Periodic Reporting for period 1 - ECOWAS-RegECs (Practical strengthening of regulatory and ethics oversight on clinical trials in West Africa using Lassa Fevervaccine development projects and increase regulatory maturity level in targeted countries)
Reporting period: 2023-06-01 to 2024-05-31
Project Name: “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” (ECOWAS-RegECs).
Public reference for project overview and updates: ECOWAS-RegECs project website in English and French language "https://www.ecowasregecsproject.com/about"
Project Context and Overall Objectives:
The ECOWAS-RegECs project on practical strengthening of regulatory and ethics oversight on clinical trials in West Africa using Lassa Fever vaccine development projects and increase maturity level in targeted countries aims to strengthen technical skills and capacity of national regulatory authorities (NRAs) and ethics committees (ECs) to be better prepared for licensure of Lassa fever vaccine as preventive intervention or response to outbreaks of Lassa fever epidemics in West Africa.
Lassa fever is a zoonotic disease associated with acute and potentially fatal hemorrhagic illness caused by Lassa fever virus. The disease is transmitted through animal vector (rat) and is prevalent in many West African Countries, such as Benin, Ghana, Guinea, Liberia, Mali, Nigeria and Sierra Leone. The prevalence of Lassa virus infections in West Africa per year is estimated at 100,000 to 300,000 cases, with approximately 5,000 deaths. Overall case fatality rate of Lassa fever is at 1%. Lassa fever virus is among the pathogens in the World Health Organization (WHO) Research and Development (R & D) Blueprint list of epidemic threats which requires urgent preventive measures.
The project will promote joint scientific advice and clinical trial review processes using African Vaccine Regulatory Forum (AVAREF) platform. ECOWAS NRAs and ECs will be exposed to Lassa fever vaccine development projects and nominated staff will be trained through simulation and observation opportunities. The objective is to enhance clinical trial oversight capacity of ECs and NRAs in West Africa and prepare for licensure of Lassa Fever vaccines or a possible emergency use approval in case of an outbreak.
A further project’s main objective is to and enhance the Maturity Level of selected NRAs, which will contribute to enhance clinical trial oversight capacity and improve epidemic and pandemic preparedness of the region.
A Consortium of Partners have been established to implement the project and is composed of Coalition for Epidemic Preparedness Innovations (CEPI), Ghana Food and Drug Authority (Ghana FDA), West African Health Organization (WAHO) and Paul-Ehrlich-Institute (PEI). The project has a duration of 24 months, from 1st June 2023 to 31th May 2025. Important collaboration partners are AVAREF, the vaccine developers, the Nigerian and Senegalese NRA and EC, the African Medicines Regulatory Harmonization Program (AMRH), WHO, Bill and Melinda Gates Foundation.
Project Activities:
One project workstream 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 will inspire and attract regulators and ethics experts/talents, and by this contribute to maintaining, enhancing, and further developing the workforce of regulatory authorities and ethics institutions.
Using AVAREF platform for scientific advice and clinical trial applications simulations and including ECOWAS observer countries in real live clinical trial application assessments will strengthen joint advice and review processes and lead to reliably generate fast decisions by NRAs and ECs in a seamlessly coordinated way.
A second project workstream intends to enhance the Maturity Level for Regulatory Systems and Clinical Trial oversight functions of 2 authorities in the ECOWAS region.
Ghana FDA lead the intended work with CEPI as project coordinator and Paul-Ehrlich-Institute and the West African Health Organization (WAHO) as supporting agency. WAHO and AVAREF ensure the dissemination and engagement among ECOWAS countries, and AVAREF support is instrumental for the joint review processes.
Public reference for project overview and updates: ECOWAS-RegECs project website in English and French language "https://www.ecowasregecsproject.com/about"
Project Context and Overall Objectives:
The ECOWAS-RegECs project on practical strengthening of regulatory and ethics oversight on clinical trials in West Africa using Lassa Fever vaccine development projects and increase maturity level in targeted countries aims to strengthen technical skills and capacity of national regulatory authorities (NRAs) and ethics committees (ECs) to be better prepared for licensure of Lassa fever vaccine as preventive intervention or response to outbreaks of Lassa fever epidemics in West Africa.
Lassa fever is a zoonotic disease associated with acute and potentially fatal hemorrhagic illness caused by Lassa fever virus. The disease is transmitted through animal vector (rat) and is prevalent in many West African Countries, such as Benin, Ghana, Guinea, Liberia, Mali, Nigeria and Sierra Leone. The prevalence of Lassa virus infections in West Africa per year is estimated at 100,000 to 300,000 cases, with approximately 5,000 deaths. Overall case fatality rate of Lassa fever is at 1%. Lassa fever virus is among the pathogens in the World Health Organization (WHO) Research and Development (R & D) Blueprint list of epidemic threats which requires urgent preventive measures.
The project will promote joint scientific advice and clinical trial review processes using African Vaccine Regulatory Forum (AVAREF) platform. ECOWAS NRAs and ECs will be exposed to Lassa fever vaccine development projects and nominated staff will be trained through simulation and observation opportunities. The objective is to enhance clinical trial oversight capacity of ECs and NRAs in West Africa and prepare for licensure of Lassa Fever vaccines or a possible emergency use approval in case of an outbreak.
A further project’s main objective is to and enhance the Maturity Level of selected NRAs, which will contribute to enhance clinical trial oversight capacity and improve epidemic and pandemic preparedness of the region.
A Consortium of Partners have been established to implement the project and is composed of Coalition for Epidemic Preparedness Innovations (CEPI), Ghana Food and Drug Authority (Ghana FDA), West African Health Organization (WAHO) and Paul-Ehrlich-Institute (PEI). The project has a duration of 24 months, from 1st June 2023 to 31th May 2025. Important collaboration partners are AVAREF, the vaccine developers, the Nigerian and Senegalese NRA and EC, the African Medicines Regulatory Harmonization Program (AMRH), WHO, Bill and Melinda Gates Foundation.
Project Activities:
One project workstream 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 will inspire and attract regulators and ethics experts/talents, and by this contribute to maintaining, enhancing, and further developing the workforce of regulatory authorities and ethics institutions.
Using AVAREF platform for scientific advice and clinical trial applications simulations and including ECOWAS observer countries in real live clinical trial application assessments will strengthen joint advice and review processes and lead to reliably generate fast decisions by NRAs and ECs in a seamlessly coordinated way.
A second project workstream intends to enhance the Maturity Level for Regulatory Systems and Clinical Trial oversight functions of 2 authorities in the ECOWAS region.
Ghana FDA lead the intended work with CEPI as project coordinator and Paul-Ehrlich-Institute and the West African Health Organization (WAHO) as supporting agency. WAHO and AVAREF ensure the dissemination and engagement among ECOWAS countries, and AVAREF support is instrumental for the joint review processes.
The roadmap for the practical training of regulatory and ethics experts through simulations and observations on Lassa fever vaccine scientific advice and clinical trial applications using the AVAREF joint review platform has been established in the Roadmap Meeting in Accra in Aug 2023. The current roadmap foresees to conduct 4 simulations, 2 for scientific advice and 2 for clinical trial applications until Feb 2025.
A real time Lassa fever vaccine joint AVAREF Scientific Advice procedure took place on 1 Nov 2023, and, on short notice, the project team could arrange for observation by other ECOWAS countries. Regulators from Senegal, Liberia, Cote d’Ivoire, Cape Verde, Ghana, Mali, Togo, Benin, and Burkina Faso could experience the joint AVAREF scientific advice on IAVI Lassa Fever Vaccine clinical development plans. In a subsequent procedural Q&A session the observers could deepen their understanding of the joint AVAREF scientific advice process. Feedback by trainees was very appreciative.
After a cumbersome preparation phase, including a first engagement meeting with ECOWAS NRAs and ECs for expression of interest and trainee assignment in July 2023, the Roadmap Meeting and the preparation and signature of Information Sharing and Confidentiality Agreements with developers, the 1st simulation of a scientific advice was scheduled for June 2024.
Maturity Level enhancement support by Ghana FDA is intended for 2 authorities in the ECOWAS region. After mapping of the maturity status of the collaborating ECOWAS NRAs, a pool of 3 candidate authorities has been suggested through the diligent work of a consultant applying predefined selection criteria, which were established und lead of WAHO. Subsequently, 2 authorities were proposed to be selected to the project governance bodies. The Maturity Level enhancement support was scheduled to start in July 2024.
A real time Lassa fever vaccine joint AVAREF Scientific Advice procedure took place on 1 Nov 2023, and, on short notice, the project team could arrange for observation by other ECOWAS countries. Regulators from Senegal, Liberia, Cote d’Ivoire, Cape Verde, Ghana, Mali, Togo, Benin, and Burkina Faso could experience the joint AVAREF scientific advice on IAVI Lassa Fever Vaccine clinical development plans. In a subsequent procedural Q&A session the observers could deepen their understanding of the joint AVAREF scientific advice process. Feedback by trainees was very appreciative.
After a cumbersome preparation phase, including a first engagement meeting with ECOWAS NRAs and ECs for expression of interest and trainee assignment in July 2023, the Roadmap Meeting and the preparation and signature of Information Sharing and Confidentiality Agreements with developers, the 1st simulation of a scientific advice was scheduled for June 2024.
Maturity Level enhancement support by Ghana FDA is intended for 2 authorities in the ECOWAS region. After mapping of the maturity status of the collaborating ECOWAS NRAs, a pool of 3 candidate authorities has been suggested through the diligent work of a consultant applying predefined selection criteria, which were established und lead of WAHO. Subsequently, 2 authorities were proposed to be selected to the project governance bodies. The Maturity Level enhancement support was scheduled to start in July 2024.
The project team could arrange for observation of a real time Lassa fever vaccine joint AVAREF Scientific Advice procedure that allowed participation of regulators from all ECOWAS countries as observers. This was the first time such an observation opportunity for regulatory strengthening could be offered.