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

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

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

In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well ...

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over ...

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

"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

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

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

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans — a move that will limit ...