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The author:(作者)aaapublished in(发表于) 2013/12/24 8:47:05 Shenzhen dead baby vaccination operations compliance， vaccine death in check
Yangcheng evening news reporter Wang Jun said South Bay of Shenzhen People's Hospital, a newborn Shenzhen kangtai produces hepatitis b vaccine suspected cause of death has not been determined. Shenzhen CDC informed the 23rd said the investigation, vaccination unit qualification valid, source of vaccine stockpiles are compliant, vaccinators are also operations as required. Dead boy's autopsy was 20th, 30-40 days later will be able to determine the cause of death is associated with hepatitis b vaccine.
Vaccination operation irregularity
Shenzhen CDC immunization program director Zhang Shiying, Center on 19th received the related report, followed by escalation and rushed to the scene to investigate. Zhang Shiying revealed: "maternal Li Moudi admitted on 16th, 17th, cesarean give birth to a baby boy, 10:35 injectable vitamin, 10:37 immunization with hepatitis b vaccine, both were in line with regulatory requirements. 10:39 baby breathing difficulties, reshape the cyanosis, rescue the hospital, using a lot of rescue medication and tools, 11:45 died. Clinical diagnosis of pulmonary hemorrhage and suffocation death in hospital at that time, received no objections. 18th afternoon, questioned the family, questioned why the child died suddenly; 19th morning, family members questioned the cause of death associated with the vaccine. ”
Zhang Shiying said, pick reported Hou Guangdong Province Wei Planning Commission and province CDC delegate of related experts, and province prevention vaccination bad reaction of experts are overnight arrived scene survey, confirmed Shenzhen South Bay people Hospital of vaccination units qualification for, Longgang District, Health Council specified, is legal; vaccination personnel of posts training certificate also are complete, vaccination operation is provides; by with hepatitis b vaccine through Guangdong Province CDC, and city CDC, and district CDC layer Layer distribution to hospital obstetric, cold chain storage meets requirements.
According to reports, the South Bay hospital has communicated with his family on 20th conducted autopsies, a clear cause of death by the Group of experts to determine whether Shenzhen kangtai hepatitis b vaccine-related. "The autopsy result 30-40 days, will try to step up the pace. "Prior to the South Bay of Shenzhen People's hospital reported that up to 19th, the obstetric vaccination involved a total lot 5 doses of hepatitis b vaccine and adverse reactions of other members of the species does not occur.
Vaccine-related certification
Shenzhen food and Drug Administration said yesterday that the Shenzhen kangtai hepatitis b vaccine lot number involved is C201207086, the current batch of recombinant hepatitis b vaccines have been sealed, and sending the sample verification Research Institute of China's food and drug inspection. "Whether the deaths associated with vaccination, to wait for the results of forensic clarity."
It is reported that Hunan lot number involved as previously C201207088, C201207090 kangtai 13th hepatitis b vaccine was halted, Shenzhen, Shenzhen kangtai produces other batches of the vaccine is still in use until the 20th, Shenzhen kangtai-hepatitis b vaccine to be completely halted. Verified statistics, as at 20th, 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.
Shenzhen food and drug administration official says, 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.
This version of cartographic/Chen Jianyi
Wang Jun
(Original title: 17.76 million vaccines were suspended sales in Shenzhen)
羊城晚报讯 记者王俊报道：深圳南湾人民医院一名新生儿疑似接种深圳康泰生产乙肝疫苗致死原因尚无定论。深圳市疾控中心23日通报称：经查，接种单位资质合法，疫苗来源及储存均合乎规范，接种人员也是按要求操作。针对死亡男婴的尸检已于20日下午开展，预计30-40天后将可判断死因是否与接种乙肝疫苗有关。
接种操作合乎规定
深圳市疾控中心免疫规划科主任张世英表示，中心于19日上午10:58接到相关报告，随后上报并赶赴现场调查。张世英透露：“产妇李某娣16日入院待产，17日上午10:00剖宫产产下一名男婴，10:35注射维生素，10:37接种了乙肝疫苗，这两项都符合规范要求。10:39小孩出现呼吸困难，面色紫绀，医院进行了抢救，用了很多抢救药物和手段，11:45抢救无效死亡。当时医院临床诊断为肺出血和窒息死亡，家属也没有异议。18日下午，家属提出疑问，质疑孩子为何突然死亡；19日上午，家属质疑死因与疫苗有关。”
张世英表示，接报后广东省卫计委与省疾控中心委派的相关专家、省预防接种不良反应的专家都连夜赶到现场调查，证实深圳市南湾人民医院的接种单位资质为龙岗区卫生局指定，属合法；接种人员的上岗培训证书也都齐全，接种操作合乎规定；所用乙肝疫苗通过广东省疾控中心、市疾控中心、区疾控中心层层分发到医院产科，冷链储存符合要求。
据介绍，南湾人民医院已与家属沟通好20日下午进行尸检，明确死亡原因后由专家组判断是否与深圳康泰乙肝疫苗有关。“尸检结果需要30~40天，会尽量加快进度。”深圳市南湾人民医院之前通报称，截至19日，该院产科共接种涉事批号乙肝疫苗5剂次，其他受种人员均未出现不良反应。
涉事疫苗获合格证
深圳市药监局昨日表示，此次涉事深圳康泰乙肝疫苗批号为C201207086，目前该批号的重组乙肝疫苗已封存，并将抽样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”。
据悉，此前湖南涉事批号为C201207088、C201207090的康泰乙肝疫苗13日被叫停，深圳康泰生产的其他批次疫苗仍在深圳使用，直至20日，深圳康泰生产的乙肝疫苗才被全部叫停。经核查统计，截至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。
深圳市药监局相关负责人表示，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。
本版制图/陈健怡
王俊
(原标题：深圳1776万支疫苗被叫停销售)
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