Moderna Inc. has announced the submission of an application to the U.S. Food and Drug Administration (FDA) for the review of its Spikevax 2025-2026 COVID-19 vaccine formula. This new vaccine targets the SARS-CoV-2 variant LP.8.1, following FDA guidance that COVID-19 vaccines should be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant. The review by the FDA is ongoing, and Moderna is awaiting potential approval in the U.S. This regulatory submission highlights Moderna's continued efforts in advancing mRNA technology to address emerging variants of the virus. There is no indication in the announcement that this submission involves funding or grants obtained by multiple organizations.
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