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.

The Data Integration and Signal Detection (DISD) system is an interim solution to pool cross-country safety data for COVID-19 vaccines. It has been implemented with technical support from the MHRA. Safety data from programme countries feed into the database to provide a larger pool of adverse events. This will strengthen signal detection activities, help to verify existing signals, and broaden the pool of data available for evaluation. Currently, the DISD system is limited to COVID-19 vaccine related safety data from the 4 initial AU-3S pilot countries.

The DISD system is the combination of both the database and signal analysis system. Leveraging the MHRA’s systems for the interim AU-3S data solution has two main benefits:

• Increased level of support that the AU-3S programme can provide to build in-country capacity to analyse safety data, notably via trainings and ongoing guidance from world-class experts.

• Allows AU-3S to use UK vaccine data as a baseline to determine the statistical significance of drug event combinations – as this data is severely limited for Africa. The DISD system and subsequent AfriVigilance system will be used to build the pool of Africa specific background adverse event incidence rates.

Outputs of data mining runs from the DISD system are used by the AU-3S Joint Signal Management (JSM) Group, which launched in April 2021, to investigate and act on potential signals. The MHRA provides technical support to the AU-3S JSM Group’s analysis and interpretation of signal reports.

As of July 2021, the DISD system received real-time data from all 4 AU-3S pilot countries for a total of 4 different COVID-19 vaccines. This data came from both passive and active surveillance efforts across the countries. The AU-3S team is furthermore looking to include safety data from clinical trials where available. When required, all data from the interim DISD system should be readily transferable to the AfriVigilance system. As mentioned above, this data will be an important input for determining and using background adverse event incidence rates that are specific to the African population.