FDA Review of COVID Vaccine for Children Under 5 Paused

Feb 15, 2022, 2:55 PM

(from EdWeek) The U.S. Food and Drug Administration has canceled a meeting of its vaccine advisory committee, which was scheduled for this week. The panel of independent experts was going to consider whether to recommend emergency use authorization for the COVID-19 vaccine developed by Pfizer and BioNTech for children under 5. The FDA’s reversal means that it likely won’t be until at least mid-April before a COVID-19 vaccine is available to young children. The FDA says it will now wait for more data from Pfizer and BioNTech on how well a third dose of the vaccine works in children 6-months through 4-years-old. Data, so far, show that while a two-dose regimen of the vaccine is safe in this age group, it was not effective at creating enough of an immune response.

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