Moderna’s 2025–2026 COVID-19 Vaccines Receive FDA Approval

The 2025–2026 formulations of Moderna’s COVID-19 vaccines, Spikevax® and mNexspike®, have received approval from the U.S. Food and Drug Administration (FDA). The LP.8.1 strain of SARS-CoV-2, which was suggested by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) at its May 2025 meeting, is the target of these updated vaccines.

Use and Indications:
Spikevax® is approved for use as an active vaccination to help prevent COVID-19, which is caused by SARS-CoV-2, in the following populations:

• People aged 6 months to 64 years who have at least one underlying condition that puts them at higher risk of developing a serious illness.
• All adults 65 years of age and older.
  Single-dose prefilled syringes containing 0.25 mL doses for children aged 6 months to 11 years and 0.5 mL doses for adults aged 12 and up will be used to administer the vaccine.
  The newly authorized mNexspike® vaccine is prescribed for individuals 12 through 64 years of age with at least one underlying health complication related to a higher risk of serious outcomes from COVID-19, as well as for all adults aged 65 years and older. This formulation will be distributed in single-dose prefilled syringes containing 0.2 mL per dose.
  

Variant-Specific Protection:

In accordance with international health recommendations to update vaccines against circulating strains of SARS-CoV-2, Spikevax® and mNexspike® both target the LP.8.1 variant. The continuous regulatory process to modify COVID-19 vaccines to accommodate new variations includes these approvals.

Availability:

The updated vaccines should be made available in the US through approved distribution channels in the next few days, according to Moderna.

Regulatory Context:

The FDA’s approval is in accordance with the established regulatory framework for mRNA-based vaccine updates in response to changing variants of concern. This guarantees that vaccines continue to be in line with public health authorities’ recommendations about the most common and clinically significant strains of SARS-CoV-2.
“These approvals are meant to support ongoing efforts to mitigate severe disease, hospitalisation, and mortality associated with COVID-19, especially among vulnerable populations,” the agency stressed.