Moderna’s 2025-2026 COVID-19 vaccines Spikevax and mNexSpike target the LP.8.1 variant of SARS-CoV-2.
The US FDA approved Moderna’s supplemental Biologics License Applications (sBLA) for the 2025-2026 COVID-19 vaccine formulas for Spikevax and mNexSpike. Spikevax and mNexSpike target the LP.8.1 variant of SARS-CoV-2, according to the company.
The updated formula for Spikevax is now approved for individuals 6 months through 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 through 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.
Moderna said its 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 US 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.
