Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before ...

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

For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the ...

The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...

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

The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...

The FDA has approved the Novavax COVID-19 vaccine, called Nuvaxovid, mainly for adults 65 or older, but people ages 12 to 64 with medical conditions that increase their risk of serious illness from ...

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

The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for ...

Advisers to the U.S. Food and Drug Administration will discuss whether to recommend COVID-19 vaccines for 2025-26 for ...