FDA Schedules June COVID Vaccine Meetings for Youngest Children

The Food and Drug Administration on Friday set tentative dates in June for a public review of COVID-19 vaccines for America’s youngest children, usually the last step before vaccines are approved.

The announcement of the meeting follows months of disappointment from families looking forward to having their young children vaccinated, as well as complaints from politicians bemoaning the slow pace of the process.

The FDA said it plans to convene an external panel of vaccine experts on June 8, 21 and 22 to review Moderna and Pfizer’s pediatric vaccine applications. The dates are not final and the FDA said it will provide more information as each company completes its application.

Currently, only children 5 years of age and older can be vaccinated with Pfizer in the US, leaving 18 million toddlers unprotected.

On Thursday, Moderna presented data to the FDA that it hopes will prove that two low-dose shots can protect children under 6 years of age. Moderna has filed applications with the FDA for older children, but the FDA has not ruled on them. It is not clear if these data for older children will be considered at the June meetings.

Pfizer is expected to announce soon whether three of its even smaller doses work for the youngest children, months after the disappointing discovery that two doses weren’t strong enough.

While questions have swirled about what is taking so long, FDA regulators have stressed that they cannot evaluate a product until a manufacturer completes an application. The FDA noted on Thursday that Moderna still needs to provide additional data to complete the process.

On Monday, a senior House Democrat asked the FDA for a briefing on the status of childhood vaccines after media reports said the FDA was considering delaying its work on Moderna’s application to jointly review it later with Pfizer.