The long-term goal of the African Union’s Smart Safety Surveillance (AU-3S) programme is to strengthen the safety surveillance of priority medical products across the African continent. Launched in 2020 with a ~10 year time horizon, the programme is being funded by The Bill and Melinda Gates Foundation (BMGF) with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a key technical partner.

The programme aims to address limited health system and safety surveillance capacity across Africa – through efficiencies like technological innovation, pooling of resources, and work sharing. Over the past two years, the AU-3S programme has worked assiduously to position itself as a continental safety surveillance system. Its primary focus has been collaborating closely with participating countries, -Ethiopia, Ghana, Kenya, Nigeria, and South Africa, to provide strategic and technical support with the aim of improving vigilance functions and safety surveillance capacity across Africa. While the programme currently operates in these five member countries, AU-3S has initiated the process of engaging additional Member States to expand its geographical coverage. These expansion plans are integral to the programme's second phase, which marks a transition from the pilot phase to a continental programme. Phase 2 is currently underway and entails the optimization of the solutions, ongoing collection and analysis of safety data, and scale-out of solutions to other additional member states and identified priority medical products.

The AU-3S team works closely with the medical products National Regulatory Authorities (NRAs) and Expanded Programmes on Immunisation (EPIs) from countries involved.

To support countries the AU-3S team has multiple initiatives, including four main programme solutions:

• Promotion of electronic safety data collection through the Med Safety App to stimulate the reporting of adverse events following immunisation (AEFIs) or adverse drug reactions (ADRs). AU-3S provides support to regulatory authorities and immunisation programmes to successfully roll the tool out and ensure usage by both healthcare providers and the public

• Implementation and operation of a common African safety database known as the AfriVigilance system, to detect safety signals in combined cross-country data from countries involved in the AU-3S programme

• Establishment and operation of a multi-country group of safety experts, known as the AU-3S Joint Signal Management Group (AU-3S JSM Group), to validate, prioritise, and assess the cross-country signal reports from cross-country data

• Facilitation of capacity strengthening through: trainings covering end-to-end aspects of safety surveillance; AU-3S JSM Group Secretariat activities to strengthen national capabilities for signal detection; and the setting up of a super user network for countries in the programme to effectively use the Vigilance Hub

These solutions are being developed by AUDA-NEPAD in conjunction with a working group that is comprised of members of the country medical products regulatory authorities, members of the EPI programme, and the MHRA.

AU-3S is also taking part in continental initiatives to ensure a collaborative and coordinated response to the COVID-19 pandemic, including the WHO-AFRO led African COVID-19 Vaccine Deployment Readiness and Execution Taskforce (ACREDT) and the Africa CDC led African Vaccine Delivery Alliance (AVDA).

In the longer term, the AU-3S programme aims to expand its scope to include additional countries and cover other novel / innovative products within AU priority disease areas: HIV, TB, Malaria, and other emergency diseases.