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 ...

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

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

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

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

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

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

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

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.