WASHINGTON – The Food and Drug Administration on Friday set preliminary dates in June for publicly reviewing COVID-19 vaccines for the youngest U.S. children, typically the final step before the shots are approved.
The meeting announcement follows months of frustration from families who are impatient for a chance to vaccinate their young children, along with complaints from politicians lamenting the slow pace of the process.
The FDA said it plans to convene its external panel of vaccine experts on June 8, 21 and 22 to review applications from Moderna and Pfizer for childhood vaccines. The dates are not final, and the FDA said it will provide more details as each company completes its application.
While questions have been swirling about what is taking so long, FDA Commissioner Robert Califf stressed on Friday that the agency cannot evaluate the vaccines until all data has been submitted.
“There will be no delays,” Califf told reporters at a health journalism conference. “We will review the data, hold an advisory committee meeting and make a decision as soon as possible once we have received the applications.”
Currently, only children 5 years of age or older can be vaccinated in the United States with Pfizer’s vaccine, leaving 18 million younger children unprotected.
On Thursday, Moderna submitted some of its data to the FDA, which it hopes will prove its two low-dose shots can protect children under 6. Moderna has filed FDA applications for older children, but the FDA has not ruled on them. It is not clear whether this data will be taken into account at the June meetings.
Pfizer is soon expected to announce whether three of their even smaller doses work for the youngest children, months after the disappointing discovery that two doses were not quite strong enough.
On Monday, a top Democrat in the House of Representatives requested a briefing from the FDA on the status of vaccines for children following 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.
The FDA also held a meeting on June 7 to review Novavax’s COVID-19 vaccine for adults. The Maryland-based company’s shots are approved in Europe and elsewhere, but have been delayed due to production issues.
The advisory group will also meet on June 28 to discuss whether current US COVID-19 vaccines need to be updated to better target coronavirus variants.
AP medical writer Lauran Neergaard contributed to this story.