It is envisioned for AfriVigilance to be a continental database that includes data on the end-to-end safety lifecycle of priority medical products in Africa. The AfriVigilance system should enable the ownership and analysis of African data in the African context. The system will pool data from multiple sources – such as clinical trials, registration processes, and passive or active surveillance systems – from multiple countries. Analysis of this data can be used to help inform key safety decisions across the continent, further providing an avenue for collaboration and capacity strengthening in safety data management for African PV systems. AfriVigilance aims to complement the WHO/Uppsala Monitoring Centre (UMC) system as data will be linked and shared with this global system.
Due to the sudden and urgent need of COVID-19 safety surveillance, the AU-3S programme first developed an interim solution named the Data Integration and Signal Detection (DISD) system. The DISD system is seen as the precursor to the AfriVigilance system which is still to be built. This was due to the longer-term timeframe that is required to develop and implement the AfriVigilance system. The DISD system therefore utilises existing technology made available by the MHRA. This approach allowed AU-3S to participate in safety surveillance of COVID-19 vaccines while still building capacity and better understanding business requirements for the longer term AfriVigilance system.