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J Korean Med Sci. 2024 Apr 1;39(12):e119. doi: 10.3346/jkms.2024.39.e119.
2
Establishment of Safety Monitoring System for Vaccines Not Included in the National Immunization Program in Korea.韩国国家免疫规划未涵盖疫苗的安全监测系统的建立
J Korean Med Sci. 2024 Feb 5;39(5):e45. doi: 10.3346/jkms.2024.39.e45.
3
Impact of age, ethnicity, sex and prior infection status on immunogenicity following a single dose of the BNT162b2 mRNA COVID-19 vaccine: real-world evidence from healthcare workers, Israel, December 2020 to January 2021.2020 年 12 月至 2021 年 1 月,以色列医护人员的真实世界数据显示,年龄、种族、性别和既往感染状况对接受一剂 BNT162b2 mRNA COVID-19 疫苗后的免疫原性有影响。
Euro Surveill. 2021 Feb;26(6). doi: 10.2807/1560-7917.ES.2021.26.6.2100096.
4
Characterization of the Differential Adverse Event Rates by Race/Ethnicity Groups for HPV Vaccine by Integrating Data From Different Sources.通过整合来自不同来源的数据,按种族/族裔群体对人乳头瘤病毒疫苗的不良事件发生率差异进行特征分析。
Front Pharmacol. 2018 May 24;9:539. doi: 10.3389/fphar.2018.00539. eCollection 2018.
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The Canadian Immunization Monitoring Program, ACTive (IMPACT): Active surveillance for vaccine adverse events and vaccine-preventable diseases.加拿大免疫监测项目,即主动监测(IMPACT):对疫苗不良事件和疫苗可预防疾病进行主动监测。
Can Commun Dis Rep. 2014 Dec 4;40(Suppl 3):41-44. doi: 10.14745/ccdr.v40is3a06.
6
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).疫苗不良事件报告系统(VAERS)中的安全性监测。
Vaccine. 2015 Aug 26;33(36):4398-405. doi: 10.1016/j.vaccine.2015.07.035. Epub 2015 Jul 22.
7
The Vaccine Safety Datalink: a model for monitoring immunization safety.疫苗安全数据链:监测免疫安全性的模型。
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8
The reporting sensitivities of two passive surveillance systems for vaccine adverse events.两种疫苗不良事件被动监测系统的报告敏感性。
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韩国非国家免疫规划疫苗相关特定关注不良事件的哨点安全监测系统

Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea.

作者信息

Hyun Hakjun, Heo Jung Yeon, Choi Yu Jung, Nham Eliel, Yoon Jin Gu, Noh Ji Yun, Song Joon Young, Kim Woo Joo, Choi Won Suk, Choi Min Joo, Seo Yu Bin, Lee Jacob, Cheong Hee Jin

机构信息

Department of Infectious Diseases, Ajou University School of Medicine, Suwon, Korea.

Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.

出版信息

J Korean Med Sci. 2025 Apr 28;40(16):e152. doi: 10.3346/jkms.2025.40.e152.

DOI:10.3346/jkms.2025.40.e152
PMID:40296829
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12040605/
Abstract

South Korea's current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI. We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for pre-defined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.

摘要

韩国目前的疫苗接种政策在非国家免疫规划(NIP)疫苗方面存在监测缺口。在本研究中,我们提出了一种哨点监测方法来监测非NIP疫苗的安全性。通过回顾五所大学医院的电子病历,对因预先定义的特殊关注不良事件(AESI)住院的患者进行回顾性疫苗接种数据收集。该方法纳入专家评估以确定因果关系。我们确认在860例被诊断为AESI的患者中有16例接种了非NIP疫苗。我们得出结论,1例先兆子痫可能与破伤风-白喉-百日咳疫苗接种有关。我们提出一种基于多医院的、针对预先定义的AESI的回顾性评估系统,作为主动疫苗安全性监测方法的替代方案。这些努力有望提高韩国安全性监测的准确性和及时性。