Center for Disease Dynamics, Economics & Policy, Okhla Industrial Area, New Delhi, India.
The INCLEN Trust International, F-1/5, 2nd Floor, Okhla Industrial Area, Phase I, New Delhi, 110020, India.
Indian J Pediatr. 2018 Feb;85(2):139-148. doi: 10.1007/s12098-017-2532-9. Epub 2017 Nov 23.
Assured quality vaccines and safe immunization practices are pre-requisite to successful immunization programs. All vaccines go through stringent safety checks during pre-licensure stage. Adverse Events Following Immunization (AEFI) Surveillance program is an integral part of routine immunization program in India to monitor the vaccine safety in the post licensure phase. Indian AEFI Program: National AEFI surveillance relies on passive surveillance and reporting by the health functionaries and practitioners. Vigorous strengthening of AEFI surveillance has resulted in manifold rise in absolute number of AEFI reports across several reporting units in the country in the last decade. Establishment of National AEFI Secretariat, National Technical Collaborating Centre, and development of risk communication strategy as well as quality management certification are some of the unique aspects of this public health program. All serious AEFI reports undergo a systematic causality assessment as per WHO-algorithm by trained committees. National AEFI surveillance system has forged formal linkages with national pharmacovigilance program, the regulators, and professional bodies. Challenges: The number of the reported serious AEFIs are still far less than the expected numbers. Although the AEFI committees at the district and state levels have been established, a large proportion are far from functional. Way forward: As the national immunization program introduces newer vaccines for different age groups and coverage improves, the issues of vaccine hesitancy and confidence are likely to be raised more often and the AEFI surveillance program will have to assume greater responsibility to comprehensively respond to the community concerns and sustain public confidence in vaccines.
确保疫苗质量和安全的免疫接种实践是成功免疫规划的前提条件。所有疫苗在获得许可前都要经过严格的安全检查。预防接种后不良反应（AEFI）监测计划是印度常规免疫规划的一个组成部分，旨在监测获得许可后的疫苗安全性。
印度 AEFI 计划：国家 AEFI 监测依赖于卫生职能部门和从业人员的被动监测和报告。通过大力加强 AEFI 监测，在过去十年中，全国几个报告单位的 AEFI 报告绝对数量呈倍数增长。国家 AEFI 秘书处、国家技术合作中心的建立以及风险沟通策略和质量管理认证的发展是该公共卫生计划的一些独特方面。所有严重的 AEFI 报告都按照世卫组织的算法由经过培训的委员会进行系统的因果关系评估。国家 AEFI 监测系统与国家药物警戒计划、监管机构和专业机构建立了正式联系。
报告的严重 AEFI 数量仍然远远低于预期数量。虽然已经在地区和州一级设立了 AEFI 委员会，但很大一部分委员会远未发挥作用。
随着国家免疫规划为不同年龄组引入新的疫苗且覆盖率提高，疫苗犹豫和信心问题可能会更加频繁地出现，AEFI 监测计划将不得不承担更大的责任，全面应对社区关注的问题，并维持公众对疫苗的信心。
