Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-modified COVID-19 vaccine in the European Union

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron KP.2-modified monovalent COVID-19 vaccine (COMIRNATY KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The European Commission will review the CHMP’s recommendation and is expected to make a final decision shortly. Following the EC’s decision, Pfizer and BioNTech’s Omicron KP.2-modified COVID-19 vaccine will be shipped to European Union (EU) member states that have specifically ordered this formulation.

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