Pfizer (PFE 1.51%) and BioNTech (BNTX 0.04%) submitted their application for an Emergency Use Authorization (EUA) to use their coronavirus vaccine in adolescents a few weeks ago. In this video from Motley Fool Live, recorded on April 12, Fool.com contributors Brian Orelli and Keith Speights discuss the data that supports the EUA and how the Food and Drug Administration might approach the application.
Brian Orelli: Pfizer and BioNTech submitted their application for the Emergency Use Authorization in adolescents. So can you walk us through the data released a week or two ago? Then what do you think the timeline will be for authorization? Then finally, do you think the FDA will want an advisory committee meeting to go over the data specific for adolescents?
Keith Speights: The key takeaway from Pfizer and BioNTech's data is that their vaccine achieved 100% efficacy in adolescents between the ages of 12 and 15. Whether or not in the real world is going to be quite that high, probably not, but still very, very good. The safety profile of the vaccine was very similar to what we saw in individuals ages 16-25, which was a very good safety profile. So everything is looking good.
So Pfizer submitted its EUA filing with the FDA on Friday, I believe, so that was April 9th. Just a few days ago. Now the FDA doesn't have to convene an advisory committee at all. This is just an amendment to an existing EUA, it's an amendment to allow the vaccine to be authorized for use in a different age groups. So the FDA really doesn't have to convene an advisory committee meeting and it very well might not.
But I wouldn't be surprised if the FDA does do it, convene the committee. The reason why I say that is because if you go back to the original advisory committee meeting for the Pfizer vaccine, the only dissenting votes against giving it authorization related to children. Pfizer's vaccine was authorized for down to age 16. The other vaccines that have been authorized only went to 18. So there were some objections about allowing the vaccine to be given to kids down that age group.
It's possible, I think, that the FDA might convene an adcom just to give themselves some cover. It also might would help build confidence in parents who are considering having their kids vaccinated. I don't know, Brian. I think the FDA might not do it, but they might. We'll see. If they do it, I think it's going to be maybe some politics at work more than anything. In terms of the timeline, it depends on what the FDA decides about whether or not to convene an advisory committee. Pfizer could win an amendment to its EUA to allow the vaccine to be used in children ages 12-16 within just a few weeks, maybe even by the end of April. But if an advisory commission, committee rather, is convened, you could push that timeline out a few weeks. At any rate, I think it's likely that the vaccine will be available for this younger age group by early summer. That's my best guess.
Orelli: I would agree with your timeline there and also your comment about the politics being involved. I think if they do do an advisory committee meeting, it's probably mostly just to cover their butts. As you said, maybe that also gives parents a little more confidence with an outside review as well as an internal review. Especially since the outside review is public and so there will be more information than the inside reviews, which is just the agency reviewing it themselves without anybody else overlooking the process.
Speights: Really, I think if I were FDA commissioner, I would probably lean toward convening the advisory committee. It doesn't hurt, it's not a huge delay, gives you a little bit of cover. Probably that's what they'll do but we'll see.
Orelli: It's two weeks, and it's teenagers who aren't necessarily susceptible to the worst possible parts of COVID-19. I think that also leans toward waiting, and doing the advisory committee meeting.
Speights: Yeah.
