儿童新冠疫苗接种不良事件:大不里士市对照组调查
COVID-19 Vaccination Adverse Events in Children: An Investigation with a Control Group in Tabriz Metropolitan City.
作者信息
Jafari N, Akbari H, Khayatzadeh S, Nobakht-Nojehdeh H, Sarbakhsh P
机构信息
Department of Epidemiology & Biostatistics, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran.
Province Health Center, Health Chancellor, Tabriz University of Medical Sciences, Tabriz, Iran.
出版信息
Arch Razi Inst. 2024 Oct 31;79(5):1031-1038. doi: 10.32592/ARI.2024.79.5.1031. eCollection 2024 Oct.
The occurrence of adverse events following vaccination with the novel coronavirus disease 2019 (COVID-19) vaccine in children remains somewhat unclear, with only a limited number of population-based studies having been conducted in this age group. The objective of this study is to ascertain the short-term adverse events associated with the Sinopharm and Soberana (Pasto CoVac) vaccination in children between the ages of 5 and 12. This study employs an observational design with a control group. The cluster sampling method was employed to recruit the study samples, with healthcare centers and mass vaccination centers of Tabriz designated as clusters. The ratio of the vaccinated and unvaccinated groups was 2:1, respectively. Information was gathered via telephone interviews with the parents or guardians of the subjects. The data were analyzed using a mixed-effect logistic regression model. In this study, a total of 913 children were investigated, comprising 577 vaccinated and 336 unvaccinated children. The results demonstrated that the most frequent complication among the vaccinated children was injection site pain, occurring in 178 cases (30.8%, 95% CI:( 27%, 35%)) The most frequently reported systemic adverse events among vaccinated and unvaccinated children were fever (9.0% vs. 3.6%, p = 0.003), fatigue (5.5% vs. 0.9%, p = 0.002), and headache (2.9% vs. 0.6%, p = 0.032). No serious adverse events, including myocarditis, multisystem inflammatory syndrome (MIS), or hospitalization, were reported. The odds of experiencing any symptoms in the vaccinated group, adjusted for potential confounding variables, were significantly higher than in the control group (adjusted OR = 4.71, CI 95%: (3.04, 7.26), with a p-value of less than 0.001. The results indicate that the Sinopharm and Soberana (PastoCoVac) vaccines did not have any serious adverse effects. Moreover, it appears that some of the reported adverse events in other studies may be overestimated due to the absence of a control group.
2019年冠状病毒病(COVID-19)疫苗接种后儿童不良事件的发生情况仍不太明确,该年龄组仅开展了数量有限的基于人群的研究。本研究的目的是确定5至12岁儿童接种国药集团和索贝拉纳(帕斯托科瓦克)疫苗相关的短期不良事件。本研究采用有对照组的观察性设计。采用整群抽样方法招募研究样本,将大不里士的医疗中心和大规模疫苗接种中心指定为群。接种组和未接种组的比例分别为2:1。通过电话采访受试者的父母或监护人收集信息。使用混合效应逻辑回归模型分析数据。本研究共调查了913名儿童,其中577名接种疫苗儿童和336名未接种疫苗儿童。结果表明,接种疫苗儿童中最常见的并发症是注射部位疼痛,有178例(30.8%,95%CI:(27%,35%))。接种疫苗和未接种疫苗儿童中最常报告的全身性不良事件是发热(9.0%对3.6%,p = 0.003)、疲劳(5.5%对0.9%,p = 0.002)和头痛(2.9%对0.6%,p = 0.032)。未报告包括心肌炎、多系统炎症综合征(MIS)或住院在内的严重不良事件。在对潜在混杂变量进行调整后,接种组出现任何症状的几率显著高于对照组(调整后的OR = 4.71,95%CI:(3.04,7.26),p值小于0.001。结果表明,国药集团和索贝拉纳(帕斯托科瓦克)疫苗没有任何严重不良反应。此外,由于缺乏对照组,其他研究中报告的一些不良事件可能被高估了。