Pfizer - BioNTech COVID-19 Vaccine Recommended For Full Approval In EU

Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for their COVID-19 Vaccine COMIRNATY to Full Marketing Authorization for all authorized indications and formulations.

The recommendation applies to all indications and formulations in the European Union, including COMIRNATY Original/Omicron BA.4-5 and COMIRNATY Original/Omicron BA.1 bivalent vaccines.

The European Commission will review the CHMP recommendation and is soon expected to make a final decision.

In a separate action, the CHMP also recommended approval for COMIRNATY as a 10-microgram booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age. COMIRNATY 10- microgram was authorized in the EU in November 2021 as a two-dose primary series for children 5 through 11 years of age.

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