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The author:(作者)aaapublished in(发表于) 2013/12/22 18:53:10 Hunan， Guangdong and Sichuan 4 infants died after injections of hepatitis b vaccine
In two or three minutes after injecting oxygen in critical condition
Express News reporter Zheng Yanhong Li Qiuling
Yesterday, Shenzhen health human rights Commission informed the recent district, Buji Town, Shenzhen People's Hospital obstetric neonatal deaths, children had been vaccinated before his death in Shenzhen kangtai biological products company limited (hereinafter referred to as "kangtai biological") of the hepatitis b vaccine. At present, the State food and drug supervision administration, the province has issued a notice ordering the suspension of kangtai biological product of all batches of recombinant hepatitis b vaccine.
In charge of district, Buji Town, Shenzhen People's Hospital, the children has been conducted autopsies, have yet to determine if the deaths associated with vaccination.
Recently, Hunan after three infants vaccinated against hepatitis b vaccine serious adverse reactions, including changning, Hengshan two infants died (this newspaper coverage).
Died after vaccination of newborns
Express News reporter learned from district, Buji Town, Shenzhen People's Hospital, the child is a baby boy, on December 17, "caesarean section" was born at term, when the weight is 3150g.
Yang Jinmin, Director of the Office of the Hospital told reporters that the newborn appearance when no significant anomalies at birth is generally good. 10:35, 10:37 on that day, doctors clinic General giving intramuscular vitamin K15 ㎎, hepatitis b vaccines in neonates (Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine) 10ug.
17th, neonatal emergencies looking cyanosis, irregular breathing, crying little, the immediate implementation of the rescue. "2-3 minutes after the vaccination, suddenly appear in children with hypoxia, there were signs of problems," Yang Jinmin said that the children did not improve, the situation continued to deteriorate and 11:45 on that day, and patients whom, in children with clinically dead.
Families have claim to the hospital
The morning of December 18, the questions the families of newborns in neonatal deaths, and written claim against the hospital in the morning the next day, suspected cause of death associated with the vaccine inoculation. "The doctor said the baby cry 5-10 minutes, in between that was vaccinated, after that I never heard the child crying, the coroner said that the child's development are good, are quite normal," said the newborn's father, because his wife is very fond of children and wives can't afford to fight, yet was afraid to tell her children died.
Yang Jinmin, told reporters after the incident, the hospital has been consulting with patients ' good on December 19, jointly apply to the Forensic Department for autopsy to identify the cause of death.
Press survey
Hunan vaccine lot number of infant deaths caused by different
This reporter learned that, after the incident, Longgang District, Shenzhen City, Guangdong provincial Center for disease control and prevention has sent someone to the hospital to investigate. Shenzhen, the SFDA also has been involved in the investigation, and sealed under the statutory procedure related to vaccines.
Yang Jinmin told Express news reporters about the newborn's death, the hospital cited multiple causes of death, "has also had to consider, with early disease." According to press reports, in Hunan province, two babies who died after injecting kangtai biological vaccine, injection of the vaccine lot number, respectively, C201207088, C201207090. The vaccines in Longgang District people's Hospital of South Bay C201207086 are now locked.
Officials said it could not yet determine the cause of death associated with vaccines
At about 1 o'clock yesterday, Shenzhen health people to keep the community informed of the Committee related to the accident.
The afternoon of December 19, medical Human Rights Commission informed the district in the city of Shenzhen in Shenzhen kangtai biological production lot number of hepatitis b vaccine suspended.
At present, it is not yet certain whether the deaths associated with vaccination, need medical evaluation results to a definitive diagnosis.
Previously, Hunan, two infants died after kangtai biological production of hepatitis b vaccination, involved companies respond that infant deaths occurring as suspect in Hunan coupling deaths yesterday, starting the company in Shenzhen this suspected vaccination of neonatal deaths declined media interviews, and said company officials have been visiting Beijing with relevant departments for further investigation.
Government response
Two ministries halted kangtai all involved vaccine
A few days ago, the State food and drug Inspection Bureau, national health planning Commission issued a circular, calling for the suspension of all batches using kangtai biological production of recombinant hepatitis b vaccine.
According to the State food and Drug Administration's official website announced that, recently, the kangtai biological production of several batches of recombinant hepatitis b vaccine (Saccharomyces cerevisiae) infant after vaccination, in Hunan, Guangdong, Sichuan, 4 deaths, cause of death is still under investigation.
In front of the reasons not to investigate, in order to protect children's health, ensure the safety of vaccinations, the State food and drug administration, the principle of supremacy of the national family planning Commission, in the spirit of health life, decided to suspend the use of the company's production of all batches of recombinant hepatitis b vaccine (Saccharomyces cerevisiae) and investigations into causes of infant mortality, further inspection on drug manufacturers, to test vaccine product quality.
Guangdong or temporary shortfall of hepatitis b vaccine
According to Wei in Shenzhen City Human Rights Commission said, after receiving the notice, the Commission immediately asked the CDC informed the Shenzhen City, Shenzhen kangtai biological production of suspended vaccination vaccinated all batches of recombinant hepatitis b vaccine.
Because of the hepatitis b vaccine is a vaccine, unified procurement and supply from Guangdong Province, Shenzhen kangtai biological production currently in use of the hepatitis b vaccine, hepatitis b vaccine should be dedicated to other companies to ensure that hepatitis b vaccine supply in Shenzhen. During the allocation period, there may be a temporary shortfall in vaccine supply. Hepatitis b vaccine on the general population was postponed, does not affect the effectiveness of hepatitis b vaccine, but the mother is HBsAg-positive newborns, giving priority to ensure its timely vaccination within 24 hours after birth.
Lines in Guangzhou
Guangzhou had already stopped playing a kind of hepatitis b vaccine
"2 days in advance, we have the kangtai company produced of all batches of the hepatitis b vaccine storage, a total of 31,500. "Yesterday, the Guangzhou Center for disease control Director, Ms Rosanna Wong said in an interview with a reporter, after previously sealed 3,410 suspected problem batches of vaccine, also deactivated, sealed up all batches of the company's hepatitis b vaccine, a total of 31,500, class of hepatitis b vaccination in Guangzhou to pause, back after a rebidding. Guangzhou not currently receiving serious adverse reactions reported after injection of the vaccine.
Ms Rosanna Wong said, because before Guangzhou Shenzhen kangtai biological products Corporation-hepatitis b vaccine, as a planned immunization program to provide children with free seedlings of the kind, this sealed also means to suspend hepatitis b vaccine inoculation of the kind recently in Guangzhou.
Public awaits you at class II vaccinations
Hepatitis b vaccine is a national requirement of vaccinations. Finish three vaccinations, respectively, at the time the child was born in January, the age, June-containing.
"If the mother is hepatitis b positive, the child needs immediate immunization with hepatitis b vaccine at birth, optional alternative against two types of hepatitis b vaccine. "Ms Rosanna Wong said because kangtai hepatitis b vaccine suspended from use, members of the public may be selected corresponding to the two types of hepatitis b vaccine, but need to spend a certain amount of their own costs.
"Apart from the hepatitis b vaccine birth infants require immediate, other needle time delay hepatitis b vaccine can be. "Dr Rosanna WONG did not reveal when to resume a class of hepatitis b vaccination, other than to say:" the sector is in full swing arrangements, I believe will soon be restored. ”
Dialogue Ms Rosanna WONG
Middle of a hepatitis b vaccine-for brand impact
The new bulletin: does that mean that the city has no category of free hepatitis b vaccine to fight?
Ms Rosanna WONG (Director of the Guangzhou Center for disease control): temporarily.
Express News: when will resume vaccinations work?
Ms Rosanna WONG: a type of hepatitis b vaccine is also waiting for the notification, I believe will get well soon. If necessary, people can focus the second type of hepatitis b vaccine, but at their own expense.
The new bulletin: vaccination schedule, now suspended vaccinations for children whether the body will be affected?
Ms Rosanna WONG: hepatitis b vaccine postponed for a few days, had no effect on inoculation effect, parents can rest assured. However, after HBV positive mothers after giving birth to a child, for the prevention of mother to child transmission of children, should be vaccinated within 24 hours, it is recommended that this case will be selected against two types of hepatitis b vaccine immediately.
The new bulletin: have one or two pins kangtai hepatitis b vaccinations, then replacement of inoculating other brands on a child's body will be affected?
Ms Rosanna WONG: General, best case scenario is indeed even three-shot hepatitis b vaccine products from the same company. But because of the choices of antigenicity, hepatitis b vaccine virus strains, fabrication process is basically the same, other needle replacement brands would not have a problem.
Guangzhou no hepatitis b vaccine adverse reactions
Express News: at present, Guangzhou received kangtai company's hepatitis b vaccination adverse reactions reporting?
Ms Rosanna WONG: it is understood that Guangzhou has received no vaccination currently kangtai biological products Corporation-hepatitis b vaccine after reports of serious adverse reactions.
The new bulletin: adverse reactions if the delay performance?
Ms Rosanna WONG: a general vaccination adverse reactions occur in half an hour, at the latest within one week. Parents can watch their kids vaccinated, and if the child had a high fever, symptoms of the nervous system, and so on should be timely registration, take their children to the community hospital for medical treatment. At present, all vaccine adverse events to have uniform registration.
The new bulletin: that is, if no adverse effects after a week, after which do not appear?
Ms Rosanna WONG: typically this is the case. But it's not absolute.
(Edit: SN091)December 22, 2013 Golden Goat excursions, Express News(湖南广东四川4名婴儿注射乙肝疫苗后死亡|深圳|疫苗|新生儿_新闻资讯
注射后两三分钟就缺氧病危
■新快报记者 郑雁虹 黎秋玲
昨日，深圳市卫人委通报，近日深圳市龙岗区南湾人民医院产科一名新生儿死亡，患儿死亡前曾接种过深圳康泰生物制品股份有限公司生产(下称“康泰生物”)的乙肝疫苗。目前，国家食药监总局、省局已经下发通知，要求暂停使用康泰生物全部批次重组乙型肝炎疫苗产品。
据深圳龙岗区南湾人民医院有关负责人介绍，已经对该患儿进行尸检，目前尚不能确定该死亡病例与接种疫苗有关。
近期，湖南三名婴儿接种了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(本报曾做连续报道)。
新生儿接种疫苗后死亡
新快报记者从深圳龙岗区南湾人民医院了解到，该患儿是一名男婴，于12月17日10时31分“剖宫产术”出生，足月，当时体重是3150g。
该院办公室主任杨锦民告诉记者，新生儿出生时外观未见明显异常，出生时一般情况好。当日10时35分、10时37分，医生按诊疗常规分别给新生儿肌肉注射维生素K15㎎、乙肝疫苗(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)10ug。
17日上午10时39分，新生儿突发面色紫绀，呼吸不规则，哭声小，该院立即实施抢救。“在接种疫苗2至3分钟后，患儿突然出现缺氧，有问题的迹象”杨锦民说，患儿不见好转，情况持续恶化，当日11时45分，抢救无效，患儿临床死亡。
家属已向医院提出索赔
12月18日上午，该新生儿家属对新生儿死因提出疑问，并于次日上午书面向医院提出索赔要求，怀疑死因与接种的疫苗有关。“医生说孩子哭了5到10分钟，在那之间，就是打疫苗的时间，在那之后就再也没有听到孩子的哭声了，法医说孩子的发育都很好，都很正常”该名新生儿的父亲说，由于其妻子非常喜欢孩子，怕妻子承受不了打击，暂时还不敢告诉她孩子死亡的事情。
杨锦民告诉记者，事件发生后，院方已经与患方协商好，于12月19日共同申请法医部门进行尸体解剖以明确死因。
■记者调查
与致湖南两婴儿死亡疫苗批号不同
记者了解到，事发后，龙岗区、深圳市、广东省疾病预防控制中心已经派人来医院调查。深圳市、区药监局也已经介入调查，并按法定程序封存了相关疫苗。
杨锦民告诉新快报记者，关于该名新生儿的死亡，医院列举了多个死因，“曾经也有考虑，跟早些疾病有关”。据记者了解，此前湖南省两名注射康泰生物疫苗后死亡的婴儿，其注射的疫苗批号分别为，C201207088、C201207090。而此次在龙岗区南湾人民医院的疫苗为C201207086，目前均已经被封存。
官方称尚不能确定死因与疫苗有关
昨日1时许，深圳卫人委向社会通报该事故相关情况。
12月19日下午，深圳市卫人委通知深圳全市各区暂停接种康泰生物生产的该批号乙肝疫苗。
目前，尚不能确定该死亡病例是否与接种疫苗有关，需要等医学鉴定结果才能明确诊断。
此前，湖南两名婴儿在接种康泰生物生产的乙肝疫苗后死亡，涉事公司回应称，湖南发生的婴儿死亡事件为疑似偶合死亡事件，昨日，该公司对深圳这起新生儿疑似注射疫苗死亡案例婉拒媒体采访，并称公司负责人已经前往北京配合有关部门作进一步调查。
■政府反应
两部委叫停康泰全部涉事疫苗
日前，国家食药监总局、国家卫生计生委下发通知，要求暂停使用康泰生物生产的全部批次重组乙肝疫苗。
据国家食药监总局官网发布消息称，近日，康泰生物生产的几个批次重组乙型肝炎疫苗(酿酒酵母)婴儿接种后，在湖南、广东、四川发生4例死亡病例，死因尚在调查中。
在原因尚未调查清楚前，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、国家卫生计生委本着生命至上的原则，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。
广东或暂时出现乙肝疫苗短缺
据深圳市卫人委方面表示，接到通知后，该委立即要求深圳市疾控中心通知深圳全市接种点暂停接种康泰生物生产的全部批次重组乙肝疫苗。
由于乙肝疫苗是一类疫苗，由广东省统一采购供应，深圳目前使用的均为康泰生物生产的乙肝疫苗，故需要调拨其他公司的乙肝疫苗来保证深圳乙肝疫苗的供应。在调拨期间，可能存在疫苗供应暂时短缺。对一般人群推迟接种乙肝疫苗，不影响乙肝疫苗的免疫效果，但对母亲乙肝表面抗原阳性的新生儿，优先保证其在出生后24小时内及时接种。
■连线广州
广州已停打一类乙肝疫苗
“2天前，我们已经将康泰公司生产的所有批次的乙肝疫苗封存，共31500支。”昨日，广州市疾控中心主任王鸣接受记者采访时透露，继此前封存3410支怀疑问题批次疫苗后，又已停用、封存所有批次该公司生产的乙肝疫苗，共计31500支，广州的一类乙肝疫苗接种也因此要暂停，待重新招标后恢复。目前广州未接到注射该疫苗后严重不良反应报告。
王鸣表示，由于事件前广州正采用深圳康泰生物制品股份有限公司生产的乙肝疫苗，作为计划免疫规划中免费为儿童提供的一类苗，本次封存也意味着广州近日的一类乙肝疫苗要暂停接种。
市民可自费接种二类疫苗
乙肝疫苗是国家规定必须接种的疫苗。分三次接种完，分别在孩子出生时、1月龄、6月龄接种。
“如果母亲是乙肝阳性，孩子出生时需要立即接种乙肝疫苗，可选打二类乙肝疫苗替代。”王鸣表示，由于康泰乙肝疫苗的暂停使用，市民可选打相对应的二类乙肝疫苗，不过需要自己花费一定的费用。
“除了出生婴儿需要立即接种乙肝疫苗外，其他针次的乙肝疫苗延迟打是可以的。”王鸣未透露何时恢复一类乙肝疫苗接种，只是表示：“相关部门正紧锣密鼓地安排，相信很快就会恢复。”
对话王鸣
接种乙肝疫苗中途换品牌影响不大
新快报：是否意味着全市已无一类免费乙肝疫苗可打？
王鸣(广州市疾控中心主任)：暂时是这样的。
新快报：何时会恢复接种工作？
王鸣：一类乙肝疫苗还要等待通知，相信很快会恢复。期间如果有需要，市民可以选种二类乙肝疫苗，只不过要自费。
新快报：本来接种疫苗有时间表，现在暂停接种对孩子身体会否有影响？
王鸣：推迟几天接种乙肝疫苗，对接种效果基本没有影响，家长可以放心。但是，乙肝阳性的产妇在生下孩子后，为防止母婴传播孩子，应该在24小时内接种疫苗，建议这种情况要立即选打二类乙肝疫苗。
新快报：已接种一针或两针康泰乙肝疫苗，接下来，更换接种其他牌子对孩子身体会否有影响？
王鸣：接常规，最好的情况的确是乙肝疫苗连打的三针都来自同一公司产品。但由于现在的乙肝疫苗选择的抗原性、病毒株、制作工艺都基本一样了，其他针次更换品牌也不会有问题。
广州暂无乙肝疫苗不良反应报告
新快报：目前，广州有收到接种康泰公司乙肝疫苗出现不良反应报告？
王鸣：据了解，广州目前还没有接到接种康泰生物制品股份有限公司生产的乙肝疫苗后严重不良反应的报告。
新快报：不良反应如果延迟表现呢？
王鸣：一般不良反应在接种半小时后会出现，最迟一周内也有相关表现。家长可以观察孩子接种疫苗后的表现，假如孩子出现高烧、神经系统症状等情况，应及时带孩子到社区医院登记、就医。目前，所有疫苗不良反应事件都有统一登记。
新快报：即是如果一周后无不良反应，之后都不会出现？
王鸣：通常情况是这样。但也不是绝对。
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