On October 6, the U.S. Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) 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.
This guidance provides further information on the EUA process for investigational vaccines and provides additional context to the information provided in the agency’s June guidance regarding the development and licensure of COVID-19 vaccines.
