Moderna’s Next-Generation COVID Shot Gets FDA Backing With Usage Limitations

The FDA approved Moderna’s next-generation COVID-19 vaccine, now named mNEXSPIKE (formerly mRNA-1283), for use in adults 65 and older, and for individuals aged 12 to 64 who have underlying risk factors such as asthma, diabetes, or COPD45.

The approval is limited, excluding healthy individuals under age 65 who do not have risk factors45.

mNEXSPIKE demonstrated non-inferiority and a similar safety profile compared to Moderna’s original Spikevax in a phase 3 trial with 11,400 participants4.

The new shot showed a 9.3% higher relative vaccine efficacy for participants aged 12 and older compared to Spikevax, with efficacy rising to 13.5% among those 65 and older in a subgroup analysis4.

Moderna anticipates making the vaccine available in the U.S. for the 2025-2026 respiratory virus season4.

This approval comes amid broader debates about mRNA vaccine safety and recent federal contract cancellations for Moderna’s other vaccine development projects5.

Sources:

4. https://www.fiercepharma.com/pharma/modernas-next-gen-covid-shot-gets-fda-backing-some-limitations

5. https://www.statnews.com/2025/05/31/moderna-covid-vaccine-mnexspike-fda-approval/