ABSTRACT:
Pandemic prevention and preparedness require more than rapid product development and deployment; they depend on trusted systems that can monitor safety, manage uncertainty, and support timely regulatory action during health emergencies. Pharmacovigilance is a critical yet often under-resourced component of preparedness, particularly in low- and middle-income countries where fragmented surveillance limits the ability to respond at scale. The Gates Foundation has supported long-term investments in regulatory systems strengthening to enable effective safety surveillance across Africa, with a focus on building sustainable, country- and region-led capacity. The flagship achievement of this work has been the African Union Smart Safety Surveillance (AU-3S) initiative1, monitoring the safety profile of COVID-19 vaccines during the pandemic and beyond. These efforts now converge with the establishment of the African Medicines Agency (AMA) in November 2025, which is positioned to serve as the continental authority for coordinating pharmacovigilance and safety decision-making. This transition creates an opportunity to institutionalize pandemic-relevant safety monitoring within African governance structures. From the Foundation’s perspective, investing in digital data integration and regulatory collaboration has enabled countries to improve detection and management of safety signals for vaccines, therapeutics, and other priority medical interventions. A data-centric, AMA-anchored pharmacovigilance model supports real-time access to safety information, coordinated signal detection across countries, and transparent communication during periods of rapid product rollout. These capabilities are essential for maintaining public trust and supporting uptake during pandemics. Positioning pharmacovigilance as core public health infrastructure under AMA strengthens preparedness for future health emergencies by linking regulatory systems, digital tools, and governance at scale. The Foundation’s experience highlights the importance of catalytic, partnership-driven investment to ensure that safety surveillance is embedded and responsive when it is most needed. Lessons from this work are relevant to other regions around the world seeking to strengthen pandemic preparedness through regulatory and public health system integration.