[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]



                          ASSESSING AMERICA'S 
                        VACCINE SAFETY SYSTEMS 
                                 PART 1

======================================================================= 

                                HEARING

                               BEFORE THE

            SELECT SUBCOMMITTEE ON THE CORONAVIRUS PANDEMIC

                                 OF THE

               COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY

                     U.S. HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 15, 2024

                               __________

                           Serial No. 118-89

                               __________

  Printed for the use of the Committee on Oversight and Accountability 
  
  
  
  
  
  
  
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 

  
  
  
  


                       Available on: govinfo.gov,
                         oversight.house.gov or
                             docs.house.gov 
                                 ------ 
                   U.S. GOVERNMENT PUBLISHING OFFICE 

54-866 PDF                 WASHINGTON : 2024 









               COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY

                    JAMES COMER, Kentucky, Chairman

Jim Jordan, Ohio                     Jamie Raskin, Maryland, Ranking 
Mike Turner, Ohio                        Minority Member
Paul Gosar, Arizona                  Eleanor Holmes Norton, District of 
Virginia Foxx, North Carolina            Columbia
Glenn Grothman, Wisconsin            Stephen F. Lynch, Massachusetts
Michael Cloud, Texas                 Gerald E. Connolly, Virginia
Gary Palmer, Alabama                 Raja Krishnamoorthi, Illinois
Clay Higgins, Louisiana              Ro Khanna, California
Pete Sessions, Texas                 Kweisi Mfume, Maryland
Andy Biggs, Arizona                  Alexandria Ocasio-Cortez, New York
Nancy Mace, South Carolina           Katie Porter, California
Jake LaTurner, Kansas                Cori Bush, Missouri
Pat Fallon, Texas                    Jimmy Gomez, California
Byron Donalds, Florida               Shontel Brown, Ohio
Scott Perry, Pennsylvania            Melanie Stansbury, New Mexico
William Timmons, South Carolina      Robert Garcia, California
Tim Burchett, Tennessee              Maxwell Frost, Florida
Marjorie Taylor Greene, Georgia      Summer Lee, Pennsylvania
Lisa McClain, Michigan               Greg Casar, Texas
Lauren Boebert, Colorado             Jasmine Crockett, Texas
Russell Fry, South Carolina          Dan Goldman, New York
Anna Paulina Luna, Florida           Jared Moskowitz, Florida
Nick Langworthy, New York            Rashida Tlaib, Michigan
Eric Burlison, Missouri
Mike Waltz, Florida

                                 ------                                
                       Mark Marin, Staff Director
             Mitchell Benzine, Subcommittee Staff Director
                        Marie Policastro, Clerk

                      Contact Number: 202-225-5074

                Miles Lichtman, Minority Staff Director
                                 ------                                

            Select Subcommittee On The Coronavirus Pandemic

                     Brad Wenstrup, Ohio, Chairman
Nicole Malliotakis, New York         Raul Ruiz, California, Ranking 
Mariannette Miller-Meeks, Iowa           Minority Member
Debbie Lesko, Arizona                Debbie Dingell, Michigan
Michael Cloud, Texas                 Kweisi Mfume, Maryland
John Joyce, Pennsylvania             Deborah Ross, North Carolina
Marjorie Taylor Greene, Georgia      Robert Garcia, California
Ronny Jackson, Texas                 Ami Bera, California
Rich Mccormick, Georgia              Jill Tokuda, Hawaii 








                         C  O  N  T  E  N  T  S

                              ----------                              
                                                                   Page

Hearing held on February 15, 2024................................     1

                               Witnesses

Daniel Jernigan, M.D., M.P.H., Director, National Center for 
  Emerging and Zoonotic Infectious Diseases, Centers for Disease 
  Control and Prevention (CDC)
Oral Statement...................................................     7
Peter Marks, M.D., Ph.D., Director, Center for Biologics 
  Evaluation and Research (CBER), Food and Drug Administration 
  (FDA)
Oral Statement...................................................     5
CDR George Reed Grimes, M.D., M.P.H., Director, Division of 
  Injury Compensation Programs, Health Resources and Services 
  Administration (HRSA)
Oral Statement...................................................     8

Written opening statements and the written statements of the 
  witnesses are available on the U.S. House of Representatives 
  Document Repository at: docs.house.gov.

                           Index of Documents

                              ----------                              

Article, New York Times, ``Covid Shots for Children''; submitted 
  by Rep. Cloud.

Article, Vox, ``Covid vaccine hesitancy could doom future 
  vaccines''; submitted by Rep. Mfume.

Report, NBER, ``Excess Death Rates''; submitted by Rep. Raskin.

Joint Statement, Group of Six; submitted by Rep. Ruiz.

Stakeholder Letter, Assessing Vaccine Safety Systems; submitted 
  by Rep. Ruiz.

Statement for the Record, Association of State and Territorial 
  Health Officials (ASTHO); submitted by Rep. Tokuda.

Questions for the Record: to Dr. Marks; submitted by Rep. Miller-
  Meeks.

Questions for the Record: to CDR Grimes; submitted by Rep. 
  Miller-Meeks.

Questions for the Record: to Dr. Jernigan; submitted by Rep. 
  Lesko.

Questions for the Record: to Dr. Marks; submitted by Rep. Lesko.

Questions for the Record: to CDR Grimes; submitted by Rep. Lesko.

Questions for the Record: to Dr. Jernigan; submitted by Rep. 
  Cloud.

Questions for the record: to Dr. Marks; submitted by Rep. Cloud.

Questions for the Record: to CDR Grimes; submitted by Rep. Cloud.

Documents are available at: docs.house.gov. 

 
                          ASSESSING AMERICA'S 
                        VACCINE SAFETY SYSTEMS 
                                PART 1

                              ----------                              


                      Thursday, February 15, 2024

                        House of Representatives

               Committee on Oversight and Accountability

            Select Subcommittee on the Coronavirus Pandemic

                                           Washington, D.C.

    The Subcommittee met, pursuant to notice, at 10:02 a.m., in 
room 2154, Rayburn House Office Building, Hon. Brad R. Wenstrup 
(Chairman of the Subcommittee) presiding.
    Present: Representatives Wenstrup, Malliotakis, Miller-
Meeks, Lesko, Cloud, Joyce, Greene, McCormick, Comer (ex 
officio), Ruiz, Dingell, Mfume, Ross, Garcia, Tokuda, and 
Raskin (ex officio).
    Dr. Wenstrup. The Subcommittee will come to order.
    I want to welcome everyone here today.
    Without objection, the Chair may declare a recess at any 
time.
    Before I move on to opening statements, I want to go ahead 
and advise Members, although there are very few here, that may 
be an advice I give again, advise Members and remind them of 
all the rules of decorum.
    The issues we are debating are important ones that Members 
feel deeply about. I understand that. While vigorous 
disagreement is part of the legislative process, Members are 
reminded that we must adhere to established standards of 
decorum and debate.
    This is a reminder that it is a violation of House rules 
and the rules of this Committee to engage in personalities 
regarding other Members or to question the motives of a 
colleague. Remarks of that type are not permitted by the rules 
and are not in keeping with the best traditions of our 
Committee. This is a very serious matter.
    The Chair will enforce these rules of decorum at all times, 
and I urge all Members to be mindful of their remarks today. If 
the Chair finds the Member to be in violation, the Member will 
be suspended from speaking for the remainder of the 
proceedings.
    I now recognize myself for the purpose of making an opening 
statement.
    Good morning. Vaccines are a crucial public health tool 
which save millions of lives. As a physician myself, I've 
administered many doses of vaccines, especially COVID-19 
vaccines. In 2020, I even volunteered to participate in the 
Moderna vaccine trials.
    Having this hearing is not an anti-vax hearing and I am not 
anti-vax. I shouldn't even have to say that, but, 
unfortunately, I do. I'm sure, as I sit here, there are people 
getting ready to use that very pejorative to discredit this 
hearing. Unfortunately, in an era of sound bites and newscycle 
whiplash, it seems there is little time for nuanced 
conversation about these topics. Today I hope we can have that 
nuanced conversation about process.
    Sometimes we don't know any weaknesses in a system until it 
is truly tested. Now is the time to safeguard for the future 
and about how we can do better next time if there are things we 
recognize that could have been done better. It's now a time to 
look at the things we did well, as well. But we need to restore 
trust in public health and the process.
    I'm very concerned with the hesitancy by so many today to 
vaccinate their children. That's a grave concern of mine. 
Testifying before us today are two senior officials who lead 
the government's post-marketing vaccine safety systems. These 
systems are absolutely critical to keeping the American people 
safe but also to earning and preserving their trust and the 
trust of the physicians that care for patients.
    Our witnesses will discuss how these systems work, what 
they can do, what they can't do, and the challenges that they 
face. That's a fair process. The testimony is important to 
design better systems in the future, as needed.
    One such system, the Vaccine Adverse Event Reporting 
System, or VAERS, as it is well-known, is perhaps the best 
known of these surveillance systems. VAERS has been a source of 
attention and controversy since the beginning of the COVID-19 
rollout.
    However, concerns about these data are usually met with 
dismissive replies. Unfortunately, they often point to the fact 
that VAERS is unable to prove causality, and it contains 
reports of people being hit by a car after vaccination. They 
say that VAERS is being misused by anti-vaccine advocates and 
that it is misinformation. These are all legitimate concerns of 
the American people especially.
    This seems to ignore many legitimate questions that have 
been raised. For example, how does the government utilize this 
data? We want to know.
    During her testimony before this Committee last June, 
Director Walensky assured us that the CDC had a responsibility 
to comb through every single report to VAERS, if you will. It's 
unclear if that has happened or if that's true.
    People who have submitted reports to VAERS have told my 
staff that they were never contacted by CDC or FDA officials. A 
recent British Medical Journal investigation found this, too. 
It seems that both sides agree that there's something wrong 
here.
    Further, while serious injuries caused by vaccines are 
rare, the government has assumed the responsibility to 
compensate for them. In doing so, vaccine manufacturers have 
been shielded from liability. Therefore, the government has an 
important duty, one that is essential in preserving trust in 
vaccines and how we message completely and honestly about them.
    Appearing before us today is Commander George Reed Grimes, 
Dr. Grimes. Dr. Grimes is HRSA's Director of Injury 
Compensation Programs and oversees the Countermeasures Injury 
Compensation Program, or CICP, as well as the Vaccine Injury 
Compensation Program, or VICP. Because COVID-19 vaccines were 
purchased and distributed by the Federal Government under the 
Public Readiness and Emergency Preparedness, PREP, Act, they 
are covered under CICP, whereas most other widely distributed 
vaccines are covered under VICP.
    As of January 2024, CICP has compensated 11 claims out of 
the more than 12,000 that have been filed for COVID-19 
vaccines. Because of its design, CICP payments are also 
significantly smaller than VICP, an average of about $3,700 
compared with almost $500,000 in VICP. So, it appears that CICP 
may not be designed or equipped to handle a vaccine that was so 
widely distributed and mandated for many as COVID-19 vaccines 
were.
    So, I have concerns that we wouldn't be able to expect 
people to line up and get vaccinated during the next pandemic 
if they feel that in some way they're going to be abandoned.
    Again, this testimony is important for designing better 
systems for the future and establishing best practices. I hope 
this hearing will provide us with an opportunity to discuss 
what lessons were learned during the pandemic about our vaccine 
safety and surveillance systems. These lessons, I believe, are 
critical in preparing for future pandemics, which is the 
mission, one of the missions, of this Subcommittee.
    And I look forward to a robust and on-topic discussion 
about these issues. And I want to thank everyone for being 
here, especially our witnesses for being here.
    I would now like to recognize Ranking Member Ruiz for the 
purpose of making an opening statement.
    Dr. Ruiz. Thank you, Mr. Chairman, and thank you to the 
witnesses for your participation in today's hearing.
    Our Nation's vaccine safety systems play a critical role in 
protecting public health. Every day scientists, physicians, and 
public health officials work together as part of this system to 
monitor the safety and efficacy of vaccines to ensure the best 
possible products reach everyday Americans.
    Their efforts have helped protect us from the threat of 
deadly diseases for decades, and their efforts during the 
COVID-19 pandemic helped contribute to one of the most 
successful vaccine rollouts in history, which, under President 
Biden's leadership, led the country out of the depths of the 
pandemic.
    In total, these efforts saved 3.2 million lives, prevented 
18.5 million hospitalizations, and saved the United States an 
estimated $1.15 trillion in medical costs.
    As a physician who went out into underserved communities to 
administer vaccines during the height of the pandemic, I saw 
firsthand the difference these vaccines made in helping our 
communities overcome COVID-19.
    So, at the end of the day, we were able to save so many 
lives, prevent so much illness, and reduce a mountain of 
medical costs on our system because these vaccines were shown 
repeatedly to be safe and effective due to extensive clinical 
data.
    And, since then, our Nation's robust vaccine surveillance 
systems and countless other studies have only reaffirmed the 
safety of these vaccines by monitoring for and evaluating 
serious adverse events, which remain rare.
    This system has worked well. In fact, we saw it 
successfully identify safety signals and vaccines during the 
pandemic when it detected cases of thrombosis with 
thrombocytopenia syndrome, or TTS, associated with the Johnson 
& Johnson vaccine, resulting in the CDC and FDA releasing 
updated recommendations for vaccine products.
    So, I do want to be clear that, while adverse events are 
rare, they are not impossible. That is why we must continue to 
invest in a strong, capable vaccine safety and surveillance 
system that is efficient in ensuring the best quality vaccines 
reach the American people. And it is why we must ensure that, 
when an adverse event does arise, people can receive the 
protection and compensation that they need.
    There is good bipartisan work I know we can do on this 
front to strengthen the National Vaccine Injury Compensation 
Program and Countermeasures Injury Compensation Program to make 
them more efficient. And I hope that discuss--I hope that we 
discuss those reforms here today.
    Today's hearing does have the potential to generate 
forward-looking policy solutions that improve people's lives. 
However, it only does so if we approach this topic with care, 
because if we don't, I worry that we are opening a Pandora's 
box that I fear we won't be able to close again.
    Right now, we are already witnessing an alarming rise in 
overall vaccine hesitancy, which has been fueled by mis-and 
disinformation spread online during the last 4 years. And, as 
this mis-and disinformation has festered, immunization rates 
among Americans have fallen for COVID-19, polio, measles, 
mumps, and rubella. This should be alarming to us all. We've 
already seen outbreaks of measles pop up in under-vaccinated 
communities in the last year including in Philadelphia and 
Columbus. And we've already seen an additional 300,000 COVID-19 
deaths in the U.S. that could have been prevented if not for a 
growing distrust in vaccines.
    I worry that the politicization of medicine, the 
politicization of science and vaccines will ultimately hurt us 
all in the end and that the manufacturing of distrust in public 
health norms and institutions that we have held true for so 
long will make us less prepared to combat a future pandemic.
    For example, Republicans are already 2.4 times more likely 
than Democrats or Independents to believe that COVID-19 
vaccines are unsafe. Childhood vaccination rates are already at 
a historic low, and we are already in the process of undoing 
decades of progress in overcoming infectious diseases. And, 
unless we handle each opportunity to discuss this with immense 
care, we are hurtling toward an even more grim future.
    So, I urge for a constructive, civil conversation among us 
all today that focuses on strengthening our current safety and 
compensation programs, enhancing confidence in our public 
health institutions, and building a brighter, healthier future 
for us all.
    And I yield back.
    Dr. Wenstrup. Thank you, Dr. Ruiz.
    Our witnesses today are Dr. Daniel Jernigan. Dr. Jernigan 
is the director of the National Center for Emerging and 
Zoonotic Infectious Diseases at the U.S. Centers for Disease 
Control and Prevention.
    Dr. Peter Marks, Dr. Marks is the director of the Center 
for Biologics Evaluation and Research at the U.S. Food and Drug 
Administration.
    Commander Dr. George Reed Grimes, Commander Grimes is the 
Director of Injury Compensation Programs at the U.S. Health 
Resources and Services Administration.
    Pursuant to Committee on Oversight and Accountability rule, 
the witnesses will please stand and raise their right hands.
    Do you solemnly swear or affirm that the testimony that you 
are about to give is the truth, the whole truth, and nothing 
but the truth, so help you God?
    Thank you. You may be seated.
    Let the record show that the witnesses all answered in the 
affirmative.
    This Select Subcommittee certainly appreciates you all for 
being here today, and we truly look forward to your testimony.
    Let me remind the witnesses that we have read your written 
statement, and they will appear in full in the hearing record. 
Please limit your oral statement to 5 minutes.
    As a reminder, please press the button on the microphone in 
front of you so that it is on, and the Members can hear you. 
When you begin to speak, the light in front of you will turn 
green. After 4 minutes, the light will turn yellow. When the 
red light comes on, your 5 minutes has expired, and we would 
ask that you please wrap up.
    I now recognize Dr. Marks to give an opening statement.

                  STATEMENT OF PETER MARKS M.D., PH.D.

                                DIRECTOR

              CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

                      FOOD AND DRUG ADMINISTRATION

    Dr. Marks. Chair Wenstrup, Chair Comer, Ranking Member 
Ruiz, Ranking Member Raskin, and Members of the Select 
Subcommittee, thank you for the opportunity to testify before 
you today to discuss the Food and Drug Administration's COVID-
19 response and ongoing vaccine safety efforts.
    Vaccines work. We know from clear and compelling evidence 
that vaccines save the lives of millions of children and adults 
every year by producing immune responses that prevent diseases, 
such as measles, influenza, and COVID-19.
    Though they may not provide perfect protection, vaccines 
can often prevent the most serious consequences of disease 
including hospitalization and death.
    The American public can be rest assured that vaccines that 
are authorized or approved are safe and effective. The vaccine 
development process and FDA's stringent regulatory and 
scientific evaluation process and continued safety surveillance 
ensure that the health benefits of available approved and 
authorized vaccines far outweigh any risks.
    Regarding COVID-19 vaccines, FDA helped make these critical 
medical countermeasures available as quickly as possible 
without compromising our scientific and regulatory standards.
    During a once-in-a-lifetime pandemic that was a public 
health emergency, FDA scientists and employees worked around 
the clock cooperatively, intensively, and efficiently alongside 
researchers and manufacturers to minimize the time between the 
clinical development process, manufacturing scale-up, and the 
regulatory review process.
    Hundreds of Americans were dying from COVID-19 daily at 
this time, and every day we could make vaccines available 
sooner counted. Every day counted, and we made them count.
    Between December 2020 and May 2023, over 270 million people 
received more than 675 million doses of COVID-19 vaccines in 
the United States including over 650 million doses of mRNA 
vaccines. The COVID-19 vaccines have had a tremendous positive 
impact over the course of the pandemic globally, ultimately 
saving millions of lives since their introduction.
    The vaccines continue to be among the most effective public 
health measures for preventing the serious consequences of 
COVID-19. A large part of what has made this public health 
success possible is the deployment of sophisticated safety 
monitoring. In fact, COVID vaccines are the most closely 
monitored vaccines that have ever been rolled out in U.S. 
history.
    The safety of the approved and authorized COVID-19 vaccines 
has been monitored by FDA through both passive and active 
safety surveillance systems in collaboration with CDC and other 
governmental and nongovernmental partners.
    FDA also participates in ongoing international 
pharmacovigilance efforts, and these are in addition to the 
safety surveillance efforts required of the vaccine 
manufacturers.
    These surveillance tools work. In early 2021, just days 
after passive safety surveillance reporting through the Vaccine 
Adverse Event Reporting System detected that six out of more 
than 6 million patients who had received the Janssen COVID-19 
vaccine had developed a rare blood-clotting disorder, CDC and 
FDA recommended pausing the use of that vaccine until the risk 
could be further evaluated.
    Another example is the detection of myocarditis that 
occurred primarily in younger males from the use of COVID-19 
vaccines, which led FDA to modify labeling and CDC to provide 
advice on the mRNA COVID vaccines to healthcare providers about 
how to reduce this risk.
    Vaccines are one of the most highly effective public health 
measures, and they're responsible for saving millions of lives 
every year. The benefits of available approved and authorized 
vaccines in the United States when used appropriately continue 
to far outweigh any risks.
    Staying up-to-date on vaccination has been and continues to 
be the best way to reduce the risk of death and serious illness 
or hospitalization from various infectious diseases including 
COVID-19.
    Thank you for the opportunity to testify today. I look 
forward to answering your questions.
    Dr. Wenstrup. I now recognize Dr. Jernigan to give an 
opening statement.

               STATEMENT OF DANIEL JERNIGAN, M.D., M.P.H.

                                DIRECTOR

                    NATIONAL CENTER FOR EMERGING AND

                      ZOONOTIC INFECTIOUS DISEASES

               CENTERS FOR DISEASE CONTROL AND PREVENTION

    Dr. Jernigan. Thank you.
    So, Chairman Wenstrup, Chair Comer, Ranking Member Ruiz, 
Ranking Member Raskin, and distinguished Members of the 
Subcommittee, it is an honor to appear before you today to 
discuss CDC's ongoing work to monitor the safety and 
effectiveness of vaccines.
    I serve as the Director of the National Center for Emerging 
and Zoonotic Infectious Diseases at CDC, which includes CDC's 
Immunization Safety Office.
    CDC works to protect against public health threats through 
prevention, detection, and response, and vaccines are a 
cornerstone of that work. They have played a leading role in 
irradicating smallpox, eliminating wild polio virus from the 
United States, and averting millions of illnesses and deaths 
from childhood-vaccine-preventable diseases.
    During the COVID-19 public health emergency, over 676 
million doses of COVID-19 vaccines were administered in the 
U.S., which are estimated to have prevented millions of 
hospitalizations and deaths. These public health successes have 
been made possible by a shared commitment to ensuring vaccines 
are safe.
    As such, vaccine safety monitoring is a top priority for 
CDC, and we collaborate closely with FDA and other partners. We 
utilize multiple data systems in a complementary and layered 
approach to detect possible safety signals, investigate them 
rigorously, and act promptly when appropriate.
    The Vaccine Adverse Event Reporting System, or VAERS, is a 
system where individuals, healthcare providers, and 
manufacturers can report adverse events following vaccination 
that may need to be investigated further. VAERS is not designed 
to determine if a vaccine caused a reported event. Rather it is 
an early warning system where we evaluate reports of serious 
adverse events and use complementary systems to further analyze 
potential safety concerns.
    These other systems include the Vaccine Safety Datalink, 
which uses electronic health records for robust analysis, and 
the Clinical Immunization Safety Assessment Project, or CISA, 
which offers consultation to providers on patient-adverse 
events.
    During the COVID-19 response, CDC also established V-safe, 
a smartphone app where individuals can report health impacts 
after vaccination. We also established a COVID-19 Vaccine 
Pregnancy Registry to monitor pregnancy and infant outcomes 
over time following vaccination.
    CDC is committed to transparency and regularly shares 
information on vaccine safety with our Federal and state 
partners. And, in addition, there have been more than 30 public 
meetings of the Advisory Committee on Immunization Practices, 
or ACIP, featuring research on COVID-19 vaccine safety and 
effectiveness. This approach to safety monitoring works. I'll 
share two examples with you and underscore Dr. Marks' comments.
    The first is, during the first 6 weeks that the J&J vaccine 
was authorized for use, CDC identified six cases of a very rare 
but life-threatening blood clot through VAERS. When additional 
review identified a causal relationship between the J&J vaccine 
and the blood clot, CDC and FDA acted within days to quickly 
inform clinicians and the public, convened an emergency meeting 
of the Advisory Committee on Immunization Practices, and 
recommended a pause in administration of the J&J vaccine.
    Further investigation led to preferential recommendation 
for mRNA COVID vaccines over J&J, and currently the J&J vaccine 
is not available in the United States.
    The second example is myocarditis. In April 2021, CDC 
observed higher reports of myocarditis following mRNA COVID-19 
vaccination, particularly in young men through the VAERS 
system. After confirming these events, using the Vaccine Safety 
Datalink, CDC quickly updated clinical considerations, while 
continuing to recommend COVID-19 vaccination. Further research 
has shown that the risk of myocarditis is substantially lower 
following vaccination than following infection.
    As these examples show, vaccine safety monitoring by CDC 
and our partners is rigorous and transparent. The data 
continues to show that staying up to date on COVID-19 vaccines 
is an effective and safe way to prevent severe illness, 
hospitalizations, and death.
    The development and administration of COVID-19 vaccines is 
a remarkable scientific achievement. After the most robust and 
comprehensive safety monitoring in our history, the science 
shows that we should all have confidence that COVID-19 vaccines 
are both safe and effective.
    I appreciate the opportunity to discuss CDC's vaccine 
safety efforts and look forward to your questions.
    Dr. Wenstrup. Thank you.
    I now recognize Commander Grimes to give an opening 
statement.

                              STATEMENT OF

               COMMANDER GEORGE REED GRIMES, M.D., M.P.H.

                                DIRECTOR

                DIVISION OF INJURY COMPENSATION PROGRAMS

              HEALTH RESOURCES AND SERVICES ADMINISTRATION

    Dr. Grimes. Good morning, Chairman Wenstrup, Ranking Member 
Ruiz, and Members of the Subcommittee.
    Thank you for the opportunity to speak with you today about 
the work of the Health Resources and Services Administration's 
Injury Compensation Programs.
    I'm Commander Reed Grimes, Director of HRSA's division that 
overseas both the Countermeasures Injury Compensation Program, 
or CICP, and the National Vaccine Injury Compensation Program.
    The Public Readiness and Emergency Preparedness Act of 
2005, or the PREP Act, created the CICP to provide compensation 
for serious physical injuries or death directly caused by the 
administration or use of a covered countermeasure.
    HRSA has received approximately 13,000 claims alleging a 
COVID-19 countermeasure injury filed with the CICP since the 
PREP Act declaration in 2020. Of these, roughly 9,600 alleged 
COVID-19 vaccines as the covered countermeasure. For context, 
the program received about 500 claims over its 10-year history 
prior to COVID-19.
    While injuries are rare and the claims we've received for 
COVID-19 vaccines represent a small fraction, less than 0.001 
percent of all COVID-19 vaccine administrations in this 
country, the caseload for the CICP is orders of magnitude 
higher than it was prior to 2020.
    When I became Director in December 2021, I immediately 
focused on the need to increase the CICP's capacity to process 
claims. The PREP Act sets a high evidence standard for an 
individual to be compensated by the CICP. By law, we are 
required to establish that the covered countermeasure directly 
caused a covered injury, which must be determined based on 
compelling, reliable, valid, medical, and scientific evidence.
    As a result, the CICP conducts medical reviews of each CICP 
claim to determine if it meets the statutory standard. This 
detailed review includes an iterative process of obtaining and 
reviewing comprehensive medical documentation from CICP 
requesters, as well as closely reviewing and monitoring the 
medical literature.
    For compensable claims, the CICP must also collect detailed 
financial information, given that the program by statute can 
provide compensation only after other third-party payers.
    At the time of the PREP Act declaration in 2020, the CICP 
had no direct appropriation and only four staff. We requested 
and Congress provided a direct appropriation for the first time 
in the history of the program in Fiscal Year 2022. With these 
funds, we've been able to increase hiring and now have over 35 
full-time staff working to process claims.
    We've also implemented other key process improvements to 
resolve claims at a faster rate. In 2023, we averaged more than 
90 claims resolved each month, which is up from zero per month 
the year before I started in this role.
    Additionally, we're improving information technology and 
other communication channels with requesters. While the program 
has made significant improvements, there's more to be done. The 
President's Fiscal Year 2024 budget requested $15 million to 
operate the CICP. With these funds, we want to continue to 
increase our capacity to analyze and resolve claims including 
through increased staffing and IT infrastructure improvements.
    We are committed to working with Congress to meet the 
program's resource needs to increase the rate of CICP claim 
resolutions.
    The CICP is also in the process of establishing an injury 
table for COVID-19 vaccine injuries that are presumed to be 
directly caused by a covered countermeasure. In order to 
establish this table, HHS must meet the high evidence standards 
set by Congress. The injury table is another tool that will 
allow us to streamline the claims review process and more 
expeditiously address requests.
    Finally, I wanted to address the National Vaccine Injury 
Compensation Program, or VICP. The VICP was established under a 
different statute, the National Childhood Vaccine Injury Act of 
1986. For a vaccine to be covered under the VICP, certain 
conditions must be met, including a recommendation from the 
CICP for routine--from the CDC for routine administration to 
children or individuals who are pregnant, and the vaccine must 
be subject to an excise tax. COVID-19 vaccines currently do not 
qualify for VICP coverage, which would require congressional 
action.
    We at HRSA are diligently carrying out these programs as 
directed by Congress and thank you for the opportunity to be 
here today to discuss HRSA's work. And we look forward to 
continuing to work with Congress on these critically important 
programs.
    Dr. Wenstrup. Thank you all very much for your testimony.
    I now recognize myself for questions, but I just want to 
say a couple of things before we start.
    You know, I want everyone to understand, especially those 
serving on the government side, that public perception becomes 
reality. And, because of that, words matter. Words matter that 
are coming out, you know.
    And, for those of us as Members of Congress or as 
physicians at home, we're face-to-face with people. We are 
sitting face-to-face with somebody. We're not just looking at 
data on a sheet and making decisions. It needs to be done, what 
you're doing, but there's a difference. And that's why I say 
words matter.
    Let me give you an example. When you say, ``safe and 
effective,'' that's relative in your mind. It's relative in 
your mind, but it's not to the person at home. They hear 100 
percent safe and 100 percent effective. That's what they hear. 
This is why words matter.
    Dr. Fauci, in his testimony even said you can never say 
that any treatment is 100 percent safe. Yet, in essence, that's 
what people heard and are still hearing today. We've got to 
change that because the doctor on the ground or the Member of 
Congress on the ground is one on one with somebody and explains 
that to them hopefully.
    Yes, this vaccine saved hundreds of thousands of lives. 
I'll advocate for that anytime, and that's why I was for 
emergency use, because people were dying, and we knew from the 
trials that it could save lives and keep people out of the 
hospital. But we also knew that you could still get COVID. We 
never really heard that from the Federal level. We just heard 
it's safe and effective.
    Now we have a society that thinks that the polio vaccine 
and the other vaccines aren't necessarily safe and effective 
the way they have been.
    We never explained mRNA technology is different from the 
technology of the other vaccines that have been around forever. 
And you lump them together.
    When people come to my office to tell me, ``I had an 
adverse event of some type,'' I'm one on one with them. It's 
not just something on a piece of paper.
    So, words matter. That's one of the things I want to stress 
across the board from this Subcommittee at the end of the day.
    Early on, I will tell you that I even said to Secretary 
Azar, America needs to be hearing from the doctors treating 
COVID patients, not the politician who says, ``If Trump makes 
this vaccine, I'm not taking it.'' Is that helpful? We needed 
to be hearing from the doctors treating COVID patients, the 
doctors administering the vaccines, the doctors that were 
trying to save lives. That's who the public needed to hear--be 
hear about--hear from. We have to be careful with our words.
    I'm grateful, Dr. Jernigan. Today you gave the caveat, 
didn't you? You said it kept you from being--in most cases it 
kept you from being hospitalized or dying, especially if you're 
amongst the most vulnerable. I appreciated that. That's the 
type of messaging we have to have going forward.
    Let me tell you I'm grateful we live in a country that has 
these systems in place because they're there to protect the 
American people and to provide for better health in America. 
But there's ways we can do better, and that's what I want to 
talk about today.
    So, I'm going to start by asking this question about 
vaccine safety surveillance as we get into that.
    I want to ask each of you this question or at least Dr. 
Jernigan and Dr. Marks. Yes or no, is any pharmaceutical 100 
percent safe?
    Dr. Marks. Thanks very much for that question, Chair 
Wenstrup.
    No pharmaceutical is 100 percent safe. In fact, even the 
water we drink is not a hundred percent safe. If you drink too 
much of it on a hot day, you can die from complications of 
water poisoning.
    Dr. Wenstrup. Well said.
    Dr. Jernigan. Yes, thanks for the question.
    You know, as clinicians, we all recognize that no medical 
intervention is risk-free.
    Dr. Wenstrup. And I'll go to Dr. Grimes. You know, you--
you've--there's a reason we have a compensation program.
    Dr. Grimes. Yes, sir. So, there's a reason we have a 
compensation program, and we're dedicated to diligently 
carrying that out.
    I can't say it any better than my colleagues sitting next 
to me have.
    Dr. Wenstrup. Thank you.
    So, it is important that we properly surveil for these 
inevitable injuries, unfortunately inevitable injuries, no 
matter how many or how few.
    Would you agree with that, Dr. Marks?
    Dr. Marks. Chair Comer, I would agree fully with that, that 
if we want to maintain confidence in the vaccines and the other 
medical products that we authorize or approve, we must have 
very robust safety surveillance systems in place.
    Dr. Wenstrup. Dr. Jernigan
    Dr. Jernigan. Yes, I agree that we really need those 
complementary layered and comprehensive and multiple vaccine 
safety monitoring systems.
    Dr. Wenstrup. Dr. Grimes?
    Dr. Grimes. Thank you. I couldn't agree more.
    Dr. Wenstrup. And I agree with that.
    Do you feel that what we currently have is sufficient? And 
I don't mean that in an adversarial way. I mean, what are some 
of the things you think we could do better?
    And, as I said at the beginning, sometimes it takes 
something like a pandemic to recognize where we can do better 
and so in that--in the vein of surveillance system being 
sufficient, any ideas that you could add to that?
    Dr. Marks. Chair Wenstrup, thanks so much for that 
question.
    I believe we had very good safety surveillance mechanisms 
in place that included overlapping systems, including passive 
and active systems, but I do believe we could do better.
    I think there were challenges in getting data in real time 
that limit us in our ability to understand what was happening 
on the ground. And hopefully we can work better together with 
all of the individual states to have a more unified safety 
surveillance system, should this ever happen again or, for that 
matter, even on an ongoing basis for our medical products.
    Dr. Wenstrup. Thank you.
    Dr. Jernigan.
    Dr. Jernigan. Yes, I think throughout the pandemic, we 
stood up really the most intensive vaccine safety monitoring in 
U.S. history. We really see the benefits of having a robust 
vaccine safety monitoring system, and sustaining that is going 
to be a critical feature for us moving forward.
    Dr. Wenstrup. Dr. Grimes.
    Dr. Grimes. And I would defer to my colleagues to my right. 
They're the experts in the field.
    Dr. Wenstrup. Fair enough.
    One of the things, as I had the pleasure of meeting with 
you all individually ahead of time, what occurred to me in 
hearing some of the concerns, especially, you know, this 
pandemic came on quickly and you had workforce challenges, if 
you will, understandably, considering that in every component 
of what you do.
    And one of the ideas I have is that I'm an Army Reservist. 
One of the ideas I have is we have a Reserve Component in each 
one of your categories of interest where we can call up experts 
in the field that can handle the increased load during a 
pandemic. To me, that would really aid our national security 
and our national health security.
    And so, it's just a thought, but I'd love to get your 
opinions on it because I know you face many challenges by the 
overload of what took place.
    Dr. Marks.
    Dr. Marks. Chair Comer--sorry--Chair Wenstrup. Sorry. Chair 
Wenstrup, thank you so much for that question.
    I really appreciate the opportunity to reflect on this 
issue. When the pandemic happened, we at FDA were dealing with 
our usual files that we have. There are many vaccines that are 
important for everyday life, measles vaccine, et cetera, that 
we have to review. So, we didn't have a cadre of people to just 
move over, and so we had to pull people to work on the COVID-19 
vaccines. And many of them had to learn how to deal with 
Emergency Use Authorization.
    I couldn't agree with you more that if we had a cadre of 
people ready to move over, very familiar with Emergency Use 
Authorization, and able to quickly move to reviewing vaccines 
in a pandemic settings, that would greatly help us in the 
future.
    Dr. Wenstrup. Thank you.
    Dr. Jernigan.
    Dr. Jernigan. Yes, thank you.
    I think you pointed out the workforce. And, certainly in 
public health, both at the state, territorial, tribal level at 
CDC, we have an aging workforce. We need more public health 
people working in the field.
    We at CDC really are having to act as a response agency and 
really not structured that way. So, having some additional ways 
to quickly mobilize folks to stand up systems quickly, to 
implement innovations very rapidly, that really requires a 
robust workforce that we really need going forward.
    Dr. Grimes. Thank you for the question.
    I think we in the CICP at the beginning of the pandemic had 
four staff, as I mentioned in my opening comments. And we 
needed to scale up to do the volume of the work, and that is 
one of the things that we look to for the future are those 
opportunities and strategies to optimize scalability and 
flexibility to perform the essential functions of our critical 
programs.
    Dr. Wenstrup. Yes, I appreciate that. As somebody who's 
endured mass casualty events, you know, to be able to be 
prepared for that or at least have the call-up ability to do 
that, I think that's something that I hope that we can look 
into as a Congress to consider that type of reserve workforce 
that's ready to go on day one.
    As of February 2024, VAERS reports for COVID-19 vaccines 
total significantly higher than all other vaccines combined 
since 1990, as reported. This is a surprising figure.
    Dr. Marks, was the government prepared for such an 
avalanche of reports to VAERS? And it kind of goes with what we 
just mentioned. So----
    Dr. Marks. Chair Wenstrup, thank you so much for that 
question.
    And I apologize about your name before. It shows when 
you're nervous, things can happen.
    But your--the point is extremely well taken. We try to be 
prepared for that, but the avalanche of reports was tremendous. 
And it, again, required retasking people on the fly to, I 
think, for--and I'll let my CDC colleagues speak to this. We 
had to usually staff up and had many meetings, working to 
increase our ability to go through these reports, because, as 
you already mentioned, the--what the public sees on the public 
VAERS page is just a small fraction of the information that we 
ultimately collect and sift through that is very important to 
determining whether an adverse event is truly related to the 
vaccine.
    Now one of the criticisms that we often receive is that we 
don't make that additional information available, and I would 
say to you that it's a challenge because what we've learned is 
it's very challenging to make available essentially protected 
health information, because if you have a ZIP Code that someone 
was pregnant, you know, if you have a ZIP Code of someone in 
Akron, Ohio, that they were pregnant and they had COVID, you 
could potentially reidentify them.
    So, this is one of the challenges we face in making 
available information, but I think we'd like to work to make 
the most information available as possible.
    Dr. Wenstrup. Do you have any concept on that, Dr. Marks? 
As far as this number, you know, childhood vaccines, they are 
spaced out. This was a vaccine that was being administered to 
a--would it be a larger swath of the population? Was the number 
higher but maybe the same per capita, if you will? Does that 
make sense, the question?
    Dr. Marks. Yes, so I can't think--you know, our seasonal 
influenzae campaigns often administer about 150 million doses 
over the course of a number of months. Here we had, you know, 
millions of doses rolled out really on top of each other at a 
tremendously rapid rate.
    And, in addition, we encouraged people. Part of the 
Emergency Use Authorization process, we were encouraging safety 
reporting because we felt we needed to know about any potential 
adverse events so we could try to investigate and find out if 
there was something we were missing.
    Dr. Wenstrup. Did you have anything to add to that, Dr. 
Jernigan?
    Dr. Jernigan. No, I think that covered--covered a lot.
    Dr. Wenstrup. I now recognize Dr. Ruiz for 5 minutes--for 
questioning.
    Dr. Ruiz. Today's hearing comes at a pivotal time in the 
ongoing efforts to fortify declining vaccine confidence, one of 
the greatest public health challenges of our time. And I agree 
with the Chairman; words matter. And what we say here today 
will have significance ramifications on whether millions of 
Americans will continue to place their trust in safe and 
effective vaccines including the COVID-19 vaccine.
    Before I get to my question, I'd like to enter into the 
record a letter the Select Subcommittee received from more than 
50 medical and public health organizations and experts ahead of 
today's hearing.
    There you go.
    Dr. Wenstrup. Without objection.
    Dr. Ruiz. This letter, which was led by Vaccinate Your 
Family and signed by a broad coalition that includes the 
American Academy of Pediatrics, the Association of State and 
Territorial Health Officials, the National Association of 
County and City Health Officials, the American Public Health 
Association, the American Heart Association, Doctors for 
America, and many more warns us of the potential damage that 
could be done if today's hearing fails to handle the subject of 
vaccine safety carefully and without bias.
    And, just this morning, a group of six leading medical 
societies representing more than 560,000 physicians issued a 
joint statement with a similar warning, calling on the Select 
Subcommittee to, quote, ``Acknowledge the overwhelming 
evidence-based science and recognize how COVID-19 vaccines 
protect and save millions of lives.''
    I'd also like to enter this statement into the record.
    Dr. Wenstrup. Without objection.
    Dr. Ruiz. Now as a physician and as Ranking Member of this 
Select Subcommittee, I want to ensure that today's conversation 
remains rooted in the facts. And the facts are that, while 
delivering effective COVID-19 vaccines to the American people 
at a historic pace, our Federal public health officials went to 
painstaking lengths to evaluate their safety, and they are 
continuing to do so.
    Dr. Marks, your division of the FDA is responsible for 
evaluating clinical trial data to authorize and approve 
products including the COVID-19 vaccine. Could you please 
explain for us the rigorous standards the FDA has followed in 
its authorization and approval processes for the COVID-19 
vaccines?
    Dr. Marks. Thanks so much for that question, Ranking Member 
Ruiz.
    The COVID-19 vaccines, the--before we even started to 
receive data, we put forth guidance, first in April and then 
subsequently in October 2020, which described our expectations 
for the safety and the efficacy of these vaccines. That's the 
standard that we would use before we could issue an Emergency 
Use Authorization.
    We then for--the initial Emergency Use Authorization 
required manufacturing data that was equal to what we would 
have or nearly equal to what we would have required for a 
biologics license application, and we required effectiveness 
data that was near or equal to what we would have required for 
a biologics license application.
    We couldn't speed up time. So, we, in order to get the 
vaccines to people in need, when thousands of people were 
dying, we actually allowed the safety to be authorized with 
just 2 months of median followup rather than the normal 6 to 
12, but we were confident that that would capture adverse 
events. So, we had good safety data.
    And then, when we went to finally do the biologics license 
application, we go through very large datasets. For instance, 
the Pfizer vaccine had 43,000 people involved in clinical 
trials, about 21--22,000 of whom had received the vaccine 
initially, and then thousands more received it after 6 months.
    So, we went through a tremendous amount of data, looked at 
the adverse events, and looked at the effectiveness data. So 
that, plus looking carefully at the manufacturing.
    Dr. Ruiz. And what has the clinical trial data shown 
regarding the safety of the COVID-19 vaccines?
    Dr. Marks. The safety of the COVID-19 vaccines includes 
that there are some initial discomfort potentially in the arm, 
fatigue that could occur. And there are rarely more serious 
side effects. We identified myocarditis and rare allergic 
reactions and, thankfully, by putting mitigation strategies in 
place, both of those have been decreased in occurrence.
    Dr. Ruiz. Dr. Jernigan, your division at CDC is responsible 
for operating surveillance systems that detect adverse health 
effects, mild or serious. Could you please explain the 
multitiered system that CDC has in place to monitor for safety 
concerns regarding vaccines that have been brought to market?
    Dr. Jernigan. Sure. Thanks for the question.
    And, you know, like I said, we've been putting through the 
most intensive vaccine safety monitoring in U.S. history, and 
that at CDC includes five different systems.
    The first of those is the Vaccine Adverse Event Reporting 
System that we talked about, which is essentially an open door 
to get those reports in.
    The second is the Vaccine Safety Datalink, which is a very 
large electronic health records, about 13.5 medical records in 
it, where we look for trends.
    We have a pregnancy monitoring system. We have a 
Smartphone-enabled app called V-safe. And we have a Clinician 
Immunization Safety Assessment Program where we have medical 
experts that can provide input into the safety monitoring.
    That system has been tremendous in us being able to follow 
what's going on with vaccine issues.
    What we've found so far, at least with the Vaccine Safety 
Datalink, is that there are lower rates of death in those that 
are vaccinated compared to the unvaccinated, and there are 
lower rates of cardiac complications compared to those that 
have been unvaccinated.
    What we're looking for in that VAERS system and these other 
systems is for signals of things that might be a problem that 
we need to followup on.
    I think this process works. We were able to find, like we 
mentioned in our opening statements, there were six cases of a 
blood clot problem, a very rare problem that we identified very 
early. We were able to communicate that to clinicians, 
communicate that, and follow a science-based process that we 
have at CDC where the science is evaluated. The data is 
analyzed. It's provided to the Advisory Committee for 
Immunization Practices. And we know that the Committee advises 
and provides it to the director to decide.
    So that process, that science-based process is what we've 
been following, utilizing the data.
    Dr. Ruiz. So, let's talk about the VAERS for a second. So 
that is a system where individuals can report their system--
symptoms that they believe may be associated with the vaccine.
    How do you then determine if it, in fact, is associated 
with the vaccine or it's not associated with the vaccine?
    Dr. Jernigan. Yes, so VAERS is a--it's essentially front 
door where anybody----
    Dr. Ruiz. It's a screening mechanism.
    Dr. Jernigan. Correct. They can put in anything they think 
may be associated with that vaccine. That means that we have a 
lot of reports that may not exactly be associated with the 
vaccine, but there's a process for reviewing those.
    Every serious adverse event in VAERS is followed up, 
medical records are collected, and autopsy records are 
collected to identify that.
    We don't use VAERS to determine if an adverse event is 
caused by the vaccine. We don't use it to look at trends about 
whether the vaccine's more commonly causing a problem versus 
what's in the general population. We use different datasets to 
do that.
    Dr. Ruiz. So, one can't subscribe the data from VAERS to 
being the actual rate of death or serious illness because 
that--that is an initial screening, and then the investigation 
that occurs afterwards will determine whether it was, in fact, 
related to the vaccine or not.
    Dr. Jernigan. Correct.
    Dr. Ruiz. So, then there are cases, for example, where 
death was reported that you found that it wasn't due to the 
vaccine, correct?
    Dr. Jernigan. Correct. So, for instance, a hospice patient 
who is one of the more vulnerable people that we do want to get 
vaccinated, they may have a standing order for ``do not 
resuscitate.'' And so that patient may die 2 days after getting 
the vaccine, but it really may not be associated with the 
vaccine.
    There are reports of vehicle injury in folks that have been 
vaccinated. There are even reports of family members who died 
for--caring for a vaccinated patient, but the death was not in 
the vaccinated patient--who had not been vaccinated.
    So, there are a number of those reports. But what we want 
is to be able to say: What's the impact of those vaccines? And 
we look to other datasets to really give us that information.
    Dr. Ruiz. Thank you.
    And as I mentioned in my opening statement, this rigorous 
surveillance system has demonstrated its effectiveness for the 
COVID-19 vaccines, detecting exceedingly rare cases of 
thrombosis with thrombocytopenia syndrome, or TTS, among 
patients who receive the J&J vaccine, for example.
    Dr. Jernigan, could you explain how the detection of these 
cases reflects the effectiveness of CDC's vaccine safety 
surveillance system?
    Dr. Jernigan. Yes, I think these indicate that the process 
works. You mentioned the TTS associated with the J&J vaccine. 
The systems have been able to pick up myocarditis and show that 
risk of getting myocarditis is much lower among those 
vaccinated than among those that were unvaccinated.
    It's even a system that we've been able to pick up signals 
that turn out not to be signals.
    Dr. Ruiz. Uh-huh.
    Dr. Jernigan. So, something called ischemic stroke can 
occur, and we picked up a signal, but when we continued to 
follow it, it went away.
    So, we get signals that sometimes are there, sometimes 
aren't. But it allows us to see things early so that we can act 
quickly and change recommendations when needed.
    Dr. Ruiz. Thank you.
    And, Dr. Marks, my understanding is that, following the 
detection of these cases, FDA limited the use of the J&J 
vaccine. Could you explain FDA reached this decision?
    Dr. Marks. Ranking Member Ruiz, thank you for that 
question.
    So, we evaluated the data that came in regarding the 
vaccine itself, the J&J vaccine. There were also another--there 
was another vaccine that was like that vaccine that was being 
used outside of the United States, which had a similar issue. 
We looked at the totality of those data.
    And then we changed the fact sheets for providers and for 
patients, making a recommendation that this not be kind of the 
first-line vaccine to be used but that it be used in those 
where a single-dose vaccine, which that particular vaccine 
was--was desirable rather than a two-dose regimen.
    Dr. Ruiz. And so, in this instance, our surveillance 
systems worked as designed, detecting rare but serious adverse 
events and informing a policy decision to best protect patients 
and consumers. Is that correct?
    Dr. Marks. That's correct.
    Dr. Ruiz. And what would you say to Americans who may 
believe that action taken to address rare adverse events with 
the J&J vaccine draw into question the safety of the broader 
universe of COVID-19 vaccines?
    Dr. Marks. I would say that this--the--I think what we see 
here in vaccine safety surveillance that may be confusing for 
the public sometimes is that, as an amateur radio operator, I 
sometimes listen to very weak signals, and sometimes that means 
you turn up the gain.
    We have the gain of our vaccine safety surveillance system 
turned up very high. That's the ability to detect signals. That 
means sometimes we hear things that turn out not to be true, as 
Dr. Jernigan just noted.
    I think we have the gain turned up high, and we've 
appropriately found signals, and we continue to look for 
signals. We sometimes find them.
    And, as I speak, we're in the process of evaluating whether 
there are signals that have been detected are real or whether 
they turn out to be just a statistical anomaly.
    Dr. Ruiz. So, I'm not an amateur radio guy. I'm a doctor. 
And it kind of sounds like what you're talking about is 
specificity and with--or sensitivity. And so, you know, it 
sounds like we want to detect as much as we can and then rule 
out the false positives, correct?
    Dr. Marks. So, in doctor's language--sorry----
    Dr. Ruiz. Yes.
    Dr. Marks. This is the idea here is indeed to have a very 
sensitive system to pick up any signal, and then we then go 
back and try to make sure it's truly related to the vaccine. 
Thank you.
    Dr. Ruiz. So, I hope my colleagues will heed the warnings 
we received ahead of today's hearings and keep our discussions 
rooted in objective information. Public confidence in vaccines, 
which have saved millions of lives and continue to be the most 
significant public health intervention of our time, is not 
something that should be undermined for partisan gain.
    So, I thank you, and I yield back.
    Dr. Wenstrup. I now recognize the Chairman of the full 
Committee, Mr. Comer, from Kentucky for 5 minutes of questions.
    Mr. Comer. Thank you, Mr. Chairman.
    I want to talk about the vaccine approval process and some 
safety signals that were downplayed.
    Dr. Marks, Pfizer submitted their full approval application 
on May 18th, 2021, correct?
    Dr. Marks. That's correct.
    Mr. Comer. And January 18, 2022, was the original required 
action due date, correct?
    Dr. Marks. That's correct.
    Mr. Comer. And you worked with Dr. Philip Krause and Dr. 
Marion Gruber on this, correct?
    Dr. Marks. That's correct.
    Mr. Comer. Thank you.
    When Pfizer submitted the application, Dr. Krause and Dr. 
Gruber oversaw the approval process. According to documents and 
testimony, they believed they could and should approve the 
vaccine faster than 8 months. They proposed the end of October 
2021. You, Dr. Marks, requested September 15, 2021. They 
hesitated, but obliged. You, Dr. Marks, then said you wanted it 
approved even faster than September 15, but they declined.
    According to them, after they declined, you and former FDA 
Commissioner Janet Woodcock relieved them from their roles in 
the approval process. They said that they felt, quote, 
``substantial pressure,'' unquote, from you to approve this 
vaccine faster than they thought was defensible.
    My question is, did anyone instruct you to speed up the 
approval timeline faster than September 15, 2021?
    Dr. Marks. Chair Comer, thank you for that question. I 
think it deserves an explanation.
    But what was going on during that summer that changed the 
situation was, in the week ending July 10th of 2021, there were 
1,645 deaths; in the week ending August 14th, there were 9,406 
deaths.
    There were an increasing number of deaths from COVID-19, 
and there was clear knowledge that having an approved vaccine 
would help Americans feel more comfortable getting vaccinated. 
So, we felt speeding up the vaccine approval process----
    Mr. Comer. So let me interrupt. Did anyone instruct you, or 
is this just a decision you made on your own?
    Dr. Marks. This was a decision that I had made on my own.
    Mr. Comer. So why were you pressuring the doctors and then 
removing them from the approval process when they disagreed?
    Dr. Marks. The approval process was one that was--needed to 
move as rapidly as possible. One of the physicians----
    Mr. Comer. OK. Let me--let me--we may go back to that.
    Do you recall any conversations regarding the need to 
approve the vaccines in order for it to then be mandated?
    Dr. Marks. There was an acknowledgment that an approval 
could allow vaccine mandates to occur, but they were not 
conversations over that, that it were----
    Mr. Comer. So, Dr. Gruber wrote that you and Dr. Woodcock 
expressed your opinion that absent a license states cannot 
require mandatory vaccination. Do you recall this conversation?
    Dr. Marks. I don't know what you're referring to, but I--
there is probably--it's just a statement of fact that that once 
you have a licensed vaccine, a mandate could be placed.
    Mr. Comer. Do you recall why Dr. Gruber and Dr. Krause 
expressed concern about accelerating the approval of the 
vaccine?
    Dr. Marks. They were concerned about the workload.
    Mr. Comer. OK.
    Dr. Gruber wrote that taking a thorough approach was 
important because of increasing evidence of association of this 
vaccine and development of myocarditis, especially in young 
men.
    Do you recall seeing safety signals regarding myocarditis 
in young men during this time?
    Dr. Marks. There were--yes, there were safety signals 
known, and they were placed on the label.
    But, Chair Comer----
    Mr. Comer. Let me finish. Did you ever have any 
conversations regarding the vaccine approval with the 
Department of Defense?
    Dr. Marks. I can't recall any conversation directly with 
the Department of Defense.
    Mr. Comer. Did anyone else at FDA have conversations 
regarding the vaccine approval with Department of Defense?
    Dr. Marks. I can't speak to the conversation of others I'm 
just not aware of.
    Mr. Comer. Did you express your desire to approve the 
vaccine by August 20th?
    Dr. Marks. I did.
    Mr. Comer. And it was ultimately approved on August 23d, 
correct?
    Dr. Marks. Correct.
    Mr. Comer. And just for the record, the military mandate 
was issued on the 24th, and that is interesting timing.
    Thank you, Mr. Chairman, and I yield back the balance of my 
time.
    Mr. Wenstrup. I now recognize Mrs. Dingell from Michigan 
for 5 minutes of questions.
    Mrs. Dingell. Thank you, Mr. Chairman.
    I am concerned that America's confidence in--in the safety 
and efficacy of vaccines is of critical importance to our 
Nation's public health. For hundreds of years, dating back to 
1796 and cow pox, vaccines have saved lives and reduced the 
threat of deadly diseases, from polio to measles to COVID-19.
    However, we are now witnessing a startling decline in 
immunization levels across the board. And I'm deeply concerned 
about what this means for our Nation's ability to respond to 
public health threats in the future. We're having measles 
breakouts. We've got one in Washington, DC, from exposure at 
the airport.
    So, I want to focus on what we can and should do to promote 
vaccine confidence with constructive reforms that enhance 
community engagement and strengthen the vaccine systems.
    One way I think we can go about this is approaching people 
with compassion, but making sure that their questions are 
answered honestly, with trustworthy, accurate information that 
breaks through some of the noise, by the way, that's a lot of 
false information online.
    During the height of the pandemic, Democrats passed the 
American Rescue Plan, which not only helped get vaccines out to 
the American people but also invested in community-based 
outreach programs to help increase vaccine uptake. These 
programs focused on meeting people where they were, to equip 
them with transparent, reliable information about vaccine 
safety and development.
    Dr. Jernigan, I'd like to get your thoughts--short, because 
I have some other questions. How does the CDC work to proceed 
people with timely, accurate information regarding vaccine 
safety and efficacy?
    Dr. Jernigan. Thanks. Yes, at CDC, we are committed to 
transparency, and we regularly share that information on 
vaccine safety with our Federal partners, state partners, 
through our different communication mechanisms that we have--
through the web, through other media, et cetera.
    Mrs. Dingell. So, I think it's important that people know 
about the known side effects of the vaccine or rare adverse 
events that may occur after vaccination.
    The Subcommittee is probably tired of hearing me talk about 
getting Guillain-Barre after a swine flu shot--which, by the 
way, I was mandated to get and assured that it was safe and 
effective, and it was obviously neither.
    And I was scared to death to get this COVID vaccine. I 
sought out accurate information from physicians at U of M and 
any doctor I knew walking down the street--some of them may not 
have been qualified--to reassure me about the safety of the 
COVID-19 vaccine. And I finally did get it, and prepared to 
die. But, unfortunately, I'm still here giving everybody a hard 
time--well, fortunately. I shouldn't say it that way.
    But, ultimately, I supported the Biden administration's 
commonsense policies to increase vaccine uptake because I 
believed we had systems in place. The systems that we're 
discussing today were working to ensure that adverse events 
could be detected and meaningfully addressed.
    Dr. Jernigan, can you please speak to the ways in which the 
CDC provides transparent information regarding rare adverse 
events that may occur from various vaccines, including COVID-19 
vaccines?
    Dr. Jernigan. Thanks.
    So, as we mentioned, there are a number of different 
surveillance systems that we monitor. Once we see any signal 
there, we communicate that to the general public, to the 
healthcare providers. We provide that information to the 
Advisory Committee, and then recommendations can be changed.
    So, we are committed to transparency. We provided 
information on risk-benefit analysis at 30 different ACIP, 
Advisory Committee, meetings over the last 3 years. So, we get 
that information out so people can understand.
    Mrs. Dingell. So do you think doctors are getting it.
    And what steps do you think Congress should take to support 
and strengthen these efforts? For example, what role does 
comprehensive funding from Congress play in CDC's ability to 
operate these surveillance programs?
    Dr. Jernigan. Certainly, we want to work very closely with 
healthcare providers. It's really that connection between the 
healthcare provider and the patient that is where the decisions 
and the understanding comes from many times. We want to get 
that information out.
    We have safety systems right now that were at one level 
before the pandemic, are at a very high level now in terms of 
the activities that we're doing. And we are not needing to go 
back to where we were before. We need to sustain those systems 
that are broad now, help us with new vaccines that come out, 
get the most information about safety.
    Mrs. Dingell. So, in the rare instances when something does 
go awry and an adverse event occurs, people need to know there 
is protection and compensation available to them should they 
need it.
    Commander Grimes, how do our Nation's vaccine compensation 
programs work to adjudicate valid claims or compensate 
individuals as quickly as possible?
    Dr. Grimes. Thank you, ma'am, for that question.
    So, the Countermeasures Injury Compensation Program, or the 
CICP--we're required by statute to make a determination based 
on the compelling, reliable, valid, medical, and scientific 
evidence that a serious physical injury or death was directly 
caused by the countermeasure.
    We have at least three advanced practice providers that 
review each claim. And a claim is reviewed for legal 
sufficiency to ensure that it meets with the statutes set by 
Congress.
    Mrs. Dingell. Thank you, Mr. Chairman. I'm out of time. But 
I hope we all will work together to make sure people do keep 
confidence in--vaccines prevent death, ultimately.
    Dr. Wenstrup. I now recognize Ms. Malliotakis from New York 
for 5 minutes of questions.
    Ms. Malliotakis. Good morning, and thank you, Mr. Chairman, 
for holding this important hearing on vaccine safety and injury 
compensation.
    I would like to extend my gratitude to all the witnesses 
for taking the time to share their expertise with us today.
    In March 2020, our world experienced a profound and 
undeniable shift, and the rapid spread of COVID-19 brought both 
fear and uncertainty. Then, in an extraordinary triumph of 
science innovation, a vaccine was developed in record time. 
This groundbreaking moment held the promise of protection and a 
return to normalcy.
    However, subsequent actions, from overstating vaccine 
efficacy to the implementation of sweeping mandates and the 
suppression of open scientific debate, eroded public trust, and 
these decisions left lingering questions about vaccine safety, 
sparking both valid concerns and unfounded fears.
    We have systems expressly designed to monitor for vaccine-
related harms and provide recourse for injuries. Unfortunately, 
the actions surrounding the COVID-19 vaccine have highlighted 
areas where these systems may have fallen short. And we can 
start rebuilding trust for safe and effective vaccines in the 
future. After all, we do know that vaccines really are 
oftentimes lifesavers.
    But I do want to point specifically to the concerns about 
post-vaccination heart issues, particularly myocarditis in 
young people. In fact, myocarditis is one of the injuries that 
have been compensated for.
    And I'd like to know from both--either Dr. Jernigan or Dr. 
Marks, what specific monitoring--or, I guess, safety monitoring 
or research projects are currently underway by the CDC or the 
FDA to delve deeper into this issue?
    Dr. Marks. So, I'm happy to start. Thank you for that 
question.
    We have had multiple go-rounds in our adverse event 
reporting systems that use active surveillance--one of them is 
called the BEST System--to look among large data bases--claims 
data bases and electronic healthcare records--to look at the 
incidence of myocarditis in vaccinated individuals versus 
nonvaccinated individuals.
    And some of that work has now been published. I think it 
leads us to understand that, after the first COVID-19 vaccine, 
where--the primary series, given two doses 3 to 4 weeks apart--
there was a risk in the younger age range of males that was 
about 1 in 10-to 1 in 20,000--1 in 10,000 to 1 in 20,000 
individuals got myocarditis. Now, with the spacing out of the 
vaccines, that risk is almost undetectable.
    And there was a recent study published in JAMA Pediatrics, 
in 3-million-plus individuals, ages 5 to 17 years, who had 
received 5.9 million vaccine doses, which really only--again, 
it confirmed what we had seen: There was a signal for 
myocarditis or pericarditis only after the primary vaccination 
series with the Pfizer mRNA vaccine in those 12 to 17 years of 
age, and that now that signal is not being seen more recently.
    So, I think we've learned something about how to deploy the 
vaccines. And I think that's why CDC--I can turn it over to Dr. 
Jernigan--has changed their recommendations for how they be 
used.
    Ms. Malliotakis. Yes, if you'd quickly add to that.
    Dr. Jernigan. No, just to say that we do have systems--the 
VAERS system, the Vaccine Safety Datalink that is also 
monitoring, other systems that are continuing to monitor for 
myocarditis.
    Ms. Malliotakis. OK.
    As more time passes, is the FDA actively conducting safety 
surveillance on those who received the early COVID-19 vaccines? 
Like, are there specific health markers that you are studying 
that may signal trends requiring further inquiry?
    Dr. Marks. Thanks very much for that question. In fact, 
every time we go through and do the safety surveillance, we 
start back, and it goes back to 2020. In some cases where we're 
looking for certain things, we might use a different window. 
But, indeed, we have to look from the beginning of the period 
of surveillance.
    I can turn it over to Dr. Jernigan because he can speak for 
CDC in that regard.
    Dr. Jernigan. So, with regard to myocarditis, we certainly 
have been monitoring the issue with various different data 
systems. I think the most recent data really demonstrates that 
there's about eight times less likely to get myocarditis if 
you're vaccinated compared to those that are unvaccinated.
    Ms. Malliotakis. Yes. Not just myocarditis; everything.
    Dr. Jernigan. Repeat the question then.
    Ms. Malliotakis. As more time passes, is the FDA actively 
conducting extended safety surveillance on those who received 
the early COVID-19 vaccines?
    Dr. Jernigan. Yes, most of the reports that we get of 
adverse events are in the few weeks following the vaccination. 
In terms of monitoring these over time, we do have vaccine 
effectiveness systems that are in place at CDC.
    Ms. Malliotakis. OK.
    I've run out of time, but thank you very much.
    Dr. Wenstrup. I now recognize Ms. Ross from North Carolina 
for 5 minutes of questions.
    Ms. Ross. Thank you very much, Mr. Chairman.
    And thank you so much to our witnesses for being here 
today.
    I just want to correct the record on some 
misrepresentations that we've heard here but we've also heard 
in the public regarding the COVID-19 vaccine and vaccine safety 
systems more broadly.
    In listening to today's hearing, one might be led to 
believe that reports submitted to the Vaccine Adverse Event 
Reporting System, or VAERS, are the most meaningful measure of 
adverse health events and should be the sole basis for 
evaluating whether the COVID-19 vaccines are safe.
    However, my understanding is that VAERS is just one 
surveillance program within a multilayered vaccine safety 
system that CDC operates, and that submissions to VAERS--which 
are unverified, can be submitted by anyone, regardless of how 
likely a vaccine is to have created an adverse event--can act 
as early warnings to be prompt deeper investigations through 
these other surveillance programs.
    Is that correct, Dr. Jernigan?
    Dr. Jernigan. Yes. Yes, so VAERS is a system for getting 
information in and quickly identifying trends, but it is not 
the data set that we use to determine causality or the impact 
of the vaccine.
    Ms. Ross. And can you explain in more detail how VAERS 
prompts this deeper investigation through other safety 
surveillance programs at the CDC?
    Dr. Jernigan. Yes. I think, over the last several years, 
there have been 676--over 676 million doses of vaccine that 
have been administered, and we've had a significantly, 
exceedingly rare number of adverse events reported. There's an 
even lower number of serious adverse events. Each of those 
serious adverse events does have a follow-up. They ask for 
medical records and for autopsy records.
    We utilize it in different systems, like our Clinician 
Immunization Safety Assessment Program that can then evaluate 
some of the findings. We also have other data sets that can 
really tell us if there's an increased signal across the 
general population that we need to be worried about.
    Ms. Ross. Thank you for that.
    And then, for the reasons you just explained it, it seems 
that the VAERS data, on its own, does not provide a strong 
basis for evaluating causality and that doing so does require 
this multilayered approach. Is that correct?
    Dr. Jernigan. Correct.
    Ms. Ross. And how far are you into that multilayered 
approach for the COVID vaccines?
    Dr. Jernigan. Well, in terms of using all those different 
systems, we have used--they're on an ongoing basis. And we've 
presented at each of the advisory committees on what we're 
finding in all of those systems regularly.
    Ms. Ross. OK.
    And so, just to be abundantly clear, using the VAERS data 
exclusively to make claims about COVID vaccines causing adverse 
health effects would be flawed?
    Dr. Jernigan. VAERS is not intended to determine if a 
vaccine is causing an adverse event.
    Ms. Ross. OK. Thank you very, very much.
    Dr. Marks, my colleagues have attempted to distort an email 
that you sent in July 2021 regarding the authorization of the 
Pfizer booster. They've claimed that this is evidence of 
political interference that undermined patient safety in favor 
of expediting the timeline for this product.
    Dr. Marks, I'd like to give you an opportunity to correct 
the record on the misrepresentations of this email that have 
been made, and just give you--I have a minute and 15 seconds. 
It's all yours.
    Dr. Marks. Thank you so much for the opportunity, 
Congresswoman Ross.
    At the time that these boosters were authorized, just 
before, we had an increasing number of deaths, starting to run 
into the thousands per day, in the United States, and there was 
great urgency to think about what we could do to try to reduce 
that number of deaths. It had become clear that immunity was 
waning and that potentially giving a booster could restore 
immunity and decrease the number of deaths.
    And so, we moved with all due haste, not because of any 
kind of external pressure, but because of internal pressure. We 
felt compelled to try to save American lives, because thousands 
of people were dying. And as somebody who was one of the 
architects of Operation Warp Speed, I had a pretty good idea 
about how to find efficiencies to move forward.
    It was critical to move as fast as we could. And, by the 
way, the data that has now been published showed that 
introduction of that first booster was probably responsible for 
saving hundreds of thousands of lives as we entered the Delta 
and Omicron waves.
    Thank you.
    Ms. Ross. Thank you so much for that explanation.
    And, Mr. Chairman, I yield back.
    Dr. Wenstrup. I now recognize Mrs. Lesko from Arizona for 5 
minutes of questions.
    Mrs. Lesko. Thank you, Mr. Chairman.
    Thank you all for being here.
    Dr. Marks, we spoke over the phone back on August 10th of 
2021, and I was asking about VAERS, because I had lots of 
constituents reaching out to me, saying there was tons of 
adverse effects, there was thousands of deaths, et cetera, and 
they were very concerned. And I asked how many were confirmed. 
And, at that time, you said four; there were four cases that 
you confirmed deaths of that were caused by the vaccine.
    And I suggested at the time that the CDC and the FDA do a 
better job of telling the public not just how many cases were 
reported but how many were actually confirmed. And if I heard 
you right, just recently you said, well, we don't want to give 
out too much information because of privacy rights.
    But certainly, we could put out how many were confirmed 
deaths, couldn't we?
    Dr. Marks. Congresswoman, thank you so much for that 
question. I fully agree with you that we probably have not done 
a good enough job of communicating, sometimes----
    Mrs. Lesko. Well----
    Dr. Marks [continuing]. The actual numbers of deaths versus 
what's in VAERS. In fact, we just nearly fell prey to it here 
at this hearing.
    There are only handfuls--and I'll ask Dr. Jernigan to 
comment on this as well--handfuls----
    Mrs. Lesko. Well----
    Dr. Marks [continuing]. That we can actually associate 
with----
    Mrs. Lesko [continuing]. Can I ask why you haven't done it?
    I mean, this was August 2021. It's very logical to me that, 
if you're saying people--the public shouldn't count on VAERS 
because anybody can report to that--which they can--why 
wouldn't you as actively report to the public, ``Well, we 
confirmed this really low number of cases that actually were 
caused by vaccines''?
    I mean, it's been years now. Why haven't you done it?
    Dr. Marks. We did present that in various settings, 
including at, I believe, at the Advisory Committee of 
Immunization Practices. It was mentioned at our Vaccine 
Advisory Committee. It perhaps did not go as broadly as----
    Mrs. Lesko. Is there an easy place for the public to find 
this? I remember you gave us some kind of link back in 2021, 
but it was really difficult to get to, if I remember right.
    And so why not spend the time, like, making--if the goal is 
to give confidence to people in getting vaccines, why in the 
world would you just not say, ``OK, what we have done is we've 
investigated these deaths, we've done this, we've done that, 
and we only found, you know, a handful''? I mean, it doesn't 
make any sense to me.
    But I want to continue. I'm sorry. I have only a short 
period of time.
    One of my former constituents--and I think I talked to you 
about this, Dr. Marks--from Surprise, Arizona, Steve Wenger, 
worked for a company that forced him, mandated him, to receive 
the COVID vaccine in May 2021. He got the J&J vaccine.
    Within a month of receiving the vaccine, he was in the 
hospital, paralyzed from his neck down. He spent over 3 months 
in the hospital and was eventually diagnosed with Guillain-
Barre syndrome. And, actually, the doctor has said right on his 
medical stuff that it was most likely caused from the vaccine.
    Steve continues to struggle with his injuries today, all 
because he was forced to take an experimental vaccine at the 
urging of the health agencies.
    Mr. Wenger's injury was also reported to VAERS. And he 
filed a claim with CICP about 2 years ago, he said, and has not 
heard back at all; he said, not even a form letter.
    So, I want you to know that, Commander, so that--maybe my 
office can give you his name so you can at least respond that 
you got the claim from 2 years ago.
    Also, there was a New York man who suffered from HLH after 
his COVID vaccine. His initial report was classified as ``life-
threatening.'' His second report, filed after his death, was 
classified as ``hospitalized.'' The family called to request a 
correction to the second report to be a fatality and was 
instructed to file another report and was then sent a form 
condolence letter from the CDC. And the fatality was in May 
2021; the form letter was received in December 2022.
    The family was subsequently sent an automated message at 
the end of 2023 to update their VAERS report on his condition. 
``He is dead,'' they said.
    The family has been very distressed by the lack of proper 
investigation done and classification that he's actually died.
    And so, all I'm saying--I've run out of time--is that, as 
you have said, you've increased the number, Commander, from 4 
personnel to, I think you said, 35. Obviously, more work needs 
to be done if people haven't been--you know, the person died, 
and it still says they're hospitalized. I mean, this is a huge 
problem.
    And, with that, I yield back.
    Dr. Wenstrup. I now recognize the Ranking Member of the 
full Committee, Mr. Raskin from Maryland, for 5 minutes of 
questions.
    Mr. Raskin. Thank you, Mr. Chairman.
    Dr. Marks, you said a moment ago that the vaccine booster 
alone saved hundreds of thousands of lives. How many lives have 
been saved by the COVID-19 vaccine generally?
    Dr. Marks. It's estimated about--in the United States, 
about 3.2 million lives. And it's estimated that, globally, 
COVID-19 vaccines have saved over 14 million lives, 
conservatively.
    Mr. Raskin. And we've lost more than a million people to 
COVID-19?
    Dr. Marks. That's correct, about 1.1 million. I kept a 
daily record of the number of people dying, which got up to 
about 3,300, about a World Trade Center disaster, a day.
    Mr. Raskin. Deborah Birx, who was former President Trump's 
White House Coronavirus Response Coordinator, stated that a 
sequence of missteps and mistakes made by the prior 
administration's pandemic response cost hundreds of thousands 
of American lives.
    So, I take it, one of the points you have to make is that 
the public health response of the Federal Government makes a 
huge difference in terms of health outcomes for the American 
people?
    Dr. Marks. I would agree with that.
    Mr. Raskin. Whether it's measles or tuberculosis or COVID-
19, would you agree that vaccines save lives in the aggregate?
    Dr. Marks. I think that, by definition, for us to approve 
or authorize a vaccine, there has to be overwhelming evidence 
that many more lives are saved than might be taken by a 
vaccine. In other words, the safety profile, by definition, has 
to be excellent.
    Mr. Raskin. Gotcha.
    So, Dr. Jernigan, it seems as if one of the things that's 
created political or social conflict around this is the 
inevitable fact that, even when vaccines save a huge number of 
lives, millions of lives, as Dr. Marks just testified, if in a 
small number of cases there are adverse results, the people who 
suffer them, and their families, are understandably very upset 
about that.
    Would you agree that that's a general conflict or dynamic 
that exists with all vaccines?
    Dr. Jernigan. Correct. I think, you know, we recognize that 
no medical intervention is risk-free. So that goes with medical 
interventions.
    Mr. Raskin. And I can imagine if I had a family member who 
suffered an adverse reaction to any vaccine--measles, TB, 
COVID-19--I would say, I just wish they hadn't gotten it in the 
first place. And, of course, if anyone had been able to predict 
it, they would've been told not to get it.
    On the other hand, if we just said to everybody, ``There's 
a tiny number of people who suffer an adverse result; therefore 
nobody should get it,'' we know a lot more people are going to 
suffer and die because of it.
    Is that a basic problem that you wrestle with in your 
field, Dr. Jernigan?
    Dr. Jernigan. Correct. I think anytime we're talking about 
public health measures, we have to think about the risks and 
the benefits. And the way that we communicate that is very 
important so that people will take those interventions.
    Mr. Raskin. Have you detected anything at the CDC, through 
your surveillance systems, that has caused you to doubt the 
safety or the appropriateness of the CDC's original and 
continuing recommendation that people get vaccinated against 
COVID-19?
    Dr. Jernigan. So, you know, I dedicated my life to public 
health, and I do care deeply about protecting Americans and 
using the best available science, and I want to stress that the 
COVID vaccine is safe, and it is effective.
    We have safety monitoring systems in place that have 
detected certain signals; we've acted on those quickly.
    Mr. Raskin. Would you agree that the COVID-19 vaccine and 
its roll-out in the Biden administration has been one of the 
great achievements of modern science and public health?
    Dr. Jernigan. I think over the last 4 years we've had a 
once-in-a-lifetime event that required an incredible response 
from all of us, and so would agree that the use of vaccines has 
been a remarkable achievement for us all.
    Mr. Raskin. There's a paper that someone sent to me called 
``Excess Death Rates for Republicans and Democrats During the 
COVID-19 Pandemic'' from the National Bureau of Economic 
Research, which makes the point that there were substantially--
or, there have been substantially higher death rates for 
registered Republicans when compared to registered Democrats, 
and this has been connected to vaccine hesitancy or fears.
    And I'd like to submit this for the record.
    But I just wonder if you would opine on this for a second. 
Have we ever seen a case like in the past, where there's 
actually partisan differences in people's willingness to get a 
vaccine, their skepticism, and then death rates arising from 
such differences?
    Dr. Jernigan. I think you point out the importance of us 
getting to--so that folks can be vaccinated.
    Mr. Raskin. Thank you very much.
    And I'll submit this for the record, Mr. Chairman, if I 
could.
    Dr. Wenstrup. I now recognize Ms. Greene from Georgia for 5 
minutes of questions.
    And, without objection, submitted to the record.
    Ms. Greene. Thank you, Mr. Chairman.
    I'm not a doctor, but I have a Ph.D. in recognizing 
bullshit when I hear it.
    I'd like to point out to everyone that we knew early on--as 
a matter of fact, everyone knew early on--that the people that 
were at risk of hospitalization and dying of COVID were those 
that were obese, had diabetes, were over the age of 65. We also 
knew that children were at no risk, practically zero risk, of 
being hospitalized or deaths from COVID-19. We knew that young 
people--healthy young people were not at risk.
    However, Dr. Marks, you rushed through this process of 
authorizing these vaccines, even though you knew the side 
effects, you knew about myocarditis, and you knew about the 
studies.
    So, let's be very real about the situation that we have.
    [Chart.]
    Ms. Greene. Here we have--let's talk about the reports on 
VAERS. Some people in here are trying to belittle these 
reports, but these reports come from people--people that died, 
people that got injured.
    And in December, in the middle of December--I think it was 
the 10th or the 11th--the first vaccine was approved, it was 
authorized, under emergency use. Boom, 10,596 reports in less 
than a month. 2021, 706,767 reports on VAERS for vaccine 
injuries and deaths. 2022, it was 206,676. 2023--and it went 
going down because the mandates stopped.
    Now, let's talk a little bit more about the vaccines. Here 
we have reports: deaths, 18,372; permanent disability, 17,842; 
hospitalizations, 86,452; emergency room or office visits, 
315,048; serious adverse events, 113,449. This is from the 
congressional Research Service about VAERS. All kinds of 
injuries--miscarriages, heart attacks, myocarditis, permanent 
disability, neurological problems. And it goes on and on and 
on.
    These are the reports from people being forced to take 
vaccines. Shouldn't have happened.
    Mr. Grimes, I've just told you the numbers of reports. 
However, under CICP, there are only 10,640 of these COVID-19 
claims that are currently pending or are in review. And as of 
January 1st, 2024, CICP only compensated 11 of the 40--oh, 
wait. Let's make that number clear to everyone. Only 11 people 
have been compensated. Only 11 people have been compensated out 
of the 40 COVID-19 claims that determined were eligible. Only 
40 were determined eligible. That is amazing.
    And the average award was only about $3,700. On the other 
hand, the average VICP payout over the last 35 years is 
approximately $490,000. If you die or get injured from a COVID-
19 vaccine, your average payout's $3,700.
    I'd like to recognize someone in the room today who's here, 
Brianne Dressen.
    She's met with you, Dr. Marks. She's met privately with you 
about her vaccine injuries.
    She participated in a clinical trial, she was injured, and 
then she was dropped from the trial for the COVID-19 vaccines. 
Her medical expenses are $433,000 a year.
    She filed with CICP. Mr. Grimes, she's gotten no response.
    She's right here.
    Could you raise your hand, Ms. Dressen, please? Thank you.
    Perhaps you could meet with her after this meeting.
    Dr. Marks, you admitted to her that vaccine injuries are 
real--that they're real--although you rushed through the 
authorization, and now you've authorized that children should 
receive these vaccines, and even babies as young as 6 months 
old. That is shameful. That's shame---I'm not asking you a 
question. I'm going to continue speaking. Thank you. This is my 
time.
    The National Institute of Health also saw Ms. Dressen for 
her neurological complications that have been quite severe. 
They studied her, and then they dropped the study and asked her 
to be quiet about it.
    These are the real stories of the vaccine-injured. They 
were totally, completely wiped off of social media. There's 
been thousands of peer-reviewed medical studies, thousands of 
them, studying vaccine injuries. They are real. People are 
dying. People are having heart attacks, strokes, blood clots. 
And many other countries are dropping the COVID-19 vaccine and 
saying we shouldn't give them to children.
    It's time to be honest about the vaccine-injured. And we 
need to stop allowing these COVID-19 vaccines to be given out--
--
    Dr. Wenstrup. The gentlelady's----
    Ms. Greene [continuing]. To children.
    Dr. Wenstrup. The gentlelady's time has expired.
    I now recognize Mr. Garcia from California for 5 minutes of 
questions.
    Mr. Garcia. Thanks, Mr. Chairman.
    I am sorry you all had to go through that. That was a lot 
of conspiracy theories and wild accusations, which we know have 
been debunked by medical science. And we should be clear that 
vaccines work and save lives, and they have millions of lives 
in this country.
    Now, it's really unfortunate that we're actually here 
having this hearing trying to poke holes and cause more vaccine 
hesitancy amongst the public. But we know that we're here 
because Committee Members on this Committee have demanded that 
we have this hearing, and we continue to cave and give those 
Members everything that they want.
    Now, we also know that we have a Member of this Committee 
that just actually made some comments, who's been on social 
media demanding that we hold this exact same hearing.
    [Chart.]
    Mr. Garcia. This is the same person that we know that has, 
on countless posts, has spread misinformation, encouraged 
parents to refuse routine vaccinations for their children--
which you just heard, by the way--and even compared our 
pandemic response efforts to the Holocaust.
    I want to just actually read something which is in the 
public record--I'm not saying anything that's not in the public 
record--that a Member of this Committee actually said, this 
same person that is actually attacking vaccines, said that 
``vaccinated employees get a vaccination logo, just like the 
Nazis forced Jewish people to wear a gold star.''
    I want to read that again: ``Vaccinated employees get a 
vaccination logo, just like the Nazis forced Jewish people to 
wear a gold star.''
    That is the level of insanity and attacks that we are 
having here as we actually debate the lives saved around 
vaccinations.
    Now, this same Member has also held shadow public hearings 
promoting ideas that COVID is a bioweapon to target people of 
specific races and the vaccines, and I quote, cause ``turbo-
cancers.''
    I want to read you this quote. And it's, again, in the 
public record, at a hearing. ``Have the COVID vaccines resulted 
in an increase in cancers? And are turbo-cancers real?''
    Now, Mr. Chairman, this is, I mean, in my opinion, just 
insanity. We know that's not the case.
    Dr. Marks, can you clarify once again for the American 
people, do the COVID vaccines cause turbo-cancers?
    Dr. Marks. I'm a hematologist and oncologist that's board-
certified. I don't know what a turbo-cancer is. It was a term 
that was used first in a paper in mouse experiments, describing 
an inflammatory response.
    There are--we have not detected any increase in cancers 
with the COVID-19 vaccines.
    Mr. Garcia. Thank you. And I--and thank you for correcting 
the record----
    Dr. Marks. But may I--may I just add something here.
    I do need to apologize to the thousand or so parents of 
children who are under 4 years of age who have died of COVID-19 
who were unvaccinated. Because there were deaths and are 
continuing to be deaths in children, and that is the reason why 
they need to get vaccinated.
    Thank you.
    Mr. Garcia. And I agree with you 100 percent. And the fact 
that we are now having parents that are choosing to vaccinate 
their kids less than before, because of all of the attacks on 
vaccinations, is shameful. And it's shameful that Members of 
Congress continue to put down vaccinations as an opportunity to 
get our communities healthier.
    And, Dr. Marks, I want to thank you for the work that you 
did. My mom passed away to COVID-19. My stepfather passed away 
due to COVID-19. Both would've taken that vaccination in an 
instant if it was available to them.
    And so, anytime that folks, especially folks on this, you 
know, Subcommittee on the pandemic, attack vaccines, it's 
personally insulting to all the families that have actually 
lost loved ones. We've saved millions of lives because of the 
vaccine. It's unfortunate we keep causing this harm.
    I just want to say, last, that--Dr. Marks, do you agree 
that additional lives would've been saved--additional--the 
lives that--the folks that were not vaccinated that we lost--
over a million, obviously, in this country--wouldn't a vast 
majority of those lives have been saved had we had the vaccine 
and had they been vaccinated?
    Dr. Marks. Multiple studies show that 80 to 85 percent of 
the deaths that occurred were in unvaccinated individuals. So, 
if we would've been able to reach a higher vaccination rate, 
it's likely that we would've had fewer deaths. And countries 
where they reached higher vaccination rates had fewer deaths 
per capita.
    Mr. Garcia. Thank you.
    And I encourage this Committee and all Members of Congress 
to encourage vaccinations across this country to save more 
American lives.
    With that, I yield back.
    Dr. Wenstrup. I now recognize Mr. Mfume from Maryland for 5 
minutes of questions.
    Mr. Mfume. Thank you, Chair Wenstrup and Ranking Member 
Ruiz.
    I want to join in with the previous comments of Members of 
the Committee and welcome all of you again for being here with 
us today.
    Mr. Chair, I would also, on a point of personal privilege, 
remind Members of this Committee, even though I am not the 
Chair, that there should be some sense of decorum, and 
vulgarity should be discouraged.
    So, if I ever say that I'm a Ph.D. in BS, it means 
``Bulgarian sunshine.'' You will not hear me talk about, 
explicitly, the thing that I won't mention here today. There 
are people watching across this Nation who want and, quite 
frankly, really expect that the Congress, if no other place, 
will conduct itself in a way that does not insult any of them 
personally because of vulgarities and in a way that we should, 
in fact, conduct business.
    Mr. Chair, the American ethic has always been one of 
independence and self-sufficiency. As a society, we see our 
health decisions as deeply personal and deeply private. In some 
instances, that proclivity toward individualism can lead to a 
hesitancy surrounding certain health innovations such as 
vaccines.
    In the case of the COVID-19 pandemic, fearmongers amplified 
vaccine hesitancy. And it was done, as we all know, without, 
necessarily, substance or facts, but through fear, by way of 
news networks, late-night talk shows, and syndicated radio 
shows.
    Those talking heads unfortunately took advantage of certain 
communities' negative experiences with the American public 
health system by playing on fear and mistrust and by amplifying 
over and over again a vaccine hesitancy across the Nation.
    Now, when you do that, you really play with fire--in this 
case, the fire that the gentleman from California mentioned 
also about how we lose loved ones, how people die, and how that 
rate of death accelerated over and over again.
    I really want to thank God that Jonas Salk, the great 
virologist, in 1955, did not run into that nonsense when he 
developed the vaccine for polio. Parents were clamoring because 
they wanted their children to be able to walk and have a good 
life. There was a sense of sense and sensibility that went 
along with that.
    So, when it's done right, it's done right. So many children 
and others were vaccinated for polio successfully. And were 
there some bad stories along the way? I'm sure there was, just 
as we've heard, when you're dealing with science, there is not 
of a 100-percent certainty in everything.
    Mr. Chairman, my colleagues on both sides of the aisle know 
that COVID vaccines, even under accelerated development 
timelines, have proven over and over again to be safe.
    I would ask unanimous consent, Mr. Chair, that I submit 
into the record this article from Vox, the general interest 
news site, entitled, ``Will America continue to turn away from 
vaccines?''
    Dr. Wenstrup. Without objection.
    Mr. Mfume. Thank you, sir.
    Dr. Jernigan, can you explain for the Committee again, if 
you don't mind--I mean, there are some people watching this 
around the Nation who have tuned in late and perhaps missed 
some of the earlier discussion.
    Can you explain for the Committee again, if you might, the 
multilayered process of vaccine safety monitoring that the CDC 
implemented for COVID-19?
    Dr. Jernigan. Thanks. And, you know, I've worked in public 
health since 1994, responded to multiple infectious disease 
emergencies, and this is the most robust vaccine safety 
monitoring system that we have ever had.
    There are five different systems. We use all of those to 
determine the impact of those vaccines and the association with 
safety. All of those systems are used by CDC.
    Mr. Mfume. And can you also corroborate that this seems to 
be, at least, by all standards, an incredibly thorough process 
that meets all the merits of scientific approach and scientific 
roll-out for such? Why are these systems so crucial in 
maintaining and strengthening vaccine confidence in the United 
States.
    Dr. Jernigan. Yes. I think, you know, we want to make the 
best recommendations with the best available science. And so, 
for that, at CDC, we use a science-based process to get to 
those recommendations.
    And so, making sure that science is first, and making sure 
that we have the data and making the right recommendations with 
the best available science.
    Mr. Mfume. Thank you.
    I want to thank all of you again for being here with us.
    And, Mr. Chairman, I yield back.
    Dr. Wenstrup. I now recognize Dr. Miller-Meeks from Iowa 
for 5 minutes of questions.
    Dr. Miller-Meeks. Thank you, Mr. Chairman.
    And I want to thank the witnesses for testifying before the 
Select Committee today.
    I want to also say that I am a former director of the State 
Department of Health in Iowa, Public Health, and was 
vaccinated, and gave vaccines in all 24 counties of my 
district; however, have never been for a vaccine mandate for 
COVID-19, both when I was distributing vaccines as well as 
today.
    Dr. Marks, COVID-19 remains somewhat of a public health 
challenge, especially given declining vaccination rates and 
growing vaccine hesitancy and fatigue. And let me say, as a 
public health director and as a state senator, vaccine 
hesitancy and fatigue is not new, this has been an issue, but 
it has been greatly enhanced through COVID-19 vaccine mandates.
    To optimize the effectiveness of COVID-19 vaccines, I 
understand that the FDA has recommended periodic updates to 
vaccine composition. As we have seen with influenza, a clear 
framework for strain selection supports the timely availability 
of a diverse supply of COVID-19 vaccine platforms.
    I believe that multiple FDA-approved vaccine options can 
play a role in preserving consumer choice of products and 
ensuring equity of access, both of which can contribute to 
increased consumer acceptance and uptake of vaccines without 
forcing Americans to receive a specific option.
    Can you please speak to how the agency is taking steps to 
ensure vaccine manufacturers have the essential time needed to 
adapt their products accordingly and scale up production for 
vaccines for new virus variants?
    Dr. Marks. Congresswoman Miller-Meeks, thanks very much for 
that question.
    I would certainly agree with you that at FDA we take 
seriously the need to have choice among vaccines, because that 
will allow a greater vaccination rate, because we understand 
that some people may not feel comfortable with certain types of 
vaccines; they may want a more traditional vaccine rather than 
a newer vaccine.
    That's why we've been continuing to work with manufacturers 
to try to make sure that, when we roll out the next update, we 
will have a diversity of choice, at least more than one type, 
of vaccine that will be available. So, you will see, as we move 
into the spring, we will, as you've noted, go through a strain 
selection process.
    We're already having dialog with manufacturers to help them 
get prepared--because there's a lot of pre-work that they can 
do at risk to prepare for this--so that we can hopefully have 
the choice that you're talking about.
    Dr. Miller-Meeks. Thank you.
    Dr. Grimes, as you know, COVID-19 vaccines are covered 
countermeasures under the Countermeasure Injury Compensation 
Program, CICP, which is overseen by HRSA, instead of the 
National Vaccine Injury Compensation Program, VICP.
    With FDA being responsible for authorizing and approving 
the COVID vaccines and HRSA being responsible for adjudicating 
CICP claims for the COVID shots, I'm concerned that there's too 
much government involvement and overlap with COVID-19 vaccine 
claim adjudication.
    Furthermore, the CICP was not designed for a pandemic as 
large as the COVID-19 pandemic was, adding to the argument that 
VICP is the appropriate location to house the COVID-19 vaccine 
injuries, in addition to the RSV and dengue vaccines, which are 
already available.
    While I recognize that adding vaccines to VICP is through a 
75-cent excise tax on pharmaceutical manufacturers, which would 
require congressional action, it nonetheless warrants attention 
by this Select Subcommittee.
    When a new vaccine is approved and marketed, what steps are 
required to ensure access to compensation under the VICP 
program? And what happens if a new vaccine is not added to the 
list of taxed vaccines?
    Dr. Grimes. Thank you for that question.
    So, as you note, we have two programs that are administered 
through HRSA--the Countermeasures Injury Compensation Program 
and the National Vaccine Injury Compensation Program--that are 
both in my division.
    With the National Vaccine Injury Compensation Program, it's 
a tripartite system, though, where we work with Department of 
Justice and with the U.S. Court of Federal Claims to do 
separate duties to adjudicate the claims.
    For a vaccine to be covered under the CICP, three criteria 
must be met. One is the routine recommendation by the CDC for 
routine administration in children or individuals who are 
pregnant. The second is the excise tax imposed by Congress, as 
you note. And the third is a notice of coverage that the 
Secretary of HHS would add.
    For a dengue or RSV or COVID-19 vaccine to be added to the 
program, all of those would need to be met.
    Dr. Miller-Meeks. So, Dr. Grimes, what's the rate of denial 
for compensation for claims for COVID-19 vaccines in CICP?
    Dr. Grimes. So, thank you. I don't have the rate, but we 
have adjudicated 2,214 claims.
    Dr. Miller-Meeks. I think it's about 98 percent.
    And if I can just quickly followup, I understand that 
there's a current backlog of claims in CICP by about more than 
10,000. Why is there a backlog of claims for the COVID-19 
vaccines?
    Dr. Grimes. Thank you for that question.
    So, at the beginning of the COVID-19 pandemic, we had not 
had a direct appropriation with the CICP. We also had only four 
staff. When we received our first direct appropriation in 
Fiscal Year 2022, we were able to ramp up quickly, and now we 
have over 35 staff who are assisting to adjudicate claims.
    Dr. Miller-Meeks. Thank you.
    My time's expired, but I'd like to submit some additional 
questions to be answered after the hearing.
    Dr. Wenstrup. So, ordered.
    Dr. Miller-Meeks. Thank you very much.
    Dr. Wenstrup. I now recognize Ms. Tokuda from Hawaii for 5 
minutes of questions.
    Ms. Tokuda. Thank you, Mr. Chair.
    I am deeply concerned about some of the dangerous rhetoric 
we've heard throughout today's hearing, which appears purposely 
aimed at undermining confidence in vaccines.
    I agree with you, Mr. Chair: Words matter. So do facts.
    Ahead of today's hearing, the Select Subcommittee received 
a letter from the Association of State and Territorial Health 
Officials, an organization representing public health officials 
from red states and blue states alike. This letter underscores 
the importance of, quote, ``informing the public truthfully 
about the safety and effectiveness of vaccines,'' end quote, 
and urging the Select Subcommittee to, quote, ``engage this 
topic responsibly and with the utmost integrity,'' end quote.
    Mr. Chair, I'd like to enter this letter into the record.
    Dr. Wenstrup. Without objection.
    Ms. Tokuda. Thank you, Mr. Chair.
    I am concerned that, with today's hearing, my Republican 
colleagues have failed to handle this subject with the care our 
public health officials have asked for, recklessly amplifying 
the spread of misinformation about the COVID-19 vaccine.
    And while my colleagues on the other side of the aisle may 
claim that today's hearing is only about the COVID-19 vaccine, 
they cannot and must not ignore the fact that the COVID 
misinformation--intentional spread of disinformation of the 
COVID-19 vaccine has resulted in across-the-board decreases in 
immunization levels over the last few years. In fact, the world 
is experiencing the largest global decline in decades in the 
number of children receiving basic immunizations.
    A recent survey conducted by the Annenberg Public Policy 
Center at the University of Pennsylvania found that the number 
of Americans who viewed vaccines as less than effective has 
increased since April 2021. According to the survey, roughly 
one in three Americans think it's likely safer to get COVID-19 
than to get the vaccine; one in six Americans believe that 
vaccines cause autism; and Americans are now less likely to 
consider getting the measles, mumps, rubella vaccines than they 
were in April 2021.
    As a mother of two boys, I am deeply concerned about what 
this means for our children, especially when we are seeing 
outbreaks of previously controlled diseases like polio and 
measles pop up not just in other countries but right here in 
the United States.
    Since measles was declared eliminated in the U.S. in 2000, 
we have seen consistent outbreaks, mostly especially in under 
vaccinated communities. These have included outbreaks of 8 
cases in Philadelphia in December 2023 most recently and an 
outbreak of 85 cases among unvaccinated children in central 
Ohio in 2022.
    The savings of vaccination to medical economic costs and to 
human lives cannot be ignored. CDC estimates that immunizations 
for children born between 1994 and 2021 will prevent over 1 
million deaths, 29 million hospitalizations, and save nearly 
$2.2 trillion in societal costs. And already we know that 
COVID-19 vaccines have saved more than 3.2 million lives, as 
has been referenced in this hearing.
    Let's be clear: No parent--no parent at all--wants to do 
their children harm. But many parents are, sadly, getting and 
trustingly acting upon false information like what we have 
heard in this hearing room today.
    So, I'd like to discuss today how we can make sure that 
parents get the best and most accurate information they need so 
that we can promote confidence in long-trusted lifesaving 
vaccines and prevent outbreaks of deadly diseases.
    Dr. Marks, can you please explain how the FDA evaluates 
vaccines to ensure that they are safe and effective for age 
groups that they are intended to be used for?
    Dr. Marks. Thanks, Congresswoman, for that question.
    So, every vaccine that we authorize or approve, we require 
to have manufacturing information to show that it's high 
quality, and that we have to have information on its 
effectiveness and safety in the specific age population that 
it's being prescribed in, or we have to be able to understand 
that it's going to function similarly in that age group that 
we're authorizing or approving it for.
    So, it is a process that we take very seriously at the 
agency. And there is a very dedicated group of people that 
spend their time poring over data to make sure that, in the 
thousands of records that are submitted to us, thousands of 
pages--for instance, over a million pages for one of the 
biologics license applications for one of the mRNA vaccines--
that we get that authorization or approval right.
    Ms. Tokuda. Thank you.
    Mr. Marks, if parents have questions about vaccines for 
their children, what steps do you recommend that they take to 
get their questions answered? And I'm not talking about the 
internet.
    Dr. Marks. No. I think Chair Wenstrup and I talked about 
this the other day.
    The primary thing that I think we need are conversations 
between parents and their providers. And that provider doesn't 
have to be a physician; it could be even a nurse practitioner 
or someone in a doctor's office that's a physician assistant.
    But having that conversation, that individual conversation, 
where people can ask questions and have them answered--at 
least--I've spent a lot of time during the COVID pandemic doing 
that, and it makes a huge difference. So, I believe in the 
primacy of the provider-patient relationship.
    Thank you.
    Ms. Tokuda. Thank you.
    I am out of time, but I would reiterate that, today, while 
we have seen Republican lawmakers across the country attempt to 
sow distrust in lifesaving vaccines, I hope that this Committee 
can correct course and focus on work that matters--keeping our 
people alive, keeping them safe. And that means preventing 
outbreaks of deadly diseases, expanding access to critical 
vaccines, and safeguarding the health and safety of Americans--
--
    Dr. Wenstrup. The gentlelady's time has expired.
    Ms. Tokuda [continuing]. Across our country.
    Thank you very much.
    Dr. Wenstrup. The gentlelady's time has expired.
    I now recognize Mr. Cloud from Texas for 5 minutes of 
questions.
    Mr. Cloud. Thank you, Chairman, and thank you all for being 
here.
    We often hear from agencies that they could fix everything 
if only they had more funding, more authority, more data. The 
COVID-19 pandemic showed us that we had a different problem, 
and that is a perverse incentive structure that governs our 
approach to public health.
    Early on in the pandemic, the Federal Government provided 
billions of dollars to pharmaceutical companies for 
development. Much of that work was aided by the work of 
taxpayer-funded scientists at NIH.
    Then we purchased the vaccines back from the pharmaceutical 
companies.
    Next, the FDA and the CDC, which were responsible for 
evaluating the safety and effectiveness of the vaccines, 
cleared them for emergency use.
    Then, not content with recommending the vaccines and 
providing information for the American people to make their own 
decisions, the Federal Government attempted to force everyone 
to get the vaccine, blatantly disregarding scientific evidence 
and constitutional considerations.
    At the same time, the government provided the vaccine 
manufacturers with special liability protections, ensuring they 
can't be sued for any adverse effects.
    And, instead, a government bureaucrat gets to decide 
whether or not someone was injured and offer them a minuscule 
amount of money as compensation if they manage to make through 
an arbitrary process, which is very intensive.
    So, right now, we have the same agency funding the 
research, approving and mandating, and then finally 
adjudicating the COVID vaccines. It concentrates too many of 
the critical government functions in the same unaccountable 
hands.
    Now one of the big issues on top of this is the fact that 
so much of the misinformation that came out during COVID was 
actually fostered by the Federal Government in the sense that 
we actually had the Federal Government colluding with system 
social media companies to discourage scientific opinion that 
went against what was the stated mandate at the time.
    And so, to help clear the record, I'd like to ask y'all a 
couple of things.
    And, Dr. Marks, you stated that vaccines work at the 
outset. I don't think this Committee is designed to question 
that. But there is a--an attempt in this conversation to kind 
of throw the COVID-19 a very new, different scientific approach 
to vaccines, with a new data set that's still developing and 
all those kinds of things, with very well-established vaccines 
like polio or chicken pox or meningitis or these types of 
things, when, I think, Americans rightfully so, after watching 
the government over the last couple of years, could have some 
concerns about COVID-19 and the information that's been 
presented.
    So, I wanted to ask you each a couple of questions. It's a 
simple yes or no.
    Does the COVID-19 vaccine prevent the disease from getting 
it--from you receiving the disease?
    Dr. Marks. You can't have a yes-or-no answer to that 
question because it will reduce your risk of serious outcomes, 
such as death or----
    Mr. Cloud. Right. I'm not--I'm not debating whether or not 
it helps people--it mitigates some of the--but what the----
    Dr. Marks. I care if I'm alive or dead. So, I think they do 
a very good job of preventing death and hospitalization.
    Mr. Cloud. I----
    Dr. Marks. They may not prevent--they may not prevent----
    Mr. Cloud. I agree.
    Dr. Marks [continuing]. Infection.
    Mr. Castor. The mantra at the time was to stop the spread, 
and so we were understood that we either did not receive it or 
could not transmit it when it was released.
    Could you speak to that, Dr. Jernigan? Can you receive it, 
or can you transmit it after receiving the COVID-19 vaccines?
    Dr. Jernigan. Yes, I think, having worked at CDC for 30 
years and seeing the benefits of vaccine, you know, we have to 
make the best recommendation.
    Mr. Cloud. Can you transmit it, or can you receive it after 
receiving the COVID-19 vaccine?
    Dr. Jernigan. I think we need to make the best 
recommendations that we have.
    Mr. Cloud. That's a yes-or-no question. It's very simple.
    Commander Grimes, can you receive?
    Dr. Grimes. I think we make the best recommendations for 
the public----
    Mr. Cloud. Can you still----
    Dr. Grimes [continuing]. As we possibly can.
    Mr. Cloud [continuing]. Get COVID after getting the COVID-
19 vaccine?
    Dr. Jernigan. Yes.
    Dr. Marks. Yes.
    Mr. Cloud. Yes. OK.
    Dr. Marks. That's correct.
    Mr. Cloud. Does it prevent you from transmitting it?
    Dr. Marks. Although it may--there's--there's data that 
shows that, earlier in the pandemic, there was some reduction 
in transmission, the data on that are very challenging to--to 
pin down, but it does not absolutely prevent transmission.
    Mr. Cloud. It does not prevent transmission. Thank you very 
much.
    I would ask you, Dr. Jernigan, why does the CDC website 
then list it as a vaccine-preventable disease? And why does it 
call it a recommended immunization?
    Dr. Jernigan. Well, vaccine-preventable diseases are 
referring to things that benefit from getting the vaccine. What 
we know from COVID is it does prevent you from getting severe 
disease, hospitalizations, and deaths.
    Mr. Cloud. I agree. No one's questioning that. No one's 
questioning that, but it's listed among these other--the issue 
right now and why we're seeing a bunch of vaccine hesitancy is 
because the information coming from the Federal Government has 
been murky at best on this subject and so people don't know 
what to trust.
    And so, my question to you is, why do you list this, along 
with very other proven that have a long set of scientific data, 
as a--as a vaccine that prevents disease?
    Dr. Jernigan. All vaccines have variable different levels 
of effectiveness, and so this is a vaccine-preventable disease 
just like all the others are.
    Mr. Cloud. OK. Y'all have done a great job of filibustering 
my time.
    I have to yield back.
    Dr. Wenstrup. I now recognize Dr. Joyce from Pennsylvania 
for 5 minutes of questions.
    Dr. Joyce. Thank you, Dr. Wenstrup, for convening this 
hearing for our panel for appearing today.
    This is an incredibly important discussion topic and as our 
continued work on this Committee to get to the bottom of both 
the origins of COVID-19 and also the government response.
    Understanding how Federal agencies tracked the rollout of 
the COVID-19 vaccines and documented instances of injury or 
adverse effects is critically important for any future 
responses.
    As a doctor, having accurate and up-to-date information 
before treating patients during a public health emergency is of 
utmost importance.
    While Federal health agencies have several systems for 
vaccine safety surveillance, the most well-known during the 
pandemic became the Vaccine Adverse Event Reporting System, or 
VAERS. The government also has two systems for adjudicating and 
compensating vaccine-related injuries, the Countermeasures 
Injury Compensation Program, which is CICP, and the Vaccine 
Injury Compensation Program, which is VICP.
    Two of the key differences between the CICP, which covered 
the COVID-19 vaccines, and the VICP, which covers most other 
vaccines, are who adjudicates the claims and who covers the 
damages.
    In CICP, in CICP, claims are adjudicated by HRSA whereas, 
in VICP, claims are adjudicated by the Court of Federal 
Appeals. And, in terms who pays for the CICP, it is 
appropriated funds whereas, in VICP, the money comes from an 
excise tax that is levied on manufacturers on each vaccine 
dose.
    Before the COVID-19 pandemic, CICP was a very small program 
due to its limited scope. However, claims have exploded now 
that widely distributed and even mandated COVID-19 
countermeasures are covered under the program.
    As of January 1 of this year, the total number of CICP 
claims ever filed was 13,406, and COVID-19 claims account for 
12,854, nearly 96 percent of the total. Because of CICP's 
design and their limited resources, adjudication of claims is a 
lengthy and a burdensome process. It is also reported that 
10,640 of these COVID-19 claims are currently pending or under 
review.
    Commander Grimes, how is the CICP structured to ensure 
accessibility and fairness to petitioners? And how does this 
compare to VICP or even the traditional litigation system?
    Dr. Grimes. Thank you for that question.
    So, in the CICP, we administer the program by statute. An 
individual that we call a requester files a request for 
benefits and then must submit medical records to the CICP to 
show that there is compelling, reliable, valid medical and 
scientific evidence to support that it was directly caused by 
the use or administration of a covered countermeasure.
    A covered countermeasure could be COVID-19 vaccine. It 
could be a smallpox vaccine.
    Dr. Joyce. Let's stay focused on the COVID-19 vaccine, 
because that's what our obligation is in this Select 
Subcommittee.
    Do you feel it is more appropriate to have petitioners, 
your word, for COVID-19 claims to be paid by the vaccine 
manufacturer or by the American taxpayer?
    Dr. Grimes. So, the petitioners are for the National 
Vaccine Injury Compensation Program, and those are through the 
routine administration with an excise tax levied on it whereas 
the requesters through the CICP are paid for compensation of 
claims through appropriated funds and through administration of 
the program--is also paid from those appropriated funds.
    Dr. Joyce. As a physician, I am also worried that, in some 
cases, health practitioners do not know where and how to report 
adverse effects, which is critical to ensuring that all vaccine 
events are accounted for. I also have concerns of how these 
events and potential risks are reported to healthcare 
providers.
    For each of you, could you take turns and describe what 
your respective agency ensures against any adverse effects that 
are reported and how those reports are managed and how those 
information is conveyed to the frontline individuals who are 
dealing with this?
    Dr. Marks.
    Dr. Marks. So, thank you for the question.
    So, we--each vaccine label actually, whether it was the 
authorized vaccines or the approved vaccines, has information 
on where to report adverse events, into the Adverse Event 
Reporting System.
    When we get those, we could combine with CDC, sort through 
those events, and we take them seriously and investigate them 
to sort out whether there are any signals there.
    Dr. Joyce. Dr. Jernigan.
    Dr. Jernigan. Yes. So, we provide information through the 
vaccine information sheets that are provided to everybody that 
gets vaccinated, so they understand the potential risks.
    We also communicate to the public and then take information 
that comes in through VAERS, put that together, put that and 
communicate that with the advisory committee. And then 
recommendation can be changed, if needed.
    Dr. Joyce. Commander Grimes, do you see any faults in this 
system?
    Dr. Grimes. I'm here to testify on behalf of the Director 
of the Division of Injury Compensation Programs and not to such 
of the--CDC and FDA systems.
    Dr. Wenstrup. The gentleman's time has expired.
    I now recognize Dr. McCormick from Georgia for 5 minutes of 
questions.
    Dr. McCormick. Thank you, Mr. Chair.
    I'll cut straight to the point because I know we're on a 
timeline, and I'm the last. So, congratulations on that.
    I want to point out that it was President Trump's Operation 
Warp Speed that had unprecedented delivery of a vaccination in 
record time.
    I think it's ironic that this scientific achievement will 
forever be tainted by the government's handling of COVID-19 and 
the mistrust that was created from this vaccine policy and the 
Federal programs that surround it.
    To void myself of partisanship in this case, I'd like to 
highlight that it is the Democrats that have touted this 
program that President Trump not only came up with but received 
the vaccination himself and admits openly to getting the 
booster, as well. So, there are some ironies in this argument 
all the way around.
    So, the question is, why has America become so distrustful 
of vaccinations, as my colleagues have pointed out. Why is it 
that they no longer want to get a vaccination that may have 
potential benefit? I would make the--a couple of points on 
this.
    First of all, when you insert yourself between a doctor and 
a patient and some doctors contradict you and you sensor them, 
even when you're not a doctor treating patients, people are 
going to say, why does the government have authority to do 
that, to sensor my doctor?
    And then, second, when you start requiring people to do 
something instead of encouraging, the natural resistance of a 
freedom-loving people that were founded on those principles 
will be to resist what you're requiring.
    So, it shouldn't be any surprise to us, when the people 
say, ``I'm not going to do what you're telling me I have to do, 
when my doctor may agree with me and not you. You're the 
government.'' Why do I--assert ourselves in inappropriate ways?
    And really, when we talk about the evolution of science, 
when you have immunity and you're still requiring a vaccination 
that could cause a hyperimmune response, which we're all 
scientists and we can admit to, there's risks versus benefits 
on every decision; when the government says we're going to make 
a carte blanche requirement without taking science into 
account, it's no wonder people are mistrustful of our 
recommendations. This is the problem we have right now.
    So, let's talk about the vaccination liability and 
compensation program. It came to my attention last February 
when I heard from constituents that COVID-19 vaccine injuries, 
claims that were sent to CICP were constantly lost, ignored, or 
denied, or caught up in the bureaucracy with little or no 
transparency.
    Now, March 3 of last year, several of my colleagues and I 
wrote a letter to HRSA about our serious concerns regarding the 
Countermeasures Injury Compensation Program, the CICP, and its 
failure to respond to our constituents in a reasonable 
timeframe.
    Now, first of all, I appreciate Commander Grimes. I will 
say, unlike a lot of the government agencies that are high up, 
you responded. You actually came by my office, and I do 
appreciate that. I think you care.
    And you also point out that you had a very small, when you 
started out, you had, what, four people working for you, which 
was based on the pre-pandemic response force on injury that can 
cause and you're trying to respond to 13,000 people with four 
employees. Since then, you've been plussed up to 35 people, I 
believe.
    Am I accurate in saying it was 13,000 claims approximately?
    Dr. Grimes. We have approximately 13,000 COVID-19 
countermeasure claims, about 9,600 of which allege vaccine.
    Dr. McCormick. OK. And of those, which ones have--how many 
have been closed?
    Dr. Grimes. 2,200, about.
    Dr. McCormick. Yes, OK. And then the number is 35 employees 
now that are handling those claims, right?
    Dr. Grimes. Yes, so since we----
    Dr. McCormick. That's OK. I got to be quick because we're 
on a timeline here.
    Dr. Grimes. Understood.
    Dr. McCormick. How many claims are you processing per month 
now?
    Dr. Grimes. So, in the year 2023, we processed 90 claims 
for a month over that year, and that velocity increased 
throughout the year.
    Dr. McCormick. Of those 2,200 claims, how many have been 
shown to have some merit for injury?
    Dr. Grimes. Currently there are about 40 that have been 
found to have an injury that was directly caused by a covered 
countermeasure.
    Dr. McCormick. OK. So, a pretty small percentage, correct?
    Dr. Grimes. Yes, sir.
    Dr. McCormick. OK. So, just to do the math, that means that 
each employee's handling about 2.7 cases per month and showing 
40 out of 2,200 cases that have been processed so far. Of the 
13,000, that means we probably have about 10,800 cases in 
backlog.
    I know you've asked for more employees so you can process 
faster, but at 2.7 per employee, it would take us about 10 
years to process the remaining claims.
    And the application process to get this denial processed 
through some sort of appeals process has an even smaller 
approval rating. It's a judge, jury, executioner.
    I just don't think it's right. I think we need to 
streamline this process. You need as a leader, in my opinion--
we talked about this any office--make sure you know what 
paperwork is required, how it's processed, and we need to 
spread the process about tenfold in order to do our job for the 
American people.
    And, with that, I'm out of time, and I yield.
    Mr. Cloud. Mr. Chairman, I'd ask unanimous consent to 
submit this for the record. It's an article from The New York 
Times that said COVID--entitled ``COVID Shots for People. Much 
of the world has decided that most young children don't need to 
receive COVID booster shots. The U.S. is an outlier.''
    Dr. Wenstrup. Without objection.
    Mr. Cloud. Thank you.
    Dr. Wenstrup. I now would like to recognize Ranking Member 
Ruiz for a closing statement.
    Dr. Ruiz. Yes, this just, again, you know, medicine is very 
nuanced. Our human body is so remarkably beautifully made, and 
our physiology is a complete wonder still. You know, taking a 
snapshot of a time and using it to go back and define the 
entire experience of COVID in children is, again, misleading.
    Now with rates that are low, with information that we have 
on children, children that are at high-risk, immunocompromised 
should get the vaccine. And, in certain areas where the rate is 
low and the risk of getting infected in an otherwise healthy 
child, then one would reconsider whether that child would need 
a booster or in this--in this situation.
    So, you know, throwing these kind of facts out there 
without the context and understanding is wrong, and it's very 
misleading.
    In fact, you know, we've talked about how VAERS here is a 
screening, not the definitive tool, to use the rate of side 
effects or serious side effects from getting the vaccine. These 
are individuals who get the vaccine. And whatever they feel 
afterwards for a certain time period, they report it, which we 
want them to do that. We want them to do that. It is a way to 
screen for this, and we want to have high sensitivity to reduce 
the false negative. But then, with this kind of screening test, 
you have a high false positive.
    And that's why we need to reevaluate, do more in-depth 
investigation on an individual basis to determine whether, in 
fact, it was caused by the vaccine.
    So, we already laid out the reasons scientifically why 
VAERS is not the, of the five systems, the five multilayered 
system, VAERS is not the system to use as the definitive rate 
of infections. But to use it, because it has the false 
positive, is intentionally falsely misinterpreting the data 
that is causing vaccine hesitancy.
    And people know but they intentionally still speak to it as 
if it's the definitive data, and that's the part that gets me. 
That's disinformation. That's not misinformation. That is 
intentionally giving false information for their own personal 
and partisan political gain. That's a clear example of what 
we've been talking about of politicizing science. OK?
    So, let's just go back and summarize that, in total, COVID-
19 vaccines saved 3.2 million lives, prevented 18.5 million 
hospitalizations, and saved the United States an estimated 
$1.15 trillion in medical costs.
    So, when we say that the vaccine doesn't prevent getting 
sick or it doesn't stop the spread of disease, let's go back 
and talk about the nuanced aspects of the use of vaccines, 
which is supposed to boost your immune system. And, if you have 
a high enough immune response to the virus, then, yes, for 
those individuals, it does prevent them from getting sick.
    Am I right, Dr. Jernigan?
    Dr. Jernigan.
    [Nonverbal response.]
    Dr. Ruiz. Am I right, Dr. Marks?
    Dr. Marks. Correct.
    Dr. Ruiz. Correct.
    So, by lowering the risk of getting infected, yes, it does 
prevent getting vaccines for those individuals. OK? But it's 
not an absolute.
    But, when we talk about absolutes, again, we are 
intentionally giving disinformation to the American public that 
they don't work. OK?
    Now, if you lower the risk of getting the illness and 
getting sick or if you increase your immune response enough to 
prevent symptomatic infection, then wouldn't you say that that 
reduces the risk of spreading it to other people?
    Dr. Jernigan.
    Dr. Jernigan. I think the more you can lower the viral 
load, the more likely you are to be able to----
    Dr. Ruiz. The ``viral load'' is a medical term that's 
important to understand.
    So, when you--the vaccines increase your immune response, 
combats the virus, lowers the viral load. If you have a small 
viral load, you decrease the risk of spreading the disease.
    Is that correct, Dr. Marks? Do I have that physiology or 
pathophysiology ready--right?
    Dr. Marks. That will be correct.
    Dr. Ruiz. That will be correct.
    So, would it be correct to say that, indeed, vaccines 
reduce the spread and, for some individuals, prevent the spread 
of the virus to other people? Correct?
    Dr. Marks. I think we can say that that's a general 
statement. I wouldn't want to make it as an absolute statement.
    Dr. Ruiz. Correct. That's my point.
    Dr. Marks. But in the spirit of today's hearing----
    Dr. Ruiz. That's my point----
    Dr. Marks [continuing]. More information.
    Dr. Ruiz [continuing]. Is by--is by intentionally using 
absolute statements like that without the nuances and you know, 
and people should know better They're disinforming the 
community.
    And what I said was not absolute. What I said was it 
reduces the risk of spread. And, for some people, it reduces 
the spread. So, it does, and it can reduce the spread with that 
nuance.
    And it is because of the safety and efficacy of these 
vaccines that we are ultimately able to overcome the pandemic. 
It's because of the vaccines that we're able to change the 
vaccine guidelines over time or our social distancing practice 
or wearing a mask, correct?
    And, yes, there is work to be done to promote vaccine 
confidence in the United States and strengthen existing 
compensation programs. Yes, we can agree on that. It requires 
funding, capacity, human resources. We can fix the systems to 
help make it better.
    But there's no doubt that the multitiered, multisystem 
vaccine safety apparatus surveillance systems is the best in 
the world. And we should talk about that instead of focusing on 
these false positives or false narratives so that we can build 
confidence in the American people.
    So, misusing our platforms as Members of Congress to spread 
false or disinformation about vaccines does a disservice to the 
American people. It manufacturers distrust. Conspiratorial 
accusations manufacturer distrust. Fearmongering manufacturers 
distrust.
    And, with increased distrust, you increase vaccine 
hesitancy. With less people taking the vaccine, more people get 
infected. The pandemic spreads, and more people die.
    So how does this help us prevent or better prepare for the 
next pandemic? It doesn't. It makes it worse and puts people's 
lives at risk and harms, actually harms, the American people. 
So, this is the opposite of helping to prepare and mitigate the 
harms of the next pandemic.
    So, I hope that we can find a path forward in the serious 
work that needs to be done to save lives in the event of a 
future pandemic and keep people safe in the here and now from 
current threats.
    And, as I said when we started today's hearing, we are 
already in the process of undoing decades of progress in 
overcoming infectious diseases. So, we must handle each 
opportunity to discuss this matter with immense care before we 
reach a point from which we cannot return.
    So, I hope going forward everyone can drop the outrageous 
false rhetoric that we've heard by some today and instead 
identify a constructive path forward that protects the people's 
health.
    I yield back.
    Dr. Wenstrup. Thank you.
    This hearing should not have been political, and most of it 
was not, I would say, today fortunately. But the fact that it 
is simply is further evidence this conversation is completely 
necessary to take place.
    You know, I can say that I have invested in all sides of 
the issues around the pandemic, starting in 2020 being on the 
Intelligence Committee and also researching what other 
countries were doing. How are we going to try and treat people? 
How are we going to try and save lives, right? Learned a lot.
    As Representatives, we're the conduit to asking their 
questions. It's not easy for them to just call you and get an 
answer, although I thank you for taking my call early on, Dr. 
Marks, during the pandemic.
    Perception is reality. I mentioned that at the beginning. 
And that's what we have to--that's what we have to face. And 
words matter because when you say ``reduce,'' it's different 
than saying ``prevent.'' And that happened too often, not 
necessarily from your voice, but it happened, and that's what 
America heard.
    I think it became clear today about the VAERS system. It's 
not the be-all to end-all. It's the initial recycling can, if 
you will, and then you decide what actually goes further. But 
we didn't say that, but it's the only one America saw. It's the 
only thing that was out there for the public. So, what do we 
expect? And I think that that matters.
    You know, we see things on some of these natural items in 
the drug store. It will say on there ``not approved by the FDA 
as legitimate treatment.'' But it's OK to take, but it isn't 
necessarily going to meet all its claims necessarily. We put 
that out there. That's an honesty. That's an honest approach to 
what--what America is out there.
    You know, look, I think there's never been a question that 
vaccines save lives by anyone. I'm from Cincinnati. Do you know 
how much pride in Cincinnati we take because it's the home of 
Albert Sabin and the polio vaccine? You know, it's huge. That's 
in our DNA in Cincinnati. We grow up knowing that. We take 
pride in it.
    But we can't leave behind those that have been injured 
simply because they don't necessarily fit a narrative regarding 
the vaccine safety. We got to take all that into consideration.
    We heard today patients and parents should have a 
conversation with their personal healthcare provider to assess 
the vaccine, whether it's appropriate for their particular 
position, condition, whatever. You know, Dr. Marks, I heard you 
today very caringly, I feel, say you have regret about those 
under 5 years old that may have died from COVID.
    But I talked to pediatricians. And some say, yes, I think 
they should be vaccinated if they've got A, B, C, D, or E.
    And I think that's important. One size doesn't fit all in 
medicine. It never has and never will. That goes back to 
talking to your doctor, and that goes back to revealing all the 
data about those that may have died. You know, these are 
children that maybe would have died if they got the common 
cold. I don't know. But those are things you have to take into 
consideration.
    I've learned a lot about COVID-19. I think if we want to 
assess somebody's vulnerability, maybe we should check their 
furin levels, and I won't go into the science of that, that 
maybe you all understand, because that's what it takes to 
cleave the furin cleavage site, which makes it more infectious 
to humans. That's another story.
    But, you know, this Committee, I think we did a good job 
today if we really look at the facts that we revealed and 
discussed openly about where our pitfalls are. And I'm not just 
blaming the government because it's politicians, too. It's 
politicians that drove a lot of distrust in what was coming out 
of public health.
    Look, I just go back to the beginning. President Trump says 
we need to restrict travel. Dr. Fauci told us that he 
recommended that we restrict travel. What happened to President 
Trump when he said that? He's a racist.
    And people started--politicians say, ``Oh, no, there's 
nothing to worry about here. That's a racist comment. Come to 
Chinatown.'' You know, let's create a super spreader.
    That's a problem. That's a problem on our side, and that's 
why I say we need to hear from the doctors treating COVID 
patients more than anyone else.
    You know, again, lives have been saved. Well, we can't 
ignore the maladies. We can't ignore certain things, you know.
    You know, I mentioned before, Dr. Marks, you're advocating 
Operation Warp Speed. We were with you all the way. But you 
have a politician saying that, in essence, Dr. Marks, if it's 
your vaccine, she's not taking it. That doesn't help us. That 
creates vaccine hesitancy.
    When a politician stands up and says, ``If you take this, 
you're not going to the ICU and you're not going to die,'' yet 
some were going to the ICU, and some were dying, that's a fact. 
And it may have been a lot of other reasons for it.
    China comes out, says, ``We've got this under control.'' 
The WHO parrots it. Dr. Lane goes to China. They got it all 
under control. That's the advice given to politicians.
    So, of course, there's distrust. But there, that came from 
China themselves. They didn't have it under control. Yet that's 
what they were telling everybody. That leads to distrust. So, 
we must trust but verify, especially when we're taking advice 
from an adversary.
    Look, the risks have to be put out. No drug can run a 
commercial--regardless of what you think of commercials on 
drugs--they can't run it without listing all the risks. Doctors 
have to sit--or it's malpractice if they don't go over the 
risks. We weren't doing that, and we issued a mandate, said you 
got to get it, or you'll lose your job. They go to the drug 
store, and get it and get their card. Did they have a sit-down?
    I'm glad to hear you all agree today, at least I think you 
do, that it requires--the best practice is to have a 
conversation with your doctor about your personal health. And 
the better data the doctor has, the better we can treat 
patients. That's what we're after, saving lives, treating 
patients better.
    I mentioned before about, you know, there's a difference 
between saying--effectiveness data is different than just 
saying it's effective. There's data that might say it's not a 
hundred percent effective, right? And we know that. But this is 
what the public hears.
    And so, they get confused because they know, ``Well, I know 
some people had an adverse reaction. Why are we saying it's 
safe? It's not a hundred percent safe.''
    So, you may have done work completely 100 percent right, 
but if it's not messaged clearly or accurately down the line, 
that's a problem.
    I often ask, where's our Surgeon General to be talking 
about this? You know, when I grew up, it was C. Everett Coop, 
and people trusted it.
    The reason I said we need to hear from doctors treating 
COVID patients, I'm reminded of General Schwarzkopf during the 
Gulf War. Every night America tuned in to see what the general 
had to say about the war, not what a politician had to say 
about the war. I think that makes a huge difference.
    We recognize today gratefully that what you're telling the 
American people, when we recognized myocarditis is a problem, 
we did something about it. That's important. That builds public 
trust. But if it's perceived that we're just ignoring it and 
mandating this anyway, it's a problem.
    I question why we quit talking about convalescent plasma as 
a form of treatment. Especially when we knew that the vaccine 
we had did not prevent you from getting COVID--you just got 
less sick--why were we not focusing more on treatments like 
that that were very effective? At least in Cincinnati, I saw 
that.
    Why did we ignore natural immunity? I was told I needed a 
booster to go to Germany. I had been vaccinated, both doses of 
Pfizer. I got COVID several months later, and the only reason I 
knew is because I couldn't smell garlic salt. That's the only 
way I knew.
    And, when I got my antibodies checked--I wanted to do T 
cells, as well. When I got my antibodies checked, when I'm 
being told I need a booster, the strong number was 40; my 
number was 821, and I've got the lab report to show it.
    Now you have a conversation with your doctor about that. 
Why did we put this aside?
    And that's what America understood. Why are we not talking 
about the benefits of natural immunity? Why are we not saying, 
if you have natural immunity, you are less likely to get 
another round of COVID? Why were we not looking at that kind of 
data to see?
    Those are things we should have done. Actually, I wanted to 
do that through the military, and Secretary Austin never 
responded. Matter of fact, it was 22 physicians that signed 
that letter to the Secretary of Defense, and he never 
responded. He never answered our question even after several 
attempts.
    So, we have some things that, you know--we've got people 
here that want to make a difference, especially going forward. 
But we can't ignore these hiccups. We can't ignore these 
questions that the American people have.
    If I only sat here in Washington, I can't have this 
discussion with you the way I'm having it. But it's you go 
home, and you're the conduit to the government. And you know 
what? If we aren't honest, if we can't be trusted, we don't get 
elected. But they see people in Washington never leave amongst 
the unelected. Just understand that. That's why it's important 
we have this conversation. That's why it's important that we do 
better going forward.
    And I thank you all for your time today. I appreciate the 
work that you do. We want to be helpful to make it even better 
in the future. So, I thank you all again for being here, for 
your important, insightful testimony.
    With that, and without objection, all Members will have 
five legislative days with which to submit materials and to 
submit additional written questions for witnesses, which will 
be forwarded to the witnesses for their response.
    If there's no further business, without objection, the 
Select Subcommittee stands adjourned.
    And thank you all for attending.
    [Whereupon, at 12:37 p.m., the Committee was adjourned.]

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