A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The U.S. Food and Drug Administration is now requiring two common COVID-19 vaccines to update their warning labels to include information on two rare heart side effects: myocarditis and pericarditis.

The mNexspike vaccine is supplied as a single-dose prefilled syringe containing 1 dose of 0.2mL. The single 0.2mL dose should be administered at least 3 months after the last dose of COVID-19 vaccine.

After federal health officials made abrupt changes to US Covid-19 vaccine recommendations for pregnant women last month, there’s new confusion and uncertainty about who can get the shots — and ...

This is the same limited use the FDA set in licensing the Novavax COVID-19 vaccine last month. This fall, Moderna anticipates offering both Spikevax and mNexspike as COVID-19 vaccines.

Dr. Paul Offit, a member of a U.S. Food and Drug Administration (FDA) vaccine committee, called Sunday for families of pregnant women with COVID who “suffer severely or die” to sue the federal ...