Last week, the Food and Drug Administration (FDA) circumvented many of its own protocols to expedite permission to administer a second booster dose of the Pfizer COVID-19 vaccine.
Many medical experts, including some on the FDA’s main vaccine advisory committee, said they did not know why the agency missed its usual approval process to allow a fourth dose of the vaccine for Americans age 50 and older. Authorization was even broader than requested by the pharmaceutical company, namely for individuals 65 years of age and older.
This vaccine group of the FDA, the Advisory Committee on Vaccines and Related Biologicals (VRBPAC), is meeting on Wednesday, and part of the agenda will be a discussion of the fourth dose of the vaccine and Israeli studies used to demonstrate its effectiveness. Typically, the vaccine authorization process involves a meeting and a VRBPAC vote on whether to recommend a permit, and then the FDA head gives that permission. The Vaccine Committee of the Centers for Disease Control and Prevention (CDC) will then vote on how to recommend the vaccine, which will then be determined by the CDC director.
Dr Paul Ofit, co-inventor of the rotavirus vaccine and a member of the VRBPAC, said he could not explain why the FDA did not present its data to the committee first before moving on to the permit: “It works here so the government they are going to do ”.
Over the last year, we have a new rule in the FDA: bypassing the voting of external experts on important authorizations, if they show a lack of support for what the FDA wants. As we have seen with boosters in young people, the 4th dose in people> 50, and in the CDC, where counselors are redundant. https://t.co/9Agv2Mwlqk
– Marty Makary, MD, MPH (@MartyMakary) April 5, 2022
In an interview with the Daily Caller, the Office expressed concern that the data used to authorize the second booster could be inaccurate. Israeli studies are examining the results of those who received the 4th injection, against those who refused it. Ofit explained that this is not enough compared to a randomized controlled clinical trial.
“This suggests that someone who decides to get a fourth dose is similar to someone who doesn’t. But you can say that those who decide to take another dose are more attentive to their health, more likely to exercise, less likely to smoke, ”he said.
Dr. Cody Meissner is an expert on child vaccination at Tufts University, who also works at VRBPAC. He also failed to explain why his understanding, as well as other committee members, was not required before allowing the fourth dose of Pfizer. (RELATED: Co-inventor of rotavirus vaccine, two former FDA officials oppose strengthening mandates, support innate immunity)
“I did not see this data, they did not bring it to the committee … but this decision was made and, of course, will not be overturned,” he told the Daily Caller. “You should have asked the FDA why they decided to go ahead and make that particular decision … because again, I haven’t seen the data.”
Like Ofit, Meissner shared some skepticism about Israeli data and a general lack of research on the fourth dose. “What all the facts were presented to the FDA, all the data, I don’t know. From what was available in the press that everyone had a chance to see, the numbers are quite small, ”he said.
The FDA has just approved the 4th booster, based on Israeli data.
I have reviewed this Israeli data to which they refer. If my student ever undertakes research so poorly planned and so poorly executed, I would recommend them to leave university and get another profession.
– Dr. Eli David (@DrEliDavid) March 29, 2022
Some experts who spoke to the Daily Caller said that although the resolution on the fourth shot was hasty and abnormal, it was still a wise decision to give it the green light. This is not a universal opinion. In an article in the Wall Street Journal Drs. Philippe Krause and Luciana Boria have argued why most Americans do not need a fourth shot.
Krause and Borrio would be authorities in this matter. The former was deputy director of vaccine research and review at the FDA before resigning last year amid political pressure from the Biden administration after more than a decade at the agency. The latter was previously an Acting Chief Scientist at the FDA.
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 the FDA rarely obtains approval in this way: “I am concerned that the FDA Committee on Vaccines and Related Biological Products. It’s rare for the FDA not to consult with advisory committees before granting permits that affect millions of Americans, especially without randomized research or better data on the need for a younger population of 50 and older. “
It is also incredibly rare for an agency to give an applicant more permission than it requested, such as permission for a fourth dose of Pfizer for Americans aged 50 and older, when the pharmaceutical giant requested approval only at age 65 and older. Ofit said the decision to do so “completely shocked” him.
There is always the opportunity to have too much good. The rush to get a fourth dose could have downsides, Daily Caller experts said. Both Ofit and Gandhi independently raised the issue of original antigenic sin – a phenomenon in which the immune system constantly produces an immune response aimed at the first encounter with a pathogen, rather than updated strains or variants. It is possible that this process may make ineffective dose-specific vaccines or boosters ineffective because the body bases its immune response on the initial dose of the vaccine.
Ofit added that there are other possible drawbacks, from the usual side effects from injections such as fatigue and pain, to depletion of the immune system. He explained that the return of each booster dose decreases. “The second thing that’s being created here, which I think is a concern, is the view that there’s just no downside, that you can just get a booster behind the amp, and there’s no downside – and I don’t think this is true. ”
Gandhi echoed these sentiments, saying that simply booster after booster could be the result of a misunderstanding of how the immune system actually copes with the coronavirus: “Without knowledge of the immune system, this discussion of antibodies alone will lead us to want to increase every 4 months unprecedented. ” (RELATED: Man under investigation after allegedly receiving 90 vaccines against COVID-19 for sale of vaccination cards in Germany)
For his two cents, Meissner said it’s not entirely clear that there’s even a widespread need for further stimulation, even if the fourth dose is safe and effective: “We don’t see a lot of breakthrough diseases in people who are properly immunized, so I’m not quite I’m sure that motivated the FDA … why at this time? “
After all, all these issues, trade-offs and issues of necessity are the topics that will be discussed at the VRBPAC meeting, which will precede the authorization. That didn’t happen, and no one who spoke to the Daily Caller could guess why.
“I can’t answer the question exactly. The question is good, but I can’t explain it, ”Meissner said.
“I don’t know. Ask the FDA. Ask the Biden administration. Ask David Kessler (Chief Research Officer of the White House COVID-19 Response Team), ”Ofit said.