Pedro Kourí Tropical Medicine Institute (IPK), Havana, Cuba.
MEDICC Rev. 2012 Jan;14(1):38-43. doi: 10.37757/MR2012V14.N1.8.
INTRODUCTION Cuba has implemented an effective National Immunization Program since 1962. The schedule, administered primarily to children, comprises 11 vaccines (8 domestically produced) protecting against 13 diseases. In 1999 Cuba launched a national vaccine adverse event surveillance system to monitor and assess the safety of the immunization program, its vaccination procedures and the products administered. OBJECTIVES Describe adverse events following vaccination reported in children aged <16 years in Cuba from 1999 through 2008. METHODS A retrospective descriptive study was conducted of adverse events following vaccination reported from January 1999 through December 2008. Variables used: year, number of adverse events, province, type of vaccine, type and severity of adverse events (common minor, rare, severe), vaccination program errors, number of deaths, and final results of investigations of severe events. Percentages and rates per dose administered were calculated. Adverse event rates were calculated per 100,000 doses administered and by percentages of individual effects among events reported. RESULTS A total of 45,237,532 vaccine doses were administered, and 26,159 vaccine-associated adverse events were reported (overall rate: 57.8 per 100,000 doses). The group aged 0-5 years reported the highest rate of vaccine-associated adverse events (82/100,000 doses). The DTwP vaccine exhibited the highest rate of adverse events. Common minor events were: fever (17,538), reactions at injection site (4470) and systemic side effects (2422). Rare events (by WHO definition) reported were: persistent crying (2666), hypotonic-hyporesponsive episodes (3), encephalopathy (2) and febrile seizures (112). Severe events included: anaphylaxis (2), respiratory distress (1), multiple organ failure (1), sudden death (1), vaccine-associated paralytic poliomyelitis (2), toxic shock syndrome (3), and sepsis (1). The 10 deaths and 3 cases of disability were investigated by an expert commission, which concluded that 8 of the 13 severe events were vaccination-related. CONCLUSIONS Low rates of severe vaccine-associated adverse events observed in this study underline the low risk of vaccination relative to its demonstrated benefits in Cuba. Decision-making for the continued success of the National Immunization Program is supported by reliable information from comprehensive national surveillance with standarized reporting, along with multidisciplinary expert analysis of rare and severe adverse events and program errors. KEYWORDS Immunization; immunization programs; vaccines; vaccination; product surveillance, postmarketing; adverse drug event; communicable disease control; Cuba.
简介
古巴自 1962 年以来实施了一项有效的国家免疫计划。该计划主要针对儿童，包括 11 种疫苗（8 种国产疫苗），可预防 13 种疾病。1999 年，古巴启动了国家疫苗不良事件监测系统，以监测和评估免疫计划、疫苗接种程序和所使用产品的安全性。
目的
描述 1999 年至 2008 年期间古巴 16 岁以下儿童接种疫苗后的不良事件。
方法
本研究采用回顾性描述性方法，对 1999 年 1 月至 2008 年 12 月期间报告的接种疫苗后不良事件进行了分析。使用的变量有：年份、不良事件数量、省份、疫苗类型、不良事件类型和严重程度（常见轻微、罕见、严重）、疫苗接种程序错误、死亡人数以及对严重事件的最终调查结果。计算了每剂疫苗接种的百分比和发生率。根据每 10 万剂接种疫苗的不良事件发生率和报告的单个不良事件的百分比来计算不良事件发生率。
结果
共接种疫苗 45237532 剂，报告接种疫苗相关不良事件 26159 例（总发生率为 57.8/10 万剂）。0-5 岁年龄组报告的接种疫苗相关不良事件发生率最高（82/10 万剂）。DTwP 疫苗的不良事件发生率最高。常见轻微事件有：发热（17538 例）、注射部位反应（4470 例）和全身副作用（2422 例）。报告的罕见事件（根据世界卫生组织的定义）有：持续性哭泣（2666 例）、低张力低反应期（3 例）、脑病（2 例）和热性惊厥（112 例）。严重事件包括：过敏反应（2 例）、呼吸窘迫（1 例）、多器官衰竭（1 例）、猝死（1 例）、疫苗相关麻痹性脊髓灰质炎（2 例）、中毒性休克综合征（3 例）和败血症（1 例）。10 例死亡和 3 例残疾的病例由一个专家委员会进行了调查，该委员会得出结论，13 例严重事件中有 8 例与疫苗接种有关。
结论
本研究观察到的接种疫苗相关不良事件发生率较低，这表明古巴接种疫苗的风险相对较低，而其带来的益处已得到证实。通过标准化报告的综合国家监测、对罕见和严重不良事件以及疫苗接种程序错误的多学科专家分析，为国家免疫计划的持续成功提供了可靠的决策信息。
关键词
免疫接种；免疫规划；疫苗；接种疫苗；产品监测，上市后；药物不良反应；传染病控制；古巴
