Many medical experts, including some on the FDA’s top vaccine advisory board, said they had no idea why the agency had skipped the normal approval process to approve the fourth vaccine for Americans 50 and older. The authorization was even broader than what the pharmaceutical company was asking for, which was to give the green light to people aged 65 and over. This group of FDA vaccines, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), meets on Wednesday and part of the agenda will be to discuss the fourth dose of the vaccine and the Israeli studies used to demonstrate its effectiveness. Typically, the vaccine approval process would involve a meeting and vote by the VRBPAC on whether to propose the approval, followed by the head of the FDA granting that authorization. The Vaccine Committee of the Centers for Disease Control and Prevention (CDC) will then vote on how the vaccine will be administered, which will then be determined by the director of the CDC. Dr Paul Offit, co-inventor of the rotavirus vaccine and a member of the VRBPAC, said he could not explain why the FDA did not present his data to the committee before proceeding with the authorization: “The way it works here is that the government is simply states that this is what it’s going to do. “ In the last year, we have a new rule in the FDA: bypass external experts who vote for major powers if they indicate a lack of support for what the FDA wants. As we have seen with boosters in young people, 4th dose in people> 50 and at the CDC where counselors predominate. – Marty Makary MD, MPH (@MartyMakary) April 5, 2022 In an interview with the Daily Caller, Offit expressed concern that the data used to approve the second amplifier may be defective. Israeli studies examine the results of people who received a 4th shot versus those who refused. Offit explained that this is missing compared to a randomized, controlled clinical trial. “This assumes that someone who chooses to take a fourth dose is just like someone who does not. “But you could argue that someone who chooses to take another dose is more careful about their health, more likely to exercise, less likely to smoke.” Dr. Cody Meissner is a child vaccination specialist at Tufts University, who also participates in VRBPAC. Likewise, he could not explain why his insight, along with the other members of the committee, was not sought before approving the fourth installment of Pfizer. (RELATED: Rotavirus vaccine co-inventor, two former FDA officials oppose aid orders, support natural immunity) “I have not seen this data, they have not brought it to the committee; but this decision has been made and it will certainly not be overturned,” he told the Daily Caller. “You have to ask the FDA why they decided to go ahead and make that particular decision; why again, I have not seen the data.” Like Offit, Meissner shared some skepticism about the Israeli data and the overall lack of studies on the fourth tranche. “I do not know what all the facts were, presented to the FDA, all the data. “From what was available to the press that everyone had the opportunity to see, the numbers are very small,” he said. The FDA has just approved the 4th amplifier, based on Israeli data. I looked at these Israeli data to which they refer. If one of my students ever did a study so poorly designed and so poorly performed, I would advise him to drop out of college and pursue another profession. – Dr. Eli David (@DrEliDavid) March 29, 2022 Some experts who spoke to the Daily Caller said that although the authorization for the fourth shot was hasty and abnormal, it was a sensible decision to go ahead with the green light. It is not a universal view. In an article in the Wall Street Journal, Dr. Philip Krause and Luciana Borio explain why most Americans do not need a fourth shot. Krause and Borio would be the starting point. The former was deputy director of vaccine research and review at the FDA before resigning last year amid political pressure from the Biden government after more than a decade at the agency. The latter was previously acting chief scientist at the FDA. Dr Monica Gandhi, an infectious disease expert at the University of California, San Francisco, who is not on the FDA Vaccine Committee, said it was rare for the FDA to authorize this way: the contribution of the Advisory Committee on Vaccines and Related Biological Products. “It is rare for the FDA not to consult advisory committees before making approvals that affect millions of Americans, especially without randomized trials or better data on the need for younger populations aged 50 and over.” It is also incredibly rare for an organization to grant an applicant a wider authorization than he or she requested, such as the approval of the fourth dose of Pfizer for Americans aged 50 and over, when the drug giant only applied for approval for those aged 65 and over. Offit said the decision to do so “shocked him”. There is always the possibility of having too much of a good thing. The rush to take a fourth dose could have its downsides, experts told the Daily Caller. Both Offit and Gandhi independently raised the issue of original antigenic sin – a phenomenon in which the immune system constantly produces an immune response that targets the first encounter with a pathogen, rather than updated strains or variants. It is possible that this procedure could make vaccine-specific doses or boosters ineffective because the body bases its immune response on the initial dose of the vaccine. Offit added that there are other possible disadvantages, from side effects beyond injury, such as fatigue and pain to depletion of the immune system. There are declining yields in each booster dose, he explained. “The other thing that comes up here, which I think is worrying, is the idea that there is simply no downside to this, that you can just take amplifiers after amplifiers and there are no downsides – and I do not think that is true. ” Gandhi echoed this sentiment, saying that simply picking up transmission memories may be the result of a lack of understanding of how the immune system actually treats the coronavirus: “Without the knowledge of the immune system, this discussion only about antibodies lead to it being strengthened every 4 months, something that is not materially feasible and is unprecedented “. (RELATED: Search for a man after allegedly getting 90 vaccines for COVID-19 to sell vaccination cards in Germany) For his two cents, Meissner said it was not entirely clear that there was even a widespread need for further reinforcement, even if the fourth dose was safe and effective: “We do not see many pioneering diseases in people who are properly immunized, so “I’m pretty sure what pushed the FDA…… why right now?” Ultimately, all of these concerns, exchanges, and necessity issues are the kinds of issues that will be discussed at the pre-approval VRBPAC meeting. That did not happen and no one who spoke to the Daily Caller could guess why. “I can not really answer the question. “The question is good, but I can not explain it,” said Meissner. “I do not know. Ask the FDA. Ask the Biden government. Ask David Kessler (the White House Chief of Staff for COVID-19),” said Offit.
