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

Added 10-07-21 08:40:03am EST - “The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.” - Nytimes.com

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Posted By TheNewsCommenter: From Nytimes.com: “Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11”. Below is an excerpt from the article.

The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.

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.”

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