Panel members had questions about whether a new FDA proposal to require randomized trials for vaccines in healthy adults ...

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the ...

Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or ...

The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.

It began in 2020 with a coordinated push to generate public backlash to lockdowns. The ultimate aim was restoring normalcy, ...

Seattle vaccine experts were confused by the country's apparent new direction around updated COVID-19 shots, which top FDA ...

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid ...

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.