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The author:(作者)aaapublished in(发表于) 2013/12/24 8:44:26 Kangtai sold 35.89 million hepatitis b vaccine， the flow has yet to publish has been questioned
Post reporter Chen Sisi
Drug Administration reported yesterday in Shenzhen City, Shenzhen kangtai biological products Corporation produces recombinant hepatitis b vaccine in the library all have suspended sales of the finished product and shipping activities, in all sizes of recombinant hepatitis b vaccine within the validity period has been sold, 186 total 35,891,194, but notice has not had sales of vaccine use and flow conditions.
Currently has at least in Guangdong, Hunan, and 7 infants in Sichuan province, following immunization with hepatitis b vaccine produced in the kangtai company, abnormal deaths occurred, the cause of death is still under investigation. Xinhua News Agency yesterday's questioning, informed the Guangdong disease control Department of the number of cases is long overdue, and at the national level, the sector is still not published national usage of involved batches of vaccine, with the remaining part exists and how to solve the shortage of vaccines, or related information.
Post reporter from Shanghai Municipal Center for disease control and prevention learned yesterday: Han hepatitis b vaccine currently in use in Shanghai, Dalian, a bio-pharmaceutical company for production, does not use the Shenzhen kangtai products, at present we have not received any report on vaccine serious adverse reactions.
3 lot number involved recombinant hepatitis b vaccine
According to Shenzhen City drug supervision authority aspects introduced, December 19, 2013 17 o'clock, Shenzhen drug prison Council received Shenzhen CDC report, said Shenzhen South Bay people hospital has a cases newborn death, death Qian has vaccination by kangtai company production of restructuring hepatitis b vaccine, parents suspected its children burst death and this times vaccination vaccine about, the Council subsequently organization drug bad reaction monitoring center expert rushed to scene tie health disease controlled sector investigation, Area Drug Administration will 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.
According to the notice, FDA requirements on December 13, 2013, Shenzhen kangtai company suspended sales lot number of the recombinant hepatitis b vaccine, C201207088, C201207090, requires prosperous company of the moratorium on the sale of all lots of December 20 recombinant hepatitis b vaccine and called Shenzhen CDC suspended kangtai company produces all the batches of recombinant hepatitis b vaccine products. Verified statistics, as of December 20, 2013, prosperous company 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.
Shenzhen City drug supervision authority aspects said, vaccine products listed sales Qian must through China food drug verification Institute of test and obtained bio batch issued certificate, by check, batch for C201207088, and C201207090, and C201207086 of involved thing restructuring hepatitis b vaccine, and the kangtai company has sales of restructuring hepatitis b vaccine are by provides obtained has China food drug verification Institute issued of bio batch issued certificate, the death cases whether and vaccination vaccine about, To wait for the results of forensic to clear.
Informed the Guangdong case long overdue
23rd Xinhua News Agency reporters from the Centers for disease control in Guangdong province confirmed that since November, the province reported a total of 4 suspected following kangtai company vaccination deaths in Meizhou, Zhongshan, Jiangmen, Shenzhen, and so on.
Among them, the case on November 29 after Zhongshan, Zhongshan, diagnosis of abnormal reaction survey expert group survey of vaccination, diagnosis of pneumonia, not related to vaccination. Additional 3 cases have begun to conduct autopsies to identify the cause of death. Because the autopsy take 30 working days to issue a formal report, and is currently still listed as suspected cases. Zhongshan, Shenzhen, in addition to two cases widely known outside, Jiangmen, had not seen publicly reported two cases in Meizhou, after or related departments announced.
Informed the Guangdong Center for disease control and the number of cases is long overdue, and infant death in Shenzhen for 5 days after we announce a batch of C201207086 vaccine distribution within the province.
The Centre said the emergency contact relevant departments, swap out 1.45 million hepatitis b vaccine for use in Guangdong. The batch of vaccine in December 22, arrived in Guangdong, delivery to the province within two days all the vaccination clinics, maternity, the province's 122 counties (cities) more than more than 3,000 inoculations can meet the normal three months free of hepatitis b vaccine inoculation needs throughout the province.
Emergency response mechanism is absent?
No later than November 25, Hunan, there have been cases of severe adverse reactions after vaccination in infants, and December 6 consecutive deaths, however national authorities until December 13 to be block the kangtai company two batches of vaccine on December 17 infant deaths in Shenzhen, 2 days after Shenzhen halted the batches of vaccine, at national level did not halt kangtai company all of the vaccines until December 20.
Shenzhen CDC immunization Director Zhang Shiying, he explained, 17th in Shenzhen after infant deaths occurred, was reported two days too late, because "at first did not think and the hepatitis b vaccine-related, hospital diagnosis there are two causes of death, pulmonary hemorrhage and suffocation, 18th families claim the vaccine and death touch. 19th morning after reported that afternoon on halted vaccine batches ".
Said Zhang Shiying, after receiving reflected family, overnight experts rushed to the scene to check found that the physician for the infant vaccination personnel induction training for the full range of practising certificates and the certificate, there will be no violations against operational problems. For provincial harmonization of procurement of the vaccines, the store also meet cold chain requirements, operating according to the specification.
District, Buji Town, Shenzhen People's Hospital official said hospitals for under-5 child deaths, there is an escalation procedures, reports during the course of treatment, hospitals have work to do, "States require reporting, but not the day." He said it also needs to be a pathological discussion of death, time of death is one week, "we shall see several reasons for this, which is the most likely, draw clinical conclusions and authority".
Has grass-roots CDC staff think, according to national food drug prison Council publishing of drug and medical devices security burst event emergency plans (pilot) under of ratings standard, no later than to December 9, Hunan appeared two suspicious may wish to vaccine death event Hou, has can constitute ⅱ level (major) drug security burst event, to 17th Shenzhen baby death Shi, has constitute ⅰ level (special major) drug security burst event.
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.
Three States not to fight hepatitis b vaccine
Shanghai Municipal Center for disease control and prevention says Shanghai using vaccine immunization class all by the City Health Department to tender for procurement, production units are domestic famous enterprises, all products have to pass stringent inspection and quarantine before or after purchase. "The hepatitis b vaccine in Shanghai from Dalian company, all of immunization vaccines in addition to the State food and drug administration and the relevant examination prior to inspection bodies in their factory, Shanghai food and Drug Administration for all vaccines are conducted every year. "City CDC immunization section Xiaodong Sun said.
Since 2002, Shanghai to the city's new babies born to hepatitis b vaccination and adverse reactions. Statistics found that hepatitis b immunization for children in the city overall security, low proportion of adverse reactions in all vaccines, adverse reactions to inoculations redness, hot pain. City CDC said mild adverse reactions are normal child vaccination, parents don't need to worry too much, but parents should avoid the child is ill or accept drug treatment, child injection of hepatitis b vaccine.
Xiaodong Sun noted that these three cases should not treat injection of hepatitis b vaccine for children: "one is the phase at the onset of acute illness, such as during the acute infectious disease, the second is in acute exacerbation of chronic diseases, such as asthma, and the third is not in favor of vaccination when the use of some drugs, such as antibiotics, antivirals and immunosuppressants. ”
Post reporter yesterday from a community health service center in Jinshan district immunization clinics learned that the Center is using a Bio-Pharmaceutical Co Ltd, Dalian's Chinese hepatitis b vaccine, vaccination virtually no serious adverse reactions.
Doctors advise: at the time of vaccination, parents to contact their doctors reflects the physical condition and past history of vaccination, vaccination after vaccination should stay for half an hour, there is no adverse reaction, and then leave. Home should still pay close attention to whether the child has an exception, once fall high fever or rash occurs, immediately go to the hospital.
(Edit: SN035)December 24, 2013 Oriental morning post(康泰乙肝疫苗已售3589万支 流向仍未公布遭质疑|疫苗|乙肝|质疑_新闻资讯
早报记者 陈斯斯
深圳市药品监督管理局昨日通报称，深圳康泰生物制品股份有限公司生产的重组乙肝疫苗在库成品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，但通告并未涉及已销售疫苗的使用和流向情况。
目前已至少有广东、湖南和四川7名婴儿，在接种了康泰公司出产的乙肝疫苗后，发生异常反应死亡，死因尚在调查中。新华社昨日质疑，广东疾控部门的病例数通报已属姗姗来迟，而在国家层面，有关部门至今尚未公布涉事批次疫苗全国使用量，其余地方是否存在和怎样解决疫苗紧缺，也无相关信息。
早报记者昨日从上海市疾病预防控制中心了解到：上海目前使用的是汉信乙肝疫苗，为大连一家生物制药公司生产，并未使用深圳康泰产品，目前也没有接到关于注射疫苗出现严重不良反应的报告。
3批号重组乙肝疫苗涉事
据深圳市药品监督管理局方面介绍，2013年12月19日17时，深圳市药监局接到深圳市疾控中心报告，称深圳市南湾人民医院有一例新生儿死亡，死亡前曾接种由康泰公司生产的重组乙肝疫苗，家长怀疑其孩子突发死亡与本次接种疫苗有关，该局随后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，同时辖区药监分局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。
据通告，深圳市药监局在2013年12月13日要求康泰公司暂停销售批号为C201207088、C201207090的重组乙肝疫苗，12月20日要求康泰公司暂停销售全部批次的重组乙肝疫苗产品，同时要求深圳市疾控中心暂停使用康泰公司生产的全部批次重组乙肝疫苗产品。经核查统计，截至2013年12月20日，康泰公司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。
深圳市药品监督管理局方面表示，疫苗产品上市销售前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、C201207090、C201207086的涉事重组乙肝疫苗，及康泰公司已销售的重组乙肝疫苗均按规定获得了中国食品药品检定研究院签发的生物制品批签发合格证，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。
广东病例通报姗姗来迟
新华社记者23日从广东省疾控中心证实，从11月至今，该省共报告4例疑似接种康泰公司疫苗后死亡病例，发生在中山、江门、深圳、梅州等。
其中，中山市病例11月29日经过中山市预防接种异常反应调查诊断专家组调查，诊断结论为重症肺炎，与疫苗接种无关。另3例正陆续进行尸体解剖以明确死亡原因。由于尸检需要30个工作日才能出具正式报告，目前仍只能列为疑似病例。而除中山、深圳两例广为人知外，江门、梅州两例并未见诸公开报道，此前也无相关部门公布。
广东疾控中心的病例数通报已属姗姗来迟，且在深圳婴儿死亡5天后，才公布了批号为C201207086的疫苗省内分发量。
该中心表示，已紧急联系有关部门，调剂出145万支乙肝疫苗供广东使用。该批疫苗于12月22日、23日抵粤，两天内可以配送至全省所有预防接种门诊、产科，即全省122个县(市)3000多个接种点，可满足全省两至三个月的免费乙肝疫苗的正常接种需求。
应急机制是否缺位？
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12月13日才叫停康泰公司两批次疫苗；12月17日深圳婴儿死亡，2天后，深圳才叫停该批次疫苗，国家层面直至12月20日才叫停康泰公司所有疫苗。
深圳市疾控中心免疫科主任张世英解释称，深圳17日发生婴儿死亡事件后，之所以晚了两天才上报，是因为“一开始没有想到和乙肝疫苗有关，医院诊断有两个死因，肺部大出血和窒息，18日下午家属索赔时才将疫苗和死亡联系上。19日上午上报后，当天下午就叫停了相关批次疫苗”。
张世英说，接到家属的反映后，专家连夜赶到现场查证发现，为该婴儿进行疫苗接种的医师人员具备齐全的执业证书和上岗培训证书，不会存在违规违法操作问题。对于由省统一采购的该疫苗，其储存也合乎冷链要求，操作按规范进行。
深圳龙岗区南湾人民医院有关负责人称，医院对于5岁以下孩子死亡，有一个上报程序，报告在救治过程中，医院都做了哪些工作，“国家都要求上报，但不是当天报”。他说，这中间还需要做一个死亡病理讨论，死亡讨论时间是一周，“我们会得出几个原因，哪些是最可能的，得出临床结论，才权威”。
有基层疾控中心工作人员认为，按照国家食药监局发布的《药品和医疗器械安全突发事件应急预案(试行)》的分级标准，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。
三种情况不要打乙肝疫苗
上海市疾病预防控制中心表示，上海使用的免疫规划类疫苗全部由市卫生部门统一招标采购，生产单位均为国内知名企业，所有产品在进货前后都需要经过严格的检验检疫。“上海的乙肝疫苗都来自大连一家企业，所有的免疫规划类疫苗除了国家食药监局和有关检验机构在其出厂之前进行检验之外，上海市食品药品监督管理局每年还会对所有疫苗进行抽检。”市疾控中心免疫规划科科长孙晓东表示。
从2002年起，上海对全市新出生婴儿进行乙肝疫苗接种，同时进行不良反应监测。统计发现，本市儿童接种乙肝疫苗总体安全，不良反应比例在所有疫苗中偏低，不良反应多为接种部位红肿、热痛等。市疾控中心表示：儿童接种疫苗出现轻微不良反应均为正常情况，家长不需要过分担心，不过家长应该避免在孩子生病或是接受一些药物治疗期间，带孩子注射乙肝疫苗。
孙晓东指出这三种情况下不该对儿童注射乙肝疫苗：“一是在急性疾病发作期，譬如急性传染性疾病发作期，二是在慢性疾病的急性发作期，如哮喘发作期，第三就是在使用一些药物时不主张接种疫苗，如抗生素药物、抗病毒药物以及免疫抑制剂。”
早报记者昨日从金山区一家社区卫生服务中心计划免疫门诊了解到，该中心使用的是大连生物制药有限公司生产的汉信乙肝疫苗，接种下来基本上没有出现严重的不良反应。
医生提醒：在疫苗接种时，家长要主动向医生反映接种者的身体情况和既往病史等，接种后在接种点应停留半小时，没有不良反应后再离开。到家后仍应密切关注孩子是否有异常，一旦出现高烧不退或皮疹等，立即去医院就诊。
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