Pfizer Inc. and BioNTech SE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for their updated COVID-19 vaccine, COMIRNATY LP.8.1. The vaccine targets the LP.8.1 variant of SARS-CoV-2 and is intended for individuals aged six months and older.
The recommendation follows guidance from the EMA’s Emergency Task Force (ETF), which advised vaccine manufacturers to update formulations to address the LP.8.1 variant for the 2025–2026 respiratory virus season. The ETF emphasized that adapting to this variant will help maintain vaccine effectiveness as the virus continues to evolve.
The CHMP’s recommendation now awaits final approval by the European Commission, which is expected soon. Pfizer and BioNTech have already begun producing doses of the updated vaccine in anticipation of increased demand during the upcoming fall and winter seasons. Distribution to EU member states is expected to begin immediately after the Commission’s decision.
According to the companies, the CHMP’s opinion is supported by a comprehensive data package, including clinical and real-world evidence demonstrating the safety and effectiveness of their mRNA-based vaccines. Data also show that the LP.8.1-adapted vaccine elicits improved immune responses against a range of circulating variants such as XFG, NB.1.8.1, and LF.7, compared to earlier JN.1- and KP.2-adapted formulations.
Pfizer and BioNTech have also submitted regulatory filings for the updated vaccine in other countries as they continue to monitor global COVID-19 trends and prepare to meet public health needs worldwide.
The vaccine is based on BioNTech’s proprietary mRNA platform and co-developed with Pfizer. BioNTech holds the marketing authorization for COMIRNATY in the EU and several other regions, including the U.S. (in partnership with Pfizer).