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Am J Public Health. 2004 Jun;94(6):947-50. doi: 10.2105/ajph.94.6.947.
2
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本文引用的文献

1
Smallpox vaccine adverse events among civilians--United States, January 24-February 18, 2003.2003年1月24日至2月18日美国平民中的天花疫苗不良事件
MMWR Morb Mortal Wkly Rep. 2003 Feb 21;52(7):136.
2
Clinical responses to undiluted and diluted smallpox vaccine.对未稀释和稀释后的天花疫苗的临床反应。
N Engl J Med. 2002 Apr 25;346(17):1265-74. doi: 10.1056/NEJMoa020534. Epub 2002 Mar 28.
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More on rotavirus vaccination and intussusception.
N Engl J Med. 2002 Jan 17;346(3):211-2. doi: 10.1056/NEJM200201173460317.
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Intussusception among infants given an oral rotavirus vaccine.口服轮状病毒疫苗的婴儿中的肠套叠。
N Engl J Med. 2001 Feb 22;344(8):564-72. doi: 10.1056/NEJM200102223440804.
5
The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA.疫苗安全数据链:美国健康维护组织中的免疫研究
Bull World Health Organ. 2000;78(2):186-94.
6
Limiting infant exposure to thimerosal in vaccines and other sources of mercury.限制婴儿接触疫苗及其他汞源中的硫柳汞。
JAMA. 1999 Nov 10;282(18):1763-6. doi: 10.1001/jama.282.18.1763.
7
Vaccine risks: real, perceived and unknown.疫苗风险:真实的、感知到的和未知的。
Vaccine. 1999 Oct 29;17 Suppl 3:S41-6. doi: 10.1016/s0264-410x(99)00292-3.
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9
Health consequences of religious and philosophical exemptions from immunization laws: individual and societal risk of measles.宗教和哲学层面豁免免疫法带来的健康后果:麻疹的个人及社会风险
JAMA. 1999 Jul 7;282(1):47-53. doi: 10.1001/jama.282.1.47.
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Making medicines safer--the need for an independent drug safety board.
N Engl J Med. 1998 Dec 17;339(25):1851-4. doi: 10.1056/NEJM199812173392512.

通过对疫苗上市后安全性进行独立监督来增强公众对疫苗的信心。

Enhancing public confidence in vaccines through independent oversight of postlicensure vaccine safety.

作者信息

Salmon Daniel A, Moulton Lawrence H, Halsey Neal A

机构信息

Institute for Vaccine Safety, Johns Hopkins University, Bloomberg School of Public Health, 615 N Wolfe Street, Suite 5034, Baltimore, MD 21205, USA.

出版信息

Am J Public Health. 2004 Jun;94(6):947-50. doi: 10.2105/ajph.94.6.947.

DOI:10.2105/ajph.94.6.947
PMID:15249296
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1448370/
Abstract

The National Immunization Program of the Centers for Disease Control and Prevention is responsible for controlling infectious diseases through vaccination, but the program also plays a key role in postlicensure vaccine safety assessment. The time has come to separate postlicensure vaccine safety assessment from vaccine risk management as recommended by the National Research Council of the National Academy of Sciences.The National Transportation Safety Board offers a useful model for developing an independent National Vaccine Safety Board that would have the authority to leverage resources and expertise of various government agencies, academia, and industry to oversee postlicensure vaccine safety investigations. Such a board would have been useful in recent vaccine safety concerns, and its independence from government programs would ensure optimal vaccine safety and enhance public confidence in vaccines.

摘要

疾病控制与预防中心的国家免疫规划负责通过接种疫苗来控制传染病,但该规划在疫苗上市后安全性评估中也发挥着关键作用。按照美国国家科学院国家研究理事会的建议,现在是时候将疫苗上市后安全性评估与疫苗风险管理区分开来了。国家运输安全委员会提供了一个有益的模式,可用于设立一个独立的国家疫苗安全委员会,该委员会将有权利用各政府机构、学术界和行业的资源与专业知识,监督疫苗上市后的安全性调查。这样一个委员会在近期的疫苗安全问题中会很有用,其独立于政府项目将确保最佳的疫苗安全性,并增强公众对疫苗的信心。