The US Food and Drug Administration has approved Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE, for individuals aged 65 and above, the company announced on Saturday. This marks the first regulatory approval since the agency tightened its vaccine authorisation requirements.

In addition to older adults, the vaccine has also been approved for people 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 said it plans to make mNEXSPIKE available 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 long-time vaccine sceptic Robert F. Kennedy Jr., has introduced stricter oversight on vaccine approvals. On 20 May, the FDA announced that drugmakers would be required to test COVID booster shots against an inert placebo in healthy adults under 65 for approval—effectively limiting authorisations to older adults and high-risk groups.

Unlike previous versions, mNEXSPIKE can be stored in standard refrigerators rather than freezers, allowing for longer shelf life and easier distribution, especially in lower-income countries facing supply-chain challenges.

The CDC, also under Kennedy’s leadership, clarified on Thursday that COVID vaccines remain an option for healthy children, provided parents and doctors agree on the need, softening Kennedy’s earlier statement that the vaccines would be removed from the immunisation schedule.

Analysts say the CDC clarification has reassured investors, as the framework for vaccinating older and at-risk populations remains unchanged. FDA officials estimate that between 100 million and 200 million Americans would still be eligible for annual COVID shots.

Facing declining demand for its original COVID vaccine Spikevax and slower-than-expected uptake of its RSV vaccine, Moderna is relying on a new wave of messenger RNA products for future growth.

The approval of mNEXSPIKE is based on late-stage trial results, which showed the vaccine was not inferior in efficacy to Spikevax in individuals aged 12 and above.

Faridah Abdulkadiri

Follow us on: