Moderna files FDA application for LP.8.1 targeting COVID-19 vaccine

Moderna (MRNA) “announced that it has submitted an application to the U.S. Food and Drug Administration for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. 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 lineage, with a preference for the LP.8.1 variant.”