Early and Advanced Stage Clinical Development Core Elements- Comparison of the Guidance and Considerations

Version 1.0 Dated: 01 September 2020

This document aims to compare guidance and core elements with regards to the design of Early Phase and Advanced Stage clinical trials of COVID-19 vaccine candidates. This comparison is based on the United States Food and Drug
Administration (US FDA) Guidance on Development and Licensure of vaccines to Prevent COVID-19, World Health Organization’s (WHO) International Randomised Trial of candidate vaccines against COVID-19, a Summary of the June 22,
2020 teleconference on global regulators convened under the auspices of International Coalition of Medicines Regulatory Authorities (ICMRA), and summary documents developed by the Coalition for Epidemic Preparedness Innovations
(CEPI).

Prepared By: Paul Oloo for CEPI COVID-19 Clinical Working Group
For questions, please write to: paul.oloo@cepi.net