Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry [February 22, 2021] [open pdf - 311KB]
From the Background: "This guidance describes FDA's current recommendations regarding the data and information needed to support the issuance of an Emergency Use Authorization (EUA) under section 564 of the FD&C Act [Federal Food, Drug, and Cosmetic Act] (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 [coronavirus disease 2019], including chemistry, manufacturing, and controls information (CMC); nonclinical data and information; and clinical data and information, as well as administrative and regulatory information. In addition, the guidance provides recommendations regarding key information and data that should be submitted to a relevant investigational new drug application (IND) or cross-referenced master file (MF) prior to submission of an EUA request in order to facilitate FDA's complete and timely review of such a submission, including convening the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This guidance also discusses FDA's current thinking regarding the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate, providing additional context to the discussion regarding EUAs in the guidance for industry entitled 'Development and Licensure of Vaccines to Prevent COVID-19.'"
U.S. Food and Drug Administration: https://www.fda.gov/