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.
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. Kids who get the COVID vaccine should be able to go maskless in school, says Dr. Alok Patel. "I can't wait to see those kids with their bright, smiling shining faces again," Patel says. He answers all our questions about the COVID vaccines being approved for administration to children.
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