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

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 ...

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.

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 ...

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

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

FDA approves Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk groups Phase 3 trial shows mNEXSPIKE outperforms original ...