In this clip from "The Pharma & Biotech Show" on Motley Fool Live, recorded on Feb. 2, Motley Fool contributors Keith Speights and Brian Orelli discuss the recently announced rolling EUA submission from Pfizer (PFE -0.49%) and BioNTech (BNTX -1.68%) regarding the vaccine for children ages six months to five years and the upcoming meeting with the FDA.
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Keith Speights: Brian, another big story this week is that Pfizer and BioNTech have announced that they've initiated their rolling EUA submission for their vaccine in younger kids. The younger kid age ranges from six months to under five years old, so up to that five-year old point. Basically, they expect to complete this submission really soon within the next few days. What's interesting here is that the FDA has already scheduled an advisory committee meeting for February 15. That's an unusual move by the FDA to go ahead and move that quickly. But I think it's because the FDA realizes the importance of this. Since the pandemic began, over 10.6 million kids have tested positive for COVID-19 in the United States. Children under four made up more than 1.6 million of those cases. Then, of course, lately the Omicron variant is causing a big spike in cases in younger kids. I was noting in the Pfizer press release, they said that for the week ending January 22, children under four accounted for 3.2% of the total hospitalizations due to COVID-19. That's a good many young kids going to the hospital because of this. Also, this is just a big opportunity because kids under five represent around 6% of the total U.S. population. That's around 20 million children. The EUA filing is going to be the first for the two doses of this vaccine, but they plan on it being three doses. Data on that third dose won't be available just quite yet, but it's expected in the next few months. Once they get that data in, then they'll file to expand that EUA to include a third booster dose.
Orelli: I thought this was the age group where they had some issue with the data not looking as good as the older kids?
Speights: What happened there, Brian, I think the two doses were effective at this really smaller dose. Much smaller dose than used in adults. It was effective for the kids under two years old, the six months to two year old, but not effective in the two to five. What Pfizer did is they said, "Hey, we're going to need to add a third dose."
Orelli: Maybe the FDA approves it for two to five year olds. Then, when they come in with the data from the third dose, maybe then they approve it for six months to two year olds. You think that can happen?
Speights: I think it's the opposite of that, but it'll be interesting to see what the FDA does here. I think the smaller dose worked better in the really young kids, which makes sense, putting it in smaller bodies.