No, AU-3S is a long-term programme to strengthen safety surveillance across Africa for novel and innovative products in African Union priority disease areas. These are HIV/AIDS, tuberculosis, malaria, and emergency diseases such as Ebola and COVID-19. AU-3S solutions were developed to meet the needs of the COVID-19 vaccine rollout but aim to also be applicable to any other future medicines or vaccines in a priority disease area.

The AU-3S programme aims to complement ongoing work done by national systems and global organisations – notably the World Health Organisation (WHO) and Uppsala Monitoring Centre (UMC). AU-3S provides an additional layer for data analysis without impacting existing national and global systems. Simultaneously, the programme aims to improve collaboration between countries’ national regulatory authorities and immunisation programmes and create a platform to access and view data in an African context. This will allow for ownership of African data by African countries whilst still sharing with global systems.

This term refers to the principles adopted by the AU-3S programme in implementing all solutions. A “smart” approach adopts the use of pilot studies to show proof of concept before scaling, adapts best practices and experiences learned from previous related initiatives, leverages accessible and evolving technologies (such as mobile reporting apps and artificial intelligence), and ensures early stakeholder engagement and buy-in across all levels of the programme. In adopting a “smart” approach the AU-3S programme aims to develop fit-for-purpose and best-in-class solutions which have been tested and adapted to the local context.

Currently, four countries (Ethiopia, Ghana, Nigeria, and South Africa) are actively involved in the pilot phase of the AU-3S programme. These countries cover roughly one third of Africa’s population and were originally selected for strategic reasons related to COVID-19. The AU-3S programme is expected to soon start expanding the pilot phase to additional countries. This will expand regional coverage and adapt pilot solutions for different languages. 

The pilot phase of the programme aims to test the principles with a small number of countries to efficiently enable the scaling of the programme to additional countries in the future. This pilot is due to be expanded in the short-term to a small number of additional countries with the aim of achieving more regional and language diversity. The long-term objective of the AU-3S programme is to operate at a continental level.

The pilot phase of the programme mobilised and launched quickly to support countries with safety monitoring of COVID-19 vaccines. The initial four pilot countries were selected for strategic reasons, with the number of countries selected kept small to ensure focused and agile development of solutions. This enabled efficient communication and seamless collaboration between the countries and the AU-3S programme while the principles of the programme were still being tested and developed. The pilot is expected to soon be expanded to a select number of additional countries with the aim of achieving more regional and language diversity.

• AU-3S aims to steadily expand into other countries and include their safety data into the database and signal analysis system used. If you wish to express interest in joining AU-3S then please email the AU-3S programme directly using AU3S@nepad.org.

• In addition to this, capacity strengthening training modules have been recorded and are available for use by all AU countries on the AU-3S e-Learning portal.

• AU Member States that are interested in obtaining the Med Safety App are to please contact WEB-RADR using WEB-RADR@mhra.gov.uk for further information.

The AU-3S programme has funding in place to test principles in a small number of representative countries. Additional funding is required to fully scale-up across the continent. AU-3S welcomes discussions with funders interested in investing in pharmacovigilance strengthening in Africa.

The AU-3S programme is driven by AUDA-NEPAD working with individuals from NRAs and EPIs of member states. The programme is technically supported by the UK Medicine and Health products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), WHO-AFRO, and WHO-EMRO. The AU-3S also works in close collaboration with other continental stakeholders such as Africa CDC, AMRH, and AVAREF. The Bill and Melinda Gates Foundation is the funding partner for AU-3S.

The MHRA is a key technical partner of the AU-3S programme. The MHRA is providing ongoing support and pharmacovigilance expertise to the AU-3S Joint Signal Management Group. The MHRA has also supported with implementing technological solutions, such as developing the AEFI reporting form for the Med Safety App and hosting the interim Data Integration and Signal Detection system. The MHRA further facilitated a series of training modules on end-to-end safety surveillance.

AU-3S, with technical support from the MHRA, has created an AEFI form in the Med Safety App to report AEFIs associated with any vaccine. The form is based on the WHO core variables for vaccine reporting and was first made available to all AU-3S pilot countries. The form has since been rolled out to all other Med Safety App users from countries using the App across the globe.

All reports entered into the Med Safety App are stored in the Vigilance Hub, the backend of the Med Safety App. Reports on the Vigilance Hub are synced with national databases and thus uploaded to VigiBase through normal processes.

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.

• 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. 

• 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. 

• 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.

• 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.  

• 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.​​​​​​​

The AU-3S JSM Group is designed to complement work done by national committees by improving signal detection and management by combining safety data and its assessment across countries. The AU-3S JSM Group further promotes collaboration between countries, creates a forum for technical support from reference regulatory authorities to African regulatory authorities, and provides an opportunity to strengthen capabilities of AU-3S JSM Group members. The AU-3S JSM Group is currently limited to only reviewing COVID-19 vaccine related safety data, but plans to expand to additional products as the programme scales in the future.

Yes, all capacity strengthening session recordings and material are accessible to the public via the AUDA-NEPAD e-Learning portal. These sessions cover a comprehensive range of topics and are recommended to anyone involved or interested in effectively monitoring the safety of medical products.