Summary and Key References

This module extended pharmacovigilance’s core discipline into two genuinely distinct but standard-curriculum territories. Vaccine safety surveillance runs on its own classification system (the five AEFI categories), its own proactive monitoring mechanism (AESIs, standardised through Brighton Collaboration definitions), and its own purpose-built causality methodology — all shaped by vaccines’ distinctive single-exposure, population-scale, public-trust-sensitive context. Materiovigilance runs on its own risk classification system, its own incident reporting pathways (EU MDR vigilance and FDA MedWatch/MAUDE), and its own traceability infrastructure (UDI) — shaped by devices’ distinctive dependence on use-context and the need to distinguish design defects from use errors from expected degradation.

The throughline connecting both halves of this module back to the rest of the course is worth stating plainly: neither discipline required inventing a new kind of reasoning. Both are the same detect-assess-understand-prevent logic Module 1 opened with, and the same seriousness-calibrated, risk-proportionate regulatory structure this course has built repeatedly since — applied to evidence structures genuinely different enough to need their own vocabulary, but never requiring a fundamentally different way of thinking about safety.

Key references: WHO Global Manual on Surveillance of Adverse Events Following Immunization, Brighton Collaboration case definitions, WHO AEFI causality assessment methodology, EU MDR (Regulation (EU) 2017/745), FDA MedWatch/MAUDE documentation, CIOMS/CITI Program materiovigilance curricula.