6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorisation for an investigational vaccine intended to prevent COVID-19.

The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.

Read FDA in Brief