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Thu Oct 7, 2021, 07:18 AM

Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11 [View all]

Source: New York Times

WASHINGTON — Pfizer and BioNTech said on Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States. The companies have said they were submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on Oct. 26 to consider it. A ruling is expected between Halloween and Thanksgiving.

Parents across the United States are anxiously awaiting the regulators’ decision, which could affect family life and the operation of schools. Clearance depends not only on the strength of the clinical trial data, but on whether they can prove to regulators that they are able to properly manufacture a new pediatric formulation. Dr. Janet Woodcock, the acting F.D.A. commissioner, said last week that children might require “a different dosage or formulation from that used in an older pediatric population or adults.” Pfizer has proposed giving children one-third of the adult dosage. That might require adding more diluent to each injection or using a different vial or syringe.

The company was expected to describe the method it intended to use in its submission to the Food and Drug Administration. Regulators will have to examine the purity and stability of mass-manufactured doses of the vaccine and determine that it matches the quality and potency of doses given to children in clinical trials. A pediatric dose will also most likely require new labeling, with special codes that would allow the Centers for Disease Control and Prevention to track specific lots in case of reports of serious side effects.

Children rarely become severely ill from Covid-19, but the Delta variant drove nearly 30,000 of them to hospitals in August. According to the American Academy of Pediatrics, nearly 5.9 million Americans younger than 18 have been infected with the coronavirus. Of the roughly 500 Americans under 18 who have died, about 125 were children ages 5 to 11.

Read more: https://www.nytimes.com/2021/10/07/us/politics/pfizer-fda-authorization-children-5-11.html



This may take a little while before an EUA is approved.

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