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

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

The agency suggested that clinical trials in humans may be required for updated Covid shots, raising questions about whether ...

Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...

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

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

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.

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

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

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

01. Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend when the agency’s commissioner, Marty Makary ...

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.