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published in(发表于) 2013/12/17 15:43:08
Vaccine companies deny that two babies died of vaccine

Vaccine companies deny that two babies died of vaccines: due to coupling | | | vaccine death of a baby _ news

Recently, after 3 babies were vaccinated against hepatitis b vaccine in Hunan province, there have been serious adverse reactions, including 2 deaths. At present, two batch of products in question has been suspended. Yesterday, the vaccine production enterprise clarification bulletin kangtai company said the cause of death due to coupling, not associated with the vaccine. Hunan provincial CDC said infant mortality has not associated with vaccines, infant autopsy results will take about 2 months.


 Hunan province disease control


Vaccine has been involved with more than 100,000


Recently, Changning, Hunan province, Hengshan County, hanshou County, 3 baby at serious adverse reactions after vaccination with hepatitis b vaccine. Among them, changning, Hengshan two babies died. 3 infants of Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine (Saccharomyces cerevisiae), involving a total of C201207088 and C201207090, two batches. At present, the two batches of vaccine has been suspended.


"Shenzhen kangtai biological products Corporation produced the two batches of the vaccine last year after a formal bidding entered Hunan, belong to the free vaccines. The total 2 batch of vaccine 311,076, and distributed to the prefecture in Hunan province in mid-September 2013. "Hunan provincial Center for disease control Deputy Director Gao Lidong said.


Gao Lidong introduced as halt, Hunan has used 108,654 vaccine, there are inventory 202,422. As of 16th, in addition to the above 3 cases, it had not yet received the hepatitis b vaccine reported suspected cases of abnormal reactions after vaccination.


"In recent years, some hundreds of millions of doses of vaccination times per year in China, but after investigation, diagnostic and vaccine related and are relatively serious abnormal reactions rarely, the incidence is very low. "Gao Lidong introduction World Health Organization immunization safety monitoring-adverse events after vaccination monitoring immunization program managers Guide (Second Edition) abnormal reaction to some vaccines studies show that incidence of allergic shock induced by immunization with hepatitis b vaccine is 1.1/1 million doses.


To ensure that routine immunization with hepatitis b vaccine is working, from Dalian, a biopharmaceutical company in Hunan province health department to urgently allocate 168,000 hepatitis b vaccine, and distributed in a timely manner to the relevant Prefecture.


Storage and transportation, and inoculation operations, no problem


Gao Lidong said, "the investigation found, involved in the vaccine inoculation during storage, transport and operation, the problem does not exist. 3 cases taken to centers for disease control, Township of vaccine storage and transportation in accordance with the relevant provisions of the code for vaccine storage and transportation management requirements. Inoculation with county-level administrative departments of public health of the vaccination certificate issued, vaccinators with vaccination of qualification, the vaccination process consistent with the code for vaccination requirements. ”


Hunan provincial disease control center director Li Junhua said: "infant deaths associated with involved vaccinations, infant autopsy results and takes approximately 2 months. ”


"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. "Gao Lidong said.


The cause of death due to coupling


It is understood that the Shenzhen kangtai biological products Corporation is the larger the hepatitis b vaccine manufacturer, product market share of more than 50%.


Yesterday, the kangtai company issued a clarification bulletin said the cause of death due to coincidence, has nothing to do with the vaccine. Via self-examination, involved two batch of vaccine production and Stockpiling, transport and other sectors are carried out according to national regulations, in line with GMP requirements. Also these two batch of product acute toxicity examination to check when the results will be announced soon.


It is understood that the coupling, refers to the species are in some sort of incubation period of the disease, or had an underlying diseases have been found, onset of coincidence after vaccination, which has nothing to do with the vaccine itself. Higher vaccination rates, more varieties, greater the coupling rate.


"This statement is also possible. Subject to the sensitivity of laboratory testing, carry the hepatitis b virus in people who are not necessarily to pass HB 5 check it out. Body someone injected with hepatitis b virus hepatitis b vaccine could start the order of magnitude of growth, resulting in death. "A hospital doctor said," but what causes death, also depends on the autopsy results. ”


Concerned enterprises


≫> links


3 serious adverse reaction baby


Children with hengsh, male, born on November 4, 2013, December 4, receive the 2nd dose of hepatitis b vaccine, died on December 6.


Changning children, male, born on April 3, 2013, December 8, 3rd dose of hepatitis b vaccinations and 1 dose of influenza vaccine, died on December 9.


Hanshou County children, male, born on October 17, 2013, 2nd dose of hepatitis b vaccine on November 25, while injection of Vitamin K1, about 2 hours after the symptoms such as lips, his face turned purple, then get sicker. After 2 weeks treatment, has been transferred to the general ward from the intensive care ward for treatment.


According to the Beijing times, Ping Yifan, Xinhua


(Original title: two infants died after vaccine companies say death was a coincidence)

(Edit: SN064)
December 17, 2013 Beijing times
(
疫苗企业否认两婴儿因打疫苗死亡:缘于偶合症|婴儿|疫苗|死亡_新闻资讯

  近期,湖南3名婴儿接种了乙肝疫苗后,出现了严重不良反应,其中2人死亡。目前,涉事两个批号产品已暂停使用。昨日,疫苗生产企业康泰公司发出澄清公报称,致死原因缘于偶合症,与疫苗无关。湖南省疾控中心表示,婴儿死亡与疫苗有无关联,要等婴儿尸检结果出来,约需2个月。


  ■湖南疾控


  涉事疫苗已用逾10万支


  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。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重组乙型肝炎疫苗(酿酒酵母),涉及C201207088和C201207090两个批次。目前,两批次疫苗已暂停使用。


  “深圳康泰生物制品股份有限公司生产的这两批次疫苗是去年经过正规招投标渠道进入湖南的,属于免费疫苗。此2批号疫苗合计311076支,于2013年9月中旬分发到湖南相关市州。”湖南省疾控中心副主任高立冬说。


  高立冬介绍,截至叫停,湖南已使用108654支相关疫苗,尚有库存202422支。截至16日8时,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。


  “近几年,我国每年预防接种大约数亿剂次,但是经过调查诊断与接种疫苗有关且较为严重的异常反应很少,发生率很低。”高立冬介绍,世界卫生组织《预防接种安全性监测-免疫规划管理人员预防接种不良事件监测指南(第二版)》对部分疫苗的异常反应研究显示,接种乙肝疫苗引起的过敏性休克发生率为1.1/100万剂次。


  为确保乙肝疫苗常规接种工作正常开展,湖南省卫生厅从大连一家生物制药公司紧急调拨16.8万支乙肝疫苗,并及时分发至相关市州。


  储运和接种操作没问题


  高立冬说:“调查发现,涉事疫苗在储存、运输和接种操作中,不存在问题。3例病例发生地疾控机构、乡镇卫生院疫苗储存运输符合《疫苗储存和运输管理规范》相关规定要求。接种单位均具备县级卫生行政部门颁发的《预防接种单位合格证》,接种人员均具有预防接种资质,接种操作过程符合《预防接种工作规范》相关要求。”


  湖南省疾控中心主任李俊华说:“婴儿死亡是否与接种涉事疫苗相关联,要等婴儿尸检结果出来,大约需要2个月时间。”


  “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。”高立冬说。


  致死原因缘于偶合症


  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。


  昨日,康泰公司发出澄清公报称,致死原因缘于偶合症,与疫苗无关。经自查,涉事两批号疫苗的生产储存、运输等环节均按国家规定进行,符合GMP要求。公司还对这两个批号的产品进行了异常毒性检查,检查有结果后将马上公布。


  据了解,偶合症,是指受种者正处于某种疾病的潜伏期,或者存在尚未发现的基础疾病,接种后巧合发病,其发生与疫苗本身无关。疫苗接种率越高、品种越多,发生的偶合率越大。


  “这种说法也是可能的。受限于实验室检测的灵敏性,体内携带乙肝病毒的人不一定都能通过乙肝5项检查出来。体内含乙肝病毒的人如果注射了乙肝疫苗可能引发病毒数量级增长,导致死亡。”某三甲医院主治医生表示,“但是具体什么原因致死,还要看尸检结果。”


  ■涉事企业


  >>链接


  3名严重不良反应婴儿情况


  衡山县患儿,男,2013年11月4日出生,12月4日接种第2 剂乙肝疫苗,12月6 日死亡。


  常宁市患儿,男,2013年4月3 日出生,12月8日接种第3剂乙肝疫苗和1剂流感疫苗,12月9日死亡。


  汉寿县患儿,男,2013年10月17 日出生,11月25日接种第2 剂乙肝疫苗,同时注射维生素K1,约2小时后出现嘴唇、脸面发紫等症状,随后病情加重。经2个多星期抢救,已从重症监护病房转入普通病房治疗。


  据京华时报记者平亦凡新华社报道


(原标题:两婴儿打疫苗后死亡企业称死因是偶合症)


(编辑:SN064)
2013年12月17日02:29
京华时报
)


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