FX.co ★ Pfizer, BioNTech Get CHMP's Positive Opinion For Marketing Authorization Of Omicron JN.1 Vaccine

Pfizer Inc. (PFE) and BioNTech SE (BNTX) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine for active immunization.

This vaccine aims to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 6 months and older. The adaptation is aligned with guidelines from the World Health Organization’s Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force.

The European Commission will now review the CHMP's recommendation and make a final decision.

The CHMP’s recommendation is underpinned by extensive previous clinical, non-clinical, and real-world evidence that supports the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines.