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The author:(作者)aaapublished in(发表于) 2013/12/24 8:42:37 Drug Administration of Shenzhen： the involved batches of vaccine are given certificates
According to Xinhua, 23rd, Shenzhen and Drug Administration reported that Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine in the library all have suspended sales of the finished product and shipping activities, in all sizes of recombinant hepatitis b vaccine within the validity period has been sold, 186 total 35,891,194, but notice has not had sales of vaccine use and flow conditions.
According to Shenzhen City drug supervision authority aspects introduced, December 19, 2013 17 o'clock, Shenzhen drug prison Council received Shenzhen CDC report, said Shenzhen South Bay people hospital has a cases newborn death, parents suspected its children burst death and this times vaccination vaccine about, the Council subsequently organization drug bad reaction monitoring center expert rushed to scene tie health disease controlled sector investigation, while area drug prison branch will this times vaccination involves of batch for C201207086 of restructuring hepatitis b vaccine sealed, Now sampling and will send Chinese Institute of food and drug inspection tests.
According to a circular, FDA requested on December 13, 2013, Shenzhen Shenzhen kangtai biological products company suspended sales of recombinant hepatitis b vaccine lot numbers C201207088, C201207090, December 20, Shenzhen kangtai biological products company suspended sales of all batches of recombinant hepatitis b vaccine products, while Shenzhen CDC suspended Shenzhen kangtai biological products Corp all batches produced recombinant hepatitis b vaccine products.
Shenzhen Municipal Drug Administration said vaccine products for sale must pass a test of China's food and drug inspection Institute before and get a batch of biological products to issue certificates, after investigation, Mfg, C201207088, C201207090, C201207086, recombinant hepatitis b vaccine involved, and Shenzhen kangtai biological products Corporation has been selling recombinant hepatitis b vaccine are provided access to the Chinese food and drug inspection Institute of biological product approved certificate issued, Whether the deaths associated with vaccination, to wait for the results of forensic clarity, current, relevant State departments to investigate the cause.
■ 回顾
Deaths not related to vaccination
News 23rd from centers for disease control in Guangdong province confirmed that since November, the province reported a total of 4 suspected inoculation produced by Shenzhen kangtai biological products company limited of recombinant hepatitis b vaccine (Saccharomyces cerevisiae) after death. 1 case unrelated to vaccination, in 3 other cases still in testing. This means that national suspected of "vaccine death" cases had risen to 7.
Guangdong provincial CDC, has allocated 1.45 million hepatitis b vaccines to meet two normal vaccination requirements. According to Xinhua News Agency
■ 质疑
1 days to stop the emergency absence?
Released by the Guangdong provincial CDC since November 4 suspected cases in the province "vaccine death" cases, Zhongshan, Shenzhen, in addition to two cases widely known outside, Jiangmen, had not seen publicly reported two cases in Meizhou, had also not been announced.
Meanwhile, on November 25, Hunan, there have been cases of severe adverse reactions after vaccination in infants, and December 6 consecutive deaths, however national authorities until December 13 to be block the kangtai company two batches of vaccine on December 17 infant deaths in Shenzhen, 2 days after Shenzhen halted the batches of vaccine, at national level did not halt kangtai company all of the vaccines until December 20.
Shenzhen CDC immunization Bureau Director Zhang Shiying, he explained, 17th in Shenzhen after infant deaths, reported two days late, because "at first did not think related to hepatitis b vaccine, 18th, families in touch claims before the vaccine and death. 19th report later in the morning, afternoon drift related batch of vaccine ".
National food drug supervision authority August 2011 publishing of drug and medical devices security burst event emergency plans (pilot) under provides, levels food drug supervision management sector to established sound drug security burst event monitoring, and warning and report system, which Dang event reached ⅰ level standard Hou, should started ⅰ level emergency response, needed "established information publishing mechanism, timely to social publishing event about information".
Primary CDC staff believe that this pilot provides breakdowns of drug safety incidents grading no later than December 9, after two suspected vaccine deaths in Hunan province, may constitute secondary (major) and drug safety incidents, 17th Shenzhen infant death and amount to grade ⅰ (significant) drug safety incidents.
People questioned, the relevant departments only simple statements that "vaccination is the most basic public health services", "vaccine is safe and effective in General", some "suspected problems vaccine" flows should not be advertised, without informing the national shortage and has not launched the emergency mechanism also did not explain the reasons, causing public misgivings. According to Xinhua News Agency
2
"Coupling of death" is the drug firms to shirk its responsibility?
16th Shenzhen kangtai company involved enterprises issued a statement "vaccine death" event called "suspected deaths coupling", and that "coincidence and unrelated to the vaccine itself." Many netizens questioned, within a short time there have been many cases of neonatal death after vaccination, are healthy companies producing vaccines and prosperous company declared a unilateral coupled has nothing to do with the vaccine itself, there is suspected of shirking responsibility.
CDC immunization section chief of Hainan Province Zeng Xuexia told reporters that medicine said "coupled" refers, among those vaccinated at the time of vaccination is in some sort of incubation period of the disease or prodromal period, coincidence after vaccination morbidity, causes not related to vaccines, "but this does not mean that all vaccination deaths without identification can be used before ' coupling death ' to explain. ”
Zeng Xuexia, from a clinical standpoint, decide whether "coupling", vaccine companies say that doesn't count diagnosis group need to be investigated by the vaccination after a detailed investigation judge. If the expert group conclusions being vaccinated against the families of the deceased appealed against, may apply to the above city level medical identification. If results still do not agree, you can take the proceedings, bring a civil action.
According to Xinhua News Agency
(Original title: Shenzhen food and Drug Administration: the involved batches of vaccine are given certificates)
据新华社电 23日17时，深圳市药品监督管理局通报称，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，但通告并未涉及已销售疫苗的使用和流向情况。
据深圳市药品监督管理局方面介绍，2013年12月19日17时，深圳市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，家长怀疑其孩子突发死亡与本次接种疫苗有关，该局随后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，同时辖区药监分局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。
据通告，深圳市药监局在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，12月20日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。
深圳市药品监督管理局方面表示，疫苗产品上市销售前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，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，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，目前，国家相关部门仍在对事件原因进行调查。
一死亡病例与接种疫苗无关
记者23日从广东省疾控中心证实，从11月至今，该省共报告4例疑似接种由深圳康泰生物制品股份有限公司生产的重组乙型肝炎疫苗(酿酒酵母)后死亡病例。其中1病例与疫苗接种无关，其他3病例仍在检测中。这意味着全国疑似“疫苗致死”病例已增至7例。
广东省疾控中心表示，已调拨145万支乙肝疫苗，满足两至三个月的正常接种需求。据新华社
1 19天后叫停 应急是否缺位？
广东省疾控中心公布的该省11月至今的4例疑似“疫苗致死”病例中，除中山、深圳两例广为人知外，江门、梅州两例并未见诸公开报道，此前也未有相关部门公布。
另一方面，在11月25日，湖南就出现了婴儿注射疫苗后严重不良反应病例，12月6日和9日连续出现死亡病例，然而国家有关部门直至12月13日才叫停康泰公司两批次疫苗；12月17日深圳婴儿死亡，2天后，深圳才叫停该批次疫苗，国家层面直至12月20日才叫停康泰公司所有疫苗。
深圳市疾控中心免疫科主任张世英解释称，深圳17日发生婴儿死亡事件后，之所以晚了两天才上报，是因为“一开始没有想到和乙肝疫苗有关，18日下午家属索赔时才将疫苗和死亡联系上。19日上午上报后，当天下午就叫停了相关批次疫苗”。
国家食品药品监督管理局2011年8月发布的《药品和医疗器械安全突发事件应急预案(试行)》规定，各级食品药品监督管理部门要建立健全药品安全突发事件监测、预警与报告制度，其中当事件达到Ⅰ级标准后，应启动Ⅰ级应急响应，需“建立信息发布机制，及时向社会发布事件有关信息”。
有基层疾控中心工作人员认为，按照上述试行规定划分的药品安全突发事件分级标准，至迟到12月9日，湖南出现两起疑似疫苗致死事件后，已可构成Ⅱ级(重大)药品安全突发事件，到17日深圳婴儿死亡时，已构成Ⅰ级(特别重大)药品安全突发事件。
有群众据此质疑，相关部门仅简单表态，“预防接种是最基本的公共卫生服务”“疫苗总体来看是安全有效的”，对于部分“疑似问题疫苗”却不公布流向，不告知全国缺口量，而且并未启动应急机制也未解释原因，致使公众疑虑重重。据新华社
“偶合死亡”是药企推卸责任？
涉事企业深圳康泰公司16日发布声明，将“疫苗致死”事件称为“疑似偶合死亡事件”，并称“偶合症的发生与疫苗本身无关”。不少网民质疑，短时间内发生了多例新生儿接种疫苗后死亡的事件，使用的都是康泰公司生产的疫苗，而康泰公司单方面宣布偶合症的发生与疫苗本身无关，有推卸责任的嫌疑。
海南省疾控中心免疫规划科科长曾雪霞告诉记者，医学上说的“偶合症”是指，受接种者在接种时正处于某种疾病的潜伏期或者前驱期，接种后巧合发病，发病原因与疫苗无关，“但是，这并不表示所有接种死亡在未经鉴定前都可以用‘偶合死亡’来解释。”
曾雪霞表示，从临床医学角度上讲，判断是否“偶合性事件”，疫苗生产企业说的不算，需要由预防接种调查诊断专家组经过详细调查后判断。如果专家组下了结论而受接种死亡者家属不服，可以向市级以上医学会申请鉴定。如果对鉴定结果仍然不认同，可以走法律程序，提起民事诉讼。
据新华社
(原标题：深圳药监局：涉事批次疫苗均获合格证)
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