Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people under 65 to get immunized.

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 ...

Dr. Jeffrey Kopin, Chief Medical Officer for Northwestern Medicine Lake Forest Hospital, joins John Williams to talk about ...

President Donald Trump said “I think we’re going to get everything we want” after a closed-door meeting with divided House ...

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

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...

FDA Commissioner Marty Makary and Dr. Vinay Prasad outlined their booster shot clinical trial requirements in the New England Journal of Medicine.

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.