Pfizer and BioNTech’s positive CHMP opinion for COVID-19 vaccine

Pfizer and BioNTech SE have officially announced that the EMA 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 6 months of age and older. This 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.

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.

This application included non-clinical and manufacturing data showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates overall improved immune responses against multiple circulating SARS-CoV-2 lineages, including XFG, NB.1.8.1, LF.7, and other currently circulating contemporary sublineages, compared to the companies’ JN.1 and KP.2-adapted monovalent COVID-19 vaccines.

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.

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