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

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels ...

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

Details of the new rules for COVID-19 vaccine approvals were also outlined in an article published by The New England Journal ...

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

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk ...

Here’s how COVID-19 vaccine guidance is changing in the U.S. For people at high risk of severe COVID-19. The process of ...

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could ...