Project description
Lassa fever vaccine development in the ECOWAS region
Developing vaccines using new technology and overseeing clinical development in Africa have the potential to attract talented individuals and inspire regulators and ethics experts, ultimately enhancing the workforce in this field. The EU-funded ECOWAS-RegECs project is designed to offer practical training to regulatory and ethics experts in the ECOWAS region, specifically focusing on the development of the Lassa fever vaccine from the early to late clinical stages. The primary goal of this project is to enhance regulatory systems and improve oversight of clinical trials. The project will provide scientific guidance and conduct simulations. Additionally, ECOWAS observer nations will actively participate in real-time clinical trial assessments, thereby contributing to more informed decision-making by national regulatory authorities and ethics committees.
Objective
The proposed strengthening project for clinical research oversight in ECOWAS region, consists of practical training of regulatory and ethics experts by exposing them to Lassa Fever vaccine development from early to late clinical stage. The exposure to novel technologies in vaccine development and the opportunities to responsibly oversee the full clinical development pathway of vaccines for Africa can inspire and attract regulators and ethics experts/talents, and by this contribute to maintaining, enhancing and further developing the workforce at the agencies and ethics institutions. The project intends to enhance the Maturity Level for Regulatory Systems and clinical trial oversight function of 2-4 authorities in the ECOWAS region. Ghana FDA will lead the intended work, with CEPI as project coordinator, Paul-Ehrlich-Institut as supporting agency and WAHO ensuring the dissemination and engagement among ECOWAS countries. The consortium between GFDA, WAHO, PEI and CEPI is confident to assure high quality regulatory and ethics oversight during Lassa Fever vaccine development and to create preparedness of ECOWAS NRAs not only for Lassa vaccine future licensure but also for decisions related to emergency use in case of a major Lassa Fever outbreak.
Using the AVAREF platform for scientific advice and CTA simulations and including ECOWAS observer countries in real live clinical trial application assessments will strengthen the common advice and review processes and lead to reliably generate fast decisions by NRAs and ECs in a seamlessly coordinated way. When processes from application to decision are reliable and fast, developers will prefer using AVAREF platform even for single country clinical trial applications. This will open further possibilities for coordinated involvement of observer countries for training purposes. Seamlessly coordinated collaboration on the basis of harmonized and well-defined processes between NRAs, NECs and AVAREF will promote clinical research in Africa and help the AMA operationalization.
Fields of science
Keywords
Programme(s)
- HORIZON.2.1 - Health Main Programme
Funding Scheme
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinator
0277 OSLO
Norway