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. With COVID-19 further reinforcing the need for strong African PV systems, AU-3S is currently piloting its approach on the safety surveillance of COVID-19 vaccines in five countries. These pilot countries are Ethiopia, Ghana, Nigeria, South Africa and Kenya – altogether comprising ~35% of Africa’s population. 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.

For more information about the AU-3S programme, download the latest AU-3S information pack by clicking here.