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The author:(作者)aaapublished in(发表于) 2013/12/22 18:55:44 Shenzhen infant suspect vaccination deaths， vaccine has involved 4 deaths
Event: Hunan, Guangdong, Sichuan, 4 cases of infant deaths after injection of hepatitis b vaccine
Involved vaccine: a recombinant hepatitis b vaccine
Manufacturer: Shenzhen kangtai biological products company limited
Progress events: babies in the cause of his death is still under investigation, it is not yet certain whether the deaths associated with vaccination. National moratorium on the use of the company all the batches of recombinant hepatitis b vaccine (Saccharomyces cerevisiae). Guangdong provincial disease control Department has purchased from Beijing emergency vaccines from other companies, estimated on Monday.
Wei in Shenzhen City Human Rights Commission official said that the 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.
Recently in Hunan province after three infants vaccinated against hepatitis b vaccine serious adverse reactions, 2 of whom died. Question vaccines labeled as Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine (Saccharomyces cerevisiae). Hardly have one wave subsided when another rise, another begins. On December 17, the district, Buji Town, Shenzhen People's Hospital, one injection of hepatitis b vaccine after birth, sudden-onset emergencies, died, found its Shenzhen kangtai immunization with hepatitis b vaccine production.
Shenzhen food and drug administration under the State food and drug administration and the National Health Commission notifications, Shenzhen kangtai suspended sales in the library have been asked all the batches of recombinant hepatitis b vaccine product. Shenzhen Wei people inoculated points throughout the city have been asked to suspend all batches inoculated Shenzhen kangtai produces recombinant hepatitis b vaccine.
Shenzhen kangtai biological products Corporation informed that self-examination and accept the on-site examination of provincial drug authorities one after another, is not currently found in batch production process in violation of the drug in question g MP and not in accordance with the quality standard for the entire examination. They hope the investigation results as soon as possible, also hoped that members of the public not to panic, to learn more about common sense of vaccination and inoculation may appear abnormal, and so.
Family members questioned the hepatitis b vaccine for infant death and related
Previously, Hunan province, two infants died after Shenzhen kangtai biological products Corporation-hepatitis b vaccine, raised doubts about the vaccine safety, relevant findings is still in progress, however, there is no confirmed death associated with vaccination.
17th, a newborn in Shenzhen following the company's hepatitis b vaccination a medical emergency and died, and the hospital has been sealed with the batches of vaccine, the relevant departments involved in the investigation.
"This baby is 10:31 A.M. on that day ' caesarean section ' delivery, weight 3150g, appearance no significant anomalies at birth. 10:35 A.M., 10:37 clinic the same day conventional intramuscular injection of vitamin k, respectively 15, ㎎, hepatitis b vaccine (Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine) 10ug. 10:39 burst looking cyanosis in newborn, irregular breathing, crying little, we immediately implemented the rescue. 11:45 day, and patients whom, in children with clinically dead. "Yesterday, the hospital district, Buji Town, people in charge, the morning of December 18, dead boy questioned the parents of newborn death and written claim against the hospital on December 19, and suspect that the cause of death associated with immunization with hepatitis b vaccine.
The hospital managers said, questioning patients, the hospital immediately conducted an investigation. Hospital is designated by the Health Bureau of Longgang District of neonatal vaccination, vaccinations with vaccination qualifications of medical staff, vaccines used in receiving and storing process in accordance with specifications. Obstetric and ended December 19 hospitals were vaccinated against the lot number 5 doses of hepatitis b vaccine and adverse reactions of other members of the species does not occur.
He said that after the incident, the hospital routinely promptly reported to higher authorities, the current district, the city, the provincial Center for disease control has sent someone to the hospital to investigate. Shenzhen, the SFDA also has been involved in the investigation, according to statutory procedures hold vaccine. "We have agreed on December 19, jointly apply to the Forensic Department for autopsy to identify the cause of death. Once you have the inspection report will be duly informed. ”
Suspended kangtai hepatitis b vaccine for the general population to defer vaccination
Yesterday, the Shenzhen health human rights Commission published communications, satellite city CDC reported to the Human Rights Commission on December 19, have immediately organized the city CDC experts rushed to the scene to investigate, and promptly report to the provincial family planning Commission and provincial centers for disease control of health, CDC experts reached the scene to guide the investigation.
Two days ago, the State food and drug administration and the national health planning Commission jointly issued a circular recently, Shenzhen kangtai biological products Corporation produced 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, principle of the supremacy of the spirit of life, decided to suspend the company's entire 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.
Current medical persons suspension authority has notified the city's various districts in Shenzhen, Shenzhen kangtai biological products Corporation produced the vaccination lot numbers of hepatitis b vaccine. At present, it is not yet certain whether the deaths associated with vaccination, need medical evaluation results to a definitive diagnosis.
Shenzhen Zhang Shiying, Director of the CDC immunization section describes after Shenzhen never happened, events of sudden death after immunization with hepatitis b vaccine, the Longgang people's Hospital of South Bay baby boy was found dead was the first, and currently is under investigation, "but that doesn't you can conclude the vaccine problem, you also need to wait for the investigation results. ”
Because of the hepatitis b vaccine is a type of vaccine, unified procurement and supply from Guangdong Province, Shenzhen are Shenzhen kangtai biological products stock company production of the hepatitis b vaccine, hepatitis b vaccine should be dedicated to other companies to ensure that hepatitis b vaccine supplies. Said Zhang Shiying, the Guangdong provincial CDC has emergency vaccines from Beijing to buy other companies, estimated on Monday.
"During the allocation period, there may be a shortage of vaccine supply for the time being. "Shenzhen Wei man said, to general population delay hepatitis b vaccine does not affect the immune effects of hepatitis b vaccine, but the newborn of mothers HBsAg-positive, give priority to ensuring the timely vaccination within 24 hours of birth.
Ask 1
Whether the vaccine the same batch?
Vaccination affect the hearts of the people, especially parents, although it may cause complex, however the recently announced firstly inoculated after baby's death is still makes many people feel afraid.
On November 20, the 1-month-old boy xiaoluo in Huangpu town, Zhongshan, Guangdong Province and prevention by injection of hepatitis b vaccine and BCG vaccine, died 12 hours after the accident. In this regard, the Guangdong provincial CDC responded that small Los Shenzhen kangtai hepatitis b vaccinations, lot number C201207091. Diagnosed as pneumonia, not related to vaccination, clinical experts agreed with the diagnosis.
Recently, Hunan province reported two deaths in infants with hepatitis b vaccine, vaccination is also manufactured by Shenzhen kangtai hepatitis b vaccine recombinant hepatitis b vaccine (Saccharomyces cerevisiae), the batch of 20 120 88 c, c-201,207,090, with batches of medicines have been mothballed findings has not been made.
So, the Longgang people's Hospital of South Bay of neonatal hepatitis b vaccine batches in which is it? With three previous deaths case uses the same batch do?
Yesterday, Shenzhen kangtai biological products company failed to respond. And Southern Reporter are not from the Shenzhen food and drug administration and CDC and other authorities to the relevant lot number batches of vaccine.
Question 2
Coupling deaths?
Judging from the current situation, Hunan, two babies and infants in Shenzhen-related causes of death are still under investigation, Shenzhen kangtai biological products company, died after two infant hepatitis b immunization in Hunan province for possible coupling death. Eventually, however, the official findings have been made.
"For relevant decisions of the national authorities, we do not comment, just common sense of hope that the public will know more about vaccination and adverse reaction, that could be more understanding. "Shenzhen kangtai biological products Corporation official says, before finding out they inconvenience to make too many comments and explanations about it. At present they had received the State Food Drug Administration of Shenzhen food and Drug Administration notice requirements, such as being in accordance with the requirements of the moratorium on the sale of all lots of HBV vaccine.
He said vaccination coupling cases in recent years, as well as analysis of abnormal reaction or too little, State health authorities had vaccinated some hot replies. "Related information said that vaccination process of coincidence probabilities have how big are you? Coupling to newborns with hepatitis b vaccine deaths, for example, Chinese newborns (0-28 day) rate of 10.7 per thousand. About 16 million children born each year nationwide, according to projections about 170,000 newborns die every year, that is, about 466 newborns die every day. In accordance with the provisions of China's hepatitis b vaccination programs, hepatitis b vaccine in children vaccinated within 24 hours of birth, neonatal hepatitis b vaccine to the country's first needle in a timely manner (within 24 hours of birth) the rate of 75% per cent, about 350 births deaths per day were vaccinated against hepatitis b vaccine, known as neonatal hepatitis b vaccine coupled 350 deaths may occur every day. ”
He said that hope that the investigation will relevant findings as soon as possible, to account to the public and society.
Tips
Domestic imported vaccine and vaccine which is better?
CDC experts said the effect and safety of no difference
In recent days, after vaccination of infants deaths reported occurred, triggering public concern, although for reasons related to yet investigate it but some of the parents of the hepatitis b vaccine to give them still trying to, how do you give a child immunization with hepatitis b vaccine, vaccination whether imports should be selected when the hepatitis b vaccine, is higher level of safety of imported hepatitis b vaccine?
In this regard, Zhang Shiying, Director of the Shenzhen Center for disease control and immunization section introduction, safety of domestic hepatitis b vaccine technology is very mature, and used for decades, and can continue to vaccinations, and imported vaccines compared prices differ in effectiveness and safety there is no difference between the two.
He said that although there may be some adverse reactions in specific vaccinations coupling as well as deaths, but the public need not panic, are basically can rest assured that the vaccination.
According to statistics, 1,047,168 doses of hepatitis b vaccine in Shenzhen last year, 1,138,411 doses have been vaccinated this year, infants at birth, 1 month, 6 months respectively, need to be vaccinated with a needle. He said that Shenzhen last year reported more than 1000 cases of newborns with hepatitis b vaccine adverse reaction, but cannot determine quality of the hepatitis b vaccine-related.
This version of writing: the South reporter Wang chengbo
(Original title: Shenzhen died after an injection of hepatitis b vaccine in infants)
事件：湖南、广东、四川发生4例婴儿注射乙肝疫苗后死亡病例
涉事疫苗：重组乙型肝炎疫苗
生产厂家：深圳康泰生物制品股份有限公司
事件进展：婴儿死因尚在调查中，尚不能确定该死亡病例是否与接种疫苗有关。全国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。广东省疾控部门已经紧急从北京购进其他公司的疫苗，估计在下周一可以到。
深圳市卫人委负责人表示，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。
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2人不幸死亡。涉事疫苗标注为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)。一波未平，一波又起。12月17日，深圳市龙岗区南湾人民医院一名新生儿出生后注射乙肝疫苗，突发紧急情况，经抢救无效死亡，经查其接种的乙肝疫苗也是深圳康泰生产。
深圳市药监局根据国家食药监总局和国家卫生计生委通知，已要求深圳康泰暂停销售在库全部批次重组乙型肝炎疫苗产品。深圳市卫人委已要求全市接种点暂停接种深圳康泰生产的全部批次重组乙肝疫苗。
深圳康泰生物制品股份有限公司通报称，已展开自查并相继接受省市药监部门的现场检查，目前未发现涉事批次产品生产过程中有违反药品G MP及不按照质量标准进行全项检验的行为。他们期望相关调查结果尽快做出，也希望市民不要恐慌，更多地了解疫苗接种常识以及接种可能出现的异常反应等。
家属质疑婴儿死因与接种乙肝疫苗有关
此前，湖南省两婴儿接种深圳康泰生物制品股份有限公司生产的乙肝疫苗后死亡，各地引发对该疫苗安全性的质疑，然而相关调查结论仍在进行，目前无法证实死亡与疫苗接种是否有关。
本月17日，深圳一名新生儿接种该公司生产的乙肝疫苗后突发急症，经抢救无效死亡，目前医院已经封存同批次疫苗，相关部门介入调查。
“这名男婴是在当天上午10时31分‘剖宫产术’娩出，体重3150g，出生时外观未见明显异常。当天上午10时35分、10时37分按诊疗常规分别予肌肉注射维生素K 15㎎、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。10时39分新生儿突发面色紫绀，呼吸不规则，哭声小，我们立即实施抢救。当天11时45分，抢救无效，患儿临床死亡。”昨日，龙岗区南湾人民医院相关负责人介绍，12月18日上午，死亡男婴家长对新生儿死因提出疑问，并于12月19日上午书面向医院提出索赔要求，并怀疑死因与接种的乙肝疫苗有关。
这名医院负责人说，针对患方的质疑，该院立即进行调查。医院是龙岗区卫生局指定的新生儿预防接种单位，接种医务人员具备预防接种资格，使用的疫苗在领取、储存等环节上符合工作规范。而且截止到12月19日医院产科共接种该批号乙肝疫苗5剂次，其他受种人员均未出现不良反应。
他表示，事件发生后，该院按常规及时上报上级主管部门，目前区、市、省疾病控制中心已经派人到医院调查。深圳市、区药监局也已经介入调查，按法定程序封存相关疫苗。“我们已经与患方协商好，在12月19日共同申请法医部门进行尸体解剖以明确死因。一旦有检查报告，将及时通报。”
暂停使用康泰乙肝疫苗 对一般人群推迟接种
昨日，深圳市卫人委发布相关通报，卫人委于12月19日中午接到市疾控中心报告，已经立即组织市疾控中心专家赶往现场进行调查，并及时向省卫生计生委和省疾控中心报告，省疾控中心专家也到达现场指导调查。
前日，国家食品药品监管总局和国家卫生计生委联合发出通知：近日，深圳康泰生物制品股份有限公司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，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。
目前深圳市卫人委已经通知全市各区暂停接种深圳康泰生物制品股份有限公司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。
深圳市疾控中心免疫规划科主任张世英介绍，此前深圳从没发生过接种乙肝疫苗后突发死亡的事件，此次龙岗南湾人民医院男婴死亡是第一次，目前相关原因正在调查，“但这并不能就可以直接下结论疫苗存在问题，还需要等待调查结果。”
由于乙肝疫苗是一类疫苗，由广东省统一采购供应，目前深圳使用的均为深圳康泰生物制品股份公司生产的乙肝疫苗，需要调拨其他公司的乙肝疫苗来保证乙肝疫苗的供应。张世英说，广东省疾控部门已经紧急从北京购进其他公司的疫苗，估计在下周一可以到位。
“在调拨期间，可能存在疫苗供应暂时短缺。”深圳市卫人委负责人表示，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。
追问1
涉事疫苗是否同一批次？
疫苗接种牵动市民特别是家长的心，尽管可能原因复杂，然而近期不断爆出的婴儿接种后死亡事件还是让不少市民心生忌惮。
今年11月20日，1个月大的男婴小洛在广东中山黄圃镇防保所注射乙肝疫苗和卡介苗疫苗，12个小时后意外死亡。对此，广东省疾控中心回应称，小洛接种的是深圳康泰乙肝疫苗，批号C201207091。经诊断为重症肺炎，与疫苗接种无关，省临床专家同意该诊断。
而近日湖南省爆出的两例婴儿接种乙肝疫苗死亡事件，接种也是深圳康泰乙肝疫苗生产的重组乙型肝炎疫苗(酿酒酵母)，批号为C 20 120 70 88、C 201207090，同批次药品已经封存，相关调查结论仍未做出。
那么，此次龙岗南湾人民医院死亡的新生儿使用的乙肝疫苗是哪一批次呢？是否与此前三例死亡案例使用的为同批次呢？
昨日，深圳康泰生物制品股份公司未对此做出回应。而南都记者也未能从深圳市药监局以及市疾控中心等部门了解到相关批次疫苗的批号。
追问2
是否偶合死亡病例？
从目前情况来看，湖南两婴儿以及深圳婴儿的相关死亡原因仍在调查之中，此前深圳康泰生物制品股份公司表示，湖南两婴儿接种乙肝疫苗后死亡为疑似偶合死亡。然而，最终的官方调查结论至今没有做出。
“对于国家有关部门的相关决定，我们不便做出评论，只是希望市民更多地了解疫苗接种的常识和异常反应等，那样可能就会更加深入理解。”深圳康泰生物制品股份有限公司相关负责人表示，调查结论出来之前，他们不便对此事做过多评论和解释。目前他们已经接到国家食药监总局以及深圳市药监局等的通知要求，目前正按照要求暂停销售所有批次的乙肝疫苗。
他说，近年来疫苗接种的偶合病例以及异常反应分析也不少，国家卫生部门曾经就接种疫苗的一些热点问题做出过答复。“相关资料是这么说的，预防接种过程中的偶合症发生概率有多大呢？以新生儿接种乙肝疫苗偶合死亡为例，中国新生儿(0-28天)死亡率为10.7‰。全国每年出生儿童约为1600万，据此推算全国每年约有17万名新生儿死亡，即每天约有466名新生儿死亡。按照中国乙肝疫苗免疫程序规定，乙肝疫苗在儿童出生后24小时内接种，以全国新生儿乙肝疫苗首针及时(出生后24小时内)接种率75%计算，则每天约350名新生儿死亡者接种了乙肝疫苗，即全国每天新生儿接种乙肝疫苗可能出现偶合死亡350起。”
他表示，希望调查部门能够就相关事件尽快做出调查结论，也好给市民和社会一个交代。
小贴士
国产疫苗与进口疫苗哪个好？
疾控专家称效果和安全方面并无差别
连日来，发生的婴儿接种疫苗死亡事件见诸报端后，引发市民关注，尽管相关原因还未调查清楚，但一些要给孩子接种乙肝疫苗的家长还在纠结，到底还要不要给孩子接种乙肝疫苗，接种时是否应该选择进口乙肝疫苗，进口乙肝疫苗的安全系数是不是更高一些？
对此，深圳市疾控中心免疫规划科主任张世英介绍，国产乙肝疫苗技术已经非常成熟安全，而且使用数十年，完全可以继续接种，和进口疫苗相比，只是价位上有所区别，两者在效果和安全上并无差别。
他说，尽管在具体接种中可能存在一些不良反应以及偶合死亡病例等，但市民无需恐慌，基本上还是可以放心接种疫苗的。
据统计，去年深圳共接种乙肝疫苗1047168剂次，今年已经接种1138411剂次，婴幼儿在刚出生、1个月、6个月时分别需要接种一针。他表示，深圳去年新生儿接种乙肝疫苗不良反应报告1000多例，但不能确定与乙肝疫苗的质量有关。
本版采写：南都记者 王成波
(原标题：深圳一婴儿注射乙肝疫苗后死亡)
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