理想的疫苗上市后安全系统应该是怎样的？
What should an ideal vaccine postlicensure safety system be?
作者信息
Griffin Marie R, Braun M Miles, Bart Kenneth J
机构信息
Departments of Preventive Medicine and Medicine, School of Medicine, Vanderbilt University, Nashville, TN, USA.
出版信息
Am J Public Health. 2009 Oct;99 Suppl 2(Suppl 2):S345-50. doi: 10.2105/AJPH.2008.143081.
Abstract
In 2007 the National Vaccine Program, along with the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Health Resources and Services Administration, sponsored a public conference titled "Vaccine Safety Evaluation: Post Marketing Surveillance." The objective was to discuss enhanced approaches to postlicensure evaluation of vaccine safety, including active and passive surveillance systems and special studies. The conference participants reviewed the evolution of the assessment of vaccine safety, detailed current national approaches to postmarketing safety, and offered new approaches to evaluating vaccine safety. A number of the participants recommended that information systems be expanded to include reliable information on vaccination and health outcomes in large populations. We summarize the major meeting presentations and discussions.
摘要
2007年，国家疫苗计划与疾病控制和预防中心、食品药品管理局、国立卫生研究院以及卫生资源与服务管理局共同主办了一次名为“疫苗安全性评估：上市后监测”的公开会议。其目的是讨论加强疫苗上市后安全性评估的方法，包括主动和被动监测系统以及专项研究。会议参与者回顾了疫苗安全性评估的演变过程，详细介绍了当前国家层面上市后安全性评估的方法，并提出了评估疫苗安全性的新方法。许多参与者建议扩大信息系统，以纳入大量人群中有关疫苗接种和健康结果的可靠信息。我们总结了会议的主要报告和讨论内容。
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