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Moderna’s new COVID-19 vaccine is aimed at seniors

It’s the first vaccine specifically for adults aged 65 and over

Updated:

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Mark Huffman
Reporter

Mark Huffman has covered consumer issues since 2004, with a special focus on protecting and empowering older adults. A former news correspondent for the Associated Press Radio Network, Westwood One, and ConsumerAffairs, Mark brings decades of journalistic experience to RetirementLiving.com. He is passionate about giving consumers a voice and helping them make informed decisions. Mark has also created educational content, including Senior Scam Alert, a video resource designed to help seniors recognize and avoid fraud. He holds a B.A. from the University of Kentucky and lives with his family in Richmond, Virginia.

Key Insights

  • FDA approves Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk groups
  • Phase 3 trial shows mNEXSPIKE outperforms original vaccine in efficacy for older adults
  • mNEXSPIKE to be available for 2025-2026 respiratory season, along with Moderna’s other vaccines

Flu, COVID-19, and other respiratory diseases usually increase during the fall months, but this fall, seniors will have a new weapon. The U.S. Food and Drug Administration has granted approval to Moderna’s 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.

Moderna CEO Stéphane Bancel called the new vaccine “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 FDA’s approval follows a Phase 3 clinical trial involving approximately 11,400 participants aged 12 and older. The study showed that mNEXSPIKE achieved non-inferior—and in some cases superior—efficacy when compared to Moderna’s original COVID-19 vaccine, Spikevax. 

Trial results

Participants received either a 10 μg dose of mRNA-1283 or a 50 μg 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.

It’s the first approved COVID-19 vaccine since the FDA tightened standards, requiring more tests to show the vaccine’s safety.

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 2025–2026 respiratory virus season, complementing its existing offerings of Spikevax and mRESVIA®, the company’s vaccine for respiratory syncytial virus (RSV). Regulatory reviews for mNEXSPIKE are also underway in multiple international markets.

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