Moderna has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its updated COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1.
The recommendation supports marketing authorization for use in individuals aged six months and older. A final decision from the European Commission is pending.
Stéphane Bancel, Chief Executive Officer of Moderna, said: “The CHMP’s positive opinion on our updated COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1 is an important milestone in our ongoing effort to protect people across the European Union.”
He added: “COVID-19 continues to place a significant burden on vulnerable populations and healthcare systems. Updated vaccines can be an important tool for protecting individuals and societies.”
The CHMP’s decision is based on manufacturing and preclinical data, alongside prior clinical, non-clinical and real-world evidence supporting the safety and efficacy of Moderna’s COVID-19 vaccines.
The updated formulation aligns with guidance from global health authorities, which have identified LP.8.1 as the recommended strain for the 2025-2026 vaccination season.
Moderna confirmed that additional regulatory applications for the LP.8.1-targeting vaccine are currently under review in other regions.
Founded in Cambridge, Massachusetts, Moderna has pioneered mRNA technology for over a decade. The company developed one of the earliest COVID-19 vaccines and continues to advance mRNA-based medicines across infectious diseases and other therapeutic areas.
