The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

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

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

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

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S. that will no longer be administered under an emergency use authorization.

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

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government ...

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and safety of COVID-19 vaccines for young children.

The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.

Pfizer and its German partner BioNTech asked London's Court of Appeal on Thursday to overturn a ruling that their COVID-19 vaccine infringed one of Moderna's patents, in the latest round of a ...