FDA Issues EUA Guidance for COVID-19 Vaccines

The FDA has issued guidance for sponsors of requests for EUA for COVID-19 vaccines including details on clinical trial data required to support award of EUA.

The Food and Drug Administration (FDA) issued this week recommendations pertaining to issuance of emergency use authorization (EUA) for investigational vaccines against infection with the SARS-CoV2 virus (COVID-19).

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.