The Food and Drug Administration (FDA) bypassed many of its own protocols to expedite the approval of Pfizer’s second booster dose of the COVID-19 vaccine last week.
Many medical experts, including some who sit on the FDA’s top advisory committee on vaccines, said they had no idea why the agency dropped its standard approval process to allow the fourth dose of vaccine for Americans 50 years and older. The authorization was even more extensive than the pharmaceutical company requested, which was that it be a green light for those aged 65 and over.
The FDA’s Vaccine Vaccine Advisory Committee (VRBPAC) will meet on Wednesday and part of the agenda will cover the fourth dose of vaccine and Israeli research used to demonstrate its effectiveness. Normally, the vaccine licensing process would involve a meeting and a vote by VRBPAC on whether to recommend a license, followed by the FDA chief granting the license. The Vaccine Committee of the Centers for Disease Control and Prevention (CDC) would then vote on how to recommend the vaccine, which would then be decided by the director of the CDC.
Dr. Paul Offit, co-inventor of the rotavirus vaccine and a member of VRBPAC, said he could not explain why the FDA did not present its data to the committee before proceeding with a statement: they are going to do. “
Over the past year, we have a new standard at the FDA: bypassing outside experts who vote on important sources if they indicate a lack of support for what the FDA wants. As we saw with stimulants in young people, the fourth dose in people> 50, and on CDC where counselors are overrated. https://t.co/9Agv2Mwlqk
– Marty Makary MD, MPH (@MartyMakary) April 5, 2022
In an interview with the Daily Caller, Offit expressed concern that the data used to authorize the second promoter could be flawed. The Israeli study examines the results of individuals who received a fourth shot against those who rejected one. Offit explained that this was deficient compared to a randomized, controlled clinical trial.
“It assumes that the person who chooses to receive the fourth dose is just like the person who does not. “But you could argue that someone who chooses to receive another dose is more aware of their health, more likely to exercise, less likely to smoke,” he said.
Dr. Cody Meissner is a pediatric vaccination specialist at Tufts University who also sits on VRBPAC. He similarly could not explain why his insight, along with that of other committee members, was not sought before allowing the fourth dose of Pfizer. (Sung: Co-inventor of the rotavirus vaccine, two former FDA officials take a stand against incentive messages, support natural immunity)
“I have not seen these documents, they have not been submitted to the committee … but this decision has been made and will certainly not be revoked,” he told the Daily Caller. “You would have to ask the Food and Drug Administration why they decided to go ahead and make that particular decision … because again, I have not seen the data.
Like Offit, Meissner shared some skepticism about Israeli data and a total lack of fourth-dose research. “I do not know what all the facts were, which were presented to the FDA, all the data. “Based on what has been found in newspapers that everyone has had the opportunity to see, the numbers are rather small,” he said.
The FDA recently approved the 4th incentive, based on Israeli data.
I reviewed the Israeli data they refer to. If my student ever studied so poorly designed and so poorly, I would recommend that he drop out of college and pursue another profession.
– Dr. Eli David (@DrEliDavid) March 29, 2022
Some analysts who spoke to the Daily Caller said that although the authorization for the fourth shot was expedited and unnatural, it was still a natural decision to continue with the green light. That is not a universal view. In an essay on the Wall Street Journal, Dr. Philip Krause and Luciana Borio argue why most Americans do not need a fourth shot.
Krause and Borio would be the authorities on the case. The former was deputy director of vaccine research and review at the FDA before resigning last year due to political pressure from the Biden administration after more than a decade at the agency. The latter was a former FDA chief scientist.
Dr. Monica Gandhi, an infectious disease specialist at the University of California, San Francisco, who is not a member of the FDA’s Vaccine Committee, said that it is rare for the FDA to go through a permit in this way: from the Advisory Committee on Vaccines and Related Biological Products. It’s rare for the FDA not to consult advisory committees before giving approvals that affect millions of Americans, especially without a randomized study or better data on the needs of younger people like 50 years and older.
It is also incredibly rare for the agency to grant the applicant a broader authorization than it requested, such as authorizing the fourth dose of Pfizer for Americans 50 years and older when the drug giant only asked for approval for those 65 and older. Offit called the decision to make it a “complete shock” to him.
There is always the possibility of having too much of the good. Hurrying to get the fourth dose could be flawed, experts told the Daily Caller. Both Offit and Gandhi independently raised the question of the original antigenic phenomenon – a phenomenon in which the immune system produces a stable immune response aimed at first encountering pathogens, rather than updated strains or variants. It is possible that this process could inactivate variant-specific vaccine doses or booster doses, because the body bases its immune response on the original vaccine dose.
Offit added that there were other possible defects, ranging from running side effects from shots such as fatigue and pain to fatigue of the immune system. There are declining yields in each booster dose, he explained. “The other thing that’s created here, which I think is worrying, is the idea that there’s just no flaw in this, that you can just get stimulation after stimulation after stimulation and there’s no flaw – and I think there is. not true. ”
Gandhi agreed with this view, saying that simply injecting stimulus after stimulus could be the result of not understanding how the immune system actually deals with the coronary heart virus: “Without knowledge of the immune system, this discussion of antibodies alone will make us want to want to promote every 4 months, which is not organizationally feasible and is unprecedented. (Sung: Man investigated after receiving 90 COVID-19 vaccination syringes 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 increase, even though the fourth dose was safe and effective: “We do not see much revolutionary disease in people who are vaccinated properly. , so I’m not quite sure what was the FDA’s motivation … why at this time?
Finally, there are all these concerns, compromises and questions about the need for the kind of material that would be discussed at the VRBPAC meeting that was ahead of schedule. That did not happen and no one who spoke to the Daily Caller could guess why.
“I really can not 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 administration. Ask David Kessler (White House Chief of Staff COVID-19 Response Team),” said Offit.