Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine (Hearing, 2020)
Summary
Transcript of the virtual hearing "Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine" before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, July 21, 2020, Serial No. 116-121, with Chairwoman Diana DeGette presiding via Cisco Webex. Frank Pallone, Jr. said in an opening statement that more than three million people in the United States had been diagnosed with COVID-19 and more than 140,000 had died, and sought transparency on Operation Warp Speed. Witnesses were Menelas Pangalos of AstraZeneca, MaCaya Douoguih of Janssen Vaccines, Johnson & Johnson, Julie L. Gerberding of Merck, Stephen Hoge of Moderna and John Young of Pfizer.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Cite this document
“Pathway to a Vaccine: Efforts to Develop a Safe, Effective and Accessible COVID-19 Vaccine (Hearing, 2020).”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/house-hearing-116th-congress-pathway-to-a-vaccine-efforts-to-develop-a-2130deeb6c/
, SHA-256 97288bef1065cacb4ce05d4e92cba36146909243c0f29140647c954bb690102c.Full text
[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
PATHWAY TO A VACCINE: EFFORTS TO DEVELOP A SAFE, EFFECTIVE AND
ACCESSIBLE COVID-19 VACCINE
=======================================================================
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
__________
TUESDAY, JULY 21, 2020
__________
Serial No. 116-121
[GRAPHIC(S) 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
55-508PDF 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. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 2
Prepared statement........................................... 4
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 5
Prepared statement........................................... 7
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 8
Prepared statement........................................... 10
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 11
Prepared statement........................................... 12
Hon. Anna Eshoo, a Representative in Congress from the State of
California, prepared statement................................. 99
Witnesses
Menelas Pangalos, Ph.D., Executive Vice President,
Biopharmaceuticals R & D, AstraZeneca.......................... 14
Prepared statement........................................... 17
Answers to submitted questions............................... 101
MaCaya Douoguih, M.D., MPH, Head of Clinical Development and
Medical Affairs, Janssen Vaccines, Johnson & Johnson........... 25
Prepared statement........................................... 27
Answers to submitted questions............................... 106
Julie L. Gerberding, M.D., MPH, Executive Vice President and
Chief Patient Officer, Merck................................... 35
Prepared statement........................................... 37
Answers to submitted questions............................... 110
Stephen Hoge, M.D., President, Moderna........................... 41
Prepared statement........................................... 43
Answers to submitted questions............................... 116
John Young, Chief Business Officer, Pfizer....................... 49
Prepared statement........................................... 51
Answers to submitted questions............................... 120
Submitted Material
Letter of July 14, 2020, to Mr. Burgess, from Lillian Salerno,
Director of External Affairs, Retractable Technologies,
submitted by Ms. DeGette....................................... 100
Article COVID-19 Second Wave Preparedness Part 2: Vaccines and
Therapeutics, by Energy and Commerce Committee, Republication
Staff, submitted by Ms. DeGettee \1\
----------
\1\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF02/
20200721/110926/HHRG-116-IF02-20200721-SD004.pdf.
PATHWAY TO A VACCINE: EFFORTS TO DEVELOP A SAFE, EFFECTIVE AND
ACCESSIBLE COVID-19 VACCINE
----------
TUESDAY, JULY 21, 2020
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., via
Cisco Webex online video conferencing, Hon. Diana DeGette
(chairwoman of the subcommittee) presiding.
Members present: Representatives DeGette, Schakowsky,
Kennedy, Ruiz, Kuster, Castor, Sarbanes, Tonko, Clarke, Peters,
Pallone (ex officio), Guthrie (subcommittee ranking member),
Burgess, McKinley, Griffith, Brooks, Mullin, Duncan, and Walden
(ex officio).
Also present: Representatives Eshoo, McNerney, Upton,
O'Halleran, McMorris Rodgers, Bucshon, and Carter.
Staff Present: Kevin Barstow, Chief Oversight Counsel;
Billy Benjamin, Systems Administrator; Jesseca Boyer,
Professional Staff Member; Jeffrey C. Carroll, Staff Director;
Sharon Davis, Chief Clerk; Austin Flack, Staff Assistant;
Waverly Gordon, Deputy Chief Counsel; Zach Kahan, Outreach and
Member Services Coordinator; Chris Knauer, Oversight Staff
Director; Kevin McAloon, Professional Staff Member; Joe
Orlando, Executive Assistant; Kaitlyn Peel, Digital Director;
Peter Rechter, Counsel; Tim Robinson, Chief Counsel; Andrew
Souvall, Director of Communications, Outreach and Member
Services; Benjamin Tabor, Policy Analyst; Kimberlee Trezciak,
Chief Health Advisor; Jennifer Barblan, Minority Chief Counsel;
Mike Bloomquist, Minority Staff Director; S. K. Bowen, Minority
Press Secretary; William Clutterbuck, Minority Staff Assistant;
Diane Cutler, Minority Detailee Oversight and Investigations;
Theresa Gambo, Minority Human Resources/Office Administrator;
Tyler Greenberg, Minority Staff Assistant; Tiffany Haverly,
Minority Communications Director; Brittany Havens, Minority
Professional Staff, Oversight and Investigations; Peter Kielty,
Minority General Counsel; Ryan Long, Minority Deputy Staff
Director; Brannon Rains, Minority Policy Analyst; Alan
Slobodin, Minority Chief Investigative Counsel, Oversight and
Investigations; Peter Spencer, Minority Senior Professional
Staff Member, Environment and Climate Change; and Everett
Winnick, Minority Director of Information Technology.
Ms. DeGette. Good morning, everybody. The subcommittee on
Oversight and Intelligence will now come to order.
Today the committee is holding a hearing entitled ``Pathway
to a Vaccine; Efforts to Develop a Safe, Effective, and
Accessible COVID-19 Vaccine.'' The purpose of today's hearing
is to examine the research, development, and manufacturing of
potential COVID-19 vaccines.
And I really want to express my thanks to all of our
witnesses for coming today, because this is obviously the area
of greatest concern to our constituents right now, one of the
areas.
Due to the COVID 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 purpose of eliminating inadvertent
background noise. Members and witnesses, you will need to
unmute your microphone each time you wish to speak.
If at any time during the hearing I'm unable to Chair the
hearing, the chairman of the full committee, who I see on my
screen here, Frank Pallone, will serve as chair until I'm
willing or able to return.
Documents for the record, can be sent to Benjamin Tabor at
the email address we provided to staff. All documents will be
entered into the record at the conclusion of the hearing.
And I want to inform all Members and witnesses that we are
expected to have a series of hearings on the floor all day
today. I expect that what we will do is, we will rotate
through, so that--both on the Republican and Democratic side,
so that we will be able to continue the hearing as seamlessly
as possible. When has to go vote, Mr. Pallone will preside and
vice versa.
Mr. Guthrie, I would hope that the Republicans can do the
same thing.
The Chair will now recognize herself for the purposes of an
opening statement.
Mr. Guthrie. My question is, are you muted, Chairwoman?
Ms. DeGette. I'm muted because my staff is looking for my
opening statement, which was not included in my briefing
notebook.
I will make my opening statement in just one moment.
Mr. Pallone, since they're looking for my opening
statement, I think I'll recognize you for purposes of an
opening statement for 5 minutes.
Mr. Pallone. Thank you. Thank you, Chairwoman DeGette.
Ms. DeGette. Sorry about that.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Today we'll explore the pursuit of vaccines
that could help contain the largest public health crisis the
Nation has faced in over a century. The extent of this crisis
cannot be overstated. In just six months, more than three
million people in the United States have been diagnosed with
COVID-19, and more than 140,000 Americans have died.
Sadly, these numbers will only continue to increase as new
COVID-19 cases are surging all across the Nation, climbing to
nearly 80,000 each day. COVID-19 has wreaked havoc on the
country's physical, mental, and economic well-being,
particularly among communities of color and low-income
communities.
Today we'll hear from some of the manufacturing companies
who have been working with the Federal Government to develop a
safe and effective vaccine, and I'm pleased that you're all
with us today so we can hear how Federal investments are being
used to find a vaccine.
But I want to extend special thanks to your colleagues and
research teams who are working around the clock to develop a
vaccine. Ultimately, it will be the collaboration of your
efforts, in partnership with the administration and the support
of Congress that will make a COVID-19 vaccine possible.
And along those lines, I also appreciate the chance to
bring some transparency to the Trump administration's Operation
Warp Speed efforts. This transparency will be crucial to
securing the American people's trust that a COVID-19 vaccine
will be made available only once it's proven to be safe and
effective.
Now, Congress has already taken action to support these
vital efforts. This spring, Congress provided billions of
dollars for COVID-19 vaccine development and manufacturing
efforts and other medical countermeasures.
Then two months ago, the House passed the HEROES Act. This
comprehensive legislation, which strengthened the Nation's
ability to fight the pandemic by bolstering the Strategic
National Stockpile and increasing funding for research,
development, and manufacturing of vaccines and treatments.
It would also require the Trump administration to submit to
Congress a vaccine plan identifying the activities being
undertaken to manufacture, distribute, and administer a COVID-
19 vaccine safely.
As I said, the House passed the HEROES Act more than two
months ago, and yet the Senate has failed to take that up, even
as new infection and death rates soar, and this delay is
compounded by the fact that so much more could have been done
to mitigate the impacts of the disease.
From day one, President Trump has done everything he can to
minimize the severity of this pandemic and to undermine his
public health experts. The administration still has not
developed a national plan to combat the pandemic. It has no
national testing strategy, no one in charge of the supply
chain, and little effort to invoke the Defense Production Act.
And we're again seeing a resurgence of the same problems
that hampered our response efforts this spring, such as testing
shortages, PPE, and medical supply shortages and attacks on
public health experts.
These problems will likely extend to the development and
distribution of a COVID-19 vaccine as long as Trump is
President, and we will want a COVID-19 vaccine to be developed
as soon as possible, but before a vaccine is distributed,
public health experts must ensure that it is safe, effective,
and available to all who need it.
My fear is that FDA will be forced by the Trump
administration to approve a vaccine that lacks effectiveness.
So we must also ensure that our supply chains can safely
manufacture the vaccine in the quantities necessary, along with
the vials, needed syringes, and other products required needed
to administer it.
This committee has a long history supporting efforts
related to vaccine development and deployment. I'm hopeful that
if we prioritize public health and strategic preparation, and
the administration finally learns from its mistakes, that our
collective efforts will result in a safe, effective, and
accessible COVID-19 vaccine.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
Today, we will explore the pursuit of vaccines that could
help contain the largest public health crisis the nation has
faced in over a century.
The extent of this crisis cannot be overstated. In just six
months, more than 3.5 million people in the United States have
been diagnosed with COVID-19 and more than 140,000 Americans
have died.
Sadly, these numbers will only continue to increase as new
COVID-19 cases are surging all across the nation--climbing to
nearly 80,000 each day. COVID-19 has wreaked havoc on the
country's physical, mental, and economic well-being,
particularly among communities of color and low-income
communities.
Today, we will hear from some of the manufacturing
companies who have been working with the Federal Government to
develop a safe and effective COVID-19 vaccine. I am pleased
that you are all with us today so we can hear how federal
investments are being used to find a vaccine.
I want to extend special thanks to your colleagues and
research teams who are working around the clock to develop a
vaccine. Ultimately it will be the collaboration of your
efforts, partnership with the Administration and the support of
Congress that will make a COVID-19 vaccine possible.
Along those lines, I also appreciate the chance to bring
some transparency to the Trump Administration's Operation Warp
Speed efforts. This transparency will be crucial to securing
the American people's trust that a COVID-19 vaccine will be
made available only once it's proven to be safe and effective.
Congress has already taken action to support these vital
efforts. This spring, Congress provided billions of dollars for
COVID-19 vaccine development and manufacturing efforts, and
other medical countermeasures.
Then two months ago, the House passed the Heroes Act. This
comprehensive legislation would strengthen the nation's ability
to fight the pandemic by bolstering the Strategic National
Stockpile, and increasing funding for research, development,
and manufacturing of vaccines and treatments. It would also
require the Administration to submit to Congress a vaccine plan
identifying the activities being undertaken to manufacture,
distribute, and administer a COVID-19 vaccine safely.
As I said, the House passed the Heroes Act more than two
months ago, and yet, the Senate has failed to take it up even
as new infection and death rates soar.
This delay is compounded by the fact that so much more
could have been done to mitigate the impacts of the disease.
From day one, President Trump has done everything he can to
minimize the severity of this pandemic and to undermine his
public health experts. The Administration still has not
developed a national plan to combat the pandemic, it has no
national testing strategy, no one in charge of the supply chain
and little effort to invoke the Defense Production Act (DPA).
We are again seeing a resurgence of the same problems that
hampered our response efforts this spring, such as testing
shortages, PPE and medical supply shortages, and attacks on
public health experts.
These problems will likely extend to the development and
distribution of a COVID-19 vaccine, as long as Trump is
President.
We all want a COVID-19 vaccine to be developed as soon as
possible, but before a vaccine is distributed, public health
experts must ensure that it is safe, effective, and available
to all who need it. My fear is that FDA will be forced by the
Trump Administration to approve a vaccine that lacks
effectiveness. We also must ensure that our supply chains can
safely manufacture the vaccine in the quantities necessary,
along with the vials, needles, syringes, and other products
required to administer it.
This Committee has a long history of supporting efforts
related to vaccine development and deployment. I am hopeful
that if we prioritize public health and strategic preparation,
and the Administration finally learns from its mistakes, that
our collective efforts will result in a safe, effective, and
accessible COVID-19 vaccine. And with that I would like to
yield the remainder of my time, to Representative Eshoo, the
chair of our Health Subcommittee.
And I'd like to now yield the remainder of my time to the
chairwoman of our Health Subcommittee, Congresswoman Anna Eshoo
of California.
Ms. Eshoo. Thank you for yielding, Mr. Pallone, and good
morning to my colleagues and to our witnesses.
Each of you represents great hope for Americans and for
people around the world. And speaking of hope, we can't help
but as we mourn his loss, think of our colleague John Lewis,
who always said, keep your eye on the prize.
And I think that's really what we're talking about this
morning because all eyes are on your companies to develop a
vaccine that will allow us to return to school, to work, to hug
our loved ones, and to begin the process of recovering from the
COVID-19 pandemic.
But with that opportunity comes great responsibility to
ensure that your products are safe, effective, affordable, and
accessible. So I look forward to hearing from each of you today
how you're going to maintain transparency and accountability
for the American taxpayer and the American patient, how you're
scaling up domestic manufacturing, your suggestions for a
nationwide vaccine distribution plan, and how Congress can
tackle the pervasive vaccine hesitancy in our country.
So thank you again to each of you for testifying, to the
chairwoman of this subcommittee for holding this hearing.
And I look forward to not only hearing from you but working
with you, and I yield back.
[Ms. Eshoo prepared statement appears at the conclusion of
the hearing.]
Ms. DeGette. The gentle lady yields back. Thank you so
much.
The Chair now recognizes the ranking member of the
subcommittee, Mr. Guthrie, for 5 minutes.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEATH OF KENTUCKY
Mr. Guthrie. Thank you, Madam Chair. I appreciate you for
holding this critical and important hearing. First, we do have
three members--I know I don't have to make a unanimous consent
request, but just for the record, that Mr. Upton, Mrs. McMorris
Rodgers, and Mr. Carter will be sitting in,--waving on to the
subcommittee.
Thank you for holding this important hearing. The COVID-19
pandemic has been a tough challenge for our Nation, but the
incredible effort to develop safe, effective, and accessible
COVID-19 vaccines gives me great hope that we are on a very
promising path to solutions.
The unified effort by vaccine manufacturers, the research
community, and Federal partners to work with each other is
remarkable, and I am confident that through this unity of
purpose, cooperation, focus, expertise, and the tremendous
amount of resources, our vaccine efforts will prove successful.
Companies are using their own funds, at their own risk, to
conduct research and develop vaccine candidates and create more
manufacturing capacity. Some companies are putting up to $1
billion at risk.
The Federal Government has poured billions more dollars
into the vaccine effort. The U.S. Government is supporting
several initiatives to help accelerate the development of
vaccines for COVID-19. Two key initiatives are Operation Warp
Speed, and the accelerating COVID-19 therapeutic interventions
and vaccines, otherwise known as the ACTIV partnership.
Operation Warp Speed was established to accelerate the
development, manufacturing, and distribution of COVID-19
vaccines, therapeutics, and diagnostics. The ACTIV public-
private partnership also aims to speed vaccines and treatment
options.
The testimony today from witnesses of leading COVID-19
vaccine candidates will be of vital interest to the American
people. The companies represent a diverse portfolio of vaccine
platforms with promising preliminary data.
For example, Moderna's experimental COVID-19 vaccine
reportedly provided all 45 of its healthy volunteers with the
immune responses to the virus in an ongoing, early-age study,
with volunteers who received two doses showing antibody levels
exceeding those found in people who have recovered from COVID-
19, and were generally well tolerated.
The University of Oxford AstraZeneca candidate might
complete human trials by September, and agreements have been
lined up to produce two billion doses by 2021. In addition,
there reportedly is positive news on the response seen from the
antibodies and T-cells.
Last month some vaccine experts expressed concerns that the
Trump administration might exert political pressure to put a
COVID-19 vaccine on the market before it's ready, and they
wanted assurances from the FDA that a vaccine will not be
authorized unless there are at least 30,000 people in each
phase 3 clinical study. It appears such assurances have been
made by the Trump administration.
The leading vaccine candidates, under the auspices of
Operation Warp Speed, are required to enroll 30,000
participants in phase 3 trials. As Dr. Fauci, the director of
the National Institute of Allergies and Infectious Diseases at
the NIH, and Dr. Stephen Hahn, Commissioner of the FDA,
testified before the full committee on June 23, there will be
no shortcuts on safety and efficacy standards.
The speed is being achieved through the financial risk--the
financial risks, I'll repeat that--of manufacturers, not safety
or efficacy, in accelerating their capacity to produce millions
of doses and not at the expense of safety and efficacy.
Concerns have also been raised about vaccine confidence and
whether there will be sufficient vaccination coverage to ensure
herd immunity. We need to have a high percentage of American
people vaccinated to achieve the protective effect of herd
immunity to save American lives.
Regarding supply and manufacturing capacity, we will hear
testimony of how these companies are working cooperatively to
address potential supply concerns. These companies in the
aggregate are committing to manufacture billions of doses.
I look forward to hearing more about how each of these
companies before us today are planning to scale up their
manufacturing efforts to ensure an adequate supply of an
authorized or approved COVID-19 vaccine.
Finally, on access and affordability, many manufacturers
have told committee staff that if their vaccine effort is
successful, they do not want cost to be a barrier to accessing
a COVID-19 vaccine. This is a welcome commitment, and we are
eager to discuss it further.
The mission to get a safe and effective vaccine has been a
driving force for committee Republicans. At the beginning of
this month, Leader Walden and I released the second pillar of
its second-wave project, with the recommendations on how to
better prepare production and distribution of vaccines and
therapeutics.
I welcome all of our witnesses and look forward to their
testimony and discussion of these issues.
And Madam Chair, I yield back.
[The prepared statement of Mr. Guthrie follows:]
Prepared Statement of Hon. Brett Guthrie
Thank you, Chair DeGette, for holding this critically
important hearing. I appreciate our bipartisan approach to this
hearing and believe this hearing is a great example of how the
Energy and Commerce Committee works. We can come together--
Republicans and Democrats--to solve vital issues presented by
the Coronavirus pandemic.
The COVID-19 pandemic has been a tough challenge for our
nation, but the incredible effort to develop safe, effective,
and accessible COVID-19 vaccines gives me great hope that we
are on a very promising path to solutions. The unified effort
by vaccine manufacturers, the research community, and federal
partners to work with each other is remarkable, and I am
confident that through this unity of purpose, cooperation,
focus, expertise, and the tremendous amount of resources, our
vaccine efforts will prove successful.
Companies are using their own funds at their own financial
risk to conduct research, develop vaccine candidates, and
create more manufacturing capacity. Some companies are putting
up to $1 billion at risk.
The Federal Government has poured billions more dollars
into the vaccine effort. The U.S. government is supporting
several initiatives to help accelerate the development of
vaccines for COVID-19. Two key initiatives are Operation Warp
Speed and the Accelerating COVID-19 Therapeutic Interventions
and Vaccines, otherwise known as the ACTIV partnership.
Operation Warp Speed was established to accelerate the
development, manufacturing, and distribution of COVID-19
vaccines, therapeutics, and diagnostics. The ACTIV public-
private partnership also aims to speed vaccine and treatment
options.
The testimony today from witnesses of leading COVID-19
vaccine candidates will be of vital interest to the American
people. The companies represent a diverse portfolio of vaccine
platforms with promising preliminary data. For example,
Moderna's experimental COVID-19 vaccine reportedly provided all
45 of its healthy volunteers with immune responses to the virus
in an ongoing early-stage study, with volunteers who received
two doses showing antibody levels exceeding those found in
people who have recovered from COVID-19 and were generally well
tolerated.
The University of Oxford-AstraZeneca candidate might
complete human trials by September and agreements have been
lined up to produce two billion doses by 2021. In addition,
there reportedly is positive news on the responses seen from
the antibodies and T-cells.
Last month, some vaccine experts expressed concerns that
President Trump might exert political pressure to put a COVID-
19 vaccine on the market before it's ready, and they wanted
assurances from the FDA that a vaccine will not be authorized
unless there are at least 30,000 people in each Phase 3
clinical study. It appears such assurance has been made. The
leading vaccine candidates under the auspices of Operation Warp
Speed are required to enroll 30,000 participants in Phase 3
trials. As Dr. Anthony Fauci, the Director of the National
Institute of Allergy and Infectious Diseases at the National
Institutes of Health, and Dr. Stephen Hahn, the Commissioner of
the U.S. Food and Drug Administration,testified before the Full
Committee on June 23rd, there will be no shortcuts on safety
and efficacy standards. The speed is being achieved through the
financial risk of manufacturers accelerating their capacity to
produce millions of doses, not at the expense of assuring
safety and efficacy.
Concerns have also been raised about vaccine confidence,
and whether there will be sufficient vaccination coverage to
ensure herd immunity. We need to have a high enough percentage
of the American people vaccinated to achieve the protective
effect of herd immunity and to save American lives.
Regarding supply and manufacturing capacity, we will hear
testimony of how these companies are working cooperatively to
address potential supply concerns. These companies in the
aggregate are committing to manufacture billions of doses. I
look forward to hearing more about how each of the companies
before us today are planning to scale up their manufacturing
efforts to ensure an adequate supply of an authorized or
approved COVID-19 vaccine.
Finally, on access and affordability, many manufacturers
have told Committee staff that if their vaccine effort is
successful, they do not want cost to be a barrier to accessing
a COVID-19 vaccine. This is a welcome commitment, and we are
eager to discuss it further.
The mission to get safe and effective vaccines has been a
driving focus for Committee Republicans. At the beginning of
this month, Leader Walden and I released the second pillar of
its Second Wave Project with recommendations on how to better
prepare production and distribution of vaccines and
therapeutics.
I welcome all of our witnesses and look forward to their
testimony and discussion of the issues.
Ms. DeGette. I thank the gentleman. The Chair will now give
her opening statement.
OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Today's hearing will examine efforts to develop a safe and
effective COVID-19 vaccine, and I know I speak for everybody
this morning in saying we're all rooting for a safe vaccine to
be developed, manufactured, and accessible for all Americans as
soon as possible. This committee and Congress have long
supported Federal efforts to advance the development and
availability of novel vaccines.
This spring we provided billions of dollars in new funding
to support vaccine research, development, and manufacturing
efforts, funds that are assisting some of the companies
testifying today in developing COVID-19 vaccines.
This committee has a responsibility--to conduct oversight
of those congressional investments. Today, we'll have the
opportunity to hear directly from some of the manufacturers
working on potential COVID-19 vaccines, and how the funds
Congress has provided are being put to use in these
unprecedented times.
I thank the witnesses again for being willing to
participate in such a critical hearing at a critical time.
We're now six months into this national public health crisis,
and COVID-19 case numbers are continuing to climb at a
staggering rate.
Today more than 140,000 Americans have lost their lives to
this disease. As long as the Trump administration continues to
shirk its responsibility to lead a coordinated national
response effort, sicknesses and deaths are going to continue to
mount.
It's also clear that we're not going to be able to contain
COVID-19 in the United States without a rapid and robust
deployment of public health measures and medical
countermeasures, including a safe and effective vaccine.
We know that containing the virus as soon as possible is of
utmost importance. Millions of Americans face continued
unemployment and loss of health insurance. Across the country,
parents are making impossibly hard decisions about childcare
and school participation, and frontline health workers,
essential employees, people of color, seniors, and others most
vulnerable to COVID-19 face daily threats to their survival.
Fortunately, there are reasons to be optimistic that the
search for a COVID-19 vaccine is headed in the right direction.
According to statements from several of the companies
testifying today, and based on the speed at which they are
progressing through clinical trials, it is possible that a
COVID-19 vaccine may become available by the end of this year
or early next year. That's a rare bit of good news in this
harrowing time.
But while some public health experts are bullish on the
development of a vaccine, we must remind ourselves that plenty
can still go wrong, and so the anticipated timeline is not
guaranteed. Determining a vaccine's safety and efficacy is
merely the first of the many challenges that must be addressed
if we are to successfully manufacture and distribute a vaccine
to Americans and to people around the globe.
While we await the results of clinical trials, the
necessary manufacturing capacity and distribution
infrastructure must be bolstered so an eventual vaccine is
readily available for hundreds of Americans once it is
determined to be safe and effective.
Additionally, as the global pursuit of a COVID-19 vaccine
speeds forward, we must be prepared not only to produce the
vaccine itself but to have the supplies required to administer
the vaccine, such as vials and syringes. Last month, the
committee heard from governors across the country just how
unprepared we were as a Nation to provide basic testing
supplies, like swabs and reagents and personal protective
equipment.
The lack of these supplies undermined our response effort,
and we're still feeling the effects today. I remain concerned
that with all of the efforts around the world to develop a
vaccine, governments and manufacturers, like with testing
supplies and PPE, may be all competing for a limited supply of
items such as glass vials and syringes. These supplies are
critical in ultimately delivering a vaccine should one prove
successful.
Further, critical decisions must be made now across the
Federal Government, industry, and public health shareholders,
regarding vaccine rollout efforts and public and provider
education. This is especially true given the value of any
future COVID-19 vaccine lies in the willingness of the American
people to get vaccinated and their ability to access and afford
it.
Developing and distributing a COVID-19 vaccine requires a
national plan, one that the Trump administration has stated is
still being developed, despite this committee urging the
administration to adopt such a plan two months ago.
But time is of the essence, and now is the time to prepare
for a nationwide vaccine program. If developed, a vaccine will
be instrumental in protecting the health and well-being of the
Nation. While we are all rooting for all of your collective
success, we must make sure it's safe, effective, and ultimately
affordable to all Americans who need it.
This committee will continue to conduct oversight to ensure
these goals remain the focus of the pursuit for a COVID-19
vaccine.
[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 response to the COVID-19 pandemic.
Today's hearing will examine efforts to develop a safe and
effective COVID-19 vaccine. I know I speak for all of us this
morning in saying that we are all rooting for a vaccine to be
developed, manufactured, and accessible for all Americans as
soon as possible.
This Committee and Congress have long-supported federal
efforts to advance the development and availability of novel
vaccines. This spring, we provided billions of additional
dollars in new funding to support vaccine research,
development, and manufacturing efforts-funds that are assisting
some of the companies testifying today in developing COVID-19
vaccines.
This Committee has a responsibility to conduct oversight of
these investments. Today, we'll have the opportunity to hear
directly from some of the manufacturers working on potential
COVID-19 vaccines and how the funds Congress provided are being
put to use in these unprecedented times. I thank the witnesses
for being willing to participate in such a critical hearing.
We are now six months into this national public health
crisis and COVID-19 case numbers are continuing to climb at a
staggering rate. To date, more than 140,000 Americans have lost
their lives.
As long as the Trump Administration continues to shirk its
responsibility to lead a coordinated, national response effort,
sicknesses and deaths will continue to mount.
It is also clear that we will not be able to contain COVID-
19 in the United States without a rapid and robust deployment
of public health measures and medical countermeasures-including
a safe and effective vaccine.
We know that containing the virus as soon as possible is of
upmost importance. Millions of Americans face continued
unemployment and loss of health insurance. Across the country,
parents are making impossibly hard decisions about child care
and school participation. And frontline health workers,
essential employees, people of color, seniors, and others most
vulnerable to COVID-19 face daily threats to their survival.
Fortunately, there are reasons to be optimistic that the
search for a COVID-19 vaccine is headed in the right direction.
According to statements from several of the companies
testifying today and based on the speed at which they are
progressing through clinical trials, it is possible that a
COVID-19 vaccine may become available by the end of this year
or early next year. That is a rare bit of good news in these
harrowing days.
But while some public health experts are bullish on the
development of a vaccine, we must remind ourselves that plenty
can still go wrong, and any anticipated timeline is not
guaranteed.
Determining a vaccine's safety and efficacy is merely the
first of many challenges that must be addressed if we are to
successfully manufacture and distribute a vaccine to Americans
and people around the globe.
While we await the results of clinical trials, the
necessary manufacturing capacity and distribution
infrastructure must be bolstered so an eventual vaccine is
readily available for hundreds of millions of Americans once it
is determined to be safe and effective.
Additionally, as the global pursuit of a COVID-19 vaccine
speeds forward, we must be prepared, not only to produce the
vaccine itself, but also to have the supplies required to
administer the vaccine, such as vials and syringes.
Last month, this Committee heard from governors across the
country just how unprepared we were as a nation to provide
basic testing supplies such as swabs and reagents and personal
protective equipment, or ``PPE.'' The lack of these supplies
undermined our response effort and we are still feeling the
effect today.
I remain concerned that with all the efforts around the
world to develop a vaccine, governments and manufacturers--like
with testing supplies and PPE--may all be competing for a
limited supply of items such as glass vials and syringes. These
supplies are critical in ultimately delivering a vaccine should
one prove successful.
Further, critical decisions must be made now across the
Federal Government, industry, and public health stakeholders
regarding vaccine roll-out efforts and public and provider
education. This is especially true given that the value of any
future COVID-19 vaccine lies in the willingness of the American
people to get vaccinated and their ability to access and afford
it.
Developing and distributing a COVID-19 vaccine requires a
national plan. One that the Trump Administration has stated is
still being developed--despite this Committee urging the
Administration to adopt such a plan two months ago. But time is
of the essence and now is the time to prepare for a nationwide
vaccine program.
If developed, a vaccine will be instrumental in protecting
the health and well-being of the nation. While we are all
rooting for your collective success, we must make sure that it
is safe, effective, and ultimately affordable to all Americans
who need it. This Committee will continue to conduct oversight
to ensure these goals remain the focus of the pursuit for a
COVID-19 vaccine.
And with that, I am pleased to yield 5 minutes to the
ranking member of the full committee, Mr. Walden.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Well, thank you very much, Chair DeGette. I
want to thank you for holding today's hearing on an incredibly
important and timely topic.
I also want to welcome today's witnesses. We know you and
your colleagues are hard at work to develop medical
countermeasures, including the vaccines that we're here to
discuss today. You are literally working to save the world. So
we greatly appreciate you taking time to participate in today's
hearing.
Energy and Commerce Committee Republicans continue to
closely examine current issues related to COVID-19 and how to
best prepare for an uptick in cases at the same time as the flu
season hits us this fall. Last month, we released a report with
recommendations on the first pillar of our work.
I've got those reports here, Madam Chair, which we'd like
to have inserted in the record. Earlier this month committee
Republicans released a second pillar focusing on vaccines and
therapeutics. This report includes a series of important
recommendations that officials should consider to better
position the country to produce and distribute vaccines and
therapeutics.
Ms. DeGette. Without objection.
[The information appears at the conclusion of the hearing.]
As discussed in our report, there are extensive efforts led
by the Federal Government, in partnership with the private
sector, to develop medical countermeasures for COVID-19
including Operation Warp Speed.
Operation Warp Speed is facilitating, at an unprecedented
pace, the development, manufacturing, and distribution of
COVID-19 vaccines. One of the many goals of Operation Warp
Speed is to have as much as 300 million doses of a safe,
effective vaccine for COVID-19 available to Americans by
January of 2021.
The speed with which we have been able to identify vaccine
candidates and move into critical trials is simply
unprecedented. To put it simply, this could not have been done
without the private sector, and they have been an integral part
of this Herculean effort.
The collaboration we have seen over the past few months,
between the Federal Government, the Trump administration, and
the private sector, is truly extraordinary, and I commend all
those who are involved.
At the committee's June 23 hearing, we heard Dr. Fauci say
we are taking financial risks, not risks to safety, no risk to
the integrity of the science, but financial risk to be able to
be ahead of the game, to make safe and effective vaccines
available to the American public.
In addition to hearing today an update on the status of
your efforts to develop vaccine candidates, we also want to
hear all this unprecedented speed does not mean--does not
mean--sacrificing safety or efficacy.
Along those lines, we also need to know how your companies
are helping to build vaccine confidence in the U.S. This is a
critically important topic that spans COVID-19 and beyond. It
is made more urgent by the fact that once a COVID-19 vaccine is
proven safe and effective and is authorized by the FDA, we want
Americans to feel confident in getting that vaccine.
This is also vital when thinking about the fast approaching
fall and the intersection of COVID-19 and the influenza season.
We need to ensure not only that the vaccine is available, but
also that it is accessible. Rural communities frequently find
themselves on the outside looking in. When it comes to COVID-
19, no American should be left behind.
As you all continue your work to provide a safe and
effective vaccine, I ask that you also take into consideration
the need for a robust manufacturing and distribution process,
providing this vaccine in a timely manner to all Americans from
every walk of life.
We also want to hear about your efforts that are under way
to ensure there are sufficient amounts of ancillary supplies
such as glass vials, in order to package and distribute
vaccines to Americans. This is another issue we need to be
taking action on now to ensure the availability of an
unauthorized or--excuse me--of an authorized or approved
vaccine to Americans as quickly as possible.
So I want to thank you all for being here today. If there
are things you need help on from the Congress, we want to hear
from you and do our part to be a good partner to provide this
vaccine and therapeutics to American citizens who are suffering
from COVID or want to make sure they never get it.
With that, Madam Chair, I yield back the balance of my
time.
[The prepared statement of Mr. Walden follows:]
Prepared Statement of Hon. Greg Walden
Chair DeGette, I want to thank you for holding today's
hearing on an incredibly important and timely topic. I also
want to welcome today's witnesses. We know you and your
colleagues are hard at work to develop medical countermeasures,
including the vaccines that we are here to discuss today. You
are literally working to save the world, so we greatly
appreciate you making time to participate in today's hearing.
Energy and Commerce Committee Republicans continue to
closely examine current issues related to COVID-19 and how to
best prepare for an uptick in cases at the same time as flu
season hits us. Last month, we released a report with
recommendations on the first pillar of our work, focused on
COVID-19 testing and surveillance. Earlier this month,
Committee Republicans released the second pillar, focusing on
vaccines and therapeutics. The report includes a series of
important recommendations that officials should consider to
better position the country to produce and distribute vaccines
and therapeutics.
As discussed in our report there are extensive efforts led
by the federal government, in partnership with the private
sector, to develop medical countermeasures for COVID-19,
including Operation Warp Speed. Operation Warp Speed
facilitates, at an unprecedented pace, the development,
manufacturing, and distribution of COVID-19 vaccines. One of
the many goals of Operation Warp Speed is to have as much as
300 million doses of a safe and effective vaccine for COVID-19
available to Americans by January 2021.
The speed with which we have been able to identify vaccine
candidates and move into clinical trials is unprecedented. To
put it simply--this could not be done without the private
sector and they have been an integral part of this herculean
effort. The collaboration we have seen over the past few months
between the federal government and the private sector is
extraordinary and I commend these efforts.
At the Committee's June 23 hearing, Dr. Fauci stated, ``we
are taking financial risks, not risks to safety, not risk to
the integrity of the science, but financial risks to be able to
be ahead of the game'' to make safe and effective vaccines
available to the American public. In addition to hearing today
an update on the status of your efforts to develop vaccine
candidates, we also want to hear how this unprecedented speed
does not mean sacrificing safety or efficacy.
Along those lines, we also need to know how your companies
are helping to build vaccine confidence in this country. This
is a critically important topic that spans beyond COVID-19. It
is made more urgent by the fact that once a COVID-19 vaccine is
proven safe and effective, and is authorized or approved by the
FDA, we want Americans to feel confident in getting a vaccine.
This is also vital when thinking about the fast-approaching
fall and the intersection of COVID-19 and the influenza season.
We need to ensure not only that a vaccine is available, but
also that it is accessible. Rural communities frequently find
themselves on the outside looking in. When it comes to COVID-
19, no one should be left behind. As you all continue your work
to provide a safe and effective vaccine, I ask that you also
take into consideration the need for a robust manufacturing and
distribution process capable of providing this vaccine in a
timely manner to all Americans from every walk of life.
We also want to hear about efforts underway to ensure there
are a sufficient amount of ancillary supplies, such as glass
vials, in order to package and distribute vaccines to
Americans. This is another issue we need to be taking action on
now to ensure availability of an authorized or approved vaccine
to Americans as quickly as possible.
I thank of all of our witnesses for appearing today and I
look forward to hearing your testimony.
Ms. DeGette. I thank the gentleman, and the Chair asks
unanimous consent that Members' written opening statements be
made a part of the record.
Without objection, so ordered.
The Chair also announces we have several members of the
full committee who will be waving onto this hearing today from
the majority--Congresswoman Eshoo, Congressman McNerney,
Congressman O'Halleran--and as we heard, from the minority--
Congressman Upton, Congresswoman McMorris Rodgers, Congressman
Bucshon, and Congressman Carter.
I now want to introduce the witnesses for today's hearing--
Dr. Mene Pangalos is the executive vice president,
biopharmaceuticals R&D of AstraZeneca. Welcome.
Dr. MacAya Douoguih, the head of clinical development and
medical affairs for Janssen vaccines of Johnson & Johnson.
Dr. Julie Gerberding--good to see you, Julie--executive
vice president and chief patient officer, Merck.
Dr. Stephen Hoge, president, Moderna.
And Mr. John Young, chief business officer of Pfizer.
Thanks to all of you for appearing today. It's really
important to hear what you have to say.
Now, I know all the witnesses are aware that the committee
is holding an investigative hearing and when doing so, we have
the practice of taking testimony under oath.
Does anyone have any objection to testifying under oath?
Let the record reflect that the witnesses have responded
no.
The Chair then advises you 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 during
your testimony today?
Let the record reflect the witnesses have responded no.
Good news, I'm not going to make you rise, but if you'd
please raise your right hand so you may be sworn in.
[Witnesses sworn.]
Ms. DeGette. Let the record reflect that the witnesses have
responded affirmatively, and you are now under oath and subject
to the penalties set forth in Title 18, Section 1001 of the
U.S. Code.
The Chair will now recognize our witnesses for 5-minute
written summaries of their written statements. There's a timer
on your screen that will count down the time, and it turns red
when your 5 minutes has come to an end.
And so first I'm going to recognize for 5 minutes, Dr.
Pangalos. You're recognized.
TESTIMONY OF DR. MENELAS PANGALOS, EXECUTIVE VICE PRESIDENT,
BIOPHARMACEUTICALS R&D, ASTRAZENECA; DR. MACAYA DOUOGUIH, HEAD
OF CLINICAL DEVELOPMENT AND MEDICAL AFFAIRS, JANSSEN VACCINES,
JOHNSON & JOHNSON; DR. JULIE L. GERBERDING, EXECUTIVE VICE
PRESIDENT AND CHIEF PATIENT OFFICER, MERCK; DR. STEPHEN HOGE,
PRESIDENT, MODERNA; AND MR. JOHN YOUNG, CHIEF BUSINESS OFFICER,
PFIZER
STATEMENT OF MENE PANGALOS, Ph.D.
Dr. Pangalos. Thank you very much, Chairwoman DeGette,
Ranking Member Guthrie, and members of the subcommittee.
I'm Dr. Menelas Pangalos, and I'm privileged to be
responsible for AstraZeneca's research and development
activity, from discovery through late-stage development for its
biopharmaceuticals therapeutic areas.
I'm here today to convey AstraZeneca's strong commitment to
ongoing efforts to develop and manufacture vaccines and
therapeutics for the prevention and treatment of COVID-19.
We greatly appreciate the opportunity to engage with you
today on this important topic, and I hope to emphasize our
dedication to finding safe and effective solutions for the
COVID-19 pandemic for the United States and across the world.
With respect to the COVID-19 vaccine, our strategic
approach is focused on partnering with scientists, governments,
international organizations, and manufacturers to establish
agreements for development, supply, and distribution of the
vaccine, in an equitable manner around the world, should it
prove to be effective and tolerated.
To support our goal of providing broad and equitable access
as quickly as possible, we've entered these agreements with the
United States and certain other governments and organizations
that a supply of hundreds of millions of doses of our vaccine.
The cost of the dose of the vaccine under those agreements will
be provided at no profit to AstraZeneca.
I would first like to provide some background on
AstraZeneca. We're a global, science-led, biopharmaceutical
company with our North American headquarters in Wilmington,
Delaware, and one of our three global R&D headquarters located
in Gaithersburg, in Maryland.
Overall, we have approximately 13,000 employees in the
U.S., with 12 operations--operating in 12 States, including in
Puerto Rico, and in total, AstraZeneca operates in over a
hundred countries, and we're leveraging that global footprint
and resources to address this worldwide crisis.
Today I'll focus on three core aspects of AstraZeneca's
approach to advancing novel vaccine and therapeutics for COVID-
19.
First, AstraZeneca is seeking to develop a novel vaccine
for the prevention of COVID-19 and has entered into a license
agreement with the University of Oxford for the global
development, production, and supply of their COVID-19 vaccine
candidate, which we're now calling AZD1222.
In the United States, to avoid any delays that could result
in unnecessary loss of life, we're scaling up to manufacture up
to 300 million doses of vaccine to be available immediately on
approval or emergency use authorization.
Our agreements across the world amount to supply
approximately two billion doses, and we're building parallel
supply chains with partners to support a broad and equitable
global access.
We fully support the mission, as a regulatory agency such
as the U.S. FDA, to ensure that our vaccine is determined to be
safe and effective, based on sound science and data before
receiving any approval or emergency use authorization. Sound
science, and patient safety and health, are and will continue
to remain our top priority in this effort.
Another vaccine candidate has begun late-stage clinical
trials now based on data from both preclinical studies in phase
\1/2\ clinical trials in over a thousand healthy volunteers.
And just yesterday, we announced some of the data from that
phase \1/2\ trial, which showed a robust immune response in all
the participants tested. We hope the results from our late-
stage trials, planned to involve nearly 50,000 volunteers, will
be available by this fall.
Second, we're advancing a combination of monoclonal
antibodies against SARS-CoV-2 in collaboration with Vanderbilt
University. This program is supported by BARDA and DARPA
through a development, and we are aiming to initiate clinical
trials in the next few weeks.
Third, we're investigating our approved medicines to see
how they could benefit COVID-19 patients, particularly those
severely ill patients. For example, our trial with our BTK
inhibitor, Calquence, will assess whether we can reduce the
exaggerated immune response, or cytokine storm, associated with
a COVID-19 infection.
Our SGLT2 inhibitor, Farxiga, is also being explored to
protect against organ damage in patients hospitalized with
COVID-19.
In addition to these efforts, we've donated three million
masks for healthcare workers across the United States, and
addressing this pandemic is an urgent priority for our company.
We come to work every day focusing on this goal and that our
efforts will save lives and alleviate the devastating
humanitarian, social, and economic consequences of the ongoing
pandemic throughout the world.
Chairwoman DeGette, Ranking Member Guthrie, and members of
the subcommittee, on behalf of AstraZeneca, thank you for the
opportunity to participate in today's hearing. We appreciate
your interest in these important issues, and I look forward to
answering your questions.
[The prepared statement of Dr. Pangalos follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much, Doctor.
Dr. Douoguih, you are now recognized for 5 minutes for your
opening statement.
STATEMENT OF MACAYA DOUOGUIH, M.D.
Dr. Douoguih. Thank you and good morning.
Chairwoman DeGette, Ranking Member Guthrie, and members of
the subcommittee, thank you for the opportunity to discuss
Johnson & Johnson's efforts to develop a vaccine for the virus
that causes COVID-19.
Thank you also to Chairman Pallone, Ranking Member Walden,
and other members of the full committee for joining this
important discussion.
I oversee clinical development of Johnson & Johnson's
vaccines portfolio, including the COVID-19 programs. I would
like to outline our efforts to develop a safe and effective
vaccine and our public commitment to provide more than one
billion doses at a not-for-profit price for emergency pandemic
use.
Working closely with health authorities, other agencies,
and academic partners, Johnson & Johnson is pursuing an
accelerated approach to the development of our vaccine,
including large-scale manufacturing, which we start in parallel
with clinical development, in advance of it actually, to make
sure the availability of substantial quantities of vaccine is
found to be safe and effective.
We have formed an important partnership with the Biomedical
Advanced Research and Development Authority, BARDA, under which
Johnson & Johnson will receive approximately $500 million for a
COVID-19 vaccine research and development.
That agreement supports vaccine research and development
efforts, which include preclinical studies, clinical studies,
and the production of clinical trial material.
Our efforts progressed rapidly since they began in January.
In March, we announced the selection of our SARS-CoV-2 vaccine
candidate, Ad26.COV2.S recombinant.
Next we completed a preclinical study in nonhuman primates
and have submitted the results to a peer-reviewed scientific
journal. We look forward to the publication of those results in
the near future.
We expect to start a first-in-humans phase \1/2\ A trial
later this month. This trial conducted in the United States and
Belgium will involve more than a thousand healthy adults ages
18 to 55 years and adults age 65 years and older. We are
anticipating preliminary results will be available in
September.
If those results are positive, we will plan to initiate a
phase 3 trial that month. We are using our AdVac technology to
develop the vaccine. This is the same technology that we've
used to develop our ebola vaccine and vaccine candidates for
HIV, RSV, and Zika.
We have extensive safety experience with the technology,
having vaccinated more than 75,000 individuals in a wide range
of populations, including adults, seniors, infants, children,
and pregnant women.
With respect to COVID, we believe that we can both
accelerate vaccine development and ensure safety, as we have
successfully done with our ebola vaccine.
As you may know, earlier this year, Johnson & Johnson
committed to bringing its vaccine to the public on a not-for-
profit basis for emergency pandemic use. The not-for-profit
price will be based on one cost structure, and it will be
validated by an external audit.
Johnson & Johnson is also committed to including diverse
populations in our studies. We are still in the process of
designing our phase 3 trials and ensuring diversity is a key
consideration. For example, we plan to implement focused
digital and community outreach, to encourage diverse
participation in our clinical trials.
Finally, my written testimony has additional information
regarding our extensive efforts to increase production capacity
at the same time that we are developing a vaccine so that we
can produce more than one billion doses in 2021, at least 400
million of which will be manufactured in the U.S.
Madam Chairwoman, we recognize that this is a critical
moment for society. Johnson & Johnson is devoting our
experience, energy, and resources to develop a safe and
effective vaccine for COVID-19 as quickly and as safely as
possible.
Thank you very much for the opportunity to speak with you
today, and I would be happy to answer your questions.
[The prepared statement of Dr. Douoguih follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much, Doctor.
Dr. Gerberding, you're now recognized for 5 minutes for
your opening statement.
STATEMENT OF JULIE GERBERDING
Ms. DeGette. You need to unmute.
Dr. Gerberding. Can you hear me now?
Ms. DeGette. Yes.
Dr. Gerberding. OK. Thank you.
Thank you, Chairwoman DeGette, Chairman Pallone, Chairwoman
Eshoo, Ranking Member Guthrie, and all the other members of the
committee. I really am honored to testify today, and thank you
for holding this really important hearing.
I also thank the frontline health workers, including my
colleagues at San Francisco General who are, as we speak,
putting their own lives at risk while providing care to the ill
people with SARS-CoV-2. They really are the true heroes of this
pandemic.
In 2003 I was serving at the CDC Director when the SARS
virus thankfully lost the first race involving a new
coronavirus, due in large part to the heroic containment
efforts in hospitals around the world. But unfortunately, SARS-
CoV-2 is proving to be a much more formidable foe. The current
pandemic has already infected 15 million people and caused the
loss of more than 140,000 Americans. And the virus is far from
contained.
So the race is on, not against each other but against this
virus, and unfortunately today the pandemic is far ahead of us.
But we in the biopharmaceutical industry are closing in faster
than we ever imagined possible.
According to the BioTracker, in the first six months, from
the time we learned about the virus, more than 660 unique
compounds are in various stages of development, including 173
vaccine candidates, 196 antivirals, and 292 other treatments.
So I have to compare that to AIDS, when it took more than
six years to get the first HIV drug approved and 15 years
before we had highly active therapies.
This astonishing progress is the result of a robust
biopharmaceutical industry and all the partners throughout
academia and the world of investigation. Now, I believe this
pandemic won't be the last or even the worst we will face.
So we have to preserve a vibrant, innovative, and
economically sustainable, biopharmaceutical business as the
frontline of our health protection. Failure to do so will
jeopardize today's patients and degrade our future health
security.
I think science is on our side as we approach the COVID-19
challenges, but these are still early days, and there's much to
be learned about this virus and how to safely combat it. Merck
is one of the few companies that has continued to invest in
vaccines and anti-infectives for almost our 130-year history.
Given that long experience and expertise, we knew when we
saw this pandemic emerge, that we had a special responsibility
to help end it. We looked at many possible vaccine candidates,
and we looked for three main attributes.
First of all, a candidate that was based on a proven
platform, known to achieve safe and effective immunity against
other viruses.
Second, we were hoping to find a candidate likely to be
effective as a single dose.
And third, we wanted a candidate feasible to scale and
distribute on a global basis.
As a result of our search, we are pursuing two promising
vaccines, one in partnership with IAVI that is based on rVSV
which is the same platform we used for our licensed, single-
dose ERBEVO vaccine that has helped contain the recent ebola
virus outbreak in the DRC.
And also a second vaccine candidate, one that we acquired
from our acquisition of Themis, which is based on a measles
virus backbone that has been used to safely immunize billions
of children.
As everyone has emphasized, speed is important, but we will
not compromise careful, scientific, efficacy, quality, and
above all, safety assessments, as we evaluate our candidates,
despite the urgency that we all truly feel. There will be no
safety shortcuts at Merck.
Finding a safe and effective vaccine is only the first
hurdle, and the second is even greater. We have to ensure that
vaccines are accessible and affordable on a global scale. No
one is safe until everyone is safe. Never in the history of
human kind have we been tasked with finding an affordable
vaccine for everyone.
To put this into context, consider today we can't even
fully immunize the world's birth cohort against vaccine
preventible childhood diseases, despite decades of effort, or
that despite our long awareness of the threat of an influenza
pandemic, the annual global supply of influenza vaccine is far
less than two billion doses, and most people in resource-
limited areas have no access at all.
Merck does have a long track record of making our vaccines
available and affordable to people around the world, and we are
committed to ensuring affordable global access to any SARS-CoV-
2 medicine or vaccine that we help create. Our goal is to
ensure that we can make these vaccines available to whoever
needs them, and we'll prioritize that access based on risk and
medical need.
At the end of the day, access also requires trust--trust in
vaccine safety, trust in the integrity of the vaccinators,
trust in the medical experts who assess them, and especially in
times of crisis, trust in government.
That's a tall order in most countries, including our own,
and we have to prepare now to support people's confidence in
safe and effective vaccine.
At Merck, we believe this is a daunting but doable
mission----
Ms. DeGette. Dr. Gerberding, if you can please wrap up
thank you.
Dr. Gerberding [continue]. Core values and the purpose that
motivates us to commit our lives to our profession. Thank you.
[The prepared statement of Dr. Gerberding follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much, Doctor. The Chair is
pleased to recognize Dr. Hoge for 5 minutes.
STATEMENT OF STEPHEN HOGE, M.D.
Dr. Hoge. Chairwoman DeGette, Ranking Member Guthrie, and
distinguished members of the subcommittee and full committee,
thank you for the opportunity to appear before you today.
My name is Stephen Hoge, and I serve as the president of
Moderna. I attended medical school at the University of
California San Francisco and briefly served as a resident
physician in a New York City hospital.
My wife is also a doctor, as are several members of my
family, and I'm proud to work for a company focused on
developing one of the vaccine candidates to stop this
devastating COVID-19 pandemic.
The pandemic has harmed millions of people. Our hearts go
out to those who have lost loved ones, who have been made sick
themselves. Millions of Americans are out of work. All of us
have been profoundly touched by this in some way.
We also know that communities of color and the working
class have disproportionately borne the burdens of COVID-19. We
must do everything we can to stop this pandemic.
I'd like to take this opportunity to provide you with an
update on our efforts to develop a safe and effective vaccine
against COVID-19.
At Moderna, we seek to improve patients' lives by creating
a new kind of medicine based on messenger RNA, or mRNA, a
molecule--a kind of molecule that plays a central role in
biology, including in human health and disease. We're proud to
be an American company with a headquarters and a major
manufacturing facility in Massachusetts.
Since our founding in 2010, we have built and invested in
our mRNA technology platform. This technology creates synthetic
messenger RNA sequences that cells recognize as if they were
produced in the body. Unlike traditional approaches to the
medicine, which introduce a protein or a chemical to the body,
our approach sends tailored mRNA into cells where the mRNA
instructs the cells to produce a specific protein.
We believe this approach can improve how we discover,
develop, and manufacture medicines across a wide range of
disease. Because our mRNA technology is flexible and quickly
adaptable, we stepped forward and pursued the rapid development
of a COVID-19 vaccine candidate in January.
We leveraged Moderna's technologies and years of research
that we had done before any of us had ever heard of COVID-19.
We collaborated with the Vaccine Research Center and Division
of Microbiology and Infectious Diseases of the National
Institute of Allergy and Infectious Diseases, which is part of
the NIH, to try to accelerate our vaccine candidate.
These efforts started with the COVID-19 virus. We used
information from the virus to develop an mRNA sequence that
instructs the cells in a patient's body to make the Spike
protein of the coronavirus. The body's immune system then
learns to attacks this Spike protein and generate a protective
immune response.
We progressed from genetic sequence of the vaccine into
human testing in just 63 days, a testament to the 10 years of
investment and hard work on our platform.
In March, the phase 1 study of our vaccine, which was led
by the NIH, dosed its first participant. Our phase 1 study had
positive results, and those findings have been published by the
NIH and others in the New England Journal of Medicine.
Earlier this month, we completed enrollment of all 600
subjects in our phase 2 study. And now, just over six months
from the sequencing of the virus, Moderna is about to become
one of the first U.S. companies to enter a phase 3 trial for a
vaccine candidate.
We've also been working to develop and scale our
manufacturing and distribution chains, which should allow us to
reach an annual production capacity of more than 500 million
doses next year.
Throughout this process, we have been focused on developing
a vaccine that is as safe and effective as possible, looking to
the science and the data to guide our decisions. I'm grateful
for the hundreds of scientists and other Moderna employees
whose hard work and sacrifice have made our rapid progress
possible.
At Moderna, we're also grateful to the many companies
around the world, including all of my colleagues here, who are
working on vaccines and treatments for COVID-19. We're also
blessed to be joined in our efforts by dedicated public health
officials and scientists at a host of Federal and State
agencies.
I'd also like to thank this subcommittee for its commitment
to this cause as well as the diligent work of your staff. We
are grateful for the actions you and your colleagues in
Congress have taken to support and fund the efforts to combat
this pandemic, and we remain committed to collaborating with
the U.S. Government as this process continues.
Thank you, and I look forward to answering your questions.
[The prepared statement of Dr. Hoge follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much.
Now I'm very pleased to yield Mr. Young 5 minutes for your
opening statement.
TESTIMONY OF JOHN YOUNG
Mr. Young. Thank you.
Chairwoman DeGette, Ranking Member Guthrie, and members of
the subcommittee, thank you for inviting me to testify today.
Like my colleagues, I'm honored to be a part of this panel. My
name is John Young, and I'm the chief business officer at
Pfizer for whom I've worked for over 30 years.
At Pfizer, our purpose is breakthroughs that change
patients' lives. In the face of COVID-19, this need is more
urgent now than ever, and we've harnessed the full breadth and
depth of our colleagues' expertise to help address this global
pandemic.
We know that safe and effective vaccines are pivotal, and
we're committed to bringing our deep heritage, our reach in
scale, and our financial capital to serve the billions of
people around the world impacted by this devastating illness.
While there are still important data on the safety and
effectiveness of our potential COVID-19 vaccine still to be
generated, if our clinical studies and manufacturing scale-up
is successful, we have a path to submit our clinical trial data
in a Biologics License Application, or a BLA, to the FDA as
early as October this year.
Pfizer's chairman and CEO, Albert Bourla, recognized early
that this pandemic was not business as usual. But on March the
13, Albert announced our five-point plan to help address the
pandemic: First, sharing tools and insights; second, marshaling
our people; third, applying our drug development expertise;
fourth, offering our manufacturing capabilities to support
others; and lastly, improving future rapid response.
As we pursue a potential vaccine for COVID 19, between
funding research and development and scaling up manufacturing
capacity at risk, we expect to invest at least $1 billion
during 2020. To date, we have not accepted any Federal
Government funding for this vaccine program, as we recognize
that we are uniquely positioned with the scientific and
manufacturing expertise and financial resources to have the
potential to deliver a vaccine without funding from the Federal
Government.
If our clinical trials progress well and we receive
regulatory approval, we hope to be able to manufacture up to
100 million doses by the end of 2020, and potentially more than
1.3 billion doses in 2021 globally, subject to final dose
selection for a pivotal study.
We extended our existing partnership with BioNTech to
develop an mRNA vaccine for flu, to develop a vaccine for
COVID-19, as both companies recognize that this technology has
the potential to be successfully applied to this disease.
Diversity in clinical trials is critical for this program,
given that COVID-19 disproportionately impacts communities of
color in the U.S., and to that end, ensuring that our clinical
trials are inclusive of diverse populations is a key priority.
On July 13, we announced that two of our four investigational
vaccine candidates had received Fast Track designation from the
FDA.
We've already shared encouraging but preliminary data from
the most advanced of our investigational vaccine candidates,
suggesting that this candidate could be administered in a dose
that appears well tolerated and generate a dose-dependent
immunogenicity.
Yesterday we also released additional data from our German
phase \1/2\ clinical trial which further demonstrated
encouraging T-cell and cytokine responses. Data from this
ongoing phase \1/2\ clinical trial will enable the selection of
a single lead candidate and identification of the optimal dose
level for a large, global phase \2b/3\ safety and efficacy
study of up to 30,000 participants. And we currently plan to
begin that study later this month subject to FDA approval.
We are working closely with regulatory authorities to
accelerate the program while maintaining the highest standards
in our development process. In order to reduce the normal time
taken for such a development program, we are doing sets in
parallel rather than sequentially, which requires more capital
to be deployed at risk but is the only way to cut significant
time from the development program while maintaining safety as a
key priority.
In the event that our clinical development program is
successful, we've already begun the work to scale up production
for global supply. We've announced that Pfizer facilities in
St. Louis, Missouri, Andover, Massachusetts, and Kalamazoo,
Michigan, will be the sites in our U.S. supply chain.
And finally our goal remains to bring a safe and effective
COVID-19 vaccine to as many people as possible globally as
quickly as we can. I have great confidence that our industry
can prevail in the ultimate outcome of our battle against
COVID-19 and that science will win.
Thank you.
[The prepared statement of Mr. Young follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much. And it's now time for the
questioning. The Chair will recognize herself for 5 minutes.
Everybody knows that time is of the essence in the search
for a COVID-19 vaccine, and obviously everybody wants it as
quickly as possible, but we need to make sure that it's going
to be safe and effective against the virus too.
I want to ask each of you your quick and honest assessment
on the likelihood of success of the vaccine candidates and when
they would be available to millions of Americans?
I only have a brief amount of time, so brevity is the
answer of the day. Dr. Pangalos, yesterday seemingly
encouraging results from your early clinical trials were
released. You stated that AstraZeneca hopes to have the results
of its phase 3 study this fall and is scaling up to manufacture
hundreds of millions of doses of the vaccine to be immediately
available upon emergency use authorization on approval.
Briefly, what do you think the probability of your vaccine
to be proven safe and effective, and do you believe it will be
available in the United States at the end of the year?
Dr. Pangalos. Thank you, Chairwoman. I think it's a great
question, a difficult question to answer in terms of
probability. I think we're very encouraged by the industry data
that we have in the phase \1/2\ study and the probability data
we have because we are seeing both an antibody response and a
T-cell response. And as you know at the moment, we don't know
what the immune correlates of protection are that will
ultimately confer protection against this virus.
Ms. DeGette. Right. But if it is approved, do you hope it
will be available at the end of the year on an emergency basis?
Dr. Pangalos. Yes, we do. So if we have efficacy data, we
hope we will have them any time from September onward.
Ms. DeGette. Thank you.
Dr. Hoge, Moderna is set to begin its phase 2--3 study this
month, but it's never brought a successful vaccine to market.
Do you believe that your vaccine candidate will be successful,
and if so, do you think it will be available for distribution
by the end of the year?
Dr. Hoge. Chairman DeGette, thank you very much for the
question. I think we're optimistic--cautiously optimistic I
think is the word others have used--that the vaccine will be
successful.
The data we published in the New England Journal of
Medicine is the basis for that, as well as other data we've
seen in challenge models. So we're quite encouraged by the
progress.
Ms. DeGette. Yes but----
Dr. Hoge. The phase 3 trial--I'm sorry.
Ms. DeGette. Yes.
Dr. Hoge. The phase 3 trial is a little bit beyond our
control in terms of timing because it's a case-driven study.
But presuming that we are able to accrue cases relatively
quickly in that study, we would hope in the fall or towards the
end of the year, we'd have data that we could submit to the FDA
for them to make a determination on whether to approve.
Ms. DeGette. And then----
Dr. Hoge. We would also hope at that point to have millions
of doses of vaccine available for disbursement.
Ms. DeGette. Thank you.
OK. Mr. Young, Pfizer is developing four vaccine candidates
and will also begin a phase 3 study later this month. It
expects to manufacture up to a hundred million vaccine doses by
the end of the year.
Again, briefly, what's the likelihood that one of your
candidates will be successful, and when would it be available
to the American public?
Dr. Young. So thank you for your question.
We are very encouraged by the early data that we've seen
from our initial phase 1 study in terms of both safety and
effectiveness. We aim to complete that study this month and
submit those data to the FDA, and subject to their approval, to
begin our large phase 3 clinical study, and obviously that
study is going to be pivotal in informing the scientific
community and regulators, particularly as to the safety and
effectiveness profile of the vaccine.
As I mentioned in my statement, we have a line of sight on
a clear, critical path, to be able to deliver up to 100 million
doses of commercial scale vaccine product in 2020, and up to
1.3 billion doses of our vaccine in 2021.
So encouraging early signs and a lot more work still to do.
Ms. DeGette. OK.
Dr. Douoguih, how realistic is it that your timeline, based
on the status of your clinical trials and your manufacturing
capacity?
Dr. Douoguih. Thank you for the question.
We are very much encouraged by our preclinical results. As
I mentioned, we are starting our first clinical trial this
month. We will be starting our phase 3 in September. Now, it's
very difficult to say whether or not we will be lucky enough to
have set up our sights in the right places to be able to get an
answer and read-out on efficacy. That's certainly possible, but
we're targeting to at least have results by early 2021, as well
as a hundred million doses by the end of March.
Ms. DeGette. Of 2021?
Dr. Douoguih. Correct.
Ms. DeGette. Thank you.
Finally, Dr. Gerberding, as we learned from your testimony,
Merck's timeline is a little bit longer than the others we've
heard from, but please tell us briefly, are there reasons to be
optimistic that all Americans who need a COVID-19 vaccine will
have access to one by early 2021, maybe even in January?
Dr. Geberding. I certainly hope my colleagues are
successful in prosecuting their pipelines. I can really only
speak for Merck. We expect to be in clinical trials imminently
for both of our products, but we would not expect to have a
licensed product until 2021 at the earliest.
Ms. DeGette. Thank you. Thanks to all of our witnesses. I
really appreciate it.
The Chair will now recognize the ranking member, Mr.
Guthrie, for 5 minutes for purposes of his questions.
Mr. Guthrie. Thank you very much. I want to answer mine
quick because I want all five of you to answer, and I want to
be able to make sure that you have time to answer, so mine's is
on the speed and--the speed versus safety and effectiveness.
Dr. Fauci and Commissioner Hahn said in testimony last month
that it is--we're not risking safety to science. I think it's
important the American people hear from each of you on your
trials.
And one, could you--so this is the question: Could you
explain whether the unprecedented speed with which you are
moving means sacrificing safety or efficacy? And what
specifically is your company doing to ensure safety and
efficacy of your vaccine? And could you tell why you believe
it's possible to bring a safe and effective COVID-19 to market
in 12 to 18 months when currently the fastest vaccine to be
developed was mumps, and that took 4 years.
So I'm just going to call on you, and I'm going to try to
manage the time to make sure you all have a chance to answer.
You each have about 45 seconds to answer that, but first, Dr.
Pangalos.
Dr. Pangalos. Thank you very much for what's a very
important question. So, in short, I do believe we can do this
in terms of delivering both a safe and efficacious vaccine.
These are unprecedented times in terms of how we're interacting
with regulatory authorities all around the world, including the
U.S. FDA, but also, how our people are working in terms of 24/7
work. All of our interactions, I think, have been consistent
with having to demonstrate a safe and effect vaccine. I don't
think any of the regulatory bodies who we interact with are
lowering their standards.
And by the end of our pivotal studies, we'll have dosed
nearly 50,000 people. So that will be, I think, a very
significant number and comparable to any of the vaccines that
have been approved in recent times.
Mr. Guthrie. Well, thank you.
Dr. Douoguih. Sorry for the quick response. Dr. Douoguih.
Dr. Douoguih. Thank you. We do also believe it's possible
to deliver a safe and effective vaccine. We have experience
with the accelerated programs, as we have developed the Ebola
vaccine. A lot needs to be done in parallel, but it can be done
safely and without compromising any of the standards that we
usually undertake for any clinical trial. There may be a need
to perform post marketing surveillance, and we're working on a
plan there to make sure that we continue to monitor safety, not
only before licensure, but after for the duration that's deemed
appropriate by the regulators. So it will be an effort, and we
will continue to monitor safety long term, but it should be
feasible to do this.
Mr. Guthrie. Thank you.
Dr. Geberding?
Dr. Geberding. Thank you. You know, Merck has a long
experience, and science is a stern taskmaster in this regard.
There is a lot we don't know about this virus, and there are
some special safety concerns that really have to be watched for
it, including enhancement of the respiratory disease under this
kind of immunologic pressure.
So, I think while we are fully prepared to move as quickly
as we can through the things we can do in parallel and gearing
up for manufacturing now at risk, we do not expect to be able
to accelerate the safety assessment. And, in fact, we're quite
relieved that the FDA insisted upon applying the same high
standards of safety and efficacy, even under these emergency
conditions, that they would apply to any of the vaccines that
we've prosecuted in the past.
Mr. Guthrie. Thank you very much.
Also, now, Dr. Hoge.
Dr. Hoge. Thank you, Congressman. We--I echo my colleagues'
earlier comments. We do believe it's going to be possible to,
in a safe way, bring afford an effective vaccine in 12 to 18
months. We have been working around the clock as an industry,
as a company, with colleagues outside of our company as well to
make sure that we're doing it this an incredibly responsible
way all the way through it. So we have a full phase 1, phase 2,
phase 3 program. And as has been referenced before, we're
following the FDA's guidance to conduct a 30,000-person, full
phase 3 program over the course of the fall. We hope that
generates a robust body of data, demonstrating the safety of
the vaccine that can give the FDA and Americans confidence in
its profile.
Mr. Guthrie. Thank you very much.
And Dr. Young.
Mr. Young. Thank you for the question. Pfizer is completely
committed, as I think you've heard from my colleagues here in
the panel, to ensuring the safety and effectiveness of any
COVID-19 vaccine.
In answer to your question about how we were able to move
quickly, we were actually in a fortunate position. We were able
to leverage a couple of years' worth of basic science that we
did along with our partners, BioNTech, for seasonal flus and to
apply those learnings to our vaccine platform for COVID-19.
I want to underscore something that my colleagues have
mentioned, which is, I think the American public should take
great confidence in the FDA's guidelines which I think clearly
and very transparently lays out standards for both
effectiveness, but importantly, for safety, and I think we're
very happy to say those clear guidances and the high standards
that they're going to expect for all of our companies to
demonstrate in our clinical trials in order for any vaccine
candidate to be approved.
Mr. Guthrie. So, good. So you're all saying there will not
be a vaccine on the marketplace that does not meet the high
standards of the safe and effectiveness regardless of the
timing. So thank you very much. My time has expired, and that's
very comforting to hear.
Thank you very much, and I yield back.
Mr. Pallone. All right. I'm going to recognize myself for 5
minutes next until Diana comes back. Let me say that I heard
what some of the previous speakers said, and you know,
historically, I've been very confident in the FDA. But now that
Trump is President, I still think there's a real possibility
that he will pressure the FDA to lower the standards, either by
maybe putting out new guidelines that say that they don't
have--the standards don't have to be as good. I think right
now, they say the vaccine has to be 50 percent effective. But
let's say--let me give you a scenario where the FDA changes its
guidance and says, Oh, it only has to be 20 percent effective,
or 10 percent effective. Or they keep to the guidance, but you
know that yours is only 10 or 20 percent effective, and they
approve it anyway, saying, Well, you know, it meets the
standards even though you don't.
I guess I'm trying to rely on you as the manufacturers to
kind of assume that the FDA will not meet the high standards
either by changing the standards, or by saying it's OK when you
know it isn't.
What do you--what can you do in those circumstances? I
mean, I want to make sure that you will guard against any
pressure that comes from the FDA to either lower its standards,
or to approve something that you know doesn't meet the
standards. How can we--what would you do as manufacturers to
help us out in that regard on the assumption that we can't
trust the FDA the way you sort of assume?
And let me start with--I guess we could start with Dr.
Pangalos. I know that's difficult to answer, but I want you to
kind of assume what, unfortunately, shouldn't happen which is,
you know that the FDA is approving the drug even though it's
only 10 or 20 percent effective. Will you tell us that? Do you
feel an obligation to tell us that and give us that
information? I'll start with Dr. Pangalos.
Dr. Pangalos. Thank you very much for, again, a very
important question.
What I will say, first of all, all of our interactions with
the regulators have given us no evidence that they're lowering
the standards or thinking about lowering the standards.
Secondly, as a company, we will always think about safety and
efficacy, first and foremost, in making is sure that we have an
effective medicine. We would not be trying to launch a medicine
that is not effective.
Mr. Pallone. But, Dr. Pangalos, what I would ask is that
regardless of what the FDA says or does that we could have some
sort of assurance from you and others that you would tell us
truth about the effectiveness of the vaccine, that they are
not--
Dr. Pangalos. Absolutely. So all of our data have been
pivotal studies that we published, as is true of all of the
studies that we run in pivotal trials, but also, remember, this
is going to be a vaccine that is going to be used globally, and
so every regulatory authority is going to have a view on the
efficacy and the safety of our vaccine.
Mr. Pallone. That's helpful. Now let me ask Dr. Douoguih
the same thing. Assuming that, you know, you find out the FDA's
going to approve something that you know is not 50 percent
effective, that's 10 or 20 percent, can you give us some
assurance that you would tell us truth about the effectiveness
of it, regardless of FDA approval?
Dr. Douoguih. Thank you for the question. So we have a
target product profile, which outlines the minimum
characteristics and desired characteristics for the development
of our product, and that includes assumptions on minimum
vaccine efficacy. If we saw 10 percent, and we would design our
trial, actually, to target the efficacy that's outlined in our
target product profile, the study would fail if it hit 10
percent. We would make those results available, but we would
not feel comfortable bringing forward a product that did not--
that was not found to be efficacious according to what we put
forth in our protocol.
Mr. Pallone. Well, I appreciate that. Now, let me ask Dr.
Hoge from Moderna. Can you describe how you would report any
adverse events that might arise in your clinical trials once
it's available for use? I'm trying to get some answers on
adverse events reporting, if you would.
Dr. Hoge. Sure. So thank you for the question. Just like
we've done recently in our New England Journal publication, any
adverse events, we would publish completely that data, and we
would expect to do that similarly for the phase 3 results,
regardless of whether the trial is successful or not.
It's important also to note, sir, that our vaccine study is
being conducted in collaboration with the NIH, and they've
actually set up an independent data safety and monitoring board
that will be adjudicating and reviewing both the safety and
efficacy of our study, which hopefully will provide another
level of confidence in the conclusions.
The Chairman. All right. Thank you all. I appreciate your
responses. And I will now yield to the ranking member, Mr.
Walden, 5 minutes. If he's not there--maybe he went to vote. I
don't know.
Mr. Guthrie. Mr. Chair, he did go vote. He was voting on
the floor.
The Chairman. Do we have another Republican that's
available? Mr. Griffith? Can we go to you, Morgan? I recognize
Mr. Griffith for 5 minutes.
Mr. Griffith. I'm available. Thank you very much, Mr.
Chairman. I do appreciate it.
We've heard a lot of comment, and I thought that when
you're answering Chairman, or Ranking Member Guthrie's
questions, you made it clear that you all felt the FDA
guidelines were sufficient. Those guidelines issued in June of
this year related to the COVID-19 vaccine, so let's go through
that again just so we can eliminate any hypotheticals.
Do you all believe--do your companies believe that the
guidance issued by the FDA is sufficient to ensure a safe and
effective vaccine, and if not, say why? We can start with you,
Dr. Young.
Mr. Young. Thank you for the question. I'd just like to
reaffirm what I mentioned in my comments previously. I think
the FDA should be commended for publishing clear, transparent,
evidence-based guidelines that set an appropriately high
standard on both safety and effectiveness for a vaccine. I
think--in echoing some of my colleagues here, I think the
clinical trial protocol that we are putting together for our
phase 3 study will follow those guidelines, and, you know, were
a vaccine to demonstrate lower effectiveness, then, frankly, it
would fail the study.
So we have great confidence that, actually, in following
the FDA's guidelines that the American public and Congress, in
fact, should be confident that any vaccine that is approved
should meet those standards for safety and effectiveness.
Mr. Griffith. All right. Anyone else want to weigh in on
that? I know that you've already answered the question sort of,
but I wanted to clear up any confusion.
All right. Let me ask this question, then: What is FDA
requiring of your companies to ensure that corners are not
being cut during the development process? Are there details
that you can give us that might quell concerns that this
process is happening too quickly? And we can start with whoever
wishes to start. Dr. Geberding?
Dr. Geberding. Thank you. Yes. I think the way to think
about this, really, is to understand that the FDA is not
loosening any standards, so business as usual. Whatever
portfolios or dossiers that we bring to the FDA have to meet
these rigorous standards.
And let me just say that when we were prosecuting our Ebola
vaccine portfolio, it took five years from the time that we did
the phase 3 study until the FDA finally approved our vaccine at
the end of 2019, in part, because they maintained a very
rigorous standard of safety in the context even of that
dreadful outbreak.
So, we are familiar with the expectations, and we're fully
prepared to be transparent about any safety signals and fully
transparent about the efficacy that we observe.
Mr. Griffith. Dr. Pangalos?
Dr. Pangalos. I think the guidelines that FDA have issued
are absolutely to the normal standards, and I think that if we
are able to meet them, we will have a safe and efficacious
vaccine. There is nothing that gives me pause that they're
lowering their standards in any way.
Mr. Griffith. I appreciate that. Any of the other witnesses
want to answer that question?
Dr. Douoguih. It's Macaya Douoguih. Yes. We also agree that
the standards are appropriate, and perhaps even more stringent
than some of the criteria we've had for some of our other
products, so we think that that will ensure that we are
developing the appropriate studies and with appropriate follow-
up to really evaluate the safety and efficacy of this vaccine.
Dr. Hoge. Congressman, all I would add is, I would also
agree that the standards put out by the FDA are really the gold
standard, and we appreciate them put out in advance, and we
intend to measure ourselves against it.
Mr. Griffith. Thank you very much.
Now, I did speak with Dr. Young earlier about this
question, but I'm happy to hear from others as well. I'm just
curious if the company has learned anything in the process thus
far of working on the COVID vaccine that might help develop
future flu vaccines and make that process both more efficient
and more effective, and frankly, have a vaccine created more
quickly when we know what's coming at us.
Mr. Young. Thank you for that question. Yes. Thank you for
the question. I think as I mentioned in my other comments, you
know, one of the things that we were able to do is to leverage
some of the basic research that we've done with our partners,
BioNTech, on mRNA technology which potentially lends itself to
having lower and more potent dosage, but also being able to
change out the coding of the mRNA in order to be able to
develop much more quickly than would normally be the case a
vaccine with an antigen for a particular pathogen or infection.
We believe that technology platform potentially lends
itself extremely well to having more effective flu vaccines in
the future, and we hope to apply the learnings from our COVID
program to that going forward.
Mr. Griffith. Now, I don't have enough time to get
everybody in, but real quickly, can you tell the folks back
home who are watching this or later tonight on C-SPAN what mRNA
is, messenger ribonucleic acid?
Mr. Young. It's actually the coding our bodies normally
use. It's essentially like a code that our cells use to--
naturally to produce proteins in our body, and we can use that
same basic technology to produce an antigen that would enable
the--potentially enable the development of an immune response
to a pathogen such as COVID-19.
Mr. Griffith. Thank you. My time is up.
And thank you, Mr. Chairman. I yield back.
The Chairman. Thank you, Mr. Griffith.
Next is Ms. Schakowsky recognized for 5 minutes.
Ms. Schakowsky. Thank you, Mr. Chairman, or Madam Chairman,
wherever she is.
So I want to talk about Pfizer. A recent Gallup poll showed
that nearly nine in ten Americans are concerned that drug
makers will take advantage of the pandemic to raise prices.
From insulin to countless other examples, we've seen drug
companies use monopoly control to price gouge patients, and
sometimes make it impossible for them to get their medications.
Ensuring the safety and efficacy of COVID-19 vaccines, of
course, is critical, but it will mean nothing if the price is a
barrier to all Americans getting it.
So, to the witnesses. Your trade association, PhRMA,
claimed in an advertisement, and I quote, ``We've had a number
of companies that have already made public a public pledge that
if their vaccine is ultimately successful that they will''--
``they will produce it essentially at cost, meaning no profit
for that company,'' unquote. Now, Mr. Young from Pfizer has
already stated that it will sell its vaccine for a profit.
So for the rest of the witnesses, will you please answer
yes or no? Will you sell your vaccine at cost and provide
contract transparency so that we can verify you aren't making a
profit? So, Dr. Hoge, yes or no?
Dr. Hoge. We will not sell it at cost.
Ms. Schakowsky. You will what?
Dr. Hoge. We will not sell it at cost. No, ma'am.
Ms. Schakowsky. You will not sell it at cost. OK.
Dr. Pangalos, yes or no?
Dr. Pangalos. Under the agreement we have with BARDA for
the 300 million doses, we are selling that to the government at
no profit.
Ms. Schakowsky. Thank you.
Dr. Geberding, yes or no?
Dr. Geberding. Yes to your question about transparency as
we have reported since 2018, transparency in our pricing. We
have not raised our prices since the pandemic began. And, no,
we will not be selling vaccine at cost, although it's very
premature for us, since we're a long way from really
understanding the cost basis of what we'll end up with.
Ms. Schakowsky. A yes and a no.
Dr. Douoguih.
Dr. Douoguih. Yes. We will be providing vaccine at a not-
for-profit price during the emergency pandemic.
Ms. Schakowsky. Thank you.
Taxpayers have provided nearly $10 billion to Operation
Warp Speed, but have no knowledge of how these resources are
being spent. For the companies receiving taxpayer funding for
your vaccines, have any of your contracts or agreements with
the Federal Government included provisions to ensure
affordability in pricing or vaccines, and affordable pricing of
vaccines or treatments? Let me start, again, with Dr. Hoge
about the agreements? What's in them?
Dr. Hoge. No. We don't have a supply agreement with the
U.S. Government, Congresswoman. We have a research and
development agreement, and it doesn't specifically speak to
those supply conditions.
Ms. Schakowsky. That's what I'm asking. OK.
Dr. Pangalos?
Dr. Pangalos. Yes. Under our agreement with BARDA which is
over $1 billion, it's funding our clinical development program
which is the 30,000-patient study in adults and children, and
it's also funding the 300 million doses that we're going to be
providing at no profit for AstraZeneca.
Ms. Schakowsky. Dr. Geberding.
Dr. Geberding. We are not receiving funding from Warp Speed
at this time, but we do have just under $40 million for
research and development of our vaccine portfolio, but we have
no procurement agreements at all.
Ms. Schakowsky. Dr. Douoguih.
Dr. Douoguih. Our funding covers research and development
activities, and we do not have a supply agreement in place.
Ms. Schakowsky. OK. I'm going to put these--this question
out there, and it may have to be answered, then, in writing.
Mr. Young from Pfizer, your company has rejected taxpayer
funding for your vaccine on concern that you will make this--
that you made this decision to be able to price gouge, or at
least I'll say that, without question from Congress. Will
Pfizer commit to affordable vaccine pricing and full
transparency around research and development?
Mr. Young. So thank you for the question. You know, let me
just say, as I mentioned in my earlier comments, that we didn't
accept the Federal Government funding solely for the reason
that we wanted to be able to move as quickly as possible with
our vaccine candidate into the clinic.
In regard to your question, let me just say that we
recognize that these are extraordinary times, and our pricing
will reflect that. And during the time of the pandemic, we'll
price our potential vaccine consistent with the urgent global
health emergency that we're facing.
And, secondly, we also believe, and critically, that COVID
vaccine should be free to the public. A vaccine is meaningless
if people are unable to afford it. And I just want to applaud
Congress for passing the CARES Act to ensure that many patients
who will not face any cost-sharing for future COVID vaccine,
and we would certainly commend that stance.
Ms. Schakowsky. OK. Well, we'll see what that means. I hope
you do find a cure.
And I yield back. Thank you.
The Chairman. Thank you, Ms. Schakowsky.
I'm told by the Republicans that next is Mr. McKinley
recognized for 5 minutes.
Mr. McKinley. Thank you, Mr. Chairman, and to the panel.
From what we've heard today, a vaccine still could be months
away, and that parents have been saying to us that they don't
want to send their children back to school without a vaccine.
So knowing what you know now, would you send your children,
your grandchildren, back to school, yes or no? Each of the
five.
Dr. Pangalos. I can say in the United Kingdom, I will be
sending my children back to school in September if the schools
are open.
Mr. McKinley. OK.
Dr. Hoge. Congressman, I can say for myself, my wife and I
are both physicians. Our local public school has asked us to
answer that question, and I honestly don't know the answer yet,
even for my three children. We're wrestling with the same
challenges parents across the country are trying to figure out
the right thing to do.
Mr. McKinley. So have you come to a conclusion?
Dr. Hoge. No, sir. We're talking about that tonight at
dinner. I don't know yet.
Mr. McKinley. Just--if you're confused, think about all
across America, if they're following the guidelines. I hope
it's not perpetuating this problem if we follow the guidelines.
So, how about quickly, the other people on the panel? They
maybe can step up and do what's right.
Dr. Geberding. I can respond to that from my perspective. I
had a conversation last night with a mother and two
grandchildren in our family, and they are facing a situation
where all three children, or the two children and the mother
are teaching in three different school districts. They may end
up with different policies. So I think there's a great deal of
local variability, and we need better science about the role of
pediatrics transmission in daycare, schools, and colleges.
Mr. McKinley. Haven't the pediatrics--hasn't the
association already said they should be back in school? So I'm
not going--I just wanted to get your input because people are
looking for you for leadership and what to do with the
children, whether we are getting our schools to open up, and
you all are waffling on this, given that the Pediatric
Association has already advocated.
So let me go to the second question. Given that what we've
learned through the difficulties that we've been dealing with
with China, would any of the ingredients in your vaccine
formula come from China?
Mr. Young. Maybe I can start. Congressman McKinley, thank
you for the question. For Pfizer's--Pfizer and BioNTech's
potential COVID-19 vaccine, none of the materials, none of the
drug substance will involve any part of the China supply chain.
So we anticipate for our vaccine candidate that we'll develop
our supply chain within the Pfizer network dedicated to the
United States. And the raw materials and drug substances,
likewise, would be sourced within the United States.
And in the case of, you know, glass and some other
important parts of our supply chain, that would be sourced from
Canada, Germany and the United States, so no contribution from
China.
Dr. Pangalos. I can answer. This is a global pandemic, so
as a company, we want to resolve this pandemic globally. We
have kept our supply chains independent of each other. So for
our U.S. supply, all of our U.S.--all of the manufacturing will
be done in the United States using our--either our own
facilities or contract manufacturers in the United States.
Mr. McKinley. OK. Let me go to the third question that I
have. I was hoping it was going to be a yes or no, that we
would be able to get through the other one. But on this last,
already--Chairman Pallone and DeGette have already brought up
this irresponsible allegation that your companies might bring a
drug to market before it's been sufficiently tested.
Are you--are your companies insulted by that--an accusation
that you could bring a drug to market that's not safe or
effective? Is that insulting? Each of the five of you, please.
Dr. Pangalos. I think people--thank you for the question. I
think given the speed at which we're working, it's
understandable that people may ask questions about whether
anyone is cutting corners. I think what you're hearing from all
of us is that despite the speed that we're working at, we're
not cutting corners, and regulators are not lowering their
standards. So I feel comfortable if there are vaccines that are
effective, they will be safe and effective, and that they'll be
good to go in terms of then getting regulatory approval.
Mr. McKinley. Any others?
Dr. Douoguih. It's Macaya Douoguih. We are working around
the clock to accelerate our developments, but we are not
cutting corners on safety. We believe that we will----
Mr. McKinley. Yes. My question was, is that insulting, that
you could even be accused--that a company of your stature, that
you could be accused of cutting corners?
Dr. Douoguih. We follow science, and we will continue to
develop safe and effective products as we always have.
Mr. McKinley. Thank you. Thank you.
I yield back. My time's expired.
The Chairman. Thank you.
Next, the gentleman from Massachusetts, Mr. Kennedy, is
recognized for 5 minutes.
Mr. Kennedy. Thank you, Mr. Chairman. I'm grateful to you
and grateful to Chairwoman DeGette for convening this hearing,
and grateful to our witnesses for being here as well. It's an
important topic of conversation.
I have no doubt that our country is capable of and
committed to developing a vaccine for COVID-19. I'm grateful
for all the work that you all are doing to get us there. But
what I also want to ensure is that there is sufficient
political will and corporate courage to ensure that a vaccine
is not only accessible to the patients and communities hit
hardest by the coronavirus, but also intentionally distributed
to them as well because it has been choices of generations of
elected officials and a healthcare industry that has led to
some of the historic disparities that we have seen throughout
the course of this pandemic, particularly for communities of
color who have been devastated by the spread of this virus.
Back home in Massachusetts, our State government recently
designated eight separate cities as hotspots even though--or
where the rate of COVID-19 infection is higher, and the rate of
testing is lower: Chelsea, Everett, Fall River, Lawrence,
Lowell, Lynn, Marlboro, and New Bedford, communities with
higher rates of immigrants and higher rates of minorities and
communities of color than the rest of our Commonwealth, and
there is, I think, well known at this point a direct
correlation between them.
Now, the companies represented here today have put forth
enormous effort and resources into the development of a
vaccine, but obviously, as Ms. Schakowsky pointed out, you
haven't been doing it alone. Many of you--well, some of you,
anyway, have received the backing of the American people
through Federal funds for support, half a billion for Johnson &
Johnson, half a billion for Moderna, and up to $1.2 billion for
AstraZeneca.
So I believe you all have a responsibility for those
investors as well. You have a commitment to the social good and
a commitment to righting the wrongs of past decisions that have
priced life-saving medicines out of those same communities, and
I'd like to start diving in a little bit here about what your
plan is.
So I want to begin with Dr. Pangalos. Do you have--have you
engaged at all in any plan to ensure that there is, in fact,
equitable distribution of a vaccine should you come up with
one, and particularly, into front line communities where you--
where we have seen rates of infection the highest?
Dr. Pangalos. Thank you for the question. And we appreciate
the impact that this disease is having, the disproportionate
impact these disease is having on those core communities,
communities of color and of ethnic diversity. And as I said in
my testimony, our goal is to provide good and equitable access
to all races, and all people in the United States and around
the world.
In terms of the agreement that we have with the United
States to supply the 300 million doses, clearly we're
supportive of making sure that distribution of vaccine is done
equitable and fairly.
Mr. Kennedy. So, sir, I don't mean to rude. I just don't
have a ton of time here. So is there a plan that is being put
forth to ensure that there is, in fact, equitable--I know you
want there to be, but is there--have you actually developed
one, and in what state of development is that?
Dr. Pangalos. No. It would be the administration that is
determining the 300 million doses that we provide, how they
wish to distribute them across the United States because we're
giving out doses to the United States Government.
Mr. Kennedy. And, Dr. Douoguih, the same circumstance. Is
it up to the administration to decide the distribution?
Dr. Douoguih. It is. However, we are prepared to share our
equitable--our plan that we are working on which is based on an
ethical framework which focuses on the highest risk and highest
medical need, and we're happy to provide that and have further
discussions on that topic, important topic.
Mr. Kennedy. I would be grateful.
Dr. Geberding. Is it up to the--the same. Do you have a
plan or not? Dr. Geberding?
Dr. Geberding. Yes. Thank you. Right now, we don't have a
plan because we don't have a product, but we will have a plan.
And, in addition, I just want to say very quickly, to count on
the ACIP as well as the National Academy of Medicine to really
help adjudicate those allocation decisions independent of the
administration, per se.
Mr. Kennedy. And Dr. Hoge?
Dr. Hoge. Congressman, we completely agree that the vaccine
should go to place of greatest need, and support that entirely.
We will be relying also on the government to advocate and
distribute the vaccine to those places.
Mr. Kennedy. Dr. Young?
Mr. Young. Thank you for that question. Like my colleagues,
we believe that in ensuring that, you know, a vaccine, if
approved, goes to the patients of greatest need is critical.
And I just want to say that we believe the CDC guidelines that
were developed a number of years ago that outline specific
patient populations and those at greatest risk is very helpful,
and we look forward to working with the administration on
distribution should we be successful.
Mr. Kennedy. But just so we're clear, and I've got 20
seconds left on this. Out of the five companies that are most--
invested the most resources, including those without government
funding, one of you has a plan. All of you are relying on a
government that couldn't procure proper PPE for wide swaths of
this population, including, still, shortages across this
country, and we've got--even with the backing of taxpayer
dollars. And we have a pharmaceutical environment here in this
country where still 26 percent of people that rely on insulin
still can't get access to it. And that's great, you're saying
you're distributing it relying on the Federal Government.
Clearly, the Federal Government has failed here multiple
times over, and I would--I'm just curious. If you don't think
that there's going to be a problem for your companies when
communities of color and lower income communities don't have
access to this, you're going to be coming back here and have
another hearing where we're grilling you on this stuff.
And so, buyer beware on this. If you don't actually make
some effort intentionally now, I would urge you to do so
because the consequence of not doing this right is going to be
dramatic for this country, and this administration I don't
trust at all to actually do this right.
I yield back.
Ms. DeGette. The gentleman yields back.
The Chair now recognizes Mr. Mullin for 5 minutes.
Mr. Mullin. Thank you, Madam Chair. And just real quick, I
don't think at all that our government has failed. I think
we're in a pandemic that we've never experienced before, but
we're responding better than any other country out there. We're
testing more. We're developing more. And the rest of the world
is depending on our country to find a vaccine. And so to say
that our government failed is completely--it's completely
wrong.
Real quick. Can each of you speak to your manufacturing
capacity and how ramping up to meet that demand will be--it
will be needed once the vaccine is authorized or approved by
FDA, and I don't really care the order. You guys can take it
one at a time.
Mr. Young. Thank you for your question. It's John Young
from Pfizer. As I mentioned in my testimony, we have a
dedicated supply chain that we're establishing for supply to
the United States. And parallel with that, we're working with
our partners to develop a supply chain for the EU. We'll be
looking to leverage our existing Pfizer network in our sites in
St. Louis, Missouri, and Andover, Massachusetts, and also
Kalamazoo, Michigan, to do the entirety of our drug
manufacturing process from drug substance through the drug
product. We're very proud of the incredible, heroic work that
our Pfizer colleagues have done to really begin the work
already before we have completed our phase 3 program to
establish our manufacturing and supply network. So we have a
lot of work still to do, a lot of work ahead of us, but we're
very proud of the work that our colleagues have done so far.
Mr. Mullin. Thank you.
Dr. Pangalos. Mr. Mullin, let me go next. So I'm confident
about our supply chain. Our operations team has done a
phenomenal job vetting facilities in AstraZeneca. But also
working with our partners, Emergence and AMRI. We will be
supplying 100 million doses this year and then a further 200
million doses in the first half of next year, and we'll
continue to build supply as the vaccine is needed, assuming
it's efficacious and safe.
Mr. Mullin. Thank you.
Dr. Hoge. I'll take a stab next. At Moderna, we've been
working on a dedicated U.S. supply chain for several years now.
In fact, we built a factory in Massachusetts to manufacture
mRNA, and we've recently partnered with a large--one of the
largest manufacturers of drugs, a company called Lonza, to use
their facility in New Hampshire. And through that dedicated
supply chain, we're very confident we're going to be able to
deliver several hundred million doses next year.
Dr. Geberding. And I can speak for Merck. Like the other
manufacturers, we are manufacturing at risk, meaning we're
preparing now. We expect to have hundreds of millions of doses
available beginning in 2021 and are securing the ancillary
supplies that we need to be able to support that.
Mr. Mullin. Thank you.
Dr. Douoguih. I can answer for Johnson & Johnson. We are
setting up global supply. We have entered partnerships with
Emergent and Catalent so we will be able to produce 400 million
doses coming out of those facilities, and we're also setting up
in other areas, entering agreements, so that we can supply the
rest of the world with the vaccine. We're targeting 100 million
doses by early 2021, with the goal of getting to 1 billion by
the end of the year.
Mr. Mullin. Thank you. Can you guys tell me if any of this
manufacturing is happening in China? Anybody? Does anybody
know?
Dr. Douoguih. It is not. It is not, not for Johnson &
Johnson.
Dr. Hoge. Our manufacturing is domestic.
Dr. Pangalos. We have a U.S. supply chain.
Mr. Mullin. So would you guys say the majority, or if not
all of this, is happening inside the U.S.?
Mr. Young. For Pfizer, 100 percent of our product, if
successful, will be supplied from our U.S.-based supply chain.
Mr. Mullin. Is that the same for everybody else?
Dr. Pangalos. So we have supply agreements around the
world. Our U.S. supply chain will be sourced from the U.S., but
other supply chains we have around the world will be supplied
from other sources to try and keep supply chains independent
and actually not competing and conflicting with each other.
Dr. Geberding. I would say Merck had committed to building
out our supply chain in the U.S. to the tune of about $9
billion prior to the pandemic, and we're only adding to that
now.
Mr. Mullin. Great.
Dr. Douoguih. For Johnson & Johnson, roughly half of the
supply will come out the U.S., and the rest will come from
other supply chains distributed around the world.
Mr. Mullin. So with 20 seconds left, real quick, does the
majority, or all of you guys have plans to expand your
manufacturing capacity inside the U.S.?
Dr. Geberding. Yes.
Dr. Douoguih. Yes.
Dr. Hoge. Yes, we're doing it now.
Mr. Mullin. Well, thank you, guys.
Madam Chair, thank you so much, and I'll yield back.
Ms. DeGette. Thank you very much.
The Chair now recognize Mr. Ruiz for 5 minutes for
questions.
Mr. Ruiz. Thank you. Thank you all for being here today. I
am cautiously optimistic after hearing the progress you all are
making in your efforts to develop an effective and safe
vaccine. And while the numbers of the vaccines that you
anticipate having in the next year seem promising, I am very
concerned about the lack of a health equity plan in the
distribution of those vaccines.
The number one step is the science of developing an
effective and safe vaccine. Number two step is to produce that
vaccine. Number three is to distribute the vaccine. And then
four is to administer the vaccine in the front lines. And we
should be able to foresee what's coming and develop a
distribution plan that's based on public health principles,
with the objectives to slow the trend of transmission, and to
save as many lives as possible.
When we ask those questions, then we need to ask the
question: Where is the highest risk and the highest rate of
transmission of coronavirus, and which communities and
demographics are dying at higher disproportionate rates of
coronavirus? And it is not too difficult to find the answers to
those questions.
We know that seniors and seniors in nursing homes are at
highest risk of dying, those with underlying conditions. We
know that African Americans, Latinos, Native Americans are at
the highest risk of getting infected, and also dying from
coronavirus. We need public health principles based on public
health equity, not politics, not-for-profit going to those who
are the highest bidders or objectives that favor the powerful,
the prosperous, or the healthy or large corporations who can
afford and offer the highest bidding amount in order to keep
their healthy workers safe to affect their bottom line and
their profit. We cannot repeat what has happened already in the
distribution of testing, in the outreach, and in the treatments
of the coronavirus.
I was just called by a previous employee yesterday who told
me--or texted who told me that his sister, who works in the
front lines as a nurse in COVID-19 units who was recently
exposed, couldn't get testing herself. It wasn't offered and
couldn't--it wasn't offered in the hospitals. She had to go to
an urgent care and pay for it for herself. It was difficult to
get testing. Yet, he has a cousin who is in training for the
Washington Nats, the professional baseball team, and they get
tested every two days.
So my office is hearing the same thing from nurses across
my district. This is unconscionable, and we cannot repeat this
mistake with the distribution of vaccine.
So having millions of vaccines is a good first step. We
also need to be planning now how we get the vaccines into the
hands of the people that need this most, and I don't want to
look back and then have health equity be an afterthought. It
has to be prioritized.
So I want to ask Dr. Geberding from Merck. What is your
company doing to ensure that the distribution of these vaccines
are getting to the populations that need them the most with the
highest transmission and the highest death rate from COVID-19?
Dr. Geberding. I think the best way to answer your question
is to think through what already works and doesn't work in this
regard. It is the CDC's responsibility, the ACIP that makes
decisions about allocation. But in this very special case, I
have personally, and I think many of us have called for the
National Academy of Medicine to create a mechanism to look at
health equity, and make sure that the allocation is fair.
Mr. Ruiz. Thank you. Thank you very much. You know, I've
heard a lot of, Well, that's the government, that's the
government, but not all of you are going to give 100 percent of
your vaccines to the government. There is going to be a
percentage that you will hold back for the private market as
well, and that market should also follow a public health
principle so that we can save as many lives, and we can stop
the surge in order to improve the public health. Dr. Young from
Pfizer, can you answer that question for me, please?
Mr. Young. So a very important question. I want to, you
know, support what my colleague, Dr. Geberding, has just said,
you know. We believe that actually the CDC has laid out very
clear criteria for a pandemic situation as to which patients
should actually be prioritized. And we look forward to working
with the Federal Government and its agencies in order to ensure
that distribution of our vaccine is equitable.
Mr. Ruiz. I'm going to ask every single one of you if you
can please mail my office and this committee your distribution
priorities, not only that go towards the government, but also
that you have within your own private market, sales, and
distribution, and what your objectives are during this
pandemic. Can you do that please?
Mr. Young. Yes, we will.
Dr. Douoguih. Yes.
Mr. Ruiz. Thank you. Dr. Pangalos, Dr. Hoge, and Dr.
Geberding, can you do that? OK. I'll take that as a yes from
all of you, and I'll follow up with you as well, and I believe
I heard from Johnson & Johnson, Dr. Douoguih, as well. Thank
you.
Ms. DeGette. The gentleman yields back.
The Chair now recognizes the ranking member of the full
committee, Mr. Walden, for 5 minutes.
Mr. Walden. Thank you again, Chairwoman. I appreciate this
hearing, and I appreciate the testimony of the witnesses. Many
of us have had an opportunity to talk before this hearing.
I have a couple of questions. First of all, just real
quickly. When we talk about the dosages that will be available
before the end of the year, and then into next year, do all of
your vaccine candidates require at least two doses to be
effective?
Mr. Young. John Young from Pfizer. Thank you for the
question. So we anticipate that the protocol that we will study
in our pivotal trial will use an initial dose plus a booster,
so yes, two doses.
Mr. Walden. All right. Is that true for the others? Our
witnesses can go on.
Dr. Douoguih. It remains to be seen. I'm sorry. I was just
going to say earlier in our development, we may have the
possibility to evaluate both, but we don't yet know if it will
be one or two.
Mr. Walden. All right. All right.
Dr. Geberding. Merck selected vaccine candidates that we
believe have a reasonable possibility of being single dose
vaccines. That's our hope, but that's unproven at this point in
time.
Mr. Walden. OK. All right.
Dr. Pangalos. Our data suggests that two doses are giving a
stronger immune response than one, but until we understand the
immune protection, we don't know ultimately whether one will be
enough.
Mr. Walden. All right.
Dr. Pangalos. We'll go with two to be sure, but it could
end up becoming one dose.
The Chairman. Thank you. That's really helpful, I think,
for us and for the public to understand that when we talk about
having 300 million doses or 30 million doses, we probably
should estimate that's half--cut that in half in terms of the
number of people that are actually going to be able to get
vaccinated, sort of in the worst-case scenario is my take-away
of that.
In terms of the supplies you need, and I know many of you
have talked about this, the ancillary supplies, such as glass
vials and stoppers and packaging and shipping. Is the Federal
Government assisting your companies in this endeavor, or do you
feel like you have the supply chain locked down to be able to
produce package, ship safely, effectively, and efficiently? Is
there more work that the administration or we in Congress need
to do to assist in that?
Dr. Pangalos. Congressman Walden, first of all, I would say
obviously the funding we're getting from the government, which
we're very thankful for, is helping us ensure that we
everything we need to enable the supply of the 300 million
doses as rapidly as possible. So from our perspective, we have
what we need, we think, to build supply as agreed with the
government.
Mr. Walden. All right. Ms. Geberding?
Dr. Geberding. Yes. From the Merck perspective, when we say
we are anticipating hundreds of millions of doses going
forward, we have secured the necessary surround sound,
ancillary supply contracts, et cetera. And we can do that
because we are a big company, and we make a lot of vaccines, so
we have existing mechanisms for those procurements.
Mr. Walden. All right. Others?
Dr. Douoguih. It's Macaya Douoguih. We are working on a
global supply chain to be able to provide what is needed in
terms of vials and stoppers to provide our vaccine.
Mr. Walden. And you're confident you'll be able to achieve
that?
Dr. Douoguih. So far, it looks as though that would be the
case, yes, but we're monitoring the situation closely. We would
certainly appreciate support if it's available.
Mr. Walden. All right. Mr. Young?
Mr. Young. We've had very positive engagement with our
suppliers, you know, both for raw materials, but also for, you
know, glass and stoppers, so we believe we have a path to be
able to have all the necessary materials for a vaccine program
should we be successful.
Mr. Walden. Dr. Hoge?
Dr. Hoge. We also believe we have a path that we've either
already procured all the necessary supplies, or we're in the
process of doing that. But we do appreciate that the career
folks at BARDA and HHS have been very helpful in helping us
identify contingency plans if we aren't able to secure those
supplies.
Mr. Walden. I want to talk about FDA for a bit, just real
quickly. Are you all comfortable with the guidance the FDA has
issued to protect consumers' safety and ensure the efficacy of
the drug? Is there anything there that disturbs you? Are you
concerned that somebody's going to try and rush you into
production?
Mr. Young. John Young from Pfizer. So I would really
commend the FDA for having been extremely proactive, and very
transparent by the criteria that they've laid out for both
safety and effectiveness. I think those standards are high and
I think should give all of us as Americans a lot of confidence,
actually, if a vaccine is approved, either as a BLA or under
emergency use authorization that the FDA has done so according
to stringent guidelines for which they're to be commended.
Mr. Walden. And I know my time's running out. Does anybody
disagree with that?
Dr. Pangalos. No.
Dr. Hoge. Agreed.
Mr. Walden. Thank you all, and the team you work with, for
the work you're doing to try and safeguard the world, frankly,
from this pandemic and bring about a vaccine and therapeutics.
I yield back my time.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes Ms. Kuster for 5 minutes for
questions.
Ms. Kuster. Thank you very much, Madam Chair, and thank you
to all of you for being with us. One point I want to make clear
because we know we're talking about confidence of consumers and
Americans who have a great deal of stress and anxiety. Could
you articulate briefly, if you can, the notion that, because
you are taking a risk on the manufacturing, that is related to
speeding up the timeline of the vaccine, but that you are not
taking a risk as to the safety and efficacy on the research
side? If you could, one by one, and we'll just start with Dr.
Pangalos.
Dr. Pangalos. Yes. It's a very good question, Congresswoman
Kuster. So you're absolutely right that what's different is
about what we're doing is that we're manufacturing that risk in
the hope that we will have a safe and efficacious vaccine, such
that when we have that data available, and hopefully, the
regulators agree that our vaccine is safe and effective, we
will have the doses rates to supply in the U.S. and around the
world straightaway. That, I think, is what this funding from
BARDA gives us is that ability to----
Ms. Kuster. How much time do you think that takes off the
clock of a typical vaccine production?
Dr. Pangalos. It's difficult a concept, but a lot. I mean,
you wouldn't be making these investments and going into pivotal
studies and trying to produce two billion doses around the
world before you have any evidence of efficacy, so I think it's
a huge help.
Ms. Kuster. Thank you. I want to focus in on the daunting
task of ramping up production to provide doses for over 320
million Americans in a matter of months. This will be an
unprecedented task, and our ranking member has pointed out that
this may take two doses per person. Recently, I introduced H.R.
7104 which would expand our manufacturing capacity and require
the administration to begin this planning now because I believe
planning is essential so that we can assure that all Americans
have equitable access to the vaccine when one is available, and
our communities can reopen fully and safely, including our
schools.
This legislation was included in the House version of the
HEROES Act, and I'm very anxious for the Senate to move forward
without delay.
So, again, Dr. Pangalos, if you will, AstraZeneca has
stated it anticipates producing 300 million doses of the
vaccine beginning as early as this fall. Does that include the
one billion doses it plans to supply around the globe?
Dr. Pangalos. It does not. The 300 million doses are for
the U.S. supply chain only. The other 1.7 billion doses plus
that we'll be supplying around the world will be done in
independent supply chains all around the world.
Ms. Kuster. Thank you. And, Mr. Young, Pfizer anticipates
producing up to 100 million doses by the end of 2020, and 1.3
globally in 2021. It's my understanding that Pfizer recently
had some challenges in manufacturing sterile injectables that
resulted in shortages and delays. What steps is Pfizer taking
to increase its capacity and mitigate any risk of future
shortages or equitable distribution issues?
Mr. Young. Thank you for the question. So since we
acquiring Hospira in 2017, we've invested several hundred
million dollars, invested in those legacy Hospira sites in
order to remediate production difficulties and some quality
challenges.
We're very proud of the work that our manufacturing team
has done. And, indeed, we're particularly proud that in the
COVID-19 pandemic, actually, those sites have been able to
respond to incredible increases in the number of really
important basic injectable medicines that are used in
intensive-care situations, and obviously, we saw a lot of that
with COVID-19.
So our plan was that that would be substantially remediated
in 2019, and completed by 2020. I am pleased to say that those
sites were on track. The sites that will ultimately manufacture
the COVID-19 vaccine are actually from our legacy Pfizer
network, where we don't have any history of compliance or
quality problems.
Ms. Kuster. All right. My time is coming to a close. I'll
do my next question for the record.
So, thank you, and I yield back, Madam Chair.
Ms. DeGette. I thank the gentle lady.
The Chair now recognizes Mr. Burgess for 5 minutes.
Mr. Burgess. I thank the chair. Madam Chair, let me first
ask unanimous consent to place into the record the letter from
Retractable Technologies about their production of 240 million
syringes with the contract they recently received from BARDA.
It is significant with us being able to provide the delivery
mechanisms that Dr. Ruiz talked about. And along the lines--I'd
just like to ask all the panelists along the lines of what Dr.
Ruiz was discussing about the availability.
You know, the price of vaccines historically has not really
been one of the big obstacles, or a big determinant in
vaccination levels. In fact, we've had some hearings in this
Oversight Investigation Subcommittee at the very beginning of
this Congress on the issue of vaccine hesitancy. I did
introduce a bill with Dr. Schrier of Washington State following
the measles outbreak up there last year. So do we--and this was
a bill designed to increase or decrease vaccine hesitancy.
So I would just ask all of our panelists: Are there
additional steps that the administration and/or the Congress
could and should take to encourage the American public to
receive the vaccine when it's available? And let's see. Why
don't we start with AstraZeneca?
Dr. Pangalos. Thank you, Congressman Burgess, and this is
an important question because, ultimately, we know that people
need to be vaccinated to be protected from the pathogen. And we
recognize the vaccine hesitancy and public distrust in the
COVID-19 vaccine, particularly given the speed at which we're
developing it. It may be perceived as a problem. However, we're
completely supportive of the U.S. Federal agencies to ensure
that Americans have vaccines that can be used safely and
effectively. And I think the FDA Commissioner, Stephen Hahn,
has already committed to showing that the FDA's regulatory
review process will uphold the highest standards, and we've
talked about those at length during the course of the hearing
so far.
Mr. Burgess. Right.
Dr. Pangalos. We also support the CDC's efforts as well to
develop materials to encourage people to be immunized,
particularly in areas and communities that are underimmunized.
Thank you.
Mr. Burgess. I think they actually identified that as a
weak point in the hearing that we did a year ago, but I do--I
agree that we are going to have to engage the CDC.
Johnson & Johnson, the same question to you.
Dr. Douoguih. Well, I fully agree that vaccine hesitancy is
an increasingly bigger challenge over time, and it certainly
will be for COVID-19. I think the outreach and discussions and
educational materials, all of that needs to happen now. And we
would very much support any efforts that really focus on solid
educational programs to make sure people understand, can share
their concerns, because it's not only about access, it's about
people willing to accept the vaccine. And they need to have
trust and confidence, not only in the safety and efficacy, but
also, have their concerns answered.
Mr. Burgess. Great.
Dr. Gerberding?
Dr. Gerberding. Thank you. I couldn't worry about this
more. I think that trust is a consequence, both of truth-
telling, as well as transparency. And it's not enough to have a
government spokesperson or a manufacturing spokesperson. We
really need to engage the people that are trusted, and often
those are doctors, doctors at the local level.
So we do have to engage the medical community and help
people get the information, and then have their own confidence
in what we're doing, so that they can translate that at the
community level.
Mr. Burgess. Great.
Dr. Hoge?
Dr. Hoge. Congressman, thank you for the question. I
couldn't agree more with the concern, just like the other
panelists. We do think it's going to take a broad effort to try
and make sure the vaccine is broadly adopted.
I would echo, too, Dr. Gerberding's last comment, there is
a trust deficit, and we have to rely on those who have that
trust, particularly given the short time horizons we have.
Mr. Burgess. Great.
And Mr. Young?
Mr. Young. Thank you for the question. I mean, I think
vaccine hesitancy is probably one of the greatest challenges
for public health that America faces. Until we fully support
the work of the CDC----
And I would endorse the comments of my fellow panelists,
that actually all of us need to play a role in ensuring that
should we be successful in this mission, that actually there is
confidence in the safety and the effectiveness of our vaccines,
based on data, based on confidence that the FDA will approve a
vaccine only if it's proven to be safe and effective.
Mr. Burgess. Yes, OK.
Mr. Young. And so we certainly support the work of this
panel in achieving that end.
Mr. Burgess. Thank you.
Look, the Federal Government has launched several
initiatives aimed at accelerating medical countermeasures,
including vaccines. How has your interaction with the Federal
Government been through the vaccine development process? Have
they been helpful, yes or no?
Let's again start with AstraZeneca.
Dr. Pangalos. Yes, they have been helpful.
Thank you very much for their support.
Mr. Burgess. And Johnson & Johnson?
Dr. Douoguih. Yes, they have been extremely helpful and
very constructive in this process.
Mr. Burgess. And Dr. Gerberding?
Dr. Gerberding. Absolutely helpful. We wouldn't have an
ebola vaccine approved and licensed if it wasn't for BARDA.
Mr. Burgess. Dr. Hoge?
Dr. Hoge. Yes, absolutely, incredibly helpful.
Mr. Burgess. And Mr. Young?
Mr. Young. Yes. We've maintained very constructive
discussions with a whole range of Federal Government agencies.
Mr. Burgess. Thank you, Madam Chairman. I yield back.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes Ms. Castor for 5 minutes.
Ms. Castor. Well, thank you, Madam Chair.
Thank you to our witnesses who are here today.
I'd like to continue the discussion about CDC and our
public health professionals across the country and how we will
distribute vaccines. Because I believe any successful effort to
deploy the COVID-19 vaccine will rely on our public health
professionals across the country.
They have been on the front lines of the pandemic from day
one. We've got to build on that long-standing public health
infrastructure that's already in place across America, and
while I believe it's been drastically underfunded in past
years, the Congress has provided some resources to CDC and our
public health departments, and the HEROES Act that we passed in
the House months ago would build on that investment.
State and local immunization leaders recently wrote to
Operation Warp Speed leaders just a couple weeks ago, and they
said our Nation has a decades' long track record of
facilitating both public and private infrastructure to
successfully deliver life-saving vaccines.
But I'm very concerned because the Trump administration has
not relied on our public health experts at a time when we need
their guidance the most, and I think this is--you know, their
dismissal of a scientist and public health experts has really
put folks at risk.
I mean, I represent the State of Florida, and we are in a
world of hurt right now. In fact, just this past weekend, it
was reported that the Trump administration is trying to block
necessary funding for testing, tracing, and the CDC to fight
COVID in the next emergency aid package.
So getting a vaccine that is safe and effective is going to
be absolutely critical, and I hope the President and those
around him will consult our public health professionals.
Dr. Gerberding, you were at CDC, you were a leader there,
and in your testimony, you state, we urge strengthening of the
systems that support routine immunization systems and preparing
now to adapt them to mobilize for mass vaccination programs
once the pandemic vaccines are available.
Would you agree that the Centers for Disease Control and
the long-standing public health professionals across the
country have been critical to our Nation's historical vaccine
distribution efforts, and what role do you believe the CDC and
our public health partners must play in a national COVID-19
vaccine plan?
Dr. Gerberding. Thank you so much for your question. I can
only believe CDC is a national treasure--I'm getting some echo.
I hope you can hear me--and that there is a long track record--
--
Ms. DeGette. If the gentle lady will suspend? Dr.
Gerberding?
Dr. Gerberding [continue]. Of success in immunizing our
children, our teenagers, and our adults. We cannot possibly do
this without the CDC and the frontline of our State and local
health departments.
We need to strengthen their support, we need to strengthen
their ranks, and we need to get fully behind them, arming them
not only with information but with the resources necessary to
really step forward and support a mass vaccination campaign in
the context of this pandemic. They are our frontline.
Ms. Castor. I concur, and that whole system has been very
successful in the past to contain outbreaks. I mean, for H1N1,
they delivered over 100 million vaccine doses during that 2009
pandemic.
Mr. Young, why will this existing vaccine distribution
network and infrastructure be essential for the COVID-19
vaccine distribution effort?
Mr. Young. Thank you for the question. So I just endorse
everything that Dr. Gerberding has just said. Plainly, the
challenge that we face, you know, is enormous. In theory, I
think Dr. Gerberding, in her testimony, actually already said,
none of us are safe until all of us are safe, and that is what
is unique about this situation and the importance of a vaccine,
that it gets to those who are at greatest risk, but ultimately
that everybody is protected.
And so the criticality of public-private partnerships
that's represented in this hearing today, but actually the
engagement of the government agencies and the full distribution
network to be able to get to potentially 330 million Americans
and ensure that they're all protected, is going to be
absolutely fundamental.
Ms. Castor. And Dr. Hoge, is this coordination happening
now? To your knowledge, has Operation Warp Speed leadership
engaged in this kind of planning with our public health
professionals across the country?
Dr. Hoge. So I can't speak to what Operation Warp Speed
would be doing outside of our field of vision, but I am aware
through our conversations they have brought in obviously
colleagues from the NIH and CDC and other public health
officials to help us both plan how to execute our study and
perhaps to begin to anticipate what happens if we end up with a
safe and effective vaccine.
Ms. Castor. Thank you, I yield back.
Ms. DeGette. I thank the gentle lady.
The Chair now recognizes Mr. Duncan for 5 minutes.
Mr. Duncan. Thank you, Madam Chair, and I want to thank the
witnesses for being here.
Just some stats in South Carolina for our population of
5,148,714 people. We've had 1,164 deaths. That's a 0.023
percent mortality rate in South Carolina, 89 percent recovery
rate from folks that have contracted COVID and have gone on to
recover.
I'm glad we're pursuing this vaccine, but I just want to
caution us to a few things. When I look up the data for an
influenza vaccine--and granted, there are many different
strains of influenza, but there's also a fear that COVID-19
could mutate and have different strains, but when I look up
something we've been dealing with a long time, and that's
influenza, we have to guess every year what strain will be
there.
And if you look at the effectiveness, in 2019, it had an
estimated 45 percent effectiveness; in 2018, a 29 percent
effectiveness; 2017 was 38 percent; 2016 was 40 percent; 2015
was 48; 2014 was 19 percent effective, for a vaccine that was
created to deal with influenza and a virus that we've been
dealing with a long time.
Now we've got a novel coronavirus, known as COVID-19, and
we're trying to create a vaccine for it. Hopefully it won't
mutate, hopefully the vaccine will work, but when I think about
influenza, I think about the fact that it affects a very
similar population more so than others. And that population
being the older population, 60-plus, especially if there's
comorbidities involved.
Influenza affects the same age group. When you look at the
data of influenza to use as a comparison, the vaccinations are
effective, most higher percentage wise, healthy adults, age 18
to 46. That's about a 70 percent effective rate. Healthy
children, age 6 to 24 months, 66 percent effective rate.
Influenza vaccine also appear to protect against other
infractions with a benefit of 15 to 45 percent.
Where it's not effective is that population 60 and above,
especially when comorbidities are involved.
So let's shift to COVID-19. We're trying to create a
vaccine for COVID-19, and my question for every company is, how
will you create a vaccine that is effective for the most
vulnerable population, and that is the 60-plus population,
especially when there's comorbidities?
Comparing to the influenza vaccine, it's not very effective
for that demographic as well. So how are you going to target
the most vulnerable population, if you look at the fatalities
of COVID-19? Answer that.
And then how are you going to deliver it to those? That's
another question. But let's talk about how you're going to
target that vulnerable population.
Ms. Gerberding?
Dr. Gerberding. Thank you. It's a really important
question, and I think at the very beginning of vaccine
development, we tend to study vaccines in the people who have
the greatest likelihood of responding to the vaccine, but we do
need to understand what will happen with these vaccines in
older people. That's one of the reasons why I think we're going
to ultimately end up with more than one vaccine.
The first vaccine might not be the best vaccine for seniors
or for children. So we need to have additional studies to
really define the value in the highest risk populations, and
the safety in those Populations.
Mr. Duncan. OK. Mr. Pangalos?
Dr. Pangalos. It's, again, a very important question, and
during our studies, we'll be treating a variety of age groups
and vulnerabilities, from five years old to 70-plus. And so
we'll be able to generate data that gives us an indication of
who is best responding to the vaccine.
As we said previously, the regulators have said they want
to see a 50 percent efficacy level in the broadest population,
but it may be that a younger population responds better than an
older population. We don't know yet.
What we do know with our vaccine is that we do see good
immune responses in the elderly, in other diseases that the
Oxford Group have tried to treat. So we are optimistic that it
will work in older adults as well.
But we also have additional therapies, like our monoclonal
antibody programs that will be independent of generating an
immune response. And so if you have, let's say, an immune
compromised individual, or a person that doesn't respond to the
vaccine, we'll be able to treat them with an antibody instead,
and then we'll be helping them--basically giving them their
immune response without therapy.
Mr. Duncan. My time is about out. Let's go to MacAya.
Dr. Douoguih. Yes. So I fully share your perspective that
the elderly are an important population, and that's why we are
planning to evaluate them in our very first study, so that we
can understand what the immune responses are, what does the
safety profile look like, and select the appropriate dose and/
or schedule such that we can evaluate them in our efficacy
study as well, because we believe they should be some of the
first people to get access to the vaccine.
We do have experience with our platform in another
respiratory virus, RSV. We have a program targeting the
elderly, and we're encouraged by some of the data that we have
now been seeing in terms of the immune response looking
comparable to what we see in younger adults. So there is a good
possibility that we may have a viable vaccine for that
population.
Mr. Duncan. Stephen?
Dr. Hoge. Thank you for the question. It's an important
question. Two quick answers because I know we're running out of
time.
Ms. DeGette. You're out of time----
Dr. Hoge. Sorry.
Ms. DeGette [continue]. So answer fast.
Dr. Hoge. We've already evaluated our vaccine in elderly
populations. That data is ongoing both in the phase \1/2\
study. We look to publish that the future. And in our phase 3
study, we have actually stratified the study to be ready for 25
to 40 percent of folks who are over the age of 65 or have
comorbidities, specifically to evaluate the efficacy of the
vaccine in that population.
Mr. Duncan. That's important.
Thank you, Madam Chair.
Ms. DeGette [continue]. Your time is expired.
Mr. Sarbanes is recognized for 5 minutes.
Mr. Sarbanes. Thank you, Madam Chair. Can you hear me?
Ms. DeGette. Yes.
Mr. Sarbanes. Excellent.
I want to thank the panel for all your work and obviously
for your testimony today. I wanted to drill down a little bit
more on this tension between safety and speed that you've
spoken about a number of times. Of course, all of you have
testified that you don't have to sacrifice safety to achieve
the speed that you've undertaken right now.
But it sort of begs the question, what happens in normal
times? Because I know, for example, that you would have said to
investors that were leaning on you to move more quickly with
getting a vaccine produced, or some other product, that you
have to go deliberately for safety reasons.
So can you, maybe, Dr. Gerberding, or Dr. Young, just to
take two of you from the panel, tell me exactly why it is that
you're able to move fast without sacrificing safety, when we
lay that against what the normal procedures would be?
Is it that you are now putting staff on this literally 24
hours a day, whereas normally you'd be working a 12-hour shift?
Is it that you've got resources coming behind you from the
government that you don't normally have that allows you to move
faster? What are the actual logistical dimensions of what it
means to go fast but stay safe?
Dr. Gerberding. I can start. You've mentioned some of the
categories. I think the biggest time-saver is the fact that
we're already investing in building the manufacturing capacity,
literally the plants that will be manufacturing the vaccine.
Because as we said earlier, normally that doesn't happen until
we've proven that the vaccine works. So that takes a huge chunk
of time out of the preparation.
But in addition, the collaborative efforts such as the NIH
is creating, bringing together industry leaders along with
scientists to try to define what are the leading candidates, so
we don't waste time and resources prosecuting a portfolio that
isn't going to go anywhere, we concentrate on the most
promising opportunities.
Then I think the FDA is doing a lot to make sure that the
portfolios are reviewed in an expeditious manner. Even putting
the guidelines out is a great help to us because it creates
more regulatory certainty about what we need to come forward
with, with a portfolio. We know we need six months of safety
data, for example.
So all of these things added together begin to chunk out
pieces of the normal, very extended timeline. That all assumes
that things will go exactly as we planned, and I think those of
us who are experienced with vaccines know that that isn't
always the case, so we don't want to over-promise on the
timeline. And that is one of the reasons why Merck is cautious
about that.
Mr. Sarbanes. Well, let me jump in and ask another
question.
I'm going to pivot a little bit here, but it's related--and
let me just say to the points that you made, I think you're
describing how this pandemic may be completely changing up the
way vaccines are produced and approved and tested and so forth,
for life after the pandemic.
Obviously this is a unprecedented situation, but it's
forcing a changing in kind of the modeling and design in how we
do this, which will be relevant on the other side of it. And I
think it's interesting, in the moment even, to step back and
consider what that means.
But let me pick up on your point about expanding the
manufacturing capacity in a sense, ahead of whether you know
that you're going to need it, because that is going to be a
time-saver. And maybe--I know that a Pfizer executive recently
indicated that even if their company's vaccine is not
successful, Pfizer will pivot and dedicate whatever capacity
it's building to help produce what is successful.
So maybe, Dr. Douoguih and Dr. Pangalos, you could speak to
whether Johnson & Johnson and AstraZeneca has a similar posture
on this, that you're going to step up and be part of a
manufacturing capacity solution, regardless of what happens
with your own vaccine pursuit?
Dr. Douoguih. That's a very good question, and I think we
can make ourselves available for those types of discussion if
our vaccine were not to be successful. We would have the
capabilities to produce. It's something that we would entertain
a discussion on, absolutely.
Mr. Sarbanes. Dr. Pangalos?
Dr. Pangalos. And I can say we've been having conversations
with the administration around our overall manufacturing
capacity. I know we're already a hundred percent full, which is
why we're also using contract manufacturers to help us actually
provide the 300 million doses.
Mr. Sarbanes. Thank you. I yield back.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes Mrs. Brooks for 5 minutes.
Mrs. Brooks. Thank you, Madam Chairwoman, and thank you for
holding this incredibly important hearing. I wish that all of
America could actually be listening in, and that's part of what
I want to ask everyone, and thank you all so very much for your
work.
Dr. Burgess already brought up the fact that this committee
has looked at the issue of vaccine hesitancy and vaccine
competence, and a recent poll showed that as few as 50 percent
of people in the United States are committing to receiving one
of your vaccines with another quarter wavering.
And so I continue to be really concerned about what we all
are doing relative to vaccine hesitancy, and so I'm really
curious what your specific companies' approaches are, whether
it's how you market it, how you communicate it, how you educate
the doctors, and the public health professionals about the
efficacy and safety of your vaccine, because as you can see,
there's been a lot of questions about that.
And I'll start with my friend and fellow--the chair of the
CSIS commission, Dr. Gerberding, if you could share with us
what Merck is doing. I know you talked about truth-telling and
so forth, but what is it the companies are doing specifically
to help educate the American people? And I'd love to hear from
everyone.
Dr. Gerberding?
Dr. Gerberding. Thank you.
And thank you for mentioning the commission. We really
appreciate your support in that regard and in all of your
efforts on behalf of our health security. You know, it's a long
answer, and perhaps I should bring some of this back to you for
the record, but the short answer is that it really does have to
do with grassroots, as much as it does top-down, and that means
getting out in the communities. For example, dealing with the
health disparities of COVID means we go to the frontline. We're
actually supporting, through various local NGOs, the
opportunities to bring information to people to encourage them
to seek care, to try to catch up with the missed vaccinations
that have occurred and the consequence of the pandemic so far,
where we're now at risk for a measles pandemic, because of the
under-immunization.
So it's the grassroots on the ground, supporting the
medical providers and supporting community leaders on their
terms, bringing them information. As chief patient officer, I
have roundtables with various patient advocacy groups, just
listening to what they know, what their concerns are, and how
can we broker better information exchange. And then of course
social media is also a big help.
Mrs. Brooks. OK, thank you. And if there are other things--
Dr. Pangalos, anything with AstraZeneca? Anything different?
Dr. Pangalos. I would just add, too, I think the other
piece that we need to be doing is being incredibly transparent
about the data that we're generating with the vaccine and the
studies that we're running. We'll be following up our patients
for 2 years post vaccination.
Making sure that data is visible for all the different
ethnic diversities in our trial population, different age
groups, I think will give more confidence to the population at
large that the vaccines are safe as well as effective.
Mrs. Brooks. Thank you.
Dr. Douoguih?
Dr. Douoguih. Yes. I think the efforts need to start now in
terms of education and outreach. I mean, of course, we have to
develop a safe and efficacious vaccine and be confident that
the data that we are presenting are shared in an understandable
and digestible way so that people feel comfortable in accepting
vaccination.
But I do think that the communities that are
disproportionately affected might require more engagement, and
that is the long process that really needs to start now such
that they could even consider participating in clinical trials.
I think that diverse participation also gives credibility
to the safety and the efficacy of the vaccine and forms the
foundation for the work that has to come after that.
Mrs. Brooks. Thank you.
Dr. Hoge, want to make sure that everyone is able to say
what your company is doing.
Dr. Hoge. So I would echo the comments about transparency
of the data we are working to generate. We need to create
information that allows trusted advisers to make these
recommendations to patients. And for us, our focus right now is
making sure that we're enrolling populations in our phase 3
study that are representative of the diversity of America and
representative of the burden of disease.
And we are partnering with a number of different groups
nationally, the National Black Church but also the NIH and
others, trying outreach to those communities, to leverage those
trusted advisers to try and communicate with those populations.
Mrs. Brooks. Thank you.
And Mr. Young, Pfizer?
Mr. Young. Thank you for your question. It's a critical
question. I would endorse the comments that my fellow panelists
have made. I would just add that for Pfizer, data transparency
is really important.
One of the commitments that we made early on in this
pandemic was to publish transparently our clinical data as we
generate it, which we have sought to do. We think that will
continue to be important.
We, like some of the other companies here, are also looking
to ensure that our pivotal study is representative of the
burden of disease for COVID-19. So recruitment of minorities,
of women, of older patients into the study is going to be
really important.
And that's critical so that when that trial completes and
when we follow-up those patients, that physicians, that the
scientific community, and then I think to all the comments that
were made, the grassroots, you know, of America can be
confident that a vaccine that is approved is going to be safe
and effective for patients.
Mrs. Brooks. Thank you all very much.
I would just remind you all, most of us are not physicians
or in the medical community, and so to the extent that you can
educate us all, in, you know, the best language possible, is
most appreciated.
Thank you all for your work and good luck. I yield back.
Ms. DeGette. The gentlelady--and the Chair now recognizes
Mr. Peters for 5 minutes.
Mr. Peters. Thank you, Madam Chair, and thanks to the
witnesses for being here. I'm sort of at the end, so I have a
long list of questions, most of them have been answered.
I want to say thank you very much for the good work that
you're doing in developing this vaccine, and of course, we wish
you the best of luck.
A couple things I didn't hear that I wanted to ask about
were about interactions with the flu vaccine. Will patients, in
the ordinary course, be able to get this vaccine at the same
time as the flu vaccine? And when will we know if there's
dangerous interactions between the vaccine and other
medication?
Anybody?
Dr. Pangalos. I think during the course of our clinical
studies around the world, we'll be looking at all of the
appropriate drug interactions, interactions with comorbidity,
et cetera, that you would need to publish,--you know, that one
would then need regulatory filing, and you would need to be
aware of that, and obviously a regulator would look at that as
a consequence, label you appropriately. I think that will be
discovered during the clinical studies that we're running.
Mr. Peters. And also you've spoken, and I think people have
spoken at length, about the elderly, and I guess the question I
had is whether the very young kids are going to be able to get
or use this vaccine. Are you testing that vulnerable population
as well as older folks as part of the phase 3 trial?
Dr. Pangalos. I can go again.
We have a pediatric study that will be ongoing in the
United States in addition to the broader population of 18-year-
olds to 70-pluses.
Dr. Douoguih. Yes, we are planning to initiate our
pediatric program once there's evidence of efficacy in the
adult population.
Mr. Peters. And I think that the vaccine is available later
for those populations than for other folks, or will that be
affected by it--will that affect the schedule at all?
Dr. Douoguih. Well, we'll need to understand what the
schedule is and the immune response, but you don't necessarily
need an efficacy study in that population to be able to just
generating the appropriate safety and immune response data.
Mr. Peters. OK. And just in the couple minutes I have left,
one of the issues that's come up as a result of us, our country
not being prepared for this, is the availability onshore of the
materials we need.
Obviously, PPE was a big topic of conversation,
ventilators. But I wanted to ask about basic pharma. A lot of
the basic pharma that has not been available, has already
become generics. It's not the ones that you're involved with
the United States in terms of domestic production, that most of
that is produced overseas in India.
I ask each of you for your thoughts on how the United
States should strategize around making sure that those drugs,
those pharmaceuticals, are available onshore when we need them
in the case of a second wave or the next pandemic.
Maybe start with Mr. Young.
Mr. Young. Thank you for your question. I think the
question of availability of high quality, essential medicines
is a critical one for every healthcare system around the world,
and that's something certainly that we've tried to play our
part and are very committed to.
I mentioned earlier in the response to the previous
question, that actually our manufacturing network in the United
States has seen a significant surge in a number of those
injectable medicines that are off patent, they're basic, but
absolutely vital to essential care, particularly in an
intensive care situation.
We've seen volume spikes of 10- or 15-fold for some of
those medicines, you know, given what we've seen in intensive
care units. We believe it's absolutely critical. Certainly we
are committed to our United States supply network. We have 12
sites in the United States across ten States and Puerto Rico,
11,000 colleagues in our manufacturing network based in the
U.S. It's something we are very committed to in trying to honor
the spirit of your question.
Mr. Peters. Let me ask the representative of Johnson &
Johnson, maybe more specifically, how would you suggest that
we, as a committee and as a Congress, strategize getting those
basic drugs, many of which are generic, onshore for the next
pandemic?
Dr. Douoguih. I'm not sure I'm the best placed to answer
that. My focus is indeed on vaccines. What I can say is that we
are committed to providing our products and making sure that
the people who are already on those medications have access to
those first and foremost, and then those who are at risk are
next in line for that.
And so far we're monitoring our supply and making sure that
we are able to continue to provide the pharmaceuticals that
we've marketed.
Mr. Peters. Thank you.
It's probably a topic for future hearings, but I really
appreciate your thoughts.
And Madam Chair, I yield back.
Ms. DeGette. Thank you.
Seeing no members of the subcommittee present at this time,
I'm going to go to the Members who are not on the subcommittee.
And thank you all for joining us, and I will start with
Congressman Upton, if you're ready, for 5 minutes.
Mr. Upton. Well, thank you. It is a delight to be here.
Thanks for the opportunity for this hearing. It's so important.
Ms. DeGette. Fred, can you put your camera on, please?
Mr. Upton. Yes. I thought I had. There. Should be on,
right?
Ms. DeGette. No.
There you go. We see you.
Mr. Upton. OK, good.
Well, thank you. I really appreciate the opportunity for
the hearing and thank our witnesses for coming today to
certainly discuss all that they're doing to quickly develop a
safe and effective vaccine and thus a treatment for COVID.
I want to especially thank John Young from Pfizer for
coming to talk about the great work that they are doing. Of
course earlier this week, we got the great news that two
vaccine candidates that Pfizer is working on, with BioNTech got
the Fast Track designation from the FDA.
Actually, last week, Thursday, I had the chance to visit
Pfizer's manufacturing facility in my district, where they're,
in fact, already gearing up to make their vaccine.
It's amazing how quickly you've been able to mobilize on
something so huge in a short period of time. And as I talk to
folks there, they had received the message from the higher-ups
at Pfizer to spend whatever it takes to get this done.
So just a quick question for Dr. Young. You know, we're so
excited, can you take us through the whole manufacturing
process, and particularly--I know you reference this in your
testimony--the idea that we would have the supply chain, in
essence, done, made in America from start to finish, at least
for these first 40 million doses that you're planning to
produce there and assemble there before the end of the year?
Can you just walk us through that manufacturing stage for me?
Mr. Young. Thank you for your question. We are extremely
proud of the role that our Kalamazoo facility in your district
is going to play potentially in the manufacture of our COVID-19
vaccine.
So the manufacturing supply chain for an mRNA vaccine is
quite unique. The three sites that we have in the United States
that will form our United States supply chain each have a
distinct role to play.
So our site in St. Louis specifically will be responsible
for the development of what we call a DNA template, which
essentially is just that, it's a template for the antigen which
is the protein that we hope will elicit an immune response
ultimately.
That DNA template is then passed to our site in Andover
where it's used to create the mRNA, and the mRNA in turn is
combined with lipid nanoparticles, so you have a very small
piece of mRNA inside this literally microscopic droplet that is
specifically been designed to be taken up by the body cells.
And then that drug substance is just taken to Kalamazoo in
Michigan where it will be put into the vials that a healthcare
professional or a patient might normally see, and that site in
turn--these are questions that have been asked by other
panelists--will then be--that drug product will then be taken
into the supply chain and enable it to be distributed to
hospitals and clinics all around the United States of America.
So we're very proud of the work that's been done to date,
but to underscore, I think, the comments of my fellow
colleagues, we know we have a lot of hard work still ahead of
us, but thank you very much for your question.
Mr. Upton. So just a quick question, because I want to ask
something else.
So I know that the next trial is going to start literally
in the next week. As many as 30,000 Americans and others will
be in that trial. What is the earliest that you might think,
assuming that everything goes well, that there's not a glitch,
safety standards remain the same, when is it the earliest that
you think that you might be able to see an EUA, an emergency
use authorization, that would then allow the unleashing of
the--produce tens of millions of vaccines to the American
public?
Mr. Young. Thank you for your question. So if all goes
well, we hope to be able to provide our dossier of clinical
data from our large phase 2b/3 study to the FDA in October.
Obviously, the FDA will then review that data, and they
will determine whether our data set meets the requirement they
have already laid out ahead of time for what would determine an
emergency use authorization.
So they won't be able to make that decision and to review
our data for our vaccine, but potentially for the other
vaccines represented here.
So you know, sometime in the fourth quarter of this year,
potentially they would have the data to enable them to make
that decision, and that's why we've invested early in our
supply chain, in order to be able to deliver up to a hundred
million commercial doses of vaccine in 2020 globally and up to
1.3 billion doses of vaccine in 2021.
Mr. Upton. Well, I think in the remaining time, let me just
say this.
So the Chair of the subcommittee, Diana DeGette and myself,
of course, we were the two leaders on passing the 21st Century
Cures through the Congress. Can you tell me how helpful this
was, as it leads to your actual production now of the vaccine?
Mr. Young. Thank you.
And you know, again, we just support the work that you and
Chairwoman DeGette have done in 21st Century Cures. I think it
really helped to inform, Producer 6 which as you know is the
funding mechanism for the FDA. It helped to lay the ground work
for many of the regulatory innovations that have been applied
during COVID.
For instance, the recent pilot program guidance on
innovative clinical trial designs, the FDA's familiarity with
real-world evidence, have all been underpinned by some of the
measures that the 21st Century Cures really helped to
establish.
And I believe that we should continue to build upon 21st
Century Cures and these advancements as the committee begins to
contemplate Cures 2.0 and also Producer 7.
So thank you very much to this committee for your support,
and thank you for your leadership.
Mr. Upton. Well, thank you. I yield back the balance of my
time.
The Chairman. [Presiding.] Hi, next we have Congresswoman
Eshoo for 5 minutes.
Ms. Eshoo. Thank you, Mr. Chairman, and I'd like to thank
all of the witnesses. I've listened highly attentively with the
exception of going over to the Capitol to vote.
So thank you for your work, as the Speaker of the House
says on a regular basis, that science will be and is the answer
to our prayers.
So what you are doing is one of the most important
undertakings relative to public health, I think, in a century,
so thank you.
Dr. Pangalos, AstraZeneca has operations in the United
States, but it's a British company. The U.K. standards are
different--or they differ from the FDA. How are you going to
meet this challenge?
Dr. Pangalos. As a global, multinational company, we get
our medicines approved throughout the world on a regular basis.
That's how our business and how our medicines reach patients
around the world.
The standards that we're working to in the U.S. are set by
the U.S. FDA, both from a manufacturing and development
perspective, and we're also working with other regulators
around the world----
Ms. Eshoo. Excuse me. Would there be a time difference
between what's approved in the U.K. and what you would seek to
have approved in the U.S.?
Dr. Pangalos. That will depend on the data that each of the
countries uses to get its approval.
So we have ongoing studies in the United Kingdom----
Ms. Eshoo. OK.
Dr. Pangalos [continue]. Where the infection rate is lower.
We also have studies going on in South Africa and Brazil that
will be part of the U.K. fob, but I think all the regulatory
authorities are working as fast as they can with us, and
ultimately it will be the data from all of our studies, more
than likely, that gives us approval around the world.
Ms. Eshoo. Good. Thank you very much.
I know that the ranking member of the full committee, Mr.
Walden, asked a question about dosages, whether there would be
one or two, and I want to follow-up on that.
If there are two, how far apart would they be? Now, most
reports that I've read have 55 and older in their trial. But in
order to--there's something about the dosage here.
If you're dosing for 55 and older, it's like the influenza
shot, you need the super-duper one to be effective. And yet for
younger patients, for children, young adults, you don't need
that higher dosage.
How are you all going to handle this? I can't remember who
said they thought they were doing--would have to do two doses,
so maybe the two-dose companies can answer that.
Dr. Pangalos. Well, I can speak for AstraZeneca because I
said that we are veering towards----
Ms. Eshoo. I don't have a lot of time, so do it quickly.
Dr. Pangalos [continue]. That we are veering towards two
doses, and you're absolutely right, the different populations
may require different schedules.
Our first priority is to demonstrate efficacy, and the best
way of demonstrating efficacy is maximizing the dose.
So we'll almost definitely goes with two doses but can then
work from that to reduce doses if, for example, the 18- to 55-
year-olds need a single dose.
But we will start with two, almost definitely.
Ms. Eshoo. Are you the only ones that are anticipating two
doses, or is there any----
Mr. Young. John Young from Pfizer. We also anticipate that
we will take two doses into our pivotal trial. The second dose
would be administered 21 days after the first dose. That's when
the booster would take place. That's what we've studied in our
phase 1 trials to date.
And we're going to look to try and find the optimal
candidate to take into our phase 3 study so that we end up with
a single construct in dosage for both older and younger
patients.
And our data will obviously inform the decision about
safety and effectiveness across all those age groups.
Ms. Eshoo. Well, I thank you for that. And while I know
you're not a scientist by reputation, you are a humanitarian,
so I'm going to salute you for that.
Why did Pfizer choose not to take any government money and
take it all on yourselves as well as the risk?
Mr. Young. Great question. And you know, our focus, as I
mentioned in my oral testimony, was on speed. We recognize that
the world is in a completely unique situation.
We also recognize that, you know, both given the experience
that we have as a company, as a vaccine development company,
but also given the financial strength of Pfizer, that we were
maybe uniquely placed to be able to put our own capital at
risk, in order to be able to move as quickly as we possibly
could.
And so speed has been our priority, while making sure that
we obviously maintain a focus on safety, and that really
underpinned our decision not to seek government funding for our
program.
Ms. Eshoo. I thank you.
And I thank the chairwoman and the chairman of the full
committee, all of the witnesses. Let me put it this way--God
speed.
I yield back.
The Chairman. Thank you. So we have to--we go to members of
the subcommittee first. So Mr. Tonko has returned, so he's
next.
I yield to the gentleman for 5 minutes.
Mr. Tonko. OK. Mr. Chair, can you hear me?
The Chairman. Yes.
Mr. Tonko. OK. Well, thank you, and thank you to the
subcommittee for arranging this hearing and to our witnesses
for your participation.
This committee has held many pandemic preparedness hearings
over the years. And we have consistently heard that the
manufacturing of enough ancillary supplies needed to go with
vaccines, such as vials and syringes and other materials, is an
essential component for administering a vaccine.
We all remember what happened this spring as States and
hospitals scrambled and competed for basic, yet critical,
supplies like N95 masks. So now as we look toward an
unprecedented effort to manufacture a vaccine for the entire
globe, there are increasing concerns about the availability of
all those ancillary supplies needed for a vaccine.
With so much riding on a vaccine, we cannot find ourselves
in another situation of widespread shortages of critical
supplies when it comes to vaccinating people around the world.
So Mr. Young, if a vaccine is approved, we may need enough
ancillary supplies to administer hundreds of millions of doses
in a compressed timeframe in this country alone. What steps are
you taking now to ensure that you will have those sufficient
supplies?
Mr. Young. So thank you for your question.
So as I mentioned in my testimony, we've engaged early to
deploy capital and to put contracts in place, at risk, with our
suppliers. So we've engaged with the suppliers of glass, of
stoppers.
We're also, you know, doing a lot of work to invest in the
development of that supply chain that's going to be critical to
get those vials from our manufacturing site to clinics. And all
of that work is requiring capital, which we are deploying at
risk.
And so really the thing that we've done is to engage early
and to invest early in that supply chain.
Mr. Tonko. Thank you very much.
And Dr. Pangalos, presumably every company in the world
working on a vaccine will be competing for these scarce vaccine
supplies. But you state in your testimony, and I quote, ``none
of the companies involved in this project view this as a
competition against each other. Our sole adversary is COVID-
19.''
So my question is, is AstraZeneca coordinating with other
companies on this production and procurement of vital supplies,
or will you be competing against each other for them?
Dr. Pangalos. So thank you for the question, Congressman
Tonko. So I think, first of all, we're all using five different
technologies, which means we're not necessarily competing for
the same raw materials, and so I think that is a benefit.
What I would say from an AstraZeneca perspective is, we
have created our supply chains in a way that they are not
competing with each other. So we have a supply chain for the
United States, a supply chain for the U.K., supply chain for
Europe, and a supply chain for international regions.
As a consequence, they're protected from one another, and
we're ensuring that each one is robust in its own right. So our
supply chain in the United States, to provide the 300 million
doses under our agreement with BARDA, is working both in our
own facilities but also with contract manufacturers based in
the U.S., such as Emergent and AMRI.
So we feel confident in the quality and the strength of our
supply chain in the United States.
Mr. Tonko. Thank you.
And as I mentioned, this past spring it was chaos as States
and hospitals scrambled to outbid each other for scarce PPE.
And as we heard from governors who testified before our
committee, the Federal Government did not effectively
coordinate PPE distribution at the national level. And in some
cases made it much worse.
So Dr. Hoge, Moderna received $53 million, I'm told, from
BARDA, specifically to expand its manufacturing capacity. What
guidance or coordination is your company receiving from the
Federal Government regarding the production and availability of
vaccine ancillary supplies, and is that going to be, again, a
situation where every company is going out there for itself?
Dr. Hoge. Thank you for the question, Congressman.
We, like other companies on the panel, have been working
with suppliers to specifically purchase all the necessary
ancillary supplies that you've mentioned, including glass and
stoppers and the like.
But we have been working with BARDA directly under the
auspice of the grant you just mentioned and providing
transparency to them on those purchasers of those contracts and
what we're doing.
The purpose of that is twofold. I think it both gives them
confidence that we've got redundancy in that supply and that we
do have what we need, but it also gives transparency to the
U.S. Government on where we're purchasing those supplies.
And certainly if the unfortunate circumstance arose that
our vaccine was not successful, I would imagine all of those
would be made available to other vaccines if they were
successful.
Mr. Tonko. Thank you very much.
Well, I thank all of our participants.
The availability of the ancillary supplies necessary to
administer a successful vaccine will require coordination, and
I'm pleased to hear that some efforts are under way, but past
supply failures by this administration makes me very wary.
So with that, Mr. Chair, I yield back, and thank you.
The Chairman. Thank you, Mr. Tonko. Next is--Mr. Carter is
recognized for 5 minutes.
Mr. Carter. Thank you, Mr. Chairman, and thank all of you
for being here, and thank you for your efforts. These are
extremely important, and I don't need to tell you that. You
understand how important this is, and we appreciate all of the
efforts that are being made here.
You know, I've always said that I think there's a
difference in knowing something and realizing something. We've
known for quite a while now that we're too dependent on other
countries for our medical supplies, but during this pandemic I
think we've realized it.
And one of the things that we've realized is that 72
percent of all the active pharmaceutical ingredients in the
U.S. supply chain are manufactured in different countries, in
fact, in more than 150 countries, and 13 percent of it comes
from China alone.
We witnessed this as well in March when India even withheld
26 drugs from exportation. This is a serious issue, and I think
we should do everything we can to increase domestic
manufacturing.
In fact, I've got legislation, the Made Act, that will
incentivize pharmaceutical manufacturers to bring their
manufacturing back to America.
But I want to talk specifically about the vaccines, and I
wanted to ask each of you, specific to your vaccine, how much
of the material that's used in your individual vaccine, in your
product, comes from overseas. A.
And I'll start with you, Sir Pangalos.
Dr. Pangalos. Thank you very much.
So for our U.S. supplies, all of our U.S. supply chain will
be coming from the United States.
Mr. Carter. All of it?
Dr. Pangalos. Yes.
Mr. Carter. What about vials? What about the other things
that are used such as vials or other delivery methods, anything
and all, even packaging?
Dr. Pangalos. To the best of my knowledge, all of the
materials that we're using for our U.S. supply are coming from
the United States, but I can check that and confirm it for you.
Mr. Carter. And are you manufacturing the vaccine in the
United States, is that your intention?
Dr. Pangalos. Yes, we are.
Mr. Carter. OK.
OK. Dr. Douoguih?
Dr. Douoguih. Yes.
So 99 percent of our materials come from either the U.S. or
Europe, and so we actually, we have very little coming from--
out of China. And in terms of how much manufacturing we have in
the U.S., it's roughly half of our supply will be produced on
U.S. soil.
Mr. Carter. And then the other half will be produced in
Europe?
Dr. Douoguih. Well, there will probably be a number of
facilities in order to best support a global supply of our
materials.
Mr. Carter. Any in China?
Dr. Douoguih. As far as I know, I'm not aware of that, but
these discussions are ongoing.
Mr. Carter. OK.
Dr. Gerberding?
Dr. Gerberding. Thank you.
I'm going to have to get back to you for the record on
this. We're prosecuting two vaccines, and while, generally
speaking, Merck's vaccine--and we have several--are very much
localized to the United States and a couple of places in
Europe.
I need to verify the entirety of the supply chain to make
sure that I'm----
Mr. Carter. OK. If you could get back to us in writing, I'd
appreciate it.
Dr. Gerberding. Absolutely.
[The information appears at the conclusion of the
hearing.]*
Mr. Carter. Dr. Hoge?
Dr. Hoge. So our manufacturing domestically is at two
facilities in the United States. The vaccine is made entirely
in the United States. Our supply chain includes a number of raw
materials, some of which have been sourced internationally, but
we've worked to secure that supply and bring it into depots in
advance of needing it for manufacturing to specific----
Mr. Carter. OK. Can you define internationally? Does that
include China?
Dr. Hoge. I do not believe so, sir, but I think there is a
lot from Europe.
Mr. Carter. I'm sorry. Does that include China
internationally?
Dr. Hoge. It may include for some of the raw materials,
sir, but I don't believe it's a major component. Most of what I
was describing was Europe.
Mr. Carter. OK.
Mr. Young, finally you?
Mr. Young. No. Thank you for the question.
As I mentioned in my testimony, we will have a dedicated
supply chain for a vaccine, if successful, for the United
States. The raw materials for our vaccine drug substance are
procured, manufactured in the United States.
Our drug substance is made within our Pfizer network, as is
the final drug product, the vials that will go to healthcare
professionals.
Mr. Carter. OK, good.
Dr. Young, while I have you here, the FDA has released the
guidelines outlining the conditions for approving a COVID-19
vaccine.
Do you believe these guidelines are fair, and are they
achievable, particularly given the time frame that we're
working in now and the development of these vaccines?
Mr. Young. Oh, thank you again for your question which I
believe is absolutely critical ultimately to addressing the
confidence issue that I think we've talked about previously.
And I think the FDA are to be commended for very
proactively releasing guidelines that are evidence-based. They
are very clear and transparent around the standards of data
that they are going to look to expect for both safety and
effectiveness.
I think they should give a lot of confidence to every
American that a vaccine, if approved, is going to meet high
standards for safety and effectiveness.
Mr. Carter. Good. Thank you for that. And just out of
curiosity, does anyone disagree with that?
Dr. Pangalos. No.
Dr. Geberding. No.
Dr. Douoguih. No.
Dr. Hoge. No.
Mr. Carter. Good. Well, I'm out of time, Mr. Chairman.
Thank you very much.
And I'll yield back.
Ms. DeGette [presiding]. I thank the gentleman.
The Chair now recognizes Mr. O'Halleran for 5 minutes.
Mr. O'Halleran. Thank you.
Thank you, Madam Chairwoman, and I thank the witnesses for
doing so much to educate the American public about the
potential for a vaccine in the coming months.
Six months ago today, the CDC reported the first case of
COVID-19 in the United States. In the months that have
followed, American life has been up-ended as we face an
unprecedented health crisis in this country.
Lack of PPE is still plaguing our healthcare system. And
with no clearly defined coordinated strategy, the
administration on testing and contact tracing, the virus is
continuing to spread throughout the country.
Congress has allocated money for testing and contact
tracing. Yet without a coordinated national strategy,
significant lapses continue.
Obviously, while not directly related, it is important for
Congress to ensure that similar distribution and accessibility
problems do not occur when a vaccine is deemed safe and
effective to provide some level of immunity to COVID-19.
I am encouraged by some of the early trials from these
vaccines, and I'm hopeful that the later phase trials will
prove that a vaccine is safe and effective for mass production
and distribution.
However, the accessibility of this vaccine to Americans
from all walks of life is critical, and that is where I want to
focus my question.
Cases have surged across Arizona, across America, and some
of the earliest hotspots occurred on Tribal lands in my
district, including Navajo Nation and the White Mountain
Apache. It took far too long for the government to respond to
our Tribal Nations and ensure that they had the proper PPE and
other equipment.
My question is to the entire panel--and we'll go right to
left--I know you all are currently in first stages of testing
vaccines. As you are planning for later-stage trials with more
people, what is your company doing to ensure that there is
broad representation across racial and ethnic groups among
participants?
Are there any difficulties that Congress needs to be aware
of as this next COVID-19 package is being negotiated? And when
I say across racial and ethnic lines, I'd like to understand a
little bit from each of you what the complexities of that mean.
Thank you.
Dr. Pangalos. So I will start and thank you for the
question.
We absolutely support making sure that our vaccine, during
the clinical trials, is tested in as diverse a community as
possible to ensure that we have data that gives us confidence
that it will be effective, and the community represents all of
the populations around the world.
It's why we're running studies in the United Kingdom, in
South Africa, in South America, and in the United States to
begin with. And we're also considering going into other regions
as well such as Japan, China, and elsewhere.
But as we----
Mr. O'Halleran. Excuse me. The United States?
Dr. Pangalos. Yes. So--but ultimately we need to make sure
that we're in the United States also. We have diversity in
terms of the communities and the populations that we're
testing, and in our 30,000-patient study working with NIAID and
the NIH, we'll make sure that we do have a diverse population
that represent both ethnic diversity as well as age diversity.
Mr. O'Halleran. Thank you. Next, please.
Dr. Douoguih. This is Macaya Douoguih. I can go next.
So we're still in the planning stages of our phase 3 study,
but we do plan to include a diverse population, not only from
an age perspective, but many of the communities that you have
mentioned. To do that, we are launching a community outreach
program that will involve digital platforms, but also are
leveraging some of our existing networks and connections in the
context of some of our other programs.
For example, we've had a very long history of doing HIV
vaccine trial work with the NIH and their networks, and they
have a very strong community engagement of a group that is very
active in the communities that you've mentioned. We want to
work and partner and leverage the experience we already have
because those populations are also disproportionately affected
by COVID to make sure that they have information about the
disease and the vaccine trials that we're planning and ample
opportunity to determine whether or not they want to
participate. So it's the past experience that we will use to
hopefully help improve the diversity in our trials.
Mr. O'Halleran. Madam Chairwoman, I think I'm going to run
too long, so thank you. I yield.
Ms. DeGette. I thank the gentleman for yielding. Do we have
any other members who I'm not seeing on my screen who have not
had the opportunity to ask questions?
Seeing none, I want to thank all of our witnesses for their
participation in this very important hearing today, and I think
I speak for all of my colleagues on both sides of the aisle
when we say we wish you well. We wish Godspeed. We wish the
development of not just one, but more than one safe and
effective vaccines that we can have, we hope, by the end of
this year or next year. And then, of course, the challenge will
be producing it, distributing it, and convincing everybody to
take it.
I want to remind Members that pursuant to the committee
rules, they have ten business days to submit additional
questions for the record to be answered by witnesses who have
appeared before the subcommittee, and I would ask all of our
witnesses to please agree to respond quickly and promptly to
any questions that you may receive.
[The information appears at the conclusion of the hearing.]
I'd ask unanimous consent to insert in the record the
following documents: A report from the Republican staff On
Vaccines and Therapeutics dated July 1, 2020, and a letter from
Retractable Technologies to Representative Burgess dated July
4th, 2020. Without objection, so ordered.
Ms. DeGette. And with that, again, thanks to all of our
witnesses and the members. Thank you for being--thanks to Mr.
Pallone for filling in when we all had to go vote. And with
that, the subcommittee's adjourned.
[Whereupon, at 12:58 p.m., the subcommittee was adjourned.]
Prepared Statement of Hon. Anna G. Eshoo
Each of you represents great hope for Americans and for the
world.
All eyes are on your companies to develop a vaccine that
will allow us to return to school and work, hug our loved ones,
and begin the process of recovering from the COVID-19 pandemic.
But with that opportunity comes great responsibility to
ensure that your products are safe, effective, affordable and
accessible.
I look forward to hearing from you today about how you will
maintain transparency and accountability to the American
taxpayer and American patient, how you are scaling up domestic
manufacturing, your suggestions for a nationwide vaccine
distribution plan, and how Congress can tackle the pervasive
vaccine hesitancy in this country.
In the meantime, I call on every American to continue to do
their part by wearing a mask and maintaining social distancing
as much as possible. Together, we can stem the tide of this
horrible disease.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
File and source
- File
- CHRG_chrg-116hhrg55508_chrg-116hhrg55508.htm
- Size
- 205,708 bytes
- SHA-256
- 97288bef1065cacb4ce05d4e92cba36146909243c0f29140647c954bb690102c
- Original
- www.govinfo.gov