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乌兹别克斯坦霍贾利区新冠疫苗接种的药物警戒:一项流行病学评估

COVID-19 vaccination pharmacovigilance in Khojaly district, Uzbekistan: an epidemiological evaluation.

作者信息

Tursinov Yunis, Horth Roberta, Kurbonov Botirjon, Denebayeva Alfiya, Adambekov Shalkar, Nabirova Dilyara

机构信息

Central Asia Field Epidemiology Training Program, Almaty, Kazakhstan.

Department of Epidemiology with the course of HIV infection, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan.

出版信息

Front Public Health. 2025 Jul 2;13:1520821. doi: 10.3389/fpubh.2025.1520821. eCollection 2025.

DOI:10.3389/fpubh.2025.1520821
PMID:40672927
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12263602/
Abstract

INTRODUCTION

COVID-19 vaccines are safe and effective, reducing global morbidity and mortality. Strong vaccine safety surveillance systems increase public confidence in vaccines. Regular evaluations are needed to ensure these systems function effectively. We evaluated the adverse events following immunization (AEFI) surveillance system for COVID-19 vaccine in Khojaly District, Uzbekistan.

METHODS

We analyzed National Vaccine Registry data for April 2021-March 2022 for Khojaly (population: 120,000). The registry captures demographic information for individuals who received or refused COVID-19 vaccination and reported AEFI. An AEFI is any untoward medical occurrence that follows immunization, but does not necessarily have a causal relationship with the vaccine. In June 2022, we also surveyed 30 consenting vaccination providers from five outpatient clinics and reviewed regulatory documents related to COVID-19 vaccination and AEFI reporting. We performed descriptive statistics using R.

RESULTS

A total of 78,453 COVID-19 vaccines doses were administered in Khojaly from April 2021 to March 2022. Of these, 70% were Zifivax (ZF2001), an adjuvant protein vaccine produced in Uzbekistan, 9% were Pfizer-BioNTech, 7% were Moderna, and 14% were others. There were 843 AEFI correctly reported by providers (1,074 per 100,000) during this time, 837 (1,067 per 100,000 doses) of which were reported as mild allergic reactions, 4 (5 per 100,000 doses) as exacerbations of chronic disease, and 2 (3 per 100,000 doses) as anaphylactic shock. Among the providers surveyed ( = 30), 15 (50%) had previously encountered at least one AEFI following COVID-19 vaccination, and 3 (10%) had encountered a severe AEFI. Among all providers, only 13 (43%) submitted an AEFI report, and 10 (33%) did not know where to report an AEFI. The most common barriers to reporting included having a large patient load (20%) and not having access to computers (7%). The AEFI surveillance system lacked a feedback loop to share summary data with healthcare facilities and clinicians for informed decision-making.

CONCLUSION

The COVID-19 vaccination surveillance system in Khojaly recorded AEFIs, but we identified gaps in AEFI reporting and knowledge among providers. Improving the AEFI registry and training providers on standard operating procedures for identifying, reporting, and investigating AEFI could improve vaccine safety surveillance.

摘要

引言

新冠病毒疫苗安全有效,降低了全球发病率和死亡率。强大的疫苗安全监测系统可增强公众对疫苗的信心。需要定期评估以确保这些系统有效运行。我们对乌兹别克斯坦霍贾利区的新冠病毒疫苗免疫后不良事件(AEFI)监测系统进行了评估。

方法

我们分析了霍贾利(人口:120,000)2021年4月至2022年3月的国家疫苗登记数据。该登记系统记录了接种或拒绝接种新冠病毒疫苗并报告AEFI的个人的人口统计学信息。AEFI是指免疫接种后发生的任何不良医学事件,但不一定与疫苗有因果关系。2022年6月,我们还对来自五家门诊诊所的30名同意参与调查的疫苗接种提供者进行了调查,并审查了与新冠病毒疫苗接种和AEFI报告相关的监管文件。我们使用R软件进行描述性统计。

结果

2021年4月至2022年3月期间,霍贾利共接种了78,453剂新冠病毒疫苗。其中,70%是Zifivax(ZF2001),这是一种乌兹别克斯坦生产的佐剂蛋白疫苗,9%是辉瑞 - 生物科技疫苗,7%是莫德纳疫苗,14%是其他疫苗。在此期间,提供者正确报告了843例AEFI(每100,000人中有1,074例),其中837例(每100,000剂中有1,067例)报告为轻度过敏反应,4例(每100,000剂中有5例)为慢性病加重,2例(每100,000剂中有3例)为过敏性休克。在接受调查的提供者(n = 30)中,15名(50%)此前在新冠病毒疫苗接种后至少遇到过1例AEFI,3名(10%)遇到过严重AEFI。在所有提供者中,只有13名(43%)提交了AEFI报告,10名(33%)不知道在哪里报告AEFI。报告的最常见障碍包括患者量大(20%)和无法使用电脑(7%)。AEFI监测系统缺乏反馈回路,无法与医疗机构和临床医生共享汇总数据以进行明智决策。

结论

霍贾利的新冠病毒疫苗接种监测系统记录了AEFI,但我们发现提供者在AEFI报告和知识方面存在差距。改进AEFI登记系统并对提供者进行识别、报告和调查AEFI的标准操作程序培训,可改善疫苗安全监测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aae2/12263602/b0cdb0d09078/fpubh-13-1520821-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aae2/12263602/b0cdb0d09078/fpubh-13-1520821-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aae2/12263602/b0cdb0d09078/fpubh-13-1520821-g001.jpg

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