Kampala, 23 July 2024 – After realizing that Africa's safety surveillance ecosystem for medical products faced pressing challenges—such as limited pre-launch data, insufficient adverse event reporting, fragmented systems, and a lack of centralized, African-owned, and controlled safety datasets—the African Union-Smart Safety Surveillance (AU-3S) program was launched in 2020 to address these issues. A fit-for-purpose interim-pilot safety surveillance technology platform for cross-country safety data pooling and signal detection was developed as a minimum viable product using a customized design approach in partnership with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and funding from the Gates Foundation. The interim interoperable-technology solution, called the Data Integration and Signal Detection System (DISD), is a strategic step towards establishing a continental safety surveillance database called AfriVigilance to ensure African ownership of data and African decision-making.

The DISD platform included: (1) the Vigilance Hub—a submission management system following ICH E2B and data protection standards, and (2) the Data Integration and Signal Detection (DISD) system, with the Sentinel database and Empirica signal detection software for cross-country signal assessment and automated detection, generating fortnightly reports on vaccine event combinations. Three pilot countries used the Med Safety app for electronic vaccine data collection, while others used the app with national databases or solely national systems. Technical rollout support was given to personnel from the Expanded Programme on Immunization (EPls) and National Regulatory Authority (NRA).

An African databank with 56000 adverse event reports for six COVID-19 vaccines, collected from Ethiopia, Ghana, Kenya, Nigeria, and South Africa, representing over 400 million people, was established. The implementation of the safety surveillance digital transformation strategy increased reporting rates 15-fold and enabled cross-country COVID-19 vaccine signal review, resulting in 10 valuable recommendations.

Scaling the technology systems to encompass additional priority diseases, products, and countries represents a crucial advancement. This expansion marks a significant stride towards realizing the overarching continental vision of establishing the AfriVigilance system in the long term. By broadening its scope, the initiative aims to enhance surveillance and response capabilities across Africa, laying the foundation for a comprehensive and integrated approach to monitoring health-related issues continent-wide.

“The digital transformation strategy executed by the African Union-Smart Safety Surveillance programme for cross country safety surveillance of COVID-19 vaccines within five pilot African countries is a pivotal move towards establishing a comprehensive continental safety platform, AfriVigilance” said Dr. Kudakwashe Dandajena, Principal Programme Officer Technology Strategy at AUDA-NEPAD

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Teko Nhlapo| Communications and Advocacy Officer, AUDA-NEPAD

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