The vaccine is designed for use by vulnerable groups
of ConsumerAffairsJune 2, 2025
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FDA approves Modernas mNEXSPIKE COVID-19 vaccine for high-risk groups
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Phase 3 trial shows mNEXSPIKE outperforms original vaccine in efficacy for older adults
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mNEXSPIKE to be available for 2025-2026 respiratory season, along with Moderna’s other vaccines
Federal health agencies no longer recommend COVID-19 vaccination for healthy children and pregnant women, but older adults now have a new weapon against the virus.
Moderna said it has received approval from the U.S. Food and Drug Administration (FDA) for its latest COVID-19 vaccine, mNEXSPIKE. The vaccine is now authorized for adults aged 65 and older, as well as individuals aged 12 to 64 who have at least one underlying health condition as defined by the Centers for Disease Control and Prevention.
It’s the first approved COVID-19 vaccine since the FDA tightened standards for vaccines, requiring more safety tests.
This marks Modernas third FDA-approved product and represents what CEO Stphane Bancel called “an important new tool” in safeguarding vulnerable populations against severe outcomes from COVID-19. Bancel underscored the ongoing threat of the virus, citing more than 47,000 deaths in the U.S. in the past year.
The FDAs green light comes on the heels of a Phase 3 clinical trial involving approximately 11,400 participants aged 12 and older. The study showed that mNEXSPIKE achieved non-inferiorand in some cases superiorefficacy when compared to Modernas original COVID-19 vaccine, Spikevax.
Trial results
Participants received either a 10 g dose of mRNA-1283 or a 50 g dose of the original vaccine. The trial found that mNEXSPIKE provided a 9.3% higher relative vaccine efficacy (rVE) overall, and a 13.5% improvement in adults over 65.
In terms of safety, Moderna said mNEXSPIKE demonstrated a comparable side-effect profile to its predecessor, with fewer local reactions and similar systemic reactions. Common side effects included injection site pain, fatigue, headache, and muscle aches.
Moderna said it plans to make mNEXSPIKE available in the U.S. for the 20252026 respiratory virus season, complementing its existing offerings of Spikevax and mRESVIA, the companys vaccine for respiratory syncytial virus (RSV). Regulatory reviews for mNEXSPIKE are also underway in multiple international markets.
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