Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

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

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccines.

Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 vaccine Spikevax in children aged six months through 11 years who are at ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots.

Those limits match the terms FDA recently approved for Novavax’s shot, Nuvaxovid and Moderna’s mNexspike. Novavax’s vaccine is the only protein-based coronavirus vaccine available in the U.S.

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.