On Jul. 25, 2025, Pfizer and BioNTech announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY^® LP.8.1) 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 EMA’s Emergency Task Force (ETF) 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 (EC), 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 CHMP’s recommendation is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical, and real-world data supporting the safety and efficacy of Pfizer and BioNTech COVID-19 vaccines. 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.¹

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.

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY^® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.