Adverse events associated with smallpox vaccination in the United States, January-October 2003
Adverse events associated with smallpox vaccination in the United States, January-October 2003
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DOI：
10.1001/jama.294.21.2734
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发表时间：
2005-12-07
影响因子：
120.7
通讯作者：
Mootrey, G
中科院分区：
文献类型：
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作者：
Casey, CG;Iskander, JK;Mootrey, G
2003年1月24日，美国卫生与公众服务部（DHHS）实施了一项预防计划，（牛痘）疫苗给联邦、州和当地志愿者接种，他们可能是生物恐怖事件发生期间的第一反应者。对2003年1月24日至10月31日期间通过疫苗不良事件报告系统（VAERS）和疾病控制和预防中心收到的DHHS天花疫苗安全监测和反应系统的不良事件报告进行描述性研究。共37 901名志愿者在55个司法管辖区接受了至少1剂天花vaccine.Main Outcome Measures接种的管理和描述的不良事件和报告rates.Results的接种数量共38 885天花疫苗的管理，与采取率为92%。VAERS收到了822份天花疫苗接种后的不良事件报告（总报告率为217/10000接种者）。在接种疫苗后14天内共报告了590起不良事件（72%）。非严重不良事件（n=722）包括轻度和自限性局部反应的多种体征和症状。100起不良事件（12%）被指定为严重事件，导致85例住院治疗，2例永久性残疾，10例危及生命的疾病和3例死亡。在严重不良事件中，21例被归类为心肌炎和/或心包炎，10例被归类为缺血性心脏事件，根据历史数据，这些事件不是预期的。发现2例全身性牛痘和1例牛痘后脑炎。未发现可预防的危及生命的不良反应、接触传播或需要用牛痘免疫球蛋白治疗的不良反应。严重的不良事件是更常见的年龄较大的revaccinees比年轻的首次vaccinees.Conclusions严格的天花疫苗安全性筛查，教育计划，和老年人接种者可能导致可预防的危及生命的不良反应的发生率低。通过及时审查VAERS数据和深入的临床病例调查，检测到其他罕见、临床显著或非预期心脏不良事件。
Context On January 24, 2003, the US Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a bioterrorism event.Objective To describe results from the comprehensive DHHS smallpox vaccine safety monitoring and response system.Design, Setting, and Participants Descriptive study of adverse event reports from the DHHS smallpox vaccine safety monitoring and response system received between January 24 and October 31, 2003, through the Vaccine Adverse Event Reporting System (VAERS) and the Centers for Disease Control and Prevention. A total of 37 901 volunteers in 55 jurisdictions received at least 1 dose of smallpox vaccine.Main Outcome Measures Number of vaccinations administered and description of adverse events and reporting rates.Results A total of 38 885 smallpox vaccinations were administered, with a take rate of 92%. VAERS received 822 reports of adverse events following smallpox vaccination (overall reporting rate, 217 per 10 000 vaccinees). A total of 590 adverse events (72%) were reported within 14 days of vaccination. Nonserious adverse events (n=722) included multiple signs and symptoms of mild and self-limited local reactions. One hundred adverse events (12%) were designated as serious, resulting in 85 hospitalizations, 2 permanent disabilities, 10 life-threatening illnesses, and 3 deaths. Among the serious adverse events, 21 cases were classified as myocarditis and/or pericarditis and 10 as ischemic cardiac events that were not anticipated based on historical data. Two cases of generalized vaccinia and 1 case of postvaccinial encephalitis were detected. No preventable life-threatening adverse reactions, contact transmissions, or adverse reactions that required treatment with vaccinia immune globulin were identified. Serious adverse events were more common among older revaccinees than younger first-time vaccinees.Conclusions Rigorous smallpox vaccine safety screening, educational programs, and older vaccinees may have contributed to low rates of preventable life-threatening adverse reactions. Other rare, clinically significant, or unexpected cardiac adverse events were detected by timely review of VAERS data and intensive clinical case investigation.