The FDA action comes weeks after US Health Secretary Robert F. Kennedy Jr said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

Cambridge: Moderna has received approval from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics ...

They include a scientist who researched mRNA vaccine technology and became a conservative darling for his criticisms of COVID-19 vaccines, a leading critic of pandemic-era lockdowns, and a ...