Moderna receives positive CHMP opinion for updated Spikevax formulation

Moderna (MRNA) nnounced that the European Medicines Agency’s Committee for Medicinal Products for Human Use 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 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.