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

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

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

“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.

In a shift away from next-generation Covid-19 vaccines, the Trump administration is investing $500 million in a vaccine ...

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

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

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.