FDA holds June meetings on COVID vaccines for younger children

The Food and Drug Administration has set tentative dates in June to publicly review COVID-19 vaccines for America’s youngest children

WASHINGTON — The Food and Drug Administration on Friday set tentative dates in June to publicly review COVID-19 vaccines for America’s youngest children, usually the last step before allowing injections.

The announcement of the reunion follows months of frustration from families eager to get their grandchildren vaccinated, as well as complaints from politicians about the slow process.

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

Currently, only children age 5 or older can be vaccinated in the United States with Pfizer’s vaccine, leaving 18 million young children unprotected.

On Thursday, Moderna submitted data to the FDA that it hopes will prove that its two low-dose injections can protect children under the age of 6. Moderna has filed applications with the FDA for older children, but the FDA has not ruled on them. It is not clear if this data for older children will be taken into account at the June meetings.

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

As questions swirled about what’s taking so long, FDA regulators have stressed they can’t assess a product until a manufacturer completes their application. Moderna still needs to submit additional data to complete the process, the FDA noted Thursday.

A senior House Democrat on Monday demanded a briefing from the FDA on the status of childhood vaccines after media reports that the FDA was considering delaying work on Moderna’s request to review it jointly with Pfizer at a later date. later date.

———

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

Comments are closed.