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社论:在 COVID-19 大流行期间,我们可以从国家和国际疫苗不良事件报告系统中学到什么?

Editorial: What Can be Learned from National and International Vaccine Adverse Event Reporting Systems During the COVID-19 Pandemic?

机构信息

Scientific Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

出版信息

Med Sci Monit. 2021 Nov 1;27:e935299. doi: 10.12659/MSM.935299.

Abstract

Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant national reporting agencies as part of the process of post-marketing drug safety monitoring. In the US, the Vaccine Adverse Event Reporting System (VAERS) is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Data from VAERS and other national and global reporting systems show very low rates of adverse events related to currently approved SARS-CoV-2 vaccines. Populations studies have supported the findings from adverse event reporting systems. The presentation, monitoring, and reporting of adverse events related to SARS-CoV-2 vaccines may have future applications in vaccine monitoring for several other potential pandemic zoonotic infections. This editorial aims to summarize the current understanding of adverse events from current COVID-19 vaccines from global adverse event reporting systems, rather than individual case reports or anecdotal reporting in the media.

摘要

医疗保健专业人员有道德、医学法律和专业责任,将所有疑似疫苗接种后不良反应报告给相关的国家报告机构,作为上市后药物安全监测过程的一部分。在美国,疫苗不良事件报告系统(VAERS)由疾病控制和预防中心(CDC)和食品和药物管理局(FDA)共同赞助。来自 VAERS 和其他国家和全球报告系统的数据显示,与目前批准的 SARS-CoV-2 疫苗相关的不良事件发生率非常低。人群研究支持不良事件报告系统的发现。与 SARS-CoV-2 疫苗相关的不良事件的呈现、监测和报告可能在未来对几种其他潜在大流行人畜共患感染的疫苗监测具有应用价值。本社论旨在总结当前对全球不良事件报告系统中来自当前 COVID-19 疫苗的不良事件的理解,而不是媒体中个别病例报告或传闻报告。

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COVID vaccines and blood clots: five key questions.新冠疫苗与血栓:五个关键问题
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