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When Will Moderna's COVID Vaccine Be Available for Kids?

By Keith Speights and Brian Orelli, PhD - Mar 25, 2021 at 6:51AM

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The answer probably will be different for younger children than it will be for teens.

Americans ages 18 and older can already receive Moderna's (MRNA -7.23%) COVID-19 vaccine. The biotech recently announced the initiation of a late-stage study of its vaccine for younger children. In this Motley Fool Live video recorded on March 17, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how long it might be before Moderna's COVID vaccine is available for kids.

Keith Speights: Now, there's some other news from Moderna, the company also just announced that the first children have been dosed in a Phase III study of its COVID-19 vaccine and so this is targeting pediatric use obviously. The study will include children ages all the way down to six months old. So infants up to a little less than 12 years old. So Brian, how soon do you think it might be before a COVID-19 vaccine is available for kids?

Brian Orelli: So they're already testing the vaccine in teenagers. Two of my four children are in that clinical trial and they're scheduled to give their second dose, I think in the next week or so. For both the child study and the teen study, the primary endpoint is safety and then also antibody levels on Day 57, which is one month after the second dose.

Then they're also measuring COVID-19 level, so if my kids get COVID-19 we have to report it to them, but that's a secondary endpoint. The teens are using the adult dose but the children, they're not quite sure whether the adult dose is the proper dose. So they are doing a dose-escalation part on because obviously, they are smaller, that makes sense, but that will slow down the doses substantially.

Ultimately, the FDA is going to want some safety data for adults. They wanted a median of two months data, I would imagine for children they are probably going to want a lot more than that. I don't know how much more because once you get a shot and then basically within two months you should see a majority of the symptoms because it's going to be out of your system within a few days, I would imagine or weeks certainly, but I would certainly imagine that they will probably wind two full months on everybody maybe, especially since these clinical trials are substantially smaller than the adult trials were. If you get the median from the adults that was half of the people had two months of data and so that was tens of thousands of people, you might expect them to require everybody to have at least two months in these studies which are much smaller.

So long story short, teens are definitely going to be available before younger children. The teens could get approved as early as maybe late 2021 this year. If you assume a few more months to get everybody through the second dose and then two to three months of safety data, for the younger kids, it's definitely going to take longer because you're going to do the dose-escalation and those might take a few months each, and then followed by a placebo-controlled portion. So I think for younger children we're looking at maybe late 2022 would be my guess, maybe even into 2023 depending on how much safety data the FDA wants.

Speights: So this is not an immediate kind of thing for anyone to look forward to, except like you said, maybe in the teen population.

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