The U.S. Food and Drug Administration has officially approved Moderna’s latest COVID-19 vaccine, named mNEXSPIKE, for use in individuals aged 65 and older, as well as those 12 and up who have underlying medical conditions that put them at greater risk of serious illness.
This next-generation vaccine showed improved performance in clinical trials, where it outpaced the original Moderna formula in effectiveness—particularly among older adults. The updated version is designed to offer broader protection, with enhanced immunity tailored to newer variants of the virus.
Unlike earlier emergency authorizations, this approval follows newer FDA guidelines that require more robust data before allowing widespread distribution, especially for healthy adults under 65. Moderna has said it plans to make the vaccine available ahead of the 2025–2026 respiratory virus season.
In addition to improved efficacy, the mNEXSPIKE vaccine also comes with practical benefits. It can be stored in standard refrigerators, simplifying logistics and making it easier to distribute globally, particularly in areas with limited cold-chain infrastructure.
Moderna’s CEO, Stéphane Bancel, highlighted the vaccine’s importance in reducing severe cases and deaths, especially given that COVID-19 still caused tens of thousands of deaths in the U.S. last year. The company will continue offering its existing products, including the original Spikevax and a vaccine for respiratory syncytial virus (RSV), alongside this new option.
With this approval, healthcare providers will have a new tool in their arsenal to protect vulnerable populations as COVID-19 remains an ongoing public health concern.
