Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...

Have you ever wondered about what became of COVID vaccine companies after the pandemic settled down? Find out in this article ...

Because the coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.