Harare Central Hospital, PO Box ST14, Southerton, Harare, Zimbabwe.
Department of Dermatology, Nelson R Mandela School of Medicine, Private Bag X7, Congella, Durban, 4013, South Africa.
BMC Public Health. 2019 Aug 27;19(1):1166. doi: 10.1186/s12889-019-7482-x.
BACKGROUND: Vaccine safety surveillance is an essential requirement in vaccination programmes. It supports signal identification, hypothesis generation, and the identification and rectification of gaps in vaccine pharmacovigilance systems. The objectives of this study were to determine the characteristics and trends of adverse events following immunisation (AEFI) and to assess the performance of the Zimbabwe Expanded Immunisation Programme safety surveillance system. METHODS: We carried out a descriptive study of passively collected vaccine-related Individual Case Safety Report (ICSR) data submitted to the World Health Organization global adverse drug reaction database (VigiBase®) from Zimbabwe during the period 1997 to 2017. We extracted AEFI/ICSR data using VigiLyze® for analysis with respect to the demographic distribution, AEFI characteristics, reporting trends over time, ICSR timeliness and case completeness. RESULTS: A total of 272 vaccine-related ICSRs were included in the analyses with a median completeness score of 0.90 interquartile range, IQR (0.63; 0.90). The overall annual reporting rate was 0.58 per 100,000 vaccine doses and the AEFI reporting ratio ranged between 0 and 30.2 AEFI reports per 100,000 surviving infants. The majority of ICSRs were male (55.3%; p value = 0.641) and the median age was 12 (0-168) months. The majority of ICSRs were reported in children who had received measles (n = 133; 48.9%) and OPV/DTP-Hib-HepB (n = 107; 39.3%) vaccines. Of the 387 observed AEFIs, 301 (77.8%) were systemic events and 86 (22.2%) were local reactions. Systemic events were more frequently reported with doses containing the measles antigen (n = 190; 49.1%) while local events were associated with the multiple antigen OPV/DTP-Hib-HepB (n = 62; 16.0%). The multiple antigen OPV/DTP-Hib-HepB was associated with higher rates for injection site abscess (n = 57), pyrexia (n = 27), diarrhea (n = 15), vomiting (n = 12), and seizures (n = 6). The measles antigen was associated with higher rates for rash (n = 44), ocular disorders (n = 26), pyrexia (n = 26), urticaria (n = 22), diarrhea (n = 8), and vomiting (n = 12). CONCLUSIONS: Most of the ICSRs were associated with measles and OPV/DTP-Hib-HepB vaccines. Zimbabwe's vaccine safety surveillance system is still developing and is not yet fully functional. However, the current system provides a reference point for the monitoring of the ongoing AEFI reporting trends and characteristics.
背景：疫苗安全监测是接种计划的基本要求。它支持信号识别、假设生成以及疫苗药物警戒系统中差距的识别和纠正。本研究的目的是确定疫苗接种后不良反应（AEFI）的特征和趋势，并评估津巴布韦扩大免疫规划安全监测系统的性能。 方法：我们对 1997 年至 2017 年期间通过世卫组织全球不良药物反应数据库（VigiBase®）向世卫组织被动提交的与疫苗相关的个别病例安全报告（ICSR）数据进行了描述性研究。我们使用 VigiLyze®提取 AEFI/ICSR 数据，以便根据人口统计学分布、AEFI 特征、随时间报告趋势、ICSR 及时性和病例完整性进行分析。 结果：共纳入 272 份与疫苗相关的 ICSR 进行分析，中位数完整性评分 0.90（四分位距 IQR，0.63；0.90）。总体年度报告率为每 10 万剂疫苗 0.58 例，AEFI 报告率在每 10 万存活婴儿 0 至 30.2 例之间。大多数 ICSR 报告的是男性（55.3%；p 值=0.641），中位年龄为 12 个月（0-168）。大多数 ICSR 报告发生在接种麻疹疫苗（n=133；48.9%）和 OPV/DTP-Hib-HepB（n=107；39.3%）的儿童中。在观察到的 387 例 AEFI 中，301 例（77.8%）为全身事件，86 例（22.2%）为局部反应。含麻疹抗原的疫苗更频繁地报告全身事件（n=190；49.1%），而局部事件与多抗原 OPV/DTP-Hib-HepB 相关（n=62；16.0%）。多抗原 OPV/DTP-Hib-HepB 与接种部位脓肿（n=57）、发热（n=27）、腹泻（n=15）、呕吐（n=12）和癫痫发作（n=6）的发生率较高相关。麻疹抗原与皮疹（n=44）、眼部疾病（n=26）、发热（n=26）、荨麻疹（n=22）、腹泻（n=8）和呕吐（n=12）的发生率较高相关。 结论：大多数 ICSR 与麻疹和 OPV/DTP-Hib-HepB 疫苗有关。津巴布韦的疫苗安全监测系统仍在发展中，尚未完全发挥作用。然而，目前的系统为监测正在进行的 AEFI 报告趋势和特征提供了一个参考点。
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