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


                          FOLLOW THE SCIENCE?:
     OVERSIGHT OF THE BIDEN COVID-19 ADMINISTRATIVE STATE RESPONSE

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

                                HEARING

                               BEFORE THE

   SUBCOMMITTEE ON THE ADMINISTRATIVE STATE, REGULATORY REFORM, AND 
                               ANTITRUST

                       COMMITTEE ON THE JUDICIARY

                     U.S. HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             SECOND SESSION
                               __________

                        WEDNESDAY, JUNE 26, 2024
                               __________

                           Serial No. 118-87
                               __________

         Printed for the use of the Committee on the Judiciary
         
         
                 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]         


               Available via: http://judiciary.house.gov
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
56-175                    WASHINGTON : 2024                


                       COMMITTEE ON THE JUDICIARY

                        JIM JORDAN, Ohio, Chair

DARRELL ISSA, California             JERROLD NADLER, New York, Ranking 
MATT GAETZ, Florida                      Member
ANDY BIGGS, Arizona                  ZOE LOFGREN, California
TOM McCLINTOCK, California           SHEILA JACKSON LEE, Texas
TOM TIFFANY, Wisconsin               STEVE COHEN, Tennessee
THOMAS MASSIE, Kentucky              HENRY C. ``HANK'' JOHNSON, Jr., 
CHIP ROY, Texas                          Georgia
DAN BISHOP, North Carolina           ADAM SCHIFF, California
VICTORIA SPARTZ, Indiana             ERIC SWALWELL, California
SCOTT FITZGERALD, Wisconsin          TED LIEU, California
CLIFF BENTZ, Oregon                  PRAMILA JAYAPAL, Washington
BEN CLINE, Virginia                  J. LUIS CORREA, California
KELLY ARMSTRONG, North Dakota        MARY GAY SCANLON, Pennsylvania
LANCE GOODEN, Texas                  JOE NEGUSE, Colorado
JEFF VAN DREW, New Jersey            LUCY McBATH, Georgia
TROY NEHLS, Texas                    MADELEINE DEAN, Pennsylvania
BARRY MOORE, Alabama                 VERONICA ESCOBAR, Texas
KEVIN KILEY, California              DEBORAH ROSS, North Carolina
HARRIET HAGEMAN, Wyoming             CORI BUSH, Missouri
NATHANIEL MORAN, Texas               GLENN IVEY, Maryland
LAUREL LEE, Florida                  BECCA BALINT, Vermont
WESLEY HUNT, Texas
RUSSELL FRY, South Carolina
Vacancy
                                 ------                                

               SUBCOMMITTEE ON THE ADMINISTRATIVE STATE,
                    REGULATORY REFORM, AND ANTITRUST

                     THOMAS MASSIE, Kentucky, Chair

DARRELL ISSA, California             J. LUIS CORREA, California, 
MATT GAETZ, Florida                      Ranking Member
DAN BISHOP, North Carolina           HENRY C. ``HANK'' JOHNSON, Jr., 
VICTORIA SPARTZ, Indiana                 Georgia
SCOTT FITZGERALD, Wisconsin          ERIC SWALWELL, California
CLIFF BENTZ, Oregon                  TED LIEU, California
LANCE GOODEN, Texas                  PRAMILA JAYAPAL, Washington
JEFF VAN DREW, New Jersey            MARY GAY SCANLON, Pennsylvania
BEN CLINE, Virginia                  JOE NEGUSE, Colorado
HARRIET HAGEMAN, Wyoming             LUCY McBATH, Georgia
NATHANIEL MORAN, Texas               ZOE LOFGREN, California
KELLY ARMSTRONG, North Dakota        STEVE COHEN, Tennessee
Vacancy                              GLENN IVEY, Maryland
                                     BECCA BALINT, Vermont

               CHRISTOPHER HIXON, Majority Staff Director
         AARON HILLER, Minority Staff Director & Chief of Staff

                            C O N T E N T S

                              ----------                              

                        Wednesday, June 26, 2024

                           OPENING STATEMENTS

                                                                   Page
The Honorable Thomas Massie, Chair of the Subcommittee on the 
  Administrative State, Regulatory Reform, and Antitrust from the 
  State of Kentucky..............................................     1
The Honorable J. Luis Correa, Ranking Member of the Subcommittee 
  on the Administrative State, Regulatory Reform, and Antitrust 
  from the State of California...................................     5
The Honorable Jim Jordan, Chair of the Committee on the Judiciary 
  from the State of Ohio.........................................     8
The Honorable Jerrold Nadler, Ranking Member of the Committee on 
  the Judiciary from the State of New York.......................     9

                               WITNESSES

Dr. Philip R. Krause, MD, Former Deputy Director, FDA Office of 
  Vaccines Research & Review
  Oral Testimony.................................................    12
  Prepared Testimony.............................................    14
Dr. Jordan Vaughn, MD, ABIM, Foundation for Spike Protein, Long 
  Covid, and Microvascular Research, Inc.
  Oral Testimony.................................................    29
  Prepared Testimony.............................................    32
Aaron Siri, Esq., Siri & Glimstad LLP
  Oral Testimony.................................................    38
  Prepared Testimony.............................................    41
Dr. Andrew T. Pavia, MD, Fellow of the American Academy of 
  Pediatrics (FAAP), Fellow of the American College of Physicians 
  (FACP), Fellow of the Infectious Diseases Society of America 
  (FIDSA), George and Esther Gross Presidential Professor, Chief, 
  Division of Pediatric Infectious Diseases, University of Utah; 
  Director, Hospital Epidemiology Program, Primary Children's 
  Hospital
  Oral Testimony.................................................    59
  Prepared Testimony.............................................    61

          LETTERS, STATEMENTS, ETC. SUBMITTED FOR THE HEARING

All materials submitted for the record by the Subcommittee on the 
  Administrative State, Regulatory Reform, and Antitrust are 
  listed below...................................................   106

An article entitled, ``Trump's Anti-Vaccine Problem,'' Jun. 14, 
  2024, The New York Times, submitted by the Honorable Mary Gay 
  Scanlon, a Member of the Subcommittee on the Administrative 
  State, Regulatory Reform, and Antitrust from the State of 
  Pennsylvania, for the record
Materials submitted by the Honorable Honorable J. Luis Correa, 
  Ranking Member of the Subcommittee on the Administrative State, 
  Regulatory Reform, and Antitrust from the State of California, 
  for the record
    An article entitled, ``Two Years of U.S. COVID-19 Vaccines 
        Have Prevented Millions of Hospitalizations and Deaths,'' 
        Dec. 13, 2022, Commonwealth Fund
    A transcript of the breifing entitled, ``Remarks by President 
        Trump at the Operation Warp Speed Vaccine Summit,'' Dec. 
        8, 2020, The White House
    A letter to Governor Kay Ivey, Alabama, from Concerned 
        Doctors, Sept. 19, 2021
    An article entitled, ``How the F.D.A. Stood Up to the 
        President,'' Oct. 20, 2020, The New York Times
    An article entitled, ``Claims that millions of people have 
        died from the COVID-19 vaccine are unfounded,'' Oct. 5, 
        2021, Poynter
    A report regarding vaccines from the Health Resources & 
        Services Administration (HRSA), Monthly Statistics 
        Report, Jun. 1, 2024
    An article entitled, ``Large measles outbreak traced to 
        Disneyland is declared over,'' Apr. 17, 2015, AP News
    An article entitled, ``Debunking COVID-19 myths,'' May 16, 
        2024, Mayo Clinic
    An article entitled, ``The youngest victims of a national 
        calamity, and the people they left behind,'' Feb. 21, 
        2021, Washington Post
    An article entitled, ``Health Officials: 2 Kentucky Children 
        Reported Dead from Flu and Covid-19,'' Jan. 11, 2024, 
        WLKY News
    An article entitled, ``Three Louisiana children died of COVID 
        over the past week; total now at 21,'' Feb. 22, 2022, 
        NOLA News
    An article entitled, ``Child Covid deaths more than doubled 
        in Florida as kids returned to the classroom,'' Sept. 10, 
        2021, Politico
    An article entitled, ``How vaccine misinformation made the 
        COVID-19 death toll worse,'' May 16, 2022, NPR
Materials submitted by the Honorable Thomas Massie, Chair of the 
  Subcommittee on the Administrative State, Regulatory Reform, 
  and Antitrust from the State of Kentucky, for the record
    The Bio and the background of Dr. Andrew Pavia, MD, Andrew T. 
        Pavia, University of Utah Health, Newswise Expert
    An article entitled, ``IDSA and ID in the News,'' Infectious 
        Diseases Society of America (IDSA)
    A list of the Board of Directors of IDSA, Clinical Infectious 
        Diseases, Infectious Diseases Society of America (IDSA), 
        Feb. 1, 2011, Oxford Academic
    A report entitled, ``IDSA Code for Interactions with 
        Companies,'' Infectious Diseases Society of America 
        (IDSA)
    An article entitled, ``IDSA Media Briefing: Covid-19 in Rural 
        America,'' Infectious Diseases Society of America (IDSA)

                 QUESTIONS AND RESPONSES FOR THE RECORD

Questions to Andrew T. Pavia, MD, FAAP, FACP, FIDSA, George and 
  Esther Gross Presidential Professor, Chief, Division of 
  Pediatric Infectious Diseases, University of Utah; Director, 
  Hospital Epidemiology Program, Primary Children's Hospital, 
  submitted by the Honorable Honorable J. Luis Correa, Ranking 
  Member of the Subcommittee on the Administrative State, 
  Regulatory Reform, and Antitrust from the State of California, 
  for the record
    No response at the time of publication

 
                          FOLLOW THE SCIENCE?:
     OVERSIGHT OF THE BIDEN COVID-19 ADMINISTRATIVE STATE RESPONSE

                              ----------                              


                        Wednesday, June 26, 2024

                        House of Representatives

               Subcommittee on the Administrative State,

                    Regulatory Reform, and Antitrust

                       Committee on the Judiciary

                             Washington, DC

    The Committee met, pursuant to notice, at 10:05 a.m., in 
Room 2141, Rayburn House Office Building, the Hon. Thomas 
Massie [Chair of the Subcommittee] presiding.
    Members present: Representatives Massie, Jordan, Issa, 
Bishop, Spartz, Fitzgerald, Bentz, Cline, Van Drew, Hageman, 
Moran, Armstrong, Correa, Nadler, Johnson, Jayapal, Scanlon, 
McBath, Ivey, and Balint.
    Also present: Representative Moore.
    Mr. Massie. Without objection, Mr. Moore from Alabama will 
be permitted to participate in today's hearing for the purpose 
of questioning the witness if a member yields him time for that 
purpose.
    Good morning. Today's hearing is being called pursuant to 
the Subcommittee's oversight responsibilities regarding 
regulatory reform and the Administrative State. Our concern is 
that in response to the Covid pandemic, the Administrative 
State, particularly leadership at the Food and Drug 
Administration and the Centers for Disease Control and 
Prevention, operated outside of their own rules, regulations 
put in place to guard against such behavior in the face of a 
national health emergency.
    The Subcommittee's oversight has found that in the wake of 
Operation Warp Speed, a Federal effort to speed up Covid 
vaccine development, there were reports of vaccine injury. 
Further, the FDA and CDC had not studied whether people who had 
been infected with Covid even needed a vaccine or whether the 
vaccine would ``stop the spread.''
    When the Biden Administration took over in January 20, 
2021, the emergency use vaccine was being rolled out. Though 
the positive and negative effects of the vaccines were just 
beginning to be understood, there was immediate talk of 
mandating the vaccine and developing vaccine boosters. Let's be 
clear. The mantra since the first days of the Covid-19 pandemic 
was that the Government would follow the science in all aspects 
of the pandemic response. The Administration's objective from 
the beginning was to act with more urgency than caution. 
Frightened Americans were working together to try to keep one 
another safe and they relied on the Government's flawed advice 
on how best to do so.
    Through Operation Warp Speed, the FDA brought Emergency Use 
Authorization, or EUA, vaccines to market, but these vaccines 
were not fully approved or licensed. From the beginning, the 
CDC issued guidance suggesting that those who had already been 
infected with Covid would benefit from the EUA vaccine. The 
science, however, did not support this. CDC's reporting did not 
take into account that those who survived infection usually 
develop natural immunity. After reading the CDC's morbidity and 
mortality weekly report which contained the most current Covid 
vaccine data at the time, I called the CDC and questioned the 
validity of the report.
    As the recently released Subcommittee report details, the 
Administrative State at the CDC circled the wagons, rather than 
being receptive to my correction of their admitted 
miscommunication, CDC officials double downed on the claims, 
warned members of their team, private citizens, in fact, that I 
had called and refused to make the changes they said they would 
make to the report. We know through other Committee oversight 
that the Biden Administration eventually grew so bold as to 
seek censorship of vaccine critics. As for mandating 
vaccination, full FDA approval, not Emergency Use 
Authorization, is needed to force someone to take a vaccine 
legally, as has been the case with vaccines required to attend 
public schools and colleges.
    The Acting FDA Commissioner Janet Woodcock began working on 
getting a fully approved Covid vaccine in early 2021. Pfizer 
filed their Biologics License Application, or BLA, to seek full 
approval on May 12, 2021. Under normal circumstances, a BLA 
takes a year to complete. A fast-tracked BLA can be ready in 
about eight months with full approval by January 20, 2022.
    Working on the vaccine license approval were Dr. Marion 
Gruber and Dr. Philip Krause, both who have about 30 years, 
three decades of experience in vaccine reviews, two of the 
world's best and most recognized scientists in vaccine 
licensing. Dr. Gruber and Dr. Krause strongly supported 
vaccines and were relied on by the World Health Organization 
for guidance and advance during the pandemic. These two 
scientists, working alongside a team of experts, committed to 
completing the BLA in only four months by September 15, 2021, 
something that they explained would be unprecedented.
    Overseeing the operation with Acting Commissioner Woodcock 
was Dr. Peter Marks, Director of the FDA Center for Biologics 
Research and Development. Drs. Gruber and Krause reported to 
Dr. Marks. As we know, vaccine injuries were already being 
reported in 2021, including instances of myocarditis in 
healthy, young people. Drs. Gruber and Krause were aware of the 
reports, but wanted more time to evaluate the data. Dr. Marks 
asked them to move the BLA completion up three weeks which 
would be in line with Biden's expected mandates. Drs. Gruber 
and Krause explained that moving the approval date up would 
mean cutting corners and lowering standards. Dr. Marks told 
Acting Commissioner Woodcock that he had Operation Warp Speed 
to live up to. They then removed Dr. Gruber and Dr. Krause from 
the licensing application review, the top two experts at the 
FDA, taken off the job because they wouldn't do what the 
politics wanted them to do.
    After the FDA rushed the licensing process, it began 
promoting boosters and expanded the vaccine authorization to 
include children. Drs. Gruber and Krause expressed their 
concern in a Lancet Medical Journal article about the boosters. 
Pfizer released a video encouraging people to get their 
vaccine, because it works against then recent Omicron variant, 
despite not having the data to back it up. Take a look. Play 
the video.
    [Video shown.]
    Mr. Massie. We will talk about this video later. There are 
some things missing there at the end.
    Soon after, the FDA and Dr. Marks created 41 videos to 
assure the public that the vaccines were safe. In one video, 
Dr. Marks suggests that there is no harm to fertility, although 
he actually did not have data to back up the claims. Take a 
look at that video.
    [Video shown.]
    Mr. Massie. At the time he made that video, he knew that 
there were reports that the vaccine affected menstruation 
cycles of women. In another video, Dr. Marks talks about 
reporting side effects and says there is a mechanism in place 
to report injuries. He claims the benefits outweigh the ``known 
and potential risks.'' Let's take a look.
    [Video shown.]
    Mr. Massie. In another vaccine promotion video, Dr. Marks 
advocates giving the EUA vaccine to children as young as six 
months. No Covid-19 vaccine had been approved for children that 
young and the vaccine had not yet been tested on that 
population. Let's take a look at that video.
    [Video shown.]
    Mr. Massie. Dr. Gruber's full testimony is being entered 
into the record, but I am going to share part of it with you 
now. So, I asked Dr. Gruber, ``so you had given them a 
September 15th day, which you considered to be very aggressive 
compared prior timelines for other vaccines. Is that correct?'' 
Dr. Gruber said, ``that is correct.'' Who was pushing you to 
move that date up? It was Dr. Marks. You said that in your 
email there are very important regulatory issues that need to 
be settled and, as an example, you mentioned a pediatric plan.
    Can you explain what that means and what needed to be 
settled? Why was the BLA approval dependent on the pediatric 
science? Because it required, by law, that a vaccine 
manufacturer will assess the vaccine further in the pediatric 
population, if they have not been tested as part of their 
efficacy studies.
    As I recall, in the efficacy trial, there were adolescents 
and children, I think down to 12 years of age, but the vaccine 
was not tested in children less than 12 years of age as part of 
this efficacy study. So, a vaccine manufacturer then has to put 
a document together describing even though the vaccine was 
ready for approval in an older population or the adult 
population, that it would conduct further studies to evaluate 
the safety and effectiveness of the product in pediatric 
subjects.
    So, that is the Pediatric Research Equity Act, PREA, that 
is the law that vaccine manufacturers and by implication FDA 
has to comply with. So, we had to review the documents that 
Pfizer submitted delineating the type of subjects they would be 
conducting in pediatric studies. They would be conducting in 
pediatric subjects. That of course, this is what I stated in my 
email was important, because safety in younger populations is 
even more paramount than in older populations.
    I then asked her, ``You mentioned that the pediatric plan 
was becoming increasingly complex. What was complex and how did 
the FDA and your team adapt to those complexities?'' Dr. Gruber 
said, ``So by definition, pediatric subjects go until age 17 
including age 17.'' As we discussed earlier on this morning, we 
had become aware of data suggesting a risk of myocarditis and 
this data became apparent because the vaccine was rolled out in 
the EUA.
    Of course, there were posted EUA surveillance systems in 
place by the CDC and the FDA. They showed it was for 
myocarditis and pericarditis in younger adults, but also 
adolescents, young males. The 12-17-year-olds includes the 
pediatric population, so we had to discuss with the sponsor. 
That was Pfizer in this case. Given that identified risk what 
further studies did need to be conducted if we were to license 
the product in the post-marketing space to further assess that 
risk. This is referred to as a post-marketing required study.
    I asked her, ``That is the complex in a way different from 
prior vaccine approval?'' Dr. Gruber replied, ``The difference 
was that we became aware of this risk of myocarditis.'' If 
there would not have been this information and this data, there 
would not have been a need to require Pfizer to conduct post-
marketing required study to further evaluate the safety signal 
as the regulations prescribe.
    So, we also had to review proposed protocols for that 
further post-marketing required study and that also comes with 
they have to give us a date when they are going to initiate 
this trial, when they are going to conclude the study. So, this 
were review activities were ongoing at that time.
    I asked her and that is part timeline that, ``Dr. Marks was 
asking you to compress?'' Dr. Gruber said, ``yes.'' So, counsel 
said it is fair to say that you were the--it had been raised--I 
am sorry, our counsel asked, So, that is fair to say that it 
had been raised that to you that the data regarding myocarditis 
or other, the pericarditis side effects that was you determined 
that based on the data before this July 19th meeting. ``Is that 
timeline accurate or could you elaborate on when you had found 
out about myocarditis side effects in relevance to this 
meeting?'' Dr. Gruber said, ``The vaccines were rolled out 
under EUA and the decision to authorize the Pfizer vaccine was 
made in December 2020.'' The FDA and the CDC set in place post-
EUA safety surveillance systems and the vaccine was rolled out 
and administered to a large number of subjects in the United 
States. The safety surveillance system picked up this risk of 
myocarditis and, of course, the sponsor was well aware of this 
group.
    So, you mentioned that Dr. Marks and Dr. Woodcock both 
mandated, mentioned mandates, vaccine mandates to you. ``Is 
that something inside of FDA's purview and should that be a 
consideration that you have to take into effect when you are 
deciding whether to issue a license or not?'' Dr. Gruber 
replied, ``I was never made aware that this is a requirement. 
As a matter of fact, that subject had never come up in vaccine 
licensures before.'' So, I asked her so, ``Is that why you 
memorialized it in this letter because they were mentioning 
mandates, and this really wasn't part of your job?'' Dr. Gruber 
said, ``yes.''
    When you left--and you can see this on the slide here, she 
memorialized in an email that they were being pressured to 
license these vaccines so the mandates could happen. I asked 
her, ``When you left, who was appointed to take over your 
responsibilities?'' Dr. Gruber said, ``That is Dr. Marks.'' 
``Who appointed him?'' Dr. Gruber said, ``Dr. Woodcock.''
    So, Dr. Gruber testified that further testing was required 
to approve the vaccine for children. Yet, Dr. Marks and the FDA 
promoted EUA vaccine for use on children without properly 
testing it for safety and efficacy. The Biden Administration 
was mandating the vaccine on the military and young people 
going to school, despite a lack of testing and data and despite 
growing reports of vaccine injuries. This kind of decision 
making by the Administrative State is concerning. The FDA 
should not have approved the vaccine for children, EUA or 
otherwise, without proper testing. Injury from Covid 
vaccination is real.
    The New York Times recently profiled several people who in 
the prime of their lives suffered from vaccine injury. ``Had 
the risk been known or shared?'' many of these injuries could 
have been prevented. Dr. Woodcock says, ``she is disappointed 
in herself for this,'' as she should be.
    It is our job in Congress to overseen government agencies. 
When agents of the Administrative State are not doing their 
job, they must be held accountable. This hearing will give us 
an opportunity to discuss this with an eye toward legislative 
reform.
    Think about this. Right when they were getting the warnings 
that myocarditis and pericarditis were real and serious side 
effects to the vaccine and they had already agreed, the top 
scientists at FDA had already agreed to compress the schedule 
as much as possible, right when they got the message that there 
were serious side effects, and Peter Marks, instead of telling 
them, we are going to give you more time to study this, they 
said--he told them to compress the schedule even more. When 
they said that compressing the schedule was not possible, he 
fired them. He took them off the job, assigned them to other 
duties. The top vaccine officials who had been there for 30 
years, taken off the job because they wanted more time to study 
the effects of the vaccine and they were told that they needed 
to do this quickly because they needed to be mandated.
    With that, I yield to the Ranking Member for his opening 
statement.
    Mr. Correa. I want to thank the Chair for holding this most 
important hearing. Let me start by saying that vaccines are a 
true miracle. They have saved at least 150 million lives in the 
last 50 years. The development represents the best of human 
ingenuity, and it is no more evident than with the development 
of the Covid-19 vaccines which began under former President 
Trump with the successful Operation Warp Speed and was carried 
through by President Biden. My hats off to the great scientists 
who created these vaccines and the leaders at the FDA and CDC 
who made the brave decisions to get them out to people as 
quickly as possible, while still making sure that vaccine shots 
were safe and effective.
    People have worked tirelessly over the years to monitor the 
safety of these vaccines and they have learned from this, 
constantly improving their knowledge and applying it quickly. 
They faced an almost impossible task of battling an emerging, 
devastating and rapidly changing crisis. They fought to 
exhaustion and disappointment, and they explored every avenue 
to combat this killing machine. Facing unprecedented 
circumstances, they did what we all try to do, to make the 
best, the most rational decisions with the information in front 
of all of us. Time has proven that they made the right 
decisions and those decisions saved millions of American lives.
    Does that mean mistakes were not made? Of course not. Can 
lessons be learned? Absolutely. Yet, hyper-focusing on the 
potential misstatements that may undermine the critical 
important work that has been done is not the answer. In fact, 
in the U.S. alone between December 2020-November 2022, the 
Covid vaccine saved more than 3.2 million lives and kept more 
than 18.5 million people out of hospitals. These aren't just 
numbers, folks. These are real people. These are friends, 
family, neighbors that are healthy and alive today.
    In this hearing, I am reminded of the darkest days of the 
pandemic, the fear and anxiety watching Covid virus take so 
many people from us, over 1.1 million to date. I remember the 
morgues overflowing with bodies, the emergency rooms packed, 
and doctors, nurses, and other medical professionals exhausted, 
emotionally and physically. All of you, at home, I worried 
about my children, my wife, and my elderly father at home. My 
wife is an OB/GYN doctor working in the emergency room. She 
treated women in the ER room, walk-in patients, patients, walk-
in patients she had never seen before. This is before the Covid 
vaccine. She did her job delivering babies in the middle of the 
pandemic. My wife was part of the happiness and joy felt by 
parents when they see the birth of a healthy child.
    The arrival of the first vaccination shots brought a wave 
of relief, a hope that many lives would be spared from such a 
horrible and tragic death. I heard from friends how relieved 
they were when they actually got the vaccine. Of course, the 
vaccines were not a cure-all, but they vastly improved 
America's chances of survival. We should not make the perfect 
the enemy of the good.
    Make no mistake, my opinion, this hearing should be about 
transparency and the decisions made by the FDA and the CDC 
under very difficult, high pressure, and constantly changing 
circumstances. I am all in favor of transparency, but in my 
opinion today, this hearing is really about vaccines, vaccines 
themselves. It contrasts to those who support science and 
understand and appreciate the life-saving value of vaccines and 
those who don't.
    Today, we are going to hear a lot of information and a lot 
of misinformation. Misinformation, the kind that causes 
unwarranted angst and leads some well-intended people and 
parents to avoid vaccines for themselves and their children. 
During the pandemic, Americans were told by some doctors to 
take ivermectin, the drug used to kill parasites; or 
hydroxychloroquine--will say that again, hydroxychloroquine--
even if it became clear that they provided no benefits. Some 
also suggested exploring remedies like injecting bleach or 
inhaling hydrogen peroxide and people were falsely told that 
vaccines were unsafe, ineffective, caused infertility, and 
would increase the likelihood of their deaths or kill them.
    Fortunately, most Americans didn't listen to this 
misinformation. Most disturbingly, some medical professionals 
made gross mis-
statements, suggesting that vaccines were worthless because 
they didn't completely stop the infections, they knowing full 
well that vaccines were designed to prevent the worst outcomes, 
by reducing severe disease, hospitalization, and death. These 
vaccines successfully reduce the transmissions by reducing the 
infection rates, yet these same people wrongly argued that the 
waning protection meant they didn't work. They refused to admit 
that infection-induced immunity also waned, claiming previously 
infected people were immune causing too many people to reject 
the vaccines.
    There are simply too many of these erroneously made 
statements to be repeated here today. Misinformation has led to 
a reduction in vaccinations, especially among children. In my 
opinion, promoting misinformation is amoral, unethical, and 
deadly. The modern-day attack on vaccines began with the 
retracted and highly discredited paper linking autism to 
vaccines. As a result of the ensuing confusion, too many 
parents are now refusing to vaccinate their children. As a 
parent, I understand the desire for answers and explanations 
when something bad happens to our children. It is heart 
breaking, but making, reaching false conclusions can do real 
damage, including undermining the herd immunity that comes from 
a large percentage of our population being vaccinated. Herd 
immunity protects everyone, especially the most vulnerable 
among us, infants, the elderly, and the immune compromised.
    As a society of human beings, we owe them protection and 
that is why we need vaccinations. Just one example, the surge 
in outbreaks of measles, a high-contagious virus that can cause 
death and many other dangers. In this country, we have gone 
from nearly 500,000 measles cases, in 1963 before the vaccine 
was approved, to under 100 in recent years. In the year 2000, 
measles was declared eradicated in the United States, but that 
could reverse as falling vaccination numbers have made measles 
outbreaks much more common.
    One of the worst outbreaks of measles in modern times 
occurred right in my hometown of Anaheim, California, in the 
year 2014. In that year, hundreds of people got measles with 
many hospitalized. In 2019, one of the worst years in record 
since vaccinations have become commonplace, there were more 
than 1,200 measles cases reported with 90 percent of the 
patients being either unvaccinated or who had an unknown 
vaccination status, and 10 percent of those were hospitalized. 
There have been 11 outbreaks reported since 2024 alone and for 
those who think that measles isn't serious, please talk to your 
local doctor.
    Nothing in life is without risk, including vaccines, but 
the benefits of vaccinations outweigh the risks to society as a 
whole. We have created programs to deal with vaccine risks. Of 
the five billion plus immunizations given since 2006, let me 
repeat, of the five billion immunizations given since 2006, 
there have been 8,600 compensation cases of which 5,300 were 
settlements awarded by the National Vaccine Injury Compensation 
Program, using a relatively low standard since VICP erred on 
the side of compensation.
    Mr. Chair, I see today's hearing as an opportunity to right 
some of the wrongs that occurred during the pandemic, to shine 
a light on the misinformation about vaccines, and specifically 
the Covid-19 vaccine. We should applaud the outstanding work 
initially under former President Trump's orders and then 
carried through under President Biden, done by our scientists 
in our Federal agencies, as well as other institutions and 
companies that brought us these live-saving treatments in 
record time.
    We have the responsibility to all Americans to shoot down 
conspiracy theories, misstatements that can cause great harm to 
the American people, especially those that are most vulnerable, 
our young, our children and elderly, and those immune 
compromised. Today, I am here to do my part.
    Mr. Chair, thank you and with that, I yield.
    Mr. Massie. I thank the Ranking Member, Mr. Correa, and now 
I recognize Mr. Jordan for his opening statement.
    Chair Jordan. I thank the Chair for all his hard work on 
this issue and for this hearing. The Ranking Member just used 
the term misinformation a couple of times in his opening 
statement. I will give you misinformation. Misinformation is 
when the Government told us that the vaccinated couldn't get 
the virus. Misinformation is when the Government told us the 
vaccinated can't transmit the virus. Misinformation is when the 
Government told us masks work. Misinformation is when the 
Government said six feet social distance is based on science. 
Misinformation is when the Government told us it wasn't gain of 
function done in the lab in Wuhan, China. Misinformation is 
when the Government said it has to be--can't be from the lab, 
it has to be a bat to a penguin to a hippopotamus to people and 
then we all get Covid. Right? That is misinformation from our 
Government to the citizens.
    We are big boys and girls. Give us the stinking truth. That 
is what this hearing is about. Why was it so important to get 
the licensure for the vaccine? Why? Because they wanted to 
mandate it on the people, mandate a vaccine they lied to us 
about, they wanted to mandate it on the people. So, what did 
they do? They had two good doctors working in our Government, 
Dr. Krause and Dr. Gruber said wait a minute, we should follow 
the rules. We should follow the process. We shouldn't speed it 
up just because you want to mandate something on the American 
people that you told us things about that were not accurate. 
Let's follow the process, like they always did. These were the 
two doctors who always handled this. What did they do? They 
kicked them to the curb. They said no, no. You are not doing it 
fast enough.
    The Biden Administration wants to mandate the vaccine on 
our military and on businesses all across this country. So, 
they got kicked to the curb and they sped this thing up and 
maybe people were harmed because of it. I am not against 
vaccines. I wasn't against this vaccine. All I am saying is 
let's do it right.
    Oh, by the way, let's not have good doctors like Dr. Vaughn 
change how they treat their patients for some political agenda 
driven by the Government who misinformed the citizens about 
this pandemic. That is why this hearing is important. I yield 
back, Mr. Chair.
    Mr. Massie. I want to be clear. Today's hearing is not an 
antivaccine hearing.
    Chair Jordan. Of course, it is not.
    Mr. Massie. Today's hearing is about what we need to do to 
restore faith in our public health institutions like CDC and 
FDA. The misinformation and the skipping of steps does not give 
trust to these organizations. Another piece of misinformation 
is that natural immunity isn't real.
    Now, I see that votes have been called and I am going to 
recognize the Ranking Member for his opening statement. We are 
told that they are gavel down on this first vote in 20 minutes. 
So, anybody that wants to get a head start, go ahead. After the 
Ranking Member delivers his statement; we will take a brief 
recess. I yield to Mr. Nadler.
    Mr. Nadler. Thank you, Mr. Chair. Once again, we are here 
to explore another Republican conspiracy theory grounded in 
misinformation that places ideology over facts. It is the 
result of yet one more so-called investigation by the majority 
that has borne no fruit despite consuming many months and 
untold hours of staff time, as well as the time of our Federal 
agencies, not to mention many wasted taxpayer dollars.
    So, just because the latest fishing expeditions have turned 
up no evidence of wrongdoing, does not mean that it is 
harmless. In fact, it is quite the opposite. By attempting to 
undermine confidence in the safety and efficacy of Covid-19 
vaccines, their unsupported and disproven claims have real and 
devastating consequences to the health of our Nation. That seen 
hesitancy is now growing, not just for Covid vaccines, but for 
other life-saving vaccines like RSV, measles, flu, and even 
polio.
    Let's remember how we got here. As of this week, seven 
million people worldwide have died of Covid-19 including 1.1 
million Americans. In January 2021, when President Biden took 
office, the Covid-19 pandemic was hitting its deadliest peak so 
far with over 3,000 Americans dying every day. By February 
2021, more Americans had died of Covid-19 than had died in the 
battlefields of World War I, World War II, and the Vietnam War 
combined. Thanks to President Biden's and Congressional 
Democrats' decisive action on Covid, 3.2 million additional 
deaths of Covid-19 were prevented; the 18\1/2\ million 
additional hospitalizations were prevented; and $1.5 trillion 
in medical costs were avoided. These interventions saved lives. 
Let me say that again. Vaccines against Covid-19 saved lives.
    Instead of accepting the overwhelming consensus of our 
Nation's scientists and doctors, the majority has wasted 14 
months trying to undermine the Nation's confidence in these 
vaccines and to prove that they were rushed for political 
reasons. The mountain of evidence shows that they were not. In 
particular, they have alleged that FDA bowed to political 
pressure and compromised its review of the Pfizer vaccine. 
Every witness they brought in as part of this investigation, 
testified that it underwent the complete, thorough, and 
scientifically rigorous review. They made clear that the FDA 
did not approve the vaccine until they ensured that it was 
safe, effective, and was of high quality. Their claims of so-
called political pressure from President Biden's authorized 
booster shots for all Americans by September 2021, that didn't 
happen either. In fact, the FDA did not authorize booster shots 
for everyone until November 2021, after they concluded a 
complete and thorough review.
    Don't take my word for it. This is what the majority's own 
witnesses told them when they were interviewed. Dr. Peter 
Marks, the Director for the Center for Biologics Evaluation and 
Research at the FDA said,

        There were no corners cut with respect to safety or 
        effectiveness or quality of these vaccines.

Dr. Marion Gruber, former Director of the Office of Vaccines, 
Research, and Review at the FDA, said that when the vaccines 
were authorized for emergency use in late 2020,

        I had confidence that the requirements as laid out by statute 
        were met. And as I said before, may be effective and the 
        potential, known and potential benefits would outweigh the 
        known and potential risks.

Dr. Philip Krause, former Deputy Director of the Office of 
Vaccines Research and Review at the FDA and the witness here 
today said,

        It turned out the vaccines blew away those criteria. The 
        vaccines were about 95 percent effective and the lower bound 
        was in the high 80s or even above 90 percent for one of the 
        vaccines. And so the public could have very high confidence 
        that those vaccines work.

    Despite the rigorous and independent assessment by the FDA 
in reviewing these vaccines, the majority is providing a 
platform today to those who seek to perpetuate this campaign of 
mis- and disinformation about Covid-19 vaccines. It is bad 
enough that they are trying to undermine confidence in vaccines 
that were essential in bringing an end to the devastating 
Covid-19 pandemic, but their efforts have a far more pernicious 
impact. They are weakening support for a wide range of vaccines 
that have kept Americans safe for decades, vaccines for 
measles, RSV, flu, polio, and for many other dangerous, 
infectious diseases have been proven over and over again to be 
safe and effective. A determined campaign against them have led 
to declining rates of vaccinations throughout the Nation. For 
example, after holding steady for decades, the routine 
vaccination rates for kindergartners have not yet rebound since 
to their prepandemic levels. This puts us all at risk.
    Congress has heard evidence time and again that these 
vaccines are safe and effective. We know that vaccinations 
reduce mortality rates, but instead of promoting public health 
guidance based on science and facts, House Republicans have 
joined efforts to spread misinformation with utter disregard 
for the health and well-being of their constituents.
    I urge my colleagues to retreat from this dangerous path. I 
thank the witnesses for appearing today and I yield back my 
time.
    Mr. Massie. I thank the Ranking Member. Without objection, 
all other opening statements will be included in the record. We 
are going to recess now for votes on the floor and please come 
back as soon as those votes are over. We will start when we 
return with the introduction of witnesses. The Committee now 
stands in recess.
    [Recess.]
    Mr. Massie. The Committee will come to order.
    We will now introduce today's witnesses.
    Dr. Philip Krause is a physician with board certification 
in internal medicine and infectious diseases. He is an MD with 
a degree from Yale University. He has a master's in business 
administration from Florida State University, a master's in 
science degree in computer science from the University of 
Illinois, and a bachelor's science degree in mathematics and 
computer science from the University of Illinois.
    He previously served as the Deputy Director of the FDA's 
Office of Vaccines Research and Review, where he led 
assessments of biological products for evaluation and licensure 
and helped to oversee the development of evaluation of vaccines 
authorized and licensed in the United States over the past 10 
years.
    Mr. Aaron Siri is the Managing Partner of Siri & Glimstad, 
where he focuses on complex civil litigation matters with a 
focus on civil rights, class actions, and commercial 
litigation. He has successfully litigated numerous civil rights 
cases involving informed consent and parental rights with 
regard to mandated medical products.
    Dr. Jordan Vaughn is a Physician, Clinical Researcher, and 
the Founder and President of the Microvascular Research 
Foundation. The Microvascular Research Foundation works to 
develop effective research-based treatment protocols for 
patients suffering from long Covid. Dr. Vaughn has extensive 
experience in the outpatient treatment of patients with Covid-
19.
    Dr. Andrew Pavia is the George and Esther Gross 
Presidential Professor, Chief of the Division of Pediatric 
Infectious Diseases, and an Adjunct Professor of Medicine at 
the University of Utah. He also serves as Director of Hospital 
Epidemiology at Primary Children's Medical Center.
    Dr. Pavia served as an Advisor to the CDC and Utah 
Department of Health on Covid-19, and he is a member of the NIH 
Covid-19 Treatment Guidelines Panel, where he was the pediatric 
team lead.
    We welcome our witnesses and thank them for appearing 
today.
    We will begin by swearing you in. Would you please rise and 
raise your right hand?
    Do you swear or affirm under penalty of perjury that the 
testimony you are about to give is true and correct to the best 
of your knowledge, information, and belief, so help you God?
    Let the record reflect that the witnesses have answered in 
the affirmative.
    Thank you, and please be seated.
    Please know that your written testimony will be entered 
into the record in its entirety. Accordingly, we ask that you 
summarize your testimony in five minutes.
    Dr. Krause, you may begin.

               STATEMENT OF DR. PHILIP R. KRAUSE

    Dr. Krause. Thank you, Chair Massie and Ranking Member 
Correa, for the opportunity to share my experience and views 
today.
    My name is Phil Krause and I worked at the FDA for 30 years 
until Fall 2021. While for the last 10 years of those years I 
was the Deputy Director of FDA's Office of Vaccines and was the 
highest-ranking infectious diseases physician in the Center for 
Biologics Evaluation and Research, I also worked in many other 
roles at FDA and can provide the perspective both of a review 
team member and of a leader.
    FDA decisions regarding vaccines should be, and almost 
always are, based on the recommendations of objective review 
teams with members who possess high levels of technical and 
scientific expertise and are led by highly experienced 
supervisors who make sure that a tried-and-true process that 
sets high standards for making science-based decisions is 
followed.
    These remarkable individuals often accept substantially 
reduced pay to work for the government, but they reap great 
rewards in the knowledge they're using their skills to 
contribute to a critical mission: That of enhancing and 
protecting the health of the American people. It is their 
mostly anonymous work that the agency's reputation for safe and 
reliable vaccines is built on. It was such a team that worked 
around the clock to responsibly evaluate the Covid vaccines for 
initial authorization, bringing us vaccines that clearly saved 
many lives.
    In December 2020, both Republicans and Democrats professed 
high levels of trust in the FDA to provide reliable and fair 
information about the Covid vaccines. As the pandemic 
continued, trust was lost. We're here today to discuss why that 
trust was lost and what can be done to restore it.
    As a starting point, we should all agree that the 
credibility of the FDA comes from objectivity, adherence to 
process, adherence to standards, and transparency. We can also 
agree that political influence can result in departures from 
these principles, and even the perception of political 
influence can undermine trust in the agency.
    Especially during a pandemic, it is not surprising that 
political leaders would seek to influence the work of the 
agency. In my experience, neither political party has a 
monopoly on this.
    In my view, political leaders do not think enough about the 
damage to the public health system that this type of pressure 
can cause. This places agency leaders, whether political or 
career, in a difficult situation. They're conflicted between 
their duty to implement the will of the Administration and 
their obligation to the agency and the public to maintain the 
agency's credibility, even beyond their tenure.
    In my written testimony, I summarize examples where the 
basic principles of objectivity, adherence to process, 
adherence to standards, and transparency were violated. Some of 
these examples come from the Covid pandemic, but others predate 
the pandemic, which suggests that the loss of trust that came 
about during Covid may have deeper systemic roots.
    All the examples I provide, including one from just last 
week, involve a senior leader interfering with the usual review 
process or singlehandedly overruling the scientific 
recommendations of review teams. This pits the senior leaders' 
individual technical expertise against the entire process that 
is designed to yield results in which the public can have 
confidence. In other words, while there may be expertise on 
both sides, the system is set up to permit hierarchy to 
overrule science.
    As I also discuss in my written testimony, while there's an 
appeal process in place that allows members of the review team 
to appeal the decision within that agency, the appeal process 
is ineffective. There needs to be a stronger and more credible 
internal dispute resolution process.
    Ideally, disputes would be addressed even before a review 
team is overruled. This problem could be partially addressed by 
establishing procedures whereby the senior leader can only 
overrule review teams on technical grounds with the support of 
outside experts.
    A separate suggestion involves providing increased 
transparency regarding Emergency Use Authorizations, or EUAs. 
In a pandemic, EUAs provide flexibility that allows the agency 
to make lifesaving products available, even if they do not meet 
the standard for licensure. Products are authorized with 
different levels of rigor, and it is essential for stakeholders 
to understand the actual standard that the product has met.
    I suggest that FDA EUA review memoranda be required to 
provide this clarity by including a detailed explanation not 
only of why it's reasonable to believe the product may be 
effective and that the risks outweigh the benefits, but also an 
explanation of what additional data would be needed to license 
the product.
    I look forward to exploring these issues and those 
described in my written statement, as well as in my transcribed 
interview, in this hearing.
    I thank you very much, Mr. Massie and Mr. Correa.
    [The prepared statement of Dr. Krause follows:]

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    Mr. Massie. Thank you, Dr. Krause.
    I now recognize Dr. Vaughn for five minutes.

                 STATEMENT OF DR. JORDAN VAUGHN

    Dr. Vaughn. Thank you, Chair Massie and Ranking Member 
Correa.
    I'm Jordan Vaughn. I'm an Internist in Birmingham, Alabama. 
As an outpatient clinician, 2020 presented a broad set of 
challenges. Specifically, as an employer of around 200 
healthcare workers and responsible for approximately 150,000 
patients, my company had to set out and do the right thing.
    As a community, we solved the problems of a lot of things 
in regard to how to take care of people with Covid--doing 
things like test, and then, getting the monoclonal antibodies 
immediately on testing positive, if they met criteria, to the 
number of about 10,000 monoclonal doses, all the way to making 
sure that the regular care of my patients was taken care of on 
a daily basis for patients with diabetes and other such things.
    This task required me to spend a lot of time learning a lot 
about what was the pathogen. It was in this reading, that an 
understanding of kind of SARS-CoV-2, and specifically, the 
spike protein, had emerged--an understanding that seemed to 
counter the emerging solutions from the experts in the Federal 
agency, pharmaceutical companies, and academic medicine.
    Based on my reading and clinical experience, what made 
Covid-19 especially unique and deadly was the spike protein. 
The spike protein, and specifically, the S1 subunit of this 
protein, is pathogenic. It's immunotoxic; it's cytotoxic; it's 
coagulopathic; and it's amyloidogenic. It's every word you 
probably don't want to be associated with whatever disease 
somebody tells you about.
    The proposed solution was a novel mechanism of injecting 
lipid nanoparticle-coated modified messenger RNA that encoded 
for a stabilized form of this very thing. That, at first, 
worried me--mainly, because of the people that actually had 
already had Covid. So, at that point, I felt one of the things 
that I did was, actually, I had probably one of the largest 
reference labs there in the outpatient setting, and I had a 
machine that actually told me, told me who actually was 
seropositive for, for Covid, before a vaccine was given.
    As I started to give the vaccine, I started to notice that 
some of my patients had some interesting side effects. My first 
encounter was with a 69-year-old patient of mine who had been 
my patient for about 10 years. He developed a significant short 
of breath, elevated BNP, and elevated d-dimer. As much as I 
wanted to think he had a pulmonary embolism, and he didn't 
based on the CT scan that was done.
    Instead, again, driving me back into the research that was 
available, thanks to the National Library of Medicine, I was 
able to find out that the coagulopathic effects of the spike 
protein can cause something like this; started him on 
anticoagulants and antiplate-
lets, and was able to get him better, which kind of started my 
journey.
    Though often called long Covid, it is the other thing that 
I want to talk about. It's really the devastating effects of 
the spike protein to multiple systems, and it's changing the 
landscape of a lot of the medical disciplines. The 
cardiologists are seeing it; the neurologists are seeing it, 
and they really don't know what to do with it.
    Since 2022, after my early encounter with the unique 
vascular and coagulation issues with the spike protein, I have 
seen over 2,000 unique patients. All of them have sequela from 
a Covid-19 injection, a SARS-CoV-2 infection, or, 
unfortunately, most often, both.
    Especially in those with vaccine injury, their faith in 
medicine and public health is shattered. Many of those patients 
were holdouts from getting vaccinated because they knew their 
own immune system sensitivities or they had already had an 
infection of Covid--one of the ways that I had actually pointed 
it out to them, because I actually had the serum samples that 
could prove their antibody evidence.
    However, it was under the August 2021 military service 
member, Federal employee, and OSHA mandate that these 
individuals faced a decision to either vaccinate, against their 
conscience and commonsense, or lose a career and gainful 
employment. Disabled from the adverse effects of these mandated 
injections, the profession they once held dear is an 
afterthought to just hoping to diagnose and possible--to a 
diagnosis and possible treatment.
    Among the most egregious is the kind of our servicemembers, 
needlessly harmed. Actually, my nurse practitioner and her 
husband is in the military. He went to West Point. So, we have 
a very good connection with the military in Birmingham.
    The amount of young individuals that, following the 
injection, had significant issues, like shortness of breath, 
myocarditis, are, basically, now being medically discharged 
because they're unable to complete their physical requirements 
in the military. It is fairly devastating. At least in my 
clinic, it's 30 individuals.
    My main area of clinical expertise happens to be on the 
coagulation effects. I actually was able to reach out and meet 
[inaudible] and Doug Kell and actually am able to look at what 
the spike protein can do to plasma, causing fibrin to aggregate 
in a way that makes it very hard to breakdown. It causes a lot 
of issues that are difficult for physicians to look at, because 
the small vessels are usually where it's affected. It's not the 
big vessels that we target.
    So, it's really the Federal regulatory bodies, including 
the FDA, that we task this to be forthright, unbiased, and 
responsive to the efficacy and evolving evidence of risk and 
consequence, a watchdog, and overseer of the pharmaceutical 
industry. Instead, the FDA's Director of the CBER advertised 
and advocated on YouTube for a product they were tasked with 
regulating and overseeing. I thought that was inappropriate 
because, in the same way, informed consent is the foundation of 
the patient-physician relationship, and absent this information 
forthcoming, that relationships irreparably harmed. So, when we 
talk about vaccine hesitancy, a lot of it is just the 
relationship between the physician and the doctor has now been 
broken.
    So, in closing, I often think back to something I read a 
few years ago about following science. Over the past few years, 
we've heard media, public health officials, and politicians use 
the phrase ``follow the science.'' The problem with following 
the science is that science does not lead anywhere. Science is 
an observer, measurer, descriptor, and not a leader. 
Individuals lead.
    Pressing science to lead is a way decisionmakers avoid 
accountability for choices they make on the public's behalf. 
The leader is appealing to the authority of science to decide a 
course of action, to conveniently sidestep accountability in 
the event of failure. I implore my physicians and scientists to 
not follow the science but lead humbly with science for the 
good of our patients.
    [The prepared statement of Dr. Vaughn follows:]

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    Mr. Massie. Thank you, Dr. Vaughn.
    Mr. Siri, you are now recognized for your opening 
statement.

                    STATEMENT OF AARON SIRI

    Mr. Siri. Thank you. Good morning.
    As mentioned earlier, I'm the Managing Partner of Siri & 
Glimstad. While our firm has a number of practices, we have a 
vaccine practice with over 40 professionals. We do all areas of 
vaccination law, including injury, exemptions, and policy work.
    When we litigate a case involving vaccines, we cannot 
appeal to our credentials; we must prove our points with high-
impact data and high-impact journal sources, often government 
data. I believe it's from that perspective I was invited to 
speak here today, and I believe that what I can provide is 
maybe a sense of the ``forest,'' so to speak, that is the 
``tree'' of this hearing, in that Covid vaccines didn't just 
fall into a vacuum. They fell into a very well-established 
economic and regulatory model that has developed over the last 
40 years with regard to vaccines in the United States of 
America.
    When you look at the clinical trials for Covid-19 vaccines, 
I'm sure that the FDA, the CBER department, the Biologics 
Division views them as robust--because, indeed, from the 
perspective of all the vaccines on the CDC's childhood 
schedule, they are incredibly robust and comparatively. Most of 
the vaccines on the CDC childhood schedule were licensed based 
on pivotal trials in which safety was monitored for days or 
weeks. There was no placebo control group, and the number of 
participants was far less than that in the Covid-19 vaccine 
trial.
    In comparison to the clinical trials for drugs, the Covid-
19 vaccine trials were anemic. Most drugs are often licensed 
from clinical trials that are multiyear against a placebo 
control group.
    You might ask yourself, why? Why the differential? To 
confirm what I said, by the way, you can look at my submission. 
Every single vaccine, there's a table that cites the FDA 
source. You can see exactly the trial.
    Why the divide? Well, I put to you the divide is a function 
of the laws of the regulatory regime around vaccines in this 
country.
    When a drug company does a trial of a drug, they have an 
economic incentive to know the safety profile before it goes on 
the market because they are liable for the injuries those 
products cause thereafter. They want to make a profit. They 
don't want to lose money.
    When they conduct a vaccine clinical trial, because of the 
National Childhood Injury of 1986, since 1986, the 
manufacturers, the sponsors who conduct the clinical trials--
not the FDA--the sponsors who conduct the clinical trials, they 
don't have that economic incentive. That creates an incredible 
moral hazard on the part of the pharmaceutical companies. I 
believe that is the primary reason you see a huge delta between 
the trials relied on to license Covid vaccines, vaccines and 
drugs.
    Could you put that chart back up, please, again, one more 
time, that I just saw flash on the screen? The next one, 
please. Nope. Back two. Well, it's in my submission and it was 
the second slide I provided, and it showed the difference 
between--keep going, keep going, two more, and one more. Thank 
you.
    So, you can see, on the left side, these are the top five 
selling drugs that Pfizer has, according to one publication. 
You could see--four of them are drugs; one is a vaccine--and 
you could see the difference between the safety followup of the 
drugs versus the one vaccine on that chart, and then, you could 
see the safety followup and the control used for the vaccines 
given in the first six months of life three times each.
    So, the primary way we assure safety in this country is 
market forces, economic interests, and corporations. That has 
worked very well. The only product I'm aware of where we have 
gutted that market force to assure safety is for vaccines to 
this degree.
    The second, far weaker way that we assure safety is through 
regulators. In this instance, unfortunately, regulators are 
structurally conflicted. When there is an agency that's 
responsible for promoting a product and for safety, we separate 
that. We do that with transportation with DOT and the NTSB. We 
do that with nuclear.
    We don't do that with vaccines. Safety and promotion are 
both in HHS, the same department. Not only that, HHS is 
responsible for defending against all claims of vaccine injury 
in the vaccination compensation forum. You can sue for vax 
injury; you just sue the Federal Government. You sued the 
Federal health authorities, and that creates an incredible 
conflict. This is the only product I'm aware of where the 
government defends the company, the product, against the 
consumer versus the other way around.
    What is the result? I'll go super quick. The result that 
can be seen in action. I'll just give a few examples.
    When they did the clinical trial for Covid-19 vaccines, 
they did a statistical comparison. When they compared the rate 
of infection, to get the 95 percent efficacy, about 100 people 
in the vaccinated group--in the placebo group had symptoms; 
about seven or so in the vax, in the vaccinated group. They 
said it's 95 percent efficacious.
    When it came to deaths in the Covid-19 trial, there were 21 
deaths in the vaccinated group; 17 deaths in the placebo group. 
Then, they didn't do a statistical comparison. They injected 
bias. They reviewed--let the pharma company, Pfizer, review 
every one of those.
    Also, our client Maddie de Garay, one of the only 1,100-or-
so participants in the 12-15-year-old clinical trial, she's in 
a wheelchair. She had a feeding tube after she got the second 
shot of Pfizer's vaccine in the trial. Pfizer reported it to 
the FDA as ``functional abdominal pain,'' that she had a tummy 
ache.
    When we told Pfizer about it--excuse me. When we told the 
FDA about it, and they finally actually listened--it took 
numerous letters--they shrugged and whitewashed it, instead of 
giving Pfizer an incredibly hard time for giving them false 
information.
    VAERS data. The CDC had a preset method by which they were 
going to do signal detection called PRR. Well, when we finally 
got the PRR data, it showed incredible signals. So, what did 
the CDC do? It said,

        We're not going to rely on that anymore. Instead, we're going 
        to rely on something the FDA does called empirical Bayesian 
        analysis, EB analysis.

Well, we asked the FDA for that data. They refused to give it. 
We're in a Federal lawsuit trying to get it.
    The V-safe is the CDC's premier safety system for vaccines, 
Covid-19 vaccines. They fought us for two years in Federal 
Court. We finally got that data. In that system of 10 million 
individuals--I will stop.
    I will, yield, and I will just end by saying that I submit 
that the--in looking at the ``forest,'' to solve a lot of the 
ills that plague what we're going to talk about today is we 
need to restore liability back to the manufacturers. We might 
be able to hold them accountable for the injuries from their 
vaccine products.
    Thank you.
    [The prepared statement of Mr. Siri follows:]

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    Mr. Massie. I thank the gentleman.
    Now, I'll recognize Dr. Pavia. If you want a little extra 
time, you're welcome to take it as well.
    Thank you.

                STATEMENT OF DR. ANDREW T. PAVIA

    Dr. Pavia. Chair Massie, Ranking Member Correa, and 
distinguished Members of the Subcommittee, thank you for the 
opportunity to testify.
    I'm a pediatric and adult infectious disease physician, or 
ID doc, and I worked for countless hours caring for 
hospitalized children who were severely ill with Covid-19, as 
well as working on healthcare safety and advising 
decisionmakers and leaders.
    Like all healthcare workers, I saw way too much tragedy and 
heartbreak, and thankfully, I saw firsthand the significant 
differences our Covid-19 vaccines made.
    Covid-19 vaccines are safe and effective in greatly 
reducing the risk of serious illness, hospitalization, and 
death from the virus. They also reduce the risk of long Covid 
and multisystem inflammatory syndrome, or MIS-C, which is a 
very serious and potentially lethal complication that affects 
children after infection.
    Covid-19 vaccines are safe and effective in--I'm sorry. By 
reducing Covid-19 hospitalizations and protecting healthcare 
workers, the vaccines help preserve our health system's 
capacity to care for patients. During surges of cases and 
hospitalizations, patients died, in part, because our 
healthcare workforce was overwhelmed. There were simply not 
enough providers to meet the extraordinary demands, and 
workforce shortages only became worse when any of us became 
ill.
    The Covid-19 vaccines were studied in large, multicenter 
clinical trials and rigorously evaluated by the FDA, CDC, and 
both agencies' independent advisory bodies, before being rolled 
out through authorization.
    Every medical product carries some degree of risk. So, it 
is for vaccines. Compared to other medical products, vaccines 
are exceedingly safe. Health problems do occur, and unlike what 
Mr. Siri said, there's a robust system for overlapping tools to 
investigate safety that continues for the entire lifespan of 
the vaccine, long after review by the FDA.
    Multiple careful investigations have identified some 
issues, but consistently found that serious adverse events 
associated with Covid vaccination are uncommon and greatly 
outweighed by the huge benefits of these vaccines.
    In September 2021, the FDA expanded the EUA for Covid-19 
vaccines to include a booster for certain populations at high 
risk of developing severe illness. Data were clear that the 
boosters were safe and provided enhanced immune response, and 
at that point it was clear that the original two-dose vaccines 
protection waned over time.
    It was a challenging decision to make in the Fall 2021. 
However, that Winter, the Omicron variant swept across the 
country. Our hospitals were overwhelmed, and for about eight 
weeks, more than 20,000 Americans died every week of Covid-19. 
Without the boosters, that death toll could have been higher.
    The benefits of vaccines for Covid and many other 
infectious diseases are tremendous. The Commonwealth Fund 
estimated that Covid vaccines saved the lives of 3.5 million 
Americans. CDC estimates that vaccination of children born 
between 1994-2021 in the U.S. will have prevented 472 million 
illnesses; helped avoid over one million deaths and saved 
nearly $2.2 trillion.
    Unfortunately, the increasing spread of vaccine 
misinformation and disinformation is a driver of increased 
vaccine hesitancy. In 2019, the World Health Organization 
identified vaccine hesitancy as one of the top 10 threats to 
human health.
    The uptake of vaccines for respiratory disease among adults 
has lagged in recent years due, in part, to vaccine hesitancy 
fueled by this misinformation. Inadequate vaccine uptake for 
these viruses leads to higher rates of hospitalization and 
death. In the Winter, in this past Winter, 225,000 people died 
weekly due to Covid-19; 25,000 deaths occurred over the Winter 
due to flu, and 178 children died of influenza.
    Similarly, rates of routine child immunizations are 
dropping. In 12 States, measles vaccine coverage is now 
critically low at below 90 percent.
    The consequences of inadequate vaccination rates are 
serious. So far in 2024, the U.S. has seen 151 measles cases 
compared to only 58 in 2023. Measles, for those who haven't 
seen it, is a severe disease and incredibly contagious. It 
kills about one in every thousand children or pregnant women 
who contract it, and it causes serious disability in another 
one to two per thousand. It cost tens to hundreds of thousands 
of dollars to contain and respond to a single introduction of 
measles.
    We must take steps to increase vaccine confidence and 
uptake by funding research, strategies to address vaccine 
hesitancy, to continue to monitor safety, to improve 
communication, and improve vaccine coverage for vaccines. We 
need to recruit more physicians, particularly ID physicians, 
with expertise on vaccines and vaccine-preventable diseases.
    The single greatest source of information for patients in 
making these decisions is their physician or healthcare 
provider. Unfortunately, nearly 80 percent of U.S. counties 
don't have a single ID physician, and because of high medical 
student debt and low reimbursement rates, we are not recruiting 
enough into the specialty.
    IDSA welcomes the opportunity to work with you. Thank you.
    [The prepared statement of Dr. Pavia follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Massie. Thank you, Dr. Pavia.
    The Committee will now proceed under the five-minute rule 
with questions.
    The Chair recognizes the gentleman from Oregon for five 
minutes.
    Mr. Bentz. Thank you, Mr. Chair.
    I'm a little curious, Dr. Krause, about the timeline on and 
the hurry you talk about in your testimony. Is it--do I have 
this right? That the vaccine had been approved for emergency 
use, if you will, in December 2020? Then, we go around into, 
roughly--was it May?--yes, May 16th when the license 
application for Pfizer came in for the license to actually sell 
it on the approved basis.
    So, during that period of time between December 2020-May 
2021, is my understanding correct that we had some 260 million 
people vaccinated? Because when President Biden stepped up in 
front of the Nation in September, after the rushed--I'll call 
it ``rushed''--approval of the Pfizer vaccine, he alludes to 80 
million people who had not been vaccinated. Do those numbers 
sound right? I don't see them in your report. I'm just curious.
    The reason I'm asking is because you talk about the 
pressure that was put on you, and eventually, resulted in your 
resignation, to hurry up and get this done. Yet, how many 
people had already been vaccinated?
    Dr. Krause. So, I don't know the exact numbers. So, I can't 
dispute your calculation. Certainly, a large number of people 
had already been vaccinated because the vaccine was made 
available under Emergency Use Authorization, as you say, 
starting in December 2020.
    Mr. Bentz. The President lectures the Nation in September 
11, 2021, after the forced, the hurried, the accelerated--
whatever the right word for it is. What word would you use in 
that process that you describe so clearly in your testimony? 
Was it rushed?
    Dr. Krause. Well, so, the process, as I think it was Mr. 
Correa or Mr. Lander [sic] pointed out--Nadler pointed out, was 
actually a process that thoroughly evaluated the vaccine for 
licensure in the end.
    The question, obviously, was more one of, what did the 
leadership of FDA want and what was it possible to promise 
them? So, the leadership of FDA requested that the vaccine, 
that the office leadership, Dr. Gruber and I, provide them with 
a date by which we were certain that we could complete the 
review.
    Mr. Bentz. You did and it was then they didn't accept it. 
They wanted it more quickly than the date that you suggested, 
even though the date you suggested was about half of the normal 
six months required.
    Dr. Krause. That's correct. They, initially, actually 
accepted a date that was beyond that, and then, they also, 
initially, accepted the September 15th date. Then, they came 
back and said, ``Well, actually, we would like this to be sped 
up even more.''
    Mr. Bentz. You suggest in your testimony that there was 
some use of the term ``mandate'' in those discussions.
    Dr. Krause. Well, in the main discussion with Drs. Woodcock 
and Marks, they cited mandates, along with the need to increase 
confidence in the vaccine, which they thought would occur if 
the vaccine was licensed versus merely authorized, as well as 
concern that there would be increased number of cases in the 
Fall, as reasons why the licensure should be sped up.
    Mr. Bentz. Yet, that's not what really, it appears, that 
the President was concerned about, President Biden, on 
September 11th. In his remarks, it appears that he was more 
concerned about the economy. He wasn't concerned about anything 
beyond that.
    He was saying, if we don't get everybody vaccinated, my 
economy may not be in the shape that I want it, and therefore, 
let's mandate it and force it on those 80 million recalcitrant 
folk that don't want to take this vaccine, and that will get 
the economy back in shape; I don't have to worry about my 
reelection, or whatever. I'm adding words that he didn't say. 
What I'm saying is he referred to the economy.
    So, I'm just trying to get at what was the reason for the 
mandate when we already had this massive amount of people 
vaccinated? That's the question.
    Dr. Krause. Of course, the vaccine was still available to 
everybody who wanted it. So, I can't speculate as to what the 
politicians were thinking, but I do agree that, if one looks at 
all the evidence, there was some significant circumstantial 
evidence that the desire to implement mandates likely had 
something to do with the speeding up of the review time.
    Mr. Bentz. Well, it seems to me that we have those review 
times for a reason, and it appears to me that they were not 
applied here, and there was a reason for folks to be concerned 
about the process. That's why I'm happy for the hearing today.
    Perhaps we can suggest to the folks on the other side of 
the aisle that looking into what actually happened makes sense. 
So, we build, rebuild the trust that's necessary for this 
important part of our lives.
    I yield back.
    Mr. Massie. I thank the gentleman from Oregon.
    I now recognize the Ranking Member from California for five 
minutes.
    Mr. Correa. Thank you, Mr. Chair.
    Dr. Pavia and Dr. Krause, I have a letter in front of me 
from a group of people advocating against Covid-19 mandate 
vaccine. Want to read a few statements from this letter that 
are a bit more medically nuanced and ask you, if you can, to 
answer either yes or no if you agree with these statements.
    I am going to start out with Dr. Pavia.
    First statement: The vaccines are injuring and killing 
historically a large number of people.
    Dr. Pavia. That is patently untrue.
    Mr. Correa. Second statement: The vaccines reduce the 
health of all vaccinated populations.
    Dr. Pavia. No evidence of that.
    Mr. Correa. Third statement: Antibody-dependent 
enhancements, or ADE, from the vaccines could cause millions of 
deaths.
    Dr. Pavia. That statement is untrue, and it was evaluated 
as a potential adverse event during the studies. Dr. Krause 
could speak to that.
    Mr. Correa. Fourth statement: The risks of children dying 
from Covid is still statistically zero.
    Dr. Pavia. That one makes my blood boil, having seen 
children die. Seventeen hundred children died of Covid, and 
that is probably an underestimate.
    Mr. Correa. Dr. Krause, I am going to ask you the same 
questions.
    First statement: The vaccines are injuring and killing a 
historically large number of people. Yes, no?
    Dr. Krause. I would say no, without knowing what 
historically large means.
    Mr. Correa. Thank you. Second statement: The vaccines 
reduced the health of all vaccinated populations.
    Dr. Krause. I would say no.
    Mr. Correa. Thank you. Third statement: Antibody-dependent 
enhancement, or ADE, from the vaccine could cause millions of 
deaths.
    Dr. Krause. That was a concern early in the development of 
the vaccines. That was addressed with a number of different 
studies, and so I would say no.
    Mr. Correa. Fourth statement: Finally, the risk of children 
dying from Covid is still statistically zero.
    Dr. Krause. There, of course, as Dr. Pavia points out, the 
answer to that is also no.
    Mr. Correa. Thank you very much, gentlemen. Let me followup 
another question.
    Dr. Pavia, you talked about the devastating consequences of 
misinformation on vaccines. We declared that measles was 
eradicated in the year 2000, but now we have had several 
outbreaks of measles across the country, including in my 
district, my hometown of Anaheim, California.
    The first reported case was an unvaccinated child, but as a 
result, 131 Californians were infected, and 16 people in other 
States, as well as 160 people in Canada. Almost all 
unvaccinated.
    I am concerned that people do not understand how serious 
measles cases are, and disinformation campaigns impact so many 
people, including threatening pregnant women and infants. Can 
you comment?
    Dr. Pavia. The parents I speak to only want good 
information; they are trying to make the best decision. They 
are confused and misled by huge amounts of information on the 
internet. If they have a chance to speak to their provider, 
they usually will make the decision to vaccinate their 
children.
    Unfortunately, what we are seeing now is that confusion 
often causes decision paralysis for parents, and that is making 
their children vulnerable to measles.
    Mr. Correa. Confusion resulting because misinformation, 
conflicting information? We all want to do the best we can for 
our children, for our families. They get conflicting 
information, so essentially you have paralysis when it comes to 
these medical decisions.
    Dr. Pavia. You essentially have the problem of false 
equivalency. When you read something on Facebook, you don't 
know that is different than well-run studies that involved 
hundreds of thousands of children. So, parents are 
understandably misled. Sometimes that misleading is actually 
intentional.
    Mr. Correa. Why would that be intentional misleading?
    Dr. Pavia. Because there are people who believe 
passionately that vaccines are bad, that they are dangerous, 
and that they are part of a conspiracy to make money for Big 
Pharma.
    Mr. Correa. Dr. Pavia, there has been a lot of discussion 
about the Covid-19 vaccines and boosters. I saw firsthand the 
fear and angst among doctors and patients before the vaccines 
arrived. It is clear to me that these vaccines are safe and 
effective and have saved many American lives.
    Do you believe vaccines save lives?
    Dr. Pavia. Absolutely.
    Mr. Correa. Do you think that the government 
recommendations for vaccines were accurate and helped bring 
normal State of being in our lives?
    Dr. Pavia. The availability of vaccines helped get people 
back to work, it helped them survive the infection, it helped 
our economy get back on track. It was incredibly important.
    Mr. Correa. Can you tell us about your experience with 
Covid, especially during the Winter of 2021, and how that 
impacted the medical profession and your patients?
    Dr. Pavia. The Winter of 2021-2022 is when the Omicron wave 
surged, and it really overwhelmed an exhausted workforce. It 
caused close to record levels of hospitalization and deaths.
    At that point, we had a decimated and exhausted workforce. 
So, we saw patients dying of treatable illnesses like heart 
attacks because we couldn't get to them. We saw our adult 
hospital having to build an extra 50-bed emergency ICU to take 
the overflow.
    It was very helpful that our healthcare providers had got 
an additional dose of vaccine and felt more protected being 
able to come to work under those circumstances.
    Mr. Correa. Thank you very much, Dr. Pavia.
    Mr. Chair, I yield.
    Mr. Massie. The gentleman yields back. The gentleman from 
California is now recognized for five--
    Mr. Issa. Thank you, Mr. Chair. I am going to continue 
right where my colleague from California, Mr. Correa, left off.
    Dr. Krause, is it fair to say that the Operation Warp Speed 
that led to a potential solution, one that was under a unique, 
fairly unique FDA provisional license, a success in that it 
gave at least something for the most vulnerable who had nothing 
before that?
    Dr. Krause. Yes, it was an enormous success.
    Mr. Issa. You would all agree with that? No one is 
disagreeing?
    So, we don't have a problem with the speed, the 
development, the funding, all the things that responded to this 
pandemic. Let's go a little further. We already heard earlier 
about basically rushing to get full approval.
    Was that inherently a shortcut that can lead to side 
effects not being fully understood in any medicine, not just in 
this one? Is that fair to say, would all of you agree that 
rushing final approval is always a different question than 
getting an early drug?
    I am one of the people that helped push for right to try, 
because I believe strongly that even when something has some 
unknown risk, those who are most going to be affected without 
it have a right to take that risk. So, I am seeing only yeses. 
Again, I want to--
    Dr. Krause. Well, Mr.--
    Mr. Issa. Yes?
    Dr. Krause. Perhaps, I have lost my train of thought, 
sorry.
    Mr. Issa. I will come back to you on that. Because Mr. 
Correa did such a good job, I don't want to eliminate the fact 
that we do need access to these, that many of the vaccines 
have, in fact, eradicated or virtually eradicated terrible 
diseases.
    Isn't it true that months and months and months after every 
member of the military was mandated to take this vaccine, 
months and months after we were told that this would stop the 
spread, months and months after we were actually discharging 
active duty military personnel who for religious reasons 
objected, that Pfizer's chief sat in Europe, and when asked 
does this stop the spread, does it create this immunity from 
receiving it, he said no, we never tested for that?
    Does anyone disagree with that being a fact?
    Dr. Pavia. I think that is partially correct. The vaccines 
decreased the risk of being infected, less so than they do the 
risk of being hospitalized. If you are not infected, you can't 
spread. There are transmission studies that showed a decrease 
in transmission. It didn't prevent transmission--
    Mr. Issa. Right, so--
    Dr. Pavia. On an absolute level.
    Mr. Issa. This statement shocked a lot of people who, as 
was intended, had developed a trust in this vaccine, a trust in 
the FDA. Isn't there one thing that we can all agree on, is 
that we need to make sure that we don't take shortcuts into a 
final approval that, for example, caused people in the 
Administration and at the FDA and Dr. Fauci to make statements 
that in retrospect, at least as said, are patently untrue?
    Doctor, you kindly said that if it reduces the side 
effects, it might and probably does somewhat reduce the 
transmission. It doesn't stop you from getting it, so it 
doesn't stop you from transmitting.
    Dr. Pavia. It does stop you from getting it, but over time 
that protection wanes and eventually becomes zero. The virus 
continues to change. So, it is not correct--
    Mr. Issa. Let me just challenge you for--
    Dr. Pavia. That it absolutely does not prevent infections.
    Mr. Issa. Let me challenge you for a moment on this. How 
many shots has the President of the United States had? If I am 
correct, he has had at least five Covid shots.
    Dr. Pavia. I will take your word for it; I am not his 
physician.
    Mr. Issa. A man who never gets out of the office 
practically has Covid like five times. We have high profile 
people who have taken all the shots, including the boosters, 
and they have demonstrated that they keep getting it.
    Doctor, would you--am I inaccurate? Because I just follow 
the President has it, his key staff has it, this person has it. 
There does seem to be a belief that it stopped, when Pfizer 
says it doesn't.
    Now people are saying well, it immeasurably reduced. We 
can't quantify exactly how much, but we are going to assert 
that it does. Is that fair to be what is going on?
    Dr. Krause. Well, the boosters do reduce the incidence of 
getting symptomatic Covid for some period of time after getting 
the booster. That period of time is shorter than one would like 
it to be.
    Mr. Issa. So, I am going to close with just one question. 
If we gave everybody antibiotics all the time, wouldn't we 
somewhat reduce infection while, in fact, making otherwise bad 
decisions that anybody in the antibiotic business would say 
don't over-prescribe? Is that fair to say, doctors?
    Thank you. I yield back.
    Mr. Massie. The gentleman yields back. I now recognize the 
Ranking Member of the Full Committee for five minutes.
    Mr. Nadler. Thank you, Mr. Chair.
    Dr. Pavia, can you recount for us what your experience was 
like in early 2021 and the impact you saw at the ground level 
of increased vaccine availability in the face of the raging 
pandemic?
    Dr. Pavia. It was an incredibly difficult time, Mr. Nadler. 
People were dying, people were scared, people were scared to go 
to work. The presence of the vaccine greatly helped with that.
    I had friends who worked as ICU nurses who saw people were 
getting intubated who said I wish I hadn't believed what I read 
on Facebook and had gotten the vaccine. So, vaccine concerns 
were very understandable, and it is a human reaction to 
question them. For many people, it proved to be a fatal 
decision.
    Mr. Nadler. Dr. Pavia, if I said to you that as of this 
week, Covid-19 has directly led to the death of over seven 
million people worldwide, including 1.1 million Americans, 
would that sound right to you?
    Dr. Pavia. Those are the figures that have been calculated 
very carefully.
    Mr. Nadler. In dealing with an infectious disease like 
Covid-19, what are our best options for controlling the spread 
of the disease among the public and to our friends and family?
    Dr. Pavia. Well, we have a number of tools. None of them 
are perfect by themselves, so we use a layered defense. 
Vaccines prevent us getting seriously ill and provide some 
protection against infection, particularly when we keep up with 
vaccines for the changing virus.
    Avoiding going out when you are sick. Wearing a mask when 
you are around vulnerable people. These are all the layers we 
have to use to try and control this disease.
    Mr. Nadler. You are saying the vaccines don't necessarily 
prevent you from getting the disease, but they do greatly 
reduce the seriousness of it if you get it.
    Dr. Pavia. So, two things. One is they do reduce your risk 
of getting infected, but it is far from perfect. So, after 
about six months, you have about a 30-50 percent reduced risk 
of getting infected. That is significant, but it is not great.
    They have a much higher efficacy for protecting you from 
being hospitalized or dying.
    Mr. Nadler. So, do you agree that vaccinating the public to 
slow and prevent the disease from spreading is a critical 
public health measure?
    Dr. Pavia. Absolutely.
    Mr. Nadler. Dr. Pavia, I hear often from my constituents 
about the fear they experienced caring for a young child with 
RSV over the past two Winters. I know that we must ensure that 
the most vulnerable among us, like the elderly, get their flu 
vaccines every year.
    Can you talk about the recent uptick in vaccine hesitancy 
and how that affects the cases you see every day as an 
infectious disease expert?
    Dr. Pavia. I will use a slightly different example, Mr. 
Nadler. There is an infection called haemophilus influenzae 
type B that those over about 60 remember that used to cause 
life-threatening infections and meningitis in about 20,000 
children each year.
    We virtually eliminated that disease, drove it down to a 
few dozen cases a year, with vaccine. With vaccine hesitancy, 
we are beginning to see small pockets of that really awful 
disease popping back up. So far, they haven't spread widely, 
and we really need to do everything we can to stop that.
    Mr. Nadler. Now, my colleagues across the aisle have 
accused President Biden of pressuring the FDA. The truth is 
that President Trump is the one who called FDA regulators part 
of the Deep State and wanted the FDA to have less rules about 
Covid vaccine authorization so that he could take credit for 
vaccines coming out before election day.
    Luckily, the scientific experts in the FDA's Office of 
Vaccines wouldn't compromise on American safety for Trump's 
political. Dr. Marion Gruber, the head of the Office of 
Vaccines at the time, told the Committee that for over a decade 
of her work at the FDA, she had never before had an instance 
where a President commented on an FDA guidance document, as 
Trump did.
    She testified,

        In the Office of Vaccines, we were not willing to compromise 
        any standards for safety and effectiveness in the interest of 
        getting a vaccine out even faster than we thought we could make 
        them available.

Dr. Krause, do you agree with Dr. Gruber's testimony that in 
2020, the Office of Vaccines did not compromise its standards 
when authorizing the Covid vaccines for emergency use, yes or 
no?
    Dr. Krause. Yes.
    Mr. Nadler. Thank you very much. Let me ask one other 
question for Dr. Krause and Dr. Pavia. When I was a child, you 
couldn't go to kindergarten, you wouldn't be admitted, unless 
you had certificates of vaccination on diphtheria, whooping 
cough, and various other childhood diseases. Eventually measles 
was added to that when we developed a vaccine for that.
    Do you think we should seriously enforce such a policy now, 
Dr. Krause?
    Dr. Krause. For all vaccines?
    Mr. Nadler. Well, for childhood illness vaccines.
    Dr. Krause. So, I think for childhood illness vaccines that 
are highly contagious, it is very important to assure that the 
children who are going to school are not going to transmit 
those diseases to other children at school.
    Mr. Nadler. So, it should be mandatory?
    Dr. Krause. It should be mandatory in most cases, yes.
    Mr. Nadler. Dr. Pavia, same question.
    Dr. Pavia. I would agree that when a disease is highly 
transmissible and when not everyone can be protected by 
vaccines, having all children in school vaccinated is--
    Mr. Nadler. Just finally, name some of the diseases you are 
talking about.
    Dr. Pavia. So, measles, haemophilus influenzae, whooping 
cough, these are highly infectious diseases. Varicella. They 
used to cause tremendous impacts on children.
    Polio would be another example. When you and I were growing 
up in New York, you couldn't go to the swimming pool because 
polio would spread and kids were ending up in iron lungs.
    Mr. Nadler. Thank you very much, and I yield back.
    Mr. Massie. Thank the Ranking Member. Now, yield five 
minutes to recognize the gentleman from North Carolina for five 
minutes.
    Mr. Bishop. Thank you, Mr. Chair.
    Dr. Krause, I am going to yield my time momentarily to 
Chair. In response to Representative Issa, you lost your train 
of thought on something. I saw you writing after. Did you have 
a point you wanted to make that you couldn't in isolation you 
would like to make?
    Dr. Krause. Only that once a product isn't licensed, 
obviously following up on that product--once it is licensed, 
the followup doesn't end there. The FDA and the CDC continue to 
look at that, they continue to comb through various databases 
to understand if there are safety problems.
    So, I wasn't sure, Mr. Issa's question might have implied 
that once it was licensed, that stopped, and I just wanted to 
make sure the Committee knew that these activities continue.
    Mr. Bishop. That is a helpful point. With that, I yield my 
time to the Chair.
    Mr. Massie. I thank the gentleman from North Carolina.
    Dr. Krause, when you reviewed the Pfizer submission for the 
EUA or the BLA, did their studies, did their trials, were they 
geared to test whether the vaccine prevent transmission?
    Dr. Krause. No, they were not.
    Mr. Massie. Does the EUA, when you issue an EUA, is it also 
accompanied, or is part of that production a list of things 
that the vaccine manufacturer can or can't say about what their 
vaccine does or its efficacy?
    Dr. Krause. Well, in general that is the case, both for EUA 
and for BLA, where the FDA not only regulates whether the 
product can be given to the public or made available to the 
public, but also regulates what statements can be made.
    It is in the fact sheet for EUA or the package insert for a 
licensed product that the claims that the FDA has vetted and 
agrees are correct need to be listed. In fact, if a company 
makes an advertisement claiming something that has not been 
shown to be correct by the FDA's review, then they are breaking 
the rules.
    Mr. Massie. They are breaking the laws too.
    Dr. Krause. The law, yes.
    Mr. Massie. Yes. Sometimes we make a distinction here 
because laws are written by Congress and rules are made--
    Dr. Krause. Fair enough.
    Mr. Massie. By the regulators sometimes. Did the FDA 
production ever say that the manufacturer was permitted to say 
that it reduces spread?
    Dr. Krause. No, that was not part of the FDA review or the 
fact sheet.
    Mr. Massie. Did you see in the media that there were at 
least politicians making that claim?
    Dr. Krause. I did see that in the media, yes.
    Mr. Massie. I would like to show a video that Pfizer 
produced. This was an ad for--I believe it is for the boosters 
maybe.
    [Video shown.]
    Mr. Massie. OK, that is good.
    Given that they weren't--this was an EUA product, is there 
anything missing from this ad? Does that seem like a compliant 
ad to you?
    Dr. Krause. Well, normally advertisements of products 
include some disclaimers of course and places to go for more 
information or a suggestion that one talk with one's physician 
and so forth. So, it does seem like something is missing here.
    Mr. Massie. Let me ask you, Mr. Siri, was the FDA, not Dr. 
Krause, but was Dr. Marks aware of this video? Isn't his, not 
within Dr. Krause's subdivision, but within a subdivision under 
Peter Marks, weren't they responsible for policing these 
things? Did Dr. Marks know about this ad?
    Mr. Siri. Absolutely. Our firm sent a letter to the FDA 
about this advertisement and others, including on Sesame 
Street, pointing out that they do not comply with the Federal 
regulations and the Federal law. Because even if the EUA itself 
issued for the Pfizer Covid vaccine said that any time the EUA 
product was going to be promoted, there was a disclaimer that 
must be put on it saying this has not been licensed as safe and 
effective.
    Nonetheless, that disclaimer, you do not see it on that 
advertisement. When we pointed it out to the FDA, they did not 
do anything about it. Even worse, the CDC itself actually 
violated the rule by promoting the vaccine as safe and 
effective when it was EUA.
    We wrote a letter to the FDA saying, are you going to 
enforce against the CDC. The FDA never took action.
    Mr. Massie. Wasn't it the case that in 41 videos, Peter 
Marks himself, the person in charge of vaccine approval, was 
making claims that were not vetted by the FDA, and in fact 
would have been illegal for the manufacturer to make, yet the 
regulatory agency was making those claims?
    Mr. Siri. I am not aware of any exception that would have 
permitted the FDA itself to violate a regulation, or I believe, 
or the United States Code in which that particular disclaimer 
is derived from.
    Mr. Massie. Thank the gentleman from North Carolina, and I 
now recognize the gentleman from Georgia for five minutes.
    Mr. Johnson. Thank you, Mr. Chair.
    To me it, I mean it is pretty clear, the Nation went 
through a once-in-a-lifetime pandemic, 1.1 million people died. 
At the height of the pandemic, 3,000-plus individuals, people, 
dying every day. Morgues full, over capacity.
    Refrigeration trucks were being used to keep bodies such 
that they could be buried months later because the funeral home 
industry was paralyzed. As was our economy, and everyone was at 
home, other than essential workers working remotely.
    Do you all remember that? It was months that we went 
through that. With people dying.
    I remember my mother who is now 97, she will be 98 in 
October. I was doing everything I could, me and my wife, to 
make sure that we did not bring Covid home to her, for her to 
catch it at the age that she was being as predisposed to be 
adversely impacted, greatly, by the virus.
    I was not alone. I am sure that there were so many people 
striving to protect their loved ones, children elderly, and 
themselves from dying from this virus. So, our government was 
speeding up the process of vaccine development, investing 
money, providing waivers of liability, Mr. Siri, for companies.
    Finally, a vaccine was produced by three companies. The 
process of approval was rushed because of the dire need for a 
vaccine. Am I right about that, Dr. Pavia? Pavia, I am sorry.
    Dr. Pavia. Yes, no, it was an absolutely dire need and--
    Mr. Johnson. So, our government came to the aid of the 
people and got this, got these vaccines to market quickly. So 
that is why we are here today, is because some folks have 
problems with, they say that it was speeded up too much.
    Dr. Krause, how many people lost their lives because they 
were adversely affected by the vaccine?
    Dr. Pavia. So, I don't have a number for that.
    Mr. Johnson. Do you have a number, Dr. Vaughn?
    Mr. Vaughn. How about you, Mr. Siri?
    Mr. Siri. Well, what I can tell you is--
    Mr. Johnson. Well, you don't have a number for it, do you?
    Mr. Siri. Well, I could tell you sources you could look to.
    Mr. Johnson. I don't want it--I just want to know if you 
know. Because you all are here as witnesses against the process 
that led to the development of the vaccine.
    I am rather suspicious about the motives of those who 
wanted this meeting to take place, because there is a vaccine 
skepticism out there. There are vaccine skeptics, conspiracy 
theorists among the MAGA crowd. It is spilling over into 
innocent parents with children who are now suspicious about 
mandates to have their children vaccinated before they can go 
to school.
    It is really hurting our public health, isn't it, Dr. 
Pavia?
    Dr. Pavia. Yes, sir, it is.
    Mr. Johnson. Folks are making money off it, Mr. Siri. Even 
your firm, a Texas-based group that campaigns against vaccine 
requirements, that is one of your major clients. They paid you 
all $3 million in 2021, and you are here to testify. You are on 
the clock right now, aren't you?
    Mr. Siri. I am not on the clock for this hearing, but yes, 
one of our clients is I believe the--but on your question--
    Mr. Johnson. Let me move forward. Dr. Krause, it would be 
inaccurate, sir, to say that you quit your job at the FDA after 
30 years and you were the top guy. Well, actually, the Deputy 
Director, and you quit because of the process that led to the 
speedy rollout of the vaccine. It would be inappropriate for a 
Member of Congress to insinuate that, would it not?
    Because actually, after 30 distinguished years in that role 
of Deputy Director, that was during a time when a new Director 
was being sought and you were--your hat was in the ring. 
Unfortunately, you got passed over for it, and you left after 
that. That is the reason why you--
    Dr. Krause. No, that is not true. There was no hat and 
there was no search. Dr. Gruber and I resigned on essentially 
the same day.
    Mr. Johnson. Dr. Kaslow became the--
    Dr. Krause. What?
    Mr. Johnson. Dr. Kaslow became the Director.
    Dr. Krause. That was more than a year later, yes.
    Mr. Johnson. You didn't have anything to do with the 
approval process of the vaccine.
    Dr. Krause. Well, no I did contribute to that. So, let's be 
clear.
    Mr. Johnson. Final approval.
    Dr. Krause. Original authorization under EUA--
    Mr. Johnson. Which you didn't--the final approval took 
place months after you left the job, correct?
    Dr. Krause. No, that is not true either. Maybe I can just 
refresh you on the chronology.
    Mr. Johnson. Well, I stand corrected.
    Mr. Massie. The gentleman from Georgia's time has expired, 
but the witness may provide an answer.
    Dr. Krause. So, the Emergency Use Authorizations occurred 
in December 2020, and this was an all-hands-on-deck effort, and 
I made major contributions to the policy and the review work--
    Mr. Johnson. I thank you for that.
    Dr. Krause. Everything that happened at the FDA that 
brought the vaccines to us.
    Mr. Johnson. Thank you.
    Dr. Krause. We then also had the question about the 
licensure of the vaccine, in particular, of the Pfizer vaccine. 
That occurred in August 2021, and I was still at the FDA at 
that point.
    That was the episode that Mr. Massie was talking about. I 
left the FDA in November 2021 after, at the end of August, 
telling--at the end of September--oh, it was the end of 
August--
    Mr. Johnson. But not--
    Dr. Krause. Telling my supervisor that I was leaving.
    Mr. Massie. Let the witness answer. The time is expired. 
Let's let him answer.
    Mr. Johnson. You didn't leave because of the way that the 
vaccine was rolled out, the certification and approval, 
correct?
    Dr. Krause. So, the things that were happening at the FDA 
at the time did, in fact, influence me to leave at the time 
that I did.
    Mr. Johnson. Thank you--
    Dr. Krause. May I quickly--
    Mr. Johnson. For your service, sir.
    Mr. Massie. Recognize the gentleman from Ohio for five 
minutes.
    Chair Jordan. I thank you. Mr. Chair, on page 1, second 
paragraph, Dr. Pavia says this, ``The spread of misinformation 
and disinformation is weakening vaccine confidence.'' I would 
agree. I would argue that the biggest cause of that is the 
government.
    Mr. Siri, would you agree that the biggest reason for 
vaccine hesitancy is because of what the U.S. Government told 
us about Covid and about the vaccine itself?
    Mr. Siri. Absolutely. I would absolutely agree with that. I 
think that when you listen to a lot of the statements made 
about vaccines, when you express benefits that clearly don't 
exist, that are easily disproven, that causes vaccine 
hesitancy. When you say it over and over it can stop 
transmission, when the actual studies show it doesn't.
    Chair Jordan. Right.
    Mr. Siri. The studies by the CDC themselves when they found 
more nasopharynx from the vaccinated--viral carriage in the 
vaccinated in their nasopharynx versus the unvaccinated and 
more rates--please.
    Chair Jordan. Totally agree.
    Dr. Vaughn, would you agree?
    Dr. Vaughn. I agree. Again, they were told one thing and 
then were fairly--most people, once the opposite happens, 
usually start to question whoever told them that.
    Chair Jordan. Exactly. Why do you think--well, let me ask 
it this way: Doctor, we had someone earlier say that--I think 
Dr. Pavia said this--he said the way it should be determined is 
patients and their doctors should decide how this works. This 
thing got so political that you couldn't even do that, could 
you? You treated I think you said, 2,000 patients in your 
practice. Someone just asked you the number, how many people 
took the vaccine and died? You said I can't give you a number, 
but you gave six examples of people who had huge complications 
in your written testimony. So, tell me about that relationship 
and how politics played into the relationship that is supposed 
to exist between the doctor and their patient?
    Dr. Vaughn. Yes, I think the biggest trust was lost when 
they were mandated to get something against their conscience. 
That is one of the things that needs to be--especially when you 
talk about a physician that knows his patient. There are 
certain patients that don't need to have their immune system in 
a sense poked. I think most physicians would agree with that. 
That knowledge is what a physician and their patient have in 
the relationship that exists. It is not something that is found 
in a parking lot when you roll down your window.
    Chair Jordan. Did you ever feel pressure from any 
government entity, certifying board, or whatever in the way you 
were treating your patients?
    Dr. Vaughn. I did not. Interestingly enough, some other 
physicians decided that when I was saying that the vaccine did 
not necessarily prevent transmission, they wrote the Board of 
Medicine. I went down and had a discussion. At that time, it 
was proven that I was correct, if that makes sense. It was at 
that time--
    Chair Jordan. Some of your colleagues tattletale'd on you--
    Dr. Vaughn. Yes.
    [Crosstalk.]
    Dr. Vaughn. Yes, people I had never met, other physicians. 
The other thing was--and again, this is my five-year-old who 
basically--
    Chair Jordan. Sit you in front of the board and you happen 
to be right?
    Dr. Vaughn. Yes. Going to kindergarten--I spoke in front of 
the board about masking my kindergartner. Again, my wife being 
a speech pathologist, masking children for 18 months didn't 
really help with their speech development, their ability to 
talk. I also was turned in for that as well. Again, I asked the 
Attorney General of our State if I had given up my free speech 
when I became a physician. He told me I had not, but evidently 
that is not true.
    Chair Jordan. Yes, I mean the cause of vaccine hesitancy, 
the reason this got so political in my judgment is because our 
government told us time and time again things that were not 
accurate. They told us--I said this in my opening statement: 
They told us masks work. They told a six-foot social 
distancing--which meant we had to close schools and shut down 
businesses and restaurants. They told us that was based on 
science.
    They told us the vaccinated couldn't get it. They told us 
the vaccinated couldn't transmit it. They told us it wasn't--
with the lab they told us all kinds of things that weren't true 
about where this thing came from in the lab. Then, maybe the 
biggest one, first virus in human history where there is no 
natural immunity. Is that true, Dr. Vaughn? Is there natural 
immunity for this virus like every other virus?
    Dr. Vaughn. I will tell you--again, I was early in actually 
having a sero--basically an immunoassay that would tell me 
among all my patients who had Covid. There was about 7,000 
people that I had that data base on, and up until omicron the 
reinfection rate among my people that were zero-positive was 
basically zero.
    Chair Jordan. Yes. Oh, no, we couldn't have that.
    You got anything to add? Well, let me just say this and I 
will let you finish, Mr. Siri.
    Kamala Harris said in 2020 before she was Vice President 
that, ``she would not trust any vaccine under development in 
the Trump Administration.'' A few months later they were trying 
to speed up the process to mandate the very vaccine she said, 
``she wouldn't trust because it was all based on politics.''
    Mr. Siri, I will give you the last word.
    Mr. Siri. I will go back to what Mr. Johnson said, who 
seemed very concerned about financial interests being able to 
influence. I certainly agree with that. Billions of dollars 
were on the line for these pharmaceutical companies and that 
really affected the way these vaccines were rolled out. That is 
a financial conflict of interest especially when they didn't 
have to pay for any injuries, and they knew it beforehand 
because the Federal Government contractually agreed the PREP 
Act can be applied to every single vaccine that was rolled out. 
It is in this submission, the citations to all those contracts.
    Chair Jordan. I yield back. Thank you, Mr. Chair.
    Mr. Massie. I thank the Chair.
    I now recognize the gentlelady from Washington State for 
five minutes.
    Ms. Jayapal. Thank you, Mr. Chair.
    Before I came to Congress, not many people knew this, but I 
spent a decade working on international public health and 
development all over the world. As a child growing up in India 
and Indonesia, I got every single vaccine possible and I really 
believe I would have died without those vaccines. I believe 
vaccines save lives. I think that is the science and the 
research of it.
    The effect of vaccines on disease worldwide has been game 
changing. Just take a look at polio. From the late 19th to 
early 20th Centuries the disease was a threat to children 
worldwide. In fact, my sister-in-law was one of the--they were 
called the Polio Pioneers, the first 50 children who got the 
vaccine. She had already contracted polio, but she was part of 
Dr. Salk's trial.
    Despite the start of regular immunizations in the 1970s 
polio still impacted over 1,000 children a day in the late 
1980s. Thanks to the global polio eradication initiative most 
countries have zero cases. Polio is the only endemic in 
Afghanistan and Pakistan, and as recently as 2020, Nigeria was 
recognized as being free of wild poliovirus.
    Unfortunately, there has been a lot of disinformation on 
vaccines. As that has ramped up we have seen reversals in our 
progress coinciding with the pandemic and interruptions in 
routine immunizations. It is important to recognize the 
incredible number of lives saved with vaccines including the 
Covid-19 vaccine.
    Listen, it is no secret that I am not a big fan of big 
pharma and so any time the--my colleagues on the other side of 
the aisle want to help me rein in big pharma, I am looking 
forward to that. I think it is essential we stay vigilant of 
the negative effects, but the best way to do that is to 
strengthen our regulatory system, in my view. Again, my 
colleagues across the aisle have done everything they can to 
undermine and under-resource the regulatory system.
    I have a Stop Corporate Capture bill that would stop the 
revolving door of pharmaceutical executives that then go into 
the Administration. I would welcome bipartisan support on those 
issues because I think that is important.
    I want to go to you, Dr. Pavia. You talked about your 
experience of what happened with the Covid-19 virus first hit 
as a medical professional. Can you talk about the difference 
between the before and after the vaccine was developed and 
distributed? What did you see?
    Dr. Pavia. So, one of the most important effects was really 
psychological. People felt like they had some degree of 
protection, some degree of control, which was so different than 
the feelings of helplessness and despair that really dominated 
early on.
    We know and it has been said multiple times the vaccine 
wasn't perfect. It didn't prevent every infection. It didn't 
prevent every death. Without it, things would have been 
immeasurably worse. We all knew that.
    Ms. Jayapal. Tell me what the science says about the 
efficacy of the Covid vaccine? I think maybe people wanted to 
hear that it would completely protect you. I know when I got 
Covid before the vaccine, I got Covid after the vaccine, I was 
never under any illusion that it was going to be 100 percent 
effective, but that it would help prevent contracting it. Then 
if I did contract it that the symptoms would be less. Tell me 
what you know, what the science says about the efficacy.
    Dr. Pavia. Science, as you know, evolves. What we know 
about the vaccines and what we know about the virus--and the 
virus itself has changed a great deal over the last four years. 
When the vaccine was first studied, when it was a perfect match 
to the virus that was circulating, it was 95 percent effective 
at preventing any infection. That dropped the longer you were 
out from the vaccine and the more the virus changed over time.
    It is still highly effective if you get the updated 
vaccines that are better, but not a perfect match for the 
current viruses at preventing severe disease and 
hospitalization. It does reduce your chances of getting 
infected, but it does not completely prevent it. I think 
willfully people are saying stop transmission when--it doesn't 
stop it entirely, but it does decrease it because people who 
are not infected cannot transmit.
    Ms. Jayapal. I want to talk about long Covid because it is 
a real issue. It continues to impact millions of Americans. Dr. 
Pavia, I have read that one of the risk factors for developing 
long-term Covid is not being adequately vaccinated. Can you 
discuss why that is a risk factor?
    Dr. Pavia. Well, I am not sure we have all the scientific 
answers yet, but it is pretty clear from observational studies 
and many overlapping studies that essentially show the same 
thing, that being vaccinated reduces your chance of long Covid 
even if you have a breakthrough infection. It probably is 
because it prevents a virus from establishing reservoirs in 
different parts of the body and leading to permanent damage, 
but that science is evolving. We don't fully understand long 
Covid yet and it is a critical need.
    Ms. Jayapal. Are there recommendations for what we need to 
do to address long Covid?
    Dr. Pavia. We clearly need science that understands the 
basic mechanisms and we need funding for trials of possible 
interventions because so far while we are making progress on 
the science front, tragically we don't have any really 
effective treatments yet.
    Ms. Jayapal. Thank you. I appreciate your testimony.I yield 
back, Mr. Chair.
    Mr. Massie. The gentlelady yields back.
    I now recognize the gentlelady from Indiana for five 
minutes.
    Ms. Spartz. Thank you, Mr. Chair.
    I have to agree with Chair Jordan that lack of transparency 
and lack of liability, that is what creates lack of trust. This 
pandemic was really unfortunately terrible example, but on top 
of it, it was politicized. We politicized people's lives. That 
is very dangerous. Vaccine was used as a political football.
    I have a question for you, Mr. Siri. Do we have other 
medications or anything else exempt that--have immunity that 
exempt from liability? Do we have--what other things are exempt 
that we put in our body from liability?
    Mr. Siri. I am not aware of any other consumer product that 
has the liability protection that vaccines are provided. You 
can sue drug manufacturers for drugs. That is why drugs come 
off the market all the time. That is why every consumer product 
in this room and that you experience every day is safer. It is 
because those companies face economic--they have to make--they 
have to pay if they injure people.
    Ms. Spartz. That is how the system was set up, our system 
of law, torte law opposed to not--regulations that have 
selective enforcement--
    Mr. Siri. Yes.
    Mrs. Spartz. --Vor whoever gives the bigger contribution 
might not be enforced or not actually government bureaucrats, 
who a lot of them have no idea even what is going on in the 
real world supposed to actually enforce it. We don't harm 
consumers. We go through tortes. We have created here immunity. 
On top of it, we are actually defending these companies. Is 
that correct my understanding?
    Mr. Siri. Yes, unfortunately for vaccines--it is the only 
product I am aware where it is the government, with DOJ 
attorneys, defend the company, the product against the 
consumers claiming injury in the Vaccination Injury 
Compensation Program. I heard earlier somebody say that the 
VICP, the Vaccination Injury Compensation Program, errs on the 
side of compensation. We have 15 folks at our firm that 
practice on that program. I can assure you that is not the 
case.
    To your point about providing immunity protection, leading 
up to 1986 there were only three routine vaccines in the United 
States totally seven injections. That is it. That was on the 
CDC schedule. Three routine, seven total injections. There are 
currently by the way 19 vaccines on the CDC schedule totaling 
84 injections, if you count Covid vaccine now given annually.
    With that said, leading up to 1986 the amount of liability 
from those three products, which were DTP, OTV, and MMR, were 
so great that every manufacturer went out of business or 
stopped making them. So, there is only one manufacturer left. 
Congress decided instead of forcing what companies have to do, 
make a better, safer product--instead it passed the National 
Childhood Vaccine Injury Act that said you can keep selling 
your product. Even though it causes harm you don't need to make 
a better and safer product. The original sin wasn't just that. 
It was that it also gave them immunity for any product going 
forward.
    I pointed out the differential that has caused and how 
clinical trials are conducted, how regulatory agencies treat 
these products. They really view themselves as partners of 
manufacturers.
    Ms. Spartz. Well listen, if I could be in business, then I 
would like to have that type of immunity and protection. Next 
business I have. That is pretty convenient. Probably cheaper to 
lobby Congress than actually defend lawsuits.
    Dr. Krause, you have been involved in this approval. 
Considering this lack of liability, how the processes are 
adjusted at the FDA process to reflect it? It seems like it 
should be more scrutiny and some much more accountability and 
responsibility the government should have.
    Dr. Krause. Well, so the FDA doesn't interface directly 
with the PREP Act or the Vaccination Injury Compensation 
Program, and yet I think it is clear that the vaccines that 
induced the passage of the Vaccination Injury Compensation 
Program needed this kind of protection. There were lawsuits and 
yet these are vaccines that were safe and effective and were 
viewed as, and still are viewed as a public good. These are 
among the vaccines that Dr. Pavia said--
    Ms. Spartz. Knowing you were looking and reviewing some 
vaccine is included during the pandemic, right? You are a 
doctor. You were reviewing some of them and seeing what is 
good, what is bad for these approvals, right? Emergency 
approval is even in the--Covid vaccine in this case. Did you 
adjust your processes based on the understanding there is 
blanket immunity? Do you do something differently or do you 
take that into consideration?
    Dr. Krause. So, when the FDA reviews these vaccines, there 
is a statutory standard that the vaccines have to meet for 
safety and efficacy. That standard is different under an EOA as 
it is under a BLA, and yet the FDA has to show that these 
vaccines meet that standard. That is the standard then that the 
vaccines that are eligible--
    Ms. Spartz. If something goes wrong and companies--was 
anything done differently during the Covid-19 pandemic and was 
it since done differently? If something goes wrong there is any 
accountability? They didn't provide information. What is the 
accountability really for the companies?
    Dr. Krause. Well, obviously the PREP Act provided the 
companies with a shield from this kind of accountability and 
yet the FDA still had the authority to look at the data, make 
sure that the fact sheets and the--
    Mrs. Spartz. Generally, the process is you do not really 
adjust it to reflect the really pure lack of accountability 
internally, or do they need to change processes? Do you believe 
the process is good for extended approval of what you have 
right now considering there is no liability?
    Dr. Krause. So, the process does account for that, but you 
don't change the process for that because that has been the 
situation for such a long time. The process is intended to be 
very rigorous which does account for that.
    Ms. Spartz. It was not followed as I understand as well, 
right, when we had this Covid-19 vaccines? Is that correct?
    Dr. Krause. Certain aspects of the process were not 
followed, although those did not influence the safety or the 
efficacy of the vaccines that eventually were authorized or 
approved. There certainly was, as has been pointed here, at 
least a strong impression of political interference, as has 
been pointed out by members of this Committee, under all 
administrations.
    So, to me the question is how can we future-proof the 
process and reduce the likelihood that there will be political 
interference and put the FDA in a stronger position to resist 
that?
    Mr. Massie. All right. Thanks the gentlelady from Indiana.
    I recognize the gentlelady from Pennsylvania now for five 
minutes.
    Ms. Scanlon. Thank you, Mr. Chair.
    I would like to thank our witnesses for joining us here 
today. I wish without a whole lot of confidence that your 
testimony here would advance the cause of public health. That 
is because as so often has occurred in this 118th Congress our 
colleagues have weaponized Congress and the entire legislative 
process to spread conspiracy theories and lies in support of 
their electoral ambitions and those of the former President.
    To be clear, vaccines work. The Covid-19 vaccine works. The 
development of the vaccine was one of the greatest medical 
discoveries in history. There is a reason nobody in this room 
has died of polio, measles, smallpox, or any number of other 
previously deadly and now rare diseases.
    Polio alone used to paralyze tens of thousands of children 
annually. It has impacted at least two Members of Congress. 
Jonah Salk became an American hero after inventing the polio 
vaccine. I have to applaud the Rotary organizations in my 
district, across the country, and around the world who have 
played such an important role in nearly eradicating that 
disease.
    We have certainly seen similar campaigns all but eliminate 
measles and other deadly childhood diseases, or at least until 
the spread of conspiracy theories and disinformation about 
vaccines allowed those deadly diseases to reemerge.
    I find it extremely disappointing that our colleagues are 
willing to abandon this history of progress to promote a 
political agenda questioning vaccine efficacy and encouraging 
people to avoid vaccination is not just dangerous, it is deeply 
disrespectful to the millions of people for whom vaccines have 
saved them from death or a lifetime of immense pain.
    In the face of a global pandemic Covid-19 vaccine and 
boosters increased immunity, saved millions of lives. We should 
be celebrating American commitment and ingenuity that allowed 
the rapid development and distribution of the vaccine. We 
should be celebrating it.
    The former President and his allies in this House are more 
interested in catering to the most extreme Members of their 
base. So, instead we get repeated lies and falsehoods about 
vaccines and public health strategies that responded to the 
pandemic. We have seen months of attacks on the vaccine 
approval process with absolutely no results. As with many of 
the investigations initiated this Congress the lack of evidence 
to back up these claims hasn't stopped our colleagues from 
sowing distrust and misleading the public about those 
investigations.
    Asking for more transparency from our Federal agencies is 
understandable. It is necessary. It is part of our job. 
Spreading lies to promote mistrust in our public institutions 
is not.
    Dr. Pavia, what danger does mis- and disinformation about 
vaccine safety pose to public health?
    Dr. Pavia. Thank you. It poses risks in a number of ways. 
So, individual parents and patients can be paralyzed by getting 
confusing information, choose not to get vaccinated and suffer 
what can be potentially life-altering disease. More importantly 
people getting infected, people who are unable to be vaccinated 
can be put at risk. So, when measles hits a classroom because 
somebody chooses not to be vaccinated a child who is being 
treated for cancer, a baby who is too young to be immunized can 
get measles and can suffer from it.
    Ms. Scanlon. One of our witnesses posed the rhetorical 
question why has trust in vaccines been lost? The Chair of this 
Committee just said that he believes one of the biggest reasons 
for vaccine hesitancy is politics. It doesn't often happen, but 
I must agree with him about that. He correctly noted that the 
issue of vaccines has been politicized.
    Dr. Pavia, what happens when people in positions of power 
like Member of Congress or a former President share--or a 
Presidential candidate share false information about vaccines 
and promote distrust in our public health and medical 
institutions?
    Dr. Pavia. Well, I have to agree that politics should 
really have no place in medical education, medical decision 
making from either side. If people are bombarded by information 
they have a hard time distinguishing good information from a 
trusted--from somebody who knows what they are talking about, 
from what they hear in the political dialog. So, it erodes 
trust, and it gets in the way of having honest conversations 
with people who actually know what they are talking about.
    Ms. Scanlon. I think that is correct. Every mom, every 
teacher knows that words matter and we try to instill that 
ethic with our kids. I think our political leaders have a 
responsibility to understand that their words matter a lot, 
particularly in this arena.
    I would just seek unanimous consent to introduce a June 14, 
2024, article from The New York Times entitled, ``Trump's Anti-
Vaccine Problem''--the anti-vax sentiment coursing through his 
die-hards shows how Trump takes his cues from his base.
    Mr. Massie. Without objection.
    Ms. Scanlon. Thank you. I yield back.
    Mr. Massie. I now recognize the gentlelady from Wyoming for 
five minutes.
    Ms. Hageman. One of the things that shocked me as we worked 
our way through this pandemic a couple of years ago was the 
level of disinformation that was coming from our political 
leaders and our medical community and the pharmaceutical 
companies. The blanket and blatant violations of our 
Constitutional rights was absolutely off the charts. The 
government tyranny was something that we had never seen before. 
The abuse of the emergency use authorization protocol was 
really pretty stunning to me including the requirement for 
informed consent before someone can be forced to take a vaccine 
that is approve pursuant to an emergency use authorization.
    Just the political elites' refusal to acknowledge the 
origin of Covid coming from the Wuhan laboratory and the 
rejection of natural immunity was something that has deeply 
affected our country and will continue to do so into the long 
distant future just absolutely shocks the conscience from the 
standpoint of seeing what our political leaders did and how 
things were politicized.
    Dr. Krause, you made that comment: How do we protect this 
process in the future? The first step is we need to prosecute 
Anthony Fauci for the level of lies and disinformation that he 
spread during the course of this including his own cover up 
related to who was funding the research at the Wuhan laboratory 
and what actually happened. We still don't have the answers to 
those question and I don't believe that we can move forward 
until we do.
    Mr. Siri, in your testimony you highlight that Covid-19 
vaccine trial were robust when compared with trials relied on 
to license most childhood vaccines. However, just because it 
was more robust it doesn't necessarily mean that the process 
was adequate. These are two very different standards. For 
example, the Pfizer trials stated that there is a two-year 
followup period, yet the emergency use authorizations for 
children were granted in as little as seven months. Our 
children.
    Mr. Siri. Oh, I completely agree that the trial relied on 
to license Covid-19 vaccine was anemic, meaning no matter how 
much delay, how much they sped it up, the problem is there not 
enough data in that trial. Only two months of placebo control 
on average information to compare is not enough time to 
actually assess the safety of that product in my opinion. You 
can see that by looking at drug trials, what they do in those 
trials. You will have years of placebo control safety review.
    Ms. Hageman. I want to cover that a little bit. In the 
chart you provided in your written testimony shows safety 
followups still under a year. This is for the trial--for age 
groups for 16 and up and 18 and up.
    Mr. Siri. Yes.
    Ms. Hageman. So, there seems to be even less review of the 
vaccines that impact our children. You also note that the Covid 
vaccine trials were, as you say, anemic when compared to drug 
trials. Mr. Siri, why are vaccines reviewed under the biologics 
process versus the drug reviews as you described in your 
written testimony?
    Mr. Siri. That is an FDA decision to do that. Technically 
vaccines could qualify as drugs as well, but they are dealt 
within CBER, and that is an FDA choice.
    Ms. Hageman. Well, is there a higher standard of review or 
more meticulous review for drugs versus the biologics?
    Mr. Siri. In practice that is what has occurred. Pursuant 
to the regulations I don't see why there should be, frankly. It 
is just a matter of practice. I think it is a product of the 
way that the regulators themselves view these products versus 
drug products. They in many ways view themselves as partners 
with the companies making them.
    When you watch Peter Marks' video, he very much sees 
himself as being--having a hand in saving everybody. He views 
himself as saving everybody. He wants this product to be part 
of what he wants to push out. Unlike drug products that are--it 
is not the same relationship.
    Ms. Hageman. Sounds like he has a bit of a god complex.
    Mr. Siri. I heard comments earlier about they believe 
passionately about vaccines. They were speaking about folks who 
take issue with vaccines. I would say some of the most fervent 
people who are passionate about vaccines or those who support 
these products will support them without even looking at some 
of the primary data and will easily dismiss the primary sources 
that do show very serious concerns.
    Ms. Hageman. Well, children and young people remain at low 
risk of Covid-19 mortality, yet the Covid vaccine has still 
been forced on America's children and at great risk. There were 
71,108 adverse events including death that have been reported 
to VAERS for children six months to 17 years due to the Covid-
19 vaccine. I would assume that this number is actually under-
reported. This includes 196 deaths, 665 permanently disabled, 
1,518 cases of myocarditis. Again, I am going to say that I 
don't even trust those numbers because I don't trust our 
government right now to accurately report information related 
to Covid.
    So again, Mr. Siri, was the use of Covid-19 vaccines in 
pediatric populations advisable given the risk of Covid-19--the 
virus in children?
    Mr. Siri. Our firm sent a number of letters as well as a 
formal petition to the FDA that we believe clearly supported 
that it was not supported use in children. In particular, this 
idea that 1,700 children died is not based on reliable data. 
They can't actually point to actual children that died--1,700. 
There are always confounders. There are not children who--
healthy children who have died from Covid-19 vaccine in case 
reports that I have seen.
    Ms. Hageman. I appreciate your testimony, your honesty, and 
your willingness to share this information with us.
    Thank you to all the witnesses today.
    With that, I yield back.
    Mr. Massie. I thank the gentlelady from Wyoming.
    I now recognize--
    Dr. Krause. Mr. Massie, would it be possible to just take a 
five-minute bathroom break?
    Mr. Massie. Yes, we will take a break right now. The plan 
here--by the way, thank you--is to go until about 2 p.m. There 
is another hearing in this Room at 2 p.m., I believe. So, we 
may do a second round, but we will plan to stop at 2 p.m. We 
will recess for about 1five minutes now. Thank you.
    Dr. Krause. Thank you.
    [Recess.]
    Mr. Massie. The Committee will now resume. I recognize the 
Ranking Member.
    Mr. Correa. Thank you, Mr. Chair. I'd like to have 
unanimous consent to introduce these articles into the record.
    Mr. Massie. Can you describe them briefly?
    Mr. Correa. (1) Commonwealth Fund, 2022, ``Two year Covid 
vaccines prevent millions of deaths.''
    (2) ``Trump warp speed, President Trump Operation Warp 
Speed vaccine summit.''
    (3) A concerned doctors' letters.
    (4) The New York Times, ``FDA stood up to the President.''
    (5) ``Poynter claims that--2021, claims that millions of 
people have died from Covid vaccine are unfounded.''
    (6) HRSA, ``How vaccine misinformation made the Covid-19 
death toll worse.''
    (7) AP News ``Large measles outbreak.''
    (8) Mayo Clinic debunking Covid-19 risks.
    (9) The youngest victims of a natural calamity and the 
people they left behind.
    (10) ``Health officials, two Kentucky children reported 
death from flu and Covid-19.''
    (11) ``Three Louisiana children died of Covid-19 over the 
last week.'' This is dated February 22, 2022.
    (12) The last one, ``Child Covid deaths more than doubled 
in Florida as kids returned to classroom.''
    Mr. Massie. Without objection.
    I now recognize the gentlelady from Georgia for five 
minutes.
    Ms. McBath. Thank you, Chair. Thank you to the Ranking 
Member and for our witness testimony today. Thank you so much.
    Thank you for taking the time to be here and to make this 
hearing possible today. My hope as we gathered here today was 
that we would have a good faith discussion on how we can use 
the lessons that we learned from Covid-19 to improve our 
pandemic preparedness and strengthen our public health system. 
I worry that today's conversation does not help, and it only 
hurts this goal, a goal that I hope that we all share to boost 
pandemic resilience, prevent unnecessary loss of life, and 
protect the most vulnerable people in our communities.
    I'm a two-time breast cancer survivor. I underwent 
lifesaving treatments to be with you today. One of the side 
effects of these common and necessary cancer treatments like 
chemotherapy, surgery, and radiation therapy is a suppressed 
immune system.
    When your immune system is suppressed and weakened, your 
body cannot fight off infections like it normally can. This 
makes you particularly vulnerable to infectious diseases and 
puts you at greater risk for disease complications and actually 
for hospitalization. For cancer patients and millions in this 
country who are immune-impaired like organism transplant 
recipients, organ transplant, people with autoimmune disorders 
and chronic diseases, infants, toddlers, and the elderly, 
vaccines are a critical safeguard that protects against 
preventative and unnecessary complications that can endanger 
lives.
    Prevention is the best medicine. I think we can all agree 
with that. The health of our communities and the strength of 
our public health system are tightly bound to preventative 
services like vaccines.
    We've seen this over and over again thanks to vaccines. We 
eradicated smallpox, nearly eliminated polio, and warded off 
the devastating impacts of diseases like measles and whopping 
cough. We've seen it firsthand.
    Four years ago, our Nation faced uncertain times, fighting 
a destructive and novel threat that we did not have the 
resources to combat. Thanks to the Biden Administration's 
leadership, we implemented the largest vaccine rollout in 
history which saved lives and kept patients out of the 
hospital. The administration of these vaccines helped ensure 
the health and safety of our communities so that we could 
reopen our businesses, jump start the economy, and get our kids 
back to school.
    As we consider the future of disease prevention and 
preparedness, it is critical to listen to the facts, pay 
attention to science, avoid the spread of misinformation, and 
prioritize health over politics. The fact is vaccines are safe. 
They're reliable and effective. They immunize the healthy, and 
they help protect the most vulnerable. While my colleagues sit 
there on the dais and purposefully see mistrust and lifesaving 
measures, measures backed by scientists and medical experts, 
our constituents are the ones who pay the price.
    Dr. Pavia, before the break, we were told, and I quote, 
``that no children have died from Covid.'' Now, we have the 
pieces of articles that have been admitted to the record. Can 
you respond to that statement for the American public so that 
we may avoid the spread of even more misinformation?
    Dr. Pavia. Thank you for that question. It's deliberate 
misinformation. The CDC receives reports from States based on 
the medical examiner's review.
    The medical examiners determined that these deaths were 
more likely than not due to Covid. So, that number of 1,700 is 
actually 1,696 if you look on their website is reasonably 
accurate as a minimum. We know that just for MIS-C which is a 
complication which children suffer about a month out that there 
were about 7,000 documented cases and 179 deaths due to MIS-C.
    So, children did die. Seventeen hundred may not be much 
compared to 1.1 million adults. How many children can die and 
is it an acceptable number?
    Ms. McBath. Thank you so much for clarifying that for the 
American public and thank you for the work that you continue to 
do. I yield back.
    Mr. Massie. The gentlelady yields back. I now recognize the 
gentleman from Wisconsin for five minutes.
    Mr. Fitzgerald. Thank you, Mr. Chair. I think my conclusion 
here today is that the damage that's been done to public health 
is going to take maybe generations to repaired. When we think 
back, some of this stuff, it is so serious but seems almost 
laughable with masks, testing two miles long at the fairgrounds 
in Wisconsin, shutting down the schools obviously which was a 
travesty, circles on the floor at Walmart for social 
distancing.
    The furniture store next door was completely closed as a 
result of what became known as the way we're going to handle 
this pandemic. So, I don't know if the boomer generation has 
failed again here for all of society. There certainly is a 
young group of adults that does not trust the government and 
certainly doesn't trust what we had forced on them.
    The Members of this Committee, I remember being in 
Judiciary one day when we had Members ratting out other Members 
because their mask wasn't fully over their mouth and nose. It's 
stuff like that, that just we're going to look back on this and 
be very embarrassed. Unfortunately, I think public health is 
not going to come back from that.
    I do have one question that's very specific to an actual 
age group who I think we completely threw to the wolves it 
appears and that is young men, young adults. Myocarditis has 
been brought up a couple times. Dr. Krause, can you talk 
specifically about why that population was affected by the 
vaccine so adversely? Do we have any idea what boys going 
through puberty all the way to probably young men in their 20s, 
how they've been affected by this and how their hearts have 
been affected?
    Dr. Krause. So, myocarditis occurred most predominantly in 
the various studies in young men, as you say, ages 16-17. There 
were increased rates higher in men than in women, going up also 
to much older ages, although not as high as the youngest. So, I 
don't know if it's necessarily a puberty issue because this 
also affected people as they got older.
    That was what we saw most frequently. The rates of 
myocarditis in these young men was quite high. In the early 
studies, it appeared to be around one in 5,000 vaccinees.
    We still don't understand why that was the case. What we 
luckily found was that most of these cases were mild. Yet, 
there were some cases that were not mild. Of course, there were 
also some cases where--many cases where if once diagnosed with 
myocarditis, of course, the changes in a young man's life 
because he'll probably then avoid being in sports and will 
still have some continued medical followup.
    So, we don't understand it. It's most common after the 
second dose of vaccine. We found luckily that it did not appear 
to be as frequent as children got younger.
    It also did not appear to occur with anywhere near as high 
a frequency with third and subsequent doses of vaccine. It is a 
real finding that is associated with the vaccine. Luckily, most 
people when they get it, not severe. Certainly, was enough to 
give us pause when we were evaluating the vaccine.
    Mr. Fitzgerald. Well, and that's why normal trials--Dr. 
Vaughn, I don't know if you want to comment on this. That's the 
type of population, a very specific niche population that might 
be identified when you're taking a full look at a vaccine, 
right?
    Dr. Vaughn. Yes, I think again a lot of what I have is just 
anecdotal stuff that we're continuing to do. Again, it's 
anecdotal in 2,000 people. It is an interesting thing to find 
out how hormones affect different things in regard to what the 
vessel can do.
    The other thing that we've seem to find is a lot of 
patients with hypermobility are more likely to have posterior 
orthostatic tachycardia syndrome afterwards. I think again that 
has to do with the vasculature being harmed by the spike 
protein in people that already have some vascular pliability.
    Mr. Fitzgerald. Very good. Chair, I'll yield back the 
balance of my time. Thank you.
    Dr. Krause. Could I just have one comment about myocarditis 
also?
    Mr. Massie. Would the gentleman yield to me?
    Mr. Fitzgerald. I do yield.
    Mr. Massie. Mr. Krause, I want to ask, is natural immunity 
real?
    Dr. Krause. Absolutely.
    Mr. Massie. Is it also--does natural immunity exist if 
you've been exposed to Covid?
    Dr. Krause. Exposed to but not infected?
    Mr. Massie. Well, infected.
    Dr. Krause. Yes, so people who have been previously 
infected with Covid or who previously had the Covid-19 disease 
were shown in a number of very good studies to have reduced 
incidents of subsequent Covid. In fact, the protection of a 
previous episode of Covid was greater than the protection that 
was received from two doses of vaccine. It turned out that if 
you both had Covid and vaccine, then you were protected even a 
little bit better. There's no doubt that a previous episode of 
Covid induces immunity that is protective.
    Mr. Massie. So, is it not some conspiracy?
    Dr. Krause. No, it's not a conspiracy.
    Mr. Massie. I think this is an example where the government 
denies this. We even have members on this dais who deny it. 
That's what reduces trust, when there's a known fact of 200 
years and it's being denied in the context of a new disease.
    It's actually applicable in the new disease. That's another 
thing that breaks the trust between health institutions and the 
public. I'll now recognize Mr. Ivey from Maryland for five 
minutes.
    Mr. Ivey. Thank you, Mr. Chair. Dr. Krause, I've got a 
question for you. A couple days ago, President Trump made the 
following statement:

        On day one, I will sign a new Executive Order to cut Federal 
        funding for any school pushing critical race theory and I will 
        not give one penny to any school that has a vaccine mandate or 
        a mask mandate.

Had you heard that quote, Dr. Krause?
    Dr. Krause. I haven't, but I hear it now.
    Mr. Ivey. Fair enough. I'm kind of curious about your 
testimony. I'll come back to that statement in a minute. One of 
the things you said, I overheard you when I was walking through 
the anteroom. So, if I misheard it a little bit, please correct 
me.
    I think you said basically that there have been challenges 
in each Presidential Administration. I take it you've been 
there for a while with respect to politicizing the process at 
FDA. A quick look at your testimony, you raised an example of 
the hydroxychloro-quine--I hope I pronounced that correctly as 
one of those examples.
    Dr. Krause. Close enough.
    Mr. Ivey. Tell me the right pronunciation.
    Dr. Krause. Hydroxychloroquine, but you're very close.
    Mr. Ivey. Thank you. That was made on March 28, 2022. It 
says the authorization on March 28, 2022, asserted--
    Dr. Krause. It should be 2020.
    Mr. Ivey. I'm sorry, 2020. I apologize. Asserted that the 
product met the EUA standard. The authorization itself cited no 
data the FDA reviewed. There was never any evidence credible 
for an experienced regulator to support the effectiveness of it 
in Covid. So, that's a statement you made in your testimony, I 
believe?
    Dr. Krause. Correct, yes.
    Mr. Ivey. OK.
    Dr. Krause. That, by the way, is one of the reasons why I 
think that the way in which these EUAs are reported needs to be 
improved. If the FDA is going to issue an EUA in the future, it 
needs to provide that kind of information. The EUA 
documentation needs to show why it is that the EUA criteria 
were met, but also then put this in context by showing what it 
would take to bring that product up to a licensure level. This 
would allow the public to understand it.
    Mr. Ivey. All right. I'll come to that in just a second. I 
think you had a second example as well. The point you were 
making was that both of these examples undermine public trust 
in the FDA because of the questions that were raised based on 
the conclusions that were reached.
    Dr. Krause. Sure.
    Mr. Ivey. All right. Then the standards that the issue--or 
the approach you suggested to correct the politicization of it 
was to, and I'll quote it,

        I would suggest the senior leader should only overrule the 
        technical review team's scientific judgment if a panel of 
        outside experts perhaps from the relevant advisory committee 
        supports the senior leader's position.

So, this goes to the issue of when the team has put together a 
proposal. The senior leader overrules that. Currently, the 
senior leader's decision stands, I take it?
    Dr. Krause. That's exactly right. It's a position where the 
senior leader's scientific judgment can in one fell swoop 
overrule the scientific decision or recommendation of an entire 
highly qualified review team that has looked at the question on 
its scientific technical merits.
    Mr. Ivey. That's not just an example that popped up from 
the most recent administration. This is based on our experience 
over the years at the FDA?
    Dr. Krause. That's correct, yes.
    Mr. Ivey. OK. Then you also mentioned too--I'm skipping a 
little bit. You raise the concern that flexibility in the EUA 
standard and lack of transparency regarding its application 
create opportunities for political interference, right?
    Dr. Krause. Correct, yes.
    Mr. Ivey. OK. Then, later you say--and I guess maybe 
because the pandemic is an emergency situation. In a pandemic, 
it is essential for there to be flexibility to allow 
availability of lifesaving products even if they do not meet 
the standard for licensure. I want to give you a chance to 
guide me through--
    [Crosstalk.]
    Dr. Krause. Thank you so much for that question, Mr. Ivey. 
So, what we found in the pandemic was that the criteria that we 
use to license--rather to even authorize the initial vaccines 
in December 2020 were very rigorous. The public deserved that 
those vaccines be looked at using very rigorous criteria.
    That's why the public had confidence in the vaccines then. 
This was true whether people were Republicans or Democrats. The 
trouble was that there also were other times when the EUA was 
used, for example, the hydroxychloroquine that you mentioned 
when, in fact, the standard was much, much lower. Yet, if the 
public says, this is an EUA and that's an EUA, they don't 
understand the difference.
    Mr. Ivey. Right.
    Dr. Krause. That's why I'm advocating that although you 
can't take and shouldn't take the EUA away, one does need to 
provide a better explanation of what an individual EUA actually 
means.
    Mr. Ivey. OK, great. Then one last question, and I 
apologize for running over. Back to the original quote that I 
read you from former President Trump about essentially 
eliminating funding for vaccines for schools. Is that something 
you would support?
    Dr. Krause. So, I think that some children do get vaccines 
in schools, and they can't get them elsewhere. So, I think that 
schools are an important part of the vaccine delivery system, 
and I would not eliminate funding for that.
    Mr. Ivey. Thank you. Mr. Chair, I yield back.
    Mr. Massie. I thank you, Mr. Ivey. I yield to the gentleman 
from North Dakota.
    Mr. Armstrong. Thank you, Mr. Chair. Just really quickly, 
is Covid more or less contagious in a school versus a football 
field, Dr. Krause?
    Dr. Krause. Well, it's probably a little more contagious 
indoors than outdoors. Of course, people are--more people are 
packed together on a football field. So, this is a tough 
question to answer. I think it would depend on--
    Mr. Armstrong. So, if you have all your kids go to school 
for 2\1/2\ days a week for social distancing but then you send 
all the kids to the same football practice five days a week, 
does that kind of defeat the purpose of the social distancing 
at school?
    Dr. Krause. I think if you're getting at the fact that 
social distancing inconsistently applied, I think it's 
certainly not difficult to come up with examples where more 
versus lower risks would've been taken.
    Mr. Armstrong. Does Covid spread higher before or after 11 
p.m.?
    Dr. Krause. I have no knowledge.
    Mr. Armstrong. So, closing the bar down at 11 p.m. instead 
of 1 a.m. Does Covid spread more at a grocery store than a 
hardware store?
    Dr. Krause. Grocery versus hardware, I'm not aware of that.
    Mr. Armstrong. The reason I say this is when we talk about 
vaccine hesitancy and we talk about trust in our institutions, 
these were rules that were put in place that any commonsense 
normal human being would look at and say this doesn't make any 
sense. This is an essential business. This isn't an essential 
business.
    You can't catch it at Target, but you can catch it at the 
local community grocery store. So, when we go through all these 
process combined by health officials that say you won't get 
Covid if you take the vaccine and then, oh, you will get Covid 
but you won't get sick. Oh, then if you get the 19 different 
boosters, you won't get Covid.
    You can't get natural immunity to this particular thing, 
what the Chair was just talking about. People aren't stupid. 
When we treat them like they're stupid and when people in 
institutions treat them like they're stupid and when social 
media and government were to say, we're going to sensor true 
information because it'll have the wrong outlook on public 
health, people recognize those things.
    So, I appreciate you all being here. If you care about 
vaccines and if you care about health, then we should take a 
look at what happened the last three years and why people have 
mistrust in their institutions. I'm glad we're doing this 
hearing, and I will yield to the Chair.
    Mr. Massie. I thank the gentleman from North Dakota. I want 
to followup on his questions. Is anybody aware of whether Covid 
is more contagious at a church than a strip club? Does anybody 
want to take a shot at that?
    The reason I ask is our Governor shut down churches on 
Easter but left the strip clubs open. I don't think there was 
any science behind that decision. Maybe there's other things 
driving it, but it certainly wasn't science.
    Dr. Vaughn. Representative Massie?
    Mr. Massie. Yes, Dr. Vaughn.
    Dr. Vaughn. The testimony, the problem with following the 
science is that it's not a leader. It's a meanderer. You will 
come to all kinds of conclusions if the science is guiding but 
the leader is basically not--is not having any accountability 
for how stupid his decision might be.
    Instead, it's leaders that make decisions. They have to be 
informed by the science. They also have to balance it against 
other benefits or risks.
    Mr. Massie. Dr. Vaughn, I want to ask you a question. You 
said you treat long Covid, and you treat vaccine injuries and 
you've seen the same sort of things from--you think a lot of 
it's caused from the spike protein which you described. Has the 
government made it easier or harder to differentiate between 
those two conditions? Haven't they confounded this issue by 
putting the data together and making no effort to distinguish 
between long Covid and a vaccine side effect?
    Dr. Vaughn. I would say a lot of the people that I see, I 
do a very robust inventory mainly because I want to collect the 
data. So, I had to add to a lot of the long Covid 
questionnaires, did you receive the vaccine? Did you have any 
side effects from the vaccine? Did the vaccine make your 
symptoms better or worse?
    That's an important discussion. I will say there's plenty 
of people that fill out my list and say the vaccine is what 
caused my symptoms. The day I got the vaccine, that's when I 
had the symptoms that I had. Now, they've had Covid since. I do 
think disambig-uating all of that is a very important thing 
because I think it's an important distinction.
    Mr. Massie. Ms. Siri, I want to ask you--and if you go over 
a little bit, that's OK--what mechanisms did the government 
have to track vaccine side effects over time as these rolled 
out? Did they even pay attention to the data?
    Mr. Siri. Well, prior to the rollout of the Covid-19 
vaccine, the primary system that was relied on that is the 
joint FDA/CDC VAERS system. Then when the Covid vaccine was 
rolled out, they rolled out a new system and we discussed that 
earlier called V-safe. The V-safe unlike VAERS doesn't just try 
to solicit adverse events from people who have been injured by 
the vaccine.
    It asked every American to sign up for this system on the 
day they got their shot and then fill out reports. Ten million 
Americans signed up for V-safe. There were to check the box 
surveys every day for seven days and once a week for six weeks 
and three more times after that.
    The CDC published about 40 studies using that data, the 
check the box data in V-safe and these ten million Americans. 
The only really relevant data was, did you seek medical care? 
OK. It only reported in those studies the first week of 
healthcare seeking behavior after the vaccine, litigated for 
two years.
    When we finally got that check the box data from the CDC, 
it showed exactly why the CDC didn't want to produce it to the 
public. It showed that 7.7 percent of the ten million Americans 
who signed up for V-safe--this was in the first six months 
after the vaccine was rolled out. These were the vaccine 
enthusiasts.
    These were not the folks mandating the vaccines. The 7.7 
percent reported needing medical care after getting the 
vaccine, on average, two to three times each. Over 70 percent 
of them was for emergency room, hospitalization, or urgent 
care.
    Mr. Massie. I thank the gentleman from North Dakota. The 
time has expired, and I yield to the gentlelady from Vermont 
five minutes.
    Ms. Balint. I thank you, Mr. Chair.
    Thank you. Thank you all for being here. Appreciate your 
time. One of the things that I think is important about getting 
to the heart of this hearing is getting some clarity on some 
basic facts.
    I know that there's been some implication here in this 
hearing that the vaccine was rushed. It was not tested well 
enough. It was irresponsible. It was dangerous, all kinds of 
dangers implied in that.
    I just want to go through a couple things. Dr. Pavia, I 
want to make sure that I understand it. So, Covid-19 virus was 
a new virus, but it had similar traits to other viruses. Is 
that correct?
    Dr. Pavia. There are seasonal coronaviruses which cause 
mild disease. Then we dealt with SARS-1 and MERS, yes.
    Ms. Balint. OK. So, scientists had studied other 
coronaviruses for about 50 years prior to Covid-19. Is that 
correct?
    Dr. Pavia. That's correct.
    Ms. Balint. Scientists already knew that the spike protein 
could be targeted by a vaccine. That was knowledge that we had 
before the warp speed initiative. Is that correct?
    Dr. Pavia. After SARS-1, the very lethal disease that 
occurred in--I think, 1997 occurred, there was a lot of concern 
that we could see another coronavirus pandemic. The NIH funded 
a lot of research on potential vaccines and treatments.
    Ms. Balint. So, is it true that there was over a decade of 
mRNA vaccine research before Covid-19 that scientists could 
build on?
    Dr. Pavia. I don't remember the exact number of years. 
There was a long track record of work on mRNA vaccines.
    Ms. Balint. After SARS--Conversation-2 was sequenced, it 
took just a couple days is my understanding to make the mRNA 
candidates. Is that correct?
    Dr. Pavia. I can't speak to that. I suspect it was more 
than a few days. It was--
    Ms. Balint. Pretty rapid?
    Dr. Pavia. Because the way mRNA vaccines work, it was 
something that could be done quite quickly.
    Ms. Balint. Do I have this right that the spike protein's 
genetic code was plugged into technology that already existed? 
That technology was not being created in real time. It already 
existed with a process that had already been evaluated for 
other vaccines. So, essentially, we're building on knowledge 
that we had?
    Dr. Pavia. Yes. The knowledge wasn't complete because no 
vaccine had been used on a large scale. Research--there was a 
heavy base of research on which this was begun.
    Ms. Balint. Vaccine developers didn't skill any of the 
testing steps is my understanding but conducted some of the 
steps on an overlapping schedule?
    Dr. Pavia. Yes, my understanding, yes, is that the way the 
timeline was shortened largely was to do things overlapping 
rather than in series.
    Ms. Balint. Appreciate that.
    Dr. Pavia. Dr. Krause has much more detailed knowledge of 
that.
    Ms. Balint. I know throughout the pandemic there was 
misinformation spread that the Covid-19 vaccines used or 
contained microchips or tracking devices. Is there any evidence 
of that?
    Dr. Pavia. Not to my knowledge. I would have multiple chips 
that were transmitting if it were true.
    Ms. Balint. Appreciate that. Now, I served in the Vermont 
State legislature during the Covid-19 crisis. It was a time 
when Democrats and Republicans came together, absolutely the 
leadership on both sides, trying to figure out in real time how 
to keep people safe.
    I took my responsibility very seriously and was grateful 
that we were able to do that in a bipartisan manner. Now, one 
of the things that is difficult, in those situations is that 
there is no medical intervention that carries zero risk. Would 
you agree with that, that no medical intervention is a zero 
risk proposal?
    Dr. Pavia. Of course. Aspirin and Tylenol have substantial 
measurable risks.
    Ms. Balint. I was looking because I was so curious. There 
is a popular pharmaceutical that millions of Americans take and 
the side effects, flushing heading, dizziness, blurred vision, 
nausea, dangerously low blood pressure, back pain, heartburn, 
nose bleeds, chest pain, sudden hearing loss, stroke, 
tightening in hands and feet, tingling, diarrhea, seeing a blue 
tinge, ringing in the ears, rash, shortness of breath, and 
heart attack, all these side effects of Viagra, all of them.
    Dr. Pavia. Sounds correct.
    Ms. Balint. Yet, three million Americans currently on that. 
My point being there are always risks to any medical 
intervention that we take. So, how do public health experts go 
about evaluating and deciding which medical interventions 
should be pursued and at what speed? How do you go about 
determining that?
    Dr. Pavia. It's always a balance of risk versus benefit 
because as you say, there's always a risk to medicines. There's 
your risk to vaccines. The benefit may be modest such as 
treating an annoying problem like eczema. Or it may involve 
millions of lives like a vaccine for Covid.
    So, you balance those risks and how much you know about the 
risks at the time with the potential benefits. We have to 
remember that as you pointed out, these decisions were made on 
the fly during an emergency. It's always possible to look back 
and see flaws that were made because of incomplete data. We all 
admit that things changed as we went and we learned.
    Ms. Balint. I really appreciate that. I don't ever want us 
to forget that over a million Americans lost their lives. We 
have to learn from this.
    We have to have real conversations because there will be 
another pandemic at some point, and we need to do better the 
next time. I really encourage all of us to be grounded in fact. 
Thank you, Dr. Pavia. I really appreciate it.
    Dr. Pavia. Thank you.
    Mr. Massie. The gentlelady yields back.
    It's my understanding that Dr. Vaughn has a plane to catch, 
so after I yield five minutes to the gentleman from Virginia 
you may excuse yourself, Dr. Vaughn, and we appreciate your 
attendance.
    Dr. Vaughn. Thank you, sir.
    Mr. Massie. With that, I recognize the gentleman from 
Virginia for five minutes.
    Mr. Cline. I thank the Chair for holding this very 
important hearing.
    The Covid-19 pandemic was tragic for all Americans, not 
just because of its organic nature as a virus and the thousands 
who died but also due to its significant mishandling by the 
U.S. Government.
    From the teeter-totter of mask and testing mandates to the 
escalating draconian vaccine requirements, for years Americans 
experienced mandate whiplash.
    That's not even mentioning the lack of information about 
the thousands of Americans who were harmed by the vaccine 
including harmed suffering from myocarditis.
    Even worse, the lockdowns like those seen in the 
Commonwealth of Virginia under the previous gubernatorial 
administration of Ralph Northam undoubtedly did more harm than 
good.
    Children missed years of foundational education and social 
skills building. People missed out on life-changing 
celebrations such as weddings and graduations.
    The sick and elderly were separated from their loved ones 
and usually the greatest advocates, families and friends, were 
not able to properly mourn their loved ones as funeral 
gatherings were prohibited.
    The government infliction of mental, emotional, and 
physical trauma experienced by Americans must never happen 
again.
    So, Mr. Siri, as a vaccine litigation expert I want to get 
your opinion on compensation for those injured by the Covid-19 
vaccine.
    As you know, the Covid vaccines are currently covered under 
the Countermeasures Injury Compensation Program and not the 
national Vaccine Injury Compensation Program. Both of these are 
government programs that offer compensation to people who 
experience negative health effects after receiving certain 
medical interventions.
    Whether one believes Covid vaccines should be moved under 
the VICP or not it's clear that the CICP is difficult to 
navigate and is experiencing major backlogs in reviewing and 
completing claims.
    Do you have any recommendations for Congress in ways to 
ensure that the vaccine injured receive appropriate care and 
compensation?
    Mr. Siri. Yes. The simplest way would just be to remove the 
immunity from the companies that make those products. It's now 
been many years that these products have been on the market.
    Everybody here is saying they're safe. A lot of the folks 
who have listened today say they're safe and there should be no 
reason to continue giving those companies the immunity to 
liability for injuries if they are safe, as has been advocated 
here today.
    Behind me is a representative from a group called React19. 
This one group has over 36,000 seriously injured Americans from 
Covid-19 vaccine. It is run by two individuals.
    One was a clinical trial participant in the AstraZeneca. 
One received the Moderna vaccine. He was an orthopedic surgeon, 
had transverse myelitis.
    There are hundreds of medical professionals that are part 
of this group. They're a very serious organization. People 
always tell me the folks who call your firm about vaccine 
injuries they're anti-vaxxers.
    No, I assure you they're not because the folks who have 
issues with the vaccines don't get vaccines. They don't call us 
about vaccine injuries. It's only after they get injured, they 
get gaslit in that way.
    These folks deserve our attention and our sympathy. Every 
person who's injured by a disease, whether it's Covid or any of 
the other diseases mentioned today, we should care about them. 
We should take care of them.
    We should care about every child injured by any infectious 
disease like the doctor here treats. We should also care about 
those injured by vaccine products and we don't.
    The CICP--we currently have a lawsuit--we have two lawsuits 
pending right now seeking to ask--asking a Federal judge to 
declare the CICP program and the PREP Act immunity 
unconstitutional because, to your point, that program has zero 
due process.
    You don't know who your trier of fact is. There's no 
opportunity for a hearing. You don't know anything. It's 
basically a black hole and they only have--and this is another 
thing Congress could potentially address--they only have a few 
million dollars. So, even if they were not constitutionally 
process deficient they don't have any money to pay anybody.
    Mr. Cline. Dr. Vaughn, as a medical provider to some of 
these patients experiencing vaccine injuries, I'm curious to 
know if you've had patients express concerns with the CICP.
    Dr. Vaughn. Absolutely. Most of them are--in some ways 
they're already devastated, and then to have no help and then 
find out that even the help that was set up in the 1980s is not 
even what they can access is quite surprising to them.
    Mr. Cline. Have you had any experience with helping 
patients to navigate the CICP and can you elaborate on your 
experiences as a doctor helping these patients?
    Dr. Vaughn. Mainly, it's just getting the documentation of 
what I see, as well as the lab abnormalities. This basically, 
filling out and fulling up what actually went on so they have a 
legitimate case.
    Mr. Cline. Do you think the fact that the Covid vaccines 
are under the CICP fueled or contributed to vaccine hesitancy 
during the pandemic?
    Dr. Vaughn. Honestly, I don't think anybody knew.
    Mr. Cline. OK. Mr. Siri?
    Mr. Siri. Absolutely. I think that the government needs to 
get out of the business of vaccines.
    There was a lot of discussion here about aspirin, Tylenol, 
and Viagra. You know what the difference is? Those aren't 
mandated by the government. Those aren't told--the government 
doesn't tell you they're safe. They don't tell you to get it.
    By doing that what the government has done is they've put 
now their credibility on the line and if those products cause 
an issue what do they have to do? They have to--you understand. 
Thank you.
    Mr. Cline. Thank you. I yield back.
    Mr. Massie. I thank the gentlemen from Virginia.
    I recognized the gentleman from New Jersey for five 
minutes.
    Mr. Van Drew. Thank you, Chair. Thank you for having this 
hearing.
    It's a good hearing and I wish I was here for part of it in 
the beginning. I wish I could have been here for all that I had 
another Committee hearing where we were doing a markup.
    Before I start, though, Mr. Siri, I want to say you're 
exactly right. I was just going to say the same thing.
    You choose to take Viagra. You choose to take an aspirin. 
You choose to take a Tylenol. You can read the bottle and find 
out what the risks and the benefits are.
    I've been in the healthcare profession for many years. I 
was a practicing dentist until I got here in Congress. By the 
way, dentistry made a lot more sense than Congress does 
sometimes.
    As somebody who cared I care about this issue a lot so I 
thank you for bringing that up.
    I wanted to touch now on the ongoing impact that persistent 
shutdowns and forced vaccinations have had on our two most 
important populations, active-duty military and particularly 
our children under five years old.
    Shutdowns forcing students not to be in school had a 
disastrous impact--the studies show it--on their educational 
levels.
    Some studies show that American children are as much as 
1\1/2\ years behind on topics such as math and reading. Our 
Americans have to compete with the world 1\1/2\ years behind.
    Test scores in these areas are significantly lower with 
other studies showing average scores as much as 20 percent 
lower in grades three through eight.
    Given even--going even younger, social isolation and lack 
of typical early childhood interactions due to pandemic 
shutdowns have led to developmental delays.
    You hear about it if you get out there and talk to the 
professionals. Children born during the pandemic, when compared 
to those scientifically that were born before the pandemic, 
have been found to have noticeably lower scores in language, 
motor skills, and cognitive abilities because of what the 
government did to them.
    The long-term effects to get these children back on track 
are going to require a comprehensive and all-out effort from 
our government for years to come. God help us. I hope we do it.
    I hope we do it better and have a better track record than 
we have had sometimes in the past. What frustrates me the most 
about this? We knew that children had a strong immune 
response--young children--to Covid-19.
    We knew that children were not dying from Covid-19. We knew 
they had a lower risk profile. We knew that and we locked them 
away from school and their friends anyway. They will have a 
much more detrimental impact on these kids than anything Covid 
could have ever done to them.
    There is no greater responsibility for a society--there is 
no greater American responsibility than to take care of our 
children, our young people.
    It was an absolute failure in the way we treated them, and 
it was an absolute failure in the way we treated our young 
children and our sacred responsibility.
    We knew the FDA and the CDC were aware of the vaccine side 
effects of myocarditis and pericarditis in pediatric and 
younger adults that needed a more fulsome evaluation.
    We knew that for young people the risk of taking the 
vaccine outweighed any potential benefits a booster ever could 
have had, and we forced it on them anyway.
    I'd like somebody to explain to me why we did that. For our 
government to know this, to be told about it by their own 
experts, and to still push the release and mandate their use, 
and that's the difference.
    Mandate, force it, had to happen. It's egregious and it's 
an act this government has committed that is worthy of--it's a 
despicable act. A despicable act.
    So, I'm going to ask you quickly, Mr. Siri, please--I 
usually ask a specific question. Just comment on all that for 
me.
    Mr. Siri. When you look at the long arc of history what has 
wrought more harm and destruction to humanity more than 
anything was the government, a central authority, a dictator, 
thinking they know better than you and are going to tell you 
how to live your life and here we see that in action, too.
    When do you need mandates? When you can't persuade on the 
merits. When a government can't persuade you of the merits 
that's when they have to resort to force, to bullying, to 
thuggery, and that's what mandates really constitute.
    If vaccines were safe and effective, you wouldn't need a 
mandate. Because there are questions about their safety and 
efficacy, because there are concerns, that's when the 
government engaged in force. It should never do that.
    There is a time when we're going to want to--CDC will want 
to have the authority to be able to tell the public listen to 
us, trust us, and they're destroying it by constantly pushing 
out mandates.
    Persuade on the merits. That's what informed consent is. 
You inform me, I know the risks and benefit, and I choose 
whether to consent, and when I say no if you mandate over 
that--
    Mr. Van Drew. Mr. Siri, the first thing we learned in 
medical school and dental school when I went there was benefit 
versus risk and then make a decision.
    All medications--yes, they were right over there. They have 
a risk, but you have to hope that the benefit--not hope--you 
have to be sure that the benefit is greater than the risk.
    We didn't know that with these children, in fact, the risk 
was greater than the benefit. It was the wrong thing to do.
    I know I don't have much time left but what we did to our 
military was wrong. You know that 8,000 soldiers--8,000 
soldiers were discharged from the military due to the fact that 
they didn't take the vaccine. Only 50 of them have been 
reinstated.
    It was their right to refuse to take the vaccine. It was 
wrong to do that. It has harmed the military. It's harmed the 
morale.
    Quick comment, Mr. Siri.
    Mr. Siri. One of the greatest honors of my life was to 
bring a class action lawsuit against the Air Force on behalf of 
over 10,0000 members and getting an injunction preventing their 
discharge from the military as well as a case we did we did 
against the Army.
    Our military brass, unfortunately, forgot what it is those 
who serve what they swear to, to defend the Constitution and 
the first right under the First Amendment is the freedom of 
religion, and those that had sincerely held beliefs contrary to 
taking those products the military was willing to just run 
right over them.
    So, we were heartened when a judge ordered that injunction.
    Mr. Van Drew. For political purity we hurt people, we 
killed people and children as well, and that's why this hearing 
is worthy.
    Thank you, Chair. I yield back.
    Mr. Massie. I thank the gentleman from New Jersey. I now 
recognize myself for questions.
    Dr. Pavia, are you a member of the Infectious Disease 
Society of America?
    Dr. Pavia. I am.
    Mr. Massie. Are you an active member?
    Dr. Pavia. I believe so.
    Mr. Massie. Were you a fellow in 2020?
    Dr. Pavia. A fellow is an honorary level. Yes, I was.
    Mr. Massie. Were you a board member at one point?
    Dr. Pavia. That was a number of years ago.
    Mr. Massie. Are you aware that they've taken moneys in 2020 
from AstraZeneca and from Pfizer?
    Dr. Pavia. So, to my knowledge, when IDSA takes money it's 
only into their foundation which is separate from the society 
itself, and the foundation uses that money for educational 
activities.
    Mr. Massie. So, I'm going to submit for the record the 
documents that show that--
    Voice. Without objection.
    Mr. Massie. All right. Mr. Siri, can you tell us about 
Maddie de Garay? Was she a participant in one of these trials 
and how was her case reported?
    Mr. Siri. Maddie de Garay, who we represent--her and her 
family--was one of only about 1,100 children in the Pfizer 12-
15-year-old Covid-19 vaccine clinical trials.
    I pointed out earlier you need to have a separate trial for 
children. When Pfizer--after her second dose she suffered a 
serious injury. She was in the emergency room. She had a 
cascading adverse reaction. She ended up in a wheelchair with a 
feeding tube, and the fact that the vaccine caused an injury, 
it happened. It's tragic.
    Injuries from products happen. Here was what happened--here 
the real incredible part of this story is that when Pfizer 
reported her injury they reported it as functional abdominal 
pain. We know that from a FOIA production that we had to fight 
to get.
    We then told the FDA in four separate letters, hey, 
``Pfizer did not fully inform you about Maddie de Garay's 
injury. She's in a wheelchair. She has a feeding tube.''
    The only thing they told you is she has functional 
abdominal--she has a tummy ache. After four letters over 120 
days later they finally responded, and what did the FDA say?
    They told her to file a VAERS report. She was in the 
clinical trial. A VAERS--which, by the way, she had already 
done months earlier.
    We then sued the FDA for all their communications regarding 
Maddie de Garay in the Southern District of Ohio Federal Court 
and when we finally got those documents here's what we found.
    The FDA did finally ask Pfizer about Maddie de Garay, but 
it was only after somebody who's very, very wealthy emailed 
Janet Woodcock about Maddie de Garay. She then asked Dr. Peter 
Marks and then Peter Marks asks, ``that a request be sent to 
Pfizer.''
    Pfizer responds, and this is the first time as far as we 
are aware that Pfizer ever tells the FDA about Maddie de 
Garay's injuries, and when you read the narrative that was 
provided to the--yes?
    Mr. Massie. What was the response to the FDA or Peter Marks 
when he found out that they had misled them?
    Mr. Siri. He seemed unconcerned, and my understanding is he 
said, well, they reported she had a serious stomach ache.
    So, they reported that she had a serious injury. It was 
basically a whitewash. He sat, as I would expect, as a partner 
with Pfizer defending them from the misconduct.
    He should have been outraged. He should have said, why 
didn't you report this? Irrespective of whether you thought it 
was related you had an obligation to tell us all injuries.
    We decide later what to do with the data, but you have got 
to report it. They didn't report it. I'm not aware of any 
penalty, any issue, with Pfizer about it and when you read the 
internal email chain, which is part, by the way, in the 
document we submitted--we have a link to all those emails, you 
can read them yourself--Pfizer's paid principal investigator 
says he doesn't, quote, ``feel''--``feel,'' that's what he 
writes--``that the vaccine caused the issue,'' and it appears 
that Marks just accepted that.
    Mr. Massie. Whether the vaccine caused the issue or not, 
can you throw somebody out of a trial and not say what happened 
to them in the--
    Mr. Siri. It corrupts the entire process. The idea is that 
you have a new product. You don't know what--how it affects the 
human body, so you take in all harms that occur after 
vaccination. You report all of them. The causality assessment 
happens afterwards, potentially, but you bring them all in and 
it should, as I pointed out earlier, be a statistical 
comparison.
    Here, basically, from what you look--if you look at the 
email chain Marks just goes, oh, ``Pfizer's paid principal 
investigator says he doesn't feel it's related.'' That goes in 
the chain of emails and looks like that's how it dies. No 
reprimands to Pfizer, takes no issue with them, as far as I can 
tell.
    Mr. Massie. So, my final question, have you heard any 
misinformation here today that you want to clear up?
    Mr. Siri. I've heard a number of things that I would 
characterize as misinformation here today.
    For example, I stated that I did not see in any case report 
of a child with no co-morbidities dying of Covid vaccine and I 
believe that was misrepresented as me saying there's never been 
a child, and then the response was, well, there are death 
certificates showing that children died of Covid vaccine.
    Well, you know what? If we're going to accept death 
certificates as proof of a cause of death there are a lot of 
death certificates that say that Covid-19 vaccine caused 
deaths. We get them all the time at our firm.
    I've also heard that it argued that pertussis vaccine stops 
transmission. It categorically does not. The science documents 
are cited in what I've submitted.
    I heard that measles kills one in a hundred people. Before 
the licensure of the measles vaccine in 1963 only about 400 
Americans--that's one in 500,000 Americans--died of measles in 
the United States.
    So, the idea of saying one in a thousand die of measles is 
wrong. There were about four million cases and about 400 
deaths. You could do that math. It's not one in a thousand, and 
that's at a time period where parts of this country were still 
a bit like a developing country where measles can cause harm.
    I heard that--a lot of talk about how vaccines apparently 
reduced--potentially saved--appears to be insinuating millions 
of lives in America from vaccines where the reality is in the 
years--a few years prior to the licensure virtually all the 
vaccines that are currently used by children there were a dozen 
to a few hundred deaths in America from those vaccines that. If 
you add--
    Mr. Massie. From the vaccines or the--
    Mr. Siri. No, sorry. I'm sorry. From the disease itself for 
most of those. There was only a dozen or a few hundred.
    The characterization that there were millions is--if you 
added them all up, the deaths the year before each vaccine in 
the current CDC schedule--putting flu shot aside was highly 
contested--you're lucky if you get to 10,000 deaths.
    Every death is a tragedy but a lot of those happened back 
50-70 years before there was even acute care. It's a total 
mischar-
acterization. When you overstate the benefits that's a danger, 
too. That's misinformation.
    Nobody seems to want to accept that part of the equation. 
Understanding the risk, certainly, a lot of misinformation 
about transmission.
    Look, most schools--required for school don't stop 
transmission. Not me saying--that's what the CDC literature 
says. The inactivated polio vaccine used in the United States 
since year 2000 does not stop transmission--CDC's own words.
    The pertussis vaccine doesn't stop transmission. The 
tetanus vaccine meningococcal--it's all cited in the document I 
provided. I heard discussion by the--
    Mr. Massie. Let's wrap up here.
    Mr. Siri. I'm sorry. I got a long list. I'll stop there. 
I'm sorry.
    Mr. Massie. All right. We're going to close today's hearing 
unless the Ranking Member has a UC.
    Mr. Correa. Mr. Chair, I just wanted to ask. We went over a 
couple of minutes. Can we give Dr. Pavia a couple of minutes to 
address any misstatements he may have heard today?
    Dr. Pavia. Thank you, Mr. Correa. So, I think I heard the 
implication that we mandated vaccine for children. To my 
knowledge, there was no group of people outside of the 
military--nobody under 18 was mandated to get the vaccine.
    Many mistakes were made. The school closure policies--I'd 
be the first to talk about that, and we have published ways to 
keep schools open safely.
    Mr. Siri is a skilled litigator. He's a better arguer and 
he's more eloquent than I am, but many of the things that he 
said are just patently not correct. They are what an advocate 
carefully puts together to represent his clients, which I fully 
respect. Science doesn't look at one side or the other. It 
tries to play straight up the middle.
    Mr. Correa. One minute. Correct the record.
    Dr. Krause. There's no doubt that vaccines cause side 
effects and a lot of people got Covid vaccines and, of course, 
when you give these vaccines to an entire population many 
things happen to those populations and it's hard to know which 
of these things are due to the vaccine and which are not.
    The vaccine safety system is actually a lot more 
complicated than what Mr. Siri said. It's not just a question 
of VAERS and other systems for collecting anecdotal reports.
    What happens then is once those anecdotal reports come in 
if it looks like there might be something that's happening this 
is looked at in more detail in large databases that allow for a 
controlled look at what happened both in people who received 
vaccine and didn't receive vaccine.
    It's, indeed, these kinds of databases that allow us to 
find a side effect like myocarditis, which is much rarer than 
the vaccine safety system would have been able to pick up 
before.
    So, the vaccine safety system is robust. It does find 
things. It's going to take time to figure out for all these 
things which of these side effects are due to the vaccine and 
which aren't.
    In the end, it still comes down to benefit and risk, and I 
would argue that there was very strong benefit with at least 
the primary series of the Covid vaccines and for many people 
the boosters, especially in the elderly and the immuno-
compromised.
    One can argue about the benefit of some of the Covid 
vaccines in some people and including some of the additional 
boosters. Overall, the work that was done to bring the Covid 
vaccine to the American public was, in fact, lifesaving.
    Mr. Massie. Dr. Krause, did you take a booster?
    Dr. Krause. I did not.
    Mr. Massie. OK. Mr. Siri, you were addressed. I want to 
give you five seconds to respond.
    Mr. Siri. Five seconds. There were absolute mandates for 
children. I know because we got an injunction against the San 
Diego School District for requiring the Covid vaccine as well 
as all the school districts California.
    In terms of the post-licensure safety systems, yes, there's 
the vaccine safety data link. There are other ones and we 
address those in the document we provided to Congress. Those 
have serious issues as well and I'll stand on my papers. Thank 
you.
    Mr. Massie. That concludes today's hearing. We thank the 
witnesses for appearing before the Committee today.
    Without objection, all Members have five legislative days 
to submit additional written questions for the witnesses or 
additional materials for the record.
    Without objection, the hearing is adjourned.
    [Whereupon, at 2:05 p.m., the Committee was adjourned.]

    All materials submitted for the record by Members of the 
Subcommittee on the Administrative State, Regulatory Reform, 
and Antitrust can be found at: https://docs.house.gov/
Committee/Calendar/ByEvent.aspx?EventID=117456.

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