Pfizer, BioNTech get CHMP opinion for COVID-19 vaccine marketing authorization

Pfizer (PFE) and BioNTech SE (BNTX) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.” The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make its final decision soon. Pfizer and BioNTech have already initiated manufacturing of the LP.8.1-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 updated vaccine will be available to ship to applicable EU member states immediately following the EC decision. The companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world. The companies are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.