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The author:(作者)aaapublished in(发表于) 2013/12/24 8:44:22 Kangtai has sold 35 million hepatitis b vaccine， part of the concerned vaccine flow is unknown
In recent days, many infant deaths after hepatitis b vaccine, triggering public fears about vaccine safety. Yesterday, the Shenzhen Municipal Drug Administration Web site relating to recombinant hepatitis b vaccine manufactured by Shenzhen kangtai company relevant information (as of December 23) Bulletin says, verified statistics, as of December 20, 2013, Shenzhen kangtai produces recombinant hepatitis b vaccine within its validity period specification has sold batches account 186, but the announcement did not involve sales of vaccine use and flow of.? In addition, up to now, involved vaccine distribution in Guangdong Province have been declared, whether distributed to other provinces, but have used, relevant departments had yet been announced. Xinhua composite CCTV website of the China Business Journal
All prosperous in the finished vaccine storage
Shenzhen SFDA website yesterday afternoon reported that verified statistics, as of December 20, 2013, Shenzhen kangtai produces recombinant hepatitis b vaccine in the finished product, 95 total 17,760,507, have all been suspended sales and shipping activities; in all sizes of recombinant hepatitis b vaccine within the validity period has been sold, 186 total 35,891,194.
According to the notification, on December 19, Shenzhen after the FDA received a CDC report on newborn deaths, experts rushed to the site immediately organized the adverse drug reaction monitoring center line with the disease control Department of health survey precinct station immediately rushed to the site at the same time the vaccination involves batch of C201207086 recombinant hepatitis b vaccine storage. Has been sampled and sent China registered Institute of food and drug inspection. Whether the deaths associated with vaccinations, having to wait for a medical evaluation of the results will be able to clear.
Informed that in accordance with State regulations, vaccines required before the products go on sale through the Chinese food and drug inspection examination and obtained at the Institute of biological products, approval and issuance of certificates. The investigation, batch number, C201207088, C201207086, recombinant hepatitis b vaccine in question, as well as Shenzhen kangtai has been selling recombinant hepatitis b vaccines are provided to obtain related certificates.
Partially involved national flow of vaccines still unknown
Batch of infant deaths suspected to Shenzhen C201207086 batches of vaccine, has announced the distribution of Guangdong Province, but is there any amount distributed to other provinces, has been used, the relevant Department has not been announced.
The other hand, accounted for a market share of about 60% kangtai company after the vaccine was deactivated, Guangdong, Hunan, Hainan and other provinces have allocated vaccines for use in the field, however up to press time, vacancy how much, and how to make up for the other provinces, has released no relevant departments and provinces.
At the national level, with the exception of 20th, official website announced that the State Food Drug Administration, the authority and the national family planning Commission have jointly sent a notice of health suspended outside the kangtai company produces recombinant hepatitis b vaccine, to a time reporter but has yet to see sections further public comments.
Did not start emergency response mechanism has been called into question
Released by the Guangdong provincial CDC since November 4 suspected cases in the province "vaccine death" cases, Zhongshan, Shenzhen, in addition to the two exceptions, Jiangmen, had not seen publicly reported two cases in Meizhou, had also not been announced.
The other hand, no later than November 25, Hunan, there have been cases of severe adverse reactions after vaccination in infants, and December 6 consecutive deaths, however the State departments two batches of vaccine will last until 13th halted kangtai company; 17th Shenzhen infant deaths, two days later, the Shenzhen halted the batches of vaccine, at national level until the 20th stop kangtai company of all vaccines.
CDC staff members at the grassroots level think in accordance with national pilot breakdowns of drug safety incidents grading no later than December 9, after two suspected vaccine deaths in Hunan province, may constitute level II (major) and drug safety incidents, 17th Shenzhen infant death, constitutes a class I (major) and drug safety incidents.
People questioned, the relevant departments only simple statements that "vaccination is the most basic public health services", "overall vaccine is safe and effective" for some "suspected problems vaccine" is not to publish the flow, do not inform the national shortage and has not launched the emergency mechanism does not explain why, to lead the public fears.
Focus
1
Determine the "coupling" who is in charge
Shenzhen kangtai 16th statement "vaccine death" event called "suspected coupled deaths", adding that "coupling has nothing to do with the vaccine itself." Internet users questioned, within a short time, there were several newborns died after vaccination events, is using the peptide vaccine production, kangtai unilateral declaration of coincidence and unrelated to the vaccine itself, are suspected of shirking its responsibilities.
CDC immunization section chief of Hainan Province described Zeng Xuexia, medically called "coupling" means, those who were vaccinated at vaccination time is in some sort of incubation period of this disease or prodromal period, incidence of coincidence after vaccination, causes not related to vaccines, "but this does not mean that all vaccinations prior to death without identification can use coupling death '."
Zeng Xuexia, from a clinical standpoint, decide whether "coupling", vaccine companies say that doesn't count diagnosis group need to be investigated by the vaccination after a detailed investigation judge. If expert group conclusions were vaccinated against the families of the deceased appealed against, may apply to the above city level medical identification. If results still do not agree, you can take the proceedings, bring a civil action.
2
Within 24 hours of birth and whether you must
Many users concerned about infant hepatitis b vaccine within 24 hours of birth must be? There are users that "infant hepatitis b vaccine is convenience, it was for the money to the national neonatal set the Devil's trap". But more netizens said, cannot do anything for anyone, now mother to child transmission in really quite considerable proportion of patients with hepatitis b.
Journalists have access to the information found, for neonatal hepatitis b vaccine issues, Chinese Academy of engineering academician Zhuang Hui indicated that hepatitis b prevention and control in China is difficult, but space is big. Neonatal hepatitis b prevention, preferably in the injection of hepatitis b vaccine within 24 hours of birth.
Shenzhen CDC immunization Director Zhang Shiying, 23rd told reporters, speaking from the medicine, neonatal hepatitis b vaccine does not easily under the risk of exposure to the hepatitis b virus, also asked the local centers for disease control in Guangdong province to ensure vaccination of newborns within 24 hours to complete. Its results, hepatitis b vaccine has been effective in reducing the incidence of hepatitis b in Shenzhen, from 17.8% down to adults cent, incidence in children under 5 years old 1%.
According to Merck, citing official statistics, from 1984 to 1987, every year, about 120 million people infected with the hepatitis b virus, 10.1% of the total population. Nearly 20 million children born each year, nearly one-tenth of infants infected with hepatitis b virus, but since 1994, there have been more than 200 million children in China has been effectively protected.
However, the issue remains controversial.
"The current genetically engineered hepatitis b vaccine technology is quite mature, production link no problem, little relationship between vaccines and infant deaths, coupled to more likely. Immunization now requires injection of hepatitis b vaccine within 24 hours of birth, result in coupling reactions more. "One vaccine experts said the current neonatal deaths, due to changes in the external environment of the fetus and cause breathing to stop 10% of neonatal of neonatal deaths, but if the injections again after 1 month after birth, coupling reaction can be reduced. "We have mentioned several times suggested that related departments have expanded program on immunization has not been modified because the operation procedures cumbersome. ”
China CDC, an immunization expert said: "the thing about neonatal injection of hepatitis b vaccine within 24 hours of birth, there are plenty of experts proposed to amend, but under the current Chinese situation, cannot be modified. There are two main reasons, one is that many rural pregnant women prior to the birth of five does not detect hepatitis b, no way of knowing whether pregnant women carriers of the hepatitis b virus; another is that while most of urban pregnant women do this check, but checks are not allowed was also a problem. And in order to prevent the spread of hepatitis b, only sweeping. ”
3
There are no known adverse reactions how to distinguish
With the spate of vaccine injuries, many parents may cause adverse reactions to vaccines are very interested. Children immunized the same batch which adverse reactions are possible? How to tell when to seek medical advice?
Peking Union Medical College, school of public health Dean Yuanli Liu believes that adverse reactions are not hard to find, but adverse reactions to predict which babies are not easy.
Yuanli Liu believes that vaccination adverse reactions are rare events, but no country in the world to be fully controlled. The vaccinated infant death, there are several possible reasons: one is the vaccine quality issues; that the infant death, even without the diseases are also sometimes happens; third, the vaccination program is worth revisiting. According to the provisions of the existing vaccination programs, babies were born on the same day at the same time and BCG immunization with hepatitis b vaccine, BCG vaccine is active, is not some baby bear? In short, medical and health community, business, Government and society should indeed be taken into, carefully analyze the causes, summarize experiences and lessons learned, but must comply with the principles of evidence-based decision making.
4
Changing brands or defer vaccination in the Middle has no effect
In accordance with the relevant provisions of the State, belongs to a class of vaccine hepatitis b vaccine, provided free by the State, vaccination has to be 3-pin: at birth, 1 pin, 1-pin, one month after 6 months the 1-pin. Well, replacement of vaccine brand or defer vaccination in the Middle, will have an impact on vaccination, please?
CDC officials said, has one or two pins kangtai hepatitis b vaccinations babies replaced midway brand and delayed for a few days on the inoculation effect no effect. But there is one exception: hepatitis b maternal, after giving birth to him, and to prevent mother to child transmission, the child should be vaccinated within 24 hours.
Experts recommend that parents need to pay attention to observe the child's response after vaccination, including mental condition, partially vaccinated have a fever, there is no obvious swelling or bleeding.
December 24, 2013 The Beijing times(康泰已售3500万乙肝疫苗 部分涉事疫苗流向未知|疫苗|乙肝|涉事_新闻资讯
连日来，多地发生婴儿接种乙肝疫苗后死亡事件，引发了公众对疫苗安全性的担忧。昨天，深圳市药品监督管理局网站发布《关于对深圳康泰公司生产重组乙肝疫苗有关情况(截至12月23日17时)的通报》称，经核查统计，截至2013年12月20日，深圳康泰生产的在有效期内的重组乙肝疫苗各规格已销售186批次合计35891194支，但通告并未涉及已销售疫苗的使用和流向情况。另外，截至目前，涉事疫苗在广东省的分发量已公布，但是否有分发至其他省份、已使用量多少，相关部门至今并未公布。 综合新华社央视人民网《第一财经日报》
康泰在库成品疫苗全部封存
深圳市药监局网站昨天下午发布通报称，经核查统计，截至2013年12月20日，深圳康泰生产的重组乙肝疫苗在库成品95批次合计17760507支，已全部暂停销售及发运工作；在有效期内的重组乙肝疫苗各规格已销售186批次合计35891194支。
据通报，12月19日17时，深圳药监局接到疾控中心有关新生儿死亡报告后，立即组织药品不良反应监测中心专家赶赴现场配合卫生疾控部门调查，同时辖区分局立即赶赴现场将本次接种涉及的批号为C201207086的重组乙肝疫苗封存。目前已抽样并将送中国食品药品检定研究院检验。该死亡病例是否与接种疫苗有关，需等待医学鉴定结果方能明确。
通报称，按照国家规定，疫苗产品上市销售前必须通过中国食品药品检定研究院的检验并获得生物制品批签发合格证。经查，批号为C201207088、201207090、C201207086的涉事重组乙肝疫苗，以及深圳康泰已销售的重组乙肝疫苗均按规定获得了有关合格证。
部分涉事疫苗全国流向仍未知
疑似致深圳婴儿死亡的批号为C201207086的批次疫苗，尽管已公布广东省的分发量，但是否有分发至其他省份、已使用量多少，相关部门至今并未公布。
另一方面，占全国市场份额约六成的康泰公司疫苗被停用后，广东、湖南、海南等省份均已从外地调拨疫苗接换使用，然而到记者发稿时为止，其他省份空缺多大、如何弥补，也未见相关部门和省份公布。
在国家层面，除20日，国家食药监总局官网发布消息称，该局和国家卫生计生委已联合发通知，暂停使用康泰公司生产的重组乙型肝炎疫苗外，至记者发稿时，一直未见两部门进一步公开表态。
未启动应急机制遭到质疑
广东省疾控中心公布的该省11月至今的4例疑似“疫苗致死”病例中，除中山、深圳两例外，江门、梅州两例并未见诸公开报道，此前也未有相关部门公布。
另一方面，至迟在11月25日，湖南就出现了婴儿注射疫苗后严重不良反应病例，12月6日和9日连续出现死亡病例，然而国家有关部门直至13日才叫停康泰公司两批次疫苗；17日深圳婴儿死亡，两天后，深圳才叫停该批次疫苗，国家层面直至20日才叫停康泰公司所有疫苗。
有基层疾控中心工作人员认为，按照国家试行规定划分的药品安全突发事件分级标准，至迟到12月9日，湖南出现两起疑似疫苗致死事件后，已可构成II级(重大)药品安全突发事件，到17日深圳婴儿死亡时，已构成I级(特别重大)药品安全突发事件。
有群众据此质疑，相关部门仅简单表态，“预防接种是最基本的公共卫生服务”“疫苗总体来看是安全有效的”，对于部分“疑似问题疫苗”却不公布流向，不告知全国缺口量，而且并未启动应急机制也未解释原因，致使公众疑虑重重。
焦点
判定“偶合性事件”谁说了算
深圳康泰16日发布声明，将“疫苗致死”事件称为“疑似偶合死亡事件”，并称“偶合症的发生与疫苗本身无关”。网民质疑，短时间内发生多例新生儿接种疫苗后死亡的事件，使用的都是康泰生产的疫苗，而康泰单方面宣布偶合症的发生与疫苗本身无关，有推卸责任的嫌疑。
海南省疾控中心免疫规划科科长曾雪霞介绍，医学上说的“偶合症”是指，受接种者在接种时正处于某种疾病的潜伏期或者前驱期，接种后巧合发病，发病原因与疫苗无关，“但是，这并不表示所有接种死亡在未经鉴定前都可以用‘偶合死亡’来解释”。
曾雪霞表示，从临床医学角度上讲，判断是否“偶合性事件”，疫苗生产企业说的不算，需要由预防接种调查诊断专家组经过详细调查后判断。如果专家组下了结论而被接种死亡者家属不服，可以向市级以上医学会申请鉴定。如果对鉴定结果仍然不认同，可以走法律程序，提起民事诉讼。
出生24小时内接种是否必须
不少网友关心，婴儿出生24小时内是否必须要接种乙肝疫苗？有网友认为“让婴儿都打乙肝疫苗是利益驱使，有人为了钱向全国新生儿设下魔鬼圈套”。但更多网友表示，凡事不能因噎废食，现在母婴传播在乙肝患者中确实占相当的比例。
记者查阅资料发现，针对新生儿接种乙肝疫苗问题，中国工程院院士庄辉曾经表示，我国乙肝防控的难度大，但空间也大。新生儿预防乙肝，最好在出生后24小时内注射乙肝疫苗。
深圳市疾控中心免疫科主任张世英23日告诉记者，从医学上讲，新生儿不接种乙肝疫苗容易暴露在乙肝病毒的风险下，广东省也要求地方疾控中心保证新生儿24小时内完成接种。从效果看，开展乙肝疫苗有效地降低了深圳的乙肝发病率，从17.8%降低到了成年人7%以下，5岁以下儿童发病率1%以下。
另据默克公司援引官方的统计数据，1984年至1987年间，全国每年约有1.2亿人口感染乙型肝炎病毒，占总人口的10.1%。当时每年出生的2000万新生儿中，近1/10的婴儿受到乙肝病毒的感染，但是自1994年至今，已有超过2亿的中国儿童得到了有效保护。
不过，有关问题事实上目前仍然存在争议。
“目前基因工程乙肝疫苗技术已相当成熟，生产环节不会出现问题，婴幼儿的死亡与疫苗的关系不大，偶合的可能性较大。现在免疫规划要求出生24小时内就要注射乙肝疫苗，导致偶合反应比较多。”一位业内疫苗专家表示，当前新生儿的死亡中，由于从胎儿到外界环境的变化而导致呼吸停止的新生儿占新生儿死亡的10%，但是如果在新生儿出生后1个月以后再注射，偶合反应会减少。“我们曾经提过几次建议，但是相关部门都没有修改免疫规划，因为操作程序上比较麻烦。”
中国疾控中心一位计划免疫专家说：“关于新生儿出生24小时内注射乙肝疫苗的事情，也有很多专家建议修改，但是当前的中国形势下，无法进行修改。主要是有两个原因，一个是很多的农村孕妇在分娩前不检测乙肝五项，无法知晓孕妇是不是乙肝病毒的携带者；另外一个是，虽然城市孕妇多数做了这项检查，但是检查得准不准也是一个问题。所以为了避免乙肝的传播，只能一刀切。”
有无未知不良反应如何判别
随着疫苗伤害事件的接连发生，不少家长对疫苗可能造成的不良反应十分关心。接种了同一批次疫苗的孩子还可能出现哪些不良反应？如何判别以便及早就医？
北京协和医学院公共卫生学院院长刘远立认为，出现不良反应不难发现，但是要预测哪个婴儿会出现不良反应就很不容易。
刘远立认为，接种疫苗出现不良反应尽管是小概率事件，但在全世界范围内还没有哪个国家得到完全控制。接种疫苗后婴儿出现死亡，原因可能有几个：一是疫苗质量有问题；二是婴儿猝死的情况，即使不种疫苗也会有时发生；三是接种程序是不是值得重新审视。按现行接种程序的规定，婴儿出生当天就同时接种乙肝疫苗和卡介苗，而卡介苗是活性的，是不是有些婴儿受不了？总之，医疗卫生界、企业、政府和社会对此事件的确应当予以重视，仔细分析原因，总结应有的经验和教训，但一定要遵照循证决策的原则。
中途换品牌或推迟接种有无影响
按照国家相关规定，乙肝疫苗属于一类疫苗，由国家免费提供，要注射3针：出生时1针、一个月1针、6个月后1针。那么，中途更换疫苗品牌或者推迟接种，会对接种者有影响吗？
疾控人员表示，对已接种一针或两针康泰乙肝疫苗的婴儿，中途更换品牌和推迟几天对接种效果基本没有影响。但有一种例外情况：乙肝产妇在生下孩子后，为防止母婴传播，孩子应该在24小时内接种疫苗。
专家建议，家长要留意观察孩子接种疫苗后的反应，包括精神状况、有没有发烧、接种的局部有没有明显红肿或出血的情况。
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