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首页> 外文期刊>Vaccine >Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997-2005
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Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997-2005

机译：纯化的鸡胚细胞狂犬病疫苗的安全性综述：疫苗不良事件报告系统（VAERS）的数据，1997-2005年

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摘要

On October 20, 1997, the U.S. Food and Drug Administration (FDA) licensed Purified Chick Embryo Cell (PCEC, RabAvert((R))) vaccine against rabies in humans following clinical trials demonstrating safety and efficacy. From October 1997 through December 2005, the Vaccine Adverse Event Reporting System (VAERS) received 336 reports of adverse events (AEs) following vaccination with PCEC vaccine in the U.S.; there were no death reports. Serious events, including 20 hospitalizations and 13 neurological events, were described in 24 (7%) reports. There was no pattern among the 13 neurological AEs suggesting a plausible relationship to vaccination. A total of 20 AEs, 3 serious, were classified as possible anaphylaxis. There were 312 non-serious AEs (93%). Nineteen reports (6%) described that the vaccination series was discontinued because of non-serious AEs. Most reported AEs are non-serious and consistent with pre-licensure safety data. The rabies risk must be carefully considered before vaccine discontinuation.
机译：在证明安全性和有效性的临床试验之后，1997年10月20日，美国食品药品监督管理局（FDA）批准了针对人类狂犬病的纯化小鸡胚胎细胞（PCEC，RabAvert（R））疫苗。从1997年10月到2005年12月，美国疫苗不良事件报告系统（VAERS）收到336例接种PCEC疫苗后的不良事件（AE）报告;没有死亡报告。 24（7％）报告描述了严重事件，包括20例住院和13例神经系统事件。在13种神经学不良事件中没有任何模式表明与疫苗接种之间存在合理的关系。总共20例AE，其中3例严重，被归类为可能的过敏反应。有312个非严重不良事件（93％）。十九份报告（占6％）描述了由于非严重AE而终止了疫苗接种系列。大多数报告的不良事件并不严重，并且与许可前的安全性数据一致。停药前必须仔细考虑狂犬病的风险。

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