The agency set tentative dates in June to publicly review the vaccines, typically the final step before authorizing the shots.
The Food and Drug Administration 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 Food and Drug Administration 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 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. On Thursday, Moderna submitted data to the FDA that it hopes will prove its two low-dose 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.
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.
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