Abstract

Adverse events after immunisation (AEFI) are a major concern for vaccine safety and for maintaining public trust in immunisation efforts. This article looks at the current regulatory systems for AEFI surveillance, reporting and causality evaluation at both global and national levels. It also highlights ongoing problems, such as differences in regulatory frameworks, inconsistent use of standard definitions, underreporting, and variations in the ability to conduct surveillance, particularly in low- and middle-income countries.

The article also assesses regulatory considerations for new vaccine technologies, socio-political factors of vaccine acceptance, and how real-world data and sophisticated analytics could increasingly contribute to post-marketing safety surveillance. The existing evidence shows that limitations in AEFI governance may be partly attributable to the uneven application of established regulatory guidance, in addition to broader system-level constraints. Through this review, harmonised standards, enhanced surveillance systems, adaptive regulatory channels and open risk communication are identified as the responses necessary to promote regulatory credibility and ensure ongoing confidence in population immunisation programmes.