Leaders of the Food and Drug Administration May 20 announced new guidelines for administering the COVID-19 vaccine in a paper published by the New England Journal of Medicine.

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

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

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

Large, lengthy studies will be needed for the agency to approve boosters for healthy adults and children, regulators said.

The order added that America would not be bound by amendments to international health regulations agreed on in 2024. Those changes, which tighten virus-surveillance and reporting obligations on ...

In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people ...

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