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Pfizer asks FDA for authorization of new booster for children, ages 5-11

The booster is already available to those who are 12 years old and up.

Published: September 26, 2022 2:09pm

Updated: September 26, 2022 2:23pm

Pfizer announced Monday that it submitted an application to the Food and Drug Administration for the authorization of its bivalent COVID-19 booster shot for children ages 5 to 11. 

The company says it has requested the federal agency authorize a 10-microgram dose of its omicron-specific booster for those ages. The bivalent booster shot is currently authorized for those 12 and older. This dosage is one-third of the 30 microgram dose for adults that was authorized in August, The Hill reported.

Pfizer is requesting authorization base off of "safety and immunogenicity data" and "non-clinical" and "pre-clinical" data. The FDA didn't wait for the completion of full human clinical trials before authorizing the bivalent boosters, basing its authorization only on animal data. 

In the company's announcement, Pfizer said it has begun a Phase 1/2/3 to determine the "safety, tolerability, and immunogenicity" of varying doses of its omicron booster shot. Sub-studies are examining using the vaccine in children as young as 6 months old, including those who haven’t received the original COVID vaccine. 

Pfizer’s authorization request comes days after Moderna also asked the FDA to authorize its updated dose for administration to children as young as six years of age. Currently, Moderna’s booster shots are only authorized for adults.

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