Explainer: Why the FDA rejected Pfizer’s COVID vaccine boosters

Sep 20, 2021, 2:50 PM
Pfizer’s COVID vaccine booster...
(Photo by Paul ELLIS / AFP) (Photo by PAUL ELLIS/AFP via Getty Images)
(Photo by PAUL ELLIS/AFP via Getty Images)

The US Food and Drug Administration’s decision to reject Pfizer’s COVID vaccine booster shots for American under 65, at first glance, might appear to be a departure from White House messaging surrounding COVID booster vaccination. President Biden had originally announced that booster shots would be available in September. A local MD breaks down the FDA’s decision.

Dr. Gordon Cohen appeared on KIRO’s Seattle Morning News to contextualize the recent FDA’s decision to reject a plan to administer Pfizer COVID booster shots.

US panel backs COVID-19 boosters only for elderly, high-risk

“Just because some is good doesn’t mean that more is better,” Cohen said. “That’s exactly the question that the FDA was trying to address: Just because we have the vaccine and because we have it available, does giving more of the vaccine mean that it’s going to be more effective than what we’ve given so far? Ultimately, what the science is what the data says, that we don’t have enough data or evidence yet to say that it is necessary. That’s why the FDA came down with the recommendation that they did.”

He applauded the FDA’s decision to stay resilient against political pressure to confirm the booster vaccines.

“I was really happy to see the outcome of the of the panel, because the FDA demonstrated that they are not politically motivated,” Dr. Cohen added. “What the panel found was that there wasn’t enough data to actually justify giving the booster.”

“They were very thoughtful and decisive in their decision making and they didn’t actually just cave into the political desires to give vaccine,” he continued. “This is consistent with what I have been saying all along, which is that this is a public health issue, and it’s not a political issue — the FDA treated it as such.”

The CDC’s Advisory Committee on Immunization Practices is scheduled to meet later this week to make further recommendations on Pfizer’s COVID vaccine booster. Cohen weighed in on how the FDA interacts with the CDC, and what the likely outcome of that committee meeting will be.

“In theory the FDA has the ultimate say,” Cohen said. “The CDC has to follow the FDA’s recommendation because ultimately it’s the FDA that gives the approval for the use of a drug and not the CDC. The CDC can only make recommendations to the FDA.”

To contextualize the problem, he brought up precedent of conflict between the two agencies.

“If we think back when President Trump was in office and Alex Azar was the head of the HHS, there was some discussion back then about the HHS overruling the FDA,” Cohen continued. “My understanding is that ultimately it’s the FDA who gives the approval for the drug, and the CDC can only make recommendations to the FDA as to what they think is necessary or not necessary. I don’t think Dr. Fauci will be ultimately overruling the FDA panel.”

He was asked about recent data which suggests that Pfizer’s lasting immunity wanes faster than other available vaccines, like Moderna’s or Johnson and Johnson’s, and if that data confirms the necessity to administer Pfizer booster shots.

“I think it’s really important to note, and I think it’s important for people here, that the research emphasized that all three vaccines are still providing strong protection against people getting so sick that they end up in the hospital,” Cohen said.

“The investigators who looked at this looked at over 3,000 people who were hospitalized between March and August of this year,” he added. “They found that the Moderna vaccine was actually 93% effective at keeping people out of the hospital, and that protection appears to be holding steady. The Pfizer vaccine didn’t fare quite as well. Their protection fell from 91% effective to 77% effective. The Johnson and Johnson vaccine was 71% effective maybe.”

He offered up some speculation as to why the clinical trials showed a discrepancy between the vaccines’ respective efficacies.

“There’s been a lot of discussion about this because the Moderna vaccine was spaced out by four weeks, whereas the Pfizer vaccine was only spaced out by three weeks,” he noted. “There has been some discussion that maybe we were giving the two vaccines too close together anyway, that they should have been spaced out by two months or even three months, [and] that by giving them just three or even four weeks apart, they were so close together that it really was like giving a single dose. The reasons for this aren’t entirely clear. All we can look at are the statistical outcomes.”

Listen to Seattle’s Morning News weekday mornings from 5 – 9 a.m. on KIRO Radio, 97.3 FM. Subscribe to the podcast here.

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Explainer: Why the FDA rejected Pfizer’s COVID vaccine boosters