In 2006, WHO created the African Vaccine Regulatory Forum (AVAREF) as an informal capacity-building platform aimed at improving the regulatory oversight of interventional clinical trials being conducted in Africa.
Over the years, AVAREF has worked to strengthen regulatory and ethics reviews, promote harmonized standards and approaches, and accelerate the review of vaccines of high public health value among member countries. It has also shed light on the growing complexity of biomedical research, which calls for increased cooperation between partners including donors, researchers, product developers, regulators and the medical ethics community.
AVAREF uses harmonization and reliance as pillars for capacity building, ensuring that there is collaboration between key stakeholders including donors, health professionals and regional economic blocs across the continent by promoting joint reviews, work sharing and use of expertise. As a result, important vaccines against meningitis, malaria, rotavirus, invasive pneumococcal diseases, pneumonia and Ebola have been developed, and important vaccines for other diseases are also under development.
Through joint reviews, AVAREF supports National Regulatory Authorities (NRAs) and Ethics Committees (ECs) to build technical capacity for accelerating review of clinical trial applications (CTAs). Joint reviews are intended to enhance the quality of the reviews of an application submitted to multiple countries by allowing regulators and ECs to exchange and validate their findings with peers. It has also helped vaccines developers to expedite launching clinical studies and eventually introduce vaccines in African Region.