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A Vaccine For Children Is Not Likely To Be Approved Until The End Of Year

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Students listen to their teacher during their first day of transitional kindergarten this month at Tustin Ranch Elementary School in Tustin, Calif.  (Paul Bersebach/MediaNews Group/Orange County (Calif.) Register via Getty Images)

Parents and caregivers may have to wait until the end of 2021 before a COVID-19 vaccine is fully approved for young children ages 5 to 11. The news comes from Dr. Francis Collins, director of the National Institutes of Health, in an interview with NPR's Morning Edition.

Collins said both Pfizer and Moderna are still collecting trial data, trying to understand — among other things — whether young children should receive a smaller vaccine dose than what has already been approved for adults.

Pfizer could submit its data to the Food and Drug Administration for review by the end of September, Collins said. But he added, "I've got to be honest, I don't see the approval for kids — 5 to 11 — coming much before the end of 2021."

While full FDA approval is likely several months away, Pfizer's vaccine could be cleared for emergency use earlier, possibly in October, after the submission of its trial data.

Collins' remarks come one day after the FDA granted full approval to Pfizer-BioNTech's COVID-19 vaccine for people 16 and older. The vaccine remains available for kids between the ages of 12 and 15 through the current emergency use authorization.

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The NIH director also weighed in on the heated fight in states requiring children to wear masks in schools. Collins said he's "puzzled" by the debate, saying there is ample evidence that wearing masks will help prevent COVID-19 outbreaks.

Several states, including Texas, Florida and Arizona, have banned school districts from broadly requiring mask-wearing. Nevertheless, some large, urban districts — including Dallas and Phoenix — have defied those orders. The Biden administration and the U.S. Department of Education have thrown their support behind these embattled district leaders, even threatening states with civil rights investigations if students feel they cannot safely learn because of a lack of masking

Ultimately, Collins said, masking will help keep schools open.

"If you want to avoid having that outbreak that's going to send all the kids home again, you should be doing everything to avoid that. And that means wearing masks," Collins told NPR. "And by the way, if somebody tries to tell you we don't really have scientific evidence to say that masks reduce infection in schools, that's just not true. There are dozens of publications, both from the U.S. and other countries, to show that's the case. So, boy, I wish we could get over that fight."

It's a fight, Collins said, that is getting in the way of "what is going to be a tough enough fall as it is."

Copyright 2021 NPR. To see more, visit https://www.npr.org.

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