Politico

NIH director: Vaccine approval for kids unlikely before late 2021


One of the federal government’s top public health experts on Tuesday predicted it is unlikely children under the age of 12 will be eligible to receive the coronavirus vaccine before late 2021, contradicting the speedier timelines offered by other Biden administration officials.

Vaccine makers Pfizer and Moderna are currently studying the shot’s safety and efficacy in younger children and infants, with Pfizer expected to deliver the results of its trials for 5-11-year-olds to the Food and Drug Administration sometime in September.

But Francis Collins, director of the National Institutes of Health, suggested it could take months after receipt of that data for the regulatory agency to grant an emergency authorization to Pfizer’s vaccine for use among children under 12.

“I got to be honest, I don’t see approval for kids 5 to 11 coming much before the end of 2021,” Collins told NPR in an interview.

Anthony Fauci, the nation’s top infectious disease expert and President Joe Biden’s chief medical adviser, gave a more optimistic assessment Tuesday, saying Pfizer’s shot could secure FDA authorization for younger children as early as fall of this year.

Asked whether children under 12 might be able to get the vaccine before the winter holiday season, Fauci — who works under Collins as director of NIH’s National Institute of Allergy and Infectious Diseases — told NBC in an interview: “I think there’s a reasonable chance that that will be the case.”

Discussing the forthcoming FDA review, Fauci added: “I hope all of that process will take place expeditiously, and that we will have it on the timetable that you just mentioned — hopefully, by the mid-late fall and early winter.”

The remarks from Collins and Fauci come after the FDA on Monday formally approved Pfizer’s vaccine for use in people 16 and older, making it the first of the three available coronavirus shots in the United States to win full federal licensure.

The vaccines from Pfizer, Moderna and Johnson & Johnson were previously granted emergency authorizations by the FDA between December 2020 and February 2021.

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