Clyburn Presses FDA on Timeline for Approving COVID Vaccine for Children Under Age 5 

Rep. Jim Clyburn, D-S.C., chair of the Select Subcommittee on the Coronavirus Crisis, sent a letter on Monday to Robert Califf, commissioner of the U.S. Food and Drug Administration, requesting a timeline for FDA approval of COVID-19 vaccines for children under age 5.

“Recent reports indicate that FDA is considering postponing its decision on whether to authorize Moderna’s vaccine for young children until early summer, so that it can be evaluated — and potentially authorized — at the same time as Pfizer’s vaccine,” writes Clyburn in the letter. 

According to the letter, Moderna has plans to apply for an Emergency Use Authorization for a two-dose vaccine for children aged 6 and younger by the end of the month, while Pfizer is likely to request authorization of its three-dose vaccine for children under 5 in June. 

The letter notes that Dr. Anthony Fauci, the White House chief medical advisor, indicated the FDA is concerned about the public confusion that could follow a staggered rollout of two vaccines with different dosing regimens and degrees of efficacy.

Moderna said in a press release on Thursday that the company has submitted a request for emergency use authorization to the FDA for its COVID-19 vaccine in children aged 6 months to 6 years. 

According to the release, EUA submission will be complete next week, and Moderna is also currently studying booster doses for pediatric cohorts.

Pfizer has also announced plans to submit the official request for a three-shot series for children under 5 by the end of June, and on Tuesday the company submitted an application to the FDA for emergency use authorization of a COVID-19 booster for children aged 5-11.

The EUA application was based on phase 1, 2, and 3 trial data of 4,500 children aged 6 months to 12 years from more than 90 clinical trial sites in the U.S., Finland, Poland and Spain.

On Feb. 11, the FDA announced they would “give the agency time to consider the additional data,” which was submitted by Pfizer regarding childhood vaccinations for children aged 6 months to 4 years.

According to a report from the American Academy of Pediatrics, since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S., and evidence from the U.S. Centers for Disease Control and Prevention finds that children under 4 account for more than 1.6 million of those cases.

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