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GUIDANCE DOCUMENT

Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry October 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-1137
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1137.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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