乙肝疫苗免疫后的不良事件报告:13 年回顾。

IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-10-13 DOI:10.1080/21645515.2024.2411824
Xiaoying Gong, Quanjun Fang, Jianyue Zhong, Canjie Zheng, Zhiying Yin
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引用次数: 0

摘要

接种乙肝疫苗是阻断乙肝病毒传播的最有效手段。尽管乙肝疫苗非常有效和安全,但免疫接种后仍会发生不良事件,需要及时报告,以便发现问题并采取适当的纠正措施。大多数关于 AEFI 的研究都集中在对新使用疫苗的安全性观察上,很少有关于乙肝疫苗 AEFI 的长期研究。本研究回顾性分析了 2011 年至 2023 年衢州市乙肝疫苗 AEFI 的报告率、临床症状和发病时间,并比较了不同类型乙肝疫苗、不同接种年龄和不同剂量乙肝疫苗 AEFI 报告率的差异。监测结果显示,2011-2023年,衢州市乙肝疫苗AEFI报告率为17.55/10万剂次。98.73%的AEFI报告为非严重感染。报告的AEFI类型包括疫苗产品相关反应、免疫焦虑相关反应和偶合事件。94.12%的疫苗产品相关反应发生在3天内,主要症状为发热、注射部位局部反应和皮疹。CHO疫苗的AEFI报告率高于酵母疫苗,接种乙肝疫苗的1岁以下儿童发生AEFI的概率后一剂高于前一剂。长达 13 年的 AEFI 监测为乙肝疫苗的安全性提供了可靠的证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse event reporting following immunization of hepatitis B vaccine: A 13-year review.

Hepatitis B vaccination is the most effective means of interrupting HBV transmission. Although the hepatitis B vaccine is very effective and safe, adverse events following immunization do occur and need to be reported so that problems can be identified and appropriate corrective action can be taken. Most of the research on AEFI focuses on the safety observation of newly used vaccines, and there are few long-term studies on AEFI of the hepatitis B vaccine. This study retrospectively analyzes the reporting rate, clinical symptoms, and onset time of AEFI of the hepatitis B vaccine in Quzhou from 2011 to 2023, and compares the differences in AEFI reporting rates between different types of hepatitis B vaccines, different vaccination ages, and different doses. The surveillance results show that from 2011 to 2023, the AEFI reporting rate of hepatitis B Vaccines in Quzhou was 17.55/100,000 doses. 98.73% of reported AEFI were non-serious. The types of AEFI reported were vaccine product-related reactions, immunization anxiety-related reactions, and coincidental events. 94.12% of vaccine product-related reactions occurred within 3 days, and the main symptoms were fever, local reactions at the injection site, and rash. The AEFI reporting rate of the CHO vaccine was higher than that of the yeast vaccines, and the probability of AEFI in children under 1 year of age receiving the hepatitis B vaccine was higher in the latter dose than in the previous dose. The 13-year-long AEFI surveillance provides reliable evidence of the safety of the hepatitis B vaccine.

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来源期刊
Human Vaccines & Immunotherapeutics
Human Vaccines & Immunotherapeutics BIOTECHNOLOGY & APPLIED MICROBIOLOGY-IMMUNOLOGY
CiteScore
7.90
自引率
8.30%
发文量
489
审稿时长
3-6 weeks
期刊介绍: (formerly Human Vaccines; issn 1554-8619) Vaccine research and development is extending its reach beyond the prevention of bacterial or viral diseases. There are experimental vaccines for immunotherapeutic purposes and for applications outside of infectious diseases, in diverse fields such as cancer, autoimmunity, allergy, Alzheimer’s and addiction. Many of these vaccines and immunotherapeutics should become available in the next two decades, with consequent benefit for human health. Continued advancement in this field will benefit from a forum that can (A) help to promote interest by keeping investigators updated, and (B) enable an exchange of ideas regarding the latest progress in the many topics pertaining to vaccines and immunotherapeutics. Human Vaccines & Immunotherapeutics provides such a forum. It is published monthly in a format that is accessible to a wide international audience in the academic, industrial and public sectors.
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