Full FDA approval of Pfizer-BioNTech vaccine expected in September

At least 165 million people have received a COVID-19 vaccine through the FDA's emergency use approval, but medical experts said they recognize the lack of full FDA approval may be holding some people back. 

Pfizer-BioNTech submitted its application this summer for full approval and it’s being fast-tracked because of the pandemic. The Pfizer vaccine was the first of three COVID-19 shots the Food and Drug Administration approved for emergency use last winter, and public health experts said that sign-off came after a lot of scrutinies.

"They actually required a very large Phase 3 trial, thirty thousand or more participants, which both Pfizer, Moderna and J & J had to do. They required two extra months of safety data after the clinical trial was done, which is not really normal either," said Dr. Michael Teng, a virologist with USF Health.

The COVID-19 vaccines have been shown to be very effective at preventing severe disease, keeping you out of the hospital and helps prevent the spread of the virus. Teng said the full FDA approval process takes the process up several notches.

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"Normally then when you go for full licensure, you need six months of safety data afterwards and then you look at the accumulating data as it comes in," said Teng. "They collect all of this information. And then Pfizer and Moderna then have started to submit they have what they call rolling submissions. So they collect the data. They submit more data to the FDA. Now, instead of the companies doing the analysis and then giving it to the FDA to check over, the FDA does the analysis."

The FDA is currently reviewing Pfizer’s application for full approval, which including looking at how the vaccines are made, stored, and any reported side effects out of millions of doses. The process usually takes 10 months, but the FDA is doing a priority review for Pfizer within six months because of the pandemic.

"They basically have to read over hundreds of thousands of pages of data and safety and efficacy," said Teng. "It's a lot of work. So they need it pretty much as many people as they can get."

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The White House COVID-19 response team senior policy advisor for equity Dr. Cameron Webb said they realize some people may wait for it. 

"I think that for people, that's the reason why you're not getting vaccinated because you perceive that there's some difference in the level of safety that receives full approval, well, that would make a difference to those folks," said Webb.

Dr. Webb said it’s very likely approval will come soon, and the national effort now is to get more people vaccinated.

"What I continue to stress to folks is that this virus isn't going to wait for that process," said Webb. "But I want to be unequivocally clear. There's nothing experimental about these vaccines. The authorization that they have and the evidence that we have tells us with certainty that they're very safe and very effective."

The shots are for emergencies like a pandemic, and experts said formal approval is the last step.

"I think if that's what you're waiting for, I completely get it. But once it's approved, that means that they've done all their due diligence. They're not cutting corners to get this approval package done," said Teng.

Public health experts said an emergency use for a shot can be revoked, but none of the vaccines currently out have been pulled. Pfizer is expected to get fully FDA-approved in September.