Pfizer, BioNTech receive positive CHMP opinion for Covid-19 vaccine in EU

Pfizer (PFE) and BioNTech SE (BNTX) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization for the companies’ Omicron JN.1-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 adaptation is based on the recommendation from the World Health Organization Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. ETF stated that “evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.” The European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. Following the EC decision, the updated vaccine will be available to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron JN.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase. The CHMP’s recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and pre-clinical data showing that the JN.1-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages, compared with the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. Pfizer and BioNTech are starting rolling applications with the U.S. Food and Drug Administration, per recent FDA recommendation, requesting approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals 6 months of age and older. The companies will continue to monitor the evolving epidemiology of COVID-19 and make appropriate preparations to meet global public health needs.