Our work - Data Integration and Signal Detection System / AfriVigilance
- Why does Africa need a continental system when other tools are already available?
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The AU-3S system provides an additional layer for data analysis without impacting existing national and global systems. AU-3S aims to complement existing systems and provide an opportunity to look at African data in an African context. This will improve ownership of African data by ensuring that safety data for key products can always be accessed and managed as and when African countries need it. Furthermore, it provides an opportunity to improve collaboration between national regulatory authorities and immunisation programmes and creates a forum for strengthening the capacity of African countries in the management of safety data.
- What is the AfriVigilance system? How does it differ from the Data Integration and Signal Detection (DISD) system?
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AfriVigilance is the long-term systems objective of the AU-3S programme. While it is still being built, the aim is for it to be a continental database containing safety data from multiple sources for a range of priority healthcare products. It will track the safety of these medical products being used in Africa throughout their end-to-end lifecycle.
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The Data Integration and Signal Detection (DISD) system is an interim solution that acts as the precursor to the continental, long-term AfriVigilance system. The DISD system was quickly developed to meet the immediate needs of monitoring COVID-19 vaccine safety across all pilot countries.
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Key learnings from AU-3S’s experience with the DISD system will feed into the development and implementation of AfriVigilance, and all safety data collected during the pilot will be easily transferable to the long-term solution.
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- Will the AfriVigilance system include pre-market-authorisation data as well as post-market-authorisation data?
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Yes, it is currently envisaged that the AfriVigilance system will include data on the end-to-end safety lifecycle of medical products. This includes pre-market and post-market authorisation data. This will create a holistic database of safety information for all medical products in Africa that can inform safety decisions taken by pharmacovigilance experts in all AU countries.
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The AfriVigilance system should also act as a repository for background incidence rates for adverse events that will be based on historical African safety data. This will help to tailor and improve accurate signal detection and analysis in the future. The vision is to ensure that background rate data for medicines and vaccines, that is specific to the African region, is readily available.
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