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

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 U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

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.

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.

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

Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 ...

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

The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one ...

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...

Science reported that the National Institutes of Health (NIH) director, Jay Bhattacharya, dismissed all members of the agency’s top external advisory body, the Advisory Committee to the Director (ACD) ...

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...