[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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