The Food and Drug Administration (FDA) bypassed many of its own protocols to expedite approval of Pfizer’s second booster dose of COVID-19 vaccine last week.
Several medical experts, including some who sit on the FDA’s top advisory committee on vaccines, said they have no idea why the agency skipped its normal approval process to approve the fourth vaccine dose for Americans age 50 and older. The approval was even broader than requested by the pharmaceutical company, namely to give the green light to people aged 65 and over.
The FDA’s vaccines body, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), meets Wednesday, and part of the agenda will be discussing the fourth dose of the vaccine and the Israeli studies being used to prove its effectiveness. Typically, the vaccine approval process would involve a meeting and vote by VRBPAC on whether to recommend approval, followed by the FDA Director granting that approval. Then the Centers for Disease Control and Prevention (CDC) vaccine committee would vote on how to recommend the vaccine, which would then be determined by the CDC director.
dr Paul Offit, a co-inventor of the rotavirus vaccine and a member of VRBPAC, said he couldn’t explain why the FDA didn’t first submit its data to the committee before proceeding with approval: “The way it’s working here, is that the government is basically just stating that they will do it.”
Over the past year, we’ve introduced a new norm at the FDA: Bypass outside experts who vote on important approvals if they indicate a lack of support for what the FDA wants. As we’ve seen with booster shots in young people, 4th doses in people over 50, and at the CDC where counselors are overruled. 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 approve the second booster could be inaccurate. The Israeli studies examine the outcomes of people who received a fourth injection versus those who refused one. Offit explained that this is lacking compared to a randomized controlled clinical trial.
“That assumes that someone who decides to take a fourth dose is the same as someone who doesn’t. But you could argue that someone who chooses a different dose is more mindful of their health, more likely to exercise, and less likely to smoke,” he said.
dr Cody Meissner is a child immunizations expert at Tufts University who is also a member of VRBPAC. Nor could he explain why his insight, along with the other committee members, was not sought before Pfizer’s fourth dose was approved. (RELATED: Rotavirus vaccine co-inventors, two former FDA officials oppose booster regulations and support natural immunity)
“I haven’t seen that data, they haven’t presented it to the committee … but that decision was made and certainly won’t be reversed,” he told the Daily Caller. “You’d have to ask the FDA why they decided to make that particular decision… because again, I haven’t seen the data.”
Like Offit, Meissner shared some skepticism about the Israeli data and the general lack of fourth-dose studies. “What was all the facts that were presented to the FDA, all the data, I don’t know. From what’s available in the press for everyone to see, the numbers are pretty small,” he said.
The FDA just approved the 4th booster based on Israeli data.
I checked these Israeli data to which they refer. If any of my students ever pursue a course so poorly designed and so poorly executed, I would recommend that they drop out of college and pursue another career.
– dr Eli David (@DrEliDavid) March 29, 2022
Some experts who spoke to the Daily Caller said that while approval for the fourth shot was hasty and unusual, it was still a sensible decision to give it the green light. This is not a universal opinion. In a Wall Street Journal op-ed, Dr. Philip Krause and Luciana Borio argue why most Americans don’t need a fourth shot.
Krause and Borio would be experts in this area. The former was deputy director of vaccine research and review at the FDA before resigning last year after more than a decade with the agency under political pressure from the Biden administration. The latter was formerly acting chief scientist at the FDA.
dr Monica Gandhi, an infectious disease expert at the University of California, San Francisco, who doesn’t sit on the FDA’s Vaccines Committee, said it’s rare for the FDA to push through an approval this way: “I’m concerned about FDA manufacturing Decisions on booster vaccinations without input from the Advisory Committee on Vaccines and Related Biological Products. It’s rare that the FDA doesn’t consult advisory committees before granting approvals that affect millions of Americans, especially without a randomized trial or better data on needs for younger populations like 50 and older.”
It’s also incredibly rare for the agency to give an applicant broader approval than they asked for, such as: For example, Pfizer’s fourth-dose approval for Americans age 50 and older, when the pharmaceutical giant only applied for an approval for people age 65 and older. Offit said he was “completely shocked” by the decision to do so.
There is always the possibility of having too much of a good thing. The fourth-dose rush could have downsides, experts told the Daily Caller. Both Offit and Gandhi independently addressed the problem of antigenic original sin – a phenomenon in which the immune system continually produces an immune response that targets the first encounter with a pathogen, rather than updated strains or variants. It is possible that this process could render variant-specific vaccine doses or booster doses ineffective because the body bases its immune response on the original vaccine dose.
Offit added that there are other potential downsides, from common side effects of the shots like fatigue and pain to immune system depletion. There are diminishing returns from each booster dose, he explained. “The other thing that’s being created here that I think is worrying is the idea that there’s just no downside, that you can just get boost after boost after boost and there’s no downside – and I don’t think there is that’s right. ”
Gandhi echoed this opinion, saying that simply pumping in booster after booster could be the result of a misunderstanding of how the immune system actually deals with the coronavirus: “Without knowledge of the immune system, just this discussion of antibodies will make us want to all.” 4 months to boost, which is logistically unfeasible and unprecedented.” (RELATED: Man probes after allegedly receiving 90 COVID-19 vaccine shots to sell vaccination cards in Germany)
For his two cents, Meissner said it’s not entirely clear if there’s even a widespread need for another boost, even if the fourth dose is safe and effective: “We don’t see many breakthroughs in people who are adequately immunized, so I’m not exactly sure what motivated the FDA…why at this point?”
Ultimately, all of these concerns, trade-offs, and questions of necessity are the sort of issues that would be discussed at the VRBPAC meeting that would precede approval. That didn’t happen, and no one who spoke to the Daily Caller could figure out why.
“I can’t really answer the question. The question is good, but I can’t explain it,” said Meissner.
“I don’t know. Ask the FDA. Ask the Biden administration. Ask David Kessler[thechiefscienceofficeroftheWhiteHouseCOVID-19responseteam],” Offit said.