National Immunization Programme, Chinese Center for Diseases Control and Prevention, China; Health Sciences unit, Faculty of Social Sciences, University of Tampere, Finland.
National Immunization Programme, Chinese Center for Diseases Control and Prevention, China.
Vaccine. 2019 Feb 21;37(9):1182-1187. doi: 10.1016/j.vaccine.2019.01.009. Epub 2019 Jan 29.
The national Adverse Events Following Immunization (AEFI) surveillance system in China (CNAEFIS) has collected AEFI reports -including deaths following all vaccines used in China since 2008.
To review reports of AEFI-associated death cases from 2010 to 2015 to assess potential vaccine safety issues.
Descriptive analysis of epidemiologic characteristic of AEFI-associated death cases and standard causality assessment for reported causes of deaths. To estimate the risk of death after vaccination, we used population data, administered doses and live births to calculate denominators.
During 2010-2015, 753 deaths were reported to CNAEFIS from mainland China. Highest numbers were reported in 2013 and 2014 when reporting peak of AEFI-associated deaths occurred after media reports concerning "death following Hepatitis B vaccination" in China. About 95% of deaths were in children <5 years of age and males accounted for 60%. Most common vaccines associated with reports of fatal AEFIs were vaccines in national immunization schedule. In causality assessment, 120 (16.0%) deaths were classified as vaccine-associated reactions such as anaphylactic reactions and disseminated BCG infections; 594 (78.9%) deaths were identified as coincidental events. The main causes of death were asphyxia, and Sudden Infant Death Syndrome. The overall estimated AEFI-associated death rates were: 0.26 per million vaccination doses administered and 0.09 per million population. The neonatal AEFI death rate was 0.77 per million live births.
These data provide reassuring information about the small risk of death following immunization. They also illustrate sensitivity of passive reporting to public information and that peaks in serious AEFI reports should be interpreted with caution. Continuous monitoring and scientific causality assessment for serious AEFIs, including AEFI-associated deaths is imperative to ensure public confidence in the immunization program.
中国国家疑似预防接种异常反应监测系统（CNAEFIS）自 2008 年以来，一直收集中国使用的所有疫苗的疑似预防接种异常反应（AEFI）报告，包括报告后的死亡病例。
回顾 2010 年至 2015 年 AEFI 相关死亡病例报告，评估潜在的疫苗安全问题。
对 AEFI 相关死亡病例的流行病学特征进行描述性分析，并对报告的死因进行标准因果关系评估。为了估计接种后死亡的风险，我们使用人口数据、接种剂量和活产数计算分母。
2010 年至 2015 年期间，中国大陆向 CNAEFIS 报告了 753 例死亡病例。2013 年和 2014 年报告的死亡病例最多，当时 AEFI 相关死亡的报告高峰出现在中国媒体报道“乙肝疫苗接种后死亡”之后。95%以上的死亡发生在 5 岁以下的儿童中，其中男性占 60%。与致命 AEFI 报告相关的最常见疫苗是国家免疫规划疫苗。在因果关系评估中，有 120 例（16.0%）死亡被归类为疫苗相关反应，如过敏性反应和播散性卡介苗感染；594 例（78.9%）死亡被认定为偶合事件。死亡的主要原因是窒息和婴儿猝死综合征。总的 AEFI 相关死亡率为：每百万接种剂量 0.26 例，每百万人口 0.09 例。新生儿 AEFI 死亡率为每百万活产 0.77 例。
这些数据提供了有关接种后死亡风险较小的令人安心的信息。它们还说明了被动报告对公共信息的敏感性，严重 AEFI 报告的高峰应谨慎解释。持续监测和对严重 AEFI（包括 AEFI 相关死亡）的科学因果关系评估对于确保公众对免疫规划的信心至关重要。
