Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

Details of the new rules for COVID-19 vaccine approvals were also outlined in an article published by The New England Journal ...

No, this is not true. Vaccines undergo rigorous safety testing and are continuously monitored for adverse events.

The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...

The agency will require manufacturers to conduct randomized, controlled trials to secure approval for healthy Americans.

The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people ...

U.S. regulators will no longer approve COVID booster shots for healthy adults and children without new studies, adding a ...

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

Since the COVID-19 pandemic, there has been a decline in U.S. vaccine uptake, while widespread misinformation and distrust ...

There also was no link between miscarriage risk and the number of vaccinations a woman had gotten, or whether she’d gotten ...

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.