What is the timeline for the FDA’s emergency use authorization for coronavirus vaccines?

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Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) should know very soon if their BNT172b2 coronavirus vaccine candidate works. The two companies plan to be able to file an emergency use authorization (EUA) application with the Food and Drug Administration by the third week of November. How long will it take the FDA to make a decision? In this Fool Live video, Corinne Cardina, head of the health and cannabis office, and Keith Speights, longtime Motley Fool collaborator, discuss the potential timeline for the FDA’s EUA process for coronavirus vaccines.

Corrine Cardina: Let’s explore the timeline a little more. Pfizer CEO Albert Bourla said they would know if the Pfizer / BioNTech vaccine works by the end of October. Last time I checked, it’s October now, so some pretty exciting stuff to come. How long, would you say, it will take the FDA to make a decision after companies submit their candidate for emergency use authorization? Are we talking about days, weeks, months?

Keith Speights: My personal opinion is that we are probably talking about weeks. How many weeks? Who knows? The reason I say this is, I wouldn’t say days, and the reason I wouldn’t say days, Corinne, is that the FDA has already said they are planning an advisory committee to review the one of those submissions. So it takes a while for you to just convene this advisory committee, bring it together, probably virtually these days, and ask it to review the regulatory emergency use authorization files, and then it will make its recommendation. The FDA doesn’t necessarily have to accept this recommendation, although I suspect it will in this case, due to some of the political dynamics at play. I guess you’re probably going to be looking at several weeks. If I had to guess, I’ll say at least three weeks, just a guess.

Corrine Cardina: I won’t hold it against you.

Keith Speights: Yeah, don’t hold me back. I wouldn’t say it’s going to go on for months and months, because the FDA is also under a lot of pressure to try to make a vaccine available to Americans, if they are convinced it is safe and effective. My best guess is several weeks. I think at least three weeks. We could look at six weeks. I don’t know, but I don’t think it will be five days or five months.

Corrine Cardina: Absolutely. It’s kind of the best of times, it looks like. A matter of maybe up to a month. What do you think would be the worst-case scenario in terms of timing?

Keith Speights: Worst case is that the FDA gets an emergency use authorization filing and determines that there isn’t enough of it or maybe there are issues, then it could be back. to the drawing board. Further testing may be necessary. If that happens, we could look at months and months. The real thing to look for there is that we have several late applicants. So I think the chances of at least one of them being able to get emergency use authorization are probably pretty good.

Corrine Cardina: Let’s hope so.

Keith Speights: Yeah.



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