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Did Pfizer's and BioNTech's FDA Submission Boost the Case for Booster Doses for All Americans?

By Keith Speights and Brian Orelli, PhD – Aug 26, 2021 at 6:15AM

Key Points

  • Pfizer and BioNTech recently submitted data to the FDA supporting a third booster dose for their COVID-19 vaccine.
  • The FDA and CDC soon thereafter announced plans to move forward with third booster doses for mRNA vaccines.
  • The most compelling reason for giving a green light for booster doses wasn't Pfizer's data but instead the number of COVID-19 cases for vaccinated Americans.

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Maybe, but there were even more important considerations.

Third booster doses are on the way for Americans who have received messenger RNA (mRNA) COVID-19 vaccines. The Food and Drug Administration and the Centers for Disease Control & Prevention made the announcement not long after Pfizer (PFE -2.01%) and BioNTech (BNTX -3.05%) submitted data to the FDA in support of a third booster dose. In this Motley Fool Live video recorded on Aug. 18, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how much weight Pfizer's and BioNTech's FDA submission might have had in the decision to move forward with booster doses.

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Keith Speights: Earlier this week, on Monday, Pfizer and BioNTech announced that they had submitted data to the FDA that support the need for a third booster dose for their COVID-19 vaccine. Now, of course, the FDA has already authorized booster doses for both of the mRNA vaccines, both the Pfizer, BioNTech and the Moderna (MRNA -1.36%) vaccine, for immunocompromised individuals, but that's really only a small part of the U.S. population.

What do you make of the Pfizer, BioNTech FDA submission, first of all? And how much weight do you think that carries with the FDA's decision to authorize booster doses for all Americans?

Brian Orelli: Yeah, I'm not sure if it was that data or some other data, but the CDC just announced within the last hour that they're recommending a booster dose after eight months. The initial reports earlier this week made it seem like that was going to happen after the FDA gave full approval to Pfizer and Moderna's vaccines, so the label wouldn't necessarily need to say a third dose.

I guess, doctors would be allowed to do it off-label, but because it's a full approval versus an Emergency Use Authorization, that would allow them to do it. Now, it sounds like it's maybe more pending the FDA's evaluation of just reading reports from the press release. There's more pending the FDA's evaluation of this safety data for third doses of Pfizer and Moderna's. This submission by the Pfizer -- it sounds what they're going to need to do to get the FDA to approve a third dose or authorize a third dose. It's not really clear on which one they would get, so it seems like it's, at this point, probably very necessary.

There's not much more to say because it's going to be a pretty fluid situation here for a little while. But I think definitely we're moving toward needing a third dose, especially with the delta variant.

I think the problem is that our antibodies are going down and the amount of virus that's replicated in our bodies when we're exposed to somebody goes up. And so the combination of those two has hit a point where the two intersect and that's when you need a new booster to get your antibodies levels back up. And hopefully we are good at that point, but we may need another booster after that, depending on how quickly our antibody levels go down after a third dose because we don't quite know that yet. And then also whether we get an even more powerful variant that has even more virus that can overwhelm the antibody levels wherever we are at.

Speights: Both Pfizer and Moderna have been saying for a while now that they anticipated that third booster doses would be needed. Pfizer, I think, has probably been more adamant than anyone. Did this data that they submitted, do you think it really made a pretty compelling case that their third booster dose was required?

Orelli: I think the compelling case is that people are getting sick who have been vaccinated. I think that's probably more compelling than anything else. I think this data seems like it was mostly just safety data and showing that the antibody levels go back up. That's what you'd expect when you get a booster.

It's nothing really shocking here. I think the main thing is it doesn't seem getting a third booster isn't going to be worse than your second booster, which for some people is bad and some people is basically nothing. I think the point here is it's safe and does what it's supposed to do.

Then the main point to when you would actually recommend a booster dose has nothing to do with that data on the third booster dose. It has everything to do with whatever your antibody levels are, and it seems like people's antibody levels are tapering off at about eight months. That's when they've recommended that people get a new booster dose.

Speights: They are saying the third dose would be after eight months. That would be eight months following the second dose received from the mRNA vaccine. I guess the first people started to be vaccinated in December of last year. That would put them receiving a second dose either, I guess with the Pfizer vaccine, Pfizer BioNTech's vaccines after three weeks, Moderna's after four weeks. Basically, we're now at that point where some people will probably be getting, or at least soon be eligible to get that third booster dose, and I'm talking about people who are not immunocompromised.

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

Stocks Mentioned

Pfizer Stock Quote
Pfizer
PFE
$49.71 (-2.01%) $-1.02
Moderna Stock Quote
Moderna
MRNA
$173.54 (-1.36%) $-2.39
BioNTech Se Stock Quote
BioNTech Se
BNTX
$161.62 (-3.05%) $-5.09

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