U.S. Approves Moderna's Next-Generation COVID-19 Vaccine with Limited Use

The U.S. Food and Drug Administration (FDA) approved Moderna's new COVID-19 vaccine, mNexspike, late Friday, marking a step toward next-generation coronavirus vaccines. Unlike the company's existing vaccine, Spikevax, the new shot is not a replacement but an additional option for certain groups.
mNexspike uses a lower dose—just one-fifth of Spikevax—by refining its immune target. FDA approval allows its use for adults aged 65 and older, as well as individuals aged 12-64 with health conditions that increase their risk of severe COVID-19. These restrictions mirror those imposed on Novavax's COVID-19 vaccine and reflect broader skepticism within the Trump administration about vaccines.
Moderna's existing vaccine, Spikevax, remains available for anyone aged 6 months and older without such limitations. The company plans to offer both options this fall.
The FDA's decision was based on a study of 11,400 participants, which found mNexspike to be safe and at least as effective as Spikevax, with some measures showing greater efficacy. The approval comes amid reports that the Trump administration canceled funding for Moderna to develop a vaccine against pandemic flu viruses, despite promising early results.

Published: 5/31/2025