Infant deaths caused by vaccine sold in Hunan, Guangdong, Guizhou food and drug supervision Bureau has suspended use of vaccine | | | death _ the food drug news

South reporter Yang Guangxia Wang chengbo Shenzhen production of vaccine to two infant deaths in Hunan, vaccines in addition to sold to Hunan, also sold in Guangdong and Guizhou provinces. Yesterday, the State food and Drug Administration informed the investigations, has suspended Shenzhen kangtai company produces recombinant hepatitis b vaccine. Shenzhen food and Drug Administration says has launched emergency mechanism for handling, as well as conducted an on-site inspection of the enterprise, is currently not yet found breaches in production process, had requested to acute toxicity to check the lot number of the company.

Media reports yesterday, Hunan province Changning, Hengyang, hengsh, changde city, hanshou County, 1 serious adverse reactions in infants after immunization with hepatitis b vaccine, changde city, hanshou County rescue babies are in intensive care rooms, two babies died. Yesterday, the State food and Drug Administration notified to recombinant hepatitis b vaccine this vaccine, Saccharomyces cerevisiae, producers are Shenzhen kangtai biological products co., Ltd. Administration and the local authorities are organizations looking into this, for control of the drugs risks, decided to suspend the lot numbers of the company c and 201,207,088 for c recombinant hepatitis b vaccine. Worth noting is that investigated by the Administration, these two batch of product has been sold to Guangdong, Hunan, and Guizhou provinces.

South reporter also learned from Guangdong Province food and drug administration, the authority has instructed the drug authority to producing enterprises to conduct on-site verification of Shenzhen, and has notified the epidemic prevention and control center in the three suspended using the same batch of vaccine.

Shenzhen food and Drug Administration said yesterday that it has asked the company quickly identify involved the sales flow and the amount of unused vaccine, to take all measures to suspend sales of the batches of drug use. The investigation, the company's vaccine stocks both lot number is zero, which sold all of a recombinant hepatitis b vaccine in Guizhou province had been used. The Office staff said, law enforcement officials have not yet found the batch production process in violation of drug g m p and not in accordance with the quality standard for the entire examination. At the same time, has asked the company for the two batches of the vaccine for acute toxicity tests. In accordance with the relevant provisions of the State, vaccines before the products go on sale must be obtained by China Research Institute of food and drug inspection testing and biological products, approval and issuance of certificates. The investigation, certificates were obtained for these two groups of vaccines.

(Original title: infant deaths caused by hepatitis b vaccines are sold to Hunan, Guangdong, Guizhou)

December 14, 2013 The Southern Metropolis daily
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致婴儿死亡疫苗销往湘粤黔 食药监局已暂停使用|疫苗|食药监局|死亡_新闻资讯

　　南都讯 记者阳广霞 王成波 深圳企业生产的疫苗在湖南致两名婴儿死亡，疫苗除销往湖南外，还销往广东、贵州两省。昨日，国家食品药品监督管理总局通报，正进行调查，已暂停深圳康泰公司生产的重组乙型肝炎疫苗的使用。深圳市药监局表示，已启动应急事件处置机制，并前往该企业进行现场检查，目前暂未发现生产过程存在违规操作，已要求该公司对相关批号进行异常毒性检查。

　　昨日有媒体报道，湖南省常宁市、衡阳市衡山县、常德市汉寿县各有1名婴儿在接种乙肝疫苗后出现严重不良反应，常德市汉寿县婴儿正在重症监护室抢救，另外两名婴儿不幸死亡。昨日，国家食品药品监管总局通报，这一疫苗为重组乙型肝炎疫苗，即酿酒酵母，生产商是深圳康泰生物制品股份有限公司。总局和当地有关部门正组织对此进行调查，为控制用药风险，决定暂停这一公司批号为C 201207088和C 201207090的重组乙型肝炎疫苗使用。而值得注意的是，经总局调查，上述二个批号的产品已经销售到了湖南、广东、贵州三省。

　　南都记者也从广东省食品药品监管局了解到，该局已责成深圳市药品监管局到生产企业开展现场核查，并已通知三省的疫病预防控中心暂停使用同批号疫苗。

　　深圳市药监局昨日表示，已要求该公司迅速查清涉事疫苗的销售流向以及尚未使用的数量，采取一切措施暂停该批次药品的销售使用。经查，该公司这两个批号的疫苗库存为零，其中销往贵州省的重组乙型肝炎疫苗全部未出库使用。该局工作人员说，执法人员尚未发现该批次产品生产过程中有违反药品G M P及不按照质量标准进行全项检验的行为。同时，已要求该公司对这两批疫苗立即进行异常毒性检查。按照国家有关规定，疫苗产品上市销售前必须通过中国食品药品检定研究院的检测并获得生物制品批签发合格证。经查，这两批疫苗均获得合格证。

(原标题：致婴儿死亡乙肝疫苗销往湘粤黔)

2013年12月14日04:00
南方都市报
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