Moderna Seeks FDA COVID Vaccine Approval for Kids Under 6: Vaccines This Summer?

Moderna has submitted data to the Food and Drug Administration (FDA), asking them to authorize the COVID-19 vaccine the company developed for kids under 6, as well as a vaccine for 6- to 11-year-olds and, separately, 12- to 17-year-olds.

The development is promising. At least 75% — or three in four kids — under the age of 11 had contracted COVID-19 by February, and parents have waited on a vaccine for kids under 5 for long and excruciating months. (Including during the Omicron wave, when kids under 4 were hospitalized at their greatest numbers yet during the pandemic.)

So far, Moderna has only had emergency use authorization for their vaccine approved for people 18 and up. Now, with data on schedule to be fully submitted by May 9th, that could drastically change.

Moderna’s application for approval comes months after Pfizer applied for authorization for a vaccine for kids under 5. However, Pfizer withdrew the application, which would’ve created a three-dose regimen for kids at a tenth of the strength of an adult dose. The FDA will require data on the efficacy of a third dose of the vaccine before it will consider approving the Pfizer regimen.

Moderna’s vaccine for kids 5 months to under 6-years-old would be a two-dose vaccine at a quarter of the strength of an adult dose. The vaccine is safe in kids, with fever being a common side effect after injection.

Moderna says the trial data of 6,700 kids shows that the vaccine is 51% effective and 37% effective for kids younger than 2 and kids 2 to through 5, respectively, against symptomatic illness. The Omicron variant was responsible for most of the breakthrough infections in the study.

Dr. Paul Burton, Moderna’s chief medical officer, noted that kids will have high protection against severe illness, potentially even more than adults, after two doses, per CNBC. None of the kids studied were hospitalized with COVID-19 during the course of the trial. Dr. Burton also suggested that these numbers are on par with how protected an adult would be after two doses of the vaccine.

As for whether or not the vaccine will be ready by June for rollout, it appears that the FDA will review the Moderna vaccine in June. Pfizer also aims to have its own vaccine approved by June. Historically, it’s taken a few weeks for the FDA to review vaccine data and approve rollout, so that could suggest that vaccines are rolled out by late June or early July, meaning that kids could start getting their first doses as summer travel begins.