Moderna announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of the COVID-19 vaccine Spikevax, targeting the SARS-CoV-2 variant LP.8.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older.

Following the CHMP's positive opinion, the European Commission will make a marketing authorization decision on Moderna's updated COVID-19 vaccine for the 2025-2026 season.

"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," said Stéphane Bancel, Chief Executive Officer of Moderna. "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 decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, non-clinical and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 vaccines. The updated vaccine composition aligns with guidance from various global health authorities, which have identified the LP.8.1 strain as an appropriate update to the COVID-19 vaccine composition for the 2025-2026 vaccination season.

Additional regulatory applications for Moderna's updated COVID-19 vaccines targeting LP.8.1 are under review around the world.