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关于b型流感嗜血杆菌(Hib)结合疫苗使用的临时建议,涉及某些批次含Hib疫苗(PedvaxHIB和Comvax)的召回。

Interim recommendations for the use of Haemophilus influenzae type b (Hib) conjugate vaccines related to the recall of certain lots of Hib-containing vaccines (PedvaxHIB and Comvax).

出版信息

MMWR Morb Mortal Wkly Rep. 2007 Dec 21;56(50):1318-20.

PMID:18097345
Abstract

On December 13, 2007, Merck & Co., Inc. (West Point, Pennsylvania) announced a voluntary recall of certain lots of two Haemophilus influenzae type b (Hib) conjugate vaccines, PedvaxHIB (monovalent Hib vaccine) and Comvax(R) (Hib/hepatitis B vaccine). Providers should return unused vaccine from these recalled lots using procedures outlined on the Merck website at http://www.merckvaccines.com/PCHRecall.pdf. Additional information regarding the affected lots is available online from the Food and Drug Administration (FDA) at http://www.fda.gov/consumer/updates/hib121307.html. Merck has suspended production of its Hib conjugate vaccines and does not expect to resume distribution of these vaccines until the fourth quarter of 2008. The recall of PedvaxHIB and Comvax and suspension of production are expected to result in short-term disruption to the Hib vaccine supply in the United States.

摘要

2007年12月13日,默克公司(宾夕法尼亚州西点)宣布自愿召回两批b型流感嗜血杆菌(Hib)结合疫苗,即PedvaxHIB(单价Hib疫苗)和Comvax®(Hib/乙型肝炎疫苗)。供应商应按照默克公司网站(http://www.merckvaccines.com/PCHRecall.pdf)上列出的程序退回这些召回批次中未使用的疫苗。有关受影响批次的更多信息可从美国食品药品监督管理局(FDA)的网站(http://www.fda.gov/consumer/updates/hib121307.html)获取。默克公司已暂停其Hib结合疫苗的生产,预计在2008年第四季度之前不会恢复这些疫苗的供应。PedvaxHIB和Comvax的召回以及生产的暂停预计将在美国短期内扰乱Hib疫苗的供应。

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