ECOWAS-RegECs

The challenge

Lassa fever is an epidemic-prone zoonotic disease endemic in parts of West Africa, including Benin, Ghana, Guinea, Liberia, Mali, Nigeria and Sierra Leone. Clinical development of Lassa fever vaccines raises complex regulatory and ethical questions, particularly during outbreaks when trial designs may need to be adapted and reviewed under urgent timelines.

National regulatory authorities (NRAs) and ethics committees therefore need practical experience with vaccine development pathways, joint review procedures, and emergency-use considerations to protect participants while enabling timely clinical trial review.

The project

ECOWAS-RegECs strengthens regulatory and ethics oversight of clinical trials in West Africa by using Lassa fever vaccine development as a practical learning platform. The project is coordinated by CEPI and implemented with Ghana FDA, WAHO and the Paul-Ehrlich-Institut, with collaboration from AVAREF, vaccine developers, AMRH, WHO, the Gates Foundation, and regulatory and ethics partners in the region.

The project activities included:

• Hands-on simulations and observation opportunities to expose ECOWAS regulators and ethics committee members to scientific advice and clinical trial review through the AVAREF platform of previous submissions from developers of Lassa fever vaccines.
• Joint review processes to support more coordinated, consistent and rapid decision-making across countries, including approaches relevant to public health emergencies.
• Targeted benchmarking and institutional development support for selected NRAs, including Liberia and Senegal, to help strengthen clinical trial oversight and progress towards higher WHO GBT maturity levels.

Impact

ECOWAS-RegECs has strengthened regulatory and ethics readiness for Lassa fever vaccine trials and other outbreak-related studies. It has built practical expertise, improved familiarity with AVAREF procedures and supported more predictable, harmonised review pathways across West Africa. 

• Regulators and ethics reviewers gained direct experience of scientific advice and clinical trial review under emergency-relevant timelines.
• Selected NRAs received support to address oversight gaps and advance institutional development plans.
• The project created a practical model for regional cooperation that can be applied to other epidemic-prone pathogens and future vaccine development programmes.

The project has led to the further fine-tuning of the AVAREF procedures, improving transparency, harmonisation, and reliability of the multi-country procedures for clinical trial application review in West Africa. From a European perspective, these advancements are particularly advantageous for European vaccine developers, as standardised review timelines and parallel regulatory and ethics processes minimise uncertainty and administrative hurdles for sponsors. The improved predictability encourages greater investment and collaboration in the region.

With higher regulatory maturity and the use of the AVAREF platform for joint reviews, European developers can expect clearer, faster pathways for vaccine approval and market access. This facilitates earlier entry into African markets and promotes stronger partnerships between European and African regulatory bodies.

Overall, this project has resulted in improving the experience of the regulators and ethicists with issuance of scientific advice and review of clinical trial applications, which provides mutual benefits: European pharmaceutical and vaccine companies gain a more predictable environment for research, while the region is better equipped to evaluate and deploy vaccines for emerging diseases. The project’s achievements contribute directly to global health security by supporting timely and effective responses to epidemics and will provide a blueprint for coordinated work on other vaccine development projects against epidemic-prone pathogens, such as Rift Valley fever.