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 ...

FDA grants full approval to Moderna's COVID-19 vaccine for children aged 6 months to 11 years with medical vulnerabilities, ...

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

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.

The FDA approved Novavax’s COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness.