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Is Moderna on Track to Win Authorization for Its Vaccine in Younger Kids?

By Keith Speights and Brian Orelli, PhD – Nov 4, 2021 at 6:05AM

Key Points

  • Moderna's data showed solid production of antibodies in younger children receiving its COVID-19 vaccine.
  • Even with a delay in filing, the company seems likely to ultimately win authorization in the younger group.

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Moderna (MRNA 0.46%) recently announced positive results from a clinical study of its COVID-19 vaccine in children ages 6 to 11. However, since then, the company has pushed back its filing for Emergency Use Authorization (EUA) in this age group because the U.S. Food and Drug Administration (FDA) extended its review of the company's data for adolescents. In this Motley Fool Live video recorded on Oct. 27, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss whether Moderna is on track to win authorization for its vaccine in younger kids.

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Keith Speights: There's some related news from earlier this week as well, Brian. Moderna announced positive results on Monday from a Phase II/III study evaluating its COVID-19 vaccine in kids ages 6-11 years old.

How did Moderna's data look and do you think that it's on track to ultimately win FDA authorization in this younger age group?

Brian Orelli: Yes. The data we got only looked at antibody levels, 99.3 percent of kids had zero response and so that's just a fancy way of saying that they went from not having the antibodies before the vaccine to having antibodies after the vaccine.

Pfizer (PFE -0.39%) and BioNTech's (BNTX 0.82%) zero response rate was 99.2 percent, essentially equivalent difference of 0.1 is a rounding error in their study of 5-11 year olds. It would obviously be nice to see if the vaccine is preventing cases of COVID-19 and especially see if it's preventing actual hospitalizations, but there's only 4,753 participants in this study so the data might not be all that useful even if Moderna actually has it.

I think it seems likely that Moderna is on its way to getting authorization for its vaccine for 6-11-year-olds considering that it looks a bit equivalent to Pfizer's that we've seen the ability to create antibodies. It should be noted that the company is also testing it on younger kids aged six months to five years, but they're still enrolling participants in that clinical trial.

Speights: You mentioned around 4,753 participants. That's not a super low number though, Brian. I mean, that's a reasonable number you think for a study like this?

Orelli: Yeah. I mean, I think they should probably be able to get some efficacy data off of it. But I don't think that was the main purpose of the study. They were basically just trying to show that it also creates antibodies in children, which it obviously does.

Generally speaking, vaccines, once they've been proven are successful in preventing a disease, the FDA, they are fine with the company just showing that they can also create antibodies and that's usually good enough to get an approval.

Speights: We will definitely be keeping our eyes on what happens with Moderna, with its vaccine in younger kids.

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

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