Practical strengthening of regulatory and ethics oversight on clinical trials in West Africa using Lassa Fever vaccine development projects and increase regulatory maturity level in targeted countries.
This project (101103241 — ECOWAS-RegECs), which is directed to the Economic Community of West African States (ECOWAS) Member States, is coordinated by CEPI and Funded by the European Union under the Global Health EDCTP3 Joint Undertaking. With CEPI acting as a Project Coordinator, the implementing partners are Food and Drugs Authority, Ghana (G-FDA), West African Health Organization (WAHO), and the Paul Ehrlich Institut (PEI).
The first main objective of the project is to improve the capabilities of Regulators and Ethics Experts in vaccines clinical research oversight, with initial focus on the early stages of vaccine development. For this objective the African Vaccine Regulatory Forum (AVAREF) will be a key partner as we intend to conduct simulations and observations of the AVAREF joint procedures. More specifically, the project team prepares simulation and observation modules making use of applications of Lassa Fever vaccine developers and running them through the AVAREF platform. This will strengthen the ECOWAS Regulators’ and Ethics Experts’ ability to provide scientific advice and assess clinical trial dossiers based on risk-benefit analysis in joint procedures. By exposing National Regulatory Authorities (NRAs) and Ethics Committees (ECs) to the assessment of Lassa Fever vaccines during the vaccine’s development cycle, the project aims to prepare them for licensure and for the case of a possible need for emergency use approval.
This work will promote collaboration between NRAs, ECs and AVAREF for efficient and reliable management of clinical research in West Africa and aims to create a Lassa disease-related regulatory and ethics network.
