Go homepage(回首页) Upload pictures (上传图片) Write articles (发文字帖)
The author:(作者)aaapublished in(发表于) 2013/12/24 8:47:53 Suspected hepatitis b vaccine deaths nationwide increased to 7 cases
Yonge wide network Beijing December 24 News (reporter Wei Xue) according to China of sound news horizontal under reported, Guangdong Province CDC yesterday confirmed, from November has, province total report 4 cases suspected vaccination by Shenzhen kangtai biological products Corporation production of restructuring b type hepatitis vaccine Hou death cases, plus country food medicine prison General previously announced of Hunan, and Sichuan two province case, national suspected "vaccine death" cases has increased to 7 cases, related aspects is full survey. At present, Shenzhen kangtai produces all the batches of recombinant hepatitis b vaccine has been suspended across the country.
The State food and Drug Administration said the infant death is still under investigation. In front of the reasons not to investigate, State food and drug administration, the National Health Commission published on December 20 decision suspended kangtai biological products Corporation-all batches of recombinant hepatitis b vaccine and intensive investigations into causes of infant mortality, further inspection on drug manufacturers, to test vaccine product quality.
Subsequently, health population and family planning Commission announced a case of Shenzhen after vaccination deaths. This is Shenzhen died after vaccination of newborns for the first time in the case.
Shenzhen Municipal Center for disease control and prevention, immunization program director Zhang Shiying: 24,753 vaccinated has, in addition to these cases, others are not.
Introduce administrative district, Buji Town, Shenzhen People's Hospital Office Director Yang Jinmin, said the adverse reactions of newborns born in the morning of December 17-time appearance with no obvious exceptions, generally in good condition. An exception has occurred after vaccination reaction.
Yang Jinmin: term of a pregnant woman, for medical reasons, need to do a caesarean section, and then we made her caesarean section, after child delivery, by routine immunization with vitamin k, were vaccinated against hepatitis b vaccine, called a few minutes later, the boy showed up a pathological response. Short of breath and sudden cries is lower, pale and some lack of oxygen may be heart and lung function under the influence of some, and then we'll start a routine rescue.
After the impact, the parents suspected sudden death associated with vaccination. In response to parent after questioning, CNDH Wei organization in Shenzhen City CDC experts rushed to the scene to investigate.
Shenzhen Zhang Shiying, Director of the Centers for disease control and prevention programme section: 19th morning, parents suspected vaccine, one of the country's suspected adverse reaction monitoring of vaccination system, into the standard system processes has, must report to the scene.
Yang Jinmin denied that the hospital staff problems in the process:
Yang Jinmin: within 24 hours to give newborn injection needles, injection needles, there are rules, we is done according to the regulations, hospital doctors and nurses are qualified, during the operation, and there are no problems.
Shenzhen Municipal Center for disease control and prevention, immunization program director Zhang Shiying confirmation found no problems in the operational processes in hospitals.
Zhang Shiying: it is designated by the Health Bureau of Longgang District, workers are also trained, practising certificate qualification is fully equipped, operation specifications.
Reporter: is to rule out these possibilities?
Zhang Shiying: Yeah, yeah, yeah.
After receiving the reports of deaths, FDA visiting the City Center for disease control in Shenzhen City, Shenzhen kangtai produces recombinant hepatitis b vaccine usage conducted on-site verification.
Shenzhen SFDA visiting the City Center for disease control: first we make an on-site inspection, second in accordance with national requirements, has suspended the sale of the lot, finally we would like to cooperate with relevant departments of medical investigation into the death of measures.
, Including the Shenzhen case, since November, Guangdong has 4 suspected cases of hepatitis b vaccine died after medical records. In addition, Hunan, Sichuan and other places also have been a neonatal death cases after the hepatitis b vaccine. All involved vaccine produced by Shenzhen kangtai biological products company limited.
Yesterday, Shenzhen kangtai biological products company closed, staff said that pending the final result of the investigation, kangtai creature is no longer accepting media interviews.
Staff: received a notification, not an interview, still waiting for the test results.
The State food and Drug Administration said the investigations into causes of infant mortality, further inspection on drug manufacturers, to test vaccine product quality. 7 newborns died after injections of hepatitis b vaccine cases, case investigation and diagnosis of the expert group, Zhongshan, Guangdong, conclusions for heavy pneumonia, not related to vaccination. Is still not sure whether other cases caused by vaccination.
Zhang Shiying: now only is suspected, is has a time Shang of has relationship, I first vaccination has kangtai of hepatitis b vaccine, later appeared has serious of reaction, is death, also cannot said is causal relationship, causal relationship also to, autopsy of report, clear death of reasons, again to death of reasons submitted exception reaction survey diagnosis experts group, by experts were collective survey diagnosis, has a conclusions, or is, or not.
According to the official website of kangtai biological introduced, founded in 1988, Shenzhen kangtai is China's largest manufacturer of the hepatitis b vaccine, covering 31 provinces and autonomous regions across the country, market share is above 50%. On December 20, the State food and drug administration and national health planning Commission jointly issued a circular, calling for the suspension of all batches used Shenzhen kangtai biological products Corporation produced recombinant hepatitis b vaccine. Window in order to fill empty inoculation, centers for disease control and prevention of Guangdong province to Beijing tiantan biological emergency purchase of 1.45 million doses of the same vaccine, being distributed to various cities and counties.
Zhang Shiying: first is probably this evening, to 33,300 us, we plan to allocate to the area 10 area, probably tonight may be distributed in proportion to each district, tomorrow is the vaccination days, fast tomorrow (24th) will be able to pick up.
Since the news came out, these days a lot of preparation of hepatitis b immunization for their children, parents seem tangled, what exactly do you want the vaccination, vaccination should choose to import the hepatitis b vaccine, hepatitis b vaccine safety factor of more imports of this high? Zhang Shiying, Director of the Shenzhen Center for disease control and immunization programmes suggested that parents do not have to panic, domestic hepatitis b vaccine has a very proven security technology can continue to inoculate vaccine compared to imported and domestically produced vaccines and they are differentiated on price, there is no difference in the effectiveness and security.
(Original title: national suspected vaccine cases increased from 7 to relevant departments to investigate the cause of death)
央广网北京12月24日消息(记者韦雪)据中国之声《新闻纵横》报道，广东省疾控中心昨天证实，从11月至今，全省共报告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后死亡病例，加上国家食药监总局 此前公布的湖南、四川两省案例，全国疑似“疫苗致死”病例已增至7例，相关方面正在全力调查。目前，深圳康泰生产的全部批次重组乙肝疫苗已在全国范围内暂停使用。
国家食品药品监督管理总局表示，对于婴儿死因，目前还在调查之中。在原因没有调查清楚前，国家食品药品监督管理总局、国家卫生计生委于12月20号公布决定，暂停使用康泰生物制品股份有限公司生产的全部批次重组乙型肝炎疫苗产品，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。
随后，深圳市人口卫生计生委公布了一例接种后死亡案例。这也是深圳市首次出现新生儿在接种疫苗后死亡的案例。
深圳市疾病预防控制中心免疫规划科主任张世英：在已经接种的2万4753例中，除了这例，其他的都没有。
深圳市龙岗区南湾人民医院行政办公室主任杨锦民介绍，这名出现不良反应的新生儿在12月17号上午出生时外观并没有明显异常，一般情况良好。在接种疫苗之后出现了异常反应。
杨锦民：足月的一个孕妇，因为医学的原因需要做剖宫产，然后我们给她做了剖宫产，孩子娩出之后，就按常规接种了维生素K，接种了乙肝疫苗，打了几分钟后，这个孩子就出现了病理反应。呼吸急促、突然哭声也变低了，面色有一些缺氧的表现，可能是心肺功能受到了一定的影响，然后我们就开始进行常规的抢救。
事发后，家长怀疑孩子突发死亡与接种疫苗有关。在接到家长质疑之后，深圳卫人委组织市疾控中心专家赶往现场进行调查。
深圳市疾病预防控制中心免疫规划科主任张世英：19号上午，家长提出来怀疑疫苗，全国有一个疑似预防接种异常反应监测系统，进入规范的系统流程中来了，那就要报告，到现场去。
杨锦民否认，医院工作人员在操作流程上出现问题：
杨锦民：24小时内要给新生儿注射这个针，要注射哪些针，这都是有规定的，我们都按这个规定来做，我们医院医生护士都是有资质的，在操作过程中，也没有什么问题。
深圳市疾病预防控制中心免疫规划科主任张世英确认，没有发现医院在操作流程上出现问题。
张世英：它单位是龙岗区卫生局指定的，人员也经过培训的，执业证书资格证书都是齐全的，操作也是规范的。
记者：是已经排除了这些可能性？
张世英：对对对。
在接到死亡案例的报告后，深圳市药监局前往市疾病控制中心，对深圳康泰生产的重组乙肝疫苗使用情况进行了现场核查。
深圳市药监局前往市疾病控制中心：第一个我们对它进行现场检查，第二个根据国家要求，暂停了该批次的销售，最后我们要配合有关部门医学死亡的调查，采取措施。
包括深圳的案例在内，11月以来，广东先后发生了4例疑似接种乙肝疫苗后死亡的病历。此外，湖南、四川等地也先后出现新生儿在接种乙肝疫苗后死亡的案例。涉事疫苗全部由深圳市康泰生物制品股份有限公司生产。
昨天，深圳康泰生物制品股份有限公司大门紧闭，工作人员表示，在最终的调查结果出来之前，康泰生物不再接受媒体采访。
工作人员：接到公司通知，暂时不接受记者采访，还在等检验结果。
国家食品药品监督管理总局表示，将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。7名新生儿再注射乙肝疫苗后死亡的案例中，广东中山市的病例经过专家组的调查诊断，结论为重症肺炎，与疫苗接种无关。其他案例目前还不能确定是否由注射疫苗引发。
张世英：现在只能是怀疑，就是有个时间上的先后关系，我先接种了康泰的乙肝疫苗，后来出现了严重的反应，就是死亡，还不能说是因果关系，因果关系还要等尸检的报告，明确死亡的原因，再把死亡的原因提交异常反应调查诊断专家组，由专家们集体调查诊断，有一个结论，要么是，要么不是。
据康泰生物的官方网站介绍，成立于1988年的深圳康泰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，市场占有率在50%以上。12月20号，国家食品药品监管总局和国家卫生计生委联合发出通知，要求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的重组乙型肝炎疫苗。为了填补接种空窗，广东省疾病预防控制中心已向北京天坛生物紧急采购了145万剂次的同类疫苗，陆续分发到各市县。
张世英：第一批可能就是今天傍晚，给我们就是3万3300支，我们计划分配到辖区的10个区，按比例大概今天晚上就可以分发到各个区，明天是接种日，最快的明天(指24号)就能够接的上。
自从这个消息出来以后，这几天很多的准备给孩子接种乙肝疫苗的父母都十分纠结，到底还要不要接种，接种是不是应该选择进口的乙肝疫苗，这个进口的乙肝疫苗安全系数会不会更高呢？对此深圳市疾控中心免疫规划科主任张世英建议，家长无须恐慌，国产的乙肝疫苗技术已经非常的成熟安全可以继续接种，和进口的疫苗相比国产疫苗和它们只是价位上有所区别，两者在效果和安全方面并无差别。
(原标题：全国疑似疫苗致死病例增至7例 相关部门调查原因)
赞