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FDA Authorizes Pfizer, BioNTech Omicron Adapted COVID-19 Vax Booster

August 31, 2022

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Pfizer Inc. and BioNTech SE was granted Emergency Use Authorization (EUA) by the U.S. FDA for a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine, bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older. An application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to the FDA in early October. The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age.

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