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2013 - 2021年中国脑膜炎球菌疫苗接种后不良事件的上市后监测

Post-Marketing Surveillance of Adverse Events Following Meningococcal Vaccination - China, 2013-2021.

作者信息

Xu Yuyang, Li Keli, Li Yan, Li Yuan, Zhang Lina, Fan Chunxiang, Ren Minrui, Yin Zundong

机构信息

Department of Expanded Program on Immunization, Hangzhou Center for Disease Control and Prevention, Hangzhou City, Zhejiang Province, China.

National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases (NITFID), National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing, China.

出版信息

China CDC Wkly. 2024 Dec 13;6(50):1325-1330. doi: 10.46234/ccdcw2024.263.

DOI:10.46234/ccdcw2024.263
PMID:39734788
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11673179/
Abstract

WHAT IS ALREADY KNOWN ABOUT THIS TOPIC?: From 2010 to 2012, the incidence of adverse vaccine reactions from meningococcal vaccine (MenV) in China ranged from 8.46 to 56.30 per 100,000 doses.

WHAT IS ADDED BY THIS REPORT?: From 2013 to 2021, the overall reported rate of adverse events following immunization (AEFI) of five types of market-authorized MenV-containing vaccines in China was 37.87 per 100,000 doses administered, with a reported incidence of adverse vaccine reactions of 37.39 per 100,000 doses. The reported incidence of adverse vaccine reactions was comparable to that from 2010 to 2012 and perceived to be within an acceptable range. Most rare vaccine reactions were allergic rashes, and most of these cases were transient and non-serious.

WHAT ARE THE IMPLICATIONS FOR PUBLIC HEALTH PRACTICE?: In China, the incidence of AEFI was very low, and serious abnormal reactions were extremely rare. We should continue to carry out technical training for vaccinators and on-site treatment capabilities to improve emergency treatment for anaphylactic shock and other serious events and ensure the continued safety of vaccination.

摘要

关于该主题已知的信息有哪些?:2010年至2012年,中国脑膜炎球菌疫苗(MenV)的不良疫苗反应发生率为每10万剂8.46至56.30例。

本报告新增了哪些内容?:2013年至2021年,中国五种市场授权的含脑膜炎球菌疫苗免疫接种后不良事件(AEFI)的总体报告率为每10万剂接种量37.87例,不良疫苗反应报告发生率为每10万剂37.39例。不良疫苗反应报告发生率与2010年至2012年相当,且被认为在可接受范围内。大多数罕见疫苗反应为过敏性皮疹,且大多数病例为短暂性且不严重。

对公共卫生实践有何启示?:在中国,AEFI发生率非常低,严重异常反应极为罕见。我们应继续开展针对疫苗接种人员的技术培训和现场处理能力培训,以改善对过敏性休克等严重事件的应急处理,并确保疫苗接种的持续安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93d7/11673179/c7bdde7dd169/ccdcw-6-50-1325-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93d7/11673179/c7bdde7dd169/ccdcw-6-50-1325-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93d7/11673179/c7bdde7dd169/ccdcw-6-50-1325-1.jpg

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本文引用的文献

1
Meningococcal Disease in the Post-COVID-19 Era: A Time to Prepare.新冠疫情后时代的脑膜炎球菌病:是时候做好准备了。
Infect Dis Ther. 2023 Dec;12(12):2649-2663. doi: 10.1007/s40121-023-00888-w. Epub 2023 Dec 4.
2
Use of a new global indicator for vaccine safety surveillance and trends in adverse events following immunization reporting 2000-2015.使用新的全球疫苗安全监测指标和 2000-2015 年疫苗接种后不良事件报告趋势。
Vaccine. 2018 Mar 14;36(12):1577-1582. doi: 10.1016/j.vaccine.2018.02.012. Epub 2018 Feb 14.
3
Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults.
一种A、C、W-135和Y群四价脑膜炎球菌结合疫苗在青少年和成人中的安全性和免疫原性。
Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 1.