免疫后不良事件的主动监测(AEFI):一项为期3年的前瞻性疫苗安全性研究

Q2 Medicine
J. Sebastian, P. Gurumurthy, M. Ravi, M. Ramesh
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引用次数: 16

摘要

背景:在国家免疫规划中使用的疫苗被认为是安全有效的,但免疫安全性已经变得与疫苗接种计划的有效性一样重要。该研究的目的是检测对印度儿科人群接种的所有疫苗免疫后的不良事件(AEFIs)。方法:前瞻性活疫苗安全性监测研究纳入了在Mysuru JSS医院免疫中心接种疫苗的0-5岁年龄组符合条件的儿童。研究参与者接种疫苗后在现场监测30分钟,并在8天后进行电话调查以确定所有aefi。使用世界卫生组织安全与警惕性部门开发的新算法对急性呼吸道感染的因果关系进行了评估。结果:报告的急性脑损伤发生率为13.7%。最常见的AEFI报告是发热(n = 3095, 93.2%),发生率为109.7 / 1000剂疫苗,其次是持续哭泣(n = 69, 2.4 / 1000剂疫苗)和腹泻(n = 57, 2.0 / 1000剂疫苗)。主要涉及的AEFIs疫苗是Pentavac®,其次是卡介苗。93.4%的病例与免疫接种有一致的因果关系。结论:与先前发表的研究相比,我们的研究人群中观察到AEFI的发生率较高。AEFI监测研究有助于发现不良事件发生频率的变化,这可能是考虑疫苗质量或确定当地人群中特定风险的警报。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Active surveillance of adverse events following immunization (AEFI): a prospective 3-year vaccine safety study
Background: Vaccines used in national immunization programs are considered safe and effective but immunization safety has become as important as the efficacy of vaccination programs. The objective of the study was to detect adverse events following immunization (AEFIs) to all vaccines administered to a pediatric population in India. Methods: The prospective active vaccine safety surveillance study enrolled eligible children in the age group 0–5 years receiving vaccination from the immunization center at JSS Hospital, Mysuru. Study participants were monitored at the site for 30 min following vaccination and a telephonic survey was made after 8 days to identify all AEFIs. Causality assessment of the AEFIs were done using a new algorithm developed by the safety and vigilance department of the World Health Organization. Results: The incidence of reported AEFIs was 13.7%. The most frequently reported AEFI was fever (n = 3095, 93.2%) with an incidence of 109.7 per 1000 doses of vaccine administered, followed by persistent crying (n = 69, 2.4 per 1000 doses of vaccine) and diarrhea (n = 57, 2.0 per 1000 doses of vaccine). The majorly implicated vaccine for AEFIs was Pentavac® followed by BCG. Consistent causal association to immunization was observed in 93.4% of cases. Conclusions: A high incidence rate of AEFI was observed in our study population when compared with previous published studies. AEFI surveillance studies help to detect changes in the frequency of adverse events, which may be an alert to consider vaccine quality or identify a specific risk among the local population.
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来源期刊
Therapeutic Advances in Vaccines and Immunotherapy
Therapeutic Advances in Vaccines and Immunotherapy Medicine-Pharmacology (medical)
CiteScore
5.10
自引率
0.00%
发文量
15
审稿时长
8 weeks
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