By Fineline Cube 
US giant Pfizer Inc., (NYSE: PFE) and Germany-based BioNTech SE (NASDAQ: BNTX) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for their LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1). This recommendation covers active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
Vaccine Adaptation and EMA Recommendation
The vaccine adaptation follows the EMA’s Emergency Task Force (ETF) recommendation to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. This recommendation underscores the importance of staying ahead of emerging variants to ensure continued protection against COVID-19.
Manufacturing and Supply Preparedness
Pfizer and BioNTech have already begun “at-risk” manufacturing of the LP.8.1-adapted monovalent COVID-19 vaccine to ensure supply readiness for the upcoming fall and winter season. The updated vaccine will be ready to ship to applicable EU member states immediately upon a decision from the European Commission.
Clinical Basis for Recommendation
The CHMP’s recommendation is based on cumulative evidence submitted by Pfizer and BioNTech. Data indicates 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 prevalent contemporary sublineages, when compared to the companies’ JN.1 and KP.2-adapted monovalent COVID-19 vaccines.-Fineline Info & Tech