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 ...

By Stephanie Brown HealthDay ReporterTUESDAY, June 3, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

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

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

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 ...

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

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

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

Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...

The safety of approved mRNA vaccines is well-established and, as with other vaccines, continues to be monitored by multiple ...

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement ...

The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to ...