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.

The AU-3S programme is governed by a Steering Group which is comprised of:

• The CEOs of medical products National Regulatory Authorities (NRAs) from countries involved in the programme

• The UK Medicines and Health products Regulatory Authority (MHRA) and the U.S. Food and Drug Administration (FDA) as technical partners

• The WHO, which is represented by both AFRO and EMRO regional offices

• The Bill & Melinda Gates Foundation as the programme funders

• Chair of the AU-3S JSM Group

• AUDA-NEPAD

As the AU-3S programme expands, the overall governance model and members of the Steering Group will be reviewed and adapted as required.

In terms of governance specific to the AU-3S JSM Group, Professor Hannelie Meyer (South Africa) has been elected as the first Chair. As of 01 March 2021, Prof Meyer is the head of The South African Vaccination and Immunisation Centre (SAVIC) at Sefako Makgatho Health Sciences University (SMU). Since joining SAVIC in 2013, Prof Meyer has dedicated her time to immunisation related activities. This includes serving as part of two ministerial advisory committees while also serving in the division of Public Health Pharmacy at SMU. Currently, she is also the Chair of the National Immunisation Safety Expert Committee (NISEC) in South Africa. For further information, click here.

For information about the AU-3S JSM Group – such as the structure of and functions within the Group – please visit the AU-3S JSM Group microsite.

Towards the end of 2020, there was a growing acknowledgement around the need for efficient and robust safety surveillance. This developed as many African countries prepared for national COVID-19 vaccination campaigns to begin. African NRA CEOs approached AU-3S to quickly implement or enhance ongoing safety surveillance protocols and activities for COVID-19 vaccines. The AU-3S pilot, which focused on supporting safety surveillance of COVID-19 vaccines, was subsequently launched in Ethiopia, Nigeria, Ghana, and South Africa. Ethiopia and Nigeria were selected as they were original entry points for COVAX vaccines. Ghana was selected as they chair AVAREF and have very strong safety surveillance systems (being rated Maturity Level 3 (ML3) by WHO). South Africa was chosen as it has the largest clinical trial base in Africa. Altogether, these 4 original AU-3S pilot countries compromise ~30% of Africa’s population.

As a first priority, AU-3S conducted a landscaping assessment of each pilot country’s safety surveillance systems to identify country needs and constraints. This helped inform future policy and strategic support that could be provided by the AU-3S programme.

A major challenge was found in the wide usage of paper forms across the pilot countries. This typically caused delays in collecting, analysing, and reviewing safety data once vaccines had been rolled out. To combat this, the AU-3S programme expanded the functionality and improved national use and effectiveness of the Med Safety App . The AU-3S team created and launched an AEFI form for use within the Med Safety App. Both healthcare workers and members of the public who wish to report any side effects that they experienced are encouraged to use the App. The App provides near real-time access to safety data and reduces the reliance on paper forms – ensuring that data is efficiently available for downstream analysis. Additionally, the AU-3S team supports national communication teams to successfully promote national usage of the Med Safety App.

AU-3S further created and implemented the interim Data Integration and Signal Detection (DISD) system to pool safety data from each country. The DISD system is the precursor to the AfriVigilance system which is the long-term systems objective for the AU-3S programme. The DISD system was implemented primarily to meet the urgent need for robust safety surveillance of COVID-19 vaccines.  The AU-3S Joint Signal Management (JSM) Group, an expert committee consisting of representatives from programme countries, was then formed to analyse this pooled safety data for any additional potential signals.

Finally, the AU-3S programme facilitated a series of capacity strengthening trainings which were conducted by world-class experts from the MHRA. These sessions covered topics along the end-to-end safety surveillance activity value chain. Capacity strengthening is also promoted through hands on signal detection activities as part of the AU-3S JSM Group Secretariat. The AU-3S team has furthermore created a network of nominated individuals from each programme country to be the national exert (super user) of the Vigilance Hub. Additional trainings and knowledge sharing on the Med Safety App and Vigilance Hub is continuously provided to this network. For further information on all AU-3S capacity strengthening initiatives, click here.

In the medium-term, the AU-3S programme plans to expand its COVID-19 response. Additional countries will help to increase AU-3S’s regional and language representation, and test new data sources’ integration with the DISD system. After this expansion is successfully up and running, the programme first plans to continue expansion to additional geographies while extending solutions to cover new and innovative medical products. Products will be selected from within African Union priority disease areas: Malaria, Tuberculosis, HIV/AIDS, and other emergency diseases such as COVID-19 and Ebola. These areas are subject to change based on public health need.

In the longer-term, AU-3S will transition towards achieving the long-term objective of strengthening safety surveillance of all priority medical products across Africa. A cornerstone of the long-term vision will be the creation of AfriVigilance, a continental database drawing from numerous different data sources across the end-to-end lifecycle of medical products. Ideally, this will include both pre-market and post-market authorisation data. AfriVigilance is envisioned to be African-owned and will aim to integrate safety data from across the African continent, empowering countries with an improved ability to act on the data. This holistic database of safety information should cover all priority medical products in Africa and should be used to inform safety decisions taken by pharmacovigilance experts from member states and at a regional level. Through AfriVigilance, the AU-3S programme aims to increase confidence in accelerated product development and/or in an emergency response.

Click here to view frequently asked questions about the AU-3S programme.

The AU-3S Team welcomes all inquiries, questions, or comments using the email address below.

Email address: AU3S@nepad.org

AUDA-NEPAD Agency

230 15th Road

Midrand

South Africa

+27 11 256 3600