WASHINGTON The Select Subcommittee on the Coronavirus Pandemic held a hearing titled Assessing Americas Vaccine Safety Systems, Part 1 to examine the effectiveness of vaccine safety reporting and injury compensation systems following the rollout of the COVID-19 vaccine. Biden Administration officials from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Health Resources and Services Administration (HRSA) all testified that Americas vaccine injury and compensation systems have serious deficiencies related to inadequate staffing, lackluster surveillance, and overlapping programs. Select Subcommittee Members pointed out the false narrative about the efficacy of the COVID-19 vaccine and pressed witnesses to explain potentially politically motivated decision making during the pandemic. This hearing served as part one of a two-part series. The second hearing will emphasize the importance of the doctor-patient relationship in order to obtain public trust in vaccines during a future public health crisis.
Key Takeaways
The Biden Administration mandated the COVID-19 vaccine without a sufficient system in place to compensate individuals injured by the policy.
HRSA Director at the Division of Injury Compensation Programs CDR George Reed Grimes: At the beginning of the COVID 19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff.
The FDA accelerated the COVID-19 vaccine approval process to seemingly meet arbitrary mandate timelines set by the Biden Administration.
Executive branch officials from the CDC and FDA agree that the federal government can never guarantee a vaccine is 100% safe.
Chairman Wenstrup: Is any pharmaceutical 100% safe?
FDA Director at the Center for Biologics Evaluation and Research, Dr. Peter Marks: No pharmaceutical is 100% safe.
CDC Director at the National Center for Emerging and Zoonotic Infectious Diseases, Dr. Daniel Jernigan: No medical intervention is risk-free.
CDR Grimes: Theres a reason we have a compensation program, and were dedicated to diligently carrying that out. I cant say it any better than my colleagues sitting next to me have.
Vaccine injury reporting and compensation systems were not prepared to handle the avalanche of injury claims caused by the COVID-19 vaccine.
Dr. Peter Marks: We tried to be prepared for that, but the avalanche of reports was tremendous. It, again, required re-tasking people on the flyWe had to usually staff up and had many meetings working to increase our ability to go through these reports.
Shortcomings in vaccine injury reporting and vaccine compensation systems, as well as ineffective government messaging during the pandemic, deteriorated public trust in vaccine safety.
Dr. Peter Marks: We probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus whats in VAERS.
Member Highlights
Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-Ohio), D.P.M, argued that advancing an accurate narrative about the COVID-19 vaccine through doctor-patient relationships during the pandemic would have decreased misinformation and disinformation.
Chairman Wenstrup: I want everyone to understand, especially those serving on the government side that the public perception becomes reality. And because of that, words matter. Words matter that are coming out, you know. For those of us as Members of Congress or as physicians at home, were face to face with people. We are sitting face to face with somebody. Were not just looking at data on a sheet and making decisions. It needs to be done, what youre doing, but theres a difference and thats why I say words matter. Let me give you an example. When you say safe and effective, thats relative in your mind. Its relative in your mind, but its not to the person at home. They hear 100% safe and 100% effective. Thats what they hear. This is why words matter. Dr. Fauci, in his testimony, even said, you can never say that any treatment is 100% safe. Yet, in essence, thats what people heard and are still hearing today. Weve got to change that because the doctor on the ground or the Member of Congress on the ground is one on one with somebody and explains that to them.
Let me tell you, Im grateful we live in a country that has these systems (vaccine injury reporting and compensation systems) in place because theyre there to protect the American people and to provide for better health in America. But theres ways we can do better.
Committee on Oversight and Accountability Chairman James Comer (R-Ky.) pressed FDA Director Dr. Peter Marks to admit he ignored warnings from his colleagues about the dangers of accelerating the COVID-19 vaccine approval process. Chairman Comer further noted that the timing of the Biden Administrations vaccine mandate and the FDAs rushed approval of the vaccine appear to correlate.
Chairman Comer: Why were you pressuring the doctors and then removing them from the approval process when they disagreed?
Dr. Marks: The approval process was one that needed to move as rapidly as possible.
Chairman Comer: Do you recall any conversations regarding the need to approve the vaccines in order for it to then be mandated?
Dr. Marks: There was an acknowledgment that an approval could allow vaccine mandates to occur.
Chairman Comer: So, Dr. Gruber wrote that you and Dr. Woodcock expressed your opinion that absent a license, states cannot require mandatory vaccination. Do you recall this conversation?
Dr. Marks: I dont know what youre what youre referring to, but theres probably, its just a statement of fact that once you have a license, vaccine and mandate could be placed.
Chairman Comer: Do you recall seeing safety signals regarding myocarditis in young men during this time?
Dr. Marks: There were yes. There were safety signals known and they were placed on the label.
Chairman Comer: Did you express your desire to approve the vaccine by August 20th?
Dr. Marks: I did.
Chairman Comer: And it was ultimately approved on August 23rd. Correct?
Dr. Marks: Correct.
Chairman Comer: And just for the record, the military mandate was issued on the 24th. And that is interesting timing.
Rep. Rich McCormick (R-Ga.), M.D., argued that the federal government wrongly inserted itself in the doctor patient relationship during the COVID-19 pandemic. This created a lack of trust between Americans and their public health system.
Rep. McCormick: When you insert yourself between a doctor and a patient, and some doctors contradict you and you censor them, even when youre not a doctor treating patients, people are going to say, why does the government have authority to do that, to censor my doctor? And then secondly, when you start requiring people to do something instead of encouraging the natural resistance of a freedom-loving people that were founded on those principles, will be to resist what youre requiring. So, it shouldnt be any surprise to us when the people say, Im not going to do what youre telling me I have to do when my doctor may agree with me and not you. Youre the government. Why do they insert themselves in inappropriate ways?
And really, when we talk about the evolution of science, when you have immunity and youre still requiring a vaccination that can cause a hyper-immune response, which were all scientists, we can admit to, theres risk versus benefit on every decision. When the government says were going to make a carte blanche requirement without taking science into account, its no wonder people are mistrustful of our recommendations.
Rep. Debbie Lesko (R-Ariz.) demanded FDA Director Dr. Peter Marks explain why the publicly reported data on vaccine injuries differs significantly from the confirmed death and injury count available to FDA officials.
Rep. Lesko: We spoke over the phone back on August 10th of 2021, and I was asking about VAERS because I had lots of constituents reaching out to me saying there were tons of adverse effects, there were thousands of deaths, etc., and they were very concerned. And I asked how many were confirmed. And at that time, you said four. There were four cases that you confirmed deaths that were caused by the vaccine. I suggested, at that time, that the CDC and FDA do a better job of telling the public not just how many cases were reported, but how many were actually confirmed. And just if I heard you right, just recently, you said, well, we dont want to give out too much information because of privacy rights. But certainly, we could put out how many were confirmed deaths, couldnt we?
Dr. Marks: I fully agree with you that we probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus whats in VAERS. In fact, we just nearly fell prey to it here at this hearing.
Rep. Lesko: It seems very logical to me that if youre saying the public shouldnt count on VAERS because anybody can report to that, which they can, why wouldnt you as actively report to the public well, we confirmed this really low number of cases that actually were caused by vaccines. I mean, its been years now. Why? Why havent you done it?
Dr. Marks: We did present that in various settings, including at, I believe, at the Advisory Committee on Immunization Practices. It was mentioned at our vaccine advisory committee. It perhaps did not go as broadly.
Rep. Mariannette Miller-Meeks (R-Iowa), M.D., uncovered evidence that the COVID-19 vaccine was mandated for healthy Americans and U.S. service members without a sufficient system in place to compensate those harmed by the coercive policy.
Rep. Mariannette Miller-Meeks: I understand that theres a current backlog of claims in CICP, by about more than 10,000. Why is there a backlog of claims for the COVID 19 vaccines?
CDR Grimes: At the beginning of the COVID 19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff. When we received our first direct appropriation in fiscal year 2022, we were able to ramp up quickly and now we have over 35 staff who are assisting to adjudicate claims.
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