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Why FDA Approval for Pfizer's COVID Vaccine Would Be a Slam Dunk for the Long Run

By Keith Speights - Updated Jun 24, 2021 at 8:32AM

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There's arguably never been a product with a greater chance of FDA approval.

Pfizer (PFE 1.17%) and BioNTech (BNTX 0.21%) have filed for U.S. Food and Drug Administration (FDA) approval for their COVID-19 vaccine that has already been given to millions of Americans after receiving Emergency Use Authorization (EUA). In this Motley Fool Live video recorded on May 17, healthcare and cannabis bureau chief Corinne Cardina and Motley Fool contributor Keith Speights discuss why this FDA approval could basically be a slam dunk.

Corinne Cardina: Pfizer and BioNTech were the first to receive Emergency Use Authorization from the FDA back in December for their two-dose mRNA vaccine. As of now, more than 61 million people in the U.S. have been fully vaccinated with this vaccine.

Now, the companies have filed for full FDA approval of its COVID-19 vaccine in the population of people 16 and older. The application is on a rolling basis and the company has requested priority review, which if that's accepted, it would set the deadline to be about six months rather than the usual 10. Let's talk about what investors should know about what full approval would mean for Pfizer-BioNTech in the longer-term vaccination efforts in the U.S.

Keith Speights: All right. Well, Corinne, you're right. Pfizer and BioNTech have requested priority review from the FDA. I personally expect that the FDA will grant this priority review to the companies. This status, by the way, is given to drugs or in this case, a vaccine, that could have an especially great impact on the treatment of a disease. I don't think there's any argument that this vaccine doesn't meet that criteria.

I do expect that the FDA is going to give priority review. If the agency does indeed get priority review, then we're probably looking at full FDA approval of the Pfizer-BioNTech vaccine toward the end of this year. I do expect that, practically speaking though, full FDA approval won't mean much from a financial impact for either of these companies.

The vaccine is already on the market under the EUA program. Pfizer and BioNTech are already getting supply deals. The full FDA approval won't really make a difference, unless of course, for some wild reason they didn't win that full FDA approval, then that would make a huge difference. I don't think anyone sees that coming.

Corinne, we usually don't like to say there is such a thing as a slam dunk when it comes to FDA approval. But in this case, this is probably about as close to a slam dunk as you're ever going to get with the FDA.

I just can't imagine a scenario where the Pfizer-BioNTech vaccine would not win full FDA approval. It's been shown to be safe and effective. It's being given to millions of Americans. If the FDA came out and didn't approve this vaccine, this would be one of the biggest healthcare stories of the century.

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.

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