The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

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

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

The agency says it is now set to only recommend Covid vaccines to older adults, those over 65 years old, and people who are ...

The FDA announced it will limit full approval of future COVID-19 booster vaccines to individuals older than 65 and those at high risk for severe disease, marking a shift from the agency’s previous one ...

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 ...

FDA outlines new COVID-19 vaccine regulations, requiring randomized trials when approving shots for healthy Americans. Read ...

COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift ...

The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new ...