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How Potential FDA Approval of Pfizer's COVID Vaccine Matters to Investors

Pfizer (NYSE: PFE) and its partner BioNTech (NASDAQ: BNTX) recently announced that they plan to soon file for full U.S. Food and Drug Administration (FDA) approval for their COVID-19 vaccine. The vaccine currently has Emergency Use Authorization. In this Motley Fool Live video recorded on May 5, Motley Fool contributors Keith Speights and Brian Orelli discuss how the potential FDA approval could matter for investors.

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Keith Speights: On Tuesday, the company, Pfizer, said that it plans to file for full FDA approval of its COVID-19 vaccine in the U.S. by the end of May. That's coming up quite quickly. What's the likely timeline for a potential approval for Pfizer's vaccine, Brian, and is this a slam dunk that really won't impact the stock or is it something investors should really watch?

Brian Orelli: Yeah, so the normal review times are 12 months for a standard review, and eight months for priority review that's from the time of submission. Assuming it gets us priority review, which would be pretty typical for an unmet medical need. Since, as you know approved vaccines for COVID-19, that would certainly qualify there. You'd be looking at early 2022.

It certainly could be earlier. The FDA's obviously reviewed a lot of the data for the emergency use authorization. I think you can definitely see the company, the FDA, making a decision a heck a lot quicker than the eight months that they actually have to review the application.

I think the approvals are a foregone conclusion. I don't think it's probably going to move the stock much, but it is an important step because as soon as the pandemic ends, companies that only have an Emergency Use Authorization will no longer be able to sell their vaccines.

You need the full approval to be able to continue to sell it. Who knows exactly when the government's going to declare the pandemic over. Certainly, I don't think it's been happening anytime in the immediate months. May talk about more than a year, but essentially all the companies are going to need to get approval.

And approval might also help make it easier to get approval for variants. They'll likely only have to show antibody production in a small number of patients rather than running a large clinical trial demonstrating protection against the disease. That's what flu vaccines have to do every time they want to change their flu concoction for each individual year as the predominant strain changes. I expect that that will be the same process for the coronavirus.

Speights: This is just a speculative question, Brian, but do you think it's likely that the US government will leave Emergency Use Authorizations in place until at least one of the vaccine makers wins full FDA approval?

Orelli: Oh yeah, and I think probably well beyond that, I mean, I think Pfizer and Moderna will have it next year. I think that then the declaration of the emergency for the pandemic will last way longer than that so yeah. Those two will definitely have full approval before the pandemic is declared over.

Speights: It makes sense that there will be some significant overlap there.

Brian Orelli, PhD has no position in any of the stocks mentioned. Keith Speights owns shares of Pfizer. The Motley Fool recommends Moderna Inc. The Motley Fool has a disclosure policy.


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