Moderna receives U.S. FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2

Moderna Inc. announced that the FDA has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax and mNEXSPIKE, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.

The updated formula for Spikevax is now approved for individuals 6 months – 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 and all adults 65 years of age and older. mNEXSPIKE, Moderna’s new COVID-19 vaccine, is approved for individuals 12 -64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. With the U.S. FDA’s decision, Moderna’s updated vaccines are expected to be available in the coming days.

“Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalizations last year,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are proud to help ensure Americans will have the latest protection against currently circulating strains this respiratory virus season.”

The updated vaccine composition is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be developed with a monovalent JN.1 lineage, with a preference for the LP.8.1 variant.

Moderna’s updated COVID-19 vaccines targeting LP.8.1 have already been granted approval by regulators in Canada, Europe, Japan, Switzerland and other countries. Additional regulatory applications are under review around the world in preparation for the coming season.