Issue Date: October 19, 2023
Issued by: Center for Biologics Evaluation and Research
Topic(s): Infectious Disease, Coronavirus, Vaccines
Status: Final
Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry
FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). FDA is committed to providing timely guidance to support the response to COVID-19. The recommendations described in the guidance are expected to assist the Agency and sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19 and reflect the Agency’s current thinking on this issue. Related Information Developing and Manufacturing Drugs Including Biologics
Download the Guidance Document
