The long-term goal of the African Union - 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, capacity strengthening, 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 the founding countries, -Ethiopia, Ghana, Kenya, Nigeria, and South Africa, to provide strategic and technical support to improve 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 ongoing 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. To this effect, there are now 12 participating countries, -DRC, Egypt, Ethiopia, Ghana, Mozambique, Kenya, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Uganda. While the product scope now covers 7 additional products in 5 priority disease areas (malaria, TB, HIV/AIDS, polio, and COVID-19).   

The AU-3S team works closely with the medical products National Regulatory Authorities (NRAs) and Expanded Programmes on Immunisation (EPIs) and will extend collaboration to other public health programmes as a result of the expanded product scope.

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

• Promotion of electronic safety data collection including through tools such as the Med Safety App to stimulate and foster faster transmission of adverse events following immunisation (AEFIs) or adverse drug reactions (ADRs reporting). AU-3S provides support to the participating countries to successfully roll the tool out and ensure usage by both healthcare providers and the public.

• Implementation and operation of a common data integration and signal detection platform to enable detection of signals from cross-country safety data. The ultimate goal is to have an African safety database known as the AfriVigilance, that will support signal management for Africa safety data.

• Establishment and operation of a multi-country group of safety experts, formerly 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. Due to the ongoing programme expansion, a new model for joint signal management activities -- the African Union Pharmacovigilance Risk Assessment Committee (AU-PRAC) is being established.

• Facilitation of capacity strengthening through training activities covering end-to-end aspects of safety surveillance; signal management activities to strengthen national capabilities for signal detection and assessment, and the operationalization of a super user network for participating countries to effectively use the Vigilance Hub.

During the pilot phase, the immediate solutions were developed by AUDA-NEPAD in conjunction with a working group that is comprised of members of the founding countries’ medical products regulatory authorities, members of the EPI programme, and the MHRA. In the current phase, AUDA-NEPAD is working with a country-owned Ad Hoc Continental Safety Platform Working Group (CWG) with representation from participating countries’ medical products regulatory authorities and the AUC.

AU-3S is also taking part in continental initiatives 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), which ensured a collaborative and coordinated response to the COVID-19 pandemic; collaboration with AMRH, AVAREF, etc. Further to this, as part of the operationalization of the African Medicines Agency (AMA), the AU-3S programme is responsible for pharmacovigilance-related activities including the establishment and operationalization of the Pharmacovigilance Technical Committee (PV-TC).

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

• The Chief Executive Officers (CEOs) of medical products National Regulatory Authorities (NRAs) from countries participating 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 secretariat

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

In terms of governance specific to the AU-3S JSM Group, Professor Hannelie Meyer (South Africa) was 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.

The envisioned plan for the AU-3S programme to expand its COVID-19 response in the on course. The programme is now in its Phase 3 depicted in the figure above. Sequel to the successful completion of the pilot, the AU-3S programme has continued to provide support to the participating countries while progressing to a continental safety surveillance platform. The expansion strategy includes the participation of more AU Member States, broadening of the priority medical product scope for cross-country safety monitoring, optimization of the current technology platforms and development of the African-owned AfriVigilance database, a new signal management model, and increased stakeholder engagement to align with and support other continental initiatives. The ongoing expansion has increased AU-3S’s regional and language representation, and is enabling the integration of new data sources with the DISD system.

A country-owned Ad Hoc Continental Safety Platform Working Group (CWG) with representation from participating countries’ NRAs and the AUC was established by the AU-3S Steering Committee, and developed a draft roadmap to guide the AU-3S programme to a functional and sustainable continental safety platform, with a focus on 7 areas:

1. Country Expansion,
2. Product Scope Expansion,
3. Signal Detection and Management,
4. Technology Optimization and AfriVigilance Development,
5. Stakeholder Engagement,
6. Pre-Licensure Safety Data, and
7. Sustainability and Finance.

The AU-3S Steering Committee accepted the report of the CWG and approved most of the recommendations, while few were considered to require further action. An Addendum (copy attached) to this report highlights the Steering Committee’s decisions to guide AU-3S to a functional and sustainable continental safety monitoring platform. Selected topics are expanded on below.

Geographical Expansion (Countries)

The AU 3S Steering Committee, during its meetings in March and September 2023, approved the engagement with 7 additional countries – DRC, Egypt, Mozambique, Rwanda, Senegal, Tanzania, and Uganda to be onboarded to the programme and 3 other countries to be engaged in the later part of 2024. This brings the number of participating countries to 12 currently and 15 by the end of 2024. Countries were selected based on the AU-3S Steering Committee’s approved criteria including representation of geographical and language diversity on the continent. It is important to note that some countries also expressed interest in joining the programme because of the associated significant impact.

Product Scope Expansion

As part of the expansion, the AU-3S Steering Committee determined that HIV/AIDS, Tuberculosis, Malaria, Polio and other emergency diseases (including COVID-19) are to be given priority for the product scope expansion. Employing risk-based criteria, Covid-19 therapeutics, nOPV2, Dolutegravir (DTG) based regimen, Bedaquilline (BDQ), Pretomanid, Malaria vaccines, and Cabotegravir/Rilpivirin were approved for the cross-country safety monitoring. Furthermore, the Lassa fever, Group B Streptococcus (GBS), and the Respiratory Syncytial Virus (RSV) vaccines will be considered for product expansion as they become available on the continent. A framework for a regular, structured, and strategic review mechanism for the product list, based on the approved risk-based criteria, for effective and relevant cross-country safety monitoring is being developed.

Technology Optimization and AfriVigilance

Technology has been identified as a central tool for delivering efficient, transparent, secure, reliable and interactive end-to-end signal management ecosystem. So far, the current data integration and signal detection (DISD) system (supported by MHRA), has been a dependable technological platform that led to successful implementation of the AU-3S COVID-19 vaccine pilot. The current programme expansion’s needs in terms of number of countries, number of priority disease and products, and number of subscribers has necessitated the need to upgrade and optimise the interim-pilot DISD technology system. A new optimised digital technology platform for advanced safety surveillance called SafetyConnect has been developed and currently undergoing testing. This process of the deployment, scaling and optimization of the interim pilot technology platform to SafetyConnect will serve as a critical step towards the broader objective of developing a fully African-owned cloud-based continental safety surveillance system called AfriVigilance. The AfriVigilance technology system will have advanced intelligent performance capabilities to serve the entire African continent. It will offer automated and seamless safety surveillance capabilities and services to monitor medicines, vaccines, devices, defects, and blood products driven by modern machine learning and artificial intelligence algorithms for both spontaneous and active safety surveillance.

New Signal Management Model

A centralized signal management model was employed for the COVID-19 pilot phase of the programme working with 5 countries. A Joint Signal Management (JSM) Secretariat comprising NRA representatives, AUDA-NEPAD and MHRA as a technical partner, and a JSM Group comprising 3 representatives per participating country and additional expertise (mainly on vaccines) implemented the centralized signal management activities. MHRA and US FDA provided additional technical advice to the JSM Group as needed.

Currently, the AU-3S programme is covering additional countries and products, therefore a centralized model as implemented during the pilot will no longer be sustainable. Expertise areas beyond vaccines are needed to manage additional disease areas and product types. Consequently, the Steering Committee approved the guiding principles for a new signal management model -- the African Union Pharmacovigilance Risk Assessment Committee (AU-PRAC) as a forum for cross-country signal management in Africa. The operational framework for the new model is still being developed. The new model aims to ensure the efficiency and sustainability of the joint signal management process.

Support on the Operationalization of the African Medicines Agency (AMA)

AMA is a specialized Agency of the AU established through a Treaty-based legal framework. The main objective of the AMA is to enhance the capacity of States Parties and RECs, to regulate medical products to improve access to quality, safe and efficacious medical products on the continent. Further to this, AMA will perform other specific functions including those relating to the safety monitoring of medical products; to coordinate the collection, management, storage and sharing of information on all medical products including SF medical products, with all its States Parties and globally; and to coordinate and collaborate, where required and on a regular basis, the inspection of drug manufacturing sites, including the regulatory oversight and safety monitoring of medical products, as determined by State Parties and/or the AMA, and make reports available to State Parties.

As part of the operationalization of the African Medicines Agency (AMA), the AU-3S programme is responsible for pharmacovigilance-related activities including the establishment and operationalization of the Pharmacovigilance Technical Committee (PV-TC). The AU-PRAC described in the new joint signal management model in Figure 2 could be used to support the PV-TC in the conduct of risk management activities on priority medical products.

The AU-3S programme, as a continental safety monitoring platform, has established safety monitoring assets that could be leveraged by AMA for its safety monitoring remit, to enhance the collection, management, storage, assessment and sharing of safety information on medical products under its purview.

Further to the above, the AU Assembly Decision on the Report of the 41st Session of the AUDA-NEPAD Heads of State and Government Orientation Committee (HSGOC) during the 37th Ordinary Session of the AU ASSEMBLY on 17-18 February 2024 in Addis Ababa (ETHIOPIA) [Assembly/AU/9(XXXVII)] “ACKNOWLEDGES progress in operationalizing the African Medicines Agency (AMA) and URGES AUDA-NEPAD, AUC and CDC to prioritize its operationalization, leveraging on the African Medicines Regulatory Harmonisation (AMRH). REQUESTS AUDA-NEPAD to develop a technical support framework for AMA in alignment with AMRH, AU Smart Safety Surveillance (AU-3S) and Africa Integrated Vector Management (IVM) programs”.

Given this decision, the AU-3S programme will develop a technical support framework (as part of the AUDA-NEPAD framework for AMA) that will describe how the safety monitoring function of AMA will be implemented using the existing AU-3S assets.

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