COVID-19 vaccine: How the FDA will determine emergency authorization

The Food and Drug Administration (FDA) issued recommendations last week pertaining to issuance of emergency use authorization (EUA) for investigational COVID-19 vaccines.

The new guidance describes the information and data that must be supplied by a manufacturer to support the authorization, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory administration information.

Click through notes on FDA's statement and requirements of data submitted from phase 3 clinical trials in support of the EUA below.