Moderna’s 2025-2026 COVID-19 Vaccines Get FDA Approval

The Food and Drug Administration (FDA) has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax^® and mNexspike^®.

The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2, which was selected as the preferred strain at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting in May 2025. 

Spikevax is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19 and all adults 65 years of age and older. The product is supplied in single-dose prefilled syringes containing 1 dose of either 0.25mL for children 6 months through 11 years and 0.5mL for individuals aged 12 years and older. 

Moderna’s new COVID-19 vaccine mNexspike is approved for individuals 12 through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19 and all adults 65 years of age and older. The vaccine is supplied in a single-dose prefilled syringe containing 1 dose of 0.2mL.

Moderna’s updated vaccines are expected to be available in the coming days.

This article originally appeared on MPR