FDA to review COVID vaccines for kids under 5

WASHINGTON — The Food and Drug Administration on Friday set tentative dates in June to publicly review COVID-19 vaccines for the youngest American children, typically the final step before authorizing the shots.

The meeting announcement follows months of frustration from families impatient for a chance to vaccinate their little children, along with complaints from politicians bemoaning the slow pace of the process.

The FDA said it plans to convene its outside panel of vaccine experts on June 8, 21 and 22 to review applications from Moderna and Pfizer for child vaccines. The dates are not final and the FDA said it will provide additional details as each company completes their application.

Currently, only children ages 5 or older can be vaccinated in the U.S. with Pfizer’s vaccine, leaving 18 million younger tots unprotected.

On Thursday, Moderna submitted data to the FDA that it hopes will prove its two lowdose shots can protect children younger than 6. Moderna has filed FDA applications for older kids, but the FDA hasn’t ruled on them. It’s not clear if that data for older children will be considered at the June meetings.

Pfizer is soon expected to announce if three of its even smaller-dose shots work for the littlest kids, months after the disappointing discovery that two doses weren’t quite strong enough.

While questions have swirled about what’s taking so long, FDA regulators have emphasized that they can’t evaluate a product until a manufacturer completes its application. Moderna still has to submit additional data to complete the process, the FDA noted Thursday.

On Monday, a top House Democrat requested a briefing from FDA on the status of vaccines for children after media reports that the FDA was considering delaying its work on Moderna’s application to jointly review it with Pfizer’s at a later date.