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Pfizer, BioNTech Submit EUA Application to FDA for Omicron Adapted Bivalent Covid Vax

Data supports the request for EUA of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 and older.

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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 booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.   The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vacci...

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