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What's the Timeline for FDA Emergency Use Authorization of Coronavirus Vaccines?

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) should know very soon if their coronavirus vaccine candidate BNT172b2 works. The two companies expect to be able to file for Emergency Use Authorization (EUA) 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, Healthcare and Cannabis Bureau Chief Corinne Cardina and longtime Motley Fool contributor Keith Speights discuss the potential timeline for the FDA's EUA process for coronavirus vaccines.

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Corrine Cardina: Let's dig into the timeline a little bit more. Pfizer's CEO, Albert Bourla, has said that they will know if the Pfizer/BioNTech vaccine works by the end of October. Last I checked, we're in October now, so pretty exciting stuff coming up. How long, ballpark, would you say, it'll take the FDA to make a decision once the companies submit their candidate for the Emergency Use Authorization? Are we talking days, weeks, months?

Keith Speights: My personal view is we're probably talking weeks. How many weeks? Who knows? The reason why I say that is, I wouldn't say days and the reason why I wouldn't say days, Corinne, is that the FDA has already said that they plan to have an advisory committee review any of these submissions. So you've got some time lag involved in just convening that advisory committee, getting them together, probably virtually in these days, and having them review the regulatory filings for Emergency Use Authorization, and then they'll make their recommendation. The FDA doesn't necessarily have to accept that recommendation, although I suspect they will in this case, because of just some of the political dynamics at play. My guess is you're going to look at probably several weeks. If I had to guess, I'm going to say at least three weeks, just a guess.

Corrine Cardina: I won't hold you to that.

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

Corrine Cardina: Absolutely. That's kind of the best-case scenario, it sounds like. A matter of maybe up to a month. What would you say would be the worst-case scenario in terms of timeline?

Keith Speights: The worst-case scenario is that the FDA gets an Emergency Use Authorization filing and determines that there's not enough there or maybe there are issues and then it could be back to the drawing board. More testing could be required. If that happens, we could be looking at months and months. The real thing to look for there though is, we have multiple late-stage candidates. So I think the chances that at least one of them is able to get an Emergency Use Authorization is probably pretty good.

Corrine Cardina: Let's hope so.

Keith Speights: Yeah.

Corinne Cardina has no position in any of the stocks mentioned. 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.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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