Moderna, Inc. 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 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.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 an authorization decision on the use of Moderna's updated COVID-19 vaccine for the autumn/winter season 2024-2025.

"The CHMP's positive recommendation for our updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 is a key milestone, demonstrating our commitment to protecting citizens across the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. "As respiratory diseases increase during the winter months, it is crucial for people to protect themselves by getting vaccinated with an updated COVID-19 vaccine that provides enhanced neutralizing antibody responses to JN.1 and its descendant lineages."

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 mRNA vaccines. The updated vaccine composition is based on guidance from the EMA's Emergency Task Force (ETF) in April 2024, which recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the 2024-2025 vaccination campaign. The EMA confirmed this recommendation in July 2024.

Moderna has received approval for its COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 in Japan, Taiwan, and the UK. In the U.S., Moderna has received approval for its COVID-19 vaccine targeting the KP.2 variant of SARS-CoV-2. Additional regulatory applications for Moderna's updated COVID-19 vaccines targeting KP.2 or JN.1 are under review by other regulatory agencies.

In the European Union, Moderna is participating in a tendering procedure for mRNA COVID-19 vaccines by the Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC).