The U.S. FDA has approved Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE, for adults aged 65 and older and those aged 12–64 with risk factors, marking a major step under tighter regulations.

The U.S. Food and Drug Administration has approved Moderna’s latest COVID-19 vaccine, mNEXSPIKE, for people aged 65 and above and for those aged 12 to 64 with at least one underlying risk factor, as defined by the CDC. This is the first approval following the agency’s recent tightening of vaccine requirements.

Moderna expects to distribute the updated mRNA-based vaccine during the 2025–2026 respiratory virus season. Unlike previous versions, mNEXSPIKE can be stored in regular refrigerators, simplifying distribution, particularly in low-resource settings.

“This approval adds an important tool to help protect high-risk groups,” said Moderna CEO Stéphane Bancel.

The FDA recently shifted its guidelines, requiring placebo-controlled trials for younger, healthy adults, effectively limiting new COVID-19 boosters to those at higher risk of severe disease. Regulatory tightening comes under the Department of Health and Human Services, now led by Robert F. Kennedy Jr., who has long expressed skepticism about vaccines.

Despite concerns over regulatory changes, the CDC reaffirmed that COVID vaccines remain an option for healthy children when deemed necessary by parents and doctors. Analysts say this helps maintain market stability for vaccine makers by preserving demand in core demographics.

The FDA also recently approved Novavax’s protein-based COVID vaccine Nuvaxovid, but similarly restricted its use to older and at-risk individuals. Moderna, meanwhile, is focusing on its newer mRNA pipeline to counter declining interest in its original Spikevax and lower-than-expected uptake of its RSV shot.

Trial data supporting mNEXSPIKE’s approval showed the new vaccine performed equally or better than Spikevax, particularly among adults aged 18 and older.

As the U.S. government pursues agency overhauls and budget cuts, questions remain about the long-term regulatory environment. Still, with 100 to 200 million Americans eligible for boosters under current rules, the market for COVID-19 vaccines - especially next-generation options like mNEXSPIKE - remains significant.

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