Pedro Kourí Tropical Medicine Institute (IPK), Havana, Cuba.
Epidemiological Surveillance and Research Department, IPK, Havana, Cuba.
MEDICC Rev. 2021 Jan;23(1):35-42. doi: 10.37757/MR2021.V23.N1.8. Epub 2021 Jan 30.
The Cuban national program for childhood immunizations began in 1962 and has included a surveillance system for monitoring adverse events following immunization since 1999. The expected rate of adverse events following childhood immunization in Cuba is 50 per 100,000 vaccine doses administered. In 2017, Pinar del Río Province reported higher-than-expected rates of adverse events, which motivated this study on their frequency and types.
Characterize adverse events following immunization reported in children in Pinar del Río Province in 2017.
We examined reports of adverse events following immunization in children from 2 months through 14 years of age in Pinar del Río Province, Cuba, from January 1, 2017 through December 31, 2017. We found 487 adverse events that met the criteria established by the national surveillance system. Information was obtained from epidemiological surveys of adverse events following immunization in Pinar del Río Province municipalities. Recorded were age, municipality, signs and symptoms, vaccine type, number of doses, anatomical site and route of vaccine administration, and the institution where the child was vaccinated. We estimated proportions for intensity and frequency related to vaccination, and calculated rates for 100,000 vaccine doses administered. We then compared the rates of observed adverse events with those of expected events.
The overall rate of adverse events was 305.6 per 100,000 doses administered. Highest rates were reported in children aged ⟨1 year (580.9 per 100,000 doses administered); in Guane Municipality (610 per 100,000 doses), for the pentavalent (DTwP-HB-Hib) vaccine (1567.7 per 100,000 doses), and in applications to the anterolateral quadrant of the thigh (772.5 per 100,000 doses). Symptoms classifi ed as moderate, common, and general occurred more often, with fever being the most frequent. Severe induration, hypotonic and hyporesponsive episodes, persisten crying and rashes were observed more frequently than expected.
The rate of adverse events following childhood immunization is similar to that reported in other provinces and elsewhere in the world. Of all childhood vaccines, the pentavalent vaccine is the most reactogenic. The absence of serious adverse events demonstrates the safety of childhood immunization in Cuba.
古巴的儿童免疫国家计划始于 1962 年，自 1999 年以来一直包括一个监测系统，用于监测免疫接种后不良事件。古巴预期的儿童免疫接种后不良事件发生率为每 10 万剂疫苗 50 例。2017 年，比那尔德里奥省报告的不良事件发生率高于预期，这促使该省开展了这项关于其频率和类型的研究。
描述 2017 年古巴比那尔德里奥省报告的儿童免疫接种后不良事件。
我们检查了 2017 年 1 月 1 日至 12 月 31 日期间古巴比那尔德里奥省 2 个月至 14 岁儿童的免疫接种后不良事件报告。我们发现了 487 例符合国家监测系统规定标准的不良事件。信息来自比那尔德里奥省各市的免疫接种后不良事件的流行病学调查。记录了年龄、市、体征和症状、疫苗类型、剂量数、疫苗接种的解剖部位和途径以及儿童接种的机构。我们估计了与疫苗接种相关的强度和频率的比例，并计算了每 10 万剂疫苗接种的发生率。然后，我们将观察到的不良事件发生率与预期事件发生率进行了比较。
不良事件总发生率为每 10 万剂 305.6 例。报告发生率最高的是 ⟨1 岁儿童（每 10 万剂 580.9 例）；瓜内市（每 10 万剂 610 例），五联疫苗（DTwP-HB-Hib）（每 10 万剂 1567.7 例），前外侧大腿象限（每 10 万剂 772.5 例）。中度、常见和一般性症状更为常见，发热最为常见。观察到硬结、低张力和低反应性发作、持续哭泣和皮疹比预期更为频繁。
儿童免疫接种后不良事件发生率与其他省份和世界其他地区报告的发生率相似。在所有儿童疫苗中，五联疫苗反应原性最强。没有严重不良事件表明古巴儿童免疫接种的安全性。
