CEPI Background Documents:
These documents provide a summary of key points from the COVID-19 literature, guidelines and other documents from experts on the subject matter, including from national and multilateral organizations and authorities. Due to the rapidly evolving situation, they not include all the latest evidence and updates are likely. It's purpose is to support organizations and institutions involved in the development of COVID-19 vaccines. These neither constitute an official guidance nor are a substitute for the same and readers are encouraged to also refer to official guidance from regulatory or other responsible agencies.
Click to access or download!
Core Elements for Advanced Stage Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Consider | 26 June 2020 | Amol Chaudhari for CEPI COVID-19 Clinical Working Group | For comments please write to tghn@cepi.net
COVID-19 Efficacy Endpoints in Interventional Trials Version 2.0: What Constitutes an Incident Clinical Disease Case and What Triggers Diagnostic Work-Up | 25 June 2020 | Edde Loeliger & Amol Chaudhari for CEPI COVID-19 Clinical Working Group | For comments please write to tghn@cepi.net
Efficacy Endpoints in COVID-19 Vaccine Trials: SARS-CoV-2 Infection | 25 June 2020 | Amol Chaudhari & Edde Loeliger for CEPI COVID-19 Clinical Working Group | For comments please write to tghn@cepi.net
Vaccine Efficacy Assessment for COVID-19 | 7 May 2020 | By Edde Loeliger and Bob Small for CEPI COVID-19 Clinical Working Group | For comments please write to tghn@cepi.net
Consensus considerations on the assessment of the risk of disease enhancement with COVID-19 vaccines: Outcome of a Coalition for Epidemic Preparedness Innovations (CEPI)/Brighton Collaboration (BC) scientific working meeting. | March 12-13, 2020 | For comments please write to tghn@cepi.net
Priority List of Adverse Events of Special Interest: COVID-19
5 Mar 2020 | By Barbara Law , Miriam Sturkenboom | For comments please write to tghn@cepi.net
COVID-19 Vaccines: Target Product Characteristics
For comments please write to tghn@cepi.net
General Core Elements for Early Phase Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Consider
16 April 2020 | Amol Chaudhari for CEPI COVID-19 Clinical Working Group | For comments please write to tghn@cepi.net
Early and Advanced Stage Clinical Development Core Elements- Comparison of the Guidance and Considerations | 01 September 2020 | Prepared By: Paul Oloo for CEPI COVID-19 Clinical Working Group | For questions, please write to: paul.oloo@cepi.net