Europe Issues Positive Opinion for Omicron KP.2-adapted COVID-19 Vaccine

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-adapted monovalent COVID-19 vaccine (COMIRNATY ® KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older.

Pfizer Inc. and BioNTech SE announced that the European Commission will review the CHMP’s recommendation and is expected to make a final decision soon.

The CHMP recommendation dated September 19, 2024, is based on the non-clinical and manufacturing data of the Omicron KP.2-adapted vaccine and the clinical and real-world evidence supporting the safety and efficacy of prior formulas of the COVID-19 vaccines by Pfizer and BioNTech.

Pending the EC's authorization of the Omicron KP.2-adapted vaccine, both the Omicron KP.2-adapted vaccine and the Omicron JN.1-adapted vaccine will be available across the EU, though availability will vary based on individual country government requests and national recommendations.