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 ...

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 ...

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

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

The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.

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

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.

Kennedy and FDA Commissioner Marty Makary’s approach to assessing vaccines could put Covid boosters out of reach.