African Vaccine Regulatory Forum (AVAREF) was established by WHO in 2006 as a network of National Regulatory Authorities (NRAs) and Ethics Committees (ECs) of African countries providing a platform for building regulatory capacity and promoting harmonization of practices in support of oversight of clinical trials in the region. AVAREF has since played a crucial role in the successful development of several vaccines, notably the meningococcal A conjugate vaccine, whose licensure and rollout has dramatically reduced epidemics of meningococcal A meningitis. The capacity of AVAREF has now been broadened beyond vaccines and includes medicines.

The Sixth set of meetings of African Vaccine Regulatory Forum (AVAREF) was held in Addis Ababa, Ethiopia from 18 to 22 February 2019 and included the Technical Coordinating Committee meeting from 18-20 February followed by the Steering Committee (SC) on 21-22 February. The meeting was attended by approximately 30 participants, including 10 SC members, 8 Technical Coordinating Committee (TCC) members, and the World Health Organization (HQ and AFRO) as the secretariat. Other stakeholders and partners include experts from the New Partnership for Africa's Development (NEPAD), the Bill and Melinda Gates Foundation (BMGF), the Center for Biologics Evaluation and Research (CBER)/US FDA, the Coalition for Epidemic Preparedness Innovations (CEPI) the Paul-Ehrlich-Institut, the Harvard Multi Regional Clinical Trials Center (MRCT), representatives from the Ministry of Health of Ethiopia, and vaccine manufacturers.

The meeting addressed the main objectives of AVAREF, namely harmonization and reliance, regulatory preparedness for emergencies and building on the value proposition of AVAREF to advance regulatory capacity on the continent. Specifically, the meeting included updates on priority vaccine candidates in development, the establishment of the African Medicines Agency and AVAREF work plan; review of the AVAREF Joint Review guideline and annexes based on findings of the Table Top exercise on regulatory preparedness for public health emergencies; as well as discussions of the plan for integration of AVAREF within the African Medicines Regulatory Harmonization initiative (AMRH) and the process of implementation of AVAREF guidelines in Regional Economic Communities (RECs) and countries (National Regulatory Authorities and Ethics Committees).

Dr Rufaro CHATORA, WHO Representative for Ethiopia speaking at the opening of the 6th meeting of AVAREF highlighted the critical importance of regulation of vaccines and medicines as well as the importance of capacity building activities in the African Region, particularly strengthening of ethical and regulatory oversight of clinical trials.

Dr David Mukanga, from the BMGF appreciated the effort of the steering committee for the progress made to date and confirmed continued support for the work of AVAREF.

The 6th meeting of the two committees took place under the new governance and operating model of AVAREF endorsed by heads of National Regulatory Authorities and Ethics Committees in June 2016 in Addis Ababa. The operating model ensures that the two Committees and Secretariat work together closely to address the needs of the Member States.

Several important working documents were reviewed, finalized and endorsed resulting from the recommendations for the next steps.

For further information please contact:

Professor Dicky AKANMORI
Email: akanmorib [at] who.int
WHO AFRO

Dr Diadié MAIGA
Email: maigad [at] who.int
WHO AFRO

Dr Samvel AZATYAN
Email: azatyans [at] who.int
WHO HQ

Dr Elisabeth PLUUT
Email: pluute [at] who.int
WHO HQ