Development and Licensure of Vaccines to Prevent COVID-19

Development and Licensure of Vaccines to Prevent COVID-19 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.