Moderna asks the F.D.A. to authorize its vaccine for children under 6

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Source: New York Times

Moderna said Thursday that it had asked the Food and Drug Administration to authorize its coronavirus vaccine for children under 6, making it the first manufacturer to do so. A top official said the firm would finish submitting data to regulators by May 9. The development, which was expected, could intensify pressure on federal regulators to authorize a vaccine for the nation’s youngest children. Parents of the roughly 18 million youngest Americans, the only population group not yet eligible for vaccination, have been waiting for months for pediatric doses.

So far, Moderna’s vaccine has been cleared only for adults. The F.D.A. has generally authorized Covid vaccines according to age group, calculating that the risks of severe disease and the benefits of vaccination are highest for the oldest Americans and reduced for young recipients. Moderna has also requested authorization of its Covid vaccine for 6- to 11-year-olds and 12- to 17-year-olds, and a spokeswoman said that it would submit data rounding out those requests in about two weeks.

At a Senate oversight hearing on Tuesday, Dr. Peter Marks, who oversees vaccine regulation for the F.D.A., hinted that the agency might consider Moderna’s applications for everyone under 18 as a whole. Some requests “are complicated because they are relatively larger, covering larger swaths of the pediatric population than others,” he said in response to a senator’s question about when a pediatric vaccine would be ready.

Moderna and Pfizer-BioNTech have both been developing doses for the youngest children since last year. Moderna is proposing a two-dose regimen for children from 6 months to 5 years old, using one-fourth the strength of an adult dose. Pfizer and BioNTech are working on a three-dose regimen for those 6 months to 4 years old, at one-tenth the strength of the adult dose. Pfizer has not yet submitted a request for F.D.A. authorization, but is expected to do so soon.

Read more: https://www.nytimes.com/2022/04/28/us/moderna-fda-vaccine-children-under-6.html