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Will Pfizer and BioNTech Win Authorization for Boosters for All Adults?

By Keith Speights and Brian Orelli, PhD – Updated Nov 19, 2021 at 11:56AM

Key Points

  • Pfizer and BioNTech are seeking U.S. authorization for COVID-19 vaccine boosters in all adults ages 18 and up.
  • If the FDA focuses on preventing infections, Emergency Use Authorization (EUA) is likely.
  • If the FDA focuses on preventing severe disease, the prospects for EUA are much more uncertain.

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Yes -- if the FDA focuses on protection against coronavirus infection.

Pfizer (PFE -1.04%) and BioNTech (BNTX 0.79%) already have U.S. Emergency Use Authorization (EUA) for their COVID-19 vaccine boosters for some Americans. The two companies now hope they'll be able to win EUA for boosters in all adults ages 18 and older. In this Motley Fool Live video recorded on Nov. 10, Motley Fool contributors Keith Speights and Brian Orelli discuss Pfizer's and BioNTech's prospects.

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Keith Speights: Brian, we'll jump right on into, I guess this is the biggest story, at least from the COVID-19 world right now, Pfizer and BioNTech have confirmed that they filed for Emergency Use Authorization for boosters of their COVID-19 vaccine in all adults. I think if everyone remembers, the FDA and CDC had OK'd use of the booster for this vaccine and certain segments of the population, older adults, people at risk.

Brian, what do you think the chances are that Pfizer and BioNTech are going to win EUA for and expansion of their boosters?

Brian Orelli: I think it largely depends on what the FDA wants to prevent. If the FDA wants it prevent infections, then Pfizer and BioNTech have the data to show that they did a phase 3 study with the booster, and they showed that the efficacy was 95.6%, that's great. It's definitely preventing infections, the booster is.

If the FDA wants to see whether it's preventing severe disease, then it's not really that clear because there weren't that many cases in either group. Pfizer didn't release any data and I don't think they have enough data to say whether the booster is preventing severe disease. A lot of those people that didn't get boosted, they got mild cases of COVID.

Then is the booster really doing anything and do the side effects of getting the booster justify that you not getting a mild case of COVID-19? That's the big question. Other countries, including the European Medical Agency, have decided that everyone should get the booster.

I think the risk-benefit proof analysis will come down on the side of benefit and that the FDA will probably approve it. But I think that's the thing that investors should be looking for is what does the FDA want: Do they want to prevent infections or do they want to prevent severe disease?

Speights: Brian, I know there will be many Americans who say, why shouldn't the FDA go ahead and do this, as you mentioned, look at the other countries, Europe is doing it. Does the FDA really look at what other countries have done?

Orelli: Yeah. They do talk to them and they talk to the European Medical Agency. But they ultimately make their own decision based on what they think.

They actually did a study where the European Medical Agency and the FDA got together and they compared at all the decisions that they made on all these different drugs over a few years. They looked and saw why, once they made the same decision weren't all that interesting, but the ones where they had made different decisions, it was interesting to see why they made those different decisions.

A lot of times, it was that one agency had more information. The companies aren't necessarily filing to both agencies at the same time. They might have filed at the FDA and the FDA has decided they didn't have enough information to approve it. Then they got more data from an updated clinical trial or a new clinical trial, and then they filed in Europe and they got approved there. That was oftentimes the difference between the two.

Speights: Brian, what's your prediction in terms of how the stocks might perform if the FDA does grant EUA to boosters for all adults? Will the stocks jump you think?

Orelli: I think they will because I think that their future valuations are so dependent on whether they can get boosters, not just this current round of boosters but the next round of boosters and round of boosters after that. If the FDA doesn't say that they will, then I think the stock moves down substantially. If they -- if they do, then maybe the smaller ones, BioNTech and Moderna, probably move up a good amount. I'm not sure if Pfizer would really be affected at as much of a level.

Keith Speights owns shares of Pfizer. The Motley Fool recommends Moderna Inc. The Motley Fool has a disclosure policy.

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