The Clinical Develoment SWAT Team is holding regular webinars (one per month) to discuss current topics in COVID-19 vaccine development. Material of past workshops can be found below.
SARS-CoV-2 variants - Practical considerations for accelerated clinical development in light of current regulatory guidance
Workshop held on 25 Mar 2021: Workshop Full Report | Workshop Complete Materials | Discussion Forum | Workshop Q&A
Immune Correlates, SARS-CoV-2 variants and ‘mix & match’: How vaccine developer approaches might be impacted by emerging data
Workshop held on 25 Feb 2021: Workshop Full Report | Workshop Complete Materials | Discussion Forum
Summary Documents and Publications
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 may not include all the latest evidence and updates are likely to be made in the future. 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.
Status Report on COVID-19 Vaccines Development | 14 April 2021 | Arun Kumar et al.
Long COVID: Implications for Clinical Development | Version 2.0 dated 29 Mar 2021 | Prepared by: Paul Oloo for CEPI COVID-19 Clinical Working Group
Identifying optimal symptoms combination for PCR trigger | 25 Nov 2020 | Posted on medRxiv
A Comparison of Vaccine Efficacy Elements in Advanced Stage Clinical Trial Protocols V3.0 | 19 Nov 2020 | Prepared by: Paul Oloo for CEPI COVID-19 Clinical Working Group
A Comparison of Study Population Inclusion and Exclusion Criteria reported in Advanced Stage Clinical Trial Protocols | 19 Nov 2020 | Prepared by: Paul Oloo for CEPI COVID-19 Clinical Working Group
Evaluating the Burden-of-Disease Endpoint to Assess Vaccine Efficacy | 26 Oct 2020 | Prepared by:Edde Loeliger and Bob Small for CEPI COVID-19 Clinical Working Group
- Also worth reading: Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials
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: email@example.com
Considerations for Inclusion of Risk Populations into COVID-19 Vaccine Efficacy Trials | 15 July 2020 | Paul Oloo & Edde Loeliger for CEPI COVID-19 Clinical Working Group
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
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
COVID-19 Efficacy Endpoints in Interventional Trials Version 2.0: What Constitutes an Incident Clinical Disease Case and What Triggers Diagnostic Work-Up | Retired as of 20 Oct 2020 | Edde Loeliger & Amol Chaudhari for CEPI COVID-19 Clinical Working Group | This document will no longer be updated and some of the information may not be current. The readers are encouraged to refer to the regulatory guidance by US FDA & the WHO PQ group in the meantime as well the publicly available clinical trial protocols of various developers. Further documents with specific focus on vaccine efficacy are being developed to address the emerging information and will be released shortly.
Vaccine Efficacy Assessment for COVID-19 | 7 May 2020 | By Edde Loeliger and Bob Small for CEPI COVID-19 Clinical Working Group
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
Advanced Stage Clinical Trial Protocols:
Moderna | Pfizer | Astra Zeneca | Janssen | Novavax | Curevac | Butantan Institute
PATHCollection of Protocols and Guidelines
Mutations and Variants