The Highwire with Del Bigtree - HOUSE SUBCOMMITTEE SCRUTINIZES BIDEN COVID RESPONSE

Episode Date: July 3, 2024

Live coverage of the House Judiciary Subcommittee on Administrative State, Regulatory Reform, and Antitrust as they conduct a hearing titled “Follow the Science?: Oversight of the Biden COVID-19 Administrative State Response” with expert testimony from witnesses including ICAN lead attorney, Aaron Siri, Esq.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.

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. Subcommittee 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, quote, stop the spread, end quote. 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.

But the administration's objective from the beginning, 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 survive 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 doubled down 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 boldest 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. 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 12th, 2021. Under normal circumstances,

a BLA takes a year to complete. A fast-track BLA can be ready in about a eight months, which meant full approval by January 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. Gruber and Dr. Krauss strongly supported vaccines and were relied upon by the World Health Organization for guidance and advice 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. Doctors Gruber and Krause reported to Dr. Marks. As we know, vaccine injuries were already being reported in 2021, including instances of myocarditis and healthy young people. Drs Gruber and Kraus 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. Dr. Gruber and Kraus explained that moving the approval date up would mean cutting corners and lowering standards. But Dr. Marks told Acting Commissioner Woodcock that he had Operation Warp Speed to live up to. Then they then removed Dr. Gruber and Dr. Krause from the licensing application review. The top two experts at the FDA taken off of the job because they wouldn't do what the politics wanted them to do.

After the FDA rushed the licensing process and began promoting boosters and expanded the vaccine authorization to include children, doctors 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 Amicron variant despite not having the data to back it up. Take a look. We play the video. Welcome guest. Everyone wishes you would just leave already. That's COVID-19. That's why I got the new updated booster designed to help protect against recent Amicron variants. We'll 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. Mark suggests that there is no harm to fertility, although he actually did not have data to back up the claims. Let's take a look at that video. Pregnant or breastfeeding women can certainly receive a COVID-19 vaccine and should discuss the potential benefit and risks of vaccination with their health care provider. There's currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in either men or women.

If you're pregnant or breastfeeding or might become pregnant in the future, the CDC recommends getting vaccinated. At the time he made that video, he knew that there were reports that the vaccine affected administration cycles of women. In another video, Dr. Mark, Marks talks about reporting of side effects and says there's a mechanism in place to report

injuries. He claims the benefits outweigh the, quote, known and potential risks, unquote. Let's take a look. 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. In FDA's analysis for both the Moderna and Pfizer Bio-N-TEC COVID-19 vaccines, the immune response to the vaccines in each age group of children was comparable to the immune response of the older participants. The immune responses showed the vaccines were effective in preventing COVID-19. The FDA's evaluation and analysis of the effectiveness data of these vaccines was rigorous

and comprehensive. For the Moderna vaccine, we evaluated data for multiple pediatric age groups. For each age group, FDA evaluated effectiveness data based on randomized placebo-controlled studies in which the immune response of children in each age group following two doses of the Moderna vaccine was compared to the immune response of adults aged 18 through 25 who received two higher doses of the vaccine

in a previous similar study, which determined the vaccine to be effective in preventing COVID-19. For the Pfizer-Bio-N-TEC COVID-19 vaccine, the effectiveness data to support the EUA and children six months through four years of age are based on a comparison of immune responses following three doses of the Pfizer-Bio-N-Tec COVID-19 vaccine

to the immune responses among individuals 16 through 25 years of age who receive two higher doses of the Pfizer-Bioentec COVID-19 vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. Please talk to your child's health care provider about any questions you have. Dr. Gruber's full testimony is being entered into the record, but I'm going to share part of it with you now. So I asked Dr. Gruber, so you had given them a September 15th date, which you considered to be, I think, very aggressive compared to prior timelines for other vaccines. Is that correct?

Dr. Gruber said that is correct. And 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 plan? 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 the efficacy study. As I recall, in the efficacy trial, there were adolescents. in 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 a, that's the pediatric research Equity Act, PREA, that is a 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. And that, of course, and 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. And 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 and the EUA. And of course, there were post-EUA surveillance systems in place by the CDC and the FDA. and they showed it was for myocarditis and paracarditis and younger adults, but also adolescents, young males, and 12 to 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? And this is referred to as a post-marketing required studies.

I asked her, and that is a complex in a way different from prior vaccine approvals? Dr. Gruber replied, the difference was that we became aware of this risk of carditis. If there would not have been this information in 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 prescribed. And 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're going to initiate this trial, when they're going to conclude these studies. So this is where review activities were ongoing at that time. And I asked her, and that's part of the timeline that Dr. Marks was asking you to compress.

Dr. Gruber said yes. So our counsel said, so it's fair to say that you were the, it had been raised, I'm sorry, our counsel asked, so that it's fair to say that you were, it had been raised 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 effect 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. FDA and the CD 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. These safety surveillance systems 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 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're deciding

whether to issue a license or not. Dr. Gruber replied, I was never made aware that this is a requirement. And 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 that they were mentioning mandates and this really wasn't part of your job? Dr. Gruber said yes. When you left, 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's Dr. Marks.

And who appointed him, Dr. Woodcock? So Dr. Gruber testified that further testing was required in order 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 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 risks 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's our job in Congress to oversee 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're going to give you more time to study this, he told them to compress the schedule even more. And when they said that compressing the schedule was not possible,

he fired them. He took them off the schedule. the job, assigned them to other duties. The top vaccine officials who've been there for 30 years, taken off the job because they wanted more time to study the effects of the vaccines 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. I want to thank the chairman for holding this most important hearing.

And let me start by saying that vaccines are a true miracle. They have saved at least 150. million lives in the last 50 years. Their 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 his successful Operation Warspeed and was carried through by President Biden. And 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've learned from this, constantly improving their knowledge and applying it quickly. They faced an almost impossible task of battling an emerging, devastating, and rapid, changing crisis. They fought through exhaustion and disappointment, and they explored 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. And time has proven that they made the right decisions in those decisions save millions of American lives. Does that mean mistakes were not made? Of course not.

Can lessons be learned? Absolutely. But 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 and November 2020, the COVID vaccine saved more than 3.2 million lives and kept more than 18.5 million people out of hospitals. These are 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, takes so many people from us. Over 1.1 million to date.

And I remember the morgues overflowing with bodies. The emergency rooms packed and doctors, nurses, and other medical professionals exhausted emotionally and physically. And like all of you at home, I worried about my children, my wife, and my elderly father at home. My wife is an OB-guine doctor working the emergency room. She treated women in the ER room, walking in patients. Patients, walk in patients she'd never seen before. This is before the COVID vaccine. She did her job delivering babies in the middle of 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 will be spared from such a horrible and tragic death. And I heard from friends how relieved they were when they actually got the vaccine. And 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. And make no mistake, in my opinion, this hearing should be about transparency and the decisions made by the FDA and the CDC under very difficult, high pressure. 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're going to hear a lot of information and a lot of misinformation.

Misinformation, the kind that causes unwarranted, 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 hydrocholaroquine. Let me say that again, hydrochloroquine. even if they 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 and effective, caused infertility,

and would increase the likelihood of their deaths or kill them. Fortunately, most Americans didn't listen to this. misinformation. And most disturbingly, some medical professionals made gross misstatements, suggesting that vaccines were worthless because they didn't completely stop the infections. They knowing full well that the vaccines were designed to prevent the worst outcomes by reducing severe disease, hospitalization, and death. These vaccines, successfully reduced 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 erroneous. made statements to be repeated here today. This information has led to reduction in vaccinations, especially among children. And in my opinion, promoting misinformation is a moral, 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, two married, too many parents are now refusing to vaccinate their children. And as a parent, I understand the desire for answers and explanations when something bad happens to our children. It's heartbreaking, 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 in humans beings we owe them protection and that is why we need vaccinations just one example the surge in outbreaks of measles a highly contagious virus that can cause death and many other dangers. In this country, we've gone from nearly 500,000 measles cases in 1963 before the vaccine was approved to under 100 in recent years. In 2000, the year 2000, measles were declared eradicated in the United States. But that could reverse as following vaccination numbers have made measles lot breaks 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. And in 2019, one of the worst years in record since vaccinations become commonplace, there were more than 1,200 measles cases reported, with 90% of the patients being either unvaccinated or who had, an unknown vaccination status, and 10% 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 5 billion plus immunizations given since 2006, let me repeat, of the 5 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 standards since VICP erred on the side of compensation. Mr. Chair, I see today's hearing is an opportunity to write some of the wrongs that occurred during the pandemic.

The 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 life-staving treatments in record time. We have the responsibility to all Americans to shoot down conspiracy theories,

misstatements that can cause grave harm to the American people, especially those that are most vulnerable, are young, our children, and elderly, and those immune compromised. And today, I'm here to do my part. Mr. Chairman, thank you, and with that, I yield. I thank the ranking member, Mr. Correa, and now I recognize Mr. Jordan for his opening statement. I thank the chairman for all his hard work on this issue and for this hearing.

The ranking member just used the term misinformation a couple times in his opening statement. I'll give you misinformation. misinformation. Missinformation 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 mask 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. And misinformation is when the government said it can be from the lab. It has to be a bat to a pangolin, to a hippopotamus, to people,

and then we all get COVID, right? That's misunderstanding. information from our government to the citizens. We're big boys and girls. Give us the stinking truth. And that's what this hearing's about. Why did they want to, 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. And 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.