PAMJ supplements

The African Vaccine Regulatory Forum (AVAREF): a model for advancing innovation and achieving continent-wide regulatory harmonization through partnerships and collaboration

AVAREF, a network of African national regulatory authorities and ethics committees, was established by WHO in 2006. The name reflects the group's origin: a joint review of a clinical trial application for a new group A meningococcal conjugate vaccine and the subsequent joint inspection of the vaccine's phase II trial. This review was successfully conducted with countries that had little prior experience in providing regulatory oversight for complex trials. Soon after launching, AVAREF's mandate expanded to enhance ethics and regulatory capacity, as well as harmonize regulatory processes for all types of medical products and devices in Africa. As a result of AVAREF's work, vaccines against meningitis, malaria, rotavirus, pneumococcal pneumonia, and Ebola have been developed and rapidly approved in Africa. AVAREF also played a key role in ensuring the swift regulatory review and decision to grant emergency use authorization (or otherwise) of COVID-19 vaccines in Africa. Now, AVAREF is slated to play a critical role in establishing a clinical trial oversight role for the new African Medicines Agency (AMA). In light of the numerous public health crises facing countries around the globe, the need for regulatory harmonization to speed people's access to lifesaving drugs is greater than ever. However, many low- and middle-income countries have struggled to find a model of regulatory harmonization they can begin implementing right away. The AVAREF model meets member states where they are, empowering them to achieve regulatory harmonization through voluntary partnerships and collaboration. This model can be implemented in any setting in which members would like to speed the development of and access to quality medical products to meet public health priorities. In the articles published in this supplement, we describe how AVAREF functions, its accomplishments, the challenges it has faced, the lessons learned since its launch in 2006, and its plans for the future. We present all this information within the greater context of the need for continental and global regulatory harmonization. We hope that this series, which includes authors from AVAREF leadership, the World Health Organization, the Bill & Melinda Gates Foundation, and participating African member states, will spark discussion of and interest in regulatory harmonization, and also give interested parties around the world the practical tools they need to maximize access to quality medical products. The titles included in this supplement include: Two decades of AVAREF: successes, lessons, and the path forward in the African Medicines Agency Era; Joint reviews and scientific advice: a deep dive into AVAREF's signature services; Harmonizing regulatory processes for clinical trials: the AVAREF toolkit and footprint; From meningitis to COVID-19 vaccines: an overview of AVAREF's contribution to research and development of priority vaccines from 2006 to 2022; Joint review for a phase 3 multicentre vaccine candidate against tuberculosis by the African Vaccine Regulatory Forum Secretariat; AVAREF: a gamechanger for vaccine and medicine regulatory harmonization in Africa and beyond; The African vaccine regulatory forum's role in research and development during public health emergencies: past, present, and future; Mpox vaccine and emergency use authorization: the role of AVAREF, WHO AFRO in accelerating access in Africa; The future of AVAREF and its role, resources, and opportunities in contributing to the success of the emerging African Medicines Agency (AMA).

Guest editors:

• Bartholomew Dicky Akanmori, World Health Organization Regional Office for Africa, Brazzaville (Congo)
• Chinwe Iwu-Jaja, World Health Organization Regional Office for Africa, Brazzaville (Congo)

Contact: Chinwe Iwu-Jaja, Vaccine Preventable Diseases Program, World Health Organization Regional Office for Africa, Brazzaville, Congo (chinwelolo@gmail.com)

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