MRNA wins FDA approval for mNexspike, a fridge-stable COVID shot, but with a narrower use label than it sought.

The Food and Drug Administration (FDA) has approved Moderna’s next-generation mRNA COVID-19 vaccine mNexspike ®.

The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna ...

NEXSPIKE becomes Moderna’s third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc.

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria ...

The product is a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years.

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

The Food and Drug Administration (FDA) has approved Moderna’s next-generation mRNA COVID-19 vaccine mNexspike ®. The new vaccine is indicated for active immunization to prevent COVID-19 caused ...

From eligibility to dosage and future rollout, here’s what you need to know about the FDA’s latest vaccine approval.

mNexspike is approved for older adults aged 65 and for individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe COVID-19. Moderna had originally sought ...