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


                          ASSESSING AMERICA'S
                         VACCINE SAFETY SYSTEMS
                                PART II

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

                                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

                               __________

                             MARCH 21, 2024

                               __________

                           Serial No. 118-98

                               __________

  Printed for the use of the Committee on Oversight and Accountability


[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

                       Available on: govinfo.gov,
                         oversight.house.gov or
                             docs.house.gov
                             
                               __________

                   U.S. GOVERNMENT PUBLISHING OFFICE                    
55-222 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                    Shontel Brown, Ohio
Byron Donalds, Florida               Melanie Stansbury, New Mexico
Scott Perry, Pennsylvania            Robert Garcia, California
William Timmons, South Carolina      Maxwell Frost, Florida
Tim Burchett, Tennessee              Summer Lee, Pennsylvania
Marjorie Taylor Greene, Georgia      Greg Casar, Texas
Lisa McClain, Michigan               Jasmine Crockett, Texas
Lauren Boebert, Colorado             Dan Goldman, New York
Russell Fry, South Carolina          Jared Moskowitz, Florida
Anna Paulina Luna, Florida           Rashida Tlaib, Michigan
Nick Langworthy, New York            Ayanna Pressley, Massachusetts
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
                      Contact Number: 202-225-5051
                                 ------                                

            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 March 21, 2024...................................     1

                               Witnesses

                              ----------                              

Patrick Whelan, M.D., Ph.D., Associate Clinical Professor of 
  Pediatrics, UCLA Division of Rheumatology
Oral Statement...................................................     5

David Gortler, Pharm.D., Senior Research Fellow for Public Health 
  Policy and Regulation, The Heritage Foundation
Oral Statement...................................................     6

Renee Gentry, Director, Vaccine Injury Litigation Clinic, George 
  Washington University
Oral Statement...................................................     8

Yvonne ``Bonnie'' Maldonado, M.D., Chief of the Division of 
  Infectious Diseases, Department of Pediatrics, Stanford 
  University School of Medicine
Oral Statement...................................................

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

                              ----------                              

  * Closing Statement; submitted by Rep. Ruiz.

  * Closing Statement; submitted by Rep. Wenstrup.

  * Statement for the Record, by Richard Hughes; submitted by 
  Rep. Ross.

  * Statement for the Record, by AAP; submitted by Rep. Tokuda.

  * Supplemental Information, from Dr. Wiseman; submitted by Rep. 
  Wenstrup.

Documents are available at: docs.house.gov.

 
                          ASSESSING AMERICA'S
                         VACCINE SAFETY SYSTEMS
                                PART II

                              ----------                              


                        Thursday, March 21, 2024

                        House of Representatives

               Committee on Oversight and Accountability

            Select Subcommittee on the Coronavirus Pandemic

                                           Washington, D.C.

    The Select Subcommittee met, pursuant to notice, at 2:49 
p.m., in room 2247, Rayburn House Office Building, Hon. Brad 
Wenstrup [Chairman of the Select Subcommittee] presiding.
    Present: Representatives Wenstrup, Malliotakis, Miller-
Meeks, Lesko, Joyce, Greene, Ruiz, Dingell, Mfume, Ross, and 
Tokuda.
    Dr. Wenstrup. The Select Subcommittee on the Coronavirus 
Pandemic will come to order. I want to welcome everyone.
    Without objection, the Chair may declare a recess at any 
time.
    Before I move on to opening statements, I want to go ahead 
and remind the Members of all the rules of decorum. The issues 
we are debating are important ones that Members feel deeply 
about. And while vigorous disagreement is part of the 
legislative process, Members are reminded that we must adhere 
to established standards of decorum in the debate. This is a 
reminder that it is a violation of House rules and rules of the 
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 this committee. The Chair will enforce these 
rules of decorum at all times and urge all Members to be 
mindful of their remarks. If the Chair finds a 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, and now I guess I am talking to everyone, not just 
the Members who aren't here.
    Anyway, I want to welcome everyone to part two of a hearing 
which we first held last month. During part one, I began by 
saying that vaccines are crucial tools for public health which 
save millions of lives, and I want to reiterate that today. 
However, the utility of vaccines is dependent on the American 
people's trust. Like any other medication, vaccines are only 
useful when people trust that they are safe, and patients elect 
to get vaccinated.
    I have heard criticism that this committee is simply 
seeking to rehabilitate the image of Federal agencies despite 
their shortcomings during the pandemic, and I disagree with 
that characterization. Rather, my goal is to reform these 
agencies so they can earn the people's trust. You know, it is 
easy to kick and scream about the Federal Government's 
failures. It is quite another to actually fix the problems so 
that we may do better the next time. That is really the goal, 
but this can't be done without buy-in from all parties 
involved, including from Federal agencies.
    During part one, we heard from three of the Federal 
Government's experts on vaccine safety, surveillance, and 
compensation. We learned that the government was unprepared for 
this massive wave of reports to its surveillance systems and 
claims to its compensation programs. You do not expect a 
pandemic every day. It is understandable. Today, we will hear 
from nongovernmental experts who utilize these systems from the 
other side, and it is important that the American people hear 
from the doctors who actually treat COVID patients. I've said 
that since the beginning of the pandemic. Unfortunately, during 
the pandemic, it seemed that the loudest voices were 
government, bureaucrats, and politicians, and I have found as a 
physician and as a Member of Congress that Americans want to be 
educated, not indoctrinated. It is key to the doctor-patient 
relationship.
    So, one doctor who was bedside during the pandemic is Dr. 
Patrick Whelan. Dr. Whelan is a pediatric rheumatologist and an 
expert in molecular biology and immunology. Now, Dr. Whelan has 
co-authored a paper which studied COVID-19 vaccine trial data 
and found excess risk of certain serious adverse events. Dr. 
Whelan also submitted a VAERS report for a young child who 
experienced a cardiac event after a second COVID vaccination. 
Sadly, a week later that young man, that boy died. When Dr. 
Whelan tried to update the report, he discovered that the VAERS 
system is not set up to acknowledge updates such as this. VAERS 
still lists the outcome as cardiac arrest.
    Dr. David Gortler is a pharmacist and pharmacologist who 
has experience as an investigational medicine scientist at 
Pfizer, as a professor at Yale School of Medicine, and as a 
medical officer and senior medical analyst at the FDA. Dr. 
Gortler has submitted written testimony today which indicates 
that the FDA systems and procedures for assessing and 
regulating COVID-19 vaccines are inadequate. Among other 
things, Dr. Gortler argues that the U.S. MedWatch surveillance 
system, which includes VAERS, should be used more aggressively 
to warn patients about adverse events.
    We will also hear from an expert on vaccine injury 
compensation. As I stated at the last hearing, the government 
has assumed the responsibility to compensate for vaccine 
injuries, however rare they might be. Yet, it appears the 
government system may not be properly upholding this 
responsibility, especially during a time of a pandemic. 
Appearing before us today is Ms. Renee Gentry. Ms. Gentry is 
the director of the George Washington University Vaccine Injury 
Litigation Clinic and has practiced as a vaccine injury 
attorney for more than 20 years. Ms. Gentry will testify 
regarding Vaccine Injury Compensation Program and 
Countermeasures Vaccine Injury Compensation Program, which 
adjudicates claims for COVID-19 vaccines. In her written 
testimony, Ms. Gentry has highlighted serious problems with 
these systems, which require modernization. Ms. Gentry also 
explains that the CICP gives the vaccine injured little more 
than a right to file and lose. We can't be fully prepared for a 
future pandemic until we properly address the shortcomings in 
our vaccine safety systems and any other shortcomings that we 
may recognize so that we can correct them.
    I look forward to a robust and on topic discussion today, 
and 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. As we 
discussed during the first part of this hearing series, our 
Nation's vaccine safety systems play a critical role in 
protecting public health. For decades, these systems, which 
operate every day, thanks to the tireless work of our Nation's 
scientists, physicians, and public health officials, have 
helped ensure that the safest and highest quality vaccines and 
medical countermeasures reach the American people, protecting 
us from the threat of deadly diseases every day. And in the 
midst of a once-in-a-century public health crisis, these 
systems worked in tandem with the massive rollout of the safe 
and effective COVID-19 vaccines, a campaign that allowed us to 
put the darkest days of the pandemic behind us.
    Working together, our Nation's public health officials, 
physicians, and healthcare workers partnered to get shots in 
arms, including through Federal initiatives and policies that 
increased availability and encouraged uptake. At every step of 
the way, they were united in putting patients first, and thanks 
to these efforts, we were able to safely reunite loved ones, 
turn the corner on the pandemic, and reopen schools, 
businesses, and workplaces. In total, 3.2 million lives were 
saved, 18.5 million hospitalizations prevented, and an 
estimated $1.15 trillion in medical costs avoided.
    And along the way, our vaccine safety systems functioned as 
they should by collecting a wide breadth of data that has 
overwhelmingly reaffirmed the safety and efficacy of COVID-19 
vaccines while detecting safety signals for rare adverse 
events. For example, during the pandemic, this system detected 
cases of thrombosis with thrombocytopenia syndrome, or TTS, 
linked to the Johnson & Johnson vaccine. When the safety 
signals were identified, the CDC and FDA took swift actions to 
update recommendations for vaccine products. During last 
month's hearing, we discussed this example as a case study of 
why it is so important that we continue to invest in our 
vaccine surveillance systems. And we discussed the importance 
of ensuring that there are adequate compensation systems in 
place so that people who experience rare, yet serious adverse 
events can receive timely compensation and access the care that 
they need. So, by pursuing these two policies--robust vaccine 
surveillance funding and necessary reforms to our Nation's 
compensation programs--we can better prepare our Nation for 
future public health crises and boost vaccine confidence in the 
process. And in doing so we will keep COVID-19 at bay and 
improve our defenses against a vast array of viruses that 
threaten our public health daily.
    So, this work could not be more important than at this 
current moment. You see, we are at a tipping point when it 
comes to vaccine confidence. 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. 
Americans are also now less likely to consider getting the 
measles, mumps, and rubella vaccines than they were 3 years 
ago. This is extremely troubling as we continue to see 
outbreaks of measles due to waning vaccination levels that 
threaten children's health across the country. In fact, the 
United States may lose our measles elimination status that we 
have held for the last 24 years. We must correct course before 
it is too late.
    Approaching each opportunity to discuss this topic with 
care, collaborating with community-based organizations on 
vaccine outreach, and strengthening access to care are all 
critical components of this work. Just as critically important 
is continuing to work with physicians and healthcare leaders to 
enhance trust in public health. As a physician, I understand 
that stronger collaboration between providers, patients, and 
policymakers is the key to solving the challenges in public 
health that we face. So, I hope that today's discussion fosters 
that collaboration and that we come away from this discussion 
better prepared for the future. I yield back.
    Dr. Wenstrup. Thank you very much. I am going to introduce 
our witnesses now. Some of the accolades I may have already 
mentioned, but we will go through them. I think it is 
important.
    Dr. Patrick Whelan. Dr. Whelan is an Associate Professor of 
Pediatrics at UCLA, Adjunct Professor in Molecular Microbiology 
and Immunology at USC, and Lecturer in Pediatrics at Harvard 
Medical School.
    Dr. David Gortler. Dr. Gortler is a pharmacist and 
pharmacologist who has worked at Pfizer, Yale Medical School, 
and the FDA. Dr. Gortler is currently a Senior Research Fellow 
for Public Health Policy and Regulation at the Heritage 
Foundation.
    Ms. Gentry. Ms. Gentry is the Director of the Vaccine 
Injury Litigation Clinic at the George Washington University.
    Dr. Yvonne ``Bonnie'' Maldonado. Dr. Maldonado is the Chief 
of the Division of Infectious Diseases, Department of 
Pediatrics at Stanford School of Medicine.
    Pursuant to Committee on Oversight and Accountability Rule 
9(g), 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?
    [A chorus of ayes.]
    Dr. Wenstrup. Thank you. Let the record show that the 
witnesses all answered in the affirmative. The Select 
Subcommittee certainly appreciates you all being here today for 
this event, and we look forward to your testimony.
    Let me remind the witnesses that we have read your written 
statements. They will appear in the full record on the hearing, 
but please limit your oral statements to 5 minutes at this 
time. And as a reminder, press the button in front of you on 
the microphone so that it is on, and members can hear you. And 
when you begin to speak, the light in front of you will turn 
green. After 4 minutes, the light will turn yellow, and when 
the red light comes on, your 5 minutes has expired, and we ask 
that you wrap things up.
    I now recognize Dr. Whelan to give an opening statement.

                STATEMENT OF PATRICK WHELAN, M.D., PH.D.

                ASSOCIATE CLINICAL PROFESSOR, PEDIATRICS

                     UCLA DIVISION OF RHEUMATOLOGY

    Dr. Whelan. My thanks to Dr. Wenstrup and Dr. Ruiz and all 
the members of the subcommittee for inviting me today to 
contribute to your deliberations on our vaccine safety systems. 
Allow me to make clear that I am speaking in my own capacity as 
a physician and researcher and not on behalf of any of the 
institutions with which I have been affiliated. I completed a 
Ph.D. in microbiology and immunology and had the privilege as a 
young man to care for Dr. Jonas Salk when he was a patient 
toward the end of his life. My day job is as a rheumatologist 
in Los Angeles, and as Dr. Wenstrup mentioned, I have been 
lecturing for the past 13 years in virology at the University 
of Southern California. And I have also had the privilege of 
being affiliated for nearly 30 years with Harvard Medical 
School in Boston, and I still teach a Harvard extension course, 
an undergraduate course in the spring.
    During the pandemic, I cared for innumerable pediatric and 
adult COVID patients, and I hold the CDC and the FDA in the 
highest regard. In November 2020, I chaired a study group for 
the American College of Rheumatology that was focused on COVID 
vasculitis, and it was attended virtually by nearly a thousand 
rheumatologists. I appreciated that day that the mRNA vaccines 
then under development were novel in a way that was not widely 
appreciated. They encode the very protein that itself is 
causing the respiratory failure in those who were most severely 
affected by the disease. This is in contrast to the other 
vaccines that we depend on, which are either attenuated live 
virus vaccines like measles, mumps, rubella; non-pathogenic 
component vaccines like the Hepatitis B virus; or inactivated 
toxins like tetanus toxin.
    In December 2020, on the eve of the first advisory 
committee hearing to consider approval of the Pfizer vaccine, I 
wrote a letter to the FDA pointing out a new study that found 
enduring myocarditis in two-thirds of healthy young people who 
had been infected with COVID. I urged the committee then to 
specifically assess the effects of vaccination on the heart and 
suggested that although everyone wanted to quickly bring the 
pandemic to an end, it would be worse if we failed to 
anticipate long-lasting side effects of these new vaccines. I 
never heard back from anyone at the FDA, but no vaccine or 
other drug is perfect, and we shouldn't have been surprised 
when a few months later reports emerged about young people 
presenting in emergency rooms with elevated heart enzymes 
following vaccination.
    I subsequently joined a group of epidemiologists who 
analyzed the data that had been collected by Pfizer and Moderna 
in their randomized controlled trials prior to the emergency 
use authorizations, and we attempted to calculate the precise 
incidence for serious adverse events, or SAEs, in adults who 
receive these experimental vaccines. We discovered that in the 
Pfizer trial, there was one additional serious adverse event 
for every 556 people vaccinated, or about 1,800 for every 
million. Yet, the regulators at that time conveyed the 
impression that there were no major safety concerns. Our peer-
reviewed study was published in the journal, Vaccine, in 2022.
    At a personal level, as Dr. Wenstrup mentioned at the 
beginning, I took care of a young boy who suffered a cardiac 
arrest in our emergency room shortly after receiving his second 
COVID vaccination. I filed the VAERS report at the time, and I 
felt it was my civic duty. I had filed other VAERS reports 
previously, but when the patient died a week later, I tried to 
update the report, and the system is not set up to do that, 
which led me to believe that the system underestimates the 
incidence of more severe outcomes since many children and 
adults who are very sick and later die, they are going to get a 
VAERS report filed initially.
    I do not know how many people are available at the FDA to 
followup on the more than 1.7 million VAERS complication 
reports that have been filed the past 3 years. But I feel 
strongly that we must work proactively in our public health 
system, both to accurately identify the true risks of all 
medications, including vaccines, but also that we must have the 
courage to trust Americans with this information in a spirit of 
ethical informed consent. Hopefully, we will ultimately know 
the true long-term risks and benefits of these vaccines that 
have been given now to nearly three-quarters of the world's 
population. Thank you again for the honor of meeting with you 
today.
    Dr. Wenstrup. Thank you. I now recognize Dr. Gortler to 
give an opening statement.

                  STATEMENT OF DAVID GORTLER, PHARM.D.

                         SENIOR RESEARCH FELLOW

                  PUBLIC HEALTH POLICY AND REGULATION

                        THE HERITAGE FOUNDATION

    Dr. Gortler. Thank you, Dr. Wenstrup, Dr. Ruiz, and 
Members. The views I express in this testimony are my own and 
do not necessarily represent any official position of the 
Heritage Foundation.
    The drugs we take and the food we eat are the most 
regulated things in the world, despite many people thinking 
that it is things like guns or airplanes or cars. Since most 
people know at least a little bit about cars, I am going to use 
a car analogy to compare COVID mRNA injections to development 
of a new car. Let's say that it normally takes 10 to 12 hours 
to assemble a car, representing the 10 to 12 years that it 
takes to bring a vaccine to market. Let's also say that due to 
some sort of emergency, new cars would be jammed down the same 
assembly line in just 45 minutes instead of 10 to 12 hours, 
representing the relative 9 months it took to bring COVID RNA 
injections to market. Let's also suppose that those cars are 
something completely different from what you know as cars. I 
don't just mean the next cool-looking car. I mean something 
visibly and technologically unrecognizable.
    Whatever advanced car you are picturing in your head right 
now, it is not that. It is something more complex. On top of 
the novel design of the car, all of the parts of that car are 
new. The new car being produced might not have wheels, a brake 
pedal, a windshield, for instance. Let's also say that it was 
not powered by electricity or combustion either. Instead, it 
uses your body as a fuel source. Not only are all the parts 
new, but the materials used to manufacture those parts are new, 
with decades of research showing them to often be extremely 
delicate, finicky, or toxic, representing the fully synthetic 
RNA nucleotide and lipid nanoparticle components. Of note, 
since the development and review time was reduced by over 90 
percent, even if the slightest error was made to those ultra 
complex cars, the car might not work at all and/or could be 
extremely unsafe and/or highly unpredictable for you, your 
family, friends, and fellow drivers.
    Let's also say that the new car was so novel and different 
from every other car on the road that it did not even meet the 
current definitions of car. Rather than call it what it was, 
the National Highway Traffic Safety Administration unilaterally 
altered its 100-year-old plus definition of a car on its 
website overnight without seeking outside input. This 
represents the CDC's fall of 2021 abrupt definition change of 
vaccines versus gene therapy.
    If a curious material scientist or engineer wanted to 
perform research about the design and materials used in this 
new car and replace some critical technical information, 70 
percent of the document would be grayed out with (b)(4) 
redactions, translating to ``protects trade secrets and 
confidential commercial or financial information.'' In other 
words, the engineering blueprints and materials used to build 
that car were secret despite taxpayer dollars being used to 
research and produce those cars.
    Let's compare that new car to an existing car. To keep 
expenses low, I personally prefer to drive a very specific 
older car, which is a true story, by the way. It is nowhere 
near as fancy or elaborate or laden with features, but it is 
inexpensive and quite safe, just like ivermectin, 
hydroxychloroquine, vitamin D, and other COVID treatments. 
Let's also say my old car was so safe and reliable that it won 
the Nobel Prize. While my 1995 Lexus LS400 never received a 
Nobel Prize for medicine, the Japanese inventor of ivermectin 
did in 2015.
    Despite that, 1 day the government, who does not have 
congressional authority to recommend what available cars to buy 
or not buy and has never done so in the past, proclaims that my 
Nobel Prize-winning car should now only be driven by horses and 
cows, as per the FDA's famous tweet. Now, they are not 
recalling the car, but they are screaming from on high their 
unmistakable disapproval, mocking patients and physicians who 
drive it. Of note, the FDA has no congressional authority to 
recommend one drug or medical treatment over another and has 
never done so in the past. Several obsequious state pharmacy 
boards take it to the next level and use the FDA's implication 
to forbid the use of my traditional car to anyone other than 
horses or cows as 20,000 career FDA employees remain 
conspicuously silent.
    Today, over a hundred studies published by over 1,100 
authors conducted in over 140,000 patients in 29 countries show 
a statistically significant lower risk for mortality, 
ventilation, ICU, hospitalization, recovery incidents and viral 
clearance for ivermectin. Similarly, positive data is 
associated with the use of vitamin D and hydroxychloroquine. 
How peculiar is it that some of the same politicians who 
believe it is OK to legalize hard street drugs such as heroin 
and methamphetamines have a cow when it comes to ivermectin, 
hydroxychloroquine, vitamin D, and other protocols to COVID? To 
the country's physicians and pharmacists who prescribed 
ivermectin or hydroxychloroquine, I would like to tell you 
right now, you were right. The pharmacy boards were wrong, 
period. I would bet you my prized 1995 LS400 on it.
    To summarize, medical scientists not only have the right, 
but the duty to ask questions about the safety and 
unnecessarily complex pharmaceuticals jammed through an 
expedited review process when there are inexpensive, 
undebatably safe, and effective alternatives available. 
Academic medical discourse should be encouraged, not quelled. 
Thank you very much. I look forward to cultivating an academic 
exchange with everybody here.
    Dr. Wenstrup. Thank you. I now recognize Ms. Gentry to give 
an opening statement.

                       STATEMENT OF RENEE GENTRY

                                DIRECTOR

                    VACCINE INJURY LITIGATION CLINIC

                      GEORGE WASHINGTON UNIVERSITY

    Ms. Gentry. Thank you, and good afternoon. Thank you to 
Chairman Wenstrup, Ranking Member Ruiz, and members of the 
subcommittee for this opportunity to discuss a critical 
national public health issue. This afternoon, I hope to be able 
to give you the perspective of the vaccine injured, a voice 
that often gets lost in the debate. My colleagues and I believe 
strongly in the importance that vaccines play in our society in 
eradicating diseases and curbing pandemics. Having said that, 
vaccine injuries while rare in the vaccinated population, are 
real.
    Routine and pandemic immunization programs are the 
cornerstone of our public health policies. The success of those 
immunization programs relies on public confidence in vaccines. 
A critical component of vaccine confidence is ensuring that 
those rare individuals who are injured by vaccines have a 
reasonable and effective forum in which to make their claims 
and an experienced bar to represent them. The VICP needs 
modernizing to shift from the aspirations of 1986 when it was 
created to reflect the realities of 2024 and our current public 
health needs. Much has changed in the nearly 40 years this 
program has existed. Congress intended that the VICP provide 
individual petitioners a swift, flexible, and non-adversarial 
alternative to the often costly and lengthy traditional tort 
civil litigation system. You cannot file a lawsuit against a 
manufacturer or administrator of a covered vaccine without 
going through our program first.
    While imperfect, the VICP was tremendously successful in 
its first 30-plus years. New vaccines were developed at such a 
rate that the program grew from six covered vaccines to 16. 
Very few petitioners rejected the decision of the vaccine court 
and filed suit against a manufacturer, and fewer still opted 
out of the program at the 240-day mark when they are permitted 
to pursue civil litigation if their claim has not been 
processed. This reality perfectly reflected Congress' intent 
that petitioners be compensated quickly and generously by 
making the VICP a reasonable and meaningful alternative to 
civil litigation.
    Three procedural events have resulted in the VICP being 
overwhelmed at this point. The addition of the influenza 
vaccination in 2005 resulted in the pool of potential 
petitioners being exponentially increased as obviously the 
influenza vaccination is generally recommended to everyone, 
adults and children, every year as opposed to the typical 
childhood vaccines. In 2015, two additional vaccines were 
added, the HPV and meningitis vaccines, which once again opened 
the VICP up to additional potential claims. Finally, in 2017, 
two significant table injuries were added: SIRVA, the shoulder 
injury related to vaccine administration, which is associated 
with nearly all the covered vaccines on the vaccine injury 
table, and Guillain-Barre Syndrome, following the influenza 
vaccination.
    The collective effect of these procedural changes was to 
triple the workload of the special masters in the vaccine 
court, the number of whom are still statutorily restricted to 
eight--eight special masters with a caseload, as of last 
Friday, of 3,618 cases. As a result, it is now the norm in the 
vaccine court to wait 2 years for a trial date after having 
already waited, in some instances, years for a record to be 
ripe for trial. There are simply no spaces on the court's 
docket. Today, through no fault of the special masters, 
vaccine-injured children and adults wait years, often without 
the ability to pay for critical time-sensitive therapies for 
the vaccine court to even be able to award compensation. To be 
clear, these crushing delays are not because vaccines are less 
safe but because the VICP's infrastructure has not been updated 
to reflect current public health policy, and we fully expect 
the ongoing development of new lifesaving vaccines. Children 
are not the only ones that get vaccinated anymore, as we all 
know.
    Even more concerning is the fact that this reality does not 
yet reflect the addition of the COVID-19 vaccines, which I 
strongly believe are more suited to the VICP than the 
Countermeasures Program. Unlike the VICP, those injured by 
COVID-19 vaccines and restricted to the Countermeasures Program 
have no right to counsel, no right to appeal, no pain and 
suffering awards, and significant limitations on economic 
damages. I have not heard of a single person currently engaged 
with the Countermeasures Program for the COVID-19 vaccine that 
feels as though their voice was being heard. This is driving 
vaccine hesitancy in individuals who have previously been 
vaccinated and were pro-vaccine.
    Finally, it is critical to distinguish the vaccine injured 
from the anti-vax. All of my clients were vaccinated. They 
suffered real and often catastrophic injuries that are 
supported by medical and scientific literature and expert 
opinion. The well-meaning, the often dismissive and critical 
comments of the pro-vaccine side directed at those individuals 
asserting vaccine injury also creates and bolsters vaccine 
hesitancy in those individuals who were previously vaccinated 
and are pro-vaccine. The vaccine injured that I and my 
colleagues represent are not anti-vax. That is a critical 
distinction that I hope you take with you as you look for 
solutions to the challenges the VICP currently faces. Thank 
you.
    Dr. Wenstrup. Thank you. I now recognize Dr. Maldonado to 
give an opening statement.

             STATEMENT OF YVONNE ``BONNIE'' MALDONADO, M.D.

              CHIEF OF THE DIVISION OF INFECTIOUS DISEASES

                        DEPARTMENT OF PEDIATRICS

                 STANFORD UNIVERSITY SCHOOL OF MEDICINE

    Dr. Maldonado. Thank you, and good afternoon. Chairman 
Wenstrup, Ranking Member Ruiz, and distinguished members of the 
subcommittee, thank you for the opportunity to testify. I am a 
pediatric infectious disease physician, epidemiologist, and 
vaccine researcher at Stanford University School of Medicine. I 
led the COVID-19 response at my institution, including scaling 
up testing capacity and clinical trials for vaccines and 
therapeutics, as well as caring for thousands of seriously ill 
patients.
    The decision at its core to use any medical product is a 
risk-benefit analysis. Decades of data underscore the enormous 
benefits of vaccines. Early in my career, I routinely saw 
children dying or suffering from severe health problems due to 
infectious diseases. We no longer see these deaths and 
complications in the United States thanks to vaccines, and, as 
a result, some individuals may not understand the benefits that 
vaccines have provided, especially to our children. But 
vaccines remain critically important, as you have heard, and 
prevent tens of thousands of deaths from vaccine-preventable 
diseases every year.
    COVID-19 vaccines are safe and provide protection against 
hospitalization and death and reduce the risk of long COVID 
and, in children, MIS-C. COVID-19 vaccination has also had 
tremendous societal benefits, including preserving our health 
system's capacity to care for patients and facilitating a 
return to normalcy. Early in the pandemic, there were rare 
instances of teenage boys and younger men experiencing heart 
inflammation, which happened about as frequently as being 
struck by lightning, about 1 in 10,000 vaccinations. Most of 
these people responded well to medicine and rest and felt 
better quickly. This small risk is even less now that we have 
safety recommendations like spacing out vaccines for young men 
and women. COVID-19 infection is also much more likely to cause 
heart damage and other severe events than the vaccine. A study 
of over 20 million people published this month found, for 
example, that COVID-19 vaccination significantly reduced post 
COVID-19 cardiovascular complications, including myocarditis, 
heart attack, and stroke.
    COVID-19 vaccines were rigorously evaluated in large 
clinical trials, through which scientists gathered significant 
safety and efficacy data from diverse populations. Healthcare 
workers like myself were among the first to be vaccinated, 
demonstrating that experts across the country had great 
confidence in the vaccine safety and effectiveness. As I said, 
any medical product carries some risk, and it is critical to 
have robust systems in place to monitor for adverse events and 
compensate individuals who are harmed. These programs are a key 
component of broader efforts to boost vaccine confidence.
    Sometimes rare events may occur after vaccination that are 
too rare to be identified within clinical trials. Vaccine 
Adverse Event Reporting System, or VAERS, is explicitly 
designed to cast a very broad net to capture all potential 
adverse events that may occur following a vaccine. Reports are 
investigated, and most severe events are ultimately found to be 
unrelated to the vaccine. In other words, correlation does not 
equal causation, and severe adverse events associated with 
COVID-19 vaccines continue to be rare.
    When investigations indicate a serious risk associated with 
a vaccine and vaccine policies and recommendations are updated 
accordingly, this indicates that our vaccine safety systems are 
working. One example is the investigation into reports of TTS, 
which we heard earlier, which led to a pause in the use of the 
Janssen COVID-19 vaccine and, ultimately, a recommendation for 
the preferential use of mRNA COVID-19 vaccines over the Janssen 
product, which is no longer used in the United States. In the 
rare event when an individual is harmed by a vaccine, it is 
important that they can receive compensation, which is the 
purpose of the Vaccine Injury Compensation Program, the VICP, 
and the Countermeasures Injury Compensation Program, CICP. 
COVID-19 vaccines are currently covered by the CICP, which has 
been underfunded as compared to the VICP. Bipartisan 
legislation has been proposed to move COVID-19 vaccines to the 
VICP and strengthen the Federal response.
    In the years leading up to the COVID-19 pandemic, our 
public health system was chronically underfunded, which has 
negative repercussions across public health, including vaccine 
safety monitoring. While Congress appropriated emergency 
funding for the COVID-19 response, providing adequate funding 
for public health before an emergency occurs is critical to 
ensure that we have a sufficiently trained work force and 
infrastructure. Thank you again for the opportunity to testify 
and for your efforts to boost vaccine confidence and uptake.
    Dr. Wenstrup. Thank you. I now recognize myself for 
questions and a few comments.
    You know, one of the things with COVID itself that makes it 
very difficult is there is so many people that got COVID and 
did not even know they had it. And so, if you are trying to say 
that it was safer to have the vaccine as opposed to getting 
COVID, it is very difficult because many patients got COVID and 
did not know. I did not know until I could not smell garlic 
salt. So, I just think we have to keep that in mind when we 
have a frank discussion about the benefits and risks of getting 
COVID, getting COVID at a certain age, getting COVID with 
certain comorbidities. All those things have to be discussed, 
but we can't ignore the fact that many people got COVID and did 
not even know it, so that is one thing. But Dr. Maldonado, do 
you think it is important to have a frank discussion with 
patients or, in your case, the parents of children to discuss 
the benefits and risks of virtually any medication, but 
especially vaccines?
    Dr. Maldonado. Absolutely. I believe that the bond between 
a physician and a parent and a patient is sacred and really 
should be transparent.
    Dr. Wenstrup. Yes, and I think that is one of the things 
that we missed. When we started putting out mandates, you 
eliminated the physician, and that is what a lot of people 
struggled with, which, in my opinion, has led to many people 
having vaccine hesitancy. When I say, ``my opinion,'' it is 
because we are out with our constituents all the time and we 
get their opinion. And so that is a difference between, say, 
just working in a lab or in an agency. You know, we are 
actually out with the people and understand what is going 
through their minds.
    You know, during part one, I asked our government witnesses 
to acknowledge that they were, well, too general in their 
assertions that the vaccine was safe and effective. I said at 
the time, to the American public, many of them heard ``100 
percent safe and effective.'' That is what they interpreted 
that to be, but they never qualified their statement. You know, 
like any drug you see on TV, they say talk to your doctor. That 
wasn't happening. You had the government saying safe and 
effective, no qualifier, not talk to your doctor. And so, from 
what I understand, the FDA standard of safe and effective is 
actually very specifically defined. So Dr. Gortler, if you can 
very quickly let me know, does the FDA have different standards 
for EUA and full BLA approval? Could you explain the 
difference, if there is one?
    Dr. Gortler. Oh, sure, and Dr. Wenstrup, I appreciate the 
question. I would also like to point out that one of my 
colleagues, Dr. David Weisman, pointed out to me yesterday that 
the approval language in Europe is actually a little bit 
different where it says, ``safe and effective.'' I think they 
precursor those words with maybe ``safe and effective.''
    Dr. Wenstrup. So, what about ours?
    Dr. Gortler. So, with ours, I believe the way the approval 
process works is, once it is authorized one way or another, it 
is authorized. You know, we heard, like, Operation Warp Speed, 
and, you know, Operation Warp Speed, while it was kind of, you 
know, a cool idea with underlying themes of, you know, the 
person who conceptualized it with Yale and ham radio and Star 
Trek, of course, I would have just liked to have seen something 
a little bit simpler.
    Maybe I am a little bit of a Luddite, a Philistine, 
perhaps, but I would be interested in seeing what already 
exists in our toolbox that isn't quite as complicated. And for 
instance, just to let you know, the molecular weight of 
hydroxychloroquine is about the same molecular weight, size as 
Tylenol, about 300 daltons. In contrast to that, we do not know 
what the exact structure is, or the exact molecular weight is 
for the spike protein encoding for RNA, but just the spike 
protein alone is, like, 4,000 bases, which is about 200,000 
daltons compared to about 300 daltons. I would have liked to 
have seen an Operation Warp Speed for things like ivermectin, 
hydroxychloroquine, vitamin D, maybe colchicine, midodrine, 
metformin----
    Dr. Wenstrup. Let me get to a different question or maybe 
get more specific. Are the systems that we have in place, in 
your opinion, adequate in ensuring the safety of COVID-19 
vaccines?
    Dr. Gortler. The question is for me, sir?
    Dr. Wenstrup. Yes.
    Dr. Gortler. No, they are not, and I can explain why. I do 
not think the collection systems are adequate for the following 
reasons. As a physician, you will know, and there are other 
physicians in here, a normal physician visit is usually billed 
out as a code, not ICD-10, but whatever the code is. It is 
99213 for a 15 minute----
    Dr. Whelan. CPT.
    Dr. Gortler. A CPT code--thank you--is a 99213, and 99213 
pays a physician something like $75 to be able to, you know, 
interview, assess, diagnose, and prescribe. And if a patient 
were to report an adverse event during one of those events, a 
physician wouldn't really have the time to collect it and go on 
the phone and spend an hour with the FDA MedWatch system. 
Likewise, a pharmacist is also someone who receives quite a bit 
of safety complaints. But a poor pharmacist, you know, working 
behind the counter at one of these grueling chain pharmacies, 
you know, they have metrics by their employer, and their 
metrics are to hammer as many round pegs in a round hole as 
fast as they can, and there is no protocol. There is no way to 
reimburse for them to be able to report adverse events.
    And so, because of that, there was a study funded by the 
AHRQ that came through out of Harvard that found that it is 
only the very, very low digits, like 1 percent, the very, very 
low single digits of adverse events ever reported to VAERS, and 
I think there needs to be a better collection method. There 
needs to be more vigilance about reporting by healthcare 
professionals. Does that answer your question?
    Dr. Wenstrup. Thank you. Yes, it does, and, yes, we also 
have concerns of reported versus verified significant event, et 
cetera, and that is the type of stuff we want to be better at. 
Dr. Whelan, do you believe that it is appropriate to house all 
of the potential updates and corrections to VAERS on a non-
public data base?
    Dr. Whelan. I think that there is a lot of trust involved 
in the medical community, but also for the general public, that 
something is happening behind the scenes when you can't see it 
right out in front. And I think, two, that people were very 
aware that you did not have the kind of followup on vaccination 
generally that we expect, for instance, from our pediatricians, 
where you got a nurse who is going to call the following week 
and make sure that your child is doing OK. And, I mean, my own 
strong feeling is that we really needed a much more proactive 
surveillance mechanism, and I think that many of us understand 
that the FDA was under enormous pressure and also that it was 
an overwhelming task. And just judging by the number of VAERS 
reports that there have been and knowing how challenging it can 
be to actually file a VAERS report, the task could have been 
even vastly larger than the large task that it already is.
    I mean, you have to have some level, I think, of internal 
dialog that takes place. But I think ultimately, as you alluded 
earlier, you have to be able to create some level of trust 
among people, and I think the system currently does not 
cultivate that.
    Dr. Wenstrup. Yes. Look, there is no doubt it is a 
challenge, you know. You might have 10 adverse events from 
vaccines in a year, and then all of a sudden you have a 
pandemic and a new vaccine, and the numbers are huge. How do we 
prepare for that? And those are some of the things that we 
wanted to discuss here. I will say, Dr. Whelan, the government 
witnesses in part one of this told us that all serious reports 
to VAERS are followed up on, and there is not a timeline on 
that statement. But do you believe that the government is 
adequately following up on all serious reports to VAERS, and 
what might we do to improve on that?
    Dr. Whelan. I do not have any high-level view of how often 
and how closely they followup, but in my own anecdotal 
experience, there was not a sense of urgency. Because I was a 
co-author on this paper, I had an opportunity to speak directly 
with Dr. Marks, who spoke at your previous hearing, and they 
were in the process of sort of, you know, critiquing our work. 
When I mentioned that I had had this patient who died, the 
whole tenor of the discussion completely changed. But even then 
it was a whole month before I was able to speak with somebody, 
and I have never received any followup about it later. I am not 
sure that they ever obtained the records on that particular 
case, so we were kind of left with the sense that if there was 
followup, they didn't do much in the way of follow through 
afterwards.
    Dr. Wenstrup. Thank you. Just a quick question for Ms. 
Gentry because I think in your opening statement you made many 
good points in your concerns for the compensation systems in 
place. And can you give us some idea of how we should change 
how our system works currently?
    Ms. Gentry. The VICP specifically?
    Dr. Wenstrup. Oh, we can start with that. Yes.
    Ms. Gentry. Sure. I think certainly the main thing with the 
VICP that we have seen is that it just needs to be modernized. 
I mean, this was originally the National Childhood Vaccine 
Injury Compensation Program. And as we all know, adults 
routinely get vaccines now, and they have always been covered, 
but it needs to be expanded. Certainly, when I say 
``infrastructure,'' we need to have an increase in special 
masters, to be sure.
    HHS and the Department of Justice that represents the 
Secretary in these cases needs to have adequate compensation or 
adequate funding rather to make sure that they can do that. We 
see long delays at HHS in processing petitions because they 
have so few reviewers to do that. And they were also deployed 
during COVID away from it, so I think there is certainly some 
delays in that. That needs to be updated. We are still looking 
at compensation from the 1980's for these cases, so you are 
looking at a death case being capped at $250,000 in the VICP. 
Pain and suffering is capped at $250. There are, thankfully, no 
caps on economic damages in the VICP, which is great. Those 
rare individuals with serious injuries have additional care, 
life care plans that can come into effect. That is critical.
    From the standpoint of the Countermeasures Program, you 
know, when you don't hear much about it, it usually means it is 
doing fairly well, and when it starts to have an issue is when 
you start to hear about it. And I think the first big hit that 
it took was with the H1N1 vaccine back in 2009, and those cases 
went into to the Countermeasures Program. That was a big chunk 
of cases, but nowhere near what we are seeing with COVID. And 
that vaccine came over because it was included in the 
formulation for the seasonal flu vaccine.
    The COVID vaccine, though, I just think it is not the 
appropriate program for it. We saw Commander Grimes speak at 
your last hearing, and he gave the burden of proof in the 
Countermeasures Program. The burden of proof in the 
Countermeasures Program is higher than in our program, and you 
do not have attorneys or experts or anything like that, so I 
think that is a really difficult burden to meet. And when I 
speak of causation, I appreciated in your last hearing that 
both you and Ranking Member Ruiz, we have talked about words 
matter, so I want to be clear with my words. When I speak of 
causation in these cases, I am talking about legal causation in 
the vaccine court, not medical certainty, not a causal analysis 
as Dr. Maldonado spoke of. We will never have epidemiology in 
support of our cases because they are rare events. That is what 
you want them to be is rare events.
    So, when I speak of legal causation, it is still much 
harder in legal causation to prove causation in the 
Countermeasures Program than in the Vaccine Program than the 
VICP. I try to use the ``Vaccine Program'' and 
``Countermeasures,'' a little less alphabet soup, but that is 
very difficult. And when you do not have right to counsel, it 
is incredibly difficult to prove, particularly if you are 
injured or you are sick or your family member is sick, to do 
that.
    So, I think there is no improvement that can be made to the 
Countermeasures Program that would make it appropriate for 
COVID-19 vaccine cases. There are improvements that could 
certainly be made to the Countermeasures Program for everything 
else. Statute of limitations can certainly be increased and 
different things like that on compensation, but that would be 
my recommendation for those improvements.
    Dr. Wenstrup. I appreciate that. I now recognize Dr. Ruiz 
for questions.
    Dr. Ruiz. Thank you. During last month's hearing, we heard 
from Federal officials at the FDA, CDC, and HRSA, who are 
tasked with overseeing America's various vaccine safety 
systems. Their testimony walked us through the multi-step 
process that ensures vaccines available to the American public 
are safe and effective as possible. Dr. Maldonado, I would like 
to get your perspective on how these systems worked for the 
COVID-19 vaccines. Is it true that COVID-19 vaccines underwent 
rigorous evaluation for safety and effectiveness as part of the 
FDA's emergency use authorization and approval process?
    Dr. Maldonado. Yes. I won't go through the various phases, 
but the process by which the Federal Government oversees 
regulation of vaccine, clinical and other products, devices, as 
well as other biologics is quite rigorous and very well defined 
in terms of steps that are laid out for industry and others to 
participate in these. And the steps taken for the COVID-19 
vaccines were similar to those that were used for all the other 
vaccines that have been studied over the many decades that we 
have these programs in place. Obviously they were accelerated 
because of the nature of the pandemic that we were in, but the 
processes were followed.
    Dr. Ruiz. And what did clinical trial data collected as 
part of these processes show about the safety of the COVID-19 
vaccines?
    Dr. Maldonado. Well, as we know, there were adverse events, 
and that is where our VAERS, VSD, and V-safe systems, among 
others, really took those into account. But overall, as we went 
through the process and as I testified earlier, as safety 
events were identified, they were explored more deeply. And 
again, within the constraints of the work force and the volume 
of the claims that were coming through, they were addressed, 
with the highest priority being to the most important safety 
considerations. But certainly, they were addressed as they went 
forward, the example being the J&J, for example, and other 
issues. But in general, the safety issues were the most common 
ones that we see with vaccines, which are pain at the site of 
injection, fever, swelling, and myolysis. But again, at the 
other end of the spectrum were the more serious things, like 
TTS, et cetera.
    Dr. Ruiz. Yes. And we talked in more detail about the 
various systems that were in place to identify adverse 
reactions, and we talked about how VAERS was the most 
nonspecific in the sense that it was where patients could write 
in about anything that they felt, any symptom, any occurrence 
that they felt was related to the vaccine and that would 
overcount what one individual would think was related. And in 
fact, many of the patient-driven were investigated and were not 
found not to be associated with COVID, but we have to cast a 
wide net like that so that we can identify any possibility of a 
true, serious adverse effect. And with Johnson & Johnson, of 
course, they found that and they made modifications with a 
recommendation. So once the COVID-19 vaccines were brought to 
market, multi-layered surveillance systems operated by the CDC 
monitored for adverse events.
    Dr. Maldonado, has data collected through the surveillance 
systems genuinely reaffirmed the safety of the COVID-19 
vaccines?
    Dr. Maldonado. Yes, they have. Generally, they have 
reaffirmed the safety, but also reaffirmed whether or not SAEs, 
or serious adverse events, were truly related or not related to 
the vaccines, and those are done by separate methods. That is 
by verifying through massive surveillance efforts. Again, no 
surveillance system is perfect, which is why you need multiple 
layers of surveillance and strengthening of those surveillance 
systems over time. The other way to do it is to confirm by 
using other datasets, for example, Medicare claims datasets, 
emergency room visit datasets. There are numerous other 
datasets where you can take large populations and verify what 
you see in your surveillance through these----
    Dr. Ruiz. In the medical and public health world, we want 
to know, we want to verify, we want to identify the adverse 
effects so that we can make the adjustments, the changes, the 
recommendations, find the populations who are contraindicated 
from taking that vaccine, et cetera. So, you know, I see how we 
take it very seriously and want to identify them so we can rule 
them out in order to give the best recommendations as possible. 
And is it true that in cases where an elevated risk of adverse 
events has been detected, such as with the J&J vaccine, our 
Federal public health officials have used this data to swiftly 
update their vaccination recommendations?
    Dr. Maldonado. Yes, absolutely that is the case, and it 
just happened recently with the followup of the potential for a 
risk of stroke from the COVID-19 vaccine, which was a signal 
that was identified and further investigated and found not to 
be a true signal.
    Dr. Ruiz. OK. But they are taken seriously, and they are 
looked into further, correct?
    Dr. Maldonado. Yes, they are.
    Dr. Ruiz. OK. So, it seems like that is the system that we 
want, is to be hyper vigilant and then do the investigation to 
determine to make the changes or adjustments. But overall, the 
vaccine has shown in a population health base to be safe and 
effective, correct?
    Dr. Maldonado. Yes, with the data that has come from a 
multiple surveillance systems.
    Dr. Ruiz. And so, has any data collected through CDC 
surveillance systems drawn into question your recommendation as 
a physician that patients should receive the COVID-19 vaccine?
    Dr. Maldonado. No, I think the data has been very 
supportive of my decision to counsel my patients.
    Dr. Ruiz. OK. Thank you. And in the case that rare but 
serious adverse events occur after vaccination, such as severe 
allergic reaction, HRSA operates a system to evaluate claims 
and adjudicate them for compensation. Ms. Gentry, you represent 
patients who have gotten vaccinated and experienced these 
serious adverse events as they navigate this system, and thank 
you for doing that. What role does the efficient processing of 
these claims and meaningful compensation when appropriate play 
in encouraging patients to receive safe and effective vaccines 
and reducing vaccine hesitancy across the United States?
    Ms. Gentry. Thank you. I think it is absolutely critical 
that they have that. I mean, the whole system was designed to 
be faster than the 240 days. And prior to the three events that 
I talked about, procedural things, we were processing claims at 
the vaccine court, some claims in under a year. I think it is 
very critical, and what you are seeing also with the COVID 
cases is the frustration of the delays. It is starting to turn 
people who, again, are pro-vaccine and got the vaccine and want 
to do the right thing turning away from it----
    Dr. Ruiz. Yes. So----
    Ms. Gentry [continuing]. And being very concerned. It is 
very disconcerting.
    Dr. Ruiz. So, it is a systematic issue that needs to be 
fixed, and----
    Ms. Gentry. Absolutely, in both programs.
    Dr. Ruiz. Yes, and I am very in support of making sure that 
the claims are processed faster and that we update the 
compensation amount when appropriate to ensure that people are 
adequately compensated. That is something that I think we can 
have bipartisan consensus on.
    Now, I would like to turn my attention to the physician-
patient relationship during the COVID-19 pandemic. As I have 
stated before in previous Select Subcommittee hearings, the 
relationship between a patient and their doctor is sacred, a 
cornerstone of healthcare delivery that is rooted in trust, 
empathy, and the oath to do no harm. As a physician, it is 
something I deeply valued when I treated and cared for my 
patients in the emergency department. And for our Nation's 
physicians who served on the frontlines of the COVID-19 
pandemic, I know it is something they deeply value too.
    Yet, over the past year, we have had hearings in this 
committee on the patient-doctor relationship during COVID and 
heard allegations that the government overreach and so-called 
one-size-fits-all vaccine requirements eliminated the 
decisionmaking power of patients and physicians. I would like 
to dwell on this a little further. Dr. Maldonado, were 
requirements a clinically appropriate tool to encourage vaccine 
uptake, and how did they help to save lives and prevent severe 
hospitalizations in the United States?
    Dr. Maldonado. So, I was also the Chair of the Committee on 
Infectious Diseases for the American Academy of Pediatrics 
during the period of the pandemic. It just happened to occur at 
the same time. And I found that our relationship with the 
67,000 pediatricians who we represent in the American Academy 
were highly supportive of the programs and processes that we 
had in place and actually worked very closely with us on a 
daily basis during this pandemic to help message not only to 
providers in, for example, rural areas that had poor access to 
information, but also to those providers' patients. So, I found 
that during the pandemic we had a stronger relationship with 
our providers and patients than I have seen actually in my 
career.
    Dr. Ruiz. So, physicians weren't left out in these 
recommendations for requirements. In fact, they gave their 
input, and they supported them?
    Dr. Maldonado. Our opinions were sought out, and when we 
requested, for example, discussions with, say, Dr. Marks, Dr. 
Wharton, and others from CDC, FDA, and others, we were at the 
table, and we were able to put in our opinion in as frontline 
providers around what would work for our providers and what 
would work for our patients in terms of communication. And it 
all has----
    Dr. Ruiz. So, you were consulted on even how to better 
communicate with patients regarding the vaccine and the 
requirements.
    Dr. Maldonado. Yes, I----
    Dr. Ruiz. And you gave your input, and the association gave 
their input, too?
    Dr. Maldonado. Yes, I believe that our input was solicited 
on a regular basis.
    Dr. Ruiz. And do you agree with the allegation that doctors 
were sidelined, and that the physician-patient relationship was 
disregarded in the discussion surrounding COVID-19 vaccine 
requirements?
    Dr. Maldonado. I did not find that to be the case either at 
the local level or at the national level in the patients that--
--
    Dr. Ruiz. How did you communicate with your patients during 
this time, and was there any scenario where you advised for any 
contraindicated reasons not to take the vaccine and what to do 
about it?
    Dr. Maldonado. So, what I will say is all of us probably 
here at the table, we worked probably 24/7 for those, you know, 
several years. And much of that time was spent in communicating 
with families, with adults, who also wanted advice for their 
own selves, and not only their children, in dealing with 
numerous town halls, webinars. I remember we were on Zoom for a 
lot of this too, but in person as well seeing patients. We set 
up large clinics where we could actually see people, talk to 
them in English, Spanish, Tagalog, whatever language we needed 
to really get to people so that they could ask the questions 
that they needed to have answers for.
    Dr. Ruiz. Thank you. Before I conclude, I would like to 
make one thing clear, which is that the physician-patient 
relationship is not one that occurs in spite of our 
government's public health institutions. Rather, it is a 
relationship that is complemented and fortified and perhaps 
even enhanced by the tireless work of our Nation's public 
health officials and experts, particularly during times of 
crisis because let's face it, we need each other. We need 
everybody in our communities to pull through in a crisis. And 
we need to be able to work with one another in a very trusting 
relationship, getting all the input that we need, and then use 
science to determine the right course of action so that we are 
not leaving it up to ideology, we are not leaving it up to 
partisanship, we are not leaving it up to chance, because, 
ultimately, science and epidemiology is the ruling out of 
chance in our recommendations to determine patterns that we can 
get close to the truth in order to provide the best 
recommendations that we can. And so that is why I see, because 
of these studies in science, that we are in a much better 
place. And so, with that, I yield back.
    Dr. Wenstrup. I now recognize Ms. Malliotakis from New York 
for 5 minutes for questions.
    Ms. Malliotakis. Thank you very much. I want to thank our 
witnesses today for being here to discuss a very critical 
issue, vaccine safety. And I know many of my constituents have 
concerns about the government's handling of the COVID-19 
vaccine rollout, the communication issues that there were, and 
the adequacy of our safety monitoring systems. And today, I 
hope we can have an open and transparent discussion about how 
to improve these programs to better protect public health, 
restore trust, and ensure accountability as we move forward, so 
I appreciate your insights and your recommendations.
    My question is for Dr. Whelan. In your testimony, you 
discussed your research that re-analyzed the Pfizer and Moderna 
clinical trial data and found a higher risk of serious adverse 
events compared to a placebo. Did your analysis reveal any 
safety signals or increased risk of cardiovascular issues like 
myocarditis, especially in the younger vaccine recipients? And 
based on your findings and your expertise as a pediatric 
rheumatologist, do you believe the risk of myocarditis after 
COVID-19 vaccination has been adequately investigated and 
communicated to the public, particularly for young males?
    Dr. Whelan. So, thank you for that question. The study that 
we performed was based on the original Pfizer and Moderna 
vaccine data in adults, so it didn't address children. And the 
studies in children which used populations that were 
considerably smaller and not powered to find the kind of 
signals, you know, that were apparent in the data for the 
adults. There were significant problems with the studies as 
they were performed or, rather, the data as it was reported. 
And I think that the value added for our group was that we went 
in, we re-analyzed the data with objective criteria--it hadn't 
been done that way previously--and we discovered that there was 
some flaws in the way that both Pfizer and Moderna reported 
their data that hid some of the adverse effects.
    Ms. Malliotakis. Would you care to share an example?
    Dr. Whelan. I don't know that this was an intentional 
thing, and I don't know that the FDA was even aware that this 
was going on, but, for instance, the Pfizer population, their 
data was reported in a form that included a very large number 
of people who had only gotten a single vaccination and people 
who did not have adequate followup afterwards.
    Ms. Malliotakis. Uh-huh.
    Dr. Whelan. So, the number of people that we analyzed were 
just the individuals who received two vaccinations and received 
at least 2 months of followup afterwards. What that did was it 
contracted the total population that we studied by about 5,000 
individuals. And all of a sudden, this significant signal 
emerged, which showed that, you know, the Pfizer vaccine had 
associated adverse events that, at least by pediatric 
standards, were pretty high.
    So, with regard to, you know, finding myocarditis in young 
people, I did get phone calls from around the country from 
providers who were anxious about, you know, young people that 
came into the emergency room with elevated troponin values and 
so on. We really don't know what the long-term consequences of 
having myocarditis as a teenager are, but it was pretty scary, 
of course, you know, when a child is coming into the emergency 
room with chest pain and then it turns out that they have got 
elevated troponin levels, which suggest, you know, that they 
might be having a heart attack. So----
    Ms. Malliotakis. Well, it is interesting because 
myocarditis is one of the vaccine injuries that are actually 
being compensated for, but I think you made a really good point 
in terms of the followup for long-term effects, right? We 
really don't know what the long-term effects of not just 
myocarditis, but also of the vaccine itself. So, in your 
opinion, how could the vaccine safety surveillance systems be 
improved to better detect and characterize rare but serious 
adverse events?
    Dr. Whelan. As I alluded before, I think that the system 
was under resourced, and I don't fault the individuals 
involved. I have discussed this with Dan Jernigan, who spoke to 
the committee last month. And I think they were just approached 
with an impossible task, which was, you know, how do you 
vaccinate an entire country and adequately followup on, you 
know, the individual vaccinations? I just think that they 
really needed to have an army of people who could have gotten 
in there and started calling people who got vaccinated and then 
find out exactly, you know, what was that person experiencing.
    Ms. Malliotakis. So in my last, like, 20 seconds, I just 
want to ask Dr. Gortler a question. You have written about the 
FDA's dependence on vaccine manufacturers for certain safety 
assessments, which some view as a conflict of interest that 
could compromise the integrity of the approval process and 
undermine public trust. In your expert opinion what are the 
most critical weaknesses in the government's vaccine safety 
surveillance systems? What specific steps could the FDA take to 
reduce reliance on manufacturers and increase transparency to 
strike a balance between promoting vaccine confidence while 
allowing space for addressing legitimate concerns openly?
    Dr. Gortler. So, the one-word answer is transparency, 
period. The FDA isn't perfect, and when they do things that are 
a little bit shortcoming, I don't have a problem, you know, 
speaking up and saying something about it. But when you look at 
the lack of information, both in the label and the technical 
documentation of how its manufactured, how the mRNA shots, in 
particular, are evaluated for safety, there is just too much 
information missing. Honestly, I don't know if I can blame the 
FDA for the transparency or some component of the emergency use 
authorization or the PREP Act that doesn't allow that 
information in there. But there is information conspicuously 
lacking, not only from the label, comparing it to other drugs 
that utilize RNAs as a mechanism of action, especially because 
this drug is so much more complex.
    I mentioned there are about 4,000 base pairs. Another drug, 
Onpattro, which is also an RNA technology, contains all the 
information you need, you know, molecular weight, number of 
strands, you know. It even shows a picture of the structure, 
and that is only 20 base pairs. And so, we don't have the 
transparency for something that is a lot more complex, per the 
introduction that I talked, the car reference. Thank you.
    Dr. Wenstrup. I now recognize Mr. Mfume from Maryland for 5 
minutes of questions.
    Mr. Mfume. Thank you very much, Mr. Chairman. I want to 
thank you and Ranking Member Ruiz for calling today's hearing. 
Obviously, I want to thank all four of our witnesses for 
traveling here to share your thoughts and your understandings, 
your recommendations, and your suggestions. As an aside, Dr. 
Whelan, let me thank you for referencing Dr. Jonas Salk, who 
was an indirect hero of mine. I was in the second grade when 
the polio vaccine was first approved and distributed. And I say 
``hero'' because it was a small Black school on the edge of the 
Chesapeake Bay that had attached to it a small, underfunded 
nursery. And I remember my mother taking me to that nursery as 
a young person, under the age of 5, and going back the next 2 
years and not seeing any of those kids because so many of them 
had contracted the virus and had passed away, so Salk was a big 
hero. In fact, my second and third grade teachers collaborated 
and threw a party to tell us why the polio vaccine was 
important and how it was going to save lives. So let me get 
away from that side talk for just a moment, but thank you for 
what you did toward the end of his life. It is very important. 
It is not lost on me.
    I want to talk about a couple of things, and on this 
committee, I have tried to be straightforward about what it was 
like then because the further we get away from the pandemic, 
recollections fade, memory serves us less. But fear was the 
order of the day, absolute stark fear, and it was fear among 
all of us. It was pain. It was anguish. There was death, and 
obviously there was a great deal of sorrow that some people are 
still experiencing. People wanted help then and they wanted it 
right away, and they looked to all of us, whether we were in 
government or not or, as you are in medicine or not, to figure 
it out because they thought that they were going to find 
themselves stricken or losing a loved one.
    So, today is a cautionary tale. That is why these hearings 
are important. We can learn what we did, what we didn't do, how 
do we do it better, how do we fix it, what were our 
shortcomings, what do we own up to. But back then, 4 years ago, 
caution went out the window, and as a result of that, many of 
the things that we are talking about today developed.
    Ms. Gentry, I really want to land on where you were because 
victims concern me, and being able to find a way to get 
compensation is important. And I am not here as a commercial 
for the Trial Lawyers Association, but I can tell you that 
people who don't have a voice who were somehow, or another 
injured by the vaccine and unable to get injury compensation 
just concerns me, and I hope it concerns all of us. The VICP 
shortage of masters tells me that things don't move through the 
courts as they should for many of them. The litigation backup 
concerns me because it says it is only probably going to get 
worse unless we put resources to it. It is kind of like what 
Dr. Whelan said about the systems that are in place. They 
probably were meant well, but we didn't do the right thing to 
resource them.
    And so, this litigation and the appeal process, can you 
take just a moment to talk about the time problems that come 
about and the cap problems that really get in the way of 
everything?
    Ms. Gentry. Certainly, and in my written testimony, I talk 
about the various lengths of time. So, when you file a claim in 
the VICP right now, in a regular lawsuit, you file a lawsuit 
and there is an answer. In our program, we file a petition and 
there is the rule for response. Right now, it is taking between 
12 and 16 months for HHS to do that because of the lack of 
reviewers on that end, so that is just the beginning. That is 
when everything is in. If you have a table case, which means 
you have a presumption of causation based on certain specified 
injuries in the vaccine injury table, those will move slightly 
faster, but in those cases, you are still looking at times 
upwards of a year in some circumstances to get a decision, 
again, just for the sheer volume of cases.
    If you have a non-table case, which is going to proceed as 
what we call a causation in fact case, it is going to look more 
like a regular lawsuit, even though I would stress these are 
no-fault compensation claims. So, you are not proving fault in 
this. It is just legal causation. In those circumstances, you 
may have several rounds of expert reports that go back and 
forth.
    Mr. Mfume. I see.
    Ms. Gentry. And nothing in our program is anything less 
than 60 days at a time. It could take 2 years to get to the 
point of a trial, 2 years to get to the trial.
    Mr. Mfume. Yes. I have got to reclaim my time. I am sorry. 
We have a limit here, unlike the Senate, where they just go on 
forever.
    Ms. Gentry. It is long, yes.
    Mr. Mfume. But this is why I want to go back to what Mr. 
Ruiz said that we could probably find bipartisan consensus on 
trying to figure out how we make that better. And I heard 
someone say that the severe events are rare and not always 
captured by clinical trials. Let's not forget that clinical 
trials are inadequate. They are not diverse. They don't come up 
with the right sort of findings. And year after year, we talk 
about finding a way to expand them, and we don't expand them at 
all, so we get results that are inadequate and cures that don't 
always cure.
    My time is up. I just want to thank all of you for what you 
are doing. Ms. Maldonado, I wanted you to talk about equity and 
your opinions, but I don't know if the Chair is going to allow 
any more time. So, thanks to all of you for being here.
    Dr. Wenstrup. We can certainly make a request for the 
record.
    Mr. Mfume. Yes. And my request would be to Dr. Maldonado to 
tell the committee how, in her opinion, we can enhance equity 
in future pandemic responses and rollouts of vaccine 
initiatives to ensure that the most vulnerable among us have 
access to the care that they need. And I say that particularly 
because of the fact that in the U.S., mortality and morbidity 
rates, Mr. Chairman, were the highest among Black communities, 
Hispanic, Asian-American, Pacific Islanders, at-risk 
populations. And those communities deserve equity or at least a 
response about how we get to equity in terms of servicing them 
and in terms of their followup.
    I yield back, and I thank you for your consideration, Mr. 
Chair.
    Dr. Wenstrup. Thank you. I now recognize Mrs. Lesko from 
Arizona for 5 minutes of questions.
    Mrs. Lesko. Thank you, Mr. Chair, and thank you to all the 
witnesses. This has been very interesting and informative.
    I am glad to hear that we actually may have bipartisan 
support in helping the victims because the system is obviously 
broken, and I just want to emphasize that by saying what 
happened to my office, OK. So as of January 1 of 2024, this 
year, the total number of CICP COVID claims filed was 12,854. I 
have a constituent that had a very severe reaction to the COVID 
vaccine. He filed a claim. He hasn't heard anything. He hasn't 
heard anything back.
    So my staff, who is sitting in the back, called or 
contacted the CICP legislative affairs person and said, OK. 
What is the update on this person? They couldn't give him any 
update. He asked, how many of the claims have you processed, 
you know, have you done, and the answer was, ``We don't have 
that information.'' I mean, how can you not have that 
information? This is absolutely ridiculous, and, Mr. Chairman, 
I think this is a really big problem if they don't even have 
the information of how many claims they have processed or they 
have awarded. I mean, $41,000, I believe, has been awarded in 
the CICP, and, you know, with how many claims: 12,854 claims. I 
mean, that is, like, nothing.
    All right. Well, that is my rant. But then I do have 
another question, and that is, Dr. Whelan, you had testified 
that you had a boy in your care that died. You had done an 
initial report and then you tried to followup. Am I correct? 
And then say, you know, he passed away, and they didn't update 
it. You didn't hear anything? Is that accurate?
    Dr. Whelan. Yes, it is.
    Mrs. Lesko. OK. Well, I have a story also of a New York man 
who suffered from--and I can't even pronounce this--H-L-H after 
the COVID vaccine. His initial report was classified as life 
threatening. Then his second report filed after his death was 
classified as hospitalized. After their initial complaint 
inquiring about why his report is not indicated as a death, his 
family subsequently received the following email: ``Good 
afternoon. Thank you for contacting the Vaccine Adverse Event 
Reporting System, VAERS, Program. Thank you for taking the time 
to file the report. VAERS data available to the public include 
only the initial report data to VAERS. Updated data, which 
contains data from medical records and corrections reported 
during followup, are used by the government for analysis. 
However, for numerous reasons, including data consistency, 
these amended data are not available to the public.'' And then 
the family subsequently sent an automated message at the end of 
2023 to update their VAERS report on his condition saying he is 
dead, and the family has just been totally distressed because, 
you know, it is not reported accurately.
    And so, do you have any suggestions? I mean, I know you 
haven't gotten anything back. Do any of you have any 
suggestions in how we can improve this process? It sounds like 
it is absolutely messed up.
    Dr. Gortler. If I may, Ms. Lesko. I am also from the state 
of Arizona. My family has lived there since the 1940's, and I 
live in Rio Verde. The information that is contained in VAERS 
is not complete. The information you can download online is not 
complete, and it can be complex to do. I personally had to 
learn how to do SQL programming and use data bases and buy some 
expensive software to get all the information to be able to 
view, but there is information which is also not submitted 
electronically.
    I mean, this is an unrelated matter. Right now, one of the 
things I am looking at are the safety of puberty modulating 
drugs, and I want to tell you about a story that I had when I 
called the FDA to request some of that information. When you 
look at all adverse events over a long period of time, I found 
about 70,000 hits. And I am not sure what those hits are made 
up of, but when I spoke with the director at the FDA, the head 
of FOIA, my first request got lost. And my second followup when 
I asked for it, I said, I would like this information, and he 
said, well, that is going to take us about 30,000 hours to get 
to you, and then he asked me for $1.2 million just to be able 
to review those data, just to be able to go over them.
    But it boils down to what one of the other Congresswomen 
was saying: it is transparency. There is a lack of 
transparency, and there is too much information that is 
redacted, and in order to redact that information, it takes 
time, right? It would take $1.2 million in salaries and 30,000 
hours for those employees to have it. But if someone who is, 
you know, familiar with the rules of HIPAA in keeping medical 
records a secret, I don't understand why they have to be 
redacted. I could just sign a form saying, OK, I promise not to 
release this information,'' and that is that. And so, there is 
a blockade, there is, like, an embargo in trying to get this 
information so that drug safety people like myself can at least 
take a look at it and see what to make of it, see if there is a 
pattern, and cross-reference it to clinical trials, et cetera. 
Thank you.
    Mrs. Lesko. Thank you all of you. It has been very 
interesting. And it is very interesting, Ms. Gentry, of what 
you said, and what the deficiencies are in the number of people 
that are processing, and that you think that the COVID vaccine 
should go under VICP. I didn't realize that under CICP, they 
couldn't have an attorney. I didn't realize that until you said 
it.
    Ms. Gentry. Well, obviously, there is no right to counsel, 
that people have their attorneys, but it is not a court 
process, so there is not really much that the attorneys can do.
    Mrs. Lesko. Got it. Thank you.
    Dr. Wenstrup. I now recognize Ms. Tokuda from Hawaii for 5 
minutes of questions.
    Ms. Tokuda. Thank you, Mr. Chair. Strengthening our 
Nation's vaccine safety systems is critical for us to advance 
public health--I think we can all agree on that--whilst 
especially addressing deficiencies in our Nation's compensation 
programs so that those who experience rare, yet serious adverse 
events can receive the compensation and care they need. That is 
important, you know, to bolster vaccine confidence in our 
country.
    Yesterday, our committee received a letter from the 
American Academy of Pediatrics, noting that, ``It is imperative 
that Congress increase funding so that the United States can 
maintain the world's most robust and effective vaccine safety 
monitoring system and help improve public understanding of and 
confidence in our vaccine safety system.'' Mr. Chairman, 
permission to enter this into the record.
    Dr. Wenstrup. Without objection.
    Ms. Tokuda. Thank you. And I think based upon the previous 
speaker's comments, she would actually agree with the American 
Academy of Pediatrics' recommendations, that they need to 
increase funding so that we can increase capacity to address a 
number of these NVICP claims, as noted in their letter that we 
will be putting in.
    Since Fiscal Year 2012 to 2021, claims have increased more 
than fivefold, from 402 claims in 2012 to 2,057 in 2021, and 
that the steep increase is largely, in part, due to the 
influenza vaccine being administered to adults. In fact, more 
than 92 percent of those claims in the last 2 fiscal years were 
filed for adults, with 74 percent of all claims being filed for 
alleged injuries from the influenza virus. Unfortunately, while 
you have seen this dramatic increase, their budget has barely 
increased from $6.5 million to $11.2 million during the same 
period, and so clearly, funding for capacity is required for us 
to maintain these systems.
    You know, I could not agree with them more in terms of the 
matter and importance of improving public confidence, as I 
think all of us agree. In our vaccine safety systems, we need 
to continue to support and enhance these vaccine safety 
monitoring and post market surveillance systems currently in 
place. We must handle each opportunity to discuss this matter 
with care because the consequences if we don't, quite frankly, 
are far too great. And since the start of the pandemic, we have 
seen growing distrust in vaccines overall. And while 
misinformation about COVID-19 vaccines have proliferated 
online, it has had ripple effects, as we know, and perhaps 
unintended consequences across our Nation's broader public 
health. A recent survey from the Annenberg Public Policy Center 
found that the proportion of respondents who believe in the 
safety of vaccines fell from 77 percent in April 2021 to 71 
percent in the fall of 2023. And while a decrease of 6 percent 
may not sound like a lot, it does have serious and real 
consequences for our Nation's health.
    As we hold today's hearings, the United States is at the 
precipice of losing our measles elimination status that we 
gained in 2000 due to repeated outbreaks of the disease that 
have popped up across the country from Florida to Ohio, to 
Missouri, to California. So far this month, we have already 
seen 58 cases of measles, many of which have occurred among 
unvaccinated children. That is just as many cases as there were 
during the entirety of 2023. This is especially concerning as 
250,000 kindergarteners nationwide haven't received their 
updated measles immunizations, leaving them unprotected from 
this deadly disease. Dr. Maldonado, why is any decrease in 
immunization levels, big or small, troubling for our overall 
public health?
    Dr. Maldonado. Well, thank you for allowing me to talk 
about this. This is something that we talk about with our 
families as providers. There is still, again, that sacred 
trust, and I think our families really continue to trust, at 
least in the pediatric population. I am sure that is true in 
other fields, but this is my field. And I think that our 
ability to have doubled our lifespan since 1900 in large part 
is due to clean water, sanitation, and vaccination. We have 
made remarkable progress in our ability to stay alive and to be 
healthy.
    And several generations have never seen these diseases that 
I have cared for in the past. And so, it is understandable that 
people think, well, they are not here. Why should I take a 
vaccine? It is going to hurt my child's arm. They are going to 
be uncomfortable. What is the good? And the good is that these 
diseases are not eliminated. I was on the panel that sought the 
certified elimination of measles in 2000. It is very sad to see 
that we may head away from that after 20 remarkable years. 
These diseases kill. They cause neurologic damage and 
developmental delay. I have seen all of this on a regular 
basis. I don't see it anymore, and I don't want to see it 
again. These diseases will come back, and they will come back 
with a fury if we don't continue to vaccinate, and especially 
if we don't continue to build that trust and confidence that 
families have in our ability to provide the safest care and be 
transparent about that.
    Ms. Tokuda. And real quick in the brief time I have, how 
have you seen medical misinformation impact patients in the 
field, directly resulting in some of these things we are 
experiencing?
    Dr. Maldonado. Is that a question? I am sorry. Yes, 
absolutely. Young people get their information from social 
media, and there are good things and bad things about that, but 
we need to make sure that, again, we don't just dismiss it, but 
listen and understand----
    Ms. Tokuda. So, we could essentially see measles, you know, 
elimination status removed because of medical misinformation, 
misinformation online, in the community?
    Dr. Maldonado. Absolutely.
    Ms. Tokuda. Thank you. I yield back.
    Dr. Wenstrup. I now recognize Dr. Joyce from Pennsylvania 
for 5 minutes of questions.
    Dr. Joyce. Thank you for convening this hearing today and 
to our panel for taking part in this. This is an important 
followup to the hearing that this subcommittee held last month, 
where we heard from government witnesses responsible for 
overseeing Federal vaccine safety systems. We now have the 
opportunity to hear from experts who have directly interacted 
with these systems and that, in many cases, found them to be 
woefully inadequate.
    Physicians are on the frontline during any public health 
emergency, and the Federal response should be guided by the 
firsthand experience of healthcare providers. Instead, the 
current administration failed to provide an adequate mechanism 
for doctors to raise concerns about vaccine safety. Reports of 
serious injuries were ignored, causing serious damage to the 
public trust, I might add, fracturing the doctor-patient 
relationship. As a doctor myself, I also worry that not all 
adverse vaccine events were accounted for, whether because a 
healthcare practitioner did not know where and how to report an 
event, or because the system that they reported it to were not 
properly monitored.
    The doctor-patient relationship needs to be reemphasized as 
we discuss how to restore public confidence in vaccines. To 
accomplish this, we must seriously examine the failures of our 
vaccine safety system and reform these systems to better 
support patients and to better support doctors. Doctors must 
have the most up-to-date information on any potential vaccine 
side effect in order to appropriately counsel patients. Our 
current vaccine safety mechanisms are insufficient to 
accomplish this goal, and patients ultimately suffer the 
consequences.
    Dr. Whelan, what reforms are necessary to ensure vaccine 
injuries are being monitored proactively, and that when 
problems do arise, that they clearly are communicated to the 
doctors and the patients in a timely fashion?
    Dr. Whelan. Thank you for that question, Dr. Joyce. I 
should start by just saying I don't see that the Biden 
Administration has done things any differently than the 
previous administration, and I think big wheels move slowly. 
So, my sense is there is more of an institutional ennui than 
there is any kind of malintent on the part of, you know, the 
current administration.
    But I do think that, as Dr. Maldonado was saying, you know, 
doctors want to be heard. They want to know that their concerns 
are being taken seriously. As I said earlier, I believe that 
there should be a more robust system for following up 
vigorously after people get vaccines and that we don't put the 
burden on the individual to report, you know, the things that 
they are experiencing, but rather, that the system really 
express an interest in finding these kinds of adverse events.
    Dr. Joyce. Can you speak about the benefits of ongoing and 
effective communications for physicians on the frontline and 
those who are responsible for providing healthcare guidelines?
    Dr. Whelan. I run a center at UCLA dealing with children 
who have neuroimmune problems, so I see a lot of kids that have 
autism and OCD and tic disorders. And so, I am confronted 
constantly with this question, you know, should my child be 
vaccinated, and I also have a lot of kids in our practice who 
have not been vaccinated at all. So, it is really an 
interesting balancing act because, on the one hand, I want to 
be sensitive to the concerns that these families have. I also 
want to, you know, express sensitivity to the fact that we 
really don't know a lot about where autism comes from. And so, 
I can't make a categorical statement to the family that 
vaccines played no role, although I share unhesitantly the data 
that we have so far. And I also think that, as Dr. Maldonado 
alluded to, you have to be able to communicate to people that 
things like measles have the capacity to permanently damage the 
immune system of that child and could potentially kill them.
    Dr. Joyce. And during the COVID crisis, did you see an 
accentuation of children or young adults with autism who were 
exposed to or received the COVID-19 vaccine?
    Dr. Whelan. So, that is a very interesting question. Did 
the vaccines play any role? Interestingly, in the Pfizer trial 
on 11-to 15-year-olds, there was an increased incidence of 
psychiatric hospitalizations.
    Dr. Joyce. I think this is an important point, and as a 
physician and as a parent of a child with autism, I am aware of 
that information. And I think that information needs to be 
shared, and I think we need to explain that to parents. I think 
it needs to be explained to healthcare providers, and, 
particularly, it is information that we have a responsibility 
of sharing to those who deal with an autistic child. I thank 
you for that candid information. Mr. Chairman, my time has 
expired, and I yield back.
    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 the witnesses for being with us today.
    In the written testimony and during today's hearing one of 
the majority's witnesses has referenced redactions in documents 
that FDA produced through FOIA, and I would like to take a 
moment to round out that discussion. While I profoundly 
appreciate the important role that taxpayer funding played in 
the research that propelled development of the COVID-19 
vaccines, we must recognize that this feat of modern science 
was a partnership between the Federal Government and industry. 
And we have to acknowledge that there are proprietary elements 
to the manufacturing process that are fundamental to 
encouraging and ensuring robust market participation for 
manufacturers of not just vaccines, but a wide variety of 
medical products essential to our public health.
    In the course of responding in good faith to 
investigations, it is commonplace for commercially sensitive 
information, such as the exact composition of products to be 
redacted, and FOIA cases are no different. The redaction of 
this proprietary information has no bearing on the robust 
process that the FDA conducts to evaluate the safety of 
vaccines and countless other medical products before they are 
brought to market. And for what it is worth, the ingredients of 
the vaccines are included on the products' labels and available 
for anyone and everyone to evaluate for themselves, as many 
preeminent researchers, including those at the University of 
Cincinnati, have already done.
    With that, I would like to turn back to the suggestion that 
COVID 19 vaccine policies infringed on the doctor-patient 
relationship. Much to the contrary, several of America's 
leading physician societies have conveyed their strong support 
for COVID-19 vaccines, and, in various cases, have filed briefs 
memorializing their support for pandemic-era COVID-19 vaccine 
requirements. For example, ahead of the Select Committee's 
first vaccine safety systems hearing, six leading medical 
associations representing nearly 600,000 physicians issued a 
joint statement reiterating that, ``COVID-19 vaccines are one 
of the most effective public health tools we have to prevent 
spread of the virus, hospitalizations, and deaths.'' This is 
consistent with the views many of America's leading medical 
societies expressed when legal challenges were mounted against 
vaccine requirements.
    The American Medical Association led dozens of other 
groups, including the American Academy of Pediatrics and the 
American Academy of Family Physicians, in filing amicus briefs 
in support of these policies in cases such as BST Holdings v. 
OSHA, Kentucky v. Biden, and Georgia v. Biden. In their amicus 
brief for BST Holdings versus OSHA, the AMA stated that halting 
enforcement of Federal vaccine requirements would ``severely 
and irreparably harm the public interest'' due to the ``grave 
danger to public health'' that COVID-19 posed.
    Dr. Maldonado, would America's major physician societies 
have filed these briefs in support of the vaccine requirements 
if they felt that these policies infringed on the doctor-
patient relationship?
    Dr. Maldonado. No.
    Ms. Ross. Thank you. With my remaining time, I would like 
to discuss written testimony submitted to the Select Committee 
from Professor Richard Hughes at George Washington University 
Law School. Professor Hughes is one of the Nation's preeminent 
experts in systems we are examining today, and his statement 
explains the importance of vaccine injury programs in ensuring 
a robust market of vaccine manufacturers and an orderly 
processing of claims, albeit imperfect. He also reminds us of 
the importance of keeping today's conversation rooted in the 
facts and not letting opinions about proven safety and 
effectiveness of COVID-19 vaccines mislead the discussion. Mr. 
Chairman, I ask unanimous consent to submit Professor Hughes' 
written statement to the record.
    Dr. Wenstrup. Without objection.
    Ms. Ross. Thank you, Mr. Chairman, and I yield back my 
time.
    Dr. Wenstrup. I now recognize Ms. Greene from Georgia for 5 
minutes of questions.
    Ms. Greene. Thank you, Mr. Chairman. Nothing creates 
vaccine hesitancy like ignoring people when they are reporting 
problems with vaccines that they are being mandated and forced 
to take; vaccines that they have to take in order to keep their 
job; vaccines that they have to take in order to be able to go 
to restaurants, go into stores, go into public places; vaccines 
the doctors are telling them to take. But yet when they are 
screaming from the rooftops something is wrong with the 
vaccines, I am telling you that creates vaccine hesitancy. The 
other problem is, is when you get censored on the internet, or 
you get permanently banned on social media when you are a 
victim of a vaccine injury or a doctor trying to report what 
you were seeing in your patients from vaccines.
    [Chart]
    Ms. Greene. This chart right here, this represents vaccine 
reports from all vaccines since 1990, 34 years. This represents 
reports on the COVID-19 vaccines since December 2020, less than 
4 years. Something is wrong with the vaccines, and just because 
people are walking around and they have been vaccinated and 
they are not reporting a problem, doesn't mean other people 
aren't having problems, and this has been virtually ignored. 
Not only has it been ignored, it has also been censored and 
banned and labeled misinformation. This was a coordinated 
effort with the White House, the Surgeon General, the CDC, the 
Department of Homeland Security, CISA, Stanford, and the 
Virility Project.
    As a matter of fact, real people with real problems got 
censored, such as Maddie de Garay. Maddie was a young child who 
developed severe symptoms and still has a feeding tube today. 
She is a very sick child. That happened from the COVID vaccine, 
but her mother was taken off of the internet when she tried to 
report the problem. Can you imagine trying to report a problem 
with your child who is having a real vaccine injury, but yet 
social media takes you off and the White House says it is OK 
and Department of Homeland Security says it OK, and they label 
it misinformation?
    We can talk about funding these government programs and 
throwing more money at these government programs, but that 
isn't going to change the fact that vaccines should have never 
been forced on all these people to begin with. And if we want 
to talk about diseases like measles being transmitted among 
Americans, then perhaps we should talk about border security 
and stopping people who are unvaccinated from coming across our 
border and allowed to come into our country and then supporting 
them with taxpayer funds. I think that is a serious issue.
    Dr. Maldonado, you are from Stanford. I am assuming you 
participated in the censorship program of so-called vaccine 
misinformation. I have got documents here showing Stanford ran 
a censorship program with the White House, commissioned by Bill 
Gates Foundation, tasked specifically with censoring content 
that would drive vaccine hesitancy, including true stories of 
vaccine injury, because this project led to the severe 
censorship of many people, including my own personal Twitter 
account, by the way, that was banned for an entire year because 
I apparently spread COVID information, things like information 
about myocarditis among our military members, neurological 
problems being reported. And I said that people shouldn't be 
forced to take a vaccine, especially like when Dr. Wenstrup 
talked about he didn't even know he had COVID until he couldn't 
smell garlic. That was the case for many people, including 
myself. I hardly had any symptoms when I had COVID. I certainly 
didn't need a vaccine. I have never had the vaccine, and I have 
never gotten COVID since.
    While some people in our society are more susceptible to 
COVID because of maybe certain conditions that they have, not 
everyone should have been forced to take a vaccine. And 
certainly, people should be heard when they suffer a vaccine 
injury, and they want to tell others about it on their own 
personal social media accounts. Just a small example of this. 
Stanford identified and directed the White House to censor two 
COVID vaccine injured clinical trial participants, true stories 
of injury, one of whom is a child trapped in a wheelchair with 
a feeding tube; Stanford, an institution that actively 
suppressed the repeated cries for help from those who were 
injured by these shots is now being sued for it. As an example, 
it is pretty interesting that a witness from Stanford brought 
in by the Democrats today who participated in censoring these 
true stories is going to give the witness testimony about 
vaccine hesitancy and about our hearing today on all of these 
reports.
    I really don't have any questions today, Mr. Chairman. What 
I would like to echo is, is that there are so many people that 
have suffered injuries from these vaccines, and there are 
continuing problems, and now this vaccine is recommended by the 
CDC for children. There are also serious issues with blood 
clots that are being completely ignored, and it is not 
misinformation. Not at all. And so, for all the people that no 
one ever listens to about vaccines and that were suppressed and 
censored and banned on social media when they reported it, I 
would like to speak up for them. Their voices deserve to be 
heard, and a lot of them deserve a lot more money than the 
$41,000 that has been awarded to vaccine victims. I yield back. 
Thank you.
    Dr. Wenstrup. Thank you. I now recognize Mrs. Dingell from 
Michigan for 5 minutes of questions.
    Mrs. Dingell. Thank you, Mr. Chairman. Right now, we are at 
a pivotal moment for vaccine confidence in the United States. 
In recent years, we have witnessed a startling decline in 
immunization levels across the board, and I am deeply concerned 
about what this means for our Nation's ability to respond to 
public health threats in the future, especially today as the 
CDC issues an alert over rising measles cases and is urging 
families traveling to a measles-affected country to get 
vaccinated. And as I was sitting here, my Washtenaw County 
Health Department just sent a notice that another child has 
measles in Washtenaw County. I think that is a problem.
    And listening to my colleague, the last victim of polio 
just died who lived in an iron lung. I am not old, but I am 
seasoned. I am really glad we were required to get polio 
vaccines, and I am somebody who, by the way, can't get a flu 
shot. We have got to focus on what we can and should do to 
strengthen our vaccine safety systems, which are crucial tools 
for promoting vaccine confidence. As I have said during our 
previous hearings, we need to do this by approaching people 
with compassion, empathy, make sure their questions are 
answered with trustworthy, accurate information that breaks 
through some of the noise that can come through, and they know 
if they are at risk, they have got a doctor to talk to.
    Many of my colleagues here have heard me tell my own story 
of my experience with Guillain-Barre syndrome following a flu 
shot, but because I have got Guillain-Barre doesn't mean people 
should never get a flu shot. We need to put this all in 
perspective. And I asked a lot of questions before I got my 
COVID vaccine, and I was scared to death, but I got it, and I 
am alive, and I am here. And as we discuss these topics today, 
I personally appreciate the importance of patients knowing that 
meaningful compensation is available if they experience a 
severe adverse event and need it.
    So Ms. Gentry--and we are going to run out of time, and we 
have got votes--can you answer this question? Why are efficient 
and adequately resourced compensation programs for patients who 
experience adverse events an important tool for improving 
vaccine confidence?
    Ms. Gentry. Because it makes them feel comfortable getting 
the vaccine, that, if something happens in those rare events, 
that they will be taken care of and compensated.
    Mrs. Dingell. So, I understand that Congress has an 
important role to play in strengthening these programs and 
streamlining the process of compensating patients with vaccine-
related injuries. For example, under the current statute, in 
order to move the COVID-19 vaccines from the Countermeasures 
Injury Compensation Program to the more appropriate Vaccine 
Injury Compensation Program, Congress must pass an excise tax. 
And to facilitate the more timely processing of claims before 
the VICP, Congress can increase the number of special masters 
to adjudicate the claims and increase the cap on damages 
provided, including to account for inflation. A number of these 
reforms or more are included in two bipartisan pieces of 
legislation led by Congressman Lloyd Doggett, H.R. 5142 and 
5143.
    Mrs. Dingell. Ms. Gentry, how would these reforms and 
others proposed in these two bills improve the processing of 
claims brought forward by people who experience serious adverse 
events from vaccines?
    Ms. Gentry. It would bring the infrastructure up to date in 
those programs and allow those claims to be processed. You 
would have more special masters to process claims, modernize 
the program to where it is supposed to be in 2024, and allow 
the excise tax which the manufacturers want to pay.
    Mrs. Dingell. Thank you. Now, Dr. Maldonado, do you agree 
that reforms, like increasing the number of special masters to 
process claims and ensuring that damages paid out reflect 
inflation, will strengthen how the Vaccine Injury Compensation 
Program operates?
    Dr. Maldonado. Yes, I do.
    Mrs. Dingell. And, Dr. Maldonado, do you agree that 
strengthening compensation programs for people who experience 
rare--I was one--but serious vaccine adverse events is an 
important tool for fortifying vaccine confidence?
    Dr. Maldonado. Yes, it is.
    Mrs. Dingell. Thank you, and I yield back, Mr. Chairman.
    Dr. Wenstrup. I now recognize Dr. Miller-Meeks from Iowa 
for 5 minutes of questions.
    Dr. Miller-Meeks. Thank you, Mr. Chair, and I thank our 
witnesses that are here today. I am both a physician, a 
military veteran, and former director of the Iowa State 
Department of Public Health, so this is an important hearing. 
And vaccine hesitancy is certainly important, although it is 
also not new, but I think the COVID-19 pandemic has exacerbated 
vaccine hesitancy and reticence. Ms. Gentry, when a new vaccine 
is approved and marketed and you may have answered this--what 
steps are required to ensure access to liability compensation 
under the VICP program, and what happens if a new vaccine is 
not added to the list of taxed vaccines?
    Ms. Gentry. To get a new vaccine on, well, first, the ACIP 
has to make a recommendation for routine administration to 
children under the age of 5. The Secretary has to take that and 
make a recommendation to add it to the table, and then it goes 
to the regulatory processes. At the same time, the excise tax 
has to be instituted on that. If it is not, it is not there.
    Dr. Miller-Meeks. And do you believe CICP is adequate for 
adjudicating COVID-19 vaccines claims?
    Ms. Gentry. No, I do not.
    Dr. Miller-Meeks. Thank you for that. Do any of you believe 
that the CDC's reluctance to identify and, in fact, deny 
adverse reactions related to the COVID-19 vaccine and I will 
specifically point out to myocarditis and pericarditis--and a 
MMWR that the CDC put out saying that there was no greater 
risk. And I think looking at the data and looking at the data 
from overseas, to me, looking at that data, that is not true. 
Does that, in fact, affect the adjudication of claims, or does 
that have no bearing on the adjudication of claims?
    Ms. Gentry. Generally speaking, we never have 
epidemiological support because vaccine injuries are rare, so 
it is very difficult for us to get an increased rate of 
incidence. If you see that, the vaccine is generally pulled 
before we would ever get that, so the significant thing for us 
is that is not our burden of proof in the program. And again, I 
am speaking of legal causation and not scientific certainty and 
causation in that term.
    Dr. Miller-Meeks. And like Representative Dingell, when I 
was Director of the Iowa Department of Public Health, soon into 
my first year, my Public Information Officer got her flu 
vaccine, and within several days, she called me up, on a 
Sunday. She was in the hospital. I went to go see her. It was 
obvious to me she had Guillain-Barre. I asked about her 
vaccination. She had just received her vaccination.
    So, I would say these conditions, they may be uncommon, but 
I would not say that they are rare. Is the compensation for 
injuries related to vaccines, is the compensation enough? 
Someone that has Guillain-Barre and is paralyzed and on a 
ventilator and then out of work for months. It was about 6 
months I was helping her to work remotely. That, to me, does 
not seem like a mild injury and would bear compensation, and 
for any other medication or drug, there certainly would be 
compensation.
    Ms. Gentry. Yes, Guillain-Barre syndrome would be a typical 
vaccine injury that we get compensated. You may have a life 
care plan that is substantial compensation in addition to lost 
wages, but the pain and suffering is still limited at 250.
    Dr. Miller-Meeks. And what advantages do claimants to the 
VICP have that CICP claimants do not because you answered that 
in the negatory?
    Ms. Gentry. Correct. For one, it is an actual court process 
in the VICP. You have right to counsel. You are not responsible 
for attorney's fees. You have appropriate ability to appeal 
cases. You have full compensation and not restrictions on 
compensation, at least for economic damages and future care.
    Dr. Miller-Meeks. Thank you very much. I thank all of our 
witnesses. I thank the Chair for this important hearing, and I 
yield the balance of my time.
    Dr. Wenstrup. Thank you. Listen, I would like to thank all 
of you for being here today, and I am sorry you were squeezed 
between vote series. Here, typically at this time, the Ranking 
Member and I would make some closing statements. Well, part of 
that is thanking you all for your testimony and your written 
testimony as well. I think it has been very valuable what each 
of you has had to offer into the conversation today. And moving 
forward, I encourage all of you to reach out with us further if 
any concerns you may have or recommendations you may have in 
the future.
    I am going to suggest because of this squeeze on time that 
the Ranking Member and I submit our closing statement for the 
record, and we will be glad to share those with you and make 
them public.
    In closing, I would like to thank our panelists once again 
for your testimony.
    With that and without objection, all Members will have 5 
legislative days within which to submit materials and to submit 
additional written questions for the witnesses, which will be 
forwarded to the witnesses for their response.
    If there is no further business, without objection, the 
Select Subcommittee stands adjourned.
    [Whereupon, at 4:40 p.m., the Select Subcommittee was 
adjourned.]

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