The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather ...

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

The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, ...

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

How did we get here? Until now, vaccines for all children under age 12 had been available under emergency use authorization ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...

Health groups led by the American Academy of Pediatrics filed a lawsuit against HHS Secretary Robert F. Kennedy Jr. on Monday ...

FDA Commissioner Dr. Marty Makary has called into question whether the agency will approve and authorize the COVID-19 vaccine for winter, saying that more data is needed.

The FDA has updated labels on the top two COVID-19 vaccines to warn of a rare heart side effect, mostly seen in young men. Here's what to know.

Here's who the FDA says can get a new COVID-19 vaccine this fall amid a change in policy 02:33. The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates ...