Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.

The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials ...

The truth is that for most of that, for many Americans, we simply do not know the answer to whether or not they should be ...

We have to admit to ourselves that America is deeply divided on the policy issue of repeat COVID-19 vaccine doses or boosters ...

The FDA’s new approach to boosters could mean that kids will no longer be able to get vaccinated against the disease to begin with.

"With the COVID pandemic behind us, it is time to adopt a common-sense approach to COVID policy," a spokesperson for the FDA ...

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which ...

But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 ...

A previous federal policy recommended an annual COVID shot for all Americans six months and older. Here is what the new proposal would be.

The US Food and Drug Administration is about to make it harder for people to get a COVID-19 vaccine. According to new ...

Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for ...