FDA Approves Moderna’s Next-Generation Covid Vaccine With Limited Use for Most Healthy People

On May 31, 2025, the FDA approved Moderna’s new next-generation Covid-19 vaccine, mNexspike, but with restrictions on its use compared to Moderna’s previous vaccine, Spikevax35.

mNexspike is intended mainly for adults 65 and older and for people ages 12 to 64 who have at least one medical condition (such as heart disease, diabetes, obesity, cancer, or COPD) that increases their risk for serious Covid illness, based on CDC definitions3.

Most healthy people under 65 are not eligible for the new vaccine, marking a significant policy shift in Covid-19 vaccine recommendations35.

Approval was based on a Phase 3 trial involving about 11,400 people, which showed mNexspike provided about 9.3% better protection than Spikevax in people 12 and older, and 13.5% better in adults 65 and older3.

mNexspike is based on the Omicron JN.1 variant and uses mRNA technology to trigger the body’s immune response3.

Side effects were generally mild and similar to previous mRNA vaccines, including injection site pain, fatigue, headache, muscle aches, and fever31.

Moderna will make mNexspike available for eligible populations in the U.S. for the 2025–2026 respiratory virus season, alongside Spikevax and its RSV vaccine mRESVIA14.

Sources:

1. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/

3. https://www.webmd.com/vaccines/covid-19-vaccine/news/20250602/fda-approves-moderna-new-covid-vaccine

4. https://www.idse.net/Covid-19/Article/05-25/Moderna-COVID-19-Vaccine-Approval/77325

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