23 May 2025 - Moderna today announced that it has submitted an application to the US FDA 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 US 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.