Moderna files FDA application for the LP.8.1 targeting Covid-19 Vaccine

Moderna Inc.  announced that it has submitted an application to the  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 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. The submission represents Moderna's continued adaptation of its mRNA platform to address evolving coronavirus variants. Moderna has not disclosed any information regarding the age group that the updated vaccine will target, nor has it mentioned if any clinical studies will be conducted for it.   "Our submission aligns with the FDA's recommendation to update COVID-19 vaccines to better match circulating variants," a Moderna company rep stated. "This approach follows the established model used for seasonal influenza vaccines, where formulations are regularly updated to address the most prevalent strains."