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@article{188273,
        author = {Aditi tripathi and Abhash kumar and Deep das},
        title = {Vaccine Pharmacovigilance in India: Systematic Approaches and Lessons from Mass Immunization Programs},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {7},
        pages = {1503-1515},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=188273},
        abstract = {Vaccination remains a cornerstone of public health, yet monitoring vaccine safety is essential to sustain confidence and guide policy. India’s large birth cohort, complex health system, and recurrent mass immunization campaigns necessitate a robust vaccine pharmacovigilance framework. This review systematically evaluates India’s vaccine safety surveillance landscape, including institutional mechanisms, surveillance models, causality assessment, and operational lessons from major immunization initiatives, to propose strategic priorities for 2025–2030.
Following PRISMA 2020 guidelines, literature from 2014–2025 was searched across PubMed, Scopus, and government repositories using defined keywords related to “AEFI”, “vaccine safety”, and “pharmacovigilance India”. National operational guidelines (2015, 2024), IPC/PvPI reports, and WHO/CIOMS/Brighton standards were included. Data were narratively synthesized into thematic domains.  India’s vaccine pharmacovigilance system has evolved through multi-institutional collaboration between MoHFW, CDSCO, IPC, and the AEFI committee network. Key advances include updated AEFI guidelines (2024), digital reporting via CoWIN, active surveillance pilots, and enhanced causality review mechanisms. Persistent challenges include underreporting, inconsistent investigation quality, limited data linkage, and uneven subnational capacity. Lessons from the polio, MR, and COVID-19 programs underscore the importance of preparedness, transparent risk communication, and integration of active surveillance.
India’s vaccine safety ecosystem is transitioning from a reactive to an increasingly data-driven model. Strategic priorities include full operationalization of the 2024 AEFI guidelines, sentinel AESI networks, real-time data linkage, workforce training, and legal frameworks for data governance. Sustained investment and global collaboration will ensure timely detection of safety signals, thereby safeguarding public trust and supporting India’s role as a global vaccine leader.},
        keywords = {Vaccine pharmacovigilance; Adverse Events Following Immunization (AEFI); India; mass immunization; causality assessment; active surveillance; PvPI; CoWIN; VigiBase},
        month = {December},
        }