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

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

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

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

The US Food and Drug Administration (FDA) announces new regulatory guidelines for future COVID-19 vaccines and booster shots.

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

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

The US Food and Drug Administration (FDA) announced today that it will only recommend COVID-19 vaccines for adults 65 and ...

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

Top officials in the Trump administration on Tuesday announced they will limit the approval of new COVID-19 vaccines to ...

The Trump administration has announced annual COVID shots for healthy younger adults and children will no longer be routinely ...

New requirements for clinical testing of vaccines, announced this month, may delay the availability of shots that had ...