Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Department of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China.
Front Public Health. 2023 Jun 16;11:1170483. doi: 10.3389/fpubh.2023.1170483. eCollection 2023.
In China, adverse events following immunization (AEFI) are reported by the China AEFI Surveillance System (CNAEFIS). Serious AEFI, including deaths, are mandatorily reported and are evaluated for causality by province-or prefecture-level panels of experts. Yeast-derived HepB is the most widely used HepB in China for infants. However, the information about the death of infants caused by HepB is unclear. The CNAEFIS data on deaths following HepB from 2013 to 2020 were used for analyses. Descriptive analysis of epidemiologic characteristics was used to report death cases following HepB. We used administered doses to calculate denominators to estimate the risk of death after vaccination. During 2013-2020, there were 161 deaths following the administration of 173 million doses of HepB, for an overall incidence of 0.9 deaths per million doses. One hundred fifty-seven deaths were categorized as coincidental, and four deaths were accompanied by an abnormal reaction determined to be unrelated to the cause of death. The most common causes of death were neonatal pneumonia and foreign body asphyxia. These data provide reliable evidence on the safety of HepB among infants in China and can enhance public confidence in HepB immunization. To ensure public confidence in infants' HepB vaccination, monitoring and scientifically evaluating AEFI-related deaths of HepB is necessary.
在中国，疑似预防接种异常反应（AEFI）由中国疑似预防接种异常反应监测系统（CNAEFIS）报告。严重 AEFI，包括死亡，必须报告，并由省级或市级专家小组评估因果关系。酵母衍生的乙型肝炎疫苗是中国婴儿最广泛使用的乙型肝炎疫苗。然而，关于乙型肝炎疫苗导致婴儿死亡的信息尚不清楚。本研究使用了 2013 年至 2020 年 CNAEFIS 关于乙型肝炎疫苗接种后死亡的数据进行分析。采用描述性分析方法报告乙型肝炎疫苗接种后死亡病例的流行病学特征。我们使用接种剂量计算分母来估计接种疫苗后的死亡风险。2013-2020 年，在接种了 1.73 亿剂乙型肝炎疫苗后，有 161 例死亡，总死亡率为每百万剂 0.9 例。157 例死亡被归类为偶合死亡，4 例死亡伴有异常反应，与死亡原因无关。最常见的死亡原因是新生儿肺炎和异物窒息。这些数据为中国婴儿乙型肝炎疫苗的安全性提供了可靠的证据，并增强了公众对乙型肝炎疫苗接种的信心。为了确保公众对婴儿乙型肝炎疫苗接种的信心，有必要对 AEFI 相关的乙型肝炎疫苗死亡进行监测和科学评估。
