If coronavirus vaccines are restricted to seniors and those at high risk, parents of young children and relatives of ...

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

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

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

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...

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

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.

Since 2023, federal health officials have recommended an annual COVID-19 shot for most people, and vaccine makers have not ...

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

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

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.