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Short abstract:

This presentation explores vaccine pharmacovigilance. It offers a brief history, emphasizing its role in ensuring safety. The focus on the spontaneous reporting system reveals methodological intricacies, contributing to debates on critical databasing, epistemic justice, and decolonial global health.

Long abstract:

This presentation delves into the intricacies of pharmacovigilance, specifically within the realm of vaccines, commonly referred to as vaccinovigilance. Defined as the comprehensive science and activities surrounding the detection, assessment, understanding, prevention, and communication of events following immunization, pharmacovigilance is a crucial component of ensuring consumer and patient safety. This contribution provides a concise historical overview of pharmacovigilance, illustrating how its evolution has been shaped by diverse actors with varying interests, needs, and resources.

In recent decades, the neoliberalization of drug regulation has heightened the significance of pharmacovigilance activities and evidence in influencing drug access and safety. This presentation highlights the intricate flow of pharmacovigilance data across global, national, and regional levels, offering an analysis of the "power geometry" between countries in the Global North and Global South.

With a primary focus on the methodological cornerstone of pharmacovigilance—the spontaneous reporting system—the presentation explores the nature of evidence generated through this form of passive surveillance. By scrutinizing what this system validates and magnifies, as well as what it diminishes and excludes, the analysis sheds light on the methodological intricacies that shape our understanding of vaccine safety and efficacy. This exploration aims to contribute to current debates about critical databasing, epistemic justice and decolonial global health.