The U.S. Food and Drug Administration has approved a new lower-dose vaccine for active immunization against COVID-19 caused ...

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 ...

Rep. Marjorie Taylor Greene slams FDA green lighting of Moderna's mNEXSPIKE COVID-19 vaccine, describing the move as "Not ...

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

The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 ...

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

The new vaccine is indicated for individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years or older, or 12 to 64 years of age with at least 1 underlying condition that ...

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

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

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.

Moderna's mNexspike COVID vaccine approved by FDA for older adults and at-risk groups after Phase 3 trial shows improved ...