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Pfizer Postpones Application to FDA for COVID Vaccine for Kids Under 5



The U.S. Food and Drug Administration on Friday said it was postponing an advisory panel meeting that was to discuss authorization of Pfizer and BioNTech’s COVID-19 vaccine for children 6 months through 4 years of age.

In a separate statement, the companies said they planned to extend the process of submitting data to U.S. regulators for the shot for children under 5.

U.S. regulators have been considering the vaccine for the only age group not yet eligible for the shots, even though the companies said initial results fell short of expectations in 2- to 4-year olds.

In December, Pfizer said it was amending its clinical trial to test a three-dose version of the vaccine because the low dose used generated an immune response in kids aged 2 to 4 that was inferior to the response measured in those aged 16 to 25.

The companies had said they submitted data on the first two doses of what would eventually be a three-dose regimen in the age group at the request of the FDA. On Friday, they said they expect to have three-dose protection data available in early April.

Some scientists were critical of this idea, suggesting that regulators should wait for data from a third shot before deciding on authorization.

In very young children between 6 months and 2 years old, the vaccine generated an immune response in line with 16- to 25-year-olds, the companies had said

© 2022 Thomson/Reuters. All rights reserved.



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