FDA sets meeting dates to weigh COVID-19 vaccines for young children

The FDA has laid out a tentative June schedule to decide whether to authorize COVID-19 vaccines for the nation's 18 million children under 5, The New York Times reports.  

Four notes:

1. The FDA in a tentative schedule released April 29 set aside June 8, June 21 and June 22 as dates it would present data on the matter to its outside advisory committee. 

2. The agency laid out the tentative timetable a day after Moderna submitted an emergency use authorization request for its two-dose vaccine regimen for children under 6. Moderna has said it plans to finish submitting data to complete its application by May 9. Pfizer is expected to have trial results of its three-dose vaccine regimen for children under 5 ready in June.

3. The meeting schedules are tentative because drugmakers have not submitted full data to complete their emergency use authorization applications, the FDA said in its announcement. Critics have raised concern the agency was delaying action on Moderna's application in order to compare it to data from Pfizer — a claim FDA officials have denied, the Times reports. 

"Just remember, we can't actually finish our reviews until we actually have complete data," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said during an April 26 agency oversight hearing. 

4. The FDA also set aside June 28 for the advisory committee to discuss how to approach updating the composition of existing vaccines to better target newer variants.

 

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