Pfizer & BioNTech Request EUA of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children

The request is supported by safety and immunogenicity data from multiple studies.

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By: Charlie Sternberg

Associate Editor

Pfizer Inc. and BioNTech SE have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age.   The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ Omicron BA.1-adapted bivalent vacci...

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