Moderna files FDA application for JN.1 targeting COVID-19 vaccine

Moderna has submitted an application to the U.S. Food and Drug Administration for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1. The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 composition for the 2024-2025 season. This guidance aligns with the recommendations from the World Health Organization Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition. Moderna is submitting data to regulators worldwide to support registration and supply of the 2024-2025 formula of Spikevax in time for the upcoming vaccination season.