A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccines.

Vinay Prasad, a prominent critic of covid vaccine policy, was ousted as the FDA’s top regulator of vaccines and gene therapies, according to two people familiar with the situation.

A negative result from a COVID test in a medical setting is more accurate than a negative result from an at-home test, ...

The new shots won’t be available until the fall, and are expected to be approved only for adults 65 and up and kids and ...

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

On Thursday, the FDA told vaccine manufacturers to, if possible, update their coronavirus shots to target the most prevalent strain of the virus circulating in the United States — increasing the ...

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

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.

Under the new FDA leadership, updated COVID shots are being limited primarily to high-risk individuals including adults over 65 and those with underlying health vulnerabilities.

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