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published in(发表于) 2013/12/16 0:36:31
Guangdong tracking infant deaths involved hepatitis b vaccine， 190 is already in use

Two infant immunization in Hunan province Shenzhen kangtai biological products company limited (hereinafter kangtai company) dies after hepatitis b vaccine, an event which has given rise to concern. South reporter learned yesterday, Guangdong bought 3,600 batches of vaccine, and employed 190 currently received no reports of adverse reactions, the remaining stock has been mothballed. Responds to the involved enterprises, if the event is to wait for the autopsy results, tentatively has a direct relationship between vaccination and death cannot be determined.

Concerned about 450,000 two batches of vaccine, have all been traced back to go

Two days ago, State Food Drug Administration informed, involved two batches of hepatitis b vaccine into kangtai company, Guangdong, Hunan and Guizhou provinces. Yesterday, the South reporter learned from the company, involved two groups of vaccines by about 150,000 people, or about 450,000, currently have all been traced back to go, most of which are sold to Hunan, Guangdong province into 3,600, vaccines were not out of Guizhou province.

Whether this vaccine in Guangdong has already been used? Yesterday, the provincial CDC said, the Centre receives the message, according to the Guangdong provincial food and drug administration, deployment and requirements, immediately notify the Centers for disease control and prevention, and vaccination hepatitis b vaccine suspended batch, overnight, and verify the relevant information on their distribution and use. On checking, 201,207,090 Canton total of purchased lot c 3,600 hepatitis b vaccine. 11:30 as of yesterday, the 1800 batch hepatitis b vaccine still in Guangzhou Center for disease control and prevention inventory, another 180 were sent to Nansha district Center for disease control and prevention, 1610 is still at the Centre of these inventory, used 190. At present, 190 of the batch of vaccine has been used have not yet received reports of adverse reactions. Inventory lot number 3 4 1 0 201,207,090 c hepatitis b vaccines have been sealed overnight as required. In addition, Guangdong has not purchased lot number C201207088 for hepatitis b vaccine.

Involved batches of vaccine production last year, vaccine production and transport is no problem

"National food drug administration experts have to get in touch with us, we're trying to figure out reasons as soon as possible. "Yesterday, is located in the science and Technology Park, Nanshan District, Shenzhen kangtai company ushered in a number of journalists, the company's Deputy General Manager Zhang Jiansan said, these vaccines has been asked to stop using stock seal, wait until the findings of the expert group to address, while other batches of vaccine are still in regular use.

Public information display, the company was established in August 1988, was one of the first high-tech enterprises in Shenzhen, mainly engaged in biological research and development, production and sales. Existing products of recombinant hepatitis b vaccine (Saccharomyces cerevisiae) introduced from abroad, since its production in 1994, sold more than 200 million people, is the largest manufacturer of hepatitis b vaccine in China, covering 31 provinces, municipalities and autonomous regions across the country, the market share of more than 50%.

"In previous years, the annual production and sales of the hepatitis b vaccine for 20 million people, the market share of more than 60%, now an annual sales of 10 million people. "Zhang Jiansan, for every batch of vaccine sales are subject to a rigorous approval and issuance system, quality problems in recent years, they have never received the hepatitis b vaccine and adverse drug reaction reporting.

Zhang Jiansan, the involved batches of vaccine were produced last year, a total of two batches, each batch of about 70,000 to 90,000 people, used by the provincial disease prevention and control departments bidding, in a 3-year term; while the production, storage, transport, and so there are no problems.

Focus question

Vaccines in question had no direct relationship with baby's death?

Investigation is still going on, and to wait for the autopsy results

Shenzhen kangtai company Deputy General Manager Zhang Jiansan said, the survey results did not come out who were unable to make firm conclusions before vaccine coupled deaths are generally a few chances of zero out of 10,000 and very complex reasons, still have to wait for the autopsy results, they have more safety tests carried out, hope to find out the cause as soon as possible.

Yesterday, Shenzhen, FDA staff said that currently relevant investigation was still going on, why can't really simple conclusion, not only to investigate the vaccine production, transport and storage and so on, have to examine whether specific uses in accordance with operating rules and be inoculated if there is a problem in itself, such as the findings, will be published for the first time.

Other batches of the vaccine if there is a problem?

Kangtai company: in normal use, and public trust

The hepatitis b vaccine as childhood immunization, almost every baby born after injection. Yesterday, who lives in Tongren city of Guizhou province, Shaw urged Southern correspondent says his son was born on November 14, just get the kangtai company's hepatitis b vaccine, is preparing a second needle, see the news he feared: "injecting the vaccine lot number C201207076, will there be problems? ”

Reporter told Mr Shaw said he is not within the involved batches of vaccine. Shaw said after the hearing, notwithstanding some peace of mind, but hopes its findings soon, because the vaccine safety issues affecting many families hearts.

Yesterday, several parents and Alex call South are informed. In this regard, the kangtai company Deputy General Manager Zhang Jiansan, said apart from the involved batches of vaccine storage investigations, other batches of products still in normal use, and hoped that members of the public at ease.

Know more about

Coupling of death

CDC experts believe that mainly refers to when the vaccination is in some sort of incubation period of this disease or prodromal period, after vaccination coupling cases. Or inoculated by the application of the existing disease relapse or aggravation of acute, causing death.

Experts say

Shenzhen Zhang Shiying, Director of the CDC immunization section:

Not due to very little vaccine reactions and "choking"

"As a manufacturer, we want this incident to get results, nor do we wish to see rare coupling of death affects the promotion of immunization for children's vaccines. "Zhang Jiansan said.

"At this point, related to immunization is to promotion only after numerous tests, generally scientific and feasible, everyone can rest assured that vaccinations. "Zhang Shiying, Director of the Shenzhen Center for disease control and immunization section introduction, died in coupling, no causal relationship between vaccination and death, coupled to death is just a small probability event, be wrong to deny the tremendous role of vaccination. He said that at present hepatitis b vaccination has been incorporated into national childhood immunization systems, Shenzhen's hepatitis b maternal and child block since the implementation of the project, played a huge role in hepatitis b infection to the newborn falls to very low frequencies, approximately 200,000 children born each year in Shenzhen now, hepatitis b immunization rate of almost 100%.

Zhang Shiying believes that after so many years of vaccinations, vaccine for hepatitis b vaccine should be more mature, it can be said very safe, improves after 2009 and relevant standards, and security is guaranteed. EPI is a State policy, because some rare vaccine reactions and chose not to vaccination was "choking".

Consistency: South reporter Yang Guangxia interviews: South Xinhua correspondent Wang chengbo honey Yue Kangxin

(Original title: infant deaths involved Guangdong emergency storage 3,410 hepatitis b vaccine)

　　湖南两名婴儿在接种深圳康泰生物制品股份有限公司(下称康泰公司)生产的乙肝疫苗后死亡，事件引起各方关注。昨日南都记者了解到，广东购进3600支相关批次的疫苗，被使用的190支目前没接到不良反应报告，剩余的库存都已被封存。涉事企业方面回应，该事件还需等待尸检结果，暂不能确定疫苗与死亡之间有直接关系。

　　涉事两批疫苗约45万支，已经全部追溯到去向

　　前日，国家食药监总局通报，涉事的康泰公司两批次乙肝疫苗流入了湖南、广东、贵州三省。昨日，南都记者从该公司了解到，涉事两批疫苗约15万人份，即约45万支，目前已经全部追溯到去向，其中大部分销往湖南，广东省流入3600支，贵州省相关疫苗均未出库。

　　这一疫苗在广东是否已被使用？昨日，省疾控中心称，该中心接到消息后，已按广东省食品药品监督管理局部署和要求，通知相关疾病预防控制中心和接种点马上暂停使用相关批次乙肝疫苗，并连夜对其发放和使用的相关情况进行核查。经核查，广东共购进批号为C 201207090的乙肝疫苗3600支。截至昨日11时30分，该批次乙肝疫苗1800支仍在广州市疾病预防控制中心库存，另外180 0支已发往南沙区疾病预防控制中心，其中1610支仍在该中心库存，已使用190支。目前，已使用的190支该批次疫苗尚未接到不良反应报告 。库 存 的3 4 1 0支 批 号 为C 201207090的乙肝疫苗已按要求连夜封存。另外，广东未购进批号为C201207088的乙肝疫苗。

　　涉事批次疫苗去年生产，疫苗生产运输没问题

　　“国家食药监总局的专家已经和我们取得联系，我们也想尽快弄清楚事件原因。”昨日，位于南山区科技园的深圳康泰公司迎来数批记者，该公司常务副总经理张建三说，这些疫苗已被要求暂停使用，库存封存，等到专家组做出调查结论后再做处理，而其他批次的疫苗仍在正常使用。

　　公开资料显示，该公司成立于1988年8月，是深圳市首批高新技术企业之一，主要从事生物制品的研发、生产和销售。现有产品重组乙型肝炎疫苗(酿酒酵母)从国外引进，自1994年投产以来，累计销售2亿多人份，是中国最大的乙肝疫苗生产企业，产品覆盖全国31个省、市、自治区，市场占有率达50%以上。

　　“在前几年，我们每年可以生产销售2000万人份的乙肝疫苗，市场占有率超过60 %，现在每年也有1000万人份的销售量。”张建三表示，对于每批疫苗的销售都是要遵循严格的批签发制度，近年来他们从来没有接到关于乙肝疫苗质量问题以及药物不良反应的报告。

　　张建三称，此次涉事批次疫苗是在去年生产，共两批次，每批次约7万至9万人份，由各省疾控部门统一招标采购使用，均在3年有效期内；而企业的生产、仓储、运输等都不存在问题。

　　焦点之问

　　涉事疫苗与婴儿之死有无直接关系？

　　相关调查还在进行，需等待尸检结果

　　深圳康泰公司常务副总经理张建三表示，调查结果没出来之前谁都无法做出确实结论，疫苗偶合死亡病例一般都是在百万分之零点几的几率，而且原因非常复杂，目前还需等待尸检结果，他们已进行更多项的安全性试验，希望尽快查明原因。

　　昨日，深圳市药监局相关工作人员表示，目前相关调查还在进行，具体原因确实不能简单下结论，不仅要调查疫苗的生产、运输及仓储等，还要调查具体使用是否符合操作规范，被接种者本身是否存在问题等，如有调查结论，将在第一时间公布。

　　其他批次疫苗是否有问题？

　　康泰公司：仍在正常使用，希望市民放心

　　作为儿童计划免疫的乙肝疫苗，几乎每个婴儿出生后都要注射。昨日，家住贵州省铜仁市的肖先生致电南都记者称，他儿子于11月14日出生，刚接种康泰公司生产的乙肝疫苗，正准备注射第二针，看到新闻后他担 心 不 已 ：“ 注 射 的 疫 苗 批 号 是C201207076，会不会有问题呢？”

　　记者告知肖先生他所说的疫苗不在此次涉事批次内。肖先生听后表示虽有些许安心，但希望早日有调查结果，因为疫苗安全问题牵动着很多家长的心。

　　昨日，还有数名家长和肖先生一样致电南都了解情况。对此，康泰公司常务副总经理张建三表示，除涉事批次疫苗封存调查外，其他批次产品仍在正常使用，希望市民放心。

　　知多D

　　偶合死亡

　　相关疾控专家认为，主要是指在疫苗接种时正处于某种疾病的潜伏期或者前驱期，接种后偶合发病。或者接种后受种者原有疾病急性复发或者病情加重，引发死亡等。

　　专家说法

　　深圳市疾控中心免疫规划科主任张世英：

　　不能因极少疫苗反应而“因噎废食”

　　“作为生产企业，我们希望此次事件能尽快有调查结果，我们也不愿意看到因为极少发生的偶合死亡事件影响到儿童疫苗计划免疫的推广。”张建三说。

　　“目前来看，相关疫苗的接种都是要经过无数次的试验才会推广，一般来说是科学可行的，大家还是可以放心接种的。”深圳市疾控中心免疫规划科主任张世英介绍，在偶合死亡中，疫苗注射与死亡没有因果关系，偶合死亡只是小概率事件，不能因此否定疫苗接种的巨大作用。他说，目前乙肝疫苗接种已经被纳入国家儿童计划免疫体系，深圳的乙肝母婴阻断项目实施以来，发挥了巨大作用，将新生儿的乙肝感染降到了很低的频率，现在深圳每年出生约20万儿童，乙肝疫苗接种率几乎达到100%。

　　张世英认为，经过这么多年的接种，乙肝疫苗应该是比较成熟的疫苗，可以说非常安全，2009年以后提高了相关检验标准，安全性更有保障。计划免疫是国家政策，因为一些极少发生的疫苗反应等而选择不接种是“因噎废食”。

　　统筹：南都记者 阳广霞 采写：南都记者 王成波 万蜜 通讯员 粤康信

(原标题：涉婴儿死亡乙肝疫苗 广东紧急封存3410支)

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