated
the importance of putting science first.
Now, let me just say that since January, the President has
consistently placed politics over science in the Nation's COVID
response, and he's undermined, in my opinion, the independence
and integrity of our public health agencies and scientific
experts. His words have created confusion amongst the American
people, eroding their trust in our public health institutions,
and so it's little wonder that polling now shows the public
trust in the future COVID-19 vaccine has declined drastically
over the past few months. That's why we have to build back the
confidence of the American people as we work to ensure a safe
and effective vaccine is developed.
Now, we're going to probably vote on an updated HEROES Act
that was introduced yesterday, and included in that is a
billion dollars in funding for an evidence-based, public
awareness campaign to outline the importance of vaccine and
combat misinformation, some of which is unfortunately coming
from the President.
In this new bill, updated HEROES Act, there is also $20
billion added to authorize the Secretary to provide grants or
contracts for vaccine and therapeutic development; $7 billion
to conduct activities to enhance, expand, and improve vaccine
distribution and administration; and also, language to provide
grants to State and local public health departments for
procurement of vaccines and data and facility enhancements.
And I would also remind everyone that the HEROES Act, as
will this updated HEROES Act, provides free treatment, drugs,
and vaccine with no copay, similar policy that we had in CARES
for testing and contact tracing with, you know, free testing,
in this case free vaccine, and no copay.
Now, of course, I regret that Mitch McConnell and President
Trump have not--I mean, really stood in the way of the HEROES
Act that the House passed back in May, and I continue to call
on Mitch McConnell and the President to come to the table to
negotiate real help. And maybe, you know, hope springs eternal,
maybe before we leave this week, we will have a consensus bill
to follow up on the CARES Act that has this language and
funding for vaccines that I just mentioned. But, unfortunately,
what we continue to see from this administration is political
calculations and not science guiding its decisions.
And now, of course, the Trump administration is attacking a
potential COVID vaccine in court because they want to strike
down the Affordable Care Act, and they have asked the Supreme
Court to do that. And remember, the ACA requires that health
insurance plans cover all recommended vaccines without cost-
sharing for patients. So if it's struck down, then we'll lose
access to healthcare, including a potential vaccine for those
who lose their coverage under the ACA. And that, to me, is an
outrage.
So I look forward to hearing from the witnesses today.
While I think the Trump administration's actions, if left
unchecked, could actually hamper the effort to develop and
administer a successful COVID vaccine, so for that reason, I
hope our witnesses can advise the panel on what guardrails they
hope to see in place to keep that from happening. That's one of
the main reasons I want to hear from all of you, to see what
you think we can do to prevent a situation where we don't have
a safe and effective vaccine, people don't want to take it, all
the other concerns that I've expressed.
So thank you, again, Madam Chair, and I yield back.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
Today, we will hear from some of the nation's leading
public health experts on one tool that could help put an end to
the pandemic and the suffering--a safe, effective, and trusted
COVID-19 vaccine. I am pleased that you are all with us today
so that expertise and science have their rightful place in
these discussions.
We all want a COVID-19 vaccine to be developed as soon as
possible. First and foremost, we must confirm that it is safe
and effective. And we must ensure it is trusted and accessible
to all who need it.
But as I said in our July hearing with vaccine
manufacturers, my fear is that the Trump Administration might
force the Food and Drug Administration (FDA) to approve a
vaccine before proven to be safe and effective, in an effort to
boost the President's political fortunes.
I hope this does not happen, and I am grateful that career
FDA officials have repeatedly stated the importance of putting
science first.
But, since January, President Trump has consistently placed
politics over science in the nation's COVID-19 response,
undermining the independence and integrity of our public health
agencies and scientific experts.
His words have created confusion among the American people,
eroding their trust in our public health institutions. It is
little wonder then that polling shows that public trust in a
future COVID-19 vaccine has declined drastically over the past
few months.
That is why we must build back the confidence of the
American people as we work to ensure a safe and effective
vaccine is developed.
In the updated Heroes Act introduced earlier this week, we
included funding for an evidence-based public awareness
campaign to outline the importance of vaccines and combat
misinformation-some of which is unfortunately coming from the
President himself.
In this new bill, there's also $20 billion to authorize the
Secretary to provide grants for vaccine and therapeutic
development, $7 billion to conduct activities to enhance,
expand and improve vaccine distribution and administration and
also language to provide grants to state and local public
health departments for procurement of vaccines, public health
data and facility enhancement.
I would also remind everyone that the updated Heroes Act
provides free treatment, drugs and vaccines, which builds on a
similar policy that we included in the CARES Act.
While I regret that Mitch McConnell and President Trump
have stood in the way of the Heroes Act, which the House passed
in May, I continue to call on Mitch McConnell and President
Trump to come to the table to negotiate real help for American
families and our public health system.
Unfortunately, in addition to blocking relief for families
and fueling concerns that political calculations--and not
science--guide its decisions, the Trump Administration is
attacking access to a potential COVID-19 vaccine in court. As
you know, Madam Chair, the Affordable Care Act required that
health insurance plans cover all recommended vaccines without
cost sharing for patients.
Should the ACA be struck down completely, as the
Administration is trying to do at the Supreme Court in just a
few weeks, millions of American families will lose access to
health care, including a potential COVID-19 vaccine. This is a
national outrage that should concern all Members of this
Committee.
I look forward to hearing from the witnesses today. While I
think the Trump Administration's actions, if left unchecked,
could actually hamper the effort to develop and administer a
successful COVID-19 vaccine, I hope our witnesses can advise
the panel on what guardrails they hope to see in place to keep
that from happening.
Thank you, I yield back.
Ms. DeGette. The Chair now is pleased to recognize the
ranking member of the full committee, Mr. Walden, for 5
minutes.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you very much, Chair DeGette, and I
appreciate you having this hearing.
Americans should have high confidence that any COVID-19
vaccine that's approved or authorized by the U.S. Food and Drug
Administration, the FDA, will have gone through the most
rigorous, independent, and transparent trials, testing and
review in the world.
In fact, the scientific and public attention focused on
COVID-19 vaccine's process is itself unprecedented. For
example, FDA has issued rigorous guidance for these vaccines,
and each of the Phase 3 trials is enrolling at least 30,000
participants.
In addition, the FDA has multiple existing safeguards in
place to ensure science-based decisions. These include
standards for the vaccine review process, the emergency use
authorization review process, and the necessary evidence
required to receive an approval that meets FDA's gold standard.
Further, there are multiple safeguards outside of the FDA.
For example, each of the Phase 3 trials will be overseen by the
Data and Safety Monitoring Board, the DSMB. Now, that's an
independent, multidisciplinary group, which includes
individuals who are experienced with clinical trials,
biostatisticians, bioethicists, immunologists, vaccinologists,
and virologists.
The purpose of the DSMB is to oversee and monitor clinical
trials to ensure participant safety and validity and the
integrity of the data. In addition, all four companies in Phase
3 trials have published their clinical trial protocols to
provide even more transparency. There are also independent
experts who serve on an FDA advisory committee who will
scrutinize safety and efficacy data of the vaccine candidates.
The evidence required of these vaccines is consistent with
the FDA's gold standard and has made the vaccine supply in the
U.S. reliable, safe, and effective.
Separately, the U.S. Centers for Disease Control and
Prevention, the CDC, Advisory Committee on Immunization
Practices, or ACIP, is comprised of medical and public health
experts who are responsible for developing recommendations on
the use of FDA-approved vaccines for Americans, including how,
when, and to whom a vaccine should be given.
It's critical that a life-saving, approved coronavirus
vaccine gets to those most at risk to this deadly virus and
without delay, once the FDA's independent scientists have
cleared it for safety and for efficacy. However, some States
now have indicated that they plan to withhold distribution of
vaccines while they conduct their own unprecedented review of
the data. I think that potentially risks the lives of their own
citizens.
It will be the first time some of these governors have done
that. Such reckless actions dangerously undermine the FDA. They
lead to greater vaccine hesitancy, delay, and obstruct vaccine
distribution. They create public confusion with inaccurate and
misleading information about vaccine safety and efficacy, and
worst of all, they will jeopardize American lives.
These States have not provided any evidence of any
expertise to conduct such a review, nor have they cited any
legal authority to prevent their citizens from accessing a
vaccine approved by the FDA, especially during a national
public health emergency.
The scientific collaboration throughout the COVID-19
vaccine research and development effort is extraordinary. That
collaboration must continue through the complex vaccine
distribution process, including the appropriate prioritization
for distribution and all the logistics involved in distributing
an approved or authorized vaccine.
American scientists are making remarkable progress toward a
COVID-19 vaccine. Experts such as Dr. Anthony Fauci are
optimistic that these efforts will lead to a life-saving
vaccine that will benefit public health in our country and
around the world. So, it's essential that all of us involved in
public policy in this space stick to the facts and not falsely
denigrate those doctors, scientists, and public health
officials who are working around the clock to save lives.
Madam Chair, in addition, I'd like to ask unanimous consent
request to submit some documents for the record.
The Energy and Commerce Committee Republicans have worked
over the last several months to develop recommendations to
address an uptick in cases or a potential second wave of COVID-
19 infections in the U.S. The results of these efforts released
a series of working documents, and I've asked unanimous consent
to include the vaccine and therapeutic second-wave document
that we just released in July into the record.
In addition----
Ms. DeGette. As noted, this will happen at the end of the
hearing.
Mr. Walden. OK. In addition, I ask the following documents
be entered into the record. First, the clinical trial protocols
recently released by Moderna, Pfizer, AstraZeneca, and Janssen.
Second, the letter signed by nine companies developing COVID-19
vaccines, pledging to uphold the integrity of the scientific
process. Third, the FDA Guidance for Industry with
recommendations for entities developing COVID-19 vaccines with
the goal of licensing the vaccine candidate which was released
in June. And fourth, the pledge by senior FDA career executives
to follow the science to protect public health in the pandemic.
And I understand these documents have already been shared
with the majority and at the appropriate time would ask that
they all be entered into the record.
Ms. DeGette. They sound great to me, and we'll do it at the
end of the hearing. Thank you.
Mr. Walden. All right. And with that, Madam Chair, thanks
again for the hearing, and I yield back the balance of my time.
[The prepared statement of Mr. Walden follows:]
Prepared Statement of Hon. Greg Walden
Americans should have high confidence that any COVID-19
vaccine that is approved or authorized by the U.S. Food and
Drug Administration (FDA) will have gone through the most
rigorous, independent and transparent trials, testing and
review in the world.
In fact, the scientific and public attention focused on the
COVID-19 vaccine process is itself unprecedented. For example,
FDA has issued rigorous guidance for these vaccines, and each
of the Phase 3 trials are enrolling at least 30,000
participants. In addition, FDA has multiple existing safeguards
in place to ensure science-based decisions. These include
standards for the vaccine review process, the Emergency Use
Authorization review process, and the necessary evidence
required to receive an approval that meets FDA's gold standard.
Further, there are multiple safeguards outside of FDA. For
example, each of the Phase 3 trials will be overseen by the
Data and Safety Monitoring Board (DSMB). The DSMB is an
independent, multidisciplinary group which includes individuals
who are experienced with clinical trials, biostatisticians,
bioethicists, immunologists, vaccinologists, and virologists.
The purpose of the DSMB is to oversee and monitor clinical
trials to ensure participant safety and the validity and
integrity of the data. In addition, all four companies in Phase
3 trials have published their clinical trial protocols to
provide even more transparency.
There are also independent experts who serve on an FDA
Advisory Committee who will scrutinize safety and efficacy data
of the vaccine candidates. The evidence required for these
vaccines is consistent with the FDA's gold standard that has
made the vaccine supply in the U.S. reliable, safe, and
effective.
Separately, the U.S. Centers for Disease Control and
Prevention (CDC) Advisory Committee on Immunization Practices
(ACIP) is comprised of medical and public health experts who
are responsible for developing recommendations on the use of
FDA approved vaccines for Americans, including how, when, and
to whom a vaccine should be given.
It is critical that a life-saving, approved coronavirus
vaccine gets to those most at risk to this deadly virus without
delay once the FDA's independent scientists have cleared it for
safety and efficacy.
However, some states have indicated that they plan to
withhold distribution of vaccines while they conduct their own,
unprecedented reviews of the data, potentially risking the
lives of their own citizens.
Such reckless actions dangerously undermine the FDA, lead
to greater vaccine hesitancy, delay and obstruct vaccine
distribution, create public confusion with inaccurate and
misleading information about vaccine safety and efficacy, and
worst of all, jeopardize American lives.
These states have not provided any evidence of any
expertise to conduct such a review nor have they cited any
legal authority to prevent their citizens from accessing a
vaccine approved by the FDA, especially during a national
public health emergency.
The scientific collaboration throughout the COVID-19
vaccine research and development effort is extraordinary. That
collaboration must continue through the complex vaccine
distribution process, including the appropriate prioritization
for distribution and all the logistics involved in distributing
an approved or authorized vaccine.
American scientists are making remarkable progress towards
a COVID-19 vaccine. Experts such as Dr. Anthony Fauci are
optimistic that these efforts will lead to a life-saving
vaccine and will benefit public health in our country and the
world.
It is essential that all of us involved in public policy in
this space stick to the facts and not falsely denigrate those
doctors, scientists and public health officials who are working
around the clock to save lives.
Ms. DeGette. I thank the ranking member.
The Chair asks unanimous consent that the members' written
opening statements be made part of the record, and without
objection, they will be entered into the record.
I'd now like to introduce our witnesses for today's
hearing. Dr. Mark McClellan, who is the former commissioner of
the Food and Drug Administration and founding director of Duke-
Margolis Center for Health Policy at Duke University; Dr. Ali
S. Khan, dean of the public health center at the University of
Nebraska Medical Center; Dr. Paul Offit, director of the
Vaccine Education Center at the Children's Hospital in
Philadelphia; Dr. Helene Gayle, co-chair of the National
Academies of Sciences, Engineering, and Medicine's Committee on
Equitable Allocation of Vaccine for the Novel Coronavirus; and
Dr. Ashish K. Jha, dean of the School of Public Health at Brown
University.
I really want to thank all of you for joining us today in
this really important hearing. And I know all of you have been
advised by staff. The committee is holding an investigative
hearing, and when doing so, we have the practice of taking
testimony under oath. Do you have any objections to testifying
under oath?
Seeing no objection, let the record reflect that the
witnesses have responded no.
The Chair then advises you that under the rules of the
House and the rules of the committee, you're entitled to be
accompanied by counsel. Does any of you desire to be
accompanied by counsel today?
Let the record reflect that the witnesses have reflected
no.0
So if you would, please raise your right hand so I may
swear you in.
Do you swear that the testimony you're about to give is the
truth, the whole truth, and nothing but the truth?
Let the record reflect the witnesses have responded
affirmatively.
All of you are now under oath and subject to the penalties
set forth in Title 18, Section 1001 of the United States Code.
We'd now like to recognize our witnesses for a 5-minute
summary of their written statement. There's a timer on your
screen, you can see it, and it will count down your time. It
will turn red when your 5 minutes has come to an end.
And so I'd like to first recognize you, Dr. McClellan, for
5 minutes.
TESTIMONY OF DR. MARK MCCLELLAN, M.D., PH.D., FOUNDING
DIRECTOR, DUKE-MARGOLIS CENTER FOR HEALTH POLICY DUKE
UNIVERSITY; DR. ALI S. KHAN, M.D., MPH, MBA, DEAN, COLLEGE OF
PUBLIC HEALTH UNIVERSITY OF NEBRASKA MEDICAL CENTER; DR. PAUL
A. OFFIT, M.D., DIRECTOR, VACCINE EDUCATION CENTER, CHILDRENS
HOSPITAL OF PHILADELPHIA; DR. HELENE GAYLE, M.D., MPH, CO-
CHAIR, COMMITTEE ON EQUITABLE ALLOCATION OF VACCINE FOR THE
NOVEL CORONAVIRUS, NATIONAL ACADEMIES OF SCIENCES, ENGINEERING,
AND MEDICINE; AND DR. ASHISH K. JHA, M.D., MPH, DEAN, SCHOOL OF
PUBLIC HEALTH, BROWN UNIVERSITY
STATEMENT OF MARK McCLELLAN, M.D.
Dr. McClellan. Chair DeGette, Ranking Member Guthrie, and
members of the subcommittee, I'm Mark McClellan, director of
the Duke-Margolis Center for Health Policy. I previously had
the privilege to serve as Commissioner of the FDA from 2002 to
2004, and I also serve on the board of directors of Johnson &
Johnson.
The development of a safe and effective vaccine, in
conjunction with other treatments and nonmedical measures like
masks and testing, represents our best path for containing and
moving beyond the pandemic. The impact of a vaccine depends on
its safety and effectiveness and also on public confidence in
the vaccine.
Guided by the healthcare providers they trust, Americans
will need to choose to get a vaccine to protect themselves and
reduce the spread to people around them. Critical to achieving
the benefits of safe and effective vaccination are actions of
our Federal Government, public health scientists, and
regulators, in particular, the expert staff of the FDA. The FDA
has set the global gold standard on issues of medical product
safety and effectiveness and has unparalleled experience and
expertise in regulating vaccines that are used safely and
effectively by hundreds of millions of Americans.
Throughout my career, I've experienced the firsthand--I
have firsthand experienced the integrity, expertise, and
commitment of the FDA's career staff, particularly in
responding to public health emergencies. The vaccine experts in
the Biologics Center are globally respected for their decades
of experience in overseeing all aspects of vaccine development,
manufacturing, and post-market monitoring.
I appreciate the FDA staff's explicit commitments to the
public that these processes are followed, FDA's approach to
COVID, vaccines as part of a well developed system of
independent checks that have been put in place over decades to
build a reliable and robust infrastructure for assuring vaccine
safety and effectiveness.
There's great urgency in a pandemic. Speed matters, given
the lives being lost daily. During my time as FDA Commissioner,
we worked on a bipartisan basis with this committee to enact
FDA's authority for emergency use authorization, which has
since been used and augmented based on experience with the H1N1
pandemic.
The administration deserves credit for the work of
Operation Warp Speed, which has led to extraordinary progress
in advancing multiple promising vaccines, converting what's
typically a long and uncertain, sequential development process
to a much shorter parallel process, including conducting
clinical trials at scale at the same time as scaling up
manufacturing.
The assurance of clinical safety and effectiveness as part
of these steps is imperative, including if an emergency use
authorization is applied. The FDA has provided industry and
researchers with early and frequent guidance in this process,
including written guidance documents for preclinical and
clinical development, as well as safe manufacturing practices.
Some recent statements from the White House have implied
that FDA's plan to release additional written guidance on its
expectations for EUA of a vaccine is unnecessarily raising the
bar. That's not the case. FDA standards are based on these
decades of experience and with the experience and development
of urgently needed countermeasures during public health
emergencies.
The FDA has been sharing its regulatory guidance directly
with manufacturers and researchers, and its guidance is
reflected in the design and conduct of the large-scale clinical
trials and other development activities underway now. Vaccine
manufacturers have committed to following FDA's guidance.
The FDA has been clear in public statements, as recently as
yesterday, that its emergency use authorization standards for
vaccines are different and much higher than those for
therapeutic products already on the market, like convalescent
plasma, and are generally the same as for the safety and
effectiveness of other vaccines. Consequently, the FDA has
required very large, randomized clinical trials. It's requiring
the trials to produce large safety databases to monitor for
side effects that extend past a month or two during which most
serious side effects typically occur. The FDA has also made
clear it intends to use its emergency use authorization to
require substantial post-market data collection, all to augment
evidence available on the vaccine.
Congress designed the emergency use authorization process
to provide the FDA with exactly this flexibility to set
standards that are appropriate for the different contexts that
arise during the pandemic.
All of these well established systems for vaccines' safety
and effectiveness are hard to disrupt, and they have kept the
COVID vaccine development process robust and on track. This is
despite a range of political actions, including proposed
actions by some governors to set up new and untested vaccine
review processes, despite the fact that vaccine development
continues to follow FDA's long-held standards and guidance.
While the concern is understandable, these political actions
create uncertainty for the public that diminishes confidence in
the FDA and vaccine development.
Over the years, this committee has provided strong
bipartisan support and resources for an effective FDA and
science-based development process for products that address
unmet medical needs. We need that today more than ever to avoid
ending up prolonging the pandemic and all of its health and
economic consequences.
And if you could put the remainder of my statement, a
longer statement, into the record, I'd appreciate it.
[The prepared statement of Dr. McClellan follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. That will be done. Thank you so much, Doctor.
Next, I'm pleased to recognize Dr. Khan for 5 minutes.
STATEMENT OF ALI S. KHAN, M.D.
Dr. Khan. Good morning, Chair DeGette, Ranking Member Brett
Guthrie, and members of the subcommittee. I'm Ali Khan, a
physician, infectious disease epidemiologist, and dean of the
College of Public Health at the University of Nebraska Medical
Center. I was formerly the assistant surgeon general at the
Centers for Disease Control and Prevention with responsibility
for national preparedness.
We are currently witnessing the greatest public health
failure in our Nation's history, from a sluggish and
shortsighted government response, combined with a disregard for
scientific expertise that has undermined trust in public
health.
I'm pleased to be here today to discuss my experience with
preparedness planning and to reinforce that we must heed the
lessons learned from prior vaccination campaigns, such as the
2009 H1N1 pandemic, including addressing the challenges with
trust. I also want to remind that with 750 preventable deaths
occurring every day in the United States, we cannot wait for a
vaccine to contain this COVID-19 pandemic.
Now, while the preliminary data is hopeful, the prediction
of an election day COVID-19 vaccine has raised numerous
concerns in the scientific and vaccine development community,
as well as among the public about trust for the vaccine. Trust
for the vaccine will be as important, if not more so, than the
safety and efficacy which are much easier to manage.
The lessons of the 2009 H1N1 experience may be helpful as
the Nation undertakes its most ambitious vaccination campaign
ever. That response uncovered communications, operational, and
policy challenges across the Federal Government regarding the
distribution of vaccines.
The H1N1 vaccine was initially available in the United
States in October 2009, about four months after the WHO
declared a pandemic, but the vaccine did not become more
broadly available until December of 2009. By that time, the
peak of H1N1 had passed and many individuals were no longer
interested in getting vaccinated. And this diminished the
credibility at all levels of government when the amount of
vaccine available to the public did not meet expectations set
by the government.
In addition, State leaders had poorly defined initial
target groups for vaccination, with unexplained variation
between entities, and despite significant outreach efforts and
provision of free vaccine, difference persisted between Blacks
and Whites and vaccination rates.
And, finally, logistics challenges included 100-dose
minimum orders, and many States were forced to break down and
repackage the vaccine to efficiently serve smaller vaccination
sites.
Now, there are a myriad of strategic and operational
challenges with potential COVID-19 vaccine, including the
probable need for two doses of the same vaccine given 21 to 28
days apart, multidose vials, complex storage requirements, and
others. So it's really going to be critical to leverage our
Nation's existing public health system and vaccine distribution
infrastructure to ensure the efficient, effective, and
equitable access to these vaccines.
Unified planning and priority setting at the State, local,
Tribal, and territorial level is a must, and we also need to
assure the interoperability and timeliness of the numerous data
systems to manage and evaluate the effectiveness of the
distribution and administration of the vaccine and monitor the
adverse events.
Now, while vaccine demand will likely be the immediate
issue for any potential licensed vaccine, we must acknowledge
that public acceptance of a COVID-19 vaccine is not a given.
There's evidence of existing vaccine hesitancy, even before any
actual or even perceived rare potential complication identified
in post-licensing monitoring. To increase vaccine uptake, we
must avoid the use of predictions in our messaging and provide
clear, consistent, and fact-based messages. Lessons learned
from H1N1 reinforce that we need to underpromise and
overdeliver.
In conclusion, there's no guarantee that vaccine efficacy
and vaccine coverage will be sufficient to contain the COVID-19
pandemic. So, right now, while we wait for the vaccine, we have
the ability to implement an evidence-based playbook that will
reduce the number of cases and deaths, and this will require
unified local, State, and Federal leadership that is evidence-
based and uses metrics.
Thank you. I will be ready to answer any questions. And if
you may, Madam Chair, include my longer testimony in the
record.
[The prepared statement of Dr. Khan follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. We will do that, and thank you very much.
Dr. Offit, you're now recognized for 5 minutes.
STATEMENT OF PAUL A. OFFIT, M.D.
Dr. Offit. I too would like to thank the Energy and
Commerce Committee for allowing me to be part of this hearing.
My name is Paul Offit. I am an attending physician in the
Division of Infectious Diseases At the Children's Hospital of
Philadelphia, and a professor of pediatrics at the Perelman
School of Medicine at the University of Pennsylvania. I'm also
the co-inventor of the rotavirus vaccine, RotaTeq, which was
recommended by the CDC for use in all infants in the United
States in 2006 and by the World Health Organization for all
infants in the world in 2013.
I've been a member of the Advisory Committee on
Immunization Practices at the CDC, and am currently a member of
the FDA's vaccine advisory committee, VRBPAC, as well as the
NIH's ACTIV group, assembled by Dr. Francis Collins, to
facilitate the development of COVID-19 vaccines.
The American public is skittish about the speed with which
vaccines to prevent COVID-19 are being developed, and it's
understandable. The language surrounding this effort is a
little frightening. Phrases like warp speed, the race for a
vaccine, and vaccine finalists, have caused some to wonder
whether critical phases of vaccine development are being
skipped, or worse, that safety guidelines are being ignored.
Further, the administration's politicization of science in
areas like mask hygiene and social distancing, as well as the
push to approve drugs such as hydroxychloroquine or biologicals
such as convalescent plasma through an EUA without clear
evidence of safety or efficacy, have caused some to wonder
whether the same low standards will be applied to COVID-19
vaccines. Indeed, recent polls have shown that more than half
of all Americans would choose not to receive a COVID-19 vaccine
if offered, which would make it difficult to achieve herd
immunity by vaccination and eventually gain control of this
pandemic. Despite these understandable concerns, I'm optimistic
that what happened with hydroxychloroquine and convalescent
plasma will not be repeated for vaccines for several reasons.
First, the Data Safety Monitoring Boards that are
supervising COVID-19 vaccines have been charged by the NIH
ACTIV group with holding them to the same standards of safety
and efficacy that would be found for any vaccine, which makes
sense, given that most of those who will initially receive
these vaccines will be healthy young people unlikely to die
from this infection.
Second, FDA Commissioner Hahn stated in a recent op-ed in
the Journal of the American Medical Association, that he would,
quote, rely on transparent discussions by the FDA's VRBPAC
committee prior to vaccine authorization or licensure, end
quote. This committee is composed of academicians and
researchers who are not associated with either industry or
government and can be counted on to give an unvarnished
appraisal of COVID-19 vaccines prior to approval.
Third, while the development of COVID-19 vaccines has been
faster than any vaccine ever produced, one aspect of that
development process is identical to the way vaccines have been
developed for the past 70 years, specifically, the Phase 3
trials.
Phase 3 trials for COVID-19 vaccines are large,
prospective, placebo-controlled trials of about 30,000 people.
The size of these trials is typical. For example, the human
papilloma virus vaccine Phase 3 trial included about 30,000
participants, and the conjugate pneumococcal vaccines, about
35,000. As long as these Phase 3 trials are allowed to proceed
until there is clear, statistically robust evidence that the
vaccines work and are safe in the groups who will soon receive
them, then they will have been held to the same standards as
previous vaccines.
Finally, during my service on FDA's vaccine advisory
committee, I've come to know the people at the FDA who are
involved in vaccine licensure. These people are exactly who you
would want them to be, dedicated to protecting the public from
products that are unsafe or ineffective. If COVID-19 vaccines
are released before they're ready to be released, you will hear
from these people. And you will also hear from people like Drs.
Francis Collins and Tony Fauci, both of whom are trusted by the
American public, as well as many other academicians and
researchers who wouldn't stand for this.
The public is already nervous about these vaccines. If
trusted health officials stand up and decry a premature
release, the celebration by the administration will be short-
lived.
In summary, while people are understandably nervous about
soon-to-be-released COVID-19 vaccines, I think they can take
comfort in the fact that many people in supervisory positions,
as well as a cadre of independent academic scientists standing
behind them, are monitoring this process and looking out for
the public's best interest.
Thank you.
[The prepared statement of Dr. Offit follows:]
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Ms. DeGette. Thank you, Doctor.
The Chair is now pleased to recognize Dr. Gayle for a 5-
minute opening statement.
STATEMENT OF HELENE GAYLE, M.D.,
Dr. Gayle. Thank you very much, and good morning to chairs,
the ranking members, and the members of the subcommittee. Thank
you very much for having this and then for inviting me and my
other panelists. My name is Helene Gayle, and I am testifying
today in my capacity as the co-chair of the National Academies'
Committee on Equitable Allocation of the Vaccine for the Novel
Coronavirus, having spent 30 years in public health, including
20 years with the Centers for Disease Control.
In July, the NIH and the CDC asked the National Academies
to develop an overarching framework for COVID-19 vaccine
allocation to assist policymakers and inform the work of
national health authorities and other advisories bodies in the
development of national and local guidelines.
On September 1st, our committee released a discussion draft
of that framework to be able to get input from the public. The
discussion draft presented lessons learned from other
allocation efforts, our draft allocation framework, and how
this framework might be applied in various scenarios. Our final
report will be released to the public this Friday, so today I
will be talking only about that discussion draft.
Now, as mentioned previously, this is not the first time
the Nation has faced allocating scarce resources during a
public health emergency. So in developing a draft framework for
the equitable vaccine allocation, our committee was informed by
lessons from previous allocation efforts for vaccines, as well
as strategies set forth in other allocation frameworks that
were being developed in the United States and around the world.
Our committee proposed six foundational principles that
informed our deliberations about allocation criteria. First, we
focused on the principle of maximization of benefits, and that
led us to adapt an overarching framework--or overarching goal
of maximizing societal benefit through the reduction of
morbidity and mortality caused by the transmission of the novel
coronavirus.
Second, the higher rates of COVID-19 infections, serious
disease, and death among people of color, linked to the
longstanding impact of systemic racism and inequity led us to a
principle of mitigation of health inequities.
Our third principle of equal regard directs attention to
the equal worth and value of every person.
The fourth principle of fairness highlighted the importance
of impartiality.
Our fifth principle of transparency emphasized the
importance of open disclosure of the principles, criteria, and
priority groups that determined our allocation framework and
who would get the vaccine sooner than others.
And the final principle is that all decisions must be
evidence-based.
To determine the population groups that comprised each
allocation phase, our committee used four risk-based criteria
to characterize population groups by the risk faced by their
typical members in each of these groups. The risk category
include the risk of acquiring or transmitting the infection,
the risk of severe morbidity and mortality, and the risk of
negative societal impact.
Our committee proposed a four-phased approach to COVID
vaccine allocation. Within the population groups included in
each of these four phases, our committee also recommended that
vaccine access should be prioritized by geographic areas
identified as vulnerable through CDC's Social Vulnerability
Index.
We had four phases, the first included a jumpstart phase,
and that included frontline health workers, not defined by
professional titles but by their actual risk of exposure, and
it also included first responders.
The jumpstart phase is followed by a phase 1b, which
includes older adults living in congregate settings,
individuals with select high-risk underlying conditions that
were--were also included in this phase.
The second phase, with an expansion of vaccine supply,
would allow for immunization of additional individuals with
underlying conditions that put them at an increased risk, all
older adults not identified in the first phase, and then also
teachers and school staff, people who are incarcerated or
detained or living in group homes, or homeless shelters or
other congregate settings. And, additionally, the first group
of critical workers who are in industries essential to the
functioning of society and at high risk of exposure. All of
those were included in the second phase.
The third phase, when vaccine supply would become more
widely available, allowed for broader immunization of workers
who were important to restoring the full economic activity and
broad immunization of children and young adults.
And, finally, once vaccine supply became more broadly
available in phase 4, vaccines would become available to any of
those who were not part of the first three phases.
While uncertainty about the COVID vaccine existed, our
committee approached our draft framework with the best
available evidence today, understanding that this would
continue to evolve.
So with that, I just want to thank you for the opportunity
to testify. This is only a brief summary of our discussion
draft. The complete and final report will be released this
Friday, October 10th, and that report will, in addition to
having our final allocation framework, will also discuss topics
related to implementation, risk communication, community
engagement, vaccine acceptance, and global consideration.
Thank you, and I am happy to answer questions.
[The prepared statement of Dr. Gayle follows:]
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Ms. DeGette. Thank you, Dr. Gayle. We'll look forward to
seeing your report on Friday.
Dr. Jha, now pleased to recognize you for 5 minutes for an
opening statement.
STATEMENT OF ASHISH K. JHA, M.D.
Dr. Jha. Great. Thank you, Chairwoman DeGette, Ranking
Member Guthrie, members of the committee. It is my honor to be
with you here today.
We are nine months into the worst pandemic in a century.
More than a million people around the world and more than
200,000 Americans have succumbed to this disease. While we have
identified a series of public health measures and therapies
that, if used effectively, can keep the disease at bay, in
order to bring the pandemic under control, we will need safe
and effective vaccines.
Now, while it usually takes years, often decades, to build
a vaccine, unprecedented collaboration among the global
scientific community means we have multiple candidates in Phase
3 trials just nine months after we identified the virus. This
is incredible progress.
But here's the problem. While the process so far has been
carried out with great scientific integrity, as we near the end
zone, we need to ensure we don't fumble the ball. We have seen
large declines in Americans' willingness to get a vaccine. And
if we fumble the ball, the cost to our lives and to our
treasures will be enormous.
And so as has been already stated, here is the key point.
We need to ensure that we have vaccines that are safe and
effective and perceived to be so by the American people.
So why are Americans worried? They're worried because of
the politicization of the scientific Federal agencies like the
FDA. Whether it was the emergency use authorization of
hydroxychloroquine or the unfortunate hyping of convalescent
plasma, physicians and nurses and the American people
increasingly worry about the integrity of the FDA
decisionmaking process.
The decision to issue an EUA for a vaccine must be based on
scientific timetable, not on a political one. And the unease
has grown recently as the Pfizer CEO has repeatedly suggested
that he is moving to get their vaccine out before the election.
This, on top of the landscape of vocal, science-denying
anti-vaxxers, has created a dangerous situation that, if
allowed to fester, could cause loss of faith in vaccines for
years. We must not let this happen.
I believe there are three things we must do. First, we must
let prespecified, scientific standards drive whether a vaccine
receives an EUA or not. Last week, FDA scientists put out
guidance about the requisite followup time period and the
impact of any vaccine on disease severity. These are right, and
they are a minimum, and we must ensure that we let the FDA use
their standards for an EUA approval.
Second, we need a lot more transparency in the process.
While I was heartened to see vaccine companies make their
protocols public, we need more transparency about safety
signals in their trials and how they're addressing them.
Unprecedented times like these call for unprecedented
transparency.
And, finally, it is critical that when an EUA is issued by
the FDA, we hear directly from the great career scientists at
the agency. This will ensure--or this will assure the American
people that science is driving this process, not politics.
These are critical steps, but they alone will not be
enough. We need a strong communication plan that engages with
clinical and public health leaders, religious leaders, and
others about the process. Americans will turn to these
individuals to get advice.
Next, we need a plan for a fair distribution. This is a
source of immense concern for many Americans. We cannot repeat
the mistakes we are making with testing where the well-
connected are able to get tested on a regular basis but regular
testing is not available for schoolteachers and nurses and
first responders. We need to ensure that vaccines are available
for all of us, not just those who are well connected.
And, finally, we need to eliminate all financial barriers
to getting vaccinated. One in three Americans report that they
will skip the vaccine because of financial concerns. We can't
possibly let this be the case.
2020 has been a very hard year for all of us. 2021 can be
better. In order to get some semblance of a new normal, we need
a vast majority of Americans to get vaccinated with a safe and
effective vaccine. The vaccine development process so far has
been done with great scientific credibility. It's now time to
let science finish the job, and let's use good science
communication to help people understand the integrity of the
scientific process, and let's eliminate financial barriers and
implement smart distribution plans to ensure that we can turn
vaccines into vaccinations. If we do all of that, we can
finally bring the pandemic under control, heal our economy, and
let Americans get back to their lives.
Thank you.
[The prepared statement of Dr. Jha follows:]
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Ms. DeGette. Thank you so much, Dr. Jha.
Thank you to all of our panelists for your excellent
testimony.
Now it is time for the members to ask questions, and the
Chair will recognize herself for 5 minutes.
So when I was watching the debate last night, I suddenly
realized that the President, who has been politicizing this
whole vaccine approval process, is actually trying to blame the
Democrats for that. And I don't think it should be politicized
by anybody. All of our panelists today testified that we need
to rely on the scientific integrity of our agencies and our
scientists. I believe so strongly in that, and I believe that
that's what we need to do.
And so that's the impetus for my questioning, because I
think that the career scientists have been systematically
undermined for months, with both the hydroxychloroquine
emergency use authorization approval, and then, of course, the
plasma emergency use approval.
And so I want to ask--and what I've been asking all of the
experts when I talk to them is, I keep hearing about these
guardrails to prevent the pressure, the undue pressure that's
been put on the agencies by the President for these other EUAs
to be used in a vaccine approval. And what I hear from
everybody is we have these guardrails.
Dr. Offit, in your testimony, you talked about several
different guardrails--the Data Safety Monitoring Board, the
FDA's VRBPAC, and other systems for review and approval of
these vaccines--that you--and plus, of course, the wonderful
FDA and NIH scientists. Do you think that these will be
sufficient to prevent undue pressure from coming on the agency
or even an abrogation of the process and just simple ordering
of approval by the President and the administration?
Dr. Offit. Yes. And there's a third thing. I mean, the
Advisory Committee for Immunization Practices, once a vaccine
is licensed or approved, will independently review data and
independently make a decision about how they would recommend
giving that vaccine. I, frankly, don't--I mean, I, like you, am
worried about the politicization of science, but I do think
that it would be hard to politicize this.
I think hydroxychloroquine----
Ms. DeGette. Let me stop you, because I want to ask the
other panelists. So you feel confident in the guardrails we've
put in place for the vaccine.
Dr. Offit. I do.
Ms. DeGette. Is that right?
And what do you think, Dr. McClellan, do you think that
these guardrails are sufficient to stop undue politicization?
Dr. McClellan. I do, and not just me, but yesterday, seven
former FDA Commissioners over the last three decades, five
administrations, all said the same thing. This is a very robust
process that is hard for any political influence to disrupt.
What we are more concerned about is the impact of political
influence on confidence, as we've been talking about today.
Ms. DeGette. Yes. And that's why we're having this hearing
today.
And I believe there was an article in The Washington Post
this morning about that statement, and it's titled, Seven
former FDA commissioners: The Trump administration is
undermining the credibility of the FDA.
And I will ask--Mr. Guthrie, at the end of this hearing, I
will ask unanimous consent to put this article in the record.
What about our other witnesses? Dr. Khan, do you think that
we have sufficient guardrails in place to stop undue
politicization of this process?
Dr. Khan. Thank you, Chairman Guthrie. I think the
guardrails are actually quite excellent--
Ms. DeGette. I'm actually Chairman DeGette.
Dr. Khan. Chairman DeGette, I think the guardrails are
quite excellent, but I think we all need to remember that those
guardrails have not worked so far where we have looked at CDC
guidance. For example, whether we test asymptomatic
individuals, what is the guidance for children in school. So
there's a number of guidelines from CDC that have not--that
have not been subject to those guardrails.
Ms. DeGette. But what do you think we can do to ensure that
those protocols are followed? Very briefly.
Dr. Khan. So even for CDC, I think we need to ensure the
same set of guidelines for public health in general. I'm not
sure the public differentiates FDA from everything else they're
reading about in terms of the politicization of science.
Ms. DeGette. Gotcha.
Dr. Jha, what's your view of this? Do you think the
guardrails that were outlined by Dr. Offit are sufficient?
Dr. Jha. Well, the guardrails are strong, and I think--I
completely agree with all of my fellow panel members. The
problem is some of the signaling that--so for instance, Dr.
Hahn has been very public in saying he doesn't have to listen
to his advisory committee, which is true, but that is
unhelpful. And it is also unhelpful when we know that he has
succumbed under pressure. And so while his words are
reassuring, what I would like is much greater clarity that the
scientists will get to really drive this process, that the FDA
Chief won't override the advisory committee's recommendations.
If all of that happens, I will feel more comfortable that the
guardrails will hold up.
Ms. DeGette. Well, and I think that you have bipartisan
agreement with that. I think everybody agrees that we need to
make strong statements that all of the scientific principles
will be followed and that this will be a very rigorous review.
Congressman Guthrie, I now recognize you for 5 minutes.
Mr. Guthrie. Thank you very much for the recognition.
And, Dr. Offit, I want to thank you for your testimony and
also what you just said just a few minutes ago, that you really
have a lot of confidence in the FDA, the FDA scientists, the
FDA Advisory Committee, independent data monitoring committee.
They really have strong guardrails in place, and a couple of
other witnesses seem to say that they are in place, but we
still need to--I don't know--they could go off rails, I guess.
And I'm just concerned that we're going to say things and not
have people confident about vaccines.
We already had a hearing on measles about vaccine
hesitancy, and it's something that, I think, Dr. Offit, you
said that the scientists would scream and yell if something
like that happened. And so we need to make sure that people can
have confidence, when a safe and effective vaccine is approved
by the FDA, it will be safe and effective. And so, hopefully,
we can keep our rhetoric going that direction.
But, Dr. McClellan, in that point, because we really need
to be that direction, I'd like to ask you, if the vaccine
manufacturers apply for an emergency use authorization prior to
submitting a biologics license application, or BLA, what kinds
of extensive scientific data would the companies have to
provide to the FDA about the safety and performance of the
vaccines for the EUA, and how similar are those packages to be
submitted under the FDA's gold standard preapproval process for
that BLA? Did you get all of that?
Dr. McClellan. I think so. Representative, I had a chance
to talk with Dr. Peter Marks at a public event last night where
he reiterated that he expects the evidence for safety and
effectiveness for the vaccine approved under an EUA to be very
similar to that for a full approval. Remember, the full
approval includes a lot of additional documentation, thousands
and thousands of pages, dealing with a lot of issues like is
the vaccine going to be stable on a shelf for the next six
months. That is not the context that we're concerned about
here.
And to make sure, all of this is not only reviewed fully by
the FDA, as Dr. Offit said, there will be an advisory committee
meeting for each vaccine--each vaccine--that comes forward with
an emergency use application, for the FDA to write a written
review for discussion with these expert independent advisers
about whether the vaccine standards are being met. And I have
full trust, not only in the FDA staff to do that right, but
people like Dr. Offit who have been doing this for years and
have tremendous amount of experience with vaccine safety,
including for vaccines used in infants.
And after that, the FDA will write a written basis for its
decision, and then, even before its used, it's going to go to
another independent review by the CDC's Immunization Practices
Committee.
So those are a lot of steps that people should be looking
for in terms of transparency and independent, regulatory
expertise, scientific expertise, all coming to bear to make
sure we got the right, sufficient amount of evidence on safety
and effectiveness.
Mr. Guthrie. My guess it will be pretty transparent if we
don't follow those pathways.
Can you explain why the EUA for a COVID-19 vaccine would be
different than the EUA for COVID-19 therapeutics?
Dr. McClellan. It's a very different context. And as you
know from working on these issues over the years, the Emergency
Use Authorization was implemented to give the FDA flexibility
to respond as needed in a public health emergency. And so, as
you mentioned earlier, it's about the totality of the evidence
in a particular context.
So, in the context of something like convalescent plasma,
where the treatment has been around for a hundred years, been
used in many different infections, it's on the market now, it's
being--it's been used in thousands of sick COVID patients with
no significant evidence of safety side effects--now, we don't
have good evidence on benefits, and that's where I think some
of the political leadership got it wrong when they were
characterizing what the FDA career staff decision was here.
They made it sound like it was a clear, beneficial treatment.
But what we're talking about is a treatment that's already
being used for people who are hospitalized that the evidence
shows is not harmful. And that kind of expanded access is
something that FDA has a tradition of doing for unmet medical
needs in people who are very high risk while evidence is being
developed.
I hope we get a clinical trial done more comprehensively to
answer this question, but it's a very, very different context
than a new vaccine used in people who are not sick who are
trying to keep well.
Mr. Guthrie. OK. Then, finally, I have just a few seconds,
but can you explain why EUA--or could you--what the FDA's
guidance is for COVID-19 vaccines that gives you confidence
that there will be strong science behind any decision made and
then any safeguards outside of the FDA to make sure you have
confidence?
So I want to end with the next 15 seconds why you are
confident we will have a safe and effective vaccine when it is
safe.
Dr. McClellan. We've already covered that. There's a whole
checklist I think that we've already talked about of public
events and writings that will be coming from the FDA staff
before any decision is made. Make sure that happens and lets
inform the public about that.
And as you pointed out earlier, all of the vaccine
manufacturers have said they are going to follow this process.
And even though this FDA written guidance on EUA hasn't been
released, believe me, all of the manufacturers know what's in
it. And Dr. Marks and the FDA staff, again yesterday, just
reiterated again publicly what all is in it.
So we've also got a lot of independent experts, other
agencies. It's a very robust process that has been developed
over decades because vaccine safety is so important.
Mr. Guthrie. Thank you, and this is important. Appreciate
it.
Appreciate it, Madam Chair, and I yield back.
Ms. DeGette. Thank you so much.
The Chair now recognizes the chairman of the full
committee, Mr. Pallone, for 5 minutes.
Mr. Pallone. Thank you, Madam Chair.
If the months of the Trump administration undermining
science, now we have a number of polls that show that the
majority of Americans have reservations about getting a COVID-
19 vaccine once it becomes available.
So let me start with Dr. Khan. What do you believe are the
consequences of this repeated subversion of science and attacks
on, you know, the public health agencies?
Dr. Khan. Thank you, Chairman Pallone.
There's no doubt that over the last eight months we've
undermined public health science in the United States through a
combination of, I would say, three or four things.
One is misinformation and manipulation of science. The
second is elevation of personal liberty above our social
responsibility. The third is equating public health science
with having enough hospital beds, ventilators, and body bags.
And, fourth, would be probably discounting the value of a life
with 20,000 preventable--200,000-plus preventable deaths in
America. And there have been numerous now documented evidence
of manipulation of science.
So there's no doubt that, from a public perspective, it's
easy to see why anything coming out of the administration could
be mistrusted. So it's fortunate, as in the prior conversation,
that there's a lot of independent review of vaccines. But this
politicalization really has undermined public health science in
America.
Mr. Pallone. Well, thank you.
And, Dr. Jha, you have expressed your disappointment in the
Nation's pandemic response, and you described it as among the
worst in the world. That's a quote. Has the Trump
administration's politicalization of science contributed to
this failed response? And what do you think the impact of that
has been?
I think he is----
Dr. Jha. Sorry. Sorry, Congressman, I was muted.
Mr. Pallone. Sure.
Dr. Jha. So a couple of quick things. I mean, first of all,
there's no doubt, if you just look at the data, if you just
look at the numbers, as Dr. Fauci said last week, if you just
look at the numbers, we are among the worst performers in the
world, certainly the worst performer among high-income
countries.
We have the best public health scientific agencies in the
world. CDC and FDA are gold standards that everybody else in
the world looks up to. Unfortunately, we have not let them
function in a way that we really need them to function.
So there is no question, I think, on anybody's mind,
certainly I doubt on anybody on this panel, about the integrity
and the capability of the great scientists at both of these
agencies. The problem has been that their voices have not
always won the day and that their voices have often been
overridden and subverted by a political process that is
unprecedented. It has never been done before under a Republican
or a Democratic administration, and that has substantially
hampered our response, made it much, much harder for us to get
the disease under control and, unfortunately, has led to a lot
of people dying unnecessarily.
Mr. Pallone. Well, thank you.
Now, Dr. McClellan, you have mentioned that you joined six
of the former FDA commissioners in this op-ed in the Washington
Post raising concerns over the Trump administration's action,
not only undermining credibility of FDA but eroding public
confidence.
Do you believe that if left alone to do their jobs that the
career staff at FDA could be trusted to let science guide their
decisions, whether for the vaccine, or new tests or treatments?
Dr. McClellan. I do believe so, Mr. Chairman. And as we
said in that op-ed, despite recent political actions, we
continue to have confidence in the integrity and high quality
of the scientific work of the FDA staff.
And this, unlike, say, CDC just writing a guidance and
having that blocked, this is a major process with a lot of
regulatory oversight, all of this independent scientific
engagement from advisory bodies, actions, including enrolling
and conducting very large clinical trials by multiple
companies. This is not an easy process to this route just
because somebody says something about it. It does undermine
confidence, though.
Mr. Pallone. Well, let me just ask, Dr. Jha, I mean, look,
we have got to fix this, right? What can we do to restore trust
in the Nation's pandemic response? I mean, you have heard some
of the things that were put in this new updated Heroes Bill.
The experts, the scientists, the processes are in place.
What do we need to get the President and his cronies out of the
way or to fix this so that we can go back to having the FDA do
its job?
Dr. Jha. Right. So, first of all, I have said this. I think
all political leaders need to stop talking about things like
timelines. Politicians don't know what the scientific timeline
is and, unfortunately, the political appointees have not been
very helpful either.
And so what I have said is if the career scientists of the
FDA or the ones at the CDC get to do their job and we hear from
them directly that they believe that the process has had high
integrity, I think that would be enormously helpful and would
go a long way to offer an assurance to the American people that
this is a process with integrity.
I generally don't believe we need whole new sets of
independent bodies at State or other levels. Now, we have got
independent bodies. If--the one that Dr. Offit is on, if that
committee comes out and says the scientific evidence is strong
and clear, I think the American people will have--will feel
assurance by that.
But we need to make sure that their words and voices carry
the day and not those of political leaders.
Mr. Pallone. All right. Thank you.
Thank you, Madam Chair.
Ms. DeGette. Thank you so much.
The Chair is now pleased to recognize the ranking member of
the full committee, Representative, Mr. Walden.
Mr. Walden. Good morning--or good afternoon, and thank you
again, Madam Chair, for this hearing, and thanks to our witness
for your fine testimony.
Dr. McClellan, some State officials, as you know, are
expressing skepticism about Federal reviews of potential COVID-
19 vaccines, and indicate that their States plan to conduct
their own independent review of the clinical trial data before
distributing a vaccine, despite an approval or authorization
from the FDA.
Do you believe such a review by States would be necessary?
Has it been done before? Are they equipped to do this? Did they
do this on anything else that the FDA approves? And do you
think that this would actually slow down access to an FDA-
approved vaccine that could save lives?
Dr. McClellan. Mr. Ranking Member, I just, like Dr. Jha has
expressed, I do have some concerns about it. We just talked
about how extensive and developed and how much resources go
into the FDA's process.
That's a process that you all have supported through your
implementation on a bipartisan basis, have continued efforts to
strengthen and improve the Federal Food, Drug and Cosmetic Act,
which is meant to provide a high level of confidence about
safety and effectiveness of medical products in general and
vaccines in particular for the American people. It is a huge
undertaking with a lot of expertise, experience, culture.
It is hard to see what a State body of some kind could add
to that. I understand where the impulse is coming from. Maybe
if what the group would do is just go through this kind of
checklist, you know, is the--all of the things we've talked
about today, are they actually happening, are we hearing from
the career staff, is the process being followed, maybe that
could help improve confidence. But it's hard to see how to
replicate anything like this national gold standard system that
we've developed.
Mr. Walden. Well, and I would just say in--I have been
through a lot of closed-door discussions with the HHS, with
NIH, Dr. Fauci, Dr. Hahn, Dr. Redfield. They all say we are
going to follow the standards, we are not going to yield in any
way, it's all going to be about the science, it's all going to
be about the data.
And, by the way, there's--aren't there independent
scientific review boards set up outside of the FDA to look at
these things, to look at the data, do the evaluation--I mean,
it might be technically encompassed within FDA and CDC, but
aren't they completely separate, independent and, I would
think, people of great integrity and scientific capability?
Dr. McClellan. That's right. It's not just FDA, but a whole
system of regulatory oversight, scientific expertise. Dr. Offit
talked about how the Data Safety Monitoring boards, which NIH
is generally involved in for these trials, NIH expertise, as
you just mentioned, CDC expertise and CDC drawing in a whole
set of independent experts through their Advisory Committee on
Immunization Practices, which will also provide a review as
part of this well-established process.
It is a system like no other in the world, and we are very
lucky to have it in the United States to give us as much
confidence as--
Mr. Walden. Yes. Let me ask you about that because we're
hearing internationally supposedly Russia has a vaccine they're
ready to push out and China. Tell me how their systems work in
contrast to ours.
Dr. McClellan. Mr. Ranking Member, in China and Russia,
there are people getting vaccines now that have not been
through anything like the process that we've described, these
large so-called phase III trials that actually have to prove,
demonstrate that the vaccine reduces the number of infections,
reduces severe infections, that have these very large data
bases of tens of thousands of people who have been followed
after they get the vaccine, that have the FDA's authority on
top of that to set up additional monitoring on the people who
are first to get the vaccines, our first responders, our health
professionals, and others who are at such big risk today
because of the ongoing pandemic. It's very different. It's a
system that really is setting standards for the world.
Mr. Walden. Mr. Khan, do you want to weigh in on these
matters? I saw your head nodding there like you wanted to add
in.
Dr. Khan. I just want to add in to Dr. McClellan's
comments.
So, in Russia, the vaccine was licensed with less than a
hundred people who had been vaccinated in a phase I, II trial.
That is impossible in the United States.
Mr. Walden. And do you agree that there are these
independent organizations that are comprised of people with
great integrity and scientific ability that aren't going to be
pushed around, if you will, by anybody?
Dr. Khan. Oh, absolutely, there's no doubt about the
integrity of the people, for example, in the ACIP. So there's
no doubt about that.
So it's really an issue of confidence and how do we assure
that when these vaccines are available the checklist has
completely been followed.
Mr. Walden. All right. Thank you very much again to all of
the witnesses.
And, Madam Chair, I yield back.
Ms. DeGette. The Chair now recognizes Congresswoman
Schakowsky for 5 minutes for questioning.
Ms. Schakowsky. Thank you so much.
I first want to welcome Dr. Helene Gayle who, in addition
to her role today, I know as head of the Chicago Community
Trust. And so welcome today.
I am so glad that my colleagues and I have passed
legislation to provide COVID-19 vaccines to most Americans at
no cost, but we must extend that protection to the uninsured
people as well. A vaccine can only be as effective--can only be
effective if Americans and people around the world can afford
to take it.
But let's be honest about it. Just because people don't
have to pay when they receive the vaccine doesn't mean that a
vaccine is free. U.S. taxpayers have already paid drug
companies over $10 billion for vaccines that--for vaccine
research and development, costing--and that's through Operation
Warp Speed.
In the years to come, public plans, like Medicare and
Medicaid and the VA, et cetera, will all be harmed by the drug
companies if they are allowed to use monopolized--monopolizing
power to charge whatever they want.
And let's be clear, that if the Republicans and the
President of the United States have their way to end the
Affordable Care Act at the Supreme Court, then the ACA, so
right now, prohibits cost sharing for preventive services, and
that would be eliminated. And that means that all Americans
will face copays for all vaccines, including COVID-19 vaccines,
once the public health emergency is over.
And, finally, I just want to say that Oxfam just issued a
report that, quote, wealthy nations represent just 13 percent--
representing just 13 percent of the world's population,
unquote, have already bought over 50 percent of future COVID-19
vaccine doses.
So I would like to ask Dr. Jha two questions. First, to
ensure equitable access, do you believe the Federal Government
should require pharmaceutical companies to sell a taxpayer-
funded COVID-19 vaccine at a transparent, fair, and reasonable
price?
Dr. Jha. Well, let me start off with that question,
Congresswoman, by saying absolutely necessary for the U.S.
Government since it has been a major investor in these efforts,
whether it's Moderna, whether it's companies that are part of
the Operation Warp Speed, that the U.S. Government needs to
make sure that the vaccine set it buys does so at a fair price.
And, of course, the big question would be what is a fair price,
what's a reasonable price?
One of the points I would like to make is that these
vaccines are going to be needed by billions of people around
the world, so you don't need a large margin on every single
vaccine to still make plenty of profit. It is absolutely
essential that the vaccines be affordable, be affordable to
Americans, to American taxpayers, but also affordable to the
rest of the world.
Ms. Schakowsky. Well, I want to thank you so much for
mentioning that in your opening statement. I appreciate your
mentioning cost because when we talk about access, cost is so
important.
And that was really my second question. If we can, we as
Americans can really be protected if other countries can't
afford the COVID vaccine. I wonder if you want to elaborate on
that anymore, especially given the Oxfam research that was just
announced.
Dr. Jha. Yes, absolutely, Congresswoman. So if your only
goal is to protect the American people--let's say, we didn't
care about other people in the world, though, of course, we as
Americans do.
But even if our only goal was to protect the American
people, we would want to make sure that much of the world was
vaccinated because, if there continues to be large outbreaks in
other places, those outbreaks will see their way here. Nobody
believes that any vaccine will be a hundred percent protective
and that a hundred percent of Americans will take it.
So there will still be vulnerable Americans, and part of
protecting America is making sure there's widespread
vaccination all over the world.
Ms. Schakowsky. Thank you so much.
And I yield back.
Ms. DeGette. Thank you, gentlelady.
The Chair now recognizes Mr. McKinley for 5 minutes.
Mr. McKinley. Thank you, Madam Chairman.
Last night's presidential debate truly was a debacle, an
embarrassment to the American people. But now the Democrat
leadership and the literal media are expressing similar
disrespect to the integrity of our scientific community by
sewing the seeds of doubt about the efficacy of a safe vaccine
and interjecting politics into this.
Ever since the virus broke out, there's been a rallying cry
across the globe to get a vaccine as soon as possible. And to
his credit, President Trump instituted Operation Warp Speed to
do just that, and Congress overwhelmingly voted to fund the
program.
But now, just as we are on the cusp of having a viable
vaccine and safe, Democratic leadership wants to move the
goalpost once again and slow down the process; but speed is
still of the essence.
So my question, what part of Operation Warp Speed don't
they understand? Look, scientists don't give two hoots about
who the President is or who controls the House or the Senate.
Using the same protocol they have been using for decades, these
scientists simply want to create a vaccine so people can
confidently return to work and our schools.
The public has been clamoring for a vaccine, and now the
Democratic leadership wants to perpetuate the political
conspiracy theories that only confuse the American public more.
It's time. Can't we just stop this foolishness and put
aside our political grandstanding? Let's trust the scientists,
our career scientists, and the FDA to do their job.
Now, my question is to McClellan, if I could, Dr.
McClellan. Do you think politics is motivating the Democrat
leadership to question the efficacy of a drug even before it's
finished clinical trials?
Dr. McClellan. Oh, Representative, there's certainly a lot
of politics around this issue and the coronavirus response.
I would just say a couple of things. One is, I agree with
you about the value of Operation Warp Speed for making the
vaccine development process faster and leading to the potential
for actually having a vaccine by the end of the year and maybe
in widespread use next year can potentially have such a big
impact on the pandemic and our health and our economic well-
being.
I would also to----
Mr. McKinley. If I could go back again. So these seeds,
these seeds of mistrust and the misinformation from the
Democratic leadership are alarming. Public trust--as you so
pointed out here, the public trust in this COVID vaccine has
dropped by nearly 30 percent in just the last couple of months.
So, therefore, is it reasonable to assume that this
mistrust of a COVID vaccine could permeate into the mistrust of
other vaccines that we need?
Dr. McClellan. It certainly is, and that's why this hearing
and, I think, the bipartisan support that this committee has
over the years steadily provided for the scientific process at
FDA, NIH, CDC is so important right now.
And I hope together you all can help restore the confidence
in the public in what I think is a very strong vaccine
development and oversight process.
Mr. McKinley. OK. So, again, let me just reinforce again
what you were saying earlier. You think the guardrails are
there in place----
Dr. McClellan. Yes.
Mr. McKinley [continue]. To be able to provide this?
Dr. McClellan. Yes.
Mr. McKinley. And this is involving politics--that's what I
heard you say, yes, politics are involved. Isn't that a shame?
Dr. McClellan. Yes. I think that politics----
Mr. McKinley. Because we have a chance, if the guardrails
are in place and we've demonstrated that, the only reason I
think this is being raised to this point is because an election
process is coming up in 5 weeks. Comments?
Dr. McClellan. I would like to get the politics out of
this, and I appreciate the bipartisan interest on the
committee, it seems, in making that happen or helping to make
that happen----
Mr. McKinley. Shame on people for making this partisan.
This thing we should resolve. We've had the mission to try to
get this vaccine approved, and people want to play politics in
delaying, and only politics, and I think all of this panel
knows that. This is politics, raw unmitigated politics.
Thank you very much. And I yield back the balance of my
time.
Ms. DeGette. The Chair now recognizes Representative
Kennedy for 5 minutes.
Mr. Kennedy. Thank you, Madam Chair. And thanks to all of
the witnesses for being here, and thank you for convening this
important hearing.
Diverse enrollment of participants in vaccine clinical
trials has been a concern long before COVID-19. It's due to a
long-standing racism within a system that systematically
targeted people of color and placed them without consent into
clinical trials. So it's not surprising that there would be
hesitancy in those communities to participate in now clinical
trials.
Given the increasing data on the disproportionate impact of
COVID-19 on communities of color, it is more important than
ever that we ensure diverse participation in clinical trials
and build trust in a vaccine in those communities.
I am particularly concerned by statements from some
companies researching vaccines that they are struggling to
recruit black participants in their clinical trials, since it
is on them, to try and right the wrongs of the past and to
engage communities and people who have historically been
undervalued.
So, Dr. Offit, I wanted to start with you. I know you have
been involved in numerous clinical trials. From what you've
seen so far, will the current clinical trials provide us with
enough information about the safety and efficacy of the vaccine
on populations that are hardest hit by COVID-19?
Dr. Offit. That's certainly the goal. I mean, I know that
one of the companies who have slowed up because they wanted to
make sure that they had gotten adequate representation. I mean,
you know, one doesn't expect that you are going to have
critical differences in terms of safety or immunogenicity based
on gender, race, or ethnic background. What you--you know,
where as you could obviously have instances regarding age. I
mean, people who are older may not respond as well to certain
vaccines as others.
So I think that certainly is the goal. I think--because if
we are going to go to people and we are going to say, look, you
need to get this vaccine, we have to be able to say you have
been represented in these trials, otherwise people won't trust
that the vaccine is formed.
Same thing with older people. I am, what, 65. I am not
going to get any vaccine that hasn't been adequately tested for
people in my age group to be found safe and effective, and the
same is true for ethnic background--ethnic or racial
minorities.
Mr. Kennedy. Thank you, Doctor.
And, Dr. Gayle, what are the consequences--Dr. Offit talked
about this a little bit, but what are the consequences if we do
not adequately--or if we don't have adequate representation
among a diverse range of populations amongst trial
participants? And what should Congress and the Federal
Government be doing to help address it?
Dr. Gayle. Yes. So thank you for that.
You know, obviously, this has been a pandemic that has
disproportionately impacted people of color as you mentioned
and as Dr. Offit also mentioned. It's so critical to have
people of color enrolled in these trials so that there can be
confidence that these trials actually have looked at this in
populations that are reflected by this pandemic.
And so I think, while we've talked a lot about the
guardrails within the Federal Government system, that's clearly
important to develop the--to have the overarching trust in the
development of the vaccine, but it also means that partnerships
beyond the Federal Government, with trusted institutions, with
communities, all of that needs to happen in order to build that
kind of confidence.
And I think there's a lot that can be done to make these
clinical trials much more accessible to communities of color:
Where the trials are done, what doctors' offices participate,
what medical institutions are part of it.
So I think there's a lot more that can be done to make sure
that the trials are made in a--done in a way that are
accessible to the populations that are being most hard hit by
this pandemic.
Mr. Kennedy. Dr. Gayle, thank you.
And, Dr. Jha, I saw you nodding to her comments. I wanted
to get your thoughts on this, and also from somebody down the
street from you in Massachusetts, thank you for your incredible
work and your outspokenness on these issues.
But you speak about some of the potential vaccine
confidence concerns amongst communities of color in your
testimony, stating that a level of, ``mistrust amongst people
of color isn't surprising considering the long history of
structural racism and unethical medical experimentation on this
population.''
Briefly, what more do you believe needs to be done to
ensure that any future vaccine will be safe, effective and
trusted within those communities?
Dr. Jha. Yes, Congressman. Again, thank you for being my
Representative.
So very quickly I will say that, building on what Dr. Gayle
said, it is absolutely critical that we engage community
leaders, we relate--we engage religious leaders.
So it is, first of all, completing what Dr. Offit said
about having representation is the first step, and that's going
to require a lot of work. But even after that, building up
confidence in communities of color is going to require engaging
with leaders in those communities, trusted voices in those
communities, and working with them. And they are not going to
give you a pass. They are not going to give anybody a pass,
unless they are confident that their communities have been well
represented and that this is beneficial to them.
So I think there's a whole strategy here that is necessary.
This is not a we show up one day, knock on the door and say,
Hey, we have a vaccine. How would people like to get it? We've
really got to take a proactive approach here.
Mr. Kennedy. I appreciate that.
Dr. Gayle. I would add that there's a lot to build on, and
this doesn't have to start from scratch. You know, we know a
lot about who are the leaders who are trusted. We know a lot
about the institutions that are trusted in communities of
color. And we just need to build on some of those things and
make it a priority and be intentional about it.
Mr. Kennedy. Dr. Gayle, thank you.
Dr. Khan, I had a brilliant question for you, too.
Unfortunately, my time is up. So I will get it before you.
But I will yield back the negative time I have. Thank you
for your patience.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes Mr. Griffith for 5 minutes.
Mr. Griffith. Thank you very much, Madam Chair.
Building on those questions, Dr. Offit, you indicated to
Mr. Kennedy when he was asking questions that one company had
slowed down their process in order to get a diverse demographic
group mix. Can you tell us who that company was?
Dr. Offit. It was Pfizer.
Mr. Griffith. OK. And I just thought it was interesting,
and I had not heard that, so I appreciate that information.
Also I would ask you and Dr. McClellan, AstraZeneca's phase
III clinical trial was recently put on hold due to an adverse
event occurring in one of its enrollees. The trials have
resumed in the United Kingdom, Brazil, and South Africa. But,
to my knowledge, the trial is still paused in the United
States.
Would you agree that this action taken by the FDA signals a
commitment to safety and not rushing the clinical trial
process?
Dr. Offit. Yes, absolutely. I think--first of all, the
AstraZeneca vaccine trial in the United Kingdom was put on
clinical hold twice, once in July and then a second time in
September. So when you do that, there's--because there's so
many investigators involved, that will always be known by the
press and, ultimately, the public.
The problem then becomes that you don't really know the
details because confidentiality precludes you from knowing
those details. And I have talked to the head of the Data Safety
Monitoring Board in the United Kingdom about this, and he can't
give me the details. And it's very frustrating for all of us
because we think we know what those two cases were, but we
don't.
We also know that the U.K. regulators have now taken that
clinical hold off because they presumably felt that this
association was coincidental and not causal, but that hasn't
happened here. And we don't know why the decision was made in
one place or the other place, and that's part of the
frustration of all of this.
I mean, people talk about transparency, but the fact of the
matter is you can't really be transparent about these cases
because of confidentiality issues. So it's sort of like, since
Joe Kennedy is on this call, I mean, it's like driving in
Boston. You know, you're bound to have an accident. And I think
that that's the way this is set up.
Dr. McClellan. I appreciate that.
Mr. Griffith. Yes, Dr. McClellan.
Dr. McClellan. Yes. Just to add to that, I think also as a
reminder that this is a scientific process that is very much in
process, and as you said, the FDA is right on top of this,
watching closely.
Before anyone gets broad access to this vaccine, there will
be a public opportunity through that advisory committee review
to go over this and any other significant safety issues that
have come up during the clinical trials and a chance for people
like Paul, who I know he wants to get that information now, but
he will get his chance before there is any actual decision
about this vaccine.
And this is the way it goes with vaccine development. These
events happen. They need investigation. They need to be put in
the context of the overall trial and all of the rules and
safeguards, including blinding and confidentiality that are----
Mr. Griffith. I appreciate it.
Dr. McClellan. And that will all happen before there's any
decision on the vaccine.
Mr. Griffith. Let me shift gears just because I see the
clock ticking.
Dr. Offit, there was an op-ed in the New York Times last
week in which Dr. Peter Doshi--I don't know if I'm pronouncing
that correct--and Dr. Eric Topol expressed concerns about
clinical trials for the COVID-19 vaccine stating, according to
the protocols for their studies which they released last week,
a vaccine could meet the company's benchmark for success if it
lowered the risk of mild COVID-19 but was never shown to reduce
moderate or severe forms of the disease or the risk of
hospitalization, admissions to the intensive care unit, or
death.
To say a vaccine works should mean that most people no
longer run the risk of getting seriously sick. That's not what
these trials will determine.
Do you agree with those concerns? And either way tell me
why.
Dr. Offit. I don't agree. If you look at the natural
history of people who are infected with SARS CoV-2, if they
have moderate to severe disease the first time they are
infected, typically when they get a second infection, it's much
more mild or asymptomatic. That was also true with the virus I
worked with, norovirus, and it was also true with the norovirus
vaccine.
I think they are exactly wrong. I think it's actually much
harder to prevent asymptomatic infection or mildly symptomatic
infection. If you can prevent that, you are much more likely to
prevent moderate to severe disease. So I think they have it
backwards. That's not really in the history of vaccine
development. So I think they are wrong.
Mr. Griffith. All right. So since I already had it, what
you're saying is if I get it again, it will be mild?
Dr. Offit. And that's what you want. I mean, as a developer
of a vaccine, what you want to see when you develop a vaccine
is you want to make sure that natural infection can protect you
against challenge. Then you know that there's hope for a
vaccine. And when you see that, usually you--all you care about
is that you can be protected against moderate to severe disease
on reinfection because that keeps you out of the hospital and
out of the morgue.
It's not usually the case where you are also prevented
against having mild disease or asymptomatic disease. And if you
look at the animal model studies for SARS CoV-2, you can
protect lower respiratory disease; i.e., pneumonia, but you
don't really protect against shedding, which is to say
asymptomatic infection or mild infection.
So I honestly think that op-ed piece was just wrong.
Mr. Griffith. All right. Thank you very much.
I yield back, Madam Chair. My time is up.
Ms. DeGette. Do we have Mr. Ruiz? He is next in the order.
OK. Not seeing him----
Mr. Ruiz. Yes, you do.
Ms. DeGette. Oh, there he is. OK. Mr. Ruiz, you are
recognized for 5 minutes.
Mr. Ruiz. Thank you so much. I really appreciate this
hearing. It is so vital that people have the confidence in the
science of the development of the vaccine.
As this pandemic continues to ravage our communities, we
have seen repeatedly that certain populations remain at high
risk for contracting and dying from COVID-19. This includes
high-risk essential workers, people of color, the elderly, and
individuals with preexisting conditions.
I know we all wish that there would be enough vaccines for
everyone as soon as one is identified, but that just will not
be the case. In fact, some experts, like CDC Director Robert
Redfield, say it will be mid to late 2021 at the earliest
before the U.S. is widely immunized.
Once the first vaccine is approved, things are going to
move fast, and that vaccine will be distributed immediately. So
it is imperative that we finalize distribution plans now that
prioritizes the most vulnerable or those at highest risk, and
the most vulnerable or those at highest risk here means those
who are most likely at highest risk to get infected and at
highest risk of dying from COVID-19.
So these vaccines can't just go to the highest bidder. It
has to have that public health approach to save as many lives
and get through this pandemic as quickly as possible.
Dr. Gayle, you state in your testimony that, ``while spread
throughout the society, the pandemic damage has more
significantly harmed some populations more than others,
particularly causing high rates of infection, serious illness,
hospitalization, death among people of color due to the long-
standing impact of systemic racism and inequity.''
This is what I and so many of my colleagues have been
concerned about throughout this pandemic and what we have
sought to address. Yet I notice that communities of color are
not specified as priority population phases in the National
Academies Committee discussion graphs.
Furthermore, essential workers have been mentioned, but
there's a difference between high-risk essential workers,
people that work in the farm fields, in grocery stores, versus
low risk, younger affluent people who can work from home and
have their own room to work from and be physically distanced
from everybody else.
So, Dr. Gayle, recognizing that the final report will not
be released until this Friday, could you shed some light as to
how the committee considered and addressed these
disproportional impacts of COVID-19 on Black, Latino, and
indigenous people in this country?
And is there any classification of the risks of essential
workers, those that are at high risk versus those who can self-
isolate, work from home that are at low risk and don't have any
underlying illnesses?
Dr. Gayle. Yes. Thank you very much.
And, you know, it was for the very reason you started out
with that this framework was asked for by the NIH and CDC so
that, in fact, as this moves rapidly, there was an overarching
guideline for these allocations.
And as you mentioned, you know, one of our principles, as I
mentioned in the report, in my statement, was the mitigation of
health inequities. We felt very strongly that we needed to
have----
Mr. Ruiz. So how do Latino, African American, and
indigenous people identify directly if they are not
specifically mentioned? And how are essential workers
categorized as high risk versus low risk?
Dr. Gayle. Right. And so, in our full report, you will see
a lot of discussion of this. But what we tried to do was to use
the Social Vulnerability Index, as well as the categories,
including high-risk critical workers, as a way of getting at
the issues because it's not because you're Black or Brown that
you are at risk. It's because of the social economics, the
historic impact on health as a result of racism and inequity.
And so what we really tried to do in our tiers, in our
phases, was to address those issues. And by using the Social
Vulnerability Index, which is an index that looks at minority
status, household crowding, other issues that put people at
risk, by using that as a guide across all of the different
phases, saying you should prioritize the geographic areas
that----
Mr. Ruiz. Well, are there any recommendations to have
transparency and measure if these principles are being
followed?
Dr. Gayle. Well, you know, that's our role as the National
Academies is to do these studies. We did this at the request of
NIH and CDC, so we expect that they will look at these
recommendations and use----
Mr. Ruiz. So I would suggest that their recommendation, as
any public health expert would say, and I--you know, I am one
of those public health experts, graduating from the School of
Public Health at Harvard, that recommendations on evaluation,
transparency, metrics, in order for the community to see if
these systems are being followed, is important because the
current system has left out these communities and rendered them
high risk of getting infected and dying to begin with.
And I yield back.
Ms. DeGette. The Chair now recognizes Ms. Brooks for 5
minutes.
Mrs. Brooks. Thank you, Madam Chairwoman, and thank you
all, to all of our panelists.
And I completely agree with, I believe it was Dr.
McClellan, who said it is so critically important to help us
restore trust and make sure there is trust in the vaccines.
And so, Dr. McClellan, I want to talk with you about the
fact that we have these vaccine candidates in the phase III
clinical trials. We've already heard that they recently
released their vaccine protocols, that the companies have,
which contain details about how the participants are being
selected and monitored and the conditions under which the
trials could be stopped early if there were problems and the
evidence that researchers will use to determine whether people
who got the vaccines were protected from COVID-19.
So I think it's unprecedented that the companies are making
these disclosures at this point in the process. And how does
this level of transparency help the experts and but, more
importantly, the public--and I think that's what we are most
concerned about, it's the public's confidence in the safety?
And what, if any, additional information should these
companies be disclosing about their clinical trials or what
should the companies be doing to increase Americans' trust in
the COVID-19 vaccine process?
Dr. McClellan. Representative, I think the companies have
done a couple of things this time around that are unusual.
First, as you mentioned, more transparency than has generally
been the case about exactly what their trial plans are that
they are in the process of executing now.
Second, as we talked about earlier, a pretty extraordinary
written letter from all of the companies that are involved in
this vaccine development, stating that they are firmly going to
adhere to the FDA processes. So those are really important.
I know now people care so much about what's actually
happening in these trials. As we talked about before, there are
just going to be some things that we won't know for sure for a
little while. You know, are the events that are happening in
the trials related to the vaccines? What do they really mean?
And so when you get some of this transparency, it also
creates some opportunities for confusion. For example, some of
the studies, as is usually the case, have some review checks
along the way by that independent expert group, the Data Safety
Monitoring Board that NIH is generally involved with, and so
forth. And those may show that the vaccine is really working
way better than people expected.
That could lead to the trial coming to an earlier
conclusion, at least in terms of leading to a proposal to the
FDA. And that's gotten tied up in some of this discussion
around the, you know, could a vaccine happen before the
election? Very, very unlikely. Technically possible if there's
just an absolute home run, which I don't think we have seen
evidence of yet, but the trials are still ongoing.
So it is challenging through this process to make sure
people get transparency about the process but recognize that we
don't have answers for a lot of these questions yet, and we
really need to take the time, as we talked about, for the FDA
scientific review to happen on any emergency use proposal, for
it to be presented to--in writing with FDA comments and review
to that independent oversight group before we reach any
conclusions.
And, again, the more we can keep the politics out of this
the better.
Mrs. Brooks. Thank you.
Very quickly, Dr. Offit and/or Dr. Gayle, we are so
concerned about flu season, about children not getting vaccines
right now, vaccine hesitancy happening, not just with what's
coming with COVID vaccine but other childhood vaccines that we
are seeing a decrease in the numbers.
What are your recommendations for how we implement a better
strategy in making sure that we are tracking flu and COVID and
also getting children--making sure that they continue to get
vaccinated?
Dr. Gayle?
Dr. Gayle. Yes. Well, you know, I think we really need to
build on the existing programs we have. You know, we have such
a strong system for childhood vaccination that needs to
continue to be strengthened.
You know, I think it also, as has been mentioned in several
of the other questions by other panelists, you know, we've got
to restore the trust and confidence that has been eroded in
vaccines.
So I think, you know, those two things to me are essential,
you know, build on the systems that we know work, get the right
information out, and continue to build on the messages of why
it really makes a difference to have children vaccinated and
build on those systems that we know work.
Mrs. Brooks. Dr. Offit, in my 15 seconds?
Dr. Offit. Sure. So initially what happened was, because of
the pandemic, there was a dramatic decrease in childhood
immunizations for measles containing vaccine, pertussis, or
whooping cough vaccine as reported by the Morbidity and
Mortality Weekly Report. That started to come up. So I think
now that people are more comfortable going to the doctor's
office, that's come up.
But you're right, we need to certainly make sure we get a
flu vaccine coming into this next winter because of this feared
twindemic as they say.
Mrs. Brooks.OK. Thank you. I got my vaccine--my flu
vaccine.
Thank you, I yield back.
Ms. DeGette. Thank you.
The Chair now recognizes Ms. Kuster for 5 minutes.
Ms. Kuster. Thank you, Madam Chair, and thank you for this
hearing.
I just want to say at the outset--and, yes, this is
bipartisan--I got my flu vaccine as well. We are not trying to
politicize. The problem is that the President of the United
States has politicized this vaccine coming just weeks before an
election.
And we owe it to the American people to explain the process
and the system and the transparency in the hopes that one of
these multiple vaccine candidates will be proven safe and
effective.
But that will be only half the battle. Once we have an
approved vaccine, we still face the formidable challenge of
distributing hundreds of millions of the doses around the
country. This will be an unprecedented effort, and we need to
start preparations right now.
Dr. Khan, what are some of the essential lessons learned
from past vaccination programs, such as H1N1 pandemic,
regarding the mass distribution of the novel vaccine?
Dr. Khan. Thank you, Congresswoman Kuster.
As I have stated in my testimony, I think it starts with
appropriate messaging, so under promise, over deliver. Make
sure we have excellent planning at all levels, local, national,
State level, Tribal and territorial level. Make sure we have
prioritization.
We know there's not going to be enough vaccine the moment
it's released, and people need to understand why if there's a
hundred people in the hospital only two are getting it as
opposed to the other 98. So that needs to be clear up front.
And there needs to be--and part of the planning needs to
deal with the logistics. This is going to be logistically
extremely difficult. Unlike the H1N1 pandemic in 2009, in the
end there was only a need for one dose. In this case you need
two doses of the exact same vaccine 21 to 28 days apart, which
will be problematic.
There's complex requirements for storing these vaccines.
And then depending on how--what the size of the orders are,
those may need to be split up and sent to various places in
rural areas. And we talk about mass vaccination, but we need to
be careful what the word``mass'' means because during a
pandemic, you don't want, you know, hundreds of people all
gathered together because that's a good way to infect them as
opposed to protect them, and we would like to keep those two
pieces apart, the infection and the protection piece.
So there's going to be significant challenges throughout
the system. And then I didn't even get into the data systems,
which--
Ms. Kuster. So I was just going to ask you further about
one of the challenges with the vaccination program on this
scale is the data systems to track the distribution and
schedule the immunizations, especially if they need two
separate doses.
How important is this aspect? And what should Congress be
doing to ensure we have good data on a vaccination program?
Dr. Khan. So how do we strengthen the four or five systems
that are going to have to work together in terms of vaccine
tracking, immunization registries within the State, the vaccine
adverse event systems.
So there's three vaccine--actually, there's another VAM
so--which is overarching vaccine systems. How do you make sure
those are working, are robust, are interoperable. And will give
you the data real-time that you will need to ensure that not
just where the vaccine is being distributed but it's actually
getting into people's arms and what the side effects are.
And that's going to be critical going back to Dr. Helen
Gayle and others' comments about equity to make sure that as
the vaccine is getting out that we are being equitable in the
distribution. And that's only going to be determined by data.
Ms. Kuster. And, Dr. Offit, is our existing health
infrastructure adequate to meet the storage and transportation
needs for national and equitable distribution, including rural
communities, communities of color that have been
disproportionately hit by the COVID-19 pandemic?
And then distributing a global vaccine will require
extensive air travel via cargo flights. Do we have the
workforce and capacity to achieve this logistical feat?
Dr. Offit. Well, I think the one thing in this that does
worry me is the requirement of at least for one of the
messenger RNA vaccines, the MRNA vaccines, to shift and store
at minus 70 to minus 80 centigrade, which will require then at
least, you know, dry ice constantly being needed to contain it.
And when they are doing studies now, which--where I'm sure
that the company has been very good about making sure that the
sites that are containing that virus should be maintained--or
the vaccine, when it gets out into the real world, it's hard.
There's no historical precedent for us maintaining vaccines on
dry ice in the United States. That's never happened. We've
always shipped and stored it at most at freezer temperatures,
not minus 70 or minus 80. So I do worry about that. I think
it's going to be an enormous challenge.
Ms. Kuster. Thank you very much.
My time is up and, Madam Chair, I yield back.
Ms. DeGette. Thank you, gentlelady.
The Chair now recognizes Mr. Mullin for 5 minutes.
Mr. Mullin. Thank you, Madam Chair, and I do appreciate
holding this hearing, although I am concerned by the fact that
everybody keeps brings up not to politicize it, the
administration is politicizing it. But, in some aspects, that's
exactly what this hearing is, we are politicizing it.
I had a constituent tell me a couple of weeks ago that
says, you know, you can tell when a natural disaster or a
national disaster is serious is when Republicans and Democrats
are both on the same page; but when we start politicizing it,
it becomes less serious.
And that's exactly what we are doing here. We have members
on this panel that is extremely bias towards the President, and
within our testimonies, you are hearing that. And that alone
drives down the confidence of the American people of do they
really need it, is it really that serious? Well, the fact is is
if you are one in the vulnerable positions, you do need to get
the vaccine, and you need to get it when it's available, not
worrying about if the President brought it out too fast.
Because do we really think that the pharmaceutical
companies or the FDA would allow that to happen? It's their
name. They are the ones that are trying to get it to the
American people to save lives. But the more we question it,
while underneath the disguise of trying to say we are trying to
keep the American people safe, the more we could actually cost
people's lives.
And we need to be very, very careful about that. Every one
of us have a responsibility to the American people and to the
public. Regardless if you are a witness or if you are a member
here, we need to keep that in mind. You, yourself, could be
driving down the confidence of the American people.
With that said, Dr. McClellan, I would like to talk to you
just real quickly about the pharmaceutical companies and the
vaccine. Do you think that the companies would knowingly
produce a vaccine that's unsafe for the public?
Dr. McClellan. No, Representative, I don't think so. And
they've affirmed the same thing in writing, and they're
affirming it by following the FDA's guidance on how to conduct
the development, the clinical trials, and making sure they are
doing safe manufacturing as well.
Mr. Mullin. So underneath President Trump's administration
with warp speed, do you think the pharmaceutical companies or
the FDA are cutting any corners in developing the COVID
vaccine?
Dr. McClellan. Well, the warp speed process is happening
much faster, and I know that makes people nervous about cutting
corners. It's important to recognize, though, that FDA is
firewalled off, even from warp speed.
So the work that the government is doing in Operation Warp
Speed with the companies on additional manufacturing and on
supporting these very large trials, with NIH getting them up
and running at an unprecedented pace is different from the
review that's going on independently by FDA.
So it's sort of like independent oversight within this very
accelerated process to make sure that--and that's FDA's role,
to make sure we're not cutting corners on the safety and
effectiveness evidence.
Mr. Mullin. Would any other panelist like to add to that?
OK. If not, we will go on then.
So are you confident, then, that when a vaccine is
authorized, that it will be safe to the public?
Dr. McClellan. Yes, I am. The other former FDA
commissioners, the group of seven, all stated their confidence
in the FDA process as well. We've heard that from Dr. Tony
Fauci, from Dr. Francis Collins, from other public health
leaders in and out of the administration.
Mr. Mullin. Well, thank you so much. I don't have anything
else.
With that, I will yield back.
Thank you sir.
Ms. DeGette. Thank the gentleman.
The Chair now recognizes Congresswoman Castor for 5
minutes.
Ms. Castor. Well, thank you, Chairman DeGette, for having
this very important hearing today on how we can ensure a safe
and effective COVID vaccine, COVID-19 vaccine. The experts have
been direct and straightforward and simply outstanding, very
helpful.
You simply can't gloss over the fact that the
administration's public health response to COVID-19 has been
weak and overly politicized. It's cost lives. It's caused a lot
of pain. So the importance of developing a safe and effective
vaccine is paramount.
Once a vaccine is approved, we will face the daunting task
of distributing it across the country. For that effort to be
successful, everyone must work together, our Federal agencies,
States, territories, local, and Tribal communities, and our
public health agencies.
At the last O & I hearing, I asked the vaccine
manufacturers about the importance of our State and local
public health professionals in vaccine distribution, and they
all agreed that our local trusted public health agencies are
critical to successful distribution.
Now, communities across America are very diverse, and COVID
is like bearer of many weaknesses in our long established
public health infrastructure, but it will be more critical than
ever that our State and local public health professionals are
empowered to implement an effective and timely vaccine
distribution.
Dr. Khan, you point to this infrastructure as a key
component of a successful COVID-19 vaccine distribution and
uptake, stating that, quote, We can leverage our Nation's
existing vaccine distribution infrastructure to ensure
efficient and equitable access to COVID-19 vaccine.
What role will they play as the partners for effective
distribution? And do you want to highlight any weaknesses in
that infrastructure now for us to address?
Dr. Khan. Thank you, Congresswoman Castor.
So let me start by saying that we don't need a vaccine, all
right. We know from experience from China, Vietnam, Thailand,
New Zealand, Taiwan that you can get pretty much zero cases
based on good public health practice, and those would be the
CDC guidelines that I discussed previously in guidance.
So we know--a vaccine is critical and will help do this,
but we know we can do this without a vaccine with the public
health tools we have today if we wanted to. And critical to
make that happen is that we have strong State and local,
Tribal, and territorial infrastructure to do what needs to be
done in terms of trace, isolate, contact, and ensure community
engagement around wearing masks, social distancing, and
handwashing.
This same infrastructure will be put to the test as we try
to undertake the most complex vaccine national campaign we've
ever done before. And Dr. Offit and others have highlighted why
it's going to be more difficult than what we had done, for
example, in 2009.
So do they have the people that are necessary to do all of
this? And this is not just the epidemiologists. This is the
epidemiologists, health communications, the laboratory people,
the emergency planners, the public health advisors.
I mean, it's a complete public health core of people that
we need to make sure they have and the associated resources
with those people to ensure that this vaccine is well planned,
can get out, has a need to get out within our communities.
Ms. Castor. Dr. Gayle, what is your view? You've devoted
your life's work to public health and boosting our trusted
authorities in that infrastructure. What do we need to be
focused on right now?
Dr. Gayle. Yes. Well, I would just add to what Dr. Khan has
already said is that what we really need to do is to make sure
that we make it possible for the systems that we know have
delivered for decades and decades have what they need to be
successful, you know.
And so all of the things that people have already talked
about around building those systems, you know, starts with
building the confidence in those systems, adequately funding
those systems, making sure that we have the personnel, and then
making sure that we have the data systems in place that are
going to be so important for continuing to track the
distribution. Also I think----
Ms. Kuster. So, Dr. Gayle, I'm afraid. I'm afraid because I
have watched in my home State of Florida over the past decade
where the public health agencies, they've let them whither on
the vine, and we don't have the same kind of infrastructure in
place. So what can we do about that?
Dr. Gayle. Yes. Well, I think, you know, part of it starts
with having the right kind of national leadership in place. You
know, it's always been important for vaccine efforts that we've
had a strong CDC, that the other agencies that are involved in
the immunization programs are fully funded, have the support
that they need.
So it starts with national leadership, national guidelines,
which is what the States, territories, and tribal leaders look
to to be able to then do what they do at the State, local, and
territorial level.
So, you know, you have to have those systems in place with
the national guideline, the infrastructure, and then make sure
that those are then being partnered with the State, local, and
territorial leaders, who really are the ones who can get to the
people and make sure that these programs are implemented.
But it takes having that whole system. You can't have the
fractionated, fragmented system. You need the whole system
working in tandem.
Ms. Castor. Thank you very much.
Ms. DeGette. I thank the gentlelady.
The Chair now recognizes Mr. Duncan for 5 minutes.
Mr. Duncan?
Mr. Duncan. Thank you, Madam Chair.
A hearing entitled, Pathway to a Vaccine: Ensuring a Safe
and Effective Vaccine People Will Trust, has taken a lot of
different paths today, and it's been very interesting to hear
the comments from my colleagues in Congress but also the
panelists.
I thought Mr. Khan's comments recently about, we don't need
a vaccine, we can do all these other things, and we're spending
billions of dollars on development of a vaccine. And I don't
disagree with him. I believe in herd immunity. I believe in
taking those necessary steps. We have a flu vaccine too. We
could take a lot of those same steps and probably eliminate a
lot of folks catching the flu, but yet we push a flu vaccine
every year. So--and it's just kind of interesting to hear the
banter back and forth.
I agree with Markwayne Mullin. Y'all talk about how this
thing, you're not trying to politicize it, but you're doing
exactly that by pointing out that the President said this,
that, and the other. I will say one thing about the President.
He's a real estate developer and a businessman who had to rely
on the CDC experts, epidemiologists like Dr. Fauci, to give him
the advice, and they have been all over the board. So if
they're advising the President and he seems to have been all
over the board, things he's said, it's because of the advice
he's been given by nonpartisan members of the CDC. So--and
other organizations that advise him.
I want to ask Dr. McClellan. You know, I understand that
FDA Vaccines and Related Biological Products Advisory
Committee, which is an independent forum of government--
independent from the government, and pharmaceutical companies,
they review and evaluate data concerning the safety,
effectiveness, and appropriate use of vaccines and related
biological products. My question is this: Why should the
American people have confidence that this committee will
provide unbiased recommendations regarding a COVID-19 vaccine
to the FDA Commissioner when we've seen so much partisan
rhetoric from all fronts, not just my colleagues, from Members
of Congress, but really the media and other groups? How can we
have confidence as the American people that this committee will
provide unbiased recommendations, Dr. McClellan.
Dr. McClellan. I have a lot of confidence in the committee,
and it goes from my own experience. You know, I was FDA
Commissioner not at a time of this level of public health
emergency but through a whole series of public health
emergencies, including dealing with the first coronavirus,
SARS.
And, you know, the agency is used to getting pressure and
different views, both political pressures and different
scientists somehow--sometimes have different views and
different interpretations of the evidence. As well, the
evidence evolves over time, so what we thought might be the
best answer, you know, in February is not what we----
Mr. Duncan. You know, wait a minute. Let me--let me ask
you--let me stop you right there, Dr. McClellan, and then to
say, you've just said this was--basically, I know it's a novel
coronavirus known as COVID-19, and we actually were learning
things about the virus from the time it came on the scene in
January until today, that things that we learn, we shift
course, right? So they're saying the President has lied to the
American people, basically shifted course based on the
knowledge that we learned about the virus. Would that not be
fair to say?
Dr. McClellan. Well, I think to your question is, do I
trust the advisory committee? I trust that they will bring all
this information together, they'll use the FDA's expert
oversight and experience to enable FDA to make an informed
decision that reflects all of the science. And that's a process
that I think we should have a lot of confidence in.
Mr. Duncan. So let me talk to Dr. Offit. In the last
vaccine hearing back in July, I questioned a witness on how
they would create a vaccine that is safe and effective for the
most vulnerable population. We know who the most vulnerable
are, and that's the 60-plus population, especially those with
underlying health issues or comorbidities.
In an interview you did with MetScape, you stated,
regarding individuals in the 65-and-up age group: I can't see
how anybody--the Data Safety Monitoring Board or the FDA
vaccine advisory committee--would ever allow a vaccine to be
recommended for that group without having adequate data.
My question to Dr. Offit, do you stand by that statement
today?
Dr. Offit. Sure. I'm on the FDA's vaccine advisory
committee. I mean, if you wonder how we operate, I can tell you
how we operate. We operate as scientists, clinicians,
academicians. That's what we are. Politics doesn't enter into
that at all. We are given a--
Mr. Duncan. Do you think Dr. Fauci has operated as a
scientist?
Dr. Offit. Absolutely.
Mr. Duncan. You think the other advisers to the President
within the epidemiologist field have operated as scientists?
Dr. Offit. I think Dr. Collins and Dr. Redfield have
operated as scientists. I think that--well, that's what I
think. You want me to tell you what--I'm sure I'm going to----
Mr. Duncan. Absolutely. They have operated as scientists
and they have advised the President about a novel coronavirus
known as COVID-19, which we have learned more and more about as
the virus has been evident within the population. And so, sure,
as the data comes in, remedies and other things will change.
Dr. Offit. Well, you always learn as you go. I mean, but
the point is, you have to be open-minded to the fact--to that
knowledge and adjust your recommendations based on what you
learn. And now we know. I mean, what do we know? We know that
masks work, even though--even though you'll have, for example,
Rose Garden meetings, or you'll have these rallies where
everybody is inside not wearing a mask. You know, you know
what----
Mr. Duncan. What about protests?
Dr. Offit [continue]. Didn't work, yet still it was pushed.
You know that convalescent plasma had no evidence for--that it
worked, but it was pushed. I mean, it's not--I don't understand
why we're having this meeting, to be honest with you. We
shouldn't need this meeting, because we should trust the FDA.
We don't trust the FDA largely because of what has happened
with the administration's pushing the FDA to do things it
shouldn't have been doing. That's why people are upset about
this.
Ms. DeGette. The gentleman's time is expired. The Chair now
recognizes Mr. Sarbanes.
Mr. Duncan. Just like some people are now in nursing homes
when they shouldn't be there.
I yield back.
Ms. DeGette. The Chair now recognizes Mr. Sarbanes for 5
minutes.
Mr. Sarbanes. Thanks, Madam Chair. Can you hear me? Good.
Ms. DeGette. I can hear you, yes.
Mr. Sarbanes. So I want to return to a topic that's been
touched on because I'm very concerned about this decline in
confidence we see in the public when it comes to the COVID
vaccine that we're working on, and we've seen that confidence
decline over the last few months pretty precipitously.
In a Pew survey, only 51 percent of U.S. adults now would
get a vaccine if one were available, and that's down from 72
percent in May. And a Kaiser Family Foundation poll found that
62 percent of Americans worry that political pressure from the
Trump administration will lead FDA to rush in its approval of
the vaccine without making sure that it's safe and effective.
So that's not a good situation to be in. That's very alarming
as we're trying to tackle this pandemic.
Dr. Khan, in your testimony, you emphasize, ``Trust of the
vaccine will be as important, if not more so, than the safety
and efficacy.'' That's a pretty powerful statement. I wonder if
you could elaborate on it.
When you're thinking of factors, you always--you think
efficacy and safety are right at the top of the list, but
you're saying you got to put trust up there or else it will not
be effective. Can you talk to that a little bit?
Dr. Khan. Yes. Thank you, Congressman Sarbanes. I'll give
you two specific examples. So the first example was with the
H1N1 outbreak in 2009, when individuals failed to get vaccine,
when they thought they were supposed to get it, that they--in
the end, I believe only about 27 percent of Americans got
vaccinated. So we did not vaccinate as many Americans as we
would have wanted for H1N1 because of this mistrust in what
they were being told.
The second example I will give you is for a highly
efficacious Lyme vaccine that was taken off the market in three
years, not because of any concern about efficacy or side
effects but due to a perceived efficacy of side effects. So
there was--essentially, it lost within the public cord of
trust, and that vaccine was pulled from the market.
So there's two examples right there where trust were really
critical to allow us to get to the vaccine coverages we would
have liked to prevent those diseases.
Mr. Sarbanes. You're pointing to how tenuous this trust can
be with the public and how careful we have to be in the process
in order to convey that sense of comfort and safety and
efficacy that will allow people to take advantage of this
opportunity when it presents. And that's what's really at stake
here and I think is cause for real concern.
Dr. Offit, you said in your testimony, the administration's
politicization of science in areas like masks, hygiene, and
social distancing, as well as the push to approve drugs like
hydroxychloroquine or biologicals such as convalescent plasma
through an EUA without clear evidence of safety or efficacy,
caused some to wonder whether the same low standards would be
applied to a COVID vaccine.
Answer this for me. We could go a long way towards
restoring trust, could we not, if the President, if the
administration, the political people, in other words, not the
public health experts but the political folks who operate in
this space, beginning with the President, who's, you know,
leading the executive branch, if they would ally themselves
with the public health experts and follow them?
It doesn't mean you don't watch over the process. It
doesn't mean you don't kick the tires and make sure it's being
vetted properly, but you could convey broadly your view that
the public health experts, the scientists, the people that are
most knowledgeable in this field, are the ones that are going
to call the shots. And couldn't that very quickly, if that was
the posture the President and the administration took, couldn't
that begin to restore trust in a meaningful way? Could you
speak to that?
Dr. Offit. Absolutely. I mean, people look to the President
for leadership. And at the very least, as Dr. Redfield and
Fauci and others have said, other countries have done much
better on getting on top of this pandemic, and we have--and the
biggest reason is the hygienic measures. That is the most
powerful thing to do. That is more powerful than vaccines.
I mean, as I'm walking down the halls a couple weeks ago
when I'm at Children's Hospital of Philadelphia, a hospital
that is now loaded with children who have COVID-19, I mean, if
you gave me the choice of a mask or a vaccine, I would choose
the mask every time. And it's such an important tool, such a
powerful tool, and I think, you know, the President could do so
much to promote that, and he doesn't.
Just one other thing, by the way, I grew up in Baltimore,
Maryland; huge fan of your father.
Mr. Sarbanes. Thank you very much.
Madam Chair, as I yield back, I would just say that if
you're fighting with the public health experts, you're
politicizing this, and if you're allying yourself with them,
then you're depoliticizing it.
And with that, I yield back.
Ms. DeGette. I thank the gentleman.
Do we have Mr. Burgess on the phone? He's next on my list,
but I don't see him. Going once, going twice?
Mr. Peters, I'm going to recognize you for 5 minutes.
Mr. Peters. All right. You surprised me, Madam Chair. Sorry
about that.
Ms. DeGette. Sorry.
Mr. Peters. I would just--I would just offer, a lot of the
questions that I had have been answered, but just to follow
along with what Mr. Sarbanes was saying, I think you and Mr.
Guthrie deserve credit for putting on this hearing. The idea is
that it not be political, but, you know--and I think to--even
to throw a bone to the administration, I like the idea of the
way that Dr. Fauci has characterized this warp-speed effort.
That effort, by the way, is to accelerate manufacturing
once a safe vaccine is developed. And he's emphasized over and
over again that the risk that we're taking is a financial risk,
and it's--and I think that's totally appropriate. So that once
you have a formulation, that you would be able to hurry up in
making it available. I think that makes all the sense in the
world.
But I do think it's important for all of us--and you may
call this political--if anything you say against President
Trump is necessarily political, I suppose it's political. But
it's necessary for us to say, you can't set a date for this
vaccine to be safe. That's something that has to follow through
the process of--that we've developed over many years and which
we're not just lucky to have, but we're smart to have in our
country, to develop these vaccines. And we have the confidence
that our public health infrastructure, from research to
industry, can come up with a vaccine. I think we all believe
that that's true. We'd maybe like to see a one-dose vaccine.
But in any event, I don't think it's--I don't think it's
inappropriate to call out any politician who suggests that that
timeline should be modified to fit a political schedule. And I
think that's absolutely appropriate. So I would just say, I
appreciate the testimony of the witnesses. And I'll yield back.
Ms. DeGette. I thank the gentleman, and I want to agree
with your comments.
Do we have Ms. Clarke on the phone?
Oh, there she is. Ms. Clarke, you're recognized for 5
minutes.
Ms. Clarke. Thank you so much, Madam Chair.
I've been listening attentively, and so much of the
concerns that we've had have been--have been responded to. But
I want to raise the issue, being a New Yorker who was at the
epicenter of this outbreak, around things that we can do to
really drill down on how we continue to protect ourselves. I'm
concerned about the mixed messaging around the public health
protocols that have been working in tandem with our awaiting of
a vaccine.
We know that today's hearing focuses on what much of the
world is eagerly anticipating: The approval of a safe and
effective vaccine for COVID-19. And we're all rooting for that,
but we all must keep in mind the bigger picture.
Public health experts have been warning for months that an
eventual vaccine, while critical, will not be a silver bullet
that instantly kills off this pandemic. And I really want us to
drill that home with the American people when I see there being
some retreating from the initial protocols that has brought New
York City down to record lows. And we're beginning to see small
upticks. It's because, I believe, people are beginning to relax
around those public health protocols.
So, Dr. Jha, we can all agree that a vaccine will be a
critical tool in this fight. Why won't this be like flipping a
switch? Will a vaccine alone be enough to stamp out this virus
or will we still need to rely on other public health measures
to some extent?
Dr. Jha. So, Congresswoman, thank you for that critical
question. And, of course, we all wish it would be like a light
switch that we could flip on, life would go back to 2019, and
we could move forward. There are several reasons why it won't
be that way.
First of all, even under the most optimistic scenarios, I
don't expect the vaccine to be 98 or 100 percent effective. If
it's 70 or 80 percent effective, that would be terrific.
There's so little we know about what will happen after you're
vaccinated, about your ability to transmit to others. And so it
may be that you're vaccinated, you may even be protected, but
you may still be able to transmit to others.
It is highly unlikely that 95 percent of Americans will get
vaccinated. In a good year, we get 60, 65 percent flu vaccine
uptake. But given all these issues of hesitancy, even if we're
effective at addressing them, a lot of people won't take it.
So if you have 70 percent of Americans, let's say, get the
vaccine, which would be wonderful, and 70 percent efficacy,
that doesn't get you kind of population level everything is
done. But let's be clear, it will be immensely helpful. It will
allow us much of our lives back, but there will be some high-
risk things we're going to need to continue to manage very
carefully.
We're going to have to continue probably avoiding large
indoor gatherings without masks. But I think a lot of the
things that we care most about--schools and work--a lot of that
will be possible again. And that's why the vaccine is so
incredibly important. But it is not a silver bullet. And even
into 2022, 2023, we'll still be dealing with this virus, though
hopefully it will be much better than where we are today.
Ms. Clarke. Thank you.
Dr. Khan, in your testimony you state, and I quote, ``we
cannot wait for a vaccine to contain this outbreak,'' that we
must use, and I quote, ``the public health tools we already
have available.'' So how does a vaccine fit into the larger
public health strategy for fighting COVID-19 if it will not be
a silver bullet and instantly end the pandemic?
Dr. Khan, you have to unmute.
Dr. Khan. Thank you, Congresswoman Clarke. I think Dr. Jha
has very nicely and succinctly stated why vaccine itself is
insufficient. Vaccine needs to sit on top of a public health
response. We know that this public health response can contain
disease from experiences in not just now multiple countries but
what we actually saw in New York and what we're seeing in a lot
of the northeast.
So we know these public health measures by trusted
guidance, by trusted CDC scientists can make a difference. We
know what the control tetra is. There's four things you need to
do. We've known this from back in January. The first is
integrated, coordinated, local, State, national leadership,
that's evidence-based, consistent messaging, looking at
metrics. That's number one is leadership.
Number two is drive down community transmission, with
trace, isolate, and quarantine people.
Number three, increase community engagement. That's masks,
hand-washing, social distancing.
And number four, which we're actually doing a very good job
at, is decrease deaths amongst people who unfortunately still
get infected. And our case management has markedly improved,
and our options--our therapeutic options have markedly improved
that we've been dropping down deaths.
But those are the four things that we need to do, and we
still have not fully implemented those in the United States
yet, which is why we see 750 deaths a day, and why we can't
wait for the vaccine to drop these deaths down to zero or as
close to zero as we can get.
Ms. Clarke. Thank you very much.
Madam Chair, after having experienced what I did in New
York City, it pains me to see the rest of the Nation going
through what it's going through, that they have not learned
from our experience and what we have done to keep our curve
flat. I hope that this discussion today, in collaboration with
the vaccine, will really provide a guide, a roadmap, to those
portions of the Nation that are still struggling with the
answer to keeping Americans safe.
And I yield back the balance of my time.
Ms. DeGette. Thank you so much.
I believe now all of the members of the subcommittee have
asked their questions, and I'm now pleased that we're joined by
several members of the full committee who are not subcommittee
members. And I'm going to start with Congressman Carter.
Congressman, you're recognized for 5 minutes.
Mr. Carter. Thank you very much, Madam Chair, for allowing
me to participate.
Let me begin by saying that, you know, as a practicing
pharmacist for over 30 years, confidence was extremely
important. When I recommended a product to--an over-the-counter
product to a patient, it was important for me to be confident
and to exude confidence that this was going to work for that
patient.
So, you know, having said that, we've spent a lot of time
today talking about the politicizing, if you will, of this
whole vaccine and this whole process. And I want to just say
that as a healthcare professional, as a pharmacist, I find it
irresponsible that Members of Congress would be doing this.
This is something that we should all be together on.
I've dealt with the FDA. I have seen the process work. Over
30 years, I've seen products that were--that went all the way
up to the fourth stage and then were not allowed to go any
further. I've seen that happen, and that's--that has built up
confidence in me in the process and knowing that the process
works. So that's all I'm going to say about politicizing this
whole ordeal.
I want to talk about something that's very important, and
that is distribution of this, and making sure that we have the
process in place, specifically, the critical aspect of allowing
pharmacists to be able to administer this vaccine.
Dr. McClellan, I want to ask you, 95 percent of all
Americans live within five miles of a pharmacy. Pharmacists are
the most accessible healthcare professionals in America. In
order to make sure that when we get this vaccine safe and
effective and when it is out there, in order to make sure that
it gets out, would you agree that pharmacists need to be able
to administer this COVID-19 vaccine?
Dr. McClellan. Yes, Representative, I agree. We've got
experience in the pandemic of pharmacists playing a critical
role in access to testing and helping people respond more
quickly, get greater access there, in helping with flu vaccines
and other issues that also play into the pandemic as we talked
about already today.
And they're also an important part, as you've said, of that
trust. People still trust their health professionals, their
doctors, their pharmacists, even if it's gone down for FDA
unfortunately, and that's another check on making sure that
we're going to really have an effective vaccine that can be
brought to the public. So pharmacists have a critical role to
play in this.
Mr. Carter. Well, I appreciate that. I always tell, one of
my favorite stories is the fact that I went from being a
pharmacist, the second most trusted profession in America, to
being a Congressman, the second least trusted profession in
America. But the point I'm trying to make here is that it is
important for pharmacists to be able to administer that.
Now, we've got a situation where a lot of the States have
authorized it, but we need a blanket policy, if you will, so
that we could have all pharmacists, whether it be independent
retail or chain retail, to be able to administer this in order
to get it out quickly.
Dr. McClellan, you were a former CMS Administrator, and I
wanted to ask you, you're aware of the issues that deal with
pharmacists getting reimbursed and being able to bill Medicare
for these types of things. This has led to a lot of problems.
And right now, we're trying to get a temporary pharmacist
provider status so that pharmacists will be able to get
reimbursed for administering these vaccines. Obviously, we've
got to have insurance, we've got to have coverage, everything
that we should have, in order to administer these vaccines.
That is something we've been working with CMS with in trying to
get that done.
Do you agree that Congress should grant temporary
authorization for pharmacists provider status to be able to
administer this vaccine?
Dr. McClellan. Well, Representative, if that's what it
comes to. As you know, CMS has authority to expand scope of
practice and coverage in a public health emergency. When I was
there, we did that in circumstances like in Hurricane Katrina.
So there are some precedents for handling this
administratively.
But I think this goes to one of the themes from today, is
that while there seems to be broad agreement that FDA's
processes around approval and to make a vaccine available are
in good shape--they're sound, they're science-based--we all
have work to do together on the distribution and access to the
vaccine, where that depends a lot on--you know, I'd love to see
more activity at the State level, the local level, focusing on
that, since we do have a good program in place for the safety
of the vaccine itself.
Mr. Carter. Right. Well, Madam Chair, again, this is--this
is not a partisan issue with pharmacists being able to be
granted provider status in order to distribute and to
administer these vaccines, and I would solicit your help, as
well as my colleagues on the other side of the aisle, as well
as everyone on this committee, to be able to help us to get CMS
to grant temporary provider status for pharmacists to be able
to administer the vaccines.
And I thank you, and I yield back.
Ms. DeGette. I think--Mr. Carter, I think you raise an
excellent point. Millions of Americans get their flu shots
right now at pharmacies, so we will work together with you on
that.
Mr. Carter. Thank you.
Ms. DeGette. The Chair is now pleased to recognize Mrs.
Dingell for 5 minutes.
Mrs. Dingell. Thank you, Madam Chair, and thank you for
allowing me, like you allowed my colleague from Georgia, to
wave on. And I'd just like to tell my colleague from Georgia,
when we know this vaccine is safe, I trust him to have him give
it to me.
But that's one of the things that people have been talking
about all day and--both members and the witnesses--about
ensuring that any eventual COVID-19 vaccine is safe and
effective, and making sure it's available is going to be
critical when we know it's safe.
Given the magnitude of this challenge, I appreciate the
committee's constructive role in helping shed light on the
challenges we face as vaccine candidates progress into Phase 3
clinical trials.
Dr. Jha, I wanted--you noted in your testimony that while
we sometimes accept a certain level of potential harm in any
experimental treatments for those who are severely ill,
vaccines are given----
[Video malfunction.]
Dr. Jha. Am I frozen?
Ms. DeGette. I believe we've lost----
Mrs. Dingell [continue]. FDA's----
[Video malfunction.]
Can you hear me?
Ms. DeGette. Yes, we can hear you now.
Dr. Jha. So I believe I have the gist of the
Congresswoman's question, so I can take a shot at it.
Mrs. Dingell [continue]. Analysis of whether to authorize a
COVID-19 vaccine, which as you point out would----
[Video malfunction.]
Ms. DeGette. OK.
Mrs. Dingell. Can you hear me?
Ms. DeGette. You know what, Debbie, Dr. Offit thinks that
he gets the gist of your question, so we'll go ahead and have
him answer.
Dr. Jha. Yes. I believe----
Mrs. Dingell. OK.
Dr. Jha. I think she was directing that to me.
So, Congresswoman, I think the question is really
important, and this is an important point that I think American
people need to understand, is that we do use a different bar
for using emergency use authorization for therapies because
these are for sick people who otherwise might die and you have
a lower threshold for what you would call effectiveness.
And when you give vaccines, you're giving it to healthy
people. And we know how to protect healthy people without a
vaccine. We can protect healthy people by having people wear
masks, by doing social distancing, by all the things that we
know about.
And so you have to have a relatively high bar for
authorizing a vaccine. This is a basic principle of medicine,
of first do no harm. Whenever you intervene on healthy people,
you have to have very clear evidence that you're going to do
much more good than you are harm to that person. And that is
why one of the reasons why we've all have said that, and
actually the processes at the FDA around vaccines have
acknowledged this and I think have been built around this, but
it's been really critical to all of us that those processes be
followed in the COVID-19 vaccine development and approval.
Mrs. Dingell. And so I am not an anti-vaxxer, let me make
that clear, but I'm a swine flu, Guillain-Barre person, so I
did----
[Video malfunction.]
Ms. DeGette. You're frozen again.
Mrs. Dingell. I'll yield back.
Ms. DeGette. OK. Thank you.
And all members can submit questions for the panelists in
writing, so we can have you go ahead and do that.
The Chair now recognizes Mr. Bilirakis, if he is still with
us.
Mr. Bilirakis?
Ms. DeGette. OK. I see he's sitting down.
Mr. Bilirakis. What we're trying to do is get this----
Ms. DeGette. Mr. Bilirakis, you need to unmute.
Where did he go?
OK. We've lost Mr. Bilirakis, and so I'm going to recognize
Mr. O'Halleran for 5 minutes.
Mr. O'Halleran. Well, thank you, Madam Chair, I appreciate
that. And thank you to the panel for all their great
conversations and information that they've put forward this
morning and this afternoon.
Over the past six months, this committee has held multiple
hearings featuring public health experts and officials, as well
as witnesses from pharmaceutical companies involved in the
development and manufacturing of the vaccine, while discussing
the public health response to the coronavirus pandemic.
Through the CARES Act, and as we have seen, the government
made significant investments, in a bipartisan way, in the
private sector to manufacture and scale a vaccine to protect
Americans from the coronavirus. And early reports on
development of vaccines are promising. The release of an
effective vaccine will mark a milestone in scientific progress
and will serve as an effective weapon to finally defeating the
public health crisis.
However, Americans are confused and scared. A Pew Research
Center poll released just two weeks ago showed that only 51
percent of Americans, adults, would definitely, or probably,
get a COVID-19 vaccine if it were available today. These
numbers represent a 21 percent drop from survey numbers
released in May. This has the potential to be a massive--of
massive concern.
I also want to address the issue of what this means to
development of future vaccines and future medicines as we go
down a path of injecting politics into this process. This is
about scientists and researchers and the process as it has been
for many, many decades. In my mind, we need--much transparency
is needed in the vac---from the vaccine manufacturers, our
public health agencies, like CDC, FDA, and NIH, so that the
public knows the vigor and the scientific discovery that are
going into the development of these products.
Unfortunately, we're seeing the current process that has
casted doubts on our apolitical public health agencies with new
stories being released daily. Clear and straightforward
information from our leaders is necessary to ensure that
Americans are vaccinated when these products are brought to
market.
Further communication is also needed from the
pharmaceutical companies, though, and their role is critical,
and their business depends on public trust that their vaccines
and medications work as intended. The American people need
unprecedented transparency from pharmaceutical companies to
explain what the vigor--various trial stages mean, what
possible side effects are, and eventually when a vaccine is
approved, are the individuals who may be given the drug, are
they compromised in any way. This first vaccine will not be the
last vaccine and hopefully will not be the only vaccine.
Dr. Jha, I would like to ask you, you have cautioned
against politicians publicly suggesting dates by which a
vaccine will be available. Can you talk about how political
intrusions into the vaccine development process are harming
Americans' trust in our public health officials and public
health agencies, and importantly, how this will be undermining
the importance of Americans being able to be vaccinated when a
safe and effective vaccine is approved? Thank you.
Dr. Jha. So, thank you, Congressman, for that very
important question. The bottom line is that so far, the
scientific integrity of the vaccine process has been superb.
It's been really world-class scientists working in the private
sector, working with NIH, to do what I think is an unbelievable
job in bringing a vaccine forward in record time.
The problem is that when I speak to people working on the
clinical trials, they can't give me a day. They don't know when
a vaccine is going to be ready for--there are processes for
looking at the data. There are independent boards that are
going to be doing this. And what we all want is we all want a
vaccine yesterday, but we want a vaccine that's safe and
effective, and we've got to let the science play that process
out.
And it makes me very anxious when I hear CEOs of companies
who technically don't have access to the data or political
leaders who are picking specific dates and saying, we're going
to have a vaccine by a specific date. I know that they don't
know what they're talking about. I'm hoping they're not
meddling in the process, but it makes the American people
deeply concerned because they don't know all of the safeguards
that are in, and we all worry that those safeguards are going
to be undermined.
So what I've been asking is for politicians to basically be
quiet, to knock it off, to stop talking about dates, let the
scientific process move forward, and we'll have a vaccine when
the scientific process, run by the FDA, and other scientists
will declare, based on scientific principles, that the vaccine
is ready for authorization and eventually approval, but not a
day before then, unfortunately. And that's what we have to work
on.
Mr. O'Halleran. Thank you. Madam Chair, I yield.
Ms. DeGette. Thank you so much.
OK. Mr. Bilirakis, you're going to have the last word. I'll
recognize you for 5 minutes.
Mr. Bilirakis. Thank you. Thank you, Madam Chair.
Appreciate it. We had technical issues. I'm sorry about that
before, but thank you for giving me the time.
Dr. Gayle, I understand that you are here in your capacity
with the National Academies, but given the importance of
enrolling diverse populations in large-scale COVID-19 clinical
trials, I wanted to ask whether your organization, the Chicago
Community Trust, has undertaken any efforts to promote and
encourage participation in clinical trials among racial and
ethnic minorities. And if so, would you be able to share the
details of those efforts?
Dr. Gayle. Yes. Thanks so much for your question. And I
would just say, you know, here in Chicago, we have an
outstanding department of public health that has really
wonderful relationships with the community. We continue to work
with them. We have had a really close relationship with them
throughout this pandemic, and we'll continue to work with our
department of public health to make sure that these efforts
actually serve all people.
And so we don't have specific details now but just to say
that this is something that we here in Chicago feel is
incredibly important, and we've always put health equity at the
center of the work that we do in public health. And so, you
know, we will stand by our public health department and, you
know, make sure that we can be part of making sure that this
vaccine, when it's available and safe, is something that is
available in an equitable fashion.
And our guidelines that, you know, we're talking about in
this hearing, really puts a real focus on equity and on
mitigating health inequities because we know that has been so
much a part of this pandemic. It's been highlighted, the long-
standing health disparities that exist in this country among
people of color, and so this is going to continue to be a big
focus for us as an organization and clearly as something that's
highlighted in our report.
Mr. Bilirakis. Thank you. Thank you.
My next question is for Dr. Khan. Can we reach out to
communities--how can we reach out, tell us how to reach out to
communities and groups that are disproportionately affected by
COVID-19 but have high rates of vaccine hesitancy. And who are
the most effective messengers to these communities? I think
this is so vitally important. Dr. Khan, if you could respond,
I'd appreciate it.
Dr. Khan. Thank you, Congressman Bilirakis. So I would say
you need to reach out with them for their current concerns
about how the disease affects people of color
disproportionately, their access to care, their access to
testing. And so that needs to happen now based on those issues
to develop the trust once it comes to the vaccine being
available. And that needs to be done by local and State health
department working with the local community organizations, make
sure that you're engaging those organizations, including faith-
based organizations in that work.
So that's a good community engagement work you need to do.
And as part of that work, you can help protect that community
today with the tools that are available to us. So please, you
know, make sure you make yourself available for contact tracing
if somebody calls, please wear a mask, wash your hands, social
distance. Right? So it's working with the community now to
decrease transmission that will markedly increase the trust
once the vaccine comes in to help all of our communities get
vaccinated.
Mr. Bilirakis. Excellent, excellent.
All right. Dr. Offit, are you familiar with the vaccine
hesitancy education programs? And if so, can these programs
help increase public confidence and increase immunization
rates?
Dr. Offit. Yes. No, I think most people who are [inaudible]
This vaccine, hesitant or just skeptical, and they should be
skeptical. I think you should be skeptical of anything you put
into your body, including vaccines. I mean, if you asked me
would I get a COVID-19 vaccine right now, I'd say, no, I want
to see the data first, because I'm skeptical like--as is true
of everybody who sits around the FDA Vaccine Advisory Board.
And so I think when that's true, I think that what you do
is you use reason and logic and passion and compassion to try
to explain those data, to frame those data in an emotional,
human story, to let people know that a choice not to get a
vaccine is not a risk-free choice. It's a choice that they take
a different and arguably more serious risk. So you have to
explain, here's what we know. I mean, we know, say, that the
vaccine is safe in 20,000 people. That doesn't mean it's safe
in 20 million people. But there are systems in place like the
vaccine safety data link and others to find those rare adverse
events when they occur.
We don't know--we know this vaccine, let's say, is 75
percent effective, but we don't know for how long it's
effective. But we will know that over time. And so then the
question when you launch a new vaccine is not whether you know
everything, you don't know everything. The question is when do
you know enough. And of those things that you don't know, how
are you going to find them out in the near future. And I think
with most reasonable people, what I would call vaccine
skeptics, you can do that.
I think there is a group, and they're a much smaller group,
although arguably disproportionately loud, who I would call
anti-vaccine activists. I mean, these are largely conspiracy
theorists who just believe that the pharmaceutical companies
control everything, control the government, control the medical
establishment. I just don't think you can reason with them. I
mean, as Neil deGrasse Tyson says, if someone comes to a
conclusion that--without using logic or reason, you're not
going to talk them out of it using logic or reason. I think
that's true here too.
So I think most of the people who I talk to, I'd say 85
percent of the people who are concerned about vaccines are
reasonably concerned and can be talked, I think, talked down,
as long as you provide data in a clear, compelling, and
compassionate way.
Mr. Bilirakis. Thank you very much. I appreciate it.
I yield back, Madam Chair.
Ms. DeGette. I thank the gentleman.
And I want to thank all of the witnesses. I think I can
speak for everybody on both sides of the aisle here that in
agreeing with what Dr. Jha said, which is the integrity of the
research process that we've had so far has been superb. We have
the pharmaceutical companies working at breakneck speed through
Operation Warp Speed, and we're hoping that we'll get a vaccine
as quickly as possible, but that we really can't--I think, Dr.
Jha, as you and the other panelists said, we cannot force a
timeline, and all of us just have to be ready to accept a
timeline. We hope it's fast, but we can't be stating dates. And
politicization includes, not just meddling in the research
process, but also announcing deadlines or timelines before
they're--before they're really appropriate.
So I think it's just imperative that we follow the process.
It's imperative that the public has confidence, and that's what
this hearing was all about today.
Frequently people ask me, why do you do oversight hearings?
And the reason we do oversight hearings is to shine the light.
Because sunlight is the best disinfectant, and we think the
more we have experts like you coming and talking about the
process and what we need to do, then the more likelihood it is
that we will have a process that will not be meddled with and
that will produce not one, but we hope more, safe and effective
vehicles.
So I want to remind Members that they have ten business
days to submit additional questions for the record to be
answered by the witnesses who have appeared before the
subcommittee--looking at you, Representative Dingell--and I
also want to ask that the witnesses respond quickly to any such
questions should you receive any.
We have some documents that have been asked for the record.
We have Mr. Walden's request, the second wave project report on
vaccines and therapeutics from the committee's minority staff,
dated July 1, 2020; the clinical trial protocols from four
COVID-19 vaccine manufacturers--Moderna, Pfizer, AstraZeneca
and Janssen vaccines; the letter signed by nine drug companies
pledging the safety of any COVID-19 vaccine, dated September 8,
2020; the FDA guidance to industry on COVID-19 vaccines, dated
June 30th 2020; a USA Today opinion from senior FDA career
staff, dated September 10, 2018. We have The Washington Post
opinion from seven former FDA Commissioners on the Trump
administration undermining the credibility of the FDA, dated
September 29, 2020, which I offered; and then we have the Oxfam
report on the world's COVID-19 vaccine supply, dated September
17th, 2020.
Without objection, these articles and information will all
be entered into the record.
[The information appears at the conclusion of the hearing.]
Ms. DeGette. And with that--thanks again to everyone--this
subcommittee is adjourned.
[Whereupon, at 2:21 p.m., the subcommittee was adjourned.]
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