[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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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.
[all]