Niu Manette T, Ball Robert, Woo Emily Jane, Burwen Dale R, Knippen Maureen, Braun M Miles
Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Division of Epidemiology, Vaccine Safety Branch, 1401 Rockville Pike, HFM-220, Rockville, MD 20852, United States.
Vaccine. 2009 Jan 7;27(2):290-7. doi: 10.1016/j.vaccine.2008.10.044. Epub 2008 Nov 6.
During the period March 1, 1998 to January 14, 2007, approximately 6 million doses of Anthrax vaccine adsorbed (AVA) vaccine were administered. As of January 16, 2007, 4753 reports of adverse events following receipt of AVA vaccination had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Taken together, reports to VAERS did not definitively link any serious unexpected risk to this vaccine, and review of death and serious reports did not show a distinctive pattern indicative of a causal relationship to AVA vaccination. Continued monitoring of VAERS and analysis of potential associations between AVA vaccination and rare, serious events is warranted.
在1998年3月1日至2007年1月14日期间,大约接种了600万剂吸附炭疽疫苗(AVA)。截至2007年1月16日,已有4753份接种AVA疫苗后出现不良事件的报告提交至疫苗不良事件报告系统(VAERS)。总体而言,向VAERS提交的报告并未明确将任何严重的意外风险与该疫苗联系起来,对死亡和严重报告的审查也未显示出表明与AVA疫苗接种存在因果关系的独特模式。有必要继续监测VAERS,并分析AVA疫苗接种与罕见严重事件之间的潜在关联。
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