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

We want to know more about what these products are doing,” said Dr. Vinay Prasad in a recent FDA livestreamed presentation. The statement is made as there has been a significant policy shift in the U.

How did we get here? Until now, vaccines for all children under age 12 had been available under emergency use authorization (EUA) since 2022. That meant that, theoretically, all children had access to ...

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

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and safety of COVID-19 vaccines for young children.

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

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

The FDA has mandated updated warning labels for Pfizer’s Comirnaty and Moderna’s Spikevax COVID vaccines, acknowledging increased risks of myocarditis and pericarditis that have emerged from ...

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.

Healthy younger adults and children will no longer be automatically approved for annual COVID-19 vaccines under a new policy from the FDA.

The FDA's expected to announce that it's authorizing COVID-19 vaccine booster shots for some people who are immunocompromised, according to a source. This would be a third shot of the current two ...

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 ...