AVAREF Achievements
Since its founding in 2006, AVAREF has helped facilitate the development of vaccines against meningitis, malaria, rotavirus, pneumococcal pneumonia, and Ebola.
It is currently supporting the development of medicines for neglected diseases such as human African trypanosomiasis and leishmaniasis. The work of AVAREF has changed and improved people’s lives by expediting the development of new vaccines in the region.
Accelerating review of Ebola clinical trial applications
In 2014-2015, AVAREF responded to the Ebola outbreak by conducting joint reviews of clinical trial applications for Ebola interventions. The affected countries participated in the AVAREF joint review process to conduct timely and best review of clinical trials of EVD candidate vaccines to expedite the vaccine development to fight against the outbreak.
During AVAREF’s 9th annual meeting (3-7 November 2014), the first two days of the meeting were devoted to Ebola, in light of the Ebola outbreak in West Africa and the urgent need to accelerate the development and use of products against the disease. The national regulatory authorities (NRAs) and ethics committees (ECs) of the three Ebola-affected countries (Guinea, Liberia and Sierra Leone) were invited to participate as observers for capacity building, and the WHO AVAREF Secretariat invited experts from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, and Swissmedic to provide technical support.
Developing guidelines for joint and assisted reviews of clinical trial applications
In 2017, AVAREF’s Steering Committee endorsed a set of guidelines for joint and assisted reviews of clinical trial applications. These guidelines, which AVAREF Member States adopted, allowed for clinical trial applications to be processed in a maximum of 60 working days for regular type review process. The newly adopted guidelines helped the members to streamline the review process and expedited the review timelines for timely and harmonized review and approvals.
At the 2019 AVAREF Assembly in Accra, Ghana, a new strategy was endorsed to expand AVAREF’s scope to include medical products beyond vaccines, as the needs for joint reviews for therapeutics had increased. A comprehensive AVAREF Strategic Plan focused on long-term efficiency gains was endorsed by Member States at that AVAREF Assembly.
Accelerating review of COVID-19 clinical trial applications
In early 2020, the AVAREF Technical and Steering committees, supported by the AVAREF Secretariat, developed a critical strategy and guidance document: “A new emergency joint review guideline to respond to the COVID-19 pandemic”. The new guideline reduces the length of time for reviewing clinical trial applications to 15 days for novel products and 10 days for products already registered for other indications. In April 2020, AVAREF’s Member States unanimously agreed to adopt the emergency joint review procedure in a virtual meeting. Since then, AVAREF has facilitated the emergency joint reviews on COVID-19 vaccines and therapeutics in the African region.
In addition, AVAREF Member States agreed to utilize an online platform to record and share data for joint reviews of clinical trial applications for preventive, diagnostic and therapeutic interventions related to COVID-19. The platform allows participating countries to post their queries online for real-time response from trial sponsors. The AVAREF Secretariat has since convened and coordinated virtual meetings for participating countries and sponsors to conduct COVID-19 related joint reviews of clinical trial applications in the African region.