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Did the FDA Move Too Slowly in Fully Approving the Pfizer-BioNTech Vaccine?

By Keith Speights and Brian Orelli, PhD – Sep 5, 2021 at 8:55AM

Key Points

  • The FDA had to perform a balancing act during the review process for Pfizer and BioNTech's COVID-19 vaccine.
  • For the agency to have moved more quickly would likely have required it to divert resources from reviewing other drugs and vaccines.

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Probably not.

The Food and Drug Administration recently gave full approval to the COVID-19 vaccine developed by Pfizer (PFE -0.52%) and BioNTech (BNTX 1.16%). Some feel that the FDA might have acted too hastily. However, there are also some scientists who have an entirely different view. In this Motley Fool Live video recorded on Aug. 25, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss whether or not the FDA moved too slowly in approving the vaccine.

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Keith Speights: The big news, obviously, from Monday: The FDA gave full approval to the Pfizer-BioNTech COVID-19 vaccine. This full approval was handed down after less than four months of review. That's a lot quicker than it normally takes the FDA to complete a review.

There were some reasons behind that, some pressure. Pfizer and BioNTech are still moving forward with their phase 3 study -- I think it goes through 2023. They're not even finished with the late-stage study. There were some people who are saying, hey, the FDA moved way too quickly here. However, there were some prominent healthcare experts and some big names who had called for an even faster full approval of the COVID-19 vaccine by the FDA.

Brian, that's an interesting angle. Do you think the FDA actually moved too slowly in fully approving the Pfizer-BioNTech vaccine?

Brian Orelli: I think there's probably a sweet spot here. Part of the benefit of issuing a full approval is that people will now get vaccinated, because it's undergone a more thorough review and there's been more safety data than we had when it just had emergency use authorization.

If the FDA went too fast, I think some of that benefit actually would have been lost. So while yes, maybe more people get vaccinated earlier, there's probably also some people who say, "Oh, they're still rushing," and so taking longer is actually maybe better.

Then the other thing is, there's a resource issue. The agency could have gone faster almost certainly, but it would have had to pull people away from reviewing other drugs and vaccines, and giving advice on clinical trials to companies that are still in the process of developing their drugs, and all the other things that the FDA does. As a biotech investor in a lot of other companies that have nothing to do with vaccine manufacturing, I'm happy that they didn't give Pfizer and BioNTech too many resources.

Speights: The bottom line here is, you think this was a "Goldilocks," about right, in terms of how fast the FDA moved?

Orelli: Yeah, exactly. It's hard to tell, but I feel like it was the appropriate speed.

Speights: Yeah. I think for those who think that the FDA moved too quickly, it is important to realize that Pfizer and BioNTech had already filed the EUA submission. The FDA has seen previous data. This didn't require as much review as a normal FDA approval would have, because they had already seen a lot of the data.

Orelli: Right. They looked at the same amount of data, but they had already looked at a lot of it before that. It was also a rolling submission, so Pfizer was handing them parts of the full data package as Pfizer and BioNTech completed it, and so that obviously helped speed up the submission.

Speights: It certainly didn't hurt the case that 160 million-plus Americans have already received vaccines. Many of those were the Pfizer-BioNTech vaccine. The safety issues have been very rare so far.

Keith Speights owns shares of Pfizer. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Pfizer Stock Quote
Pfizer
PFE
$49.23 (-0.52%) $0.26
BioNTech Se Stock Quote
BioNTech Se
BNTX
$165.50 (1.16%) $1.89

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