How Big of an Opportunity Do Pfizer and BioNTech Have in Vaccinating Younger Kids?

Pfizer (PFE 0.23%) and BioNTech (BNTX 0.55%) recently reported positive data from a late-stage study of their COVID-19 vaccine in children ages 5 to 11. The companies plan to soon file for Emergency Use Authorization in this age group. In this Motley Fool Live video recorded on Sept. 22, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how big of an opportunity Pfizer and BioNTech have in vaccinating younger kids.

Keith Speights: Probably the biggest news right now is on Monday, Pfizer and BioNTech announced positive results from their study of COVID-19 vaccine in kids ages 5-11. This is from a late-stage study.

Brian, what did you think about those results first of all? Then just a hypothetical question, assuming the companies do ultimately win approval or authorization for this younger age group, how big of an opportunity is this market for Pfizer and BioNTech?

Brian Orelli: Yeah, the clinical trial looked at the 10-microgram dose, that is a third of what the people that are 16 and older get. The clinical trial just looked at antibody levels, and they were comparable for the 10-microgram dose for kids versus the 30-microgram dose for adults.

Pfizer and BioNTech, they're looking at a surrogate endpoint. They are just looking at antibody levels that's generally acceptable for expanded approval for other vaccines. You'd think that's what the FDA probably told the companies that was required for this clinical trial before they ran the clinical trial.

The question is really whether the agencies might backtrack, given the fluid situation with vaccines. We've seen more side effects crop up since the clinical trial started. I think the FDA, even since the clinical trials started, said they wanted more safety data than was originally requested at the beginning of the clinical trial.

Then the Delta variant, that's probably maybe a more positive sign that the kids could get approved. Even if it isn't going to kill an unvaccinated kid, they might pass it on to a unvaccinated adult, they might die. I think the FDA is going to weigh those two things; the side effects, which are definitely a negative, versus the Delta variant, which is probably a positive for getting it approved. We'll have to wait and see what the FDA actually does.

I personally think the side effects are probably low enough to justify an approval, but we'll have to wait and see. Then on the opportunity side, it's hard to really know. There is around 28 million kids in the US at that age range. Then if we figure $20 a dose or $40 per kid, that's around a billion dollars, but we'll have to see how many parents actually get their kids vaccinated.

It's hard to know exactly what the potential could be. Then of course, if those doses are just coming from doses that the US government has already requested and paid for, then it doesn't really benefit Pfizer and BioNTech at all financially.

Speights: Brian, I've seen some reports from some officials within the Biden administration who seem to be pretty optimistic that a decision will be made quickly here. I think I saw Dr. Fauci over the weekend giving his opinion anyway that there could be a decision by Halloween. I saw that FDA Commissioner Janet Woodcock, she wasn't quite that specific, but I think she was saying, "Yeah, we're going to try to move pretty quickly."

Obviously, they've got to review all the data, but they're going to expedite this. I think maybe by November anyway, we could know whether or not this vaccine for younger kids is going to be available.

Orelli: Yeah. The thing about expanded approvals is they don't have to do any of the manufacturing review. A lot of the total review time is actually the manufacturing and making sure that you can make the drug and you can prove that you can make the drug reliably. That takes up a lot of the review time for the manufacturing. Typically, expanded approvals take less time than initial approvals. I could say a month seems reasonable to me.