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Pfizer, BioNTech seek US FDA emergency use authorization for Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children under 5 years

New York
Wednesday, December 7, 2022, 16:00 Hrs  [IST]

Pfizer Inc. and BioNTech SE announced that the companies have submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated Covid-19 vaccines may help prevent severe illness and hospitalization.

If authorized, children in this age group would receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech Covid-19 Vaccine followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine. An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency (EMA).

The Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine is currently authorized as a booster dose for ages 5 years and older in the US and European Union (EU).

The Pfizer-BioNTech Covid-19 Vaccines (COMIRNATY) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (Original) and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.


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