CHMP Recommends Marketing Authorization For Pfizer, BioNTech's Omicron KP.2-adapted COVID-19 Vaccine

(RTTNews) - Pfizer (PFE) and BioNTech SE (BNTX) announced that the CHMP of the European Medicines Agency has recommended marketing authorization for the companies' Omicron KP.2-adapted monovalent COVID-19 vaccine 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.

In July 2024, the EC granted marketing authorization for Pfizer and BioNTech's Omicron JN.1-adapted COVID-19 vaccine. In the U.S., the FDA approved the companies' Omicron KP.2-adapted COVID-19 vaccine for individuals 12 years of age and older and granted emergency use authorization for individuals 6 months through 11 years of age on August 22, 2024.

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