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

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

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.

The Food and Drug Administration expanded the approval of Moderna’s RSV vaccine on Thursday, extending the license to include adults aged 18 to 59 who are at high risk of severe illness if they ...

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the agency’s division that regulates vaccines, announced the new framework for COVID-19 vaccines in a livestreamed video 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.

The Food and Drug Administration has approved Moderna's mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at ...

Moderna’s RSV shot was the first non-COVID-19 mRNA vaccine to be approved in the United States. The Centers for Disease Control and Prevention’s (CDC) independent vaccine panel, the Advisory ...