Pfizer and BioNTech ask FDA to authorize updated COVID booster for children

September 26, 2022 covid19

Pfizer and BioNTech announced Monday that they are seeking emergency use authorization from the FDA for its Omicron-specific COVID-19 booster for children ages 5-11.

The big picture: The companies’ submission comes after Moderna on Friday requested emergency use authorization for its Omicron-specific COVID booster shots for children 6-17 years old.

Driving the news: Pfizer and BioNTech also said Monday that they have started a study of different dosing regimens of the updated boosters in children 6 months to 11 years of age.

The request is “supported by safety and immunogenicity data,” the companies said in a news release.

State of play: Vaccine uptake among older groups for the updated booster, called bivalent, has been slow. Approximately 4.4 million people have received updated boosters so far, which amounts to less than 2% of those eligible, per the CDC.

However, that’s likely an undercount due to reporting lags in the states.
Anybody over 12 was eligible to receive the Pfizer-BioNTech bivalent booster beginning in August.

Go deeper… Experts alarmed by COVID vaccination rates among America’s youngest kids

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