July 11, 2025 — The FDA has given full approval to Moderna's COVID-19 shot, Spikevax, allowing it to be used in children 6 months to 11 years old, with some limits on who can get it.

The leader of the U.S. FDA's division that oversees vaccines, Vinay Prasad, overruled the recommendations of his agency's staff by limiting broader use of two COVID-19 vaccines. The FDA scientists ...

COVID-19 remains a public health threat, resulting in a recorded 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control ...

The agency's career scientists had initially concluded on April 1 that Novavax's data submitted in its Biologics License Application, or BLA, and COVID-19's ongoing public health threat warranted ...

Moderna is preparing to test Health Secretary Robert F. Kennedy Jr.'s tougher vaccine policies with a combination flu-COVID shot. The question is whether it gets approved for both viruses. Why it ...

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 ...

COVID-19 remains a public health threat, resulting in a recorded 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control ...

COVID-19 remains a public health threat, resulting in a recorded 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control ...