FDA may authorize COVID-19 vaccine for children by midwinter
The Food and Drug Administration could grant an emergency use authorization for a COVID-19 vaccine for children by midwinter.
Thus far, the FDA has only given COVID-19 vaccines emergency approval for those over age 12. Both Pfizer and Moderna are currently running trials for those under age 12.
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Although trial results are expected in the fall, an FDA official told NBC News the soonest an EAU would be granted for those under age 12 would be midwinter, as the agency requires more safety data. For adults, the FDA required two months of follow-up safety data after the vaccine trials. It will require four to six months for the under-12 trials.
Dr. Buddy Creech — one of the primary researchers for the Moderna KidCOVE clinical trials, which includes children as young as 6 months old — predicted a rollout of pediatric data similar to Pfizer's.
"I can't imagine, except maybe for the 6- to 11-year-olds, that we're going to have too much data before the late fall," Creech told NBC News.
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He added it may take even longer to have data for those 5 and under.
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Tags: Healthcare, Coronavirus, Vaccination, Pfizer, FDA, News
Original Author: David Hogberg
Original Location: FDA may authorize COVID-19 vaccine for children by midwinter
