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

Moderna

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.

Read Moderna press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Dossier , Registration , COVID-19