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Moderna Receives US FDA Approval for Updated COVID-19 Vaccines Targeting the LP.8.1 Variant
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Moderna Receives US FDA Approval for Updated COVID-19 Vaccines Targeting the LP.8.1 Variant
Aug 27, 2025 12:08 PM

02:54 PM EDT, 08/27/2025 (MT Newswires) -- Moderna ( MRNA ) said Wednesday that the US Food and Drug Administration has approved its supplemental biologics license applications for the updated 2025-2026 formulas of Spikevax and mNexspike vaccines, targeting the LP.8.1 variant of SARS-CoV-2 to prevent COVID-19.

The drugmaker's updated vaccines are expected to be available in the coming days. The composition of the vaccines is based on guidance from the FDA to develop COVID-19 vaccines with a monovalent JN.1 lineage with a preference for the LP.8.1 variant, Moderna ( MRNA ) said.

The updated Spikevax formula was approved for individuals aged 6 months through 64 years with at least one underlying condition that increases their susceptibility to severe outcomes from COVID-19, and for adults 65 years and above, the company said.

The new mNexspike vaccine is approved for those aged between 12 and 64 years with at least one underlying condition that puts them at high risk for severe outcomes, as well as for adults 65 years and older, Moderna ( MRNA ) added.

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