The COVID-19 pandemic exposed Africa’s vulnerability in accessing vaccines, with much of the continent relying on external donations and slow global distribution.
This highlighted the urgent need for stronger regulatory systems to ensure timely vaccine approval and distribution.
In response, the Coalition for Epidemic Preparedness Innovations (CEPI), in collaboration with the West African Health Organization (WAHO), the Paul Ehrlich Institute (PEI), and the Ghana Food and Drugs Authority (FDA), launched the ECOWASRegECs Project.
This initiative aims to strengthen regulatory and ethical oversight for clinical trials, ensuring West Africa is better prepared for future health threats, such as Lassa fever.
From March 10-12, 2025, Work Package 2, led by Ghana FDA hosted over 50 regulators and ethics professionals from 11 ECOWAS nations and Chad in a hybrid simulation exercise designed to sharpen vaccine trial oversight in Accra. The training included:
- Scientific Advice Meeting: Focused on assessing early-stage clinical development plans for a Lassa fever vaccine.
- Clinical Trial Application (CTA) Review: A real-world review of a vaccine trial application to test regulators’ ability to assess trial readiness.
These exercises provided a practical, high impact learning experience, ensuring that national regulators and ethics committees can independently evaluate and approve vaccines.
The ECOWASRegECs Project is anchored in expert-led training, featuring world-class regulatory institutions, including:
- Ghana FDA – The only regulatory authority in Africa with WHO Maturity Level 4 status in clinical trial oversight.
- PEI, Germany – A global leader in vaccine regulation.
- NAFDAC, Nigeria – One of West Africa’s most advanced regulatory agencies.
- CEPI – A key player in Africa’s regulatory preparedness.
Through direct mentorship and real-time feedback, these experts are equipping African regulators with the knowledge and skills to manage vaccine trials without external dependency.
Beyond training, the project is making long-term investments in Africa’s regulatory capacity. Under Work Package 3 (WP3), led by Ghana FDA, national regulatory authorities are being strengthened using WHO’s Global Benchmarking Tool (GBT). This ensures that West African countries can independently approve and regulate vaccines, reducing reliance on foreign regulatory systems.
The ECOWASRegECs Project is more than a training initiative-it is a strategic step towards Africa’s vaccine autonomy. With funding from the Global Health EDCTP3 Joint Undertaking, this initiative places West Africa at the forefront of vaccine regulation, ensuring the region is ready, resilient, and self-reliant in the face of future epidemics.
The future of vaccine regulation in Africa starts now.
