Development and Licensure of Vaccines To Prevent COVID-19; Guidance for Industry; Availability

The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled "Development and Licensure of Vaccines to Prevent COVID-19." This guidance revises the guidance of the same name, which was announced in the Federal Register on August 3, 2020. FDA is issuing this guidance to assist the Agency and sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19. Additionally, this guidance provides an overview of key considerations to satisfy regulatory requirements set forth in the investigational new drug application (IND) regulations and in the licensing regulations for chemistry, manufacturing, and controls (CMC), and nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation of COVID-19 preventive vaccines. FDA is also announcing the withdrawal of an FDA guidance document related to COVID-19.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.