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The author:(作者)aaapublished in(发表于) 2013/12/22 18:51:51 Four infants died after vaccination, manufacturers say anecdotal
Beijing authorities wide nets, December 22 (reporters Wen Fei), according to voice of the news aspect ratio reported recently, Hunan, Guangdong, Sichuan and other infants, immunized Shenzhen kangtai biological products produced by the company after the hepatitis b vaccine, a series of suspected adverse reaction, as of now there has been 4 deaths, cause of death is still under investigation.
In this regard, the night before, the State food and drug administration, National Planning Commission issued urgent notices, and suspended the company's entire batches of recombinant hepatitis b vaccine product. So, infant deaths are concerned about hepatitis b vaccine and vaccination? How to ensure vaccine safety?
Recently, Changning, Hunan province, Hengshan County, hanshou County, a total of 3 infant in serious adverse reactions after vaccination with hepatitis b vaccine. Among them, changning, Hengshan two babies died. A dead baby's aunt told reporters unable to hide his grief.
Reporter: what is vaccination?
Aunt: prevention of influenza and hepatitis b, both are called.
According to the Hunan provincial Center for disease control and immunization section chief physician Zhang Shujun introduction, 3 baby vaccination by Shenzhen kangtai biological products company limited production batch of two batches of vaccines against hepatitis b, C201207090, C2012070882. Subsequently, the State food and Drug Administration issued a notice, requiring batch products are sold to Guangdong, Hunan, and Guizhou province suspended. Hunan provincial Center for disease control Deputy Director Gao lidong told reporters that ended before the halt, Hunan has used 108,654 vaccine, there are inventory 202,422. At present, in addition to the above 3 cases, it had not yet received the hepatitis b vaccine reported suspected cases of abnormal reactions after vaccination. GAO lidong, involved in storage, transportation and operation to be immunized, the vaccine, there is no problem.
GAO lidong: we investigate the situation, our bodies are the three cases where the Centers for disease control, and the vaccination unit, for vaccine storage complies with the relevant requirements set out, our vaccination units including our vaccination vaccination of personnel have relevant qualification.
So, involved two types of vaccine meets the production process?
Head of the drug administration of Shenzhen: Judging from our test results, production of this enterprise is approved by the State, these two groups of products are also obtained State approval and issuance of certificates of competency.
It is understood that the Shenzhen kangtai biological products Corporation is the larger hepatitis b vaccine companies, product market share of more than 50%. For society's doubts, the company's Deputy General Manager Zhang Jiansan responded by saying that this is incidental.
Zhang Jian III: Hunan, is probably to be vaccinated at least 3 million a year or more, so on the base of a large, appears sporadic cases turned out to be hard. But this time it was from the three cases, one of our news is basically excluded and vaccine-related.
Hunan provincial Center for disease control Deputy Director Gao lidong disclosed that at present, Hunan province food and drug administration of the vaccines and related products for sampling involved vaccine samples have been sent to conduct quality checks by the control of pharmaceutical and biological products in China. In addition, the autopsy results were combined to determine in infants, it takes approximately 2 months.
GAO lidong: we have to wait for a vaccine test results, and two infant deaths, the autopsy results, combined with our relevant clinical information for comprehensive judgment.
Infant deaths involved vaccine and associated cannot currently make a judgment. But coincidentally is, Guangdong, Sichuan and other infants, following Shenzhen kangtai biological products produced by the company for hepatitis b vaccination, or suspected adverse reaction occur consecutively.
Before the reason not to investigate, in order to protect children's health, ensure the safety of vaccinations, the State food and drug administration, the national health planning Commission decided to suspend the use of the company's production of all batches of recombinant hepatitis b vaccine in Saccharomyces cerevisiae, and investigations into causes of infant mortality, further inspection on drug manufacturers, to test vaccine product quality. How to ensure vaccine safety? What does infant immunization should pay attention to?
It is understood that the current vaccine in China fall into two categories, first is vaccine available free of charge to citizens by the Government, second is voluntarily by citizens at their own expense and subject to other vaccines. This question belongs to the first category of free hepatitis b vaccine vaccines by health departments, procurement is generally, CDC uniform pension, need to reefers to take when receiving vaccines and put plenty of ice, ensure that the cooler temperatures to vaccine storage requirements, and then place the vaccine refrigerators, transport to the hospital.
Currently, the suspected adverse reaction monitoring of vaccination system has been established. Suspected to occur after vaccination and immunization-related adverse reactions are required to report and monitor various kinds of inoculation, disease prevention and control institutions and medical agencies and duty officers found the suspected adverse reaction after vaccination were reported to and, if necessary, investigate and deal with.
In addition, the experts cautioned that not every newborn for hepatitis b vaccine inoculation. With fever symptoms, immune deficiencies, birth weight less than 2,500 grams, as well as vaccination of children with severe eczema.
Li Bo, Director of Hunan provincial maternal and child health hospital medical: some vaccine use is some premature infants, or the birth of a child in the future there are a number of diseases, the disease duration of treatment should not be vaccinated.
(Original title: four babies died after injections of hepatitis b vaccine manufacturer: random instances)
央广网北京12月22日消息（记者温飞）据中国之声《新闻纵横》报道，近期，有湖南、广东、四川等地的婴儿，在接种了深圳康泰生物制品公司出产的乙肝疫苗后，连续发生疑似异常反应，截至目前已出现4例死亡病例，死因尚在调查中。
对此，前天晚上，国家食药监局、国家卫计委紧急发出通知，暂停使用该公司生产的全部批次重组乙型肝炎疫苗产品。那么，婴儿死亡是否与接种涉事乙肝疫苗有关？疫苗安全如何保证？
近期，湖南省常宁市、衡山县、汉寿县共有3名婴儿在接种同一种乙肝疫苗后出现严重不良反应。其中，常宁、衡山两名婴儿不幸死亡。一名死亡婴儿的姑姑面对记者采访难掩悲痛。
记者：打的什么预防针？
姑姑：预防流感和那个什么乙肝，两样一起都打了。
据湖南省疾控中心免疫规划科主任医师张淑君介绍，3个婴儿接种的是深圳康泰生物制品股份有限公司生产的批号为C201207090、C2012070882两个批次的乙肝疫苗。随后，国家食品药品监督管理局下发通知，要求同批号产品销往地的湖南、广东、贵州三省暂停使用。湖南省疾控中心副主任高立东告诉记者，截至叫停前，湖南已使用108654支相关疫苗，尚有库存202422支。目前，除上述3例病例外，尚未接到乙肝疫苗疑似预防接种异常反应病例报告。高立东表示，涉事疫苗在储存、运输和接种的操作中，不存在任何问题。
高立东：我们调查的情况来看，我们机构就是三个病例所在的疾控机构，和我们的接种单位，对于疫苗的储存都符合相关的一些规定的要求，我们的接种单位包括我们的接种人员都具备相关的接种资质。
那么，涉事的两种型号疫苗是否符合工艺生产流程？
深圳市药品监督管理局相关负责人：从我们的检查结果来看，这个企业是按照国家批准的工艺生产的，这两批的产品也是获得了国家的批签发合格证书。
据了解，深圳康泰生物制品股份有限公司是国内较大乙肝疫苗生产企业，产品市场占有率达50%以上。对于社会上的种种质疑声，该公司常务副总经理张建三回应说，这是偶发事例。
张建三：像湖南，每年大概是有要接种的起码是300万以上的，所以在很大的基数上，出现的偶发事例原来是没有过。但是这一次它是从三例当中有一例基本上我们得到的消息是排除了和疫苗有关。
湖南省疾控中心副主任高立东透露，目前，湖南省食品药品监督管理部门对相关疫苗和药品进行采样，涉事疫苗样本已送至中国药品生物制品检定所进行质量检查。此外，还要等婴儿尸检结果出来进行综合判断，大约需要2个月时间。
高立东：我们要等待疫苗的检测结果，和两名婴儿的死亡病例的尸检结果，结合我们相关的临床一些资料，进行综合判断。
婴儿死亡是否与接种涉事疫苗相关联，目前还不能做出判断。但是无独有偶的是，广东、四川等地的婴儿，在接种了深圳康泰生物制品公司出产的乙肝疫苗后， 也连续发生疑似异常反应。
在原因尚未调查清楚之前，为保护儿童健康，确保预防接种安全，国家食品药品监管总局、国家卫生计生委决定暂停使用该公司生产的全部批次重组乙型肝炎疫苗酿酒酵母产品，并深入调查婴儿死亡原因，进一步对药品生产企业进行检查，对疫苗产品质量进行检验。那么疫苗安全如何保证？婴儿接种疫苗又该注意什么呢？
据了解，目前我国疫苗分为两类，第一类是政府免费向公民提供的疫苗，第二类是由公民自费并且自愿受种的其他疫苗。这次涉事的乙肝疫苗就属于第一类免费疫苗，一般由卫生部门负责招标、采购，疾控中心统一领取，领取疫苗时需要携带冷藏箱，并放置足量冰块，确保冷藏箱温度达到疫苗储存要求，再将疫苗放置冷藏箱中，运输至医院。
目前，在我国已建立了疑似预防接种异常反应监测系统。对疫苗接种后出现的怀疑与预防接种有关的不良反应均需要报告和监测，各级各类医疗机构、疾病预防控制机构和接种单位及其执行职务的人员发现疑似预防接种异常反应均要进行报告，必要时进行调查处理。
另外，专家也提醒，乙肝疫苗并非每个新生儿都适合接种。有发烧症状、免疫缺陷、体重低于2500克以及有严重湿疹的孩子不能接种。
湖南省妇幼保健院医务部主任李博：有的疫苗使用就是有一些早产儿、或者小孩出生以后有一些疾病的，在疾病的治疗期是不宜接种疫苗的。
（原标题：四名婴儿注射乙肝疫苗后死亡 生产企业：偶发事例）
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