Pfizer and BioNTech have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY LP.8.1.

The vaccine is designed to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.

The CHMP’s recommendation is based on 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.

While the European Commission (EC)’s final decision is pending, the companies have already started manufacturing the 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 companies said that the updated vaccine will be available to ship to applicable EU member states immediately following the EC decision.

The COMIRNATY 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 companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world.

The COVID-19 vaccines developed by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology. BioNTech is the marketing authorisation 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 authorisations or equivalents in the United States (jointly with Pfizer) and other countries.

Meanwhile, the companies continue to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.