The U.S. Food and Drug Administration (FDA) has approved Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE, for adults aged 65 and older, the company announced Saturday. The approval is the first since the FDA implemented stricter vaccine authorization standards earlier this year.
In addition to seniors, the vaccine has also been authorized for individuals aged 12 to 64 who have at least one underlying health condition identified by the Centers for Disease Control and Prevention (CDC), according to Moderna’s statement.
Moderna plans to roll out mNEXSPIKE for the 2025–2026 respiratory virus season.
“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” said Moderna CEO Stéphane Bancel.
The Department of Health and Human Services, now led by vaccine skeptic Robert F. Kennedy Jr., recently introduced more stringent oversight for vaccine approvals. On May 20, the FDA announced that COVID-19 booster approvals would now require testing against a placebo in healthy adults under 65—effectively narrowing eligibility for new vaccine authorizations to older and high-risk populations.
A key advantage of mNEXSPIKE over previous vaccines is its storage capability. Unlike Spikevax, which requires freezer storage, mNEXSPIKE can be stored in standard refrigerators. This makes it more suitable for global distribution, particularly in lower-income countries where cold-chain logistics pose a challenge.
Meanwhile, the CDC—also under Kennedy’s leadership—issued a clarification Thursday regarding COVID-19 vaccinations for children. While Kennedy had previously suggested removing the vaccine from the childhood immunization schedule, the agency stated that COVID-19 vaccines remain available for healthy children if parents and healthcare providers agree on their use.
Analysts say the CDC’s clarification helped ease investor concerns, reinforcing that the core strategy of targeting older adults and high-risk groups remains intact. FDA estimates suggest that between 100 million and 200 million Americans will still qualify for annual COVID vaccinations.
Moderna, facing waning demand for its original COVID vaccine Spikevax and slower-than-anticipated uptake of its RSV vaccine, is betting on a new generation of mRNA-based products to drive future growth.
The approval of mNEXSPIKE is based on late-stage clinical trial results, which showed that its efficacy in individuals aged 12 and above was not inferior to that of Spikevax.
