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The author:(作者)aaapublished in(发表于) 2013/12/24 8:47:08 Shenzhen food and Drug Administration： kangtai company sold more than 35 million hepatitis b vaccine
People's network, Shenzhen, Beijing, December 23 Drug Administration Web site released today on the Shenzhen kangtai company produces recombinant hepatitis b vaccine-related cases (as of December 23) bulletin. According to informed, verified statistics, as of December 20, 2013, Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine in the finished product batches account 95, have all been suspended sales and shipping activities; in the recombinant hepatitis b vaccine within the validity period of the specifications have been selling batch account 186.
It is reported that on December 19, Shenzhen, Shenzhen CDC reported to the FDA, called the South Bay of Shenzhen People's Hospital, a newborn died, before his death has been vaccinated against recombinant hepatitis b vaccine produced by Shenzhen kangtai biological products company limited, parents who suspect their children of sudden death associated with this vaccination. Shenzhen food and Drug Administration adverse drug reaction monitoring center immediately organized experts to the scene to tie in with the disease control Department of health survey and District Branch immediately rushed to the site of this vaccination involves recombinant hepatitis b vaccine storage lot number C201207086. Has been sampled and sent China registered Institute of food and drug inspection. Whether the deaths associated with vaccinations, having to wait for a medical evaluation of the results will be able to clear.
According to the National Bureau of notification requirements, drug administration of Shenzhen asked Shenzhen kangtai biological products company limited moratorium on the sale of lot number December 13, 2013 as C201207088, C201207090, recombinant hepatitis b vaccine. On December 20, according to the National Bureau and national planning Commission joint notification requirements, drug administration of Shenzhen asked Shenzhen kangtai biological products company limited moratorium on the sale of all lots of recombinant hepatitis b vaccine and called Shenzhen CDC suspended Shenzhen kangtai biological products Corporation all batches of recombinant hepatitis b vaccine products.
Informed that in accordance with State regulations, vaccines required before the products go on sale through the Chinese food and drug inspection examination and obtained at the Institute of biological products, approval and issuance of certificates. The investigation, lot numbers C201207088, C201207090, C201207086, recombinant hepatitis b vaccine in question, as well as Shenzhen kangtai biological products Corporation has been selling recombinant hepatitis b vaccines are provided access to the China biological products, approval and issuance of certificates issued by the Institute of food and drug inspection.
At present, the relevant departments to investigate the cause.
人民网北京12月23日电 深圳市药品监督管理局网站今日下午发布《关于对深圳康泰公司生产重组乙肝疫苗有关情况（截至12月23日17时）的通报》。据通报，经核查统计，截至2013年12月20日，深圳康泰生物制品股份有限公司生产的重组乙肝疫苗在库成品95批次合计17760507支，已全部暂停销售及发运工作；在有效期内的重组乙肝疫苗各规格已销售186批次合计35891194支。
据悉，12月19日下午17时，深圳药监局接到深圳市疾控中心报告，称深圳市南湾人民医院有一例新生儿死亡，死亡前曾接种由深圳康泰生物制品股份有限公司生产的重组乙肝疫苗，家长怀疑其孩子突发死亡与本次接种疫苗有关。深圳药监局立即组织药品不良反应监测中心专家赶赴现场配合卫生疾控部门调查，同时辖区分局立即赶赴现场将本次接种涉及的批号为C201207086的重组乙肝疫苗封存。目前已抽样并将送中国食品药品检定研究院检验。该死亡病例是否与接种疫苗有关，需等待医学鉴定结果方能明确。
根据国家总局的通知要求，深圳药监局已在2013年12月13日要求深圳康泰生物制品股份有限公司暂停销售批号为C201207088、C201207090的重组乙肝疫苗。在12月20日，根据国家总局和国家卫计委联合通知要求，深圳药监局要求深圳康泰生物制品股份有限公司暂停销售全部批次的重组乙肝疫苗产品，同时要求深圳市疾控中心暂停使用深圳康泰生物制品股份有限公司生产的全部批次重组乙肝疫苗产品。
通报称，按照国家规定，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验并获得生物制品批签发合格证。经查，批号为C201207088、C201207090、C201207086的涉事重组乙肝疫苗，以及深圳康泰生物制品股份有限公司已销售的重组乙肝疫苗均按规定获得了中国食品药品检定研究院签发的生物制品批签发合格证。
目前，国家相关部门仍在对事件原因进行调查。
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