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The author:(作者)aaapublished in(发表于) 2013/12/16 0:37:52 Hunan： infant vaccination death not found that have a direct relationship to the vaccine
Authorities wide nets of changde News December 14, according to voice of the evening peak reported, according to China's national immunization program, every neonatal injection of hepatitis b vaccine in 24 hours after birth. This is because, for the hepatitis b virus, and younger, against bigger and bigger. Newborns infected with hepatitis b virus, and develop into chronic hepatitis b as much as 90%. And hepatitis b have not been radical way, so that prevention is better than cure.
Recently, Hunan province 3 serious adverse reactions in infants vaccinated against hepatitis b vaccine, Changning, Hengshan County 2 babies have already died, hanshou County 1 baby fly just go from the intensive care room. Three children, Max was only 8 months old and the other 2 only 1 month.
Fei-fei's mother: for more than an hour, to feed my son, feed, milk after about three hours, my son showed up her face is gray, there's nothing.
Fei is also currently in first people's Hospital in changde city, Associate Professor of Pediatrics said Wang Minghui, children's series of mainly due to sudden shock, asphyxiation caused by the illness. But so far the cause of the disease can't judge.
Wang Minghui: baby diarrhea, discharge large amounts of blood, then there is necrosis of the intestinal contents of because there are breathing a trip to cardiac arrest, hypoxia and asphyxia. His multiple organs may be affected as a result.
Three babies symptoms of adverse reactions is inconsistent
According to reports, three babies symptoms of adverse reactions are not the same. Changning baby without any symptoms before his death, Hengyang City hengsh infant crying and vomiting reaction, low-grade fever, vaccination after the death of the day, changde city, hanshou County baby, that is, fly, was diagnosed with intestinal necrosis.
However, the three infants, were Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine. The company is currently the largest hepatitis b vaccine manufacturer, annual production capacity of more than 100 million, the market share of over 50%. But today we make company related calls over and over again, no answer.
Two batch of vaccine production management and quality standards have been found not compliant behavior
Baby's body was found there have a direct causal relationship and the hepatitis b vaccine
In accordance with the relevant provisions of the State, the vaccine before the product goes on sale, it must pass the verification test and obtained at the Institute of China's food and drug and biological products, approval and issuance of certificates. Shenzhen food and drug administration released yesterday on its website: the investigation, recombinant hepatitis b vaccine lot numbers C201207088, C201207090, or 3 an infant vaccine batches, have received such certificate issued by the relevant institutions.
Moreover, Shenzhen food and Drug Administration inspection of two batch of vaccine production and sterility assurance process compliance with drug GMP requirements, that is, pharmaceutical production quality management standard requirements and test verification according to quality standards, and did not discover any nonconforming behavior. Meanwhile in Hunan provincial Center for disease control also has set up an expert group to investigate.
Hunan provincial Center for disease control Deputy Director Gao lidong, currently initial tests and found no hepatitis b vaccine and 3 body abnormal babies have a direct causal relationship.
GAO lidong: we turn now to further verify the operation of the local, a vaccine or some other reasons, diagnosis and taking a survey-related programs, it was not possible to determine if the vaccine is.
Following a preliminary investigation, two recombinant hepatitis b vaccine lot number sold to Hunan province, Guizhou province and the Guangdong Center for disease control, inventory is zero. According to the requirements of State Food Drug Administration, the CDC has been suspended in the three batches of vaccine use, which are sold to all libraries use of vaccines in Guizhou province. Investigations are still underway.
Although at present all the possible causes are excluded, but the truth is still not the final answer. This has created 2 babies to die, is by no means a small thing, it concerns the life of all newborns. Want to investigate the early researchers concluded.
(Original title: infant vaccination deaths continued, Hunan: not directly related to the discovery and vaccine)
央广网常德12月14日消息 据中国之声《新闻晚高峰》报道，根据我国的国家免疫规划，每一个新生儿在出生后24小时里都要注射乙肝疫苗。这是因为，对于乙肝病毒来说，年龄越小，危害越大。感染乙肝病毒的新生儿，发展成慢性乙肝的比例高达90%。而且乙肝至今没有根治的方法，所以，预防重于治疗。
近日，湖南省3名婴儿接种乙肝疫苗后出现严重不良反应，其中常宁市、衡山县的2个婴儿已经不幸死亡，汉寿县的1个婴儿飞飞刚从重症监护室转出。三个孩子中，最大的才8个月，另2个只有1个多月。
飞飞的妈妈：一个多小时了，给我儿子喂奶，喂了奶以后，大概有三个小时以内，我儿子就出现了脸是灰的，没什么意识了。
飞飞目前还在常德市第一人民医院治疗，儿科副主任医师汪明辉表示，孩子的一系列病症主要是由于突发休克、窒息引起的。但目前致病原因还无法判断。
汪明辉：小孩有腹泻，排出大量的血，然后有坏死的肠内溶物，因为有心脏呼吸猝停、缺氧、窒息。他的多脏器可能会因此而受到影响。
三婴儿不良反应症状不一致
根据报道，三个婴儿的不良反应症状并不一样。常宁市的婴儿在死亡前没有任何不适症状，衡阳市衡山县婴儿出现呕吐和哭闹反应，有低烧，在注射疫苗一天以后死亡，常德市汉寿县婴儿，也就是飞飞，被诊断为肠坏死。
不过，三个婴儿接种的，都是深圳康泰生物制品股份有限公司生产的重组乙肝疫苗。这个公司是目前全国最大的乙肝疫苗生产企业，年生产能力超过1亿支，市场占有率在50%以上。但我们今天反复拨打公司相关电话，都无人接听。
两批号疫苗生产管理及质量标准未发现不合规行为
未发现婴儿身体出现异常与乙肝疫苗有直接因果关系
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。深圳市药监局昨天在官网发布：经查，批号为C201207088、C201207090的重组乙肝疫苗，也就是3个婴儿的所注射疫苗批次，都获得了相关机构签发的这种合格证。
而且，深圳市药监局在对两个批号疫苗生产检验和无菌保证等环节是否符合药品GMP要求，也就是药品生产质量管理规范的要求，以及是否按照质量标准进行全项检验的核查中，并没有发现有任何不合规的行为。同时湖南省疾控中心也已经成立专家组进行调查。
湖南省疾控中心副主任高立东表示，目前初步检测，并没有发现乙肝疫苗和3名身体出现异常的婴儿有直接的因果关系。
高立东：我们现在在进一步核实当地的操作，看是疫苗还是其他的原因，调查诊断还要经过相关的程序，现在还不能确定疫苗是不是有关系。
经初步调查，这两个批号的重组乙肝疫苗分别销往湖南省、贵州省和广东省疾控中心，库存为零。根据国家食药监总局的要求，三个省疾控中心已经暂停这些批次疫苗的使用，其中销往贵州省的疫苗全部未出库使用。调查仍在进行当中。
虽然目前所有可能的原因在一个个被排除，但真相依然没有最后的答案。这起已经造成了2个婴儿丧命的事情，绝不是一件小事，它关乎所有新生儿的生命安全。希望调查能早日给出结论。
(原标题：湖南婴儿接种疫苗死亡续：未发现与疫苗有直接关系)
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