Vaccinovigilance (AEFI- Adverse Event Following Immunisation) in India: Current status and shortcomings

With the increasing occurrence of epidemics and pandemic of communicable diseases, vaccines are becoming an effective tool and at times the only tool to curtail disease impact. India, being a major player in vaccine manufacturing, holds greater responsibility & accountability to develop better products and Vaccinovigilance to avoid untoward events & long-term implications. This review sheds light on the challenges in India about AEFI screening, reporting, association and the causality assessment of adverse events following immunisations. The concept of Vaccinovigilance in India needs modern upgradation with digitisation and inclusion of public reporting (active surveillance) to overcome the underreporting. This feedback mechanism will not only strengthen the safety profile of the vaccine to assure global validation but also augment evidence-based studies. We have also summarised in brief how Ministry of Health and Family Welfare(MoHFW) and the global regulatory bodies in collaboration, have developed the new guideline since 2020, after facing a spectrum of mild to severe adverse effects following COVID-19 vaccination. There is a need to develop awareness among healthcare provider about reporting AEFI for casualty assessment and active surveillance for a robust framework in India.