Simon Sophie, Rawat Shalini, Sangam Rohan, Velhal Gajanan D
Postdoctoral Research Fellow, University of British Columbia, Vancouver, Canada.
Assistant Professor, Govt Doon Medical College, Dehradun, Uttarakhand, India.
Indian J Community Med. 2025 Aug;50(Suppl 1):S90-S97. doi: 10.4103/ijcm.ijcm_42_24. Epub 2025 Feb 21.
India has a functional and mature National Regulatory Authority which ensures that vaccines manufactured and used in the country are safe. Monitoring adverse events post-licensure is equally critical to identify infrequent adverse events due to the vaccine product.
This was a cross-sectional observational qualitative study done in a Metropolitan city in Maharashtra from January 2017 to June 2018. Focus group discussions (FGDs) were conducted with healthcare workers and stakeholders involved in adverse event following immunization (AEFI) surveillance in the city. The data obtained were transcribed and analyzed using the inductive method. Thematic analysis was done using the grounded theory. Data were analyzed using ATLAS ti 5.7.1.
It was found that both active and passive surveillance were being followed in the study area helped in improving reporting rates and in early detection and management of adverse events. It was noted that there was no proper training provided to doctors in the private sector. Reporting of adverse events depended upon a number of factors such as clinical seriousness, temporal proximity to vaccination and health care workers' awareness of and obligation to report particular adverse events, fear of blame, time pressures in completing a report, and confusion in whose responsibility it was to report.
Mandatory training of all private practitioners conducting immunizations, CHVs to work in collaboration with private doctors for active surveillance of AEFI, and online reporting to be made available for easy reporting. Proper counseling of mothers regarding giving paracetamol to the vaccine beneficiaries. Greater convergence is required between national regulators, and vaccine pharmacovigilance stakeholders including Central drugs standard control organisation (CDSCO), Pharmacovigilance programme of India (PvPI), and AEFI surveillance program, especially at the city and state level is required to handle vaccine safety issues at various levels in a faster and more effective manner.
印度拥有一个运作良好且成熟的国家监管机构，该机构确保在该国生产和使用的疫苗是安全的。在疫苗获得许可后监测不良事件对于识别由疫苗产品引起的罕见不良事件同样至关重要。
这是一项于2017年1月至2018年6月在马哈拉施特拉邦的一个大城市进行的横断面观察性定性研究。对参与该城市免疫接种后不良事件（AEFI）监测的医护人员和利益相关者进行了焦点小组讨论（FGD）。所获得的数据进行了转录，并采用归纳法进行分析。使用扎根理论进行主题分析。使用ATLAS ti 5.7.1对数据进行分析。
研究发现，研究区域内同时采用了主动监测和被动监测，这有助于提高报告率以及对不良事件的早期发现和管理。注意到私营部门的医生未得到适当培训。不良事件的报告取决于多个因素，如临床严重程度、与接种疫苗的时间接近程度、医护人员对特定不良事件报告的意识和义务、对受责备的恐惧、完成报告的时间压力以及对报告责任归属的困惑。
对所有进行免疫接种的私人执业者进行强制性培训，社区卫生工作者（CHV）与私人医生合作以主动监测AEFI，并提供在线报告以便于报告。就给疫苗接种受益者服用扑热息痛对母亲进行适当的咨询。国家监管机构与包括中央药品标准控制组织（CDSCO）、印度药物警戒计划（PvPI）和AEFI监测计划在内的疫苗药物警戒利益相关者之间需要更大程度的融合，特别是在城市和州一级，以便以更快、更有效的方式处理各级的疫苗安全问题。
