Pathway to Protection: Expanding Availability of COVID-19 Vaccines — House Hearing (February 23, 2021)
Summary
Transcript of the February 23, 2021 virtual hearing Pathway to Protection: Expanding Availability of COVID-19 Vaccines, before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives (Serial No. 117-7), with Chair Diana DeGette presiding by Cisco Webex. Witnesses were John Young of Pfizer, Stephen Hoge of Moderna, Richard Nettles of Janssen for Johnson & Johnson, Ruud Dobber of AstraZeneca and John Trizzino of Novavax. At the close DeGette said the aim was to get the shots into Americans' arms by the summertime, and letters dated February 17, 2021 from Representative Tonko to the heads of Moderna and Pfizer were entered into the record. The subcommittee adjourned at 1:30 p.m.
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 Protection: Expanding Availability of COVID-19 Vaccines — House Hearing (February 23, 2021).”
Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/pathway-to-protection-expanding-availability-of-covid-19-vaccines-36a25b7415/
, SHA-256 0dde468c9fe235bba0ece0985add73a113a9f48f7c64744fd4614187c8af099f.Full text
[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
PATHWAY TO PROTECTION: EXPANDING AVAILABILITY OF COVID-19 VACCINES
=======================================================================
VIRTUAL HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
FEBRUARY 23, 2021
__________
Serial No. 117-7
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
45-576 PDF WASHINGTON : 2022
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois CATHY McMORRIS RODGERS, Washington
ANNA G. ESHOO, California Ranking Member
DIANA DeGETTE, Colorado FRED UPTON, Michigan
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida DAVID B. McKINLEY, West Virginia
JOHN P. SARBANES, Maryland ADAM KINZINGER, Illinois
JERRY McNERNEY, California H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
PAUL TONKO, New York BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York BILLY LONG, Missouri
KURT SCHRADER, Oregon LARRY BUCSHON, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California TIM WALBERG, Michigan
DEBBIE DINGELL, Michigan EARL L. ``BUDDY'' CARTER, Georgia
MARC A. VEASEY, Texas JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire GARY J. PALMER, Alabama
ROBIN L. KELLY, Illinois, Vice NEAL P. DUNN, Florida
Chair JOHN R. CURTIS, Utah
NANETTE DIAZ BARRAGAN, California DEBBBIE LESKO, Arizona
A. DONALD McEACHIN, Virginia GREG PENCE, Indiana
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
DARREN SOTO, Florida JOHN JOYCE, Pennsylvania
TOM O'HALLERAN, Arizona KELLY ARMSTRONG, North Dakota
KATHLEEN M. RICE, New York
ANGIE CRAIG, Minnesota
KIM SCHRIER, Washington
LORI TRAHAN, Massachusetts
LIZZIE FLETCHER, Texas
------
Professional Staff
JEFFREY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
NATE HODSON, Minority Staff Director
Subcommittee on Oversight and Investigations
DIANA DeGETTE, Colorado
Chair
ANN M. KUSTER, New Hampshire H. MORGAN GRIFFITH, Virginia
KATHLEEN M. RICE, New York Ranking Member
JAN SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas
PAUL TONKO, New York DAVID B. McKINLEY, West Virginia
RAUL RUIZ, California BILLY LONG, Missouri
SCOTT H. PETERS, California NEAL P. DUNN, Florida
KIM SCHRIER, Washington JOHN JOYCE, Pennsylvania
LORI TRAHAN, Massachusetts GARY J. PALMER, Alabama
TOM O'HALLERAN, Arizona CATHY McMORRIS RODGERS, Washington
FRANK PALLONE, Jr., New Jersey (ex (ex officio)
officio)
C O N T E N T S
----------
Page
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 1
Prepared statement........................................... 3
Hon. H. Morgan Griffith, a Representative in Congress from the
Commonwealth of Virginia, opening statement.................... 5
Prepared statement........................................... 6
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 7
Prepared statement........................................... 9
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 10
Prepared statement........................................... 12
Witnesses
John Young, Chief Business Officer, Pfizer....................... 14
Prepared statement........................................... 16
Answers to submitted questions............................... 105
Stephen Hoge, M.D., President, Moderna, Inc...................... 19
Prepared statement........................................... 21
Answers to submitted questions............................... 113
Richard Nettles, M.D., Vice President of U.S. Medical Affairs,
Janssen Infectious Diseases and Vaccines, Johnson & Johnson.... 29
Prepared statement........................................... 31
Answers to submitted questions............................... 119
Ruud Dobber, Ph.D., Executive Vice President, BioPharmaceuticals
Business Unit, and President, North America, AstraZeneca....... 38
Prepared statement........................................... 40
Answers to submitted questions............................... 124
John Trizzino, Executive Vice President, Chief Commercial
Officer, and Chief Business Officer, Novavax................... 46
Slide shown during oral presentation......................... 47
Prepared statement........................................... 49
Answers to submitted questions............................... 129
Submitted Material
Letter of February 17, 2021, from Mr. Tonko to Stephane Bancel,
Chief Executive Officer, Moderna, submitted by Mr. Tonko....... 101
Letter of February 17, 2021, from Mr. Tonko to Albert Bourla,
Chairman and Chief Executive Officer, Pfizer, submitted by Mr.
Tonko.......................................................... 103
PATHWAY TO PROTECTION: EXPANDING AVAILABILITY OF COVID-19 VACCINES
----------
TUESDAY, FEBRUARY 23, 2021
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:30 a.m., via
Cisco Webex online video conferencing, Hon. Diana DeGette
(chair of the subcommittee) presiding.
Members present: Representatives DeGette, Kuster, Rice,
Schakowsky, Tonko, Ruiz, Schrier, Trahan, O'Halleran, Pallone
(ex officio), Griffith (subcommittee ranking member), Burgess,
McKinley, Long, Dunn, Joyce, Palmer, and Rodgers (ex officio).
Also present: Representatives McNerney, Eshoo, Bucshon,
Walberg, Carter, and Pence.
Staff present: Kevin Barstow, Chief Oversight Counsel;
Jesseca Boyer, Professional Staff Member; Jeffrey C. Carroll,
Staff Director; Austin Flack, Policy Analyst; Waverly Gordon,
General Counsel; Tiffany Guarascio, Deputy Staff Director;
Rebekah Jones, Counsel; Chris Knauer, Oversight Staff Director;
Mackenzie Kuhl, Digital Assistant; Kevin McAloon, Professional
Staff Member; Kaitlyn Peel, Digital Director; Peter Rechter,
Counsel; Tim Robinson, Chief Counsel; Chloe Rodriguez, Clerk;
Benjamin Tabor, Junior Professional Staff Member; C.J. Young,
Deputy Communications Director; Sarah Burke, Minority Deputy
Staff Director; Theresa Gambo, Minority Financial and Office
Administrator; Brittany Havens, Minority Professional Staff
Member, Oversight and Investigations; Nate Hodson, Minority
Staff Director; Peter Kielty, Minority General Counsel; Bijan
Koohmaraie, Minority Chief Counsel; Clare Paoletta, Minority
Policy Analyst, Health; Alan Slobodin, Minority Chief
Investigative Counsel, Oversight and Investigations; Michael
Taggart, Minority Policy Director; and Everett Winnick,
Minority Director of Information Technology.
OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. The Subcommittee on Oversight and
Investigations hearing will now come to order.
Today, the Subcommittee on Oversight and Investigations is
holding a hearing entitled ``Pathway to Protection: Expanding
Availability of COVID-19 Vaccines.''
The purpose of today's hearing is to examine manufacturers'
ongoing efforts to develop and scale up production of COVID-19
vaccines in the United States.
Due to the COVID-19 public health emergency, today's
hearing is being held remotely. All Members, witnesses, and
staff will be participating via video conferencing. And, as
part of our proceeding, microphones will be set on mute for the
purposes of eliminating inadvertent background noise. Members
and witnesses, I'll remind you now--I have a feeling we'll need
to do it again during the hearing--to unmute your microphone
each time you wish to speak.
And, if any time during the hearing I'm unable to chair the
hearing, the chairman of the full committee, Frank Pallone,
will serve as chair until I'm able to return.
Documents for the record can be sent to Austin Flack at the
email address we've provided to staff. All documents will be
reviewed and entered into the record as appropriate at the
conclusion of the hearing.
The Chair now recognizes herself for purposes of an opening
statement.
Today, the subcommittee continues its oversight of the
ongoing COVID-19 pandemic. Over the last year, we've held
hearings examining various aspects of this crisis, including
the Federal Government's response to COVID-19, the ramping up
of testing, and the development of vaccines.
Last July, we heard testimony from several of the companies
represented at today's hearing about the status of their
clinical trials and their production plans as they worked
diligently to develop a safe and effective vaccine. And I want
to thank all of you for coming in July and all of the work that
you've done.
And we're back today in a much better position to fight
COVID-19, with two vaccines authorized and possibly more on the
way. We're now in the midst of one of the most important public
health campaigns in American history.
So it's often said: Vaccines don't save lives, vaccinations
do. And, as of course we just passed the grim milestone of half
a million American deaths from COVID-19, we don't have a lot of
reason to celebrate. But, with the vaccination program
underway, there is hope that we can begin to turn the tide
against the virus.
Frankly, it's nothing short of a scientific marvel that
multiple COVID-19 vaccines have been demonstrated to be safe
and effective in such a short amount of time, but all of us
know we're not out of the woods. The most pressing challenge
that we have right now is the lack of supply of vaccine doses.
We saw the frustration late last year when the initial
vaccine allocations to States were less than what was needed to
vaccinate high-risk priority populations. And, while we
continue to commend manufacturers' efforts to develop the
vaccines, some of the companies here today are still short of
the number of doses they promised to initially deliver when
they testified before this subcommittee in July.
Many of the companies received significant Federal
investment to build their manufacturing capacity last year,
even while the clinical trials were ongoing, so that we would
be able to deliver millions of vaccines just as soon as they
were authorized.
Two vaccines have been authorized, and production is
ramping up. But we still have way insufficient supply to meet
current demand. Things are improving lately with the companies'
increasing production and the Biden administration increasing
weekly allocations to States as well as providing greater
transparency around future allocations, which we heard a couple
of weeks ago from State health officials. And, with additional
companies seeking authorizations, we have hope that the supply
will increase substantially in the coming months.
But, frankly, we still face a lack of vaccine supply to
meet current demand. Americans around the country are lining
up, sometimes for hours, to secure their shots. Many high- risk
individuals have not been vaccinated, and millions more are
waiting for their turn.
Last week, President Biden said that every American who
wants a vaccine should be able to get one by the end of July.
That is a welcomed goal and one that the companies joining us
today will be--will play a central role in hopefully achieving.
That's why it's critical for us to hear from our witnesses
today a straightforward assessment about where the
manufacturing capacity stands, how much vaccine they expect to
be able to produce, and when they will be able to meet those
milestones.
And, indeed, emerging virus variants may require us to
develop even new vaccines or booster shots. So, if that's so,
these shots will only put more pressure on manufacturing
capacity.
This hearing is an opportunity to examine ideas to speed up
the vaccination effort, whether it's something that companies
could be doing differently or something more that the Federal
Government can be doing to help. We're all in this together, so
we look forward to exploring solutions today.
Finally, while these vaccines are undoubtedly good news, we
must remember they're only part of the solution to ending this
pandemic. Although the authorized vaccines are highly effective
at preventing people from getting seriously ill from COVID-19,
they might not prevent people from unknowingly spreading the
virus to others.
Therefore, it can't be said enough, so I'm going to say it
right here: It's essential that Americans continue mitigation
efforts, like wearing masks and practicing social distancing,
even if you've been vaccinated. These vaccines will be an
enormous aid in fighting the virus, but we all need to do our
part if we are to defeat it.
Once again, I want to thank these witnesses for being here
today. The ongoing work of each of your companies is critically
important to the country and the world, and this committee
remains ready to assist in those efforts.
[The prepared statement of Ms. DeGette follows:]
Prepared Statement of Hon. Diana DeGette
Today, the Oversight and Investigations Subcommittee holds
the first hearing of the 117th Congress, on an issue that holds
the promise to finally end this pandemic: the rollout of the
COVID-19 vaccination program.
This committee has conducted relentless oversight of the
COVID-19 pandemic response from the very start. Last year, we
saw endless dysfunction and chaos as our country was left
adrift by the absence of strong, competent Federal leadership.
As bad as it was last spring, this winter has brought an
even more dangerous surge.
In recent weeks, cases and hospitalizations were soaring
all over the country, and as many as 4,000 Americans were dying
every day from this awful virus.
As the title of this hearing makes clear, we have no time
to lose. We must act with a sense of urgency and use every
resource available--at the Federal, State, and local levels--to
fight the spread of this virus, end the suffering and death,
and return to a sense of normalcy.
The Biden administration has its work cut out for it.
Indeed, it faces the greatest and most immediate challenge of
any presidential administration in modern memory. But we are
already seeing signs of the ship turning around.
The Biden administration recently announced a comprehensive
national strategy for the COVID-19 pandemic, something this
committee has long called for. This plan advances urgently
needed solutions to mount a successful vaccination program,
restore trust with the American people, and mitigate the spread
of the virus, while providing the emergency relief Americans
desperately need.
We will continue to engage with the administration on what
the Federal Government needs from Congress to execute this plan
and get America on track.
The key task we are faced with now is the rollout of COVID-
19 vaccines.
The Federal-private partnership to research and develop
these vaccines, test them in clinical trials for safety and
efficacy, and get them authorized for use was an enormous
undertaking and a profound victory for the country.
But that was only the first step. If we do not ensure that
every American is able to get vaccinated quickly, those efforts
will have been in vain. Those charged with administering the
COVID-19 vaccine program around the country--including our
excellent witnesses today--have a tremendous opportunity and
responsibility to ensure equitable and expeditious
administration of these life-saving vaccines.
That is why we are convened today: to hear from State
leaders on the front lines about how we can significantly ramp
up vaccinations.
As we will hear today, States are mobilizing to expand who
will be eligible to receive the vaccine next, with a special
emphasis on ensuring equity for those most vulnerable to COVID-
19 and historically marginalized communities.
For instance, my home State of Colorado recently announced
plans to hold pop-up vaccination clinics in 50 high-density,
low-income, communities of color.
Despite these efforts, we have also been seeing a lot of
frustration and confusion. Since the rollout started in
December, one consistent theme has been the lack of
transparency about how many vaccines are coming and when.
Compounding matters, surveys indicate that, while the majority
of Americans want to get the COVID-19 vaccine, some adults
continue to have reservations.
Thankfully, the Biden administration has committed to
changes--such as transparent data for the States and the
public--that will address some of those issues, so that we can
build trust and work to get every available vaccine
administered quickly and equitably.
Indeed, the biggest challenge I'm hearing from most States
now is simply a lack of supply. After some initial challenges
administering the vaccines, States and local communities are
reporting that the demand for the vaccine far exceeds the
supply. And they stand ready to vaccinate many more Americans,
if they are given the doses they need.
We have an excellent panel today, representing five States
aggressively working to end this pandemic. I thank them for
their efforts, and I'm grateful for the time they've committed
to provide critical testimony on how to improve our fight
against this pandemic. I look forward to a candid discussion
with the panel about what is working and what is not working. I
hope they will also elaborate on what more the Federal
Government and Congress can do to improve the partnership in
this fight.
The end of this nightmare is in sight. Now is the time to
double-down on our efforts, and finally turn the corner on this
pandemic.
Ms. DeGette. And now, at this time, the Chair will
recognize the ranking member of the subcommittee, Mr. Griffith,
for 5 minutes for purposes of an opening statement.
Mr. Griffith?
OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF VIRGINIA
Mr. Griffith. Thank you very much, Chair DeGette, and I
appreciate you having this important hearing on the
availability of COVID-19 vaccines.
I also want to thank the witnesses for taking the time to
join us today.
Two of the companies before us, Pfizer and Moderna, have
COVID-19 vaccines that have been granted Emergency Use
Authorizations, EUAs, by the FDA. One company, Johnson &
Johnson, has filed an EUA application. And two companies,
AstraZeneca and Novavax, have ongoing phase 3 clinical trials.
Thanks to the last administration's great partnership with
private industry, Pfizer and Moderna started shipping vaccines
across the United States within 24 hours of receiving their
EUAs. They have committed to supply 600 million doses to the
United States Government by the end of July. That will mean we
will have enough supply to vaccinate 300 million people. In
addition, more COVID-19 vaccine doses will be available should
more companies receive authorization or approval from the FDA.
This timeline is unprecedented, especially since the path
from clinical trial production to commercial scale
manufacturing is highly complex. For example, according to a
U.S. Government Accountability Office report, the traditional
vaccine timeline from the exploratory stage all the way to the
large-scale manufacturing and FDA review and licensure takes
approximately 10 years, and sometimes longer. But, in just 11
months since our first reported case of COVID-19, two companies
received the EUAs from the FDA for their vaccines. As of
February 18, over 73.3 million doses of COVID-19 vaccine have
been delivered across the United States.
This is a remarkable achievement. We should applaud these
efforts that have been undertaken by manufacturers to help
crush the virus. However, as we've heard in a subcommittee
hearing a few weeks ago with representatives from a handful of
States, vaccine supplies remain the number one hurdle to
vaccinating Americans at a faster pace.
The challenge is that the vaccine manufacturing process
takes time. The immediate availability of vaccine doses was
made possible because of the efforts of the private sector, as
well as their partnerships with the Federal Government.
Because manufacturing was being done at risk and in
parallel with the clinical trial process, we were able to move
fast. In addition to at-risk manufacturing, the vaccine
manufacturers have looked for ways to increase and expand their
manufacturing capacity.
Some efforts undertaken by manufacturers include
rearranging existing capacity, acquiring additional facilities,
partnering with other companies to increase their production
capacity, or hiring and training additional personnel to work
in the manufacturing facilities. Some companies have even
looked to increase the number of doses included in their vials,
which conserves resources and supplies. Other companies have
been able to increase efficiencies in their processes by
incorporating lessons learned.
All of these efforts not only allow vaccines to reach
Americans faster, but it also highlights private-sector
innovation. But, to be clear, expanding capacity takes time.
This is a complex process that includes the availability of
every piece of equipment and material needed, making sure that
the equipment is approved and assuring all of the processes and
people in the facility are validated.
There have also been disruptions to manufacturing supply
chains and processes throughout the pandemic. With the demand
for medical supplies at an all-time high across the world and
disruptions in the workforce, we have faced challenges in
securing materials for vaccine production.
The Federal Government, including Operation Warp Speed and
the use of the Defense Production Act, DPA, have helped to
boost and secure essential supplies that are needed to
manufacture COVID-19 vaccines. While the DPA has been a useful
tool thus far, we must be judicious in how we utilize it, as it
can lead to major disruptions in our healthcare supply chain.
Finally, COVID-19 continues to mutate, causing new variants
to emerge that seem to spread more quickly and easily.
Thankfully, vaccine manufacturers are already looking for ways
to stay ahead of these variants.
I look forward to our discussion today to learn more about
your manufacturing processes, actions you have taken to expand
your manufacturing capacity, and whether you feel more capacity
or resources are needed to meet the demands for COVID-19
vaccines.
I also look forward to hearing about any challenges
manufacturers are facing and how we might address them. We are
all in this fight together, as you heard Chair DeGette say, and
I want to thank you all for the important work you've already
done.
Thank you, Madam Chair, and I yield back.
[The prepared statement of Mr. Griffith follows:]
Prepared Statement of Hon. H. Morgan Griffith
Thank you, Chair DeGette, for holding this important
hearing on the availability of COVID-19 vaccines.
I also want to thank the witnesses for taking the time to
join us today. Two of the companies before us--Pfizer and
Moderna--have COVID-19 vaccines that have been granted
Emergency Use Authorizations (EUAs) by the FDA; one company--
Johnson & Johnson--has filed an EUA application; and two
companies--AstraZeneca and Novavax--have ongoing Phase 3
clinical trials.
Thanks to the last administration's great partnership with
private industry, Pfizer and Moderna started shipping vaccines
across the United States within 24 hours of receiving their
EUAs. They have committed to supply 600 million doses to the
United States Government by the end of July--that will mean we
will have enough supply to vaccinate 300 million people. In
addition, more COVID-19 vaccine doses will be available should
more companies receive authorization or approval from the FDA
This timeline is unprecedented, especially since the path
from clinical trial production to commercial scale
manufacturing is highly complex. For example, according to a
U.S. Government Accountability Office (GAO) report, the
traditional vaccine timeline from the exploratory stage all the
way to the large-scale manufacturing and FDA review and
licensure takes approximately 10 years, or longer. But in just
11 months since our first reported case of COVID-19, two
companies received EUAs from the FDA for their vaccines. As of
February 18, over 73.3 million doses of COVID-19 vaccine have
been delivered across the U.S. This is a remarkable
achievement--we should applaud these efforts that have been
undertaken by manufacturers to help crush the virus.
However, as we heard at a subcommittee hearing a few weeks
ago with representatives from a handful of States--vaccine
supply remains the number one hurdle to vaccinating Americans
at a faster pace.
The challenge is that the vaccine manufacturing process
takes time. The immediate availability of vaccine doses was
made possible because of the efforts of the private sector, as
well as their partnerships with the Federal Government. Because
manufacturing was being done at-risk and in parallel with the
clinical trial process, we were able to move fast.
In addition to at-risk manufacturing, the vaccine
manufacturers have looked for ways to increase and expand their
manufacturing capacity. Some efforts undertaken by manufactures
include rearranging existing capacity, acquiring additional
facilities, partnering with other companies to increase their
production capacity, or hiring and training additional
personnel to work in the manufacturing facilities. Some
companies have even looked to increase the number of doses
included in their vials, which conserves resources and
supplies. Other companies have been able to increase
efficiencies in their processes by incorporating lessons
learned. All of these efforts not only allow vaccines to reach
Americans faster, but it also highlights private-sector
innovation.
But to be clear--expanding capacity takes time. This is a
complex process that includes the availability of every piece
of equipment and material needed, making sure that the
equipment is approved, and ensuring all of the processes and
people in the facility are validated.
There have also been disruptions to manufacturing supply
chains and processes throughout the pandemic. With the demand
for medical supplies at an all-time high across the world and
disruptions in the workforce, we have faced challenges in
securing materials for vaccine production. The Federal
Government, including Operation Warp Speed and the use of the
Defense Production Act (DPA), have helped to boost and secure
essential supplies that are needed to manufacture COVID-19
vaccines. While the DPA has been a useful tool thus far, we
must be judicious in how we utilize it as it can lead to major
disruptions in our healthcare supply chain.
Finally, COVID-19 continues to mutate, causing new variants
to emerge that seem to spread more easily and quickly.
Thankfully, vaccine manufacturers are already looking at ways
to stay ahead of theses variants.
I look forward to our discussion today to learn more about
your manufacturing processes, actions you have taken to expand
your manufacturing capacity, and whether you feel more capacity
or resources are needed to meet the demands for COVID-19
vaccines. I also look forward to hearing about any challenges
manufacturers are facing and how we might address them. We are
all in this fight together, and I want to thank you all for the
important work you've already done.
Thank you, Madam Chair, I yield back.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes the chairman of the full
committee, Mr. Pallone, for 5 minutes for purposes of an
opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairwoman DeGette. I know that
this was a hearing that you've been wanting to do for a while,
so I'm glad that it worked out today and we're able to get the
manufacturers here.
Obviously, we're continuing our oversight of this effort to
develop and produce COVID-19 vaccines to the American people,
and one of my top priorities this year is to ensure we have the
tools and resources needed to crush the virus.
I do believe it's a new day, because, unlike under Trump,
under Biden now, we have a national plan and effort to
coordinate and get vaccine and testing and contact tracing and
supplies out to States. But we need to have the tools and
resources for that national plan, and we're going to do that
with the Reconciliation Act, which I think will be on the House
floor this Thursday or Friday.
But among the most powerful tools in this arsenal to crush
the virus is obviously a safe and effective vaccine. That's why
this committee is working tirelessly to find solutions for
rapidly expanding the availability of COVID-19 vaccines across
the country.
The pain and devastation inflicted by this pandemic cannot
be overstated as we mark the tragedy of half a million lives
lost to COVID in the U.S. Nearly 10 million jobs have been
lost, and long-term unemployment is on the rise. Life
expectancy in the United States fell for an entire year in the
first half of 2020, a decline not seen since World War II, with
communities of color suffering the largest declines.
In order to achieve herd immunity, which is essential to
ultimately defeating the virus, we must vaccinate the majority
of the population, and that starts with securing widespread
access to vaccines and ensuring reliable production lines are
in place.
Unfortunately, the initial vaccine rollout under the Trump
administration was marred in confusion, poor planning, and
limited supply. Thankfully, the Biden administration has taken
decisive action to get the vaccine effort back on track.
So, just last week, President Biden announced that States
will receive their largest weekly dose allocations, a 57
percent overall increase from when he took office. The
administration also announced it was doubling the number of
doses being sent directly to pharmacies and will begin sending
vaccines directly to community health centers, actions that
will facilitate broader access across the country.
And, thanks to these efforts, we're already seeing
encouraging results. Before the disruptions caused by last
week's winter storm, an average of 1.7 million vaccine doses
were being administered per day, marking a nearly twofold
increase over the past month. And this trend is promising, and
many experts believe we need to be administering close to 3
million doses per day to stay ahead of the virus.
So I recognize the goal is challenging, but the stakes of
our nationwide vaccination campaign could not be higher. A
protracted rollout would only result in more Americans becoming
infected and would also increase the likelihood that more
variants will become dominant in the United States.
And I noted in the subcommittee's last hearing, we're
currently in a race to keep vaccines ahead of the new virus
variants. And, in order to win this race, we have to increase
our vaccine supply as swiftly as possible.
So, today, we're going to hear from five leading
manufactures of COVID-19. We must acknowledge there have been
setbacks on vaccine production and supply. Congress needs to
hear what steps each company is taking to rapidly expand
vaccine production, what hurdles might stand in the way, and
what additional help is needed to increase supply. Simply put,
all options must be on the table.
While increasing vaccine supply is essential, much more is
needed to actually vaccinate hundreds of millions of Americans
quickly and equitably. To that end, Democrats in Congress are
moving swiftly to pass the American Rescue Plan, and this is
the Biden proposal that commits the resources and support
necessary to crush the virus.
This legislation, which we dealt with last week and should
be on the floor at the end of the week, would invest more than
$20 billion to expand the Federal Government's ongoing work to
aggressively ramp up vaccine distribution administration,
including by establishing mobile vaccination units in
underserved communities, expanding community vaccination
centers, and facilitating clear communication with the public.
And I also am pleased that this committee passed its
portions of this legislation without delay, and the full House,
as I said, will vote later this week, and so we really look
forward to getting the bill on the President's desk as soon as
possible.
And I just want to thank our witnesses for taking the time
to be with us today. Your work is really vital, and this
committee recognizes your extraordinary efforts. If we all work
together, I'm confident that this historic vaccination campaign
will succeed and we will crush COVID-19.
So thank you again, Madam Chair, for putting this together
today. I couldn't think of a more important reason to have a
hearing with your subcommittee.
Thank you. Thank you, Diana.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
Today, we convene the Energy and Commerce Committee's first
hearing of the 117th Congress to examine the urgent need to
increase COVID-19 vaccinations across the country. This
committee's top priorities this year are to combat this
pandemic, provide relief to struggling families, and rebuild
our economy. In the coming months, we will push an aggressive
agenda that will ensure the Biden administration has all the
tools and resources it needs to crush this terrible virus.
This goal is more pressing than ever. Thousands of
Americans continue to die each day from COVID-19, while new,
more contagious strains are emerging in the United States. We
are now in a race to keep vaccines ahead of new virus
variants--and the stakes could not be higher.
The pandemic's toll on the Nation is tragic. To date,
nearly 440,000 Americans have lost their lives from COVID-19--
surpassing the total number of U.S. soldiers killed during
World War II. More than 10 million Americans are unemployed,
while 1 in 3 households struggles to make ends meet. It's no
wonder Americans' assessment of their mental health is worse
than at any point in the past two decades. Experts warned of a
dark winter, and unfortunately, they were right.
Amid these dark days, we're now seeing the rollout of some
of the most powerful tools we have to contain the virus: safe
and effective vaccines. Unfortunately, the initial rollout has
been marked by confusion and delays. It's no secret that the
demand for vaccine is outpacing supply--leading to canceled
appointments, endless lines, and mounting concerns.
Limited transparency into the Nation's vaccine supply, as
well as conflicting accounts about a reserve held by the
Federal Government, have all contributed to uncertainty and
frustration.
Thankfully, the Biden administration is already taking
action to address these issues, including purchasing additional
doses that will increase our vaccine supply by 50 percent by
the end of summer. I hope to learn today what more Congress and
the Federal Government can do to provide more certainty and
help accelerate vaccinations across the country, while ensuring
equitable access for those most vulnerable to COVID-19.
Despite the issues we've encountered with the vaccine
rollout and the painful road still ahead, I'm optimistic that
we are finally on a path to beating the virus.
As I mentioned, there are currently two extraordinarily
effective and safe COVID-19 vaccines authorized by the Food and
Drug Administration--and more could soon be on the way.
States have stretched their limited resources to implement
an unprecedented vaccination program, reaching 26 million
Americans and counting.
And we now have a new administration that will be guided by
science and a comprehensive national strategy to beat the
pandemic--something I have long called for.
So there is hope on the horizon, but we have much work to
do to get there. That starts with tackling the biggest
challenges standing in the way of containing the pandemic:
getting vaccines into as many arms as possible, as quickly as
possible.
This nationwide vaccination campaign is truly historic, and
it will require substantial support from Congress to succeed.
To that end, Democrats in Congress are moving swiftly to
pass the American Rescue Plan--a bold, comprehensive proposal
from the Biden administration that would fund vaccination
efforts and provide Americans much-needed relief. Critically,
the plan would invest $20 billion in a national vaccination
program to help ensure greater accessibility and availability
of vaccines across the country.
It includes critical financial support to State and local
governments, which have been pleading for any support from the
Federal Government to assist in their efforts to combat this
virus.
I hope my Republican colleagues will join me, without
delay, in supporting this bill for the American people. There
is simply no time to waste.
I welcome the State health officials with us and look
forward to their on-the-ground assessments of the national
COVID-19 vaccination effort. You are our vital partners in this
extraordinary campaign, and you are being called upon to
execute innovative solutions to unparalleled challenges. Thank
you for dedicating your valuable time to sharing your important
perspectives with the committee today.
The COVID-19 vaccines authorized in the United States are
potent tools in our fight against the virus. But vaccines in
vials don't protect people--vaccines in arms do. We must act
now to overcome the remaining logistical hurdles and strengthen
the Nation's COVID-19 vaccination campaign. There is no time to
lose.
Ms. DeGette. Thank you so much, Mr. Chairman.
The Chair now recognizes the ranking member of the full
committee, Mrs. Rodgers, for 5 minutes for purposes of an
opening statement.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Thank you, Chair DeGette, and Republican
Leader Griffith for this hearing on COVID-19 vaccines made
possible by the Trump administration and the incredible success
of Operation Warp Speed.
Vaccines normally take more than 10 years to develop.
Thanks to Operation Warp Speed, we have two safe and effective
vaccines in less than 1 year, and one more on the way, and
others on the way. Operation Warp Speed is one of the greatest
health achievements in history, and it will help us win the
future. It puts us on a path to crush this virus, to restore
our way of life, and also provide a new model of innovation for
future life-saving breakthroughs.
President Biden entered the White House and inherited a
vaccine program with a million Americans being vaccinated a
day. President Trump set ambitious and bold goals. President
Biden should, too. And that's why the Energy and Commerce
Republicans will continue to push for a plan to vaccinate 2
million people a day in the first hundred days of this
administration.
To be certain, mass vaccinations like our ongoing effort
are complex and difficult. Thanks to American ingenuity and
grit, we continue to lead the world. Last week, the CDC said
that 72.4 million doses have been delivered, and more than 56.2
million of those had been administered.
Pfizer projects it will supply 120 million doses to the
U.S. by the end of March, 20 million more than initially
promised. Moderna expects 100 million doses 2 months earlier
than expected. Based on current projections, by the end of July
we'll have enough vaccines for 300 million people, well more
than the estimated 250 million currently eligible, and we have
more vaccines on the horizon.
Johnson & Johnson submitted their Emergency Use
Authorization for their one-dose vaccine, which is scheduled to
be reviewed Friday. Authorizing this vaccine would
significantly boost our supply.
Our current efforts and projected supply are promising. We
want to make vaccines available so that everyone who wants one
can get one. So we have more work to do.
New COVID variants have emerged, posing new threats.
Thankfully, recent lab studies show that Pfizer and Moderna's
vaccines are effective against the South African variant, and
all manufacturers report that their vaccine candidates are
effective against hospitalizations and death.
We seem poised to tackle these new challenges, and we must
remain focused to ensure we do. Distribution issues need to be
fixed.
Earlier this month, we heard from five States who made
clear supply limitations are the number-one barrier to getting
more shots in people's arms. Hopefully, our projections for
increased supply and new vaccines will resolve this. To crush
the virus, States also need to resolve self-inflicted problems.
My home State is no exception.
The Seattle Times revealed that the Washington Department
of Health ignored basic logistics in their rollout plan. It was
called a, quote, ``bureaucratic nightmare.'' Had Washington
planned better, the most vulnerable could have been vaccinated
much faster.
I also recently learned of Governor Inslee's unacceptable,
unfair, and irresponsible intervention in Whitman County. After
vaccinating all phase 1B, tier 1-eligible people who wanted the
vaccine, Whitman County was ready to vaccinate the next group,
teachers. But Governor Inslee interfered. He threatened to
withhold vaccines if they proceeded. One school superintendent
called the Governor's decision demoralizing.
I agree we should be doing everything we can to get our
kids back to school. That means supporting counties that are
delivering the vaccine with efficiency and speed.
I know that this has been a very long year, full of fear of
the unknown, the uncertainty, and more isolation. This week
marks 500,000 lives lost. Social distancing, school closures,
long hours and nights for people on the front lines, the rise
of suicides and overdoses--it all adds up, and it's taking a
toll. People are tired. Many are in despair. I'm especially
worried about the mental health of our children.
So my message today is this: There is hope. Our vaccine
supply is expected to increase. Distribution is becoming more
efficient. We will get through this pandemic. It's American
innovation and ingenuity that's going to end this crisis and
give people hope, the ability to heal, and the courage to dream
again. We will emerge stronger than ever before. That's our
mission today.
Thank you, Madam Chair. I yield back.
[The prepared statement of Mrs. Rodgers follows:]
Prepared Statement of Hon. Cathy McMorris Rodgers
Thank you, Chair DeGette and Republican Leader Griffith,
for holding this hearing on expanding COVID-19 vaccine
availability.
People are still struggling to get access to COVID-19
vaccines. The problem is that we need more supply.
Earlier this month, witnesses representing five State
governments testified that there wasn't enough vaccine, and
that each of the States could distribute more if they had more
supply.
With more supply, we can accelerate our vaccination efforts
and protect Americans from severe disease, COVID-19
hospitalizations, and death as quickly as possible.
In addition, the COVID-19 variants that have been detected
thus far seem to spread more easily and quickly than other
variants, which can lead to more cases of COVID-19. Swift
vaccinations may be able to help us combat the rising threat of
the virus' mutations, and we may need to respond and pivot at
some point in the future to address variants with things like
booster shots.
While our current situation of limited vaccine supply is
frustrating to the American people and may seem dire, we have
reasons to be hopeful that the vaccine supply will skyrocket in
the coming months and that we will be well-positioned to deal
with the variants.
The Nation's vaccine rollout is improving. According to the
latest CDC data as of February 17, over 72.4 million doses have
been delivered and over 56.2 million doses have been
administered. Recently, the U.S. administered 2 million vaccine
doses a day, which is at twice the pace of the President's goal
for his first 100 days. In fact, the U.S. vaccine rollout, for
all of its reported problems, is ahead of almost every country
in the world.
The manufacturers are getting better, more efficient, and
faster at making the vaccine. Pfizer projects it will supply
120 million doses to the U.S. by the end of March--20 million
more doses than initially promised. Moderna also expects to
provide 100 million doses 2 months earlier than expected.
Other manufacturers have submitted an Emergency Use
Authorization (EUA) or expect to submit an EUA soon. For
example, Johnson & Johnson submitted an EUA to the FDA earlier
this month, and the Vaccine and Related Biological Products
Advisory Committee has scheduled a meeting for this Friday to
discuss the request for an EUA. If the FDA authorizes the
Johnson & Johnson vaccine, the U.S. supply will be further
boosted, especially since the Johnson & Johnson vaccine only
requires one dose.
As the President has noted, Pfizer and Moderna are
projected to provide 600 million doses to the U.S. by the end
of July, which is enough to vaccinate 300 million people. This
is well more than the estimated 260 million people who are
currently considered eligible for the vaccines.
This is due to the accomplishments of vaccine
manufacturers, with the strong backing from the Federal
Government, including Operation Warp Speed, actions taken by
the Trump administration to use the Defense Production Act, and
the career professionals who continue these efforts in the
Biden administration. This is a strong foundation that needs
more appreciation.
Further, Congress has already provided a tremendous amount
of support, including funding to the States to fight the virus.
Much of these resources remain unspent, including $4.5 billion
given to States to improve vaccine rollouts in the December
COVID-19 relief package.
The COVID-19 variants pose a continuing threat. It is
anybody's guess how much the variants could slow down our
progress or worse. However, even here, there is room for
optimism. Recent lab studies show that Pfizer and Moderna's
vaccines are effective against the South African variant, and
all manufacturers report that their vaccine candidates are
effective against hospitalization and death.
Bringing in new manufacturers, increasing production
capacity, or modifying a vaccine in response to a variant would
take several months' lead time before additional supply will be
ready. Our ability to get through the immediate threat of the
variants will rely on a combination of mitigation measures,
improved vaccine allocation and administration, advances in
vaccine production, and the use of therapeutics.
While there is progress regarding vaccine supply,
unfortunately, distribution and administration challenges
remain in the States. For example, an investigation by the
Seattle Times revealed that the Washington Department of Health
neglected in its vaccine rollout to plan for basic logistics
that would have allowed for quick vaccination of those most
vulnerable to the virus. Just last week in my district,
Governor Inslee foolishly interfered with Whitman County's plan
to vaccinate teachers and school staff by threatening to
withhold vaccines. I realize that the witnesses before us today
don't have a role in distribution and administration efforts,
especially at the State level, but I wanted to raise the issue
since it remains a concern in my home State.
We will get through this pandemic by pulling together, not
through the dictates of misguided leadership.
Thank you, Madam Chair, I yield back.
Mr. Griffith. Madam Chair, you're muted.
You're muted, Madam Chair.
Ms. DeGette. Sure, I have to tell everybody else to unmute,
and you had to tell me.
Once again, I ask unanimous consent that Members' written
opening statements be made part of the record, and, without
objection, so ordered.
I now want to introduce the witnesses for today's hearing:
John Young, who is the group president and chief business
officer for Pfizer; Dr. Stephen Hoge, who is the president of
Moderna; Dr. Richard Nettles, who is the vice president of
medical affairs at Janssen Pharmaceutical Company's Johnson &
Johnson; Dr. Ruud Dobber, who is the executive vice president
and president of BioPharmaceuticals Business Unit at
AstraZeneca; and John Trizzino, who is the executive vice
president, chief commercial officer, and chief business officer
at Novavax.
I want to thank everyone once again for appearing today. I
know you're very busy, and your testimony is very important.
I know all of you are aware that this committee holds an
investigative hearing, and, when we do so, we take all of our
practice of taking testimony under oath.
Do any of you have any objection to testifying under oath
today?
Mr. Young. No.
Dr. Hoge. No.
Dr. Nettles. No.
Dr. Dobber. No.
Mr. Trizzino. No.
Ms. DeGette. Let the record reflect the witnesses have
responded no.
The Chair then advises you, under the rules of the House
and under the rules of the committee, you're entitled to be
accompanied by counsel. Do any of you wish to be accompanied by
counsel during your testimony today?
Mr. Young. No.
Dr. Hoge. No.
Dr. Nettles. No.
Dr. Dobber. No.
Mr. Trizzino. No.
Ms. DeGette. Let the record reflect the witnesses have
responded no.
And so, if you would, would you please raise your right
hand so you may be sworn in.
[Witnesses sworn.]
Ms. DeGette. Let the record reflect the witnesses have
responded affirmatively, and you are now under oath and subject
to the penalties set forth in Title 18, Section 1001 of the
U.S. Code.
The Chair now will be pleased to recognize our witnesses
for 5-minute summaries of their written statements.
You can see right in the second level of the screen there
is a timer that will count down, and it turns red when your 5
minutes have come to an end.
So, first, I'd like to recognize you, Mr. Young, for 5
minutes for your opening statement.
STATEMENTS OF JOHN YOUNG, CHIEF BUSINESS OFFICER, PFIZER;
STEPHEN HOGE, M.D., PRESIDENT, MODERNA, INC.; RICHARD NETTLES,
M.D., VICE PRESIDENT OF U.S. MEDICAL AFFAIRS, JANSSEN
INFECTIOUS DISEASES AND VACCINES, JOHNSON & JOHNSON; RUUD
DOBBER, Ph.D., EXECUTIVE VICE PRESIDENT, BIOPHARMACEUTICALS
BUSINESS UNIT, AND PRESIDENT, NORTH AMERICA, ASTRAZENECA; AND
JOHN TRIZZINO, EXECUTIVE VICE PRESIDENT, CHIEF COMMERCIAL
OFFICER, AND CHIEF BUSINESS OFFICER, NOVAVAX
STATEMENT OF JOHN YOUNG
Mr. Young. Thank you.
Chairwoman DeGette, Ranking Member Griffith, and members of
the subcommittee, thank you for inviting me to testify today. I
am John Young, chief business officer at Pfizer, and I'm
honored to be a part of this panel.
When I appeared before this committee last July, we were in
the middle of our journey to develop a COVID-19 vaccine. Since
then, our vaccine became the first to be granted Emergency Use
Authorization by the FDA.
This EUA was based on data from our phase 3 study, which
demonstrates that our vaccine met the FDA's stringent safety
requirements and indicated efficacy of 95 percent, consistent
across age, gender, and racial demographics, and participants
reflecting the diversity of the United States' population.
As of February the 17th, we have shipped approximately 40
million doses to points of use as directed by the U.S.
Government. To date, no serious safety concerns have been
identified that have changed the favorable risk-benefit profile
of the vaccine.
To get our vaccine to points of use, we provide the
Government a rolling weekly forecast of doses available for
shipment, enabling the Government to provide States with a 3-
week forecast. The U.S. Government then allocates doses weekly
to the States. Providers submit orders through the CDC's VTrckS
system, which are submitted to us, and weekday orders are
shipped the day after.
We recognize the need to vaccinate more people more quickly
and have worked hard to significantly increase production.
Since July, we've increased projected 2021 global production
from 1.3 billion doses to at least 2 billion doses.
Pfizer has made significant investments in our U.S.
manufacturing sites, including St. Louis, Missouri; Andover,
Massachusetts; Kalamazoo, Michigan; and Pleasant Prairie,
Wisconsin. We added new lines at our site in McPherson, Kansas;
started lipid production at our site in Groton, Connecticut;
added two contract manufacturers.
Further improvements have come from the FDA's approval of a
six-dose label for each vial, doubling batch sizes, increased
yields per batch, reduced cycle times, and deployment of faster
laboratory tests to reduce release times. As a result of these
improvements, we expect to increase the number of doses
available from approximately 4 to 5 million doses per week at
the beginning of February to more than 13 million doses per
week by the middle of March.
We are on track to make 120 million doses available for
shipment by the end of March and an additional 80 million doses
by the end of May. We anticipate all 300 million contracted
doses will be made available for shipment to the points of use
as directed by the U.S. Government by the end of July, enabling
the vaccination of up to 150 million Americans.
We continue to gather evidence on safety and efficacy to
support the use of our vaccine by important subpopulations of
patients not indicated under the current EUA. We're conducting
studies in patients between 12 to 15 years of age and hope to
soon begin studies in children under the age of 11. Last week,
we initiated a study in pregnant women.
We are laser focused on the potential impact emerging
variants of the SARS-CoV-2 virus could have on the ability of
vaccine to protect against COVID-19. Our mRNA vaccine affords
the opportunity to provide boosting doses if needed and the
ability to rapidly alter the mRNA sequence in the vaccine to
address potential changes in the virus if evidence suggests
that they might reduce protection from the current vaccine.
With 95 percent protection against the original strain,
we've now performed in vitro studies on immune responses
elicited by the vaccine against new variants, such as those
from the U.K. and South Africa. Based on these data, we believe
the vaccine should provide protection from these variants.
Real-world evidence from the U.K. and Israel appears to confirm
this for the U.K. strain. And, to date, we've seen no real-
world evidence that suggests a significant reduction in
protection provided by our current vaccine.
However, we are preparing to respond quickly and hope to
initiate a study to investigate the effectiveness of a third
booster of our vaccine in trial participants who have already
received two doses. We are discussing clinical trial designs
with the FDA to investigate safety and immunogenicity of an
updated vaccine that involves a change to the mRNA construct to
target an emerging variant. We will fight every step of the way
until this devastating pandemic is under control.
In closing, I would like to express Pfizer's sincere thanks
to the more than 46,000 trial participants, the hundreds of
investigators, and thousands of Pfizer and BioNTech scientists,
clinicians, and manufacturing professionals who have worked day
and night knowing every moment matters.
Thank you for the opportunity to be with you today.
[The prepared statement of Mr. Young follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much, Mr. Young.
Dr. Hoge, I'm now pleased to recognize you for 5 minutes
are for an opening statement.
STATEMENT OF STEPHEN HOGE, M.D.
Dr. Hoge. Chairwoman DeGette, Ranking Member Griffith,
Chairman Pallone, and Ranking Member Rodgers, and distinguished
members of the subcommittee, thank you for the opportunity to
appear before you today.
My name is Stephen Hoge, and I serve as the president of
Moderna. Since we last spoke in July, the collaborative effort
to end this pandemic has made remarkable progress. We've also
confronted new challenges. We've seen continued suffering and
hardship. We know that much work remains and that this is not
over until all of us are safe.
The work could not be more pressing. Half a million people
have died in the United States alone, and many more have been
made ill. The pandemic has cost jobs, shuttered businesses,
closed schools, burdened families, and disrupted countless
traditions. We also know that communities of color and
essential workers have been disproportionately impacted by the
burdens of COVID-19. We must bring this pandemic to an end.
Now, when I testified before this subcommittee last July,
Moderna was days away from starting the phase 3 clinical trial
for our COVID-19 vaccine candidate, and we were cautiously
optimistic that it could play an important role in ending the
pandemic. With the support of the U.S. Government, we had also
begun to modify our facilities, procure supplies, hire and
train staff, and establish partnerships with leading
pharmaceutical manufacturing companies to give us a head start
on producing a vaccine.
We've made significant progress since then. The phase 3
trial showed our vaccine was 94 percent effective at preventing
COVID-19, leading to an Emergency Use Authorization from the
FDA in December of 2020. Less than 2 weeks later, we had
delivered the first 17.8 million doses to the Federal
Government.
Now, given the importance of vaccine availability to ending
this pandemic, I'd like to take this opportunity to provide you
with an update on our ongoing efforts to manufacture and
deliver our vaccine to the United States.
Two weeks ago, we had delivered over 45 million doses of
our vaccine to the Federal Government. Last week, we delivered
another 9 million doses, bringing the total number of doses
delivered to over 54 million. We currently are on track to
deliver the first 100 million doses of the vaccine by the end
of March. To do this, we have doubled our monthly deliveries
since the end of 2020, and we are aiming to double them again
by April to more than 40 million doses a month.
Our success in scaling up production recently allowed us to
move up our timetable for deliveries. We are now targeting
delivery of the second 100 million doses of our vaccine by the
end of May, and a third 100 million doses by the end of July, a
full 2 months ahead of schedule.
I want to provide you with a brief overview of our
manufacturing process.
First, Moderna and its manufacturing partner, Lonza, create
the vaccine at facilities in Massachusetts and New Hampshire.
Our fill-finish partner, Catalent, then fills the vaccine into
vials at their facility in Indiana. Catalent then follows a
rigorous process for inspecting, testing, and packaging the
vials for delivery. At every step, we and our partners are
committed to maintaining the highest standards of quality.
Now, on any given day, millions of doses of vaccine will be
at the different stages of the manufacturing process. And, over
time, the buildup of this work-in-process inventory allows the
entire system to operate more efficiently. The pace of
production also increases as the highly skilled personnel
working at each step gain experience and greater familiarity
with the process.
We work continuously with the U.S. Government to identify
additional opportunities to accelerate production or address
bottlenecks. For example, Moderna recently approached the
Government about the possibility of adding more doses of the
vaccine to each vial. Doing so would improve output by allowing
us to complete manufacturing runs more quickly and reduce the
need for some high-demand materials. The FDA has given us
positive feedback on the proposal, and we are now working to
enable up to 15 doses per vial in the near term.
At Moderna, we are grateful for the opportunities we've had
to collaborate with the Government in our efforts to deliver a
safe, effective COVID-19 vaccine. We're also grateful for the
many companies around the world, including my colleagues
testifying today, that are working to deliver COVID-19 vaccines
and treatments.
I'd 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 efforts to combat this pandemic,
and we remain committed to collaborating with the U.S.
Government in this fight.
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, Dr. Hoge.
Dr. Nettles, you're now recognized for 5 minutes for your
opening statement.
STATEMENT OF RICHARD NETTLES, M.D.
Dr. Nettles. Chairman DeGette, Ranking Member Griffith, and
members of this subcommittee, I'm pleased to have the
opportunity to update you on the remarkable progress that
Johnson & Johnson has achieved by our vaccine over the past
several months, allowing us to request Emergency Use
Authorization with the FDA less than 3 weeks ago. Although we
are cautious not to prejudge the outcome of the ongoing FDA
review process, we believe that our single-dose vaccine will be
a critical tool for fighting this global pandemic.
In January 2020, Johnson & Johnson launched a major
research and development effort for a vaccine. Our pace since
then has been extraordinary. We selected a single-dose
candidate in June, began human trials in July, launched a
large-scale pivotal trial in September, released top-line
results last month, and sought an Emergency Use Authorization
from the FDA on February 4.
The clinical trial showed that our single-dose vaccine
addresses the most important healthcare need in the pandemic:
the prevention of COVID-19-related hospitalization and death.
Twenty-eight days after vaccination, the vaccine provided
complete protection against COVID-19-related hospitalization
and death. The vaccine was 85 percent effective overall in
preventing severe disease, including across countries with
newly emerging variants. The vaccine was 72 percent effective
in the United States at preventing moderate to severe disease.
Based on these data earlier this month, we sought Emergency
Use Authorization from the FDA. The FDA's advisory committee
will meet later this week.
Assuming necessary regulatory approvals, we are ready to
begin shipping immediately and deliver enough single doses by
the end of March to enable the vaccination of more than 20
million Americans. Furthermore, we will meet our target to
deliver 100 million single-dose vaccines to the United States
during the first half of 2021.
For many months, we have been working to expand our
manufacturing capacity and contract with third-party
manufacturers for additional production. We assessed nearly 100
different production sites, and we selected the sites that were
able to support an accelerated timeline. We are working around
the clock to scale our manufacturing capabilities to supply the
United States with vaccine.
Our plans call for production in the United States, in
Europe, in Africa, and Asia. Importantly, our vaccine can be
distributed using the existing supply chain and routine
refrigeration that we use to transport other medicines today.
The vaccine is based on Johnson & Johnson's AdVac
technology. We have significant clinical experience with
vaccines based on this technology, including vaccines
administered for more than a decade. Johnson & Johnson is
committed to ensuring that clinical trials include a wide
variety of populations, including historically underrepresented
communities.
The Ensemble study for our COVID vaccine included
approximately 45,000 participants across diverse populations.
Forty-five percent were Hispanic or Latinx. Nineteen percent
were Black or African American. Nine percent were Native
American, and 3 percent were Asian. More than one-third of the
participants were over the age of 60. We are truly grateful for
all the participants who volunteered for our trials.
As you know, Johnson & Johnson is making our COVID-19
vaccine available on a not-for-profit basis for emergency
pandemic use.
Finally, I want to note that the U.S. Government's support
has been an important contributor to our ability to develop our
vaccine on an accelerated pace. We appreciate our partnership
with the Government, the financial support provided by the
Congress, and this committee's extraordinary leadership on this
critically important effort.
Thank you for the opportunity to provide this update
regarding our vaccine against COVID-19. I would be happy to
answer any questions that you may have.
[The prepared statement of Dr. Nettles follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much, Dr. Nettles.
And I'm now pleased to recognize Dr. Dobber for 5 minutes.
Dr. Dobber?
STATEMENT OF RUUD DOBBER, Ph.D.
Dr. Dobber. Thank you so much.
Chairwoman DeGette, Ranking Member Griffith, and members of
the subcommittee, I'm Ruud Dobber, the executive vice president
of AstraZeneca.
I'm here today to convey AstraZeneca's continued commitment
to developing and manufacturing our vaccine candidate for the
prevention 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 delivering safe and effective
solutions for fighting the pandemic in the United States and
across the world.
AstraZeneca is a global science-led biopharmaceutical
company which focuses on the discovery, development,
manufacturing, and commercialization of innovate medicines. We
are proud to have our North American headquarters in Delaware,
and one of our three global R&D centers in Maryland.
Today, I will focus on four key elements of AstraZeneca's
vaccine program. First, we are proud of our collaboration
across all areas of the vaccine program. Our strategic approach
has focused on partnering with scientists; governments;
organizations like CEPI, GAVI, and the WHO; and manufacturers
for the development, supply, and distribution of our vaccine in
an equitable manner across the world.
AstraZeneca was the first global pharmaceutical company to
join COVAX in June 2020. Together with our partner, the Serum
Institute of India, we plan to supply over 300 million doses to
145 countries through COVAX in the first half of 2021 as part
of our global and equitable access pledge. The majority of this
supply will go to low- and middle-income countries.
Our agreement with the U.S. Government covered the
development and supply of 300 million doses of our vaccine
should it receive authorization. The course of the doses and
the dose agreements will provide no profit for AstraZeneca.
I would like to take this opportunity to thank the U.S.
Government for its commitment to advancing these efforts.
Second, to date, we have received conditional marketing or
emergency authorization in more than 50 countries, and recently
the WHO listed our vaccine for emergency use against COVID-19.
Studies conducted to date indicate our vaccine is well
tolerated and effective. And, just this week, we were
encouraged to see the first real-world evidence from over 5.4
million subjects in Scotland demonstrating risk reduction of
COVID-19-related hospitalizations by 94 percent after the first
dose of our vaccine. Comparable vaccine effects were seen
across all age groups, including in those over 80 years of age.
In addition, we've completed enrollment in our U.S. phase 3
trial, comprising over 30,000 participants, to support FDA
authorization. It is important to note that the dosing interval
used in the U.S. trial is 4 weeks, which may not maximize
efficacy. We anticipate the data will be available in the
coming weeks, and we will submit it to the FDA thereafter.
In the U.K., a vaccination strategy based on a 3-month
dosing interval is underway, and additional real-world evidence
should become available in the next few weeks.
Third, our supply of the vaccine for the U.S. Government is
being produced in the United States, and our manufacturing
operations are at or near full capacity. We are not currently
experiencing significant material or equipment constraints.
Despite the speed in scaling up, safety and quality standards
have been and remain of paramount importance.
We are working closely with the U.S. Government to ensure
transparency around our progress. In addition, we are
continually identifying and implementing new ways of working to
accelerate production and reduce the time to reach communities
while maintaining the highest standards of quality. Based on
current projections, assuming EUA, we expect to deliver up to
50 million dose by the end of April.
Fourth, AstraZeneca has initiated studies to address
emerging threats posed by new COVID-19 variants. Initial
analysis, while still ongoing, suggests our vaccine shows
promise against U.K. variants of the virus. Additionally, as we
speak, we are actively studying our vaccine in multiple
variants, including the South African variants.
Before I close, I would like to recognize my AstraZeneca
colleagues and our partners for their heroic efforts and
unwavering commitment to bring our vaccine to millions of
people around the world. Together with the other companies with
us today, we are forging ahead in our collective goal of
beating COVID-19.
Chairwoman DeGette, Ranking Member Griffith, and members of
the subcommittee, on behalf of AstraZeneca, thank you for the
opportunity to participate in today's hearing.
[The prepared statement of Dr. Dobber follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much.
And now, last but not least, Mr. Trizzino, you're
recognized for 5 minutes.
STATEMENT OF JOHN TRIZZINO
Mr. Trizzino. Thank you.
Good morning, Chairwoman DeGette, Ranking Member Griffith,
and members of the subcommittee. Thank you for the opportunity
to appear before you today. I am John Trizzino, and I'm the
executive vice president, chief commercial officer, and chief
business officer at Novavax.
Novavax is a biotechnology company focused on the
development of next-generation vaccines for serious infectious
diseases. We are headquartered in Gaithersburg, Maryland, and
we are proud to be at the forefront of the fight against COVID-
19.
Shortly after the threat was identified, we initiated
clinical research, and so far we've seen very strong data from
our clinical trials. I am pleased to be here so that the
American people can become familiar with our company and the
vaccine platform we've been building and refining for decades.
As you'll hear, our technology was built for this moment.
Our scientists continually scan the landscape for emerging
threats, and we started development of our COVID-19 vaccine
candidate in January 2020.
My written testimony for the subcommittee provides
extensive information about our company, our clinical
development program, our manufacturing capacity, and more. I
look forward to answering your questions on those topics.
But, first, I want to take this opportunity to speak about
how our vaccine technology works and how we are applying it to
address the COVID-19 pandemic.
We've shared a slide with the subcommittee, and I'd like to
request that be pulled up at this time.
[Slide follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Trizzino. You are now looking at a representation of
the coronavirus on the left and a representation of our vaccine
on the right. Novavax has a very unique way of making vaccines.
We use nanoparticles, shown here on the right in blue.
Our nanoparticles carry a modified version of the
coronavirus spike protein, shown here in red. This creates a
signal for your body. This signal enables your immune system to
learn to fight the real virus. To ensure your immune system
hears that signal loud and clear, we boost it with our Matrix-M
adjuvant. This adjuvant increases your body's ability to launch
a powerful response and to help protect you.
One of the most important characteristics of our technology
is that it enables us to rapidly adapt our vaccine as the
COVID-19 pandemic evolves. This is extremely relevant as new
variants, like those observed in South Africa and the U.K., are
surfacing and spreading.
Thank you for sharing the slide. Can you please now take it
down?
Vaccines like ours can be efficiently produced at massive
scale to help meet global demand. Novavax vaccines are
manufactured, transported, and stored at standard refrigeration
temperatures, 2 to 8 degrees Celsius. This helps to simplify
production, distribution, and use.
Yesterday, we announced that our PREVENT-19 phase 3 trial
in the U.S. and Mexico completed enrollment of 30,000
volunteers. Last month, we reported interim results from our
phase 3 study in the United Kingdom with efficacy of over 95
percent against the original COVID-19 strain and over 85
percent against the U.K. variant strain.
We are optimistic about our ability to help address urgent
global health needs, and we have already initiated development
of new constructs against the emerging strains. Novavax is
working closely with U.S. Government partners, as well as
nongovernmental organizations and industry partners, to advance
development of our vaccine candidate. These exceptional
partnerships have enabled us to make extraordinary progress.
Thank you so much for inviting me to participate in this
hearing. It is an honor to appear before you today. I request
that my longer written testimony be included in the record, and
I look forward to your questions about Novavax and our COVID-19
vaccine candidate.
Thank you.
[The prepared statement of Mr. Trizzino follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. DeGette. Thank you so much, Mr. Trizzino. Your
testimony will be made part of the record.
I'll note we haven't enjoyed a good meaty slide like that
since the last time Dr. Fauci was over, so thank you for
bringing that slide.
It's now time for the Members to have an opportunity to ask
you questions, and the Chair will recognize herself first for 5
minutes.
As I said in my opening statement, the vaccines you've
developed are really a marvel of science, and they hold the
promise of turning the tide on this pandemic. Everybody on this
subcommittee and the full committee, we are really amazed at
the extraordinary work and the timely fashion that you've done
it in.
And, as you know, a lot of the vaccines were developed as
part of Operation Warp Speed, which involved the Federal
Government contributing enormous amounts of money to scale up
vaccine manufacturing at the same time the research and
approval process was going on.
I guess we shouldn't be surprised that we had some
glitches, and the glitches that we had was that the--even
though several of the vaccines had emergency use approval late
last year, still the amount of supply has fallen short of
expectations. And, for our constituents, that has been very
frustrating.
So I just want to ask some questions going forward about
where we expect to be for vaccine production and distribution.
Mr. Young, I'll start with you.
Last October, Pfizer's CEO said he expected Pfizer to
deliver 30 to 40 million doses to the U.S. by the end of 2020,
but Pfizer only hit the 40 million mark last week. And I was
just wondering: You have said that you're going to provide the
Federal Government 300 million doses by the end of July. Given
current production levels, are you going to be able to meet
that deadline?
Mr. Young. Thank you for your question.
It's correct to say that, you know, we did initially
experience some problems with the initial ramp up of our
vaccine, and I think, in common with other panelists here,
we've been in the process of developing a manufacturing process
for a vaccine product that we've never made before. We
particularly saw some great limiting steps with raw materials,
but we anticipate that we will be on track to deliver those 300
million doses before the end of July.
Ms. DeGette. Thank you.
Dr. Hoge, last July you testified before this subcommittee,
quote, ``We're very confident we're going to be able to deliver
several hundred million doses next year.''
Now, that was over 6 months ago. To date, we've had 45
million doses. Moderna has agreed to provide the Federal
Government 300 million doses by the end of July, and will you
be able to meet that deadline?
Dr. Hoge. Chairwoman, thank you for the question.
The short answer is we do believe we're on track to meet
those deadlines. We have--as I noted in my oral remarks, we
had, as of 2 weeks ago, delivered 45 million doses.
Ms. DeGette. Right.
Dr. Hoge. And then, last week, we are pleased that we
finally got to delivering 9 million doses, which puts us on a
track record, if you look at the number of weeks ahead, that we
should be able to continue to deliver approximately 40 to 50
million doses a month through the balance of our commitment.
If we're able to do that----
Ms. DeGette. Does that--yes. Does that get you to 300 by
the end of July?
Dr. Hoge. Yes, ma'am, it does.
Ms. DeGette. Super.
Dr. Nettles, Johnson & Johnson's Federal contract is for
100 million doses by the end of June. Last month, a J&J board
member said the goal was to have 100 million doses even
earlier, maybe by April.
Now, we're hoping that the EUA for Johnson & Johnson's
COVID-19 vaccine could come any day, and, if it does, will you
able to deliver the 100 million doses by the end of June, if
not sooner?
Dr. Nettles. Yes. We are on track to deliver the 100
million doses by the end of June, yes.
Ms. DeGette. Super. Thank you so much.
Now, Dr. Dobber, AstraZeneca's Federal contract is for 300
million doses. Last year, you testified, quote: ``We are
scaling up to manufacture up to 300 million doses of the
vaccine so that they will be able--available immediately upon
approval or Emergency Use Authorization.''
And so this seems to appear to me that 300 million doses
would be ready if you got authorization, and is that the case?
And, if not, then how many would be available?
Dr. Dobber. Well, thank you so much for the question. And,
once again, what I said in my oral statement, the moment we
have EUA--and we are expecting that in the beginning of April--
we will release instantly 30 million doses; at the end of the
month, up to 50 million; and thereafter, we will have a
production roughly of 15 to 25 million doses a month.
So, in short, we are on track in order to deliver the
commitment of 300 million doses.
Ms. DeGette. But not immediately upon EUA. It's going to
take some time?
Dr. Dobber. It will take some time. And, as we're working
on scaling our production, that will take some time, but we
feel very comfortable that we will deliver the 300 million soon
after.
Ms. DeGette. OK. Keep us updated.
Mr. Trizzino, last but not least, Novavax's contract with
the Federal Government is for 100 million doses, and your CEO
recently said he expects to manufacture up to 150 million doses
monthly by May or June. Do you think you're going to be able to
immediately deliver the 100 million doses if your vaccine is
authorized?
Mr. Trizzino. We are dependent upon EUA, obviously, but we
would be prepared by the end of June to produce that 100
million doses per the existing agreement with OWS.
Ms. DeGette. OK. Well, I will just say to all of you: Thank
you for your efforts, and we all stand ready on both sides of
the aisle to help you do what you need to do to make sure we
have the production.
Mr. Chairman, I think our next hearing, I hope, will be on
how we can expedite disbursal of all of these doses of vaccine
so everybody gets it in their arm.
And, with that, I'm proud to recognize our ranking member,
Mr. Griffith, for 5 minutes for asking questions.
Mr. Griffith. Thank you very much, Madam Chair.
I am sitting here amused because many of your questions
were similar to the ones that I had written out, and, as so
often happens, while people back home think that Republicans
and Democrats can't get along or that everything is a fight,
this is not one where there is a fight, and those doses are
important.
And, in fact, the Director of NIH, Francis Collins, you
know, remarked how amazing it was that, with precontracting and
making sure that we had, you know, contracts in place as those
Emergency Use Authorizations came in play is why we were able
to get vaccines out there and why we have so many doses that
you went through each one of the companies on.
One of the things that, you know, I'm really excited about
in many ways--and it does depend on the EUA coming through for
some of these other vaccines besides Pfizer and Moderna, but it
appears, based on the numbers that you went through, Madam
Chair, it appears that by midsummer we may actually have a
surplus of vaccine. Because it doesn't last forever, you can't
just leave it on the shelf. And, while we will probably need
additional doses for the following year, because most
scientists believe that we'll need a second--that it's going to
be like the flu; you have to take the vaccine fairly
regularly--we may actually have enough vaccine, again, assuming
that we have the EUA, the Emergency Use Authorizations, from
the FDA and that they feel the other vaccines are safe, but, by
July, we may have enough that we have a surplus in the United
States because there are only about 260 million people who are
vaccine eligible. And I was just wondering if our witnesses
could tell us: Is it a plausible scenario that we'll have a
surplus and that we'll be able to share that with other
countries who aren't as fortunate as the United States?
And, if each of you could answer that, I'd appreciate it.
Do you think that's plausible? Do you think that scenario is
plausible?
Mr. Young. Thank you for the question.
I do think that there will come a point, you know, in the
second quarter this year where I think the companies that
you've heard from today are likely to be in a position to be
able to supply significant doses of vaccine to the United
States. And we certainly hope that we're going to be in a
position where every eligible adult will be able to receive
vaccinations. That scenario is entirely plausible.
Thank you.
Mr. Griffith. Thank you.
Who wants to go next?
Dr. Hoge. I would just add to that that I agree that's the
hope, is that we definitely have a surplus of vaccines. And
then, obviously, we want to find a place to make that available
to other countries who don't have access to it.
We are, on our side, just focused on making sure we deliver
the 300 million doses we're under obligation to. We're going to
work 24/7 to deliver on that commitment.
Mr. Griffith. And we appreciate that.
Next? Just----
Dr. Nettles. I would say much the same.
Mr. Griffith. Yes.
Dr. Nettles. On behalf of J&J, yes, we are extremely
focused on delivering that 100 million doses by the end of
June. And, if the Emergency Use Authorization is received this
week, we hope to contribute to ending this pandemic as soon as
possible, yes.
Mr. Griffith. I appreciate that.
Dr. Dobber. Thank you so much.
Like the other witnesses, I truly hope and believe that
there will be a surplus if everyone is able to deliver and,
equally, also hope that we can make those doses available to
other parts of the world, including the COVAX facility.
There is a huge need in order to vaccinate people also in
low- and middle-income countries. So it's a clear pledge to the
U.S. Government as well as to the other companies here today in
order to also to make sure that those people are getting
vaccinated sooner than later.
Mr. Trizzino. At Novavax, we've got a global supply
infrastructure that is important to us and to equitable access.
We're intending to make sure that our U.S. supply and
manufacturing facilities are maximizing capacity out of those
facilitates, and it certainly is very plausible that there will
be excess capacity that we would expect and hope would be
distributed around the globe where it's needed.
Mr. Griffith. I want to make sure that Americans are taken
care of in this process first, but we also want to share with
other countries because that helps to keep the virus from
coming back or to having more mutations.
That being said, we do have children under 16 years of age
that are not currently eligible to get the vaccines. If you all
could briefly just tell me if you're working on research. I
know Pfizer told me they were in an earlier conversation. And
I'm running out of time, so if you could just say, ``Yes, we're
working on something for children under 16, and maybe even
under 12.''
Dr. Hoge. Yes, we are.
Mr. Trizzino. A trial in less than 16 in the spring.
Dr. Nettles. At Johnson & Johnson, we have a track record
of using our adenovirus-based platform in children and infants,
and we'll look to leverage it for the coronavirus vaccine.
We're in discussions with the FDA on how to move forward.
Dr. Dobber. From AstraZeneca's perspective, we have already
started the pediatric trial in the U.K., and we will also start
a trial in the United States. So the answer is yes.
Mr. Griffith. And let me say, Madam Chair, before I close
out, if you will bear with me just a second. The reason I think
that's so important is that plagues in the past, and pandemics
in the past, have indicated that, while they may not affect
children the first time around, sometimes there's a mutation
that comes back around that then affects children in ways that
we hadn't originally expected. So I am glad that we're
preparing for that so we are not caught unaware.
Thank you very much. I yield back.
Ms. DeGette. Good point. Thank you.
The Chair now recognizes the chairman of the full
committee, Mr. Pallone, for 5 minutes.
Mr. Pallone. Thank you, Chairwoman DeGette.
Because of the inaction by the Trump administration,
availability of the vaccine is not where the country needs to
be. And as I said in my opening statement, all options for
expanding capacity and increasing supply must be on the table.
I have some questions, I'm going to try to get some short
answers from you so I can get through them. Let me start with
J&J. Dr. Nettles, Johnson & Johnson has promised to deliver 100
million doses to the U.S. by the end of June. You mentioned
that. Your contract calls for at least 12 million of those
doses to be delivered by the end of February, which is almost
here. But, unfortunately, reports indicate that J&J has
struggled to ramp up production and will be able to deliver
only about 2 million doses in the next weeks or so.
So, what caused you to fall behind your delivery schedule?
And why is it taking so long to ramp up production? And are you
planning to partner with other manufacturers to boost
production?
Dr. Nettles. Thank you for the question. This has really
been an unprecedented effort on behalf of J&J to scale up
manufacturing for a vaccine against a disease that didn't even
exist more than a year ago. We're in a position where, as I
mentioned, we will have 20 million doses of the vaccine to be
made available by the end of March. And we're prepared to ship
immediately, upon Emergency Use Authorization, nearly 4 million
doses of our vaccine.
Mr. Pallone. Are you planning to partner with other
manufacturers to boost production? If you would answer that.
Dr. Nettles. We have, and we will. There was an
announcement just yesterday of a collaboration with Sanofi to
increase manufacturing globally as well.
Mr. Pallone. Thank you.
Dr. Hoge from Moderna, as virus variants emerge and we work
to develop new vaccines for them, I'm concerned about the
potential for additional demands on our strained manufacturing
capacity. So, if Moderna is already taxing its manufacturing
capacity at its current level, how will you be able to rapidly
produce new vaccines or booster shots, if necessary? And are
you considering partnering again with other manufacturers to
expand your production?
Mr. Hoge. Yes, sir. So, on both counts, we have worked
already to partner with two of the largest manufacturers of
pharmaceuticals in the world, a company called Lonza, and
establish production, both domestically and internationally, at
their facility in Switzerland.
And then we've been partnering with Catalent to make sure
that we can do the last step of that filling at high
throughput. Now, if there a need for more supply, we're
absolutely open to additional partnerships and will engage in
that. At this point, we think we can satisfy our obligations to
the United States Government as well as develop variant
vaccines.
Mr. Pallone. So, you think that you can rapidly produce new
vaccines or booster shots if necessary because of variants? Did
you answer that part?
Dr. Hoge. Yes, sir, we do. It's important to note that we
are trying to deliver the first 300 million by July, but for
the back half of the year we'll have additional capacity. And
there is work to do to develop those variant vaccines. And so a
few months of clinical work before we'd even need to be scaling
up that manufacturing.
Mr. Pallone. Thank you.
Let me go back to Dr. Nettles with J&J.I wanted to ask you
about vaccine efficacy. J&J's vaccine candidate was found to
have 66 percent efficacy, but it was shown to be 85 percent
effective in preventing severe disease. And there were zero
hospitalizations or deaths among the thousands of trial
participants. So please explain, why should the public have
confidence that J&J's vaccine, if it is authorized, will
protect them from the most serious risks?
Dr. Nettles. Thank you for the question. We are very
enthusiastic about the findings that you just mentioned from
our phase 3 Ensemble study. This vaccine was tested at the
height of pandemic globally and included a significant number
of participants from South Africa, from South America, and
Central America, where we know these variants have emerged.
And, despite that pressure, the vaccine showed that 28 days
after receiving a single dose of the vaccine, there were no
instances of hospitalization or death, and that includes in the
countries where these variants have emerged, as well as 85
percent protection against severe disease in those countries as
well.
So, to us, that single-dose approach with those results
make us a potential, really important addition to dealing with
this pandemic.
Mr. Pallone. I just want to thank you.
Lastly, Mr. Young, what is Pfizer's current assessment of
whether your vaccine may reduce transmissions? And when would
we have a more definitive answer to that, about its ability to
reduce transmissions? Because that's what a lot of people ask.
You have got about half a minute.
Mr. Young. OK. Thank you for your question, which is a
really important question and one that we are really focused
on. We don't definitively know the answer to that question
today for any of the vaccines, as to whether it would reduce
asymptomatic transmission. However, we believe the real-world
data which we're certainly seeing from the U.K. and Israel and
some other countries will certainly help to inform whether you
see, in vaccinated populations, a significant reduction in
transmission, which would allow you to infer whether you see a
reduction in asymptomatic transmission as well. So it is a very
important question, and one that we'll continue to monitor very
closely.
Mr. Pallone. Thank you so much. Thank you, Madam Chair.
Ms. DeGette. Thank you so much.
The Chair recognizes Mrs. Rodgers for 5 minutes.
Mrs. Rodgers. Thank you, Madam Chair.
I just want to join in recognizing the success of Operation
Warp Speed. And I don't think we can emphasize that enough. It
is really impressive that we have two safe and effective
vaccine in less than a year, and with more on the way. And that
normally takes up to 10 years. So it's a very successful
public-private partnership, and it is really one of our
greatest health achievements. I applaud the Trump
administration for the bold goals in setting up this public-
private partnership that has led to helping us crush this
virus.
Mr. Hoge, I wanted to ask what lessons has your company
learned from Operation Warp Speed related to R&D and
manufacturing that can help us speed the process from the lab
to shots in the arm for future vaccines?
Dr. Hoge. Well, we have a lot to learn over this whole
COVID response, and we are still learning it. And, so, I would
say that we're still in the process of learning how to scale up
the manufacturing and address the challenges of making sure the
vaccine becomes available and, as you said, Congresswoman, get
shots in arms.
One of the things that I think we all have already
recognized, and I've heard even Dr. Fauci and other testify on,
is that the aggressive approaches to making sure that we take
financial risks when there is a pandemic and accelerate the
development of vaccines, and their manufacturing has been
critical to accelerating our response. And I hope that
Americans are proud of the all-of-government response that has
happened over the last, now it's been a year that we've been
fighting this.
I think some of the unsung heroes in that are the career
folks at HHS, whether it is at NIH or BARDA or even the FDA, as
well as DoD, the Department of Defense that have been essential
in ensuring success of at least Moderna, and I suspect all of
the manufacturers.
Mrs. Rodgers. Thank you for that.
And I know it has been referred to as all-of-government,
but I also really think it has been all of society, really.
It's been everyone that's been a part of this response. And I
certainly appreciate your commitment.
Mr. Young, would you just speak to the lessons that you
believe your company has learned through the development of the
vaccine and accelerating future breakthroughs?
Mr. Young. Again, thank you for the question. I think one
of the things that enabled us to be able to move very quickly
is that we deployed significant amounts of Pfizer's financial
and human capital at risk before we knew whether we were going
to be successful. That enabled us to do really, in parallel, a
whole number of things that normally in drug development you
would do sequentially. And it was only by, you know, having a
completely different paradigm to how we develop our vaccine
that we were able to move so quickly.
And the second thing that I would say is that we really
applaud the nature of the interaction that we were able to have
with the FDA and the CDC and other government agencies. Much
more real-time sharing of information data, much quicker
responses and guidance from the FDA as to how to conduct our
clinical studies. All those things together are what helped us
all to be able move as quickly as we did to achieve a safe and
effective vaccine approved by the FDA at the end of last year.
Mrs. Rodgers. Thank you for that.
Mr. Nettles, I think we're all learning how development and
manufacturing of vaccines is incredibly complex. And I just
wanted you to speak to any steps that your company has taken to
enhance domestic manufacturing capability and how you addressed
any supply chain issues that might have slowed down production.
Dr. Nettles. Absolutely. So, really, over this past year,
with a high level of focus in parallel with the development of
our clinical program, we've been looking at ways to accelerate
the production of this vaccine. We have assessed nearly 100
sites where this vaccine can be either produced or filled or
finished, and selected those that have the capabilities to do
it on an accelerated timeline.
So what we have learned is taking this broad approach and
then partnering to bring on the necessary partners to deliver
this vaccine on time.
Mrs. Rodgers. Well, I just want to say thanks to all of
you. It's really extraordinary, and let's just keep the focus
on getting these vaccines in people's arms as quickly as
possible.
And I will yield back the balance of my time. Thank you.
Ms. DeGette. I thank the gentlelady.
The Chair now recognizes Ms. Kuster for 5 minutes.
We can't hear you, Annie. Looks like your headphones are
on.
Ms. Kuster. Can you hear me now?
Ms. DeGette. Yes. We can hear you now.
Ms. Kuster. I'm sorry. My apologies.
I want to address my remarks to the new variants of the
COVID-19 virus that are already circulating in the United
States, including right here in New Hampshire, where we have
identified a highly contagious variant first identified in the
U.K. The CDC projects that the U.K. variant may be the dominant
strain here by March, and the South African variant has been
found in at least 10 States. And, according to Dr. Fauci, the
data on these variants are, quote, ``a wake-up call.''
To Mr. Trizzino: We understand your company, Novavax, has
already developed vaccines against the emerging strains and,
according to your written testimony, plans to begin clinical
testing of the new candidates from the first half of the year.
Could you explain what that means for Novavax's production
plans? And how quickly could the vaccine against the new
strains be moved into production?
Mr. Trizzino. Thank you for the question. Yes, indeed, we
have observed some interesting phenomenon in our clinical
trials in the South Africa and U.K. trials about the
significant circulation of the new variant, where 94 percent of
the cases in that study were of the new variant. That caused us
to pay attention to what that new strain development needs to
be. And as you said, we've already begun our development work
to identify that new strain, put it into discovery
manufacturing so that we can develop either a pathway that
would lead us to a booster vaccination of the new strain or,
potentially, a bivalent vaccine, which would be both strains in
a single vaccination.
Scale-up has not begun yet in large scale, but we do have a
global capacity, both with our--an existing Novavax facility,
facilities in the U.S., our partners in India and Serum
Institute. And we believe that we could scale up that new
strain very quickly and add it to our vaccine.
We are at a low dose because of our matrix adjuvant. And
so, therefore, adding a new strain to our vaccine is something
that we have experience with and are capable of doing very
quickly. Thank you.
Ms. Kuster. Thank you.
Dr. Hoge from Moderna, I understand that alternating an
mRNA vaccine may be easier than it is for vaccines using other
platforms. You've described the process as ``copy and paste.''
What does that process entail? And what is the approximate
timeline to get from identifying a problematic variant,
altering the vaccine, and getting it into production?
Dr. Hoge. Thank you for the question. Yes, I have described
it as copy and paste, because messenger RNA really is just an
information molecule. It sends instructions to your body and
your cells, and in this case with any instructions to make a
spike protein. And it would be a relatively quick and small
change to modify that and put in the information for the new
variants of the spike protein that are seen on these variants.
We've done that--actually, we announced several weeks ago that
we had already started that, that transition and manufacturing
and process. The actual copy-and-pasting part goes real fast.
But we are in the process of scaling up manufacturing for
clinical trial right now to test whether or not a variant
vaccine booster is useful.
And, in that sense, we're already in discussions with the
FDA. We are going to be following their recent guidance about
the best way to test and evaluate that, and moving forward. So
hopefully, quite quickly.
Ms. Kuster. Great. Thank you very much.
And Dr. Nettles of Johnson & Johnson, I just have 30
seconds left, but, depending upon how the virus mutates, people
may be getting vaccines every year for the next several years.
If this is the case, how do we avoid going back to square one
in terms of building up production?
Dr. Nettles. Thank you for the question. So at J&J we have
undergone over the last 6 months, really, a rapid and a broad
scale-up of our ability to produce these vaccines. We really
started from scratch against the disease we didn't even know
existed more than a year ago. So I think we're definitely not
going to be in a position where we're starting from square one
in the future.
Ms. Kuster. Great.
I have another minute. I'm sorry. Thank you very much for
that.
So, Mr. Young from Pfizer, how is Pfizer approaching
production of boosters? And will that production have any
effect on your current schedule of 300 million doses by July
31st?
Mr. Young. Thank you for the question. So, first of all,
no, we believe that we are still on track to be able to deliver
300 million doses to the United States Government before the
end of July. And that's something we're focused on and believe
we will be able to deliver to you.
As I mentioned in my testimony, we are going to be--or hope
to initiate a study looking at the benefit of a booster in
patients that have already received two doses of the vaccine,
because we believe that there is some emerging evidence where
having higher antibodies may well be protected even against
newer variant strains. As I also mentioned in my testimony, we
are also in discussions with the FDA to potentially developing
an upgraded vaccine against a new variant of concern, should it
arise. So thank you for the question.
Ms. Kuster. Great. Thank you very much. And I will yield
back just asking my colleagues to take a look at my bill,
Coronavirus Vaccine and Therapeutic Development Act, to support
both the development and then manufacturing of vaccines and to
keep up with these emerging variants.
Thank you, Madam Chair.
Ms. DeGette. Thank you so much. I am now pleased to
recognize Mr. Burgess for 5 minutes.
Mr. Burgess. Thank you. And I want to also congratulate our
witnesses on the outstanding work that they've done over this
past year. And, I think, one of the truly remarkable things is
you've developed vaccines that are different technologies, some
based on the mRNA, some based on an actual breaking off a piece
of the antigen and making the vaccine from that technology. But
it is truly remarkable that, with the different technologies
available, we are now sitting here with five companies that may
all have a component of the answer to the coronavirus.
Let me start with our two that have received emergency-use
authorization and currently are in the process of vaccinations
of American citizens.
So, Dr. Hoge and Mr. Young, there has been a lot of
discussion over the past week and, certainly, the last weekend,
about the use of real-world evidence and how that may impact
things going forward. So my understanding at the current time,
the FDA cannot rely on real-world evidence, but do you have any
thoughts--again, this is for Dr. Hoge and Mr. Young, who have
vaccines in production in the United States--is real-world
evidence of value for you?
Mr. Young. Maybe I can start. John Young from Pfizer. Yes,
we believe that the FDA's approach to, you know, answer the
first basic question around the safety and effectiveness and
randomized clinical-controlled trials is, you know, very
appropriate. But we do believe there is an enormous value for
regulators but also public health officials to really
understand the safety and also the effectiveness, you know, of
a vaccine in real-world clinical practice in much larger
populations than can be possible in a randomized clinical-
control trial.
We have 46,000 patients in our clinical study, but we
already have data from millions of patients from around the
world who have been vaccinated. And that data, we believe, can
be enormously helpful and informative to public health
officials.
Dr. Hoge. Sir, I would completely agree with Mr. Young's
comments. And I would add to it that, as a part our ongoing
commitment, even in the development of the drug, the vaccine,
we are actually conducting very large real-world evidence
studies, and we will be sharing that data with the FDA and
obviously with the public as well, hoping to confirm what we
are already really seeing emerge in terms of the deployment of
the vaccine, which is that the large, well-powered phase 3
trials were predictive of the type of response that we are
seeing. But that's an important part of developing data and
driving confidence in the vaccines out.
Mr. Burgess. Well, of course, the whole issue of being able
to interrupt asymptomatic spread--I think, Mr. Young, you
addressed that earlier, but that is incredibly important and
something that people are anxious for answers on.
Let me--Dr. Hoge, I'll stick with you and Mr. Trizzino, on
the issue of patent--there has been some discussion of, can
patents be relaxed to allow for other companies around the
world to produce your product? And I believe the Biden
administration is revisiting this position with the World Trade
Organization to waive patents and other intellectual property.
How is that going to impact how you respond going forward? Mr.
Trizzino, we'll start with you.
Mr. Trizzino. Yes. Thank you for the question.You know,
there's a significant amount of know-how and expertise that it
takes in order to make these vaccines, in particular, the
Novavax vaccine. So we are very, you know, open to tech
transferring to partners where we would be sharing that know-
how. We've done that already with CRM Institute, for example,
for the manufacturing of significant quantities up to a billion
doses on an annual basis for low- and middle-income countries.
And we've done with partners, contract manufacturing
organization partners, around the globe. But we feel it's
critically important for us to make sure that we manage that
process. The process used to manufacture it is very
complicated, and I think it's important for us to maintain
control over the quality of the product.
Dr. Hoge. I would echo many of the same ideas and just add
that we have also partnered with one of the largest
manufacturers of drugs in the world, Lonza, and we have tech
transferred to them to scale up that manufacturing.
As I said in my opening remarks, I think the biggest gain
we've seen as we've now moved to almost 9, 10 million doses a
week has been, really, the incredible advances of the highly
skilled personnel who are operating each step of that process,
both ourselves and externally at our manufacturing partners.
And, as they develop familiarity with that process, they've
gotten better and better at it. And I think we're focused,
really, intentionally, on making sure that they are successful,
because if that group of people are successful in delivering
more of the vaccine, then we're going to be able to satisfy the
need.
Mr. Burgess. Can I just say, of course, Moderna and the
Pfizer vaccine are the ones that are generally available. Texas
Motor Speedway in Denton County has done a great job of getting
shots in arms, as people say. The one thing that would help
them is if they could have visibility as to the number of
vaccines that are going to be available next week and the
following week, for planning purposes, to be able to begin to
get the people in the parking lot so that they can receive
their vaccines. If there's any way we can increase the
visibility to the end user, that would be most helpful.
Thank you, Madam Chair.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes Congresswoman Rice for 5 minutes.
Miss Rice. Thank you, Madam Chairwoman.
In New York and nationally, we are--obviously, still have a
lot of work to do to improve vaccine confidence. But I think
that an important step towards achieving that goal should be to
help the public understand just how effective these vaccines
are.
So, Mr. Trizzino, although the results from Novavax's U.S.
trials are still pending, you talked about results from a U.K.
trial indicating your vaccine candidates' efficacy at 89
percent, and how encouraging it was to see that none of the
trial participants who received your vaccine candidate
experienced severe illness or death. When we--so, Mr. Trizzino,
when we talk about vaccine efficacy, would you agree it is
important for people to understand not just a vaccine's top-
line efficacy results, but, also, how well it prevents severe
illness and death?
Mr. Trizzino. Yes. Thank you for the question. And it's
very important. And first and foremost, anybody, any
manufacturer that is involved in the vaccine industry, first,
is concerned with safety and then efficacy, right? That's kind
of a hallmark of a vaccine. You want to do no harm if they are
to prevent a disease and not create any additional problem.
So safety is a critical element of everything that we do.
And at this point, we have over 50,000 subjects involved in all
of our clinical trials from phase 1, 2, to 2b in South Africa,
the 15,000 subjects in the U.K., and another 30,000 in the U.S.
And that provides a very robust database of safety information
that we will report and that will provide significant
confidence to everybody that we have a safe and effective
vaccine.
Miss Rice. Thank you.
Dr. Hoge, earlier this year, Moderna's CEO stated that its
vaccine will offer protection I believe he said, quote,
``potentially for a couple of years.'' Is Moderna still
confident in this assessment? And when will we know for certain
how long your vaccine, and I guess to anyone else, how long the
vaccine will offer protection?
Dr. Hoge. That's a great question, and one that we ask
ourselves regularly. At this point, I think we're still
optimistic, given the high efficacy that we saw in the initial
phase 3, in our case, 94 percent, that there is going to be
long durability, because we saw, really, high levels of
antibodies in the earlier studies and really good efficacy in
that base to be studied. But, unfortunately, the only real way
we will know about the duration of that protection is over
time. And that's why we're trying to stay very vigilant and
looking both at whether additional boosters of the existing
vaccine will be useful, or boosters with new variants and
blends.
Miss Rice. Dr. Dobber, if I can just go back to, I think my
colleague the chairman of the full committee, Mr. Pallone,
asked about how to prevent symptomatic infections. I mean, your
testimony highlighted a primary analysis of your vaccine
candidate, which suggested that it might reduce transmission of
the virus, in addition to preventing symptomatic infections.
Should we be optimistic that your vaccine candidate and other
vaccines using similar platforms will reduce transmission? You
know, I just keep thinking about people, I think it is really
important that we engage in educational vaccine education for
the general public to give them a level of confidence to take
it. But then you worry about, well, overconfidence in not
wearing masks and socially distancing until we have much more
better data to suggest that there is more permanent protection.
Dr. Dobber. Yes. So once again, it is an excellent
question, and in one of our studies in the U.K. we did a short
study, so that means that after vaccination you take a swab
every 2 weeks in order to detect whether there is still virus
in the nose. And, although the data is preliminary data,
initial data, it was very promising to see there was a
reduction of 67 percent in that specific study. But I
completely agree with you. I think all companies, including
AstraZeneca, need to do even more in managing that [inaudible]
because it is one of the crucial questions they need to
address, but after vaccination, if it protects us but also not
able anymore in order to transmit the disease.
Miss Rice. Exactly, sir. For instance, in New York now, we
have 136 cases, a combination of the U.K. and the South African
variant. But Mr. Young, if I could just go to you, this is
not--I mean, there's vaccine development, but then there is how
do we effectively distribute it? And, Mr. Young, you and I had
a conversation the other day just talking about how do you
know--where do you distribute it to, and your communications
with the individual States who come up with the distribution
plan. But I think it is really important for us to remember
that it is great to have all this vaccine development, but if
we're not distributing it and getting shots in arms
effectively, we're not doing our best.
So, Mr. Young, if you could just talk about--you have about
30 seconds to just talk about your conversations with New York
and how you work with them.
Mr. Young. Thank you for the question. So we couldn't agree
more with your premise that what's most important is that
vaccines get to patients who can be protected. What we do is to
provide, each week, a forward-looking, 8-week forecast of the
vaccine doses that will be available. The Federal Government
then liaises with States, States then order or tell the Federal
Government what doses they want, and we then fulfill those
orders. So that's the process.
But we also work very collaboratively with States in order
to ensure that they have accurate information as well.
Miss Rice. Thank you, Mr. Young. Thank you to all the
witnesses.
And I yield back, Madam Chair. Thank you.
Ms. DeGette. The Chair now recognizes Mr. McKinley for 5
minutes.
We can't hear you. We can't hear you. You need to unmute.
Mr. McKinley. I unmuted, and it muted me again.
Anyway, let me start again with this. Thank you, Madam
Chairwoman. And let me just kind of remind people about this.
The Trump administration was listening during last spring, as
this thing was unfolding. So, despite all this unrelenting
criticism that's unfounded, the Trump administration actually
ordered a billion vaccines from the five companies that are
represented here today. A billion. That's enough to vaccinate
every American and then some across America.
Chairman DeGette brought up a good point, but she said very
clearly in her opening remarks, but the rollout has been slow.
So my question--we've heard from Dr. Nettles. I'm curious, from
Dr. Hoge, can you explain or maybe give me some insight from
your perspective, does the international supply chain impact
the base and manufacturing of the vaccine from your
perspective, Dr. Hoge?
Dr. Hoge. No, sir, it doesn't. We have a completely
separate supply chain that we established in the United States
in partnership with the Federal Government, and they are
completely separate. And all of the units supplied is
delivering for the U.S. Government.
Mr. McKinley. OK. Thank you.
Let me switch gears here substantially. Last year, during
2020, we had about 400,000 people die from COVID across the
country. But, at the same time, we had over 80,000 people die
from substance abuse. Now, that's a horrible number to think
about: 480,000 people dying unnecessarily. And the ratio is 5:1
between deaths of drug overdose and COVID. But the American
Government has made an absolute commitment--and I'm proud of
it--but they are spending 750 times the amount of money to deal
with COVID as they are on substance abuse, even though the
ratio is only 5:1, or is 5:1. It is 750. And we also know,
according to Johns Hopkins, it just came out with their study
that said the 7-day rolling average for daily deaths has
actually been decreasing in America during this period of time.
But, at the same time, drug overdoses have not been. They are
continuing to rise. Vivitrol has been a proven treatment. We
know about that. Numbers of--you know, that's a competing
product, but the supply and demand has made it difficult to
get.
So, thank you for stepping up when we needed you for COVID
in developing a vaccine. But I want to know whether any of you
are equally committed to solving this substance abuse problem,
getting us a treatment, the equivalent of a Vivitrol, that we
might be able to deal with it. Because, as I said, COVID is
going to go away, but not the drug abuse. So any of you want to
chip in and say your companies are doing something on that?
Mr. Young. John Young from Pfizer. Let me thank you for the
question. One of the things I would say is that we manufacture
Naloxone injectable, Naloxone, which is an antidote to certain
opioids that can cause death and other serious effects. We've
worked closely with the Federal Government to make sure that we
continue to supply that to States in emergency----
Mr. McKinley. OK. I'm aware of that. If I could reclaim my
time. I am aware that several of you are doing something. But
I'm trying to stop it from the beginning, not treat it
afterward, after the fact.
So let me flip back to the COVID issue. You all--at the
beginning, when Chairman Pallone just opened up the testimony
by trashing President Trump, former President Trump. And the
Biden administration has been calling for unity, but the
rhetoric has not been matched to words. The President has
actually said there has been no distribution plan. And the Vice
President said that the cupboard was bare when they took over,
they were starting from scratch.
Well, quite frankly, the cupboards should be bare. It is
not meant to be on shelves in Washington but in people's arms.
So, if there is no distribution plan that they are alleging,
how did over 60 million doses get out to the public? And, for
us in West Virginia, we're now at a rate--we're nearly 20
percent of the population in West Virginia has gotten at least
one shot, and 10 percent has been fully vaccinated. So I don't
know how this happens without a plan.
So, Dr. Nettles, I'm going to put you on the spot here. Do
you agree with President Biden that there was no plan and with
the Vice President that the cupboards were bare?
Dr. Nettles. What I can say is that J&J very much
appreciates the collaboration we've had and we continue to have
with the Federal Government. It has certainly been an important
contributor to allow us to move forward at the pace we have to
potentially bring forward a vaccine that's under consideration
for emergency use this week.
Ms. DeGette. I thank the gentleman.
Mr. McKinley. I yield back my time.
Ms. DeGette. The Chair now recognizes Ms. Schakowsky for 5
minutes.
Ms. Schakowsky. It has been said today that we are all in
this together. And when we say ``all,'' it reflects an
understanding that this is a worldwide pandemic, and that
crushing the virus therefore requires the access to vaccines,
and that must extend to countries across the globe.
So I want to ask you each, in a yes-or-no answer, that's
it: Do you agree that the presence of the virus anywhere is a
threat to humanity everywhere, including in the United States?
So let me ask you, Mr. Young, yes or no?
Mr. Young. We believe the presence of the virus is
certainly a threat anywhere around the world.
Ms. Schakowsky. Thank you.
And Dr. Hoge, yes or no?
Dr. Hoge. Yes, the presence of the virus is a threat.
Ms. Schakowsky. And Dr. Nettles?
Dr. Nettles. Yes, I agree, the presence of the virus
anywhere in the world is a threat to us.
Ms. Schakowsky. And Dr. Dobber?
Dr. Dobber. A firm yes, correct.
Ms. Schakowsky. Thank you.
As you I'm sure know, that over 100 countries--and it was
mentioned by Dr. Burgess--led by India and South Africa, have
appealed to the World Health Organization to put a halt on
TRIPS, the Trade-Related Intellectual Property Standard. In
other words, to have a waiver that would allow countries around
the world, poor and middle-income countries, to be able to
manufacture their own vaccines. And it seems to me that this is
something that we should do so that we have plenty for us and
plenty for the rest of the world.
You know, taxpayers have invested in this issue billions of
dollars right now to be able to open our country, and to doing
that, we have said that intellectual--that we want to make sure
that the airlines are supported, that all the industries that
rely on travel should be supported. But if we spend all that
money and yet we don't have other nations that are protected
against the virus, it is all in vain. Those billions of dollars
are in vain.
And so I am very anxious because there is a meeting
Monday--Monday and Tuesday--on the question of whether or not
this waiver to the TRIPS program is going to be allowed. And I
want to ask again, each of you, if you can support doing that.
Mr. Young?
Mr. Young. Sorry. We don't support that waiver. We believe
it incorrectly portrays intellectual property as being the
barrier to update. That we have [inaudible] with other
companies here, we consider all viable options and mechanisms
to ensure that any potential treatment or vaccine is available
to address the----
Ms. Schakowsky. Dr. Hoge?
Mr. Young [continuing]. Acceptable to those who need it.
Ms. Schakowsky. Dr. Hoge, yes or no?
Dr. Hoge. We'd agree that we want to find a way to get
vaccines to everybody who needs it everywhere. I'm actually not
familiar with the issue personally. I don't think we have a
perspective as a company.
Ms. Schakowsky. Dr. Nettles?
Dr. Nettles. We don't believe that intellectual property is
the limitation to a global supply. We have scaled up our global
supply chain and made significant contributions and commitments
to WHO.
Ms. Schakowsky. Dr. Dobber?
Dr. Dobber. We are willing to give sublicenses to other
parties as we have done already multiple times in order to
safeguard the quality of our vaccine. I think that's much more
important than what you are suggesting.
Ms. Schakowsky. And Mr.--Mr. Trizzicki?
Mr. Trizzino. Trizzino. Yes. Thank you, Congresswoman. We
do not support, but we have tech transferred and licensed our
technology to other countries.
Ms. Schakowsky. Well, let me just say this in ending, I
understand that it was recorded that in South Africa, that the
cost of the AstraZeneca was more than twice the amount for the
Europeans. So I'm concerned that, without the waiver, that what
we're going to see is that the rich countries in the world, who
are the only ones really who are opposing this waiver, are
going to monopolize the vaccine. I have no problem making sure
that we have enough here. But the fact that we would keep these
middle- and low-income countries, particularly the poor
countries, from having those drugs, I think, is immoral, quite
frankly, and not the productive way to go forward.
And I yield back.
Ms. DeGette. The gentlelady yields back.
The Chair now recognizes Mr. Long for 5 minutes.
Mr. Long. Thank you, Madam Chair. And thank you all for
being here today.
The week before last, I went on a 3-day tour through my
district. I toured six hospitals, two clinics, and one
vaccination center. And I would highly recommended that to all
of my colleagues, if they want to do something similar in their
district, if they haven't already. But I called the hospitals
and clinics and said, ``I want to sit down with your frontline
workers, your nurses, your doctors.'' And they not only poured
out their hearts, some poured out their life stories to me, and
everything they have been doing throughout the last year is
just incredible, whether they are doing rounds at night when
they are asleep, or giving shots while they are asleep at home,
or having to steal off time from their family to go in another
room to call another family member and explain to them that
their other family member that they were caring for for months
haven't seen their family, has deceased.
So it was quite a moving 3 days, and I'm glad I invested
the time in that.
Mr. Young, while I visited the hospitals in my district to
hear from them about their efforts to get people vaccinated,
one of the problems they mentioned after they distributed the
Pfizer vaccine was that they didn't have low dead space
syringes. And this impacted the number of vaccine shots per
vial they were able to administer, as I'm sure you're aware.
The vaccine made by Pfizer is shipped in the vials initially
indicated the whole five doses. Six doses can be drawn with low
dead syringes, which minimizes the amount of vaccine wasted in
the syringe after it's used.
These specialized syringes are in limited supply. In fact,
they were out of them when I visited. The United States
Government has been giving all--or giving healthcare providers
new syringe kits to extract six shots of each vial.
Can you walk me to the change from five to six doses per
vial? Is Pfizer confident that the supply of low dead space
syringes needed to fulfill the obligations of its agreement
with the United States Government?
Mr. Young. Thank you for the question. In order to make
sure that we could, recognizing the vaccine doses were short,
we did everything that we could to make sure that we could
maximize the supply of vaccine doses. And one of the things
that we did was validate more than 30 individual low dead
volume syringe-and-needle combinations to enable a sixth dose
to be reliably extracted from each vial. We provided that
information to the FDA, and also supplied that information to
the Federal Government.
So the Federal Government supplies the kits by McKesson,
which includes needles, syringes, and wipes, to the States and
all vaccination centers. And we work very closely in
collaboration with the Federal Government in order to make sure
that they were able to reliably procure those low dead volume
syringes from the manufacturers concerned.
Mr. Long. OK, thank you.
And I'll stick with Mr. Young here for a minute. Many of
you all's companies--in fact, I'll try to get to everybody, but
I may run out of time. But many of your all's companies have
undertaken efforts to expand manufacturing capacity for COVID-
19 vaccines. Pfizer, notably, expanded its manufacturing in my
home State of Missouri. Can you share what your company has
done to expand the manufacturing capacity of last year?
Mr. Young. Thank you for your question. I think probably in
common with all the other manufacturers on this panel, we have
made significant investments in new lines in St. Louis,
Missouri, it plays an incredibly important role in
manufacturing the mRNA--I'm sorry, the DNA templates that are
used to, in turn, manufacture the mRNA. That takes place in St.
Louis. We've invested in significant engineering work to build
complex machines that actually enable formulation of lipid
nanoparticles, and have scaled up supply of, you know, really
specialized raw materials, including lipids. So we made
significant investments into our U.S. supply chain.
Mr. Long. And how long does it take for additional
manufacturing capacity to be built out, whether it's a new line
or an entirely new facility?
Mr. Young. That work that we really started in the middle
of last year, we didn't wait for approval to begin that work
and began investing substantial capital, with financial and
human capital at risk, even before we knew we had a vaccine.
And that work has continued and is one of the things that has
helped to feed an increase in our projected 2021 production to
more than 2 billion doses this year.
Mr. Long. And I am going to, again, thank you all for being
here today. I'm going to submit that question to the other
folks that I don't have time to be fair to today. And I'm going
to yield back 14 seconds.
Ms. DeGette. I thank the gentleman for yielding back.
And the Chair now recognizes Mr. Tonko for 5 minutes.
Mr. Tonko. Thank you, Madam Chair, for arranging this
hearing. I think it is very important and very timely. And we
thank our witnesses for joining us today.
Throughout my home district in New York's capital region,
both vaccine supply and access are still major issues. I've
spoken with local families whose loved ones are in their 90s,
and they can't get a vaccine. Just how can this be?
So last week I sent a letter to the leaders of Pfizer and
Moderna, specifically, Dr. Bourla and Mr. Bancel, asking how
Congress can help remove limitations on production and
distribution so we can vastly increase access to vaccines.
Madam Chair, I ask that these two letters be entered for
the record.
Ms. DeGette. We will review the letters and determine at
the end of the hearing.
Mr. Tonko. Thank you, thank you.
We understand better than ever that vaccine production is
incredibly complex, with bottlenecks possible up and down the
line, from raw materials and supplies to storage and
distribution, even just having enough highly trained people
working in lockstep coordination across the entire process.
While complex systems can be difficult to manage, they also
present opportunities for efficiency and ingenuity.
I'd like to hear from you on how we can do better. What
solutions--what limitations, rather, are you running into? What
solutions are you looking into for increasing production and
expanding your manufacturing capacity?
So Mr. Young, millions of Americans are anxiously awaiting
their vaccine, and Pfizer is working around the clock to meet
its obligations to provide doses to the United States. Is
Pfizer currently producing at full capacity? And what would it
take to produce even more quickly?
Mr. Young. Thank you for the question. I just want to
underscore what I mentioned in my testimony that we are very
clear that the United States and every other country needs more
doses more quickly, and we are working to achieve that end. So,
as I mentioned in my testimony, by the end of March we should
be pretty much at maximum capacity in our U.S. supply chain and
able to deliver 13 million doses a week, which is a significant
increase from the around about 5 million doses a week even at
the beginning of this month.
So we are in the process right now of seeing the benefits
of the various stages of process improvement that I mentioned
in my testimony and seeing that flow through to delivery to
providers all around this country.
Mr. Tonko. Thank you.
And Dr. Hoge, Moderna is seeking approval from FDA to
increase the number of doses per vial from 10 to up to 15.
While that's encouraging news, you estimated it could take 2 to
3 months to make these adjustments. What would be the impact of
increasing the number of doses in each vial?
Dr. Hoge. Thank you for the question, sir. If we can
increase dosing, we can actually decrease the amount of time it
takes to create a batch and actually decrease the demand for
some of these critical, high-demand raw materials, and
particularly vials. We think that would accelerate delivery
substantially, probably not 15:10 as a ratio, but we need to
demonstrate an improvement in delivery or time.
Where we are right now is, last month--or actually, just
last week, as I said in my oral remarks--we delivered over 9
million doses to the United States Government.
And, so, we think we're in a very good spot at about 9 to
10 million doses a week. We now need to demonstrate reliability
in that production. But, obviously, any gains, for instance,
like filling more doses in a vial, we will take, because I
agree with Mr. Young's comment, we need to get more doses more
quickly into people's arms.
Mr. Tonko. So more doses per vial, what can be done to--is
there anything that could be done do speed it up?
Dr. Hoge. At this point, the obligation is on us to develop
the data that the FDA would support for us to go forward with
that approach. We're in the process of doing that right now.
And we are working 24/7, I assure you. We hope to pull in those
timelines as best we can. But we want to make sure that we're a
reliable partner to the United Sates Government, so we don't
want to overcommit.
Mr. Tonko. And Dr. Hoge, sticking with you for just a
minute. In January, Moderna's CEO stated that if there is, and
I quote, ``one raw material missing, we cannot start making
products, and that capacity will be lost forever because we
cannot make it up.'' Is this an area where Congress or the
Federal Government could be providing more support?
Dr. Hoge. Well, I would say, sir, that the Federal
Government is already providing tremendous support exactly on
this point. And so, we have been partnered with the folks at
the Department of Defense and HHS on all aspects of our supply
chain, really, for almost a year now. And that means that they
have visibility down to the single raw material level and those
deliveries--and have been working with us to make sure that
they are delivered. So I hope you take confidence in the fact
that that actually is a daily exchange between us and the
Government.
Mr. Tonko. Is there anything else related to raw materials
or otherwise that we could be doing right now to help you boost
your vaccine output?
Dr. Hoge. If there are, we haven't identified it yet, sir.
But we are working every day to identify new opportunities.
Mr. Tonko. Thank you so much.
Madam Chair, I yield back.
Ms. DeGette. The gentleman yields back. Mr. Dunn, do we
have you?
Mr. Dunn. Yes. Can you hear me?
Ms. DeGette. I see you. You're recognized for 5 minutes.
Mr. Dunn. Thank you very much, Chairwoman DeGette.
I had the opportunity to read the testimonies of each of
the witnesses. And I feel compelled to say that all of these
companies represented here today have accomplished amazing
things in the last year. And I want to commend you all and your
staffs for the work that you did in rising to the challenge of
expediting your research and development of COVID-19 vaccines
to serve the entire world, and doing so in a miraculously short
amount of time.
I would like to be able to tell you today to lay down your
burdens and take a victory lap. But, unfortunately, we still
face production and distribution hurdles. And, of course, we
are dealing with a virus that by its very nature tends to
mutate rapidly. It is entirely conceivable that some of these
mutations could enable the virus to begin to invade even your
brilliantly engineered vaccines. So, as the vaccine supply
ramps up to allow for mass vaccination, we as Congress and
industry leaders still need to plan and prepare distribution
challenges, such as the extreme weather we saw just last week
in the southern States.
Not only should supply of distribution chains be resilient
and redundant, but they must also accommodate the surge of more
vaccines coming online over the next few months. So, from the
manufacturing lines to vaccination sites, there must be
adequate personnel and infrastructure to support the
vaccination activities.
I also want to be sure that we're considering and planning
how to combat potentially resistant variants of SARS-CoV-2 and,
for that matter, the next totally new pandemic disease,
whatever that may be. We already know that some of the more
contagious variants have been identified in the United States.
Fortunately, according to the CDC, early data suggests that
for now the existing vaccines are effective against these
variants, but we will be doing ongoing collection of data and
sequencing.
I'd like to hear from our witnesses on this topic. And let
me address, if I may, this question to Mr. Young and Dr. Hoge.
If changes are made from the original vaccine formula in order
to address resistant variant strains, the FDA released just
yesterday some guidelines for applying for a modified EUA. I
wonder if you've had a chance to review these guidelines and
digest them. I read them, and I was concerned that another
major clinical phase 3 study may be required. Do you have any
insight on that and what kind of delay that might entail?
Mr. Young. Thank you for the question. I think we, like
you, only recently received the FDA guidelines. We are still in
the process of reviewing them. But, in terms of the approach,
you know, I think all of the companies that received an EUA,
which is the authorization by the FDA, have been able to
demonstrate that our vaccines are safe and effective in large,
randomized, clinical-controlled trials.
Certainly, we believe that a more of a seasonal flu-like
process, where a new variant might be able to demonstrate
safety and immunogenicity in a smaller number of patients,
might be a much quicker way to expedite a new variant vaccine
to patients in this country.
Mr. Dunn. Dr. Hoge?
Dr. Hoge. Yes. We also received that just recently, as we
all did yesterday. We have been in productive conversations
with the FDA. Ultimately, they have responsibility to set the
bar and make the recommendation whether a vaccine is effective
and safe against those new variants. But we are hopeful that we
will be able to do it without large, randomized phase 3 trials.
And, in fact, that process can proceed over the course of
months rather than a long year, as it has in the past.
Mr. Dunn. So I join you in that hope. I think that would be
imperative.
Another question I know I'm not going to be able to have
time to get everybody to answer, but I am going to submit this.
I would like to have all of you consider it. And this is the
question: In addition to your heroic efforts in vaccine
development, are your companies also engaged in research and
development of therapeutics, that is to say, antivirals, that
could potentially have a broader spectrum of activity across
the coronavirus variants?
I already had an opportunity to talk to Pfizer about their
ongoing efforts. Very encouraging. I'd like to hear from the
other companies. And I see we only have 29 seconds left. I
don't believe that we can get a meaningful answer in that
period of time, so I'm going to ask you to take that question
and respond to my office about that. We are keenly interested
in therapeutics, the entire Doc Caucus is interested in
therapeutics, treatments in antivirals.
With that, Madam Chair, I yield back.
Ms. DeGette. Thank you so much, Mr. Dunn. And we will ask
all the witnesses to respond to that question as we do all
written questions.
Mr. Ruiz, you are recognized next for 5 minutes.
Mr. Ruiz. Thank you, Madam Chair.
The disproportionate impact of COVID-19 on communities of
color is undisputed. We've seen the horrible statistics of
Black and Hispanic Americans being at high risk of getting
infected. They are more likely to be hospitalized and die from
COVID than White Americans. And yet, at this point, they are
less likely to have been vaccinated against the disease.
In my county, here in Riverside County, Hispanics make up
47 percent of the population. They comprise 65 percent of
infections, but only 19 percent have received the vaccines.
We have talked a lot over the past several months about the
importance of the equitable distribution of vaccines. I have
used that platform many times to implore stakeholders,
including your companies, earlier this summer to make sure that
these underserved communities and communities of color have
access to the vaccine.
And I have continued to advocate for more vaccines to be
sent to the underserved and hardest-hit areas in my own
district and across the Nation. However, prioritizing
vaccinations for high-risk groups hardest hit by COVID-19 is
not effective if these communities are not able to access the
vaccine or don't have the information they need to navigate the
system.
Unfortunately, we are learning that many people don't have
the information that they should, or worse, have wrong and
inaccurate information. I have seen this firsthand when I have
teamed up with other providers and nonprofits to literally go
into the field and provide public health, vaccine education
campaigns to farm workers, and also packing--produce packing
workers.
And working within these communities and with providers and
community leaders is critical to the public health education
component of our vaccines. As manufacturers of the vaccine that
will help end this pandemic, it is critical to make sure the
public and providers have accurate information about the
vaccine through community public education.
Dr. Hoge, before the committee last July, you shared that
in an effort to enroll diverse participants in this clinical
trial Moderna partnered with different groups to, quote,
``leverage those trusted advisers within these communities.''
Now that Moderna's vaccine has been available for 2 months, I'm
curious if these partnerships continue. Who were they with? And
if you are using them or taking additional access to provide
communities of color the information they need to have
confidence in getting vaccines.
So can you tell us specifically what Moderna is doing and
what resources are being directed towards those efforts? And
can you tell us, specifically, how much money Moderna is
spending on those efforts?
Dr. Hoge. So first, I think I would echo your comments
about the devastating impact in communities of color and how
they have disproportionately borne the burden of this disease.
It is absolutely something we need to address, because none of
us are safe until all of us are safe. That's something we have
taken very serious as a company.
On the question of distribution first, we--our contract
with the United Sates Government has----
Mr. Ruiz. My focus right now is not necessarily
distribution. My question is very specific to your public
health educational outreach. And do you have partnerships, and
what are you doing to combat the misinformation and build
public confidence within the hardest-hit, highest-risk
communities of color?
Dr. Hoge. So we are active in on many fronts there. I will
say we are also a relatively small company, about 1,300 people,
and somewhat of a newcomer. And in that sense, we are still
building the capabilities to reach out to all the public health
communities you are describing. However, one area that we
focus----
Mr. Ruiz. Do you have a program and partnerships or grants
available to the community?
Dr. Hoge. We've been very active in doing that, in
particular during our clinical trial. So, as has been widely
reported during our phase 3 clinical trial, as you----
Mr. Ruiz. I'd like to talk to you further to get more of
the specifics on what you're actually doing to increase the
public health educational outreach.
I'd like to give Mr. Young the opportunity to answer that
question. What is Pfizer doing? What exactly, in partnerships
or funding, you are using or creating in order to combat
misinformation and improve public trust and confidence within
the hardest-hit minority communities?
Mr. Young. Thank you for the question.
We also couldn't agree more with the question that you're
asking, given how impacted minority communities in the United
States are.
First of all, we are doing a lot to work with minority
organizations that represent minority healthcare professionals
with Hispanic and Black nurses and doctors associations. We're
working very closely with grassroots community organizations
all around the country to be able to supply information in
other languages----
Mr. Ruiz. What amount of money are you spending on those
efforts? Do you know?
Mr. Young. I know we're spending a significant amount of
money to support education, but I couldn't tell you an exact
figure. I would be happy to follow up with your office if that
would be helpful.
Mr. Ruiz. I would like both Moderna and Pfizer to follow up
with my office on these questions.
Thank you very much.
Ms. DeGette. Thank you so much.
The Chair now recognizes Mr. Joyce for 5 minutes.
Mr. Joyce. Good afternoon.
First of all, thank you, Chairwoman DeGette and Ranking
Member Griffith, for holding this hearing. Thanks to all the
witnesses for participating today.
We all know it remains critical that we continue to build
on the two existing vaccines that have already been approved
for use and continued success of Operation Warp Speed. We
recognize the need for more vaccine supply across the United
States, and especially in Pennsylvania, where I hail from.
I remain hopeful that we will see more vaccines and receive
their EUA in short order to help with this problem. The advent
of additional strains could raise the amount of vaccine that is
needed to achieve the necessary herd immunity, but we must
remain ahead of this virus.
Americans everywhere are desperately seeking to return to
their normal lives. They look to reopen their businesses and,
most important, get their kids back into school. Safe,
effective, and readily available vaccines are necessary to
achieve this goal.
Ramping up production on this scale and in this
unprecedented timeframe has presented some challenges. So I'd
like to ask each of the witnesses to respond. Do you expect
shortages in raw materials or component supplies, such as
filters or specialized bags, that are needed to manufacture
your COVID-19 vaccine, especially if you're looking to produce
more vaccines and if other companies receive EUAs in the coming
months?
And I'll start with Dr. Dobber.
Dr. Dobber. Well, first of all, thank you so much for the
question. I think it's an incredibly important question. At
this moment I can confirm that we are not foreseeing any
shortage of raw materials as you have mentioned.
Mr. Joyce. Dr. Nettles, your response, please?
Dr. Nettles. I agree with the previous response. At this
time shortages as you describe are not a limitation to us
providing the vaccine.
Mr. Joyce. And Dr. Hoge?
Dr. Hoge. As I've said, at this point we think we have the
supplies and consumables we need to do it.
Mr. Joyce. Mr. Trizzino?
And, first of all, I certainly enjoyed the graphics. It
took me back to immunology in medical school to see you discuss
nanoparticles, but let me allow you to address raw materials
and component supplies. Do you feel that Novavax will face any
shortages?
Mr. Trizzino. We've been working very closely with the U.S.
Government to ensure a sufficient supply for our manufacturing
facility with Fuji Diosynth, so we don't expect any shortages
in the U.S.
Mr. Joyce. And Mr. Young from Pfizer?
Mr. Young. Thank you for the question. In common with my
other panelists, we don't anticipate currently any shortages of
raw materials or supplies that would prevent us being able to
deliver 300 million doses by the end of July.
Mr. Joyce. Thank you.
And I'd like to continue in the fashion that we've
outlined. So, specifically, each of you, have you seen issues
in obtaining vaccine supplies from foreign manufacturing
companies? And, if so, what type of products have you found
those challenges to lie within, and during what time of
production did these challenges occur?
And, again, I'd like to start with Dr. Dobber.
Dr. Dobber. So, in the United States, we have a very
specific supply chain for the U.S., and once again I reiterate
we haven't seen any shortages of essential materials in order
to produce our vaccine. And we are on track to deliver 50
million doses in the month of April.
Mr. Joyce. And thank you.
Dr. Nettles?
Ms. DeGette. Doctor, you need to unmute. You're muted.
Dr. Nettles. Sorry. No, we have not encountered any
shortages or issues with foreign supply of equipment that would
prohibit us from delivering on the 100 million doses that we've
committed to by the end of June.
Mr. Joyce. Thank you.
Dr. Hoge?
Dr. Hoge. No, we haven't identified any such issues.
Mr. Joyce. Mr. Trizzino?
Mr. Trizzino. All of our raw materials are sourced within
the U.S., so we don't have any shortages for our U.S.
manufacturing.
Mr. Joyce. And Mr. Young with Pfizer?
Mr. Young. We don't currently see any shortages that would
constrain our ability to meet our commitments.
Mr. Joyce. And, while I have you--and, specifically, this
is regarding Pfizer--can you please tell us if you feel that
you're able to provide us any updates regarding transportation
and storage temperatures for the vaccine that would make this
process easier, that would allow more shots to be put into
patients' arms?
Mr. Young. Thank you for the question.
Last week, we actually supplied an update to the FDA, which
was based on data--stability data for our vaccine, that found
that we would be able to reliably store it for up to 2 months
in conditions that are equivalent to a normal freezer. So we
were certainly very happy with that update, and we hope that
would enable the vaccine to be able to supply to more
communities around this country.
Mr. Joyce. Thank you. I see I'm over time, and I yield
back.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes Ms. Schrier for 5 minutes.
Ms. Schrier. Thank you so much, Madam Chair, and thank you
to our witnesses.
Let me first just express my gratitude to you, your
scientists, your investigators, who continue to work around the
clock. We are so grateful.
As a pediatrician, it may not surprise you that I'm going
to ask about vaccinations in children. Now, as typical, studies
in children and pregnant women always happen after studies in
the general public, for very good reasons. And children
themselves generally, at least with these variants, have very
mild or no symptoms, so the risk-benefit calculations are also
different.
And every day in practice I encounter vaccine-hesitant
parents, and I expect the same thing will happen here. And the
one thing that I think would change the parents' risk- benefit
calculation is whether the vaccines prevent transmission. In
other words, giving Johnny the vaccine means Johnny can visit
Grandma and won't bring the virus home from school to his
parents.
And some of my colleagues have touched on this issue of
transmissibility. Chairman Pallone asked about studies at
Pfizer. Representative Rice asked about studies at AstraZeneca.
And so I was just wondering, could our other witnesses comment
on this, maybe starting with Dr. Hoge?
Dr. Hoge. I'm sorry. Still on mute.
So we are actively studying the vaccine in 12-to-18
population and rolling out studies very quickly and moving into
younger populations in the near term.
Ms. Schrier. I'm sorry. Any studies of whether the
vaccine--whether Moderna prevents transmissibility?
Dr. Hoge. Oh, yes. We have seen some early data that we
presented to the FDA showing a decrease in patient nomadic
infections between the first and second dose. The data that
will hopefully support that evidence more broadly is evolving
and will be a part of our subsequent filings. We don't have any
data yet, but we are studying it actively.
Ms. Schrier. Thank you.
And, Dr. Nettles, did you have anything to add to that
issue of studying transmissibility and what your early findings
are?
Dr. Nettles. We are deep diving into our phase 3 clinical
trial results in Ensemble, as was just mentioned, to understand
what is the impact on asymptomatic disease from our vaccine. We
hope to bring forward that after discussions with the FDA.
Ms. Schrier. Great. Thank you.
And, Dr. Trizzino, did you want to add anything about
transmissibility and what you're finding?
Mr. Trizzino. Just that--thank you for the question--we are
expecting to start pediatric studies in the spring. We believe,
as you do, that it's important for us to get data--safety data,
and particularly about that population.
We are looking at our clinical trials now for
transmissibility and looking at future studies in that regard
but don't have any data to share today.
Ms. Schrier. Thank you.
I have another question. This is about pediatric studies,
because, Dr. Trizzino, you just mentioned looking at safety in
children. I was wondering, Mr. Young, can I ask you about how
studies in children are different? Like the studies in adults
look for endpoints of severe disease and death, but that's not
a reasonable endpoint to look at in children because that
doesn't happen, for the most part.
Can you talk about what you're using as endpoints, whether
that's antigen testing, you name it? How are you designing
those studies?
Mr. Young. Thank you for the question.
So, as I mentioned in my comments, we have an ongoing study
in children between the ages of 12 to 15 years, and we hope to
do another study in children under the age of 11 later on this
year. The endpoints in those studies are primarily safety. As
my colleagues have mentioned, we know that that is of primary
importance.
And then we're also going to look to demonstrate
immunogenicity. And, in the course of those studies, obviously
we'll look at reactogenicity, which is what I call the normal
effects that you would see when your body begins to produce an
immune response. We will be able to collect all of these data
and hope to submit those to the FDA later on this year.
Ms. Schrier. That's great. So that would imply
effectiveness, if you have evidence of immunity.
I have just a little bit of time left, and I thought I
would ask about pregnant women because, you know, of course the
studies are later, because you want to test it in the general
population first. And yet now this is really being left up to
pregnant women and their OB/GYNs to decide whether to recommend
it.
My discussions with ACOG suggests that most obstetricians
are recommending it because, although pregnant women are not at
high risk for contracting it, they are, I believe, 70 percent
more likely to die of COVID. And I was wondering if you would
talk about your studies in pregnant women and what you're
finding.
Sorry. I should go to Mr. Young.
Mr. Young. Thank you.
We actually initiated a study in pregnant women just last
week, so that study is obviously in the early stages by
recruiting patients. And, again, we want to make sure that that
study from an endpoint perspective can demonstrate safety for
the mom, safety for the baby, as well as obviously the
immunogenicity data that would enable that vaccine potentially
to be approved for use in pregnant women.
So that study is ongoing, and we'll move as quickly as we
possibly can.
Ms. Schrier. And anything real life out of Israel?
Mr. Young. That's a really good question, but we
potentially are going to be in a position where we may have
real-world data for women who became pregnant after being
vaccinated, and so that is an additional set of real-world data
that could potentially complement that formal randomized,
clinical-controlled trial.
Ms. Schrier. Thank you very much.
I'm over time. I yield back.
Ms. DeGette. Thank you so much.
The Chair now recognizes Mr. Palmer for 5 minutes.
Mr. Palmer. Thank you, Madam Chairman.
Mr. Young, when was the Emergency Use Authorization granted
for the Pfizer vaccine?
Mr. Young. The EUA was granted at the end of last year, in
December.
Mr. Palmer. December.
Mr. Young. Eleventh of December, I believe.
Mr. Palmer. How many doses have been administered to date
by Pfizer?
Mr. Young. Well, obviously Pfizer doesn't administer the
doses. That's something which is done by the States. But I
think, as I mentioned in my testimony, we're--to date, we've
supplied approximately 40 million doses, I believe, at this
point in the United States since that EUA was received last
year.
Mr. Palmer. Dr. Hoge, when was the Emergency Use
Authorization granted to Moderna?
Dr. Hoge. December 17th, sir.
Mr. Palmer. Since we've been doing the vaccinations, over
64 million have been administered. We'll probably go over 65
million by the end of today. So do you all--you guys have an
idea of when vaccinations--when we started giving the
vaccinations? Was it December 15th, the end of December, when
they were widely available to the public?
Mr. Young. We started shipping our vaccine the day after
the EUA was received so that vaccine sites were able to begin
vaccinations on the Monday. So we received that EUA over the--
later in one week, and by the Monday vaccination sites had
vaccine doses to be able to begin vaccination programs.
Mr. Palmer. Well, given the comments from my Democratic
colleagues that there was no infrastructure, how do you account
for the fact that we've given 65 million vaccinations in such a
short amount of time? That's roughly a million a day. There was
1.6 million on Inauguration Day.
How were we able to accomplish that?
Mr. Young. We, and I'm sure in common with the other
companies on this panel, have worked very closely with the
Federal Government. We've worked very closely with States in
order to make sure that we were clear and transparent about the
number of vaccine doses that were available so that they could
be allocated to the States and so that those vaccine doses
could get to patients who need them as quickly and reliably as
possible.
Mr. Palmer. In terms of infrastructure issues, Mr. Young,
with the Pfizer drug, it needs to be maintained in a cool
environment. Do you feel confident that we have the
infrastructure in place to make sure that that virus--is not
only available to the public, but it's available in its proper
form?
Mr. Young. Thank you. Yes. We have worked extremely hard to
develop a robust and reliable supply chain. Recognizing that
our vaccine currently needs to be stored at ultralow
temperatures, we designed specific thermal shippers to be able
to effectively and safely get those doses to site to be used.
Today, I think globally we've supplied more than 46,000 of
our shippers that contain our vaccine vials, and we have a 99.9
percent accuracy and reliability in delivering those vaccines
safely to the points of use and administration. That's
something we'll continue to be focused on.
Mr. Palmer. OK. And this is kind of off infrastructure
track, but do you have any confidence that these vaccines might
be effective against the mutations that we're seeing now, or do
you see this as something similar to the flu vaccine that
people will have to get administered year after year?
And make your answers as concise as possible. I've got a
couple other questions I want to ask.
Mr. Young. Thank you.
We are very focused on emerging mutations, variants of
concern. To date, we believe our vaccine appears to show
effectiveness, and that's something we'll continue to monitor.
We're certainly prepared to develop an upgraded vaccine should
that be suggested to be necessary by the real-world data that
we are seeing.
Dr. Hoge. And we also have confidence that the current
vaccine is active against the emerging variants, but we need to
remain vigilant, which is why we've started the development of
a booster against those variants.
Mr. Palmer. Very quickly, back in some respects to the
infrastructure issue. Given that we've really haven't had a flu
epidemic and we've been pretty effective in getting flu
vaccinations out to a broad population through drugstores and
big-box pharmacies and things like that, I see that as an
opportunity to get this out.
We also--to Dr. Ruiz' issue, all of us need to be involved
in doing what we can to educate minority populations about the
vaccination. And I was going to ask you, each one of you--
you've gotten the vaccination. But, because you're under oath,
I was going to ask you if it hurts.
So I will not ask that question, Madam Chairman. I yield
back.
Ms. DeGette. I thank the gentleman.
The Chair now is pleased to recognize Mrs. Trahan for 5
minutes.
Mrs. Trahan. Thank you, Madam Chair, and thank you to the
witnesses here today. We all appreciate the efforts of the
companies and the employees you work here representing to
develop lifesaving vaccines as quickly and safely as possible.
This week, the U.S. sadly surpassed 500,000 COVID-19
deaths. And, with the rising death toll and millions of
Americans anxious to get vaccinated, we must explore any and
all options to increase supply and get more doses into our
communities.
Last Congress, I introduced the Pandemic Production Act,
which will incentivize American manufacturers to maintain
domestic production capacity for medical equipment necessary to
respond to an infectious disease outbreak and safeguard our
supply chain. And I do invite all my colleagues here today to
support the PPA when I reintroduce it this Congress.
But one such tool that we can utilize now is the Defense
Production Act, which allows the President to prioritize
certain supplies for the vaccination effort. President Biden
recently announced that he would expend--expand--excuse me--the
use of the DPA, which is critical to our public health and our
national security. And it's important for us to hear from you
all your perspectives on the DPA.
Surely it's helped expand manufacturing capacity, but how
we can further expand the use of the DPA in our pandemic
response and future pandemic prevention?
Dr. Hoge, earlier in the hearing you mentioned that, in May
2020, Moderna and Lonza announced a collaboration to scale up
production in manufacturing up to 1 billion doses per year of
the mRNA vaccine you produce. What barriers prevent Moderna
from expanding manufacturing capacity with Lonza or other
contract manufacturing organizations? And, if barriers exist,
could a contract or a series of contracts authorized by the DPA
help expand production with Lonza or other manufacturers?
Dr. Hoge. Thank you for that question.
As I tried to describe in the opening statement, it's a
pretty complicated system, as you pointed out. We don't only
just need raw materials there. We need supplies. You need
installed infrastructure like we've done at Lonza and Catalent.
And then you need highly skilled laborers, people who actually
work every step of that process, and they get better over time.
In fact, that's one of the great gains in terms of production
you get, is, as people get familiar with the process and
experience, they get more productive.
So our challenge is that, anytime we want to bring more
capacity online, we have to line all of those things in that
system up, and it takes 4, 6, sometimes 9 months to establish
that capacity. And what we really need to know in doing that
is: Is there interest in any of our partners, including the
United States Government, in supply on those timelines?
Now, the good news is we've been working hard at it for the
last 6 months, which is why we think we're going to be able to
get to our deliveries 2 months ahead of schedule. But, looking
forward, that's really a question for the U.S. Government to
answer.
Mrs. Trahan. Great. Thank you. And I think the workforce is
an important issue for us to tackle.
Mr. Young, in your testimony you say that Pfizer has been
able to ramp up their manufacturing capacity because of the
significant investments the company has made in U.S.
manufacturing sites, including in Andover, Massachusetts,
located in the heart of my district.
Because of the dire need to vaccinate more people, Pfizer
has increased projected 2021 global production from 1.3 billion
doses to at least 2 billion doses. And the Federal Government
has reportedly invoked the DPA to help Pfizer get priority
access to components you need to make your vaccine.
Has the DPA been helpful in your efforts to expand
manufacturing capacity, and are there any additional ways it
could aid in scaling up that production?
Mr. Young. Thank you for the question.
We certainly were in close collaboration with the Federal
Government, and some of the rated orders that were used
alongside the DPA were certainly helpful in ensuring that
certain raw materials that initially were constrained,
particularly some of the specialized lipids we use in the
production of our vaccine, were prioritized by our third- party
suppliers.
As I mentioned in my testimony, we've actually made
decisions to bring in-house the manufacturing of some of those
materials, so currently we don't believe they are constrained.
I think the DPA generally is certainly very useful, but I
think it's a very targeted--a targeted piece of legislation and
something that should be used to address very specific problems
rather than used generally.
But we've certainly found that to be very helpful, and I'm
very grateful for the Government's continued support.
Mrs. Trahan. Great. That's helpful.
And, Madam Chair, with only 15 seconds left to go, I will
submit my last question for the record. Thank you.
Ms. DeGette. I thank the gentlelady. You can bank those 15
seconds for later.
I'm now very pleased to recognize Mr. O'Halleran for 5
minutes.
Mr. O'Halleran. Thank you, Madam Chair, Ranking Member. I
appreciate this whole process that's come today. I've learned a
lot. We have a lot to learn, though.
And I guess my--the panel has been just great. I really
have respected the content of what's been said today.
The Emergency Use Authorization has obviously helped out.
The vaccines have come along pretty well. I wish you could have
them earlier, but we had them as fast as history has shown that
can be done.
They're safe and effective, it appears. I think we need to
get more of that information out to the public. And important
challenges remain.
In recent weeks, the variant COVID-19 strains have emerged
around the globe, including the United States. Two of the
variants, one from--first identified in United Kingdom and
another in South Africa--appear to be more contagious, which
poses a continuing and ongoing threat to our efforts to contain
the pandemic.
Now, I took a look at the questions I was going to have,
and they're--kind of been represented throughout this process.
Representative Trahan mentioned something that I think I
wanted to talk about a little bit more, though, and that is
after-action reports, getting ready for after-action reports,
getting ready to identify what we did wrong throughout this
process, and what can be done better in the future.
And how are you--how have you--the different groups been
identifying clearly through your process that you've kept
appropriate data so that we know and can observe what we need
into the future and how the working relationships have worked
throughout this process and how they can be improved?
And I ask that question to each and every one of the
panelists.
Dr. Nettles. Well, I can start.
At J&J, this has been a really--an unprecedented experience
for us, scaling up the process of this vaccine. So we've
learned many steps along the way about how to quickly scale up
manufacturing in parallel with running our clinical trials.
I would say one thing that we've learned is really the
unprecedented unselfishness of the American population, so
people coming forward to volunteer for participation in our
trials has been really outstanding and beyond what we could
have wished for, and we want to thank all the volunteers that
did that.
Mr. O'Halleran. Before we go to the next panelist, I
appreciate what was just said. I want to get into specifically
what you need to do or we need to do to work with you into the
future, the next 10, 20, 30 years, so that this doesn't happen
again, so that we're out in front on research and identifying
clearly the path ahead of us to prevent this in the future.
Dr. Nettles. Yes. I can follow on----
Mr. O'Halleran. Next, please.
Dr. Nettles. One of the things that has helped us move
forward as quickly as possible is the development and
investment in the platform that we're using to bring forward
this vaccine, that we've been using to develop other vaccines
for Ebola, HIV, and RSV. So that's one lesson that we've
learned, is that's tremendously helpful so that, in the event
that you experience a pandemic, you can leverage platforms like
that and transition to whatever infectious disease you're
facing during a pandemic.
Mr. O'Halleran. Thank you.
I know time is fast here in 5 minutes. I still want to hear
from you what--not specifically the recent panelists, but from
anybody: What are you doing now so that we can learn from this?
Not what we've done, what we are going to do in the future to
work together so that this doesn't happen again to the American
public and the people of the world.
Mr. Young. Thank you for the question.
I mean, it's a great question. We believe there are many
lessons learned. I think probably all of our companies have
experienced extremely productive and timely interactions with
regulators. And I think that's something that we should carry
forward, you know, to any future pandemic, but I think we
should carry forward for other important medicines and
treatments that our companies are developing.
Specifically as it relates to the pandemic, I also think
that this has shown around the world that we don't have
adequate capability to really conduct viral surveillance and
genomic screening to make sure that we can identify variants of
concern. And that's something that I think would certainly be a
real enhancement to the benefit of public health in the United
States.
Mr. O'Halleran. And time is running out.
Dr. Hoge. I think----
Mr. O'Halleran. And I just want to thank--let's go quickly.
Go ahead.
Dr. Hoge. I'm so sorry, sir. The only thing I would add to
that--I agree with everything that has been said there. I think
the other thing that was important in all of our cases was the
investments in science. Somebody has already mentioned
platforms. That was important in the private sector. But,
actually, in science, in the NIH and NIAID, to identify
prefusion-stabilized spike proteins on coronavirus as a key way
to make vaccine, that's something we all have in common. And so
those sorts of investments against new potential emerging
pathogens are absolutely essential.
Mr. O'Halleran. And I'll apologize to the chair for the
overtime, but this is an area that I think, in the future, we
strongly need to look into on a continuing basis, and I thank
you.
Ms. DeGette. And I agree. I thank the gentleman, and I
thank all of the regular members of the Oversight Subcommittee.
As I mentioned at the outset, we now have several members
of the full committee who are here to waive on, and we welcome
and appreciate all of you.
And, with that, I will start with Mr. Bucshon for 5
minutes.
Mr. Bucshon. Thank you, Madam Chairwoman. I appreciate you
allowing me to sit on in this important subcommittee hearing.
I'm a physician before coming to Congress, so this is really
critical.
Mr. Young, can you walk us through the timeline in regard
to the progression of efficacy for Pfizer's vaccine? For
example, per your trials, how many days after the first dose
did participants start displaying efficacy or an antibody
response? And at what mark did they reach 50 percent? And then
how many days after receiving their second dose did
participants reach the full or near full 95 percent efficacy?
Mr. Young. Thank you very much for your question.
In our clinical trial, we certainly did begin to see some
evidence of effectiveness, efficacy, in our study, you know,
somewhere between 10 and 14 days compared to the placebo group,
which is very encouraging.
I would say that actually recent real-world data from
Israel also supports the potential benefit that patients begin
to see even after one dose. However, our phase 3 study very
clearly used two doses, you know, so first dose, and then 21
days, a second dose.
And so we certainly--our study demonstrated maximal
effectiveness 7 days after that second dose, and that's really
what our data set supports.
Mr. Bucshon. Well, thank you very much because I do think
it's important to walk people through this timeline, because--I
mean, it is remarkable how quickly vaccines do cause an effect,
but it's not instantaneous, which doesn't make it any less
effective and should cause no hesitancy for people to get the
vaccine. Vaccines--as you just outlined, it's not to get the
vaccine and you're immune. It takes some time for your body to
respond.
Mr. Hoge, what is the key purpose of Moderna's vaccine, the
main outcome of every company is striving to achieve with any
COVID-19 vaccine at this point based on the data we have?
What's the primary goal here?
Dr. Hoge. So our primary objective in the study, and
therefore the primary objective in deploying it under UA, is
prevention of COVID-19. It's a symptomatic disease. We think,
if we can stop the disease, we'll actually be able to get out
of this pandemic.
We do look at secondary endpoints, like severe disease and
hospitalization. And we also looked at things like transmission
and infection. And the good news is all the emerging data there
is very supportive of the vaccine. But the primary focus is
stopping the disease of COVID-19.
Mr. Bucshon. Yes. I mean, I think it's important to
understand, I guess, at this point--and anyone can comment. We
don't know specifically whether or not this vaccine, like some
other vaccines, will be completely preventive of the disease or
will do some of that in some people, and then some people just
prevent severe cases and hospitalizations, which is also,
honestly, not as good, but a pretty solid endpoint. I mean,
vaccines may--this may or may not totally prevent disease.
Does anyone have any discussion on--want to discuss that a
little bit about what we know so far about whether or not our
goal of preventing disease versus preventing severe cases and
hospitalizations will ultimately be where we end up with COVID-
19?
Dr. Hoge. I mean, I would just offer that what we do know
from our clinical trials and the emerging real-world evidence,
but--from our focus on the clinical trials--is that we were
very effective in the mRNA vaccines at preventing disease, so
94, 95 percent effective at disease.
And, actually, in our case, we were--and I think in the
Pfizer case parts as well--they're even more effective at
severe disease, so we did not have any cases of severe disease
in our--in our clinical trial at the interim analysis.
So, as a result of that, we're quite optimistic that we're
not only preventing most terrible outcomes at severe disease,
but ultimately preventing the more moderate disease.
I think part of your question, sir, is to, you know, what
do we know about prevention of infection, or prevention of
transmission? And, as I think we've said, I think we have a lot
of work ahead to develop that data and ultimately have that
answer.
Dr. Nettles. I would jump in, too. I very much agree with
your premise, and one of the features we're very enthusiastic
about with J&J's single-dose vaccine is that, even in countries
like South America and South Africa and in countries in South
America where we have seen the emergence of these variants, 28
days after that single dose we have not seen patients need
hospitalization against--hospitalization for COVID-related
issues or death.
And so we agree with you. That is critical and very
promising information.
Mr. Bucshon. Yes, I think what I'm--as you pointed out, Mr.
Hoge, that what I'm getting at is, you know, we're still trying
to determine, you know, if people are fully vaccinated, can
they spread the disease? Should they still--you know, at what
point do we back away from our other public health things,
which I totally agree we need to do now--mask wearing, social
distancing--and, if we can really solidly show that this
actually prevents disease at a solid level, then I think the
governmental officials in all countries and also the people
will feel more confident when we start to back away from our
other public health initiatives that are critically important
still at this point.
So that's basically, I think, the question that ultimately
we'll need to specifically answer, is: Can people who have been
vaccinated still infect other people but they're just not
showing the symptoms?
So, with that, Madam Chairwoman, I'll yield back. Thank
you.
Ms. DeGette. Thank you. Thank you.
And now thank you for waiving on, and I'll recognize you,
Mr. McNerney, for 5 minutes.
Mr. McNerney. Well, I thank the chairwoman, and I thank the
witnesses.
First, I want to be clear. I'm very impressed and pleased
by your companies' historic efforts to develop safe and
effective vaccines on such a rapid timeline. That being said,
it's important to understand how the taxpayer dollars were
spent to increase manufacturing capacity and vaccine supply so
that we can better prepare for the next pandemic.
In that spirit, last summer Operation Warp Speed leaders
told us that large quantities of vaccines would be produced at
the same time, simultaneously, with clinical trials. That way,
as soon as FDA authorization of a COVID-19 vaccine was
available, the manufacturers would make a significant supply of
doses available for immediate distribution.
In other words, American taxpayers were assuming financial
risk in exchange for quick access to vaccines if and when they
were authorized for use. But, as we see, vaccine supply remains
limited, and manufacturing capacity is still a major concern.
So today I'd like to better understand exactly how Operation
Warp Speed helped ramp up your manufacturing capacity.
Dr. Hoge, you told this committee last July that Moderna
was using $483 million in Federal grant money to help scale
your manufacturing capacity. Although Moderna initially
projected delivering 20 million doses in the United States by
the end of 2020, it fell short of this goal and has encountered
production delays.
How exactly did Operation Warp Speed help increase your
manufacturing capacity? Could more have been done earlier to
build a larger vaccine stockpile prior to your authorization?
Dr. Hoge. Thank you for the question, sir.
We--as you note, we delivered by December 31st 17.8 million
doses. And, in the middle of last year, we were hoping that
that could be up to 20 million doses by year end. We ultimately
had never, when we were trying to make those estimates,
manufactured doses at this scale, and so we had a lot to learn
along the way. And many of the challenges that we run into were
the normal sort of training experiences as you train people to
operate a complicated process.
And so, as we look back, could we have maybe started
earlier in that process in lining up all of the critical raw
materials sooner, would we have been able to get there a little
bit faster instead of first week of January, last week of
December? It's possible. Certainly hindsight--and that is 20/20
for us--but we do feel very pleased with how we've moved
forward with those learnings and where we are right now
delivering 9 million doses this past week.
Mr. McNerney. Well, OK.
Dr. Dobber, Operation Warp Speed awarded AstraZeneca $1.2
billion last May to accelerate development in manufacturing of
your vaccine.
In July, AstraZeneca's executive vice president told the
committee that your company was, quote, ``scaling up to
manufacture up to 300 million doses of the vaccine so that they
will be available immediately upon approval or Emergency Use
Authorization.''
Does this mean that AstraZeneca currently has 300 million
doses ready for immediate release in United States if an EUA is
issued? If not, what happened? What did the American taxpayers
invest in?
Dr. Dobber? Are you muted?
I'm not hearing Dr. Dobber. I'm going to move on.
Dr. Nettles, last August, Operation Warp Speed operated--
awarded Johnson & Johnson 1 billion to ramp up its
manufacturing capacity. Unfortunately, J&J has already
encountered manufacturing delays and supply challenges. Could
these delays and supply challenges have been avoided with even
greater taxpayer support, or do you--do your challenges go
beyond the fundraising issues--the funding issues?
Dr. Nettles. At J&J, we very much appreciated the
investment. We have used that investment in the last 6 months
to significantly scale up our ability to produce this vaccine,
bringing on live sites in Indiana, Maryland, Pennsylvania, and
Michigan. And I'm happy to say that we have, as I mentioned,
continued to commit to the 100 million by the end of June,
being able to vaccinate 20 million individuals in March, as
well as having 4 million doses available to ship immediately if
we're granted an Emergency Use Authorization.
Mr. McNerney. Thank you.
In the interest of time, I'm just going to wrap it up by
saying a significant amount of American taxpayer dollars were
invested to be able to produce the vaccine immediately upon
approval. We need to learn from those lessons so that, next
time that we have a need like this, that the capacity is ready
to meet the demand on a comparable timeline.
Thank you, and I yield back.
Ms. DeGette. I thank the gentleman.
The Chair now recognizes Mr. Walberg for 5 minutes.
Mr. Walberg. Thank you, Madam Chair. I appreciate this
hearing and appreciate the witnesses being here, and, like my
other colleagues have said, the good work that you've done--
historic work that you've done in a very difficult period of
time, but in an amazingly short period of time as well.
I want to especially welcome Mr. Young here. As you know,
Pfizer's largest manufacturing facility is located in
Kalamazoo, Michigan, just 40 miles down I-94 from my district,
and so we appreciate the fact of seeing what work has been done
there, and I think Michiganders are summarily proud of what
they see when they see the Pfizer trucks and the lifesaving
pharmaceuticals going down the road to assist us and fill the
needs not only of Michigan but those of the rest of the Nation.
When President Biden visited the Kalamazoo facility last
week, he called it a miracle of manufacturing. I guess that's a
point that I can quickly jump in and say I agree with the
President on.
Many of my colleagues have already acknowledged this, but
it bears reiterating: Operation Warp Speed was an unprecedented
success. In fact, NIH Director Dr. Francis Collins recently
called the success of OWS breathtaking. In what typically takes
about 10 years or longer to go from an exploratory stage to a
large-scale manufacturing and FDA review and licensure, the
Trump administration achieved in less than 11 months. Sadly,
however, all these efforts will be for naught if we cannot get
the vaccine into the arms of people who need it and want it.
In Michigan, our State government has had serious problems.
Last week, Beaumont, one of the State's largest health systems,
announced the cancellation of nearly 2,000 second [inaudible]
unexpected reduction in the Pfizer vaccine allocation from the
State. I note that was allocation from the State.
Our Governor has said that the problem is demand, which
exceeds supply. And, while demand is certainly high, we're
seeing certain areas of the State receive larger vaccine
supplies per capita than others. As a result, the city of
Detroit is now vaccinating food service, restaurant, grocery
workers, regardless of age. And they certainly need it. But the
residents in other parts of the State, including my district,
are left wondering when it will be their turn.
Orrin in Saline, Michigan, up near the University of
Michigan, whose mother is 90 years old and in need of a hip
replacement, has been delaying treatment until she receives the
vaccine.
Carol in Temperance, Michigan, wrote me to say that she and
her husband are 81 years. They have been on a wait list for
weeks and were notified that their local grocery store pharmacy
is now out of doses. She and many of my constituents have
instead been left to go through Ohio and Indiana health
systems.
Steven from Chelsea, Michigan, receives daily chemo
treatments for leukemia but said he has been unable to get on a
waiting list for the vaccine.
And Mark, who is 70, said he can't get the vaccine, yet his
35-year-old son in Texas just got his second dose.
And so, Mr. Young, my constituents and I are trying to
better understand the process from when the doses leave your
facilities to when they are received by local health
departments. In a rough estimate, how many vaccine doses is
Pfizer capable of shipping out on any given day, and how
specifically are those doses distributed?
Mr. Young. So thank you for the question.
I couldn't agree more that what is incredibly important is
that, you know, vaccine doses are made available to everyone
who needs them. And so, as I mentioned in my testimony, we're
very focused on making more doses more quickly.
What we are able to currently supply is, on average, at the
beginning of February, around about 5 million doses per week.
We anticipate that that will get up to 13 million doses a week
by the end of March.
What we do is to supply an 8-week forward-looking forecast
of that weekly production to the Federal Government. The
Federal Government, in turn, then tells States what is
available. States then order it.
We supply the vaccine doses to the points of use as
directed by the U.S. Government. So we work closely with the
Federal Government, but we also look to work closely with the
States to ensure that they also have accurate information and
support.
Mr. Walberg. But then, if the State is responsible for
ordering it from the supply that you've been instructed by
Federal Government, they order it. How does it get to the
places where they need to be? Do they tell you where it's to be
sent?
Mr. Young. Yes, exactly. The Federal Government literally
tells us which center we should deliver how many vaccine doses
to. And that's something that we have--thus far have been able
to perform very accurately, 99.9 percent reliability of
delivery of the number of doses to the center as directed by
the U.S. Government.
Mr. Walberg. That gives needed information. Thank you. I
yield back.
Ms. DeGette. I thank the gentleman.
And now I'm very pleased that the chair of our Health
Subcommittee has joined us on this hearing. Thank you so much,
and I'm pleased to recognize you, Congresswoman Eshoo, for 5
minutes.
Ms. Eshoo. Thank you, Madam Chairwoman, for extending the
courtesy to have me join your Oversight Committee today. And
thank you to all of the witnesses. I've listened in since much
earlier this morning, and I want to say bravo to the companies
in the work that has been done, the scientists, and everyone
that is part of the effort to develop the vaccines.
Vaccines are extraordinarily difficult to develop. I think
that this is a moment in the history of our country, a moment
of great pride amidst great sorrow because of the enormous loss
of life in our country. So thank you to all of you.
I have two questions, and I hope they haven't been asked
before I joined. The first is about the clinical trials, and
they certainly have been the most closely watched in history, I
think. And I believe that companies spoke to achieving racial
diversity in the trials, and so I want to learn more about what
has been achieved in the trials relative to this issue. I don't
believe that any of the trials achieved racial representation
based on disease impact.
So my essential question is: Why? What's worked for a
diverse trial recruitment? What did you invest in order to get
there? Do you have recommendations to the Congress on policies
that could reduce the barriers for diverse recruitment?
I have said many times that we have many preexisting
conditions in our country, and we know that, in the minority
communities, that they are hard hit by this pandemic.
So that's my first question, about diversity and the
trials.
And the other is: I authored the Best Pharmaceutical for
Children's Act many, many years ago to specifically address the
need for pediatric studies. It provided the incentive of an
additional 6 months patent exclusivity if a company performed
pediatric studies. How do you think we could update this act to
address the barriers we're seeing in performing vaccine trials
for children?
So, to each one of the witnesses, there you go, and thank
you again.
Mr. Young. So thank you for question. Let me just say, you
know, we've worked extremely hard to ensure that the
recruitment of patients--participants in our vaccine study was
representative of the demographics of the disease. In fact, in
total, 42 percent of our total study population were
minorities. I know the patients who participated in our study
from the United States, 30 percent were minorities. So we came
very close, and we worked very hard to accomplish that.
We certainly agree that there are barriers, you know, for
minorities being able to either access healthcare systems or
providers, you know, to enable them to participate in clinical
trials, not something we--and we certainly welcome Congress'
continued support for that.
I would just say very quickly on your second question that
we're starting to think that's a very intriguing idea as to
whether there are some further incentives or measures that
could be put in place to ensure that all clinical studies
really include a population that is representative of the
population of the United States.
Dr. Hoge. Thank you. And I would also echo many of the
things that have been said. We worked incredibly hard in our
phase 3 trial to enroll a representative, the demographic
community.
In our trial, which was exclusively done in the United
States, 37 percent of our participants were from communities of
color. And so, overall, we did represent the demography of the
country at a high level, but we did not represent the
demography of the disease, as you point out. And so we can
always do better.
Learnings from that, we certainly--you know, we ran into
the challenges that you know well, that most of the public
health community knows well, around trust, and how do you build
trust between communities that have historically been
underrepresented or disenfranchised in terms of healthcare?
It took time. Our approach was to actually slow down
enrollment so that we could actually build those relationships
through the local investigators and physicians in the
communities on their parts.
Dr. Nettles. I can answer very quickly. We're very happy
with the enrollment that we've seen in our phase 3 clinical
trial, where we had 45 percent of the enrollment Hispanic, 19
percent Black or African American, and 9 percent Native
American.
With regard to lessons learned, it's developing long-term
relationships with national and local organizations that
represent the minority populations. And that's what I'd advise
us to continue to do moving forward.
Dr. Dobber. [Inaudible.] At AstraZeneca we are very happy
with the minority population in our clinical trial. Hopefully,
it will read out very soon so that you'll see the numbers.
Equally, we have a global trial in countries like Chile and
Peru, so we feel very comfortable. And we acknowledge the
importance of including minorities in the [inaudible]. So we're
very supportive. And [inaudible]. One of the witnesses remarked
about building trust in those communities, and we are doing an
[inaudible] amount of work in order for that to happen.
Mr. Trizzino. Thank you for the question.
Novavax worked very diligently with ICON, our clinical
trial partner, as well as the NIH clinical trial network in
order to make sure that we had representation from minority
populations, and that was 39 percent were represented from
minorities.
We also worked very closely with traditional Black
colleges, Howard University specifically here in DC, in order
to make sure that we got the representation that we desired.
So, you know, we're satisfied that we accomplished a
significant goal in the recruitment of our 30,000-subject trial
that just finished its recruitment.
Thank you.
Ms. Eshoo. I think my time has expired, Madam Chairwoman. I
thank you again for the legislative courtesy.
I thank all the witnesses, and bravo to the scientists.
This is--they are a blessing, not only to the people of our
country but the entire world.
Thank you.
Ms. DeGette. Thank you so much, Ms. Eshoo.
The Chair now recognizes Mr. Carter for 5 minutes.
Mr. Carter. Thank you, Madam Chair, and thank all of you
for being here. I appreciate it very much.
As a member of the Doctors Caucus and as also a pharmacist,
I felt it was very important for me to set an example, and so I
entered into the clinical trials here in my hometown, and I was
actually very fortunate to get the vaccine. After I was
unblinded, I found out that I had gotten the vaccine during the
clinical trials. Of course, as you well know, it's a double
blind study. But it was very important.
And I want to highlight what I feel like is the important
role pharmacists have been playing in this--in the
administration and also obviously in the distribution and
administration of the vaccine.
One of the things that they have been doing is what's
called pooling, and that is, in the multidose vials, they may
have a little bit left over, and, in order to combine that,
they can actually get some extra shots.
Now, I understand that you may be a little sensitive to
responding to that or commenting on that because of the--
because of the role that you play, but I just want you to know
that, as one thing--one of the many things that pharmacists are
doing that is really enhancing and helping us to get more
vaccines out there--and this is something that is common among
pharmacists that we do and something that traditionally has
worked very well and is helping us to get more vaccines out
there.
Anyone want to comment on that event?
Well, I understand.
But I want to mention one thing, and I suspect you won't
want to comment on this either. However, it is very important.
I got a phone call this morning from an independent retail
pharmacist. I myself was an independent retail pharmacist.
Already, we've got pharmacists that are being audited by PBMs
for the claims that they have submitted for the COVID-19
vaccine.
And I find that to be very alarming. And, in fact, I find
it to be despicable. These PBMs are out of control. And I know
that you're in a very precarious position to be able to comment
on this, but I want you to know that these PBMs already are
auditing these pharmacists who are administering these COVID-19
vaccines.
And that's the last thing we need right now, is for them to
be bullying the pharmacies, like they so often do, and
intimidating them and actually discouraging them from getting
the COVID-19 vaccine.
And I know all of you are aware of what's going on with
PBMs, and I know that you're going to have trouble commenting
on it, but I'm just wondering. Anyone want to comment on that?
I didn't think so. Maybe--and I'm not trying to put you on
the spot. I know how you feel, and I know you're in a very
precarious position, as I say, but I want you to be aware that
that's going on, because I think that is very despicable.
Finally, I wanted to ask you about vaccine hesitancy,
particularly in the communities of color. I represent a very
Republican district. However, I've got a large minority
population in my district, and it's something that I'm very
concerned with. This is my hometown where I've lived all my
life and where I intend to live the rest of my life, and I'm
very close to the community of color.
And it's very important to me. Now, as I said, I wanted to
set an example, and I did by entering into the clinical trials.
But, you know, I'm not a person of color, and therefore I try
to set the best example I can as a pharmacist, as a healthcare
professional, but at the same time is there anything we can do
as healthcare professionals, as Congresspeople, anything as
Members of Congress, anything that we can do, do you think, Mr.
Young, that we might be able to enhance the acceptance of
vaccines?
I mean, vaccines are the single most lifesaving innovation
in the history of medicine. We all know that. And how we get
that point across and get more acceptance with the vaccines,
not only with communities of color, but we are having trouble
here in the State of Georgia with getting healthcare
professionals to take it. It's just--it's just baffling to me.
Mr. Young. I thank you. I think it's an incredibly
important question, and I think that, you know, vaccine
hesitancy is one of the great threats to public health in the
middle of this pandemic. So I think all of us have a
responsibility to play our part in making sure that we can be
open and transparent, people can be confident in the
information that they see, that they're able to get information
from reliable sources rather than from unreliable sources, and
that all of us--the companies represented on this panel and
others, Congress, healthcare professionals, and government
agencies--all have responsibility to make sure that we can get
the message across that, if a vaccine is approved by the FDA,
that it's safe and it is effective.
Mr. Carter. Mr. Hoge, anything?
Dr. Hoge. I would agree with what--Mr. Young's comment. I
do think we have that obligation collectively, and we're doing
our very best to do our part.
Mr. Carter. Good. Well, again, I want to thank you. Look,
I'm a big fan. I'm a--as a pharmacist, a practicing pharmacist
for over 30 years, I've seen nothing short of miracles come out
of the result of research and development.
And one thing that I hope happens through this process, the
Operation Warp Speed, is that some of the improvements we've
made in speeding up the process--I hope we don't just go
straight back to the way we used to do it. I hope we've learned
and that we can expedite the process.
I know that there are people out there--I have patients out
there who are waiting on lifesaving medications, such as these
vaccines. And anything that we can do to speed it up--and I get
it. During a pandemic, it's different. But, when we get back to
whatever normal is going to be, I hope that we will look at the
process. I hope the FDA will look at the process and that we
can make improvements on the approval of medication because
this is extremely important.
One last thing--and I thank the Madam Chair--is just----
Ms. DeGette. The gentleman's time has expired.
Mr. Carter [continuing]. Don't forget what I said about
PBMs. They're the devil.
Thank you, and I yield back.
Ms. DeGette. I thank the gentleman.
And I believe everyone has--that I see has been able to ask
their questions. I'd ask the ranking member, does he have any
last words of wisdom for us?
Mr. Griffith. Well, I would be interested, because the
witnesses testified in--to answering your questions that they
were confident that they would meet their goals and meet their
commitments to the Federal Government.
And then, with Congressman Joyce, they suggest or they
answered that they didn't have any shortages in raw materials.
Given that we're all partners in this fight, I want to confirm:
Is there anything else you need from the Federal Government in
order to meet your commitments or to continue to ramp up your
companies' production, or do you feel that you have everything
you need at this point?
Mr. Young. Thank you for the question.
At Pfizer, we currently believe that we have everything we
need to be able to meet the commitments that we've outlined
today. Thank you.
Dr. Hoge. From Moderna, it's the same. All we need is the
continued partnership from the Government that we've benefited
from.
Mr. Griffith. And, in the interest of time, is there
anybody who doesn't--who feels like there is something we need
to do? That's probably a better way to put it.
All right.
Ms. DeGette. Great.
Mr. Griffith. I yield back, Madam Chair. Thank you so much
for the followup.
Ms. DeGette. Thank you. Thank you so much.
And I really do want to thank all of the witnesses. We all
have a lot of respect and admiration for the work that you've
done. We just want to make sure we stay on track to get all of
these shots into Americans' arms by the summertime.
And I also want to thank for the great participation of all
of our Members.
I'd like to remind Members that, pursuant to committee
rules, they have 10 business days to submit additional
questions for the record to be answered by the witnesses who
have appeared before the subcommittee.
I ask that the witnesses agree to respond quickly to any
such questions should you receive any.
We have had unanimous consent by Mr. Tonko to insert
records for the record--documents for the record, and we have
reviewed them, and now we would like to insert them by
unanimous consent: a letter from Representative Tonko to
Moderna's chief executive officer, dated February 17, 2021, and
a letter from Representative Tonko to Pfizer's chairman and
chief executive officer, dated February 17th, 2021.
Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Ms. DeGette. And I believe we don't have any further
business, so, with that, the subcommittee is adjourned.
Thanks again.
[Whereupon, at 1:30 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
File and source
- File
- CHRG_chrg-117hhrg45576_chrg-117hhrg45576.htm
- Size
- 208,512 bytes
- SHA-256
- 0dde468c9fe235bba0ece0985add73a113a9f48f7c64744fd4614187c8af099f
- Original
- No public link identified.