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The author:(作者)delvpublished in(发表于) 2013/12/30 5:43:56 Hepatitis b vaccination in Zhejiang province for many years subject to sole-source tendering
Post reporter Lu Mei Chen Sisi Gong Fei
Died after suspected hepatitis b immunization in Zhejiang Yongjia baby Zhang Jiayue body Anatomy of 27th, identification of 30 working days that were the cause of death is expected, and determine whether the injection of hepatitis b vaccine-related.
Zhang Jiayue died the day before the vaccination of Dalian Chinese biopharmaceutical company limited (hereinafter referred to as "Dalian Han") production, batch of 201,205,037 hepatitis b vaccine. Introduction according to the Zhejiang Provincial disease prevention and control, the province all hepatitis a vaccines (vaccines for free) to Dalian Chinese production, gradually comes to the inoculation point. Post reporter read from a Zhejiang government procurement network discovered that the provincial CDC several times with the "sole source" procurement of hepatitis b vaccine from Dalian Han.
Media had reported the "Dalian Chinese hepatitis b vaccine plant shutdown". In this regard, the Dalian Han sun Manager, marketing in a Post reporter interview said: "the company currently produces all normal business order. "He said that national drug manufacturing practice (as revised in 2010) (hereinafter referred to as the new GMP), pharmaceutical manufacturers vaccine production of sterile drugs should meet the new GMP requirements before December 31 this year," hepatitis b vaccine plant shutdowns are GMP certified, will not affect the normal supply of the hepatitis b vaccine. ”
"Single source" tender
Post reporter in China, Zhejiang government procurement government procurement network, network discovery, query context, Zhejiang in recent years, a vaccine against hepatitis b tender all references to "single source" approach to supplier for Dalian Han.
Zhejiang government procurement online, December 23, the Zhejiang Provincial Government procurement Center of the calibration result of publicity about a kind of vaccine showed that Dalian Han believed the "sole-source procurement" bid for Zhejiang Province disease control type of centralized procurement of vaccines. Yesterday, the Zhejiang Provincial Government procurement Center confirmed to the Post reporter, the superscript of the hepatitis b vaccine.
China's Government procurement network on December 6 on Zhejiang Provincial Government procurement Center, hangs out in a sole-source procurement of public displays of the vaccine, CDC acquisition of Zhejiang province that the category of vaccines have only one supplier and, therefore, apply for a sole-source procurement. Among them, 10 μg/g developed hepatitis b vaccine supplier for Chinese in Dalian.
Purchase publication or display: September 3, Dalian Han to 930,000 yuan bid that the provincial CDC hepatitis b vaccines, procurement methods as "sole-source"; in November 2012, the provincial CDC application with "sole source" procurement of hepatitis b vaccine from Dalian Han in November 2011, the Centre for 930,000 dollars, "sole-source" Dalian Chinese hepatitis b vaccine procurement.
"Purchase by the purchaser to apply, after the assessment panel argument, and then approved by the Finance Department. A case study of hepatitis b vaccine, the provincial disease control reasons for selection of procurement set out in the request, the review panel is made up of the municipal disease prevention and control, according to the demonstration the advice of finance. "Staff in the Finance Department of Zhejiang told Post reporter, other suppliers if any objection can be made within 3 working days.
2012 immunization vaccination programmes using vaccines to children in Jiangsu province for public bidding, sizes 3/person of 10ug hepatitis b vaccines (yeast) successful candidates respectively for the Beijing tiantan biological products Corporation, Han Bio-Pharmaceutical Co Ltd, Dalian and Shenzhen kangtai biological products Corporation of the three companies. The first package specification as 10ug for hepatitis b vaccine, 3/of the successful candidate only Beijing tiantan biological products Corporation company.
Mr Sun said, "we are also waiting for identification of the health sector in Zhejiang province. Dalian Chinese hepatitis b vaccine supply per cent since 2004, listing more than 200 million doses, there have been no 1 abnormal reactions to death. ”
Grounds for application of different
According to the public procurement Act, the use of sole-source procurement is subject to one of the 3 types of cases: you can only purchase from a sole supplier;, unforeseen emergencies, you cannot purchase from other suppliers; original procurement project consistency must be guaranteed or service requirements, need to continue to purchase from the original supplier, procurement and acquisition funding amount does not exceed the original contract amount of 10%.
According to the publicity, Zhejiang Provincial disease control in Dalian han proposed sole-source procurement in recent years hepatitis b vaccines in the grounds of the application of two different expressions.
One is "only purchase from a sole supplier". In 2013, the reasons for applying for "10 μg/g hepatitis b vaccines have only one supplier, one single source procurement" in 2012 and apply reason to "standard hepatitis b vaccine can only be obtained from a sole supplier" in 2009 and "people under 15 years of age with 10 μg/g of yeast for hepatitis b vaccine domestic manufacturing enterprises in Dalian Han only".
Second expression appeared in 2011, the provincial CDC was intended to "sole source" procurement of 1.83 million doses from Dalian Han 10ug hepatitis b vaccines (yeast), the application on the grounds that "only Dalian hanxin cast products for the domestic and the quote is still within budget, experts, recommended that sole-source procurement".
Statistics show that hepatitis b vaccine into a category (the national immunization programme, free of charge) and class II (own expense); since 1992 in the immunization program after seedling, monopoly market for a type of vaccine. Hepatitis b vaccines currently has 4 specifications: 5 μg/g, 10 μg/g, 20 μg/g, 60 μg/g, top 3 specification for immunization programs portfolio. Due to hepatitis b vaccines have different production processes, each manufacturer producing injection specifications are different.
Frame "hansenula" vaccine
Post reporter trying to find out from the Zhejiang Provincial disease control "why sourcing is required within a project in 2013, hansenula hepatitis b vaccine and therefore narrow the range of suppliers", as well as applications for other years "single source" circumstances of the procurement of vaccines, but received no reply.
According to Zhao Kai, a researcher at the Beijing bio-introduction, internally divided into 3 types of vaccine, one is Saccharomyces cerevisiae, Shenzhen kangtai, the Temple of heaven in Beijing; a Dalian Han hansenula vaccine; the other is CHO cells.
CDC officials told Post reporter in Zhejiang Province, the province's Dalian Chinese hepatitis b vaccine has been used for many years without any serious anomalies.
On disease prevention and control in Zhejiang Province several times with the "single source" Dalian Chinese hepatitis b vaccine procurement. Mr Sun explained that the Dalian Han is the only production for enterprises of 10 μg/g of total population for hepatitis b vaccine, vaccines have a higher conversion of antibody positive rate and antibody titer, mother-blocking rates, levels of cell-mediated immunity, with robust security, "the most consistent with CDC requirements for products of Zhejiang Province, and the issue does not occur for many years cooperation has been. ”
Related news
Gansu: Lanzhou early childhood vaccinations
Died after vaccine is coupled
AP Health Planning Commission of Gansu province informed the 29th, by a joint investigation diagnosis analysis of the expert group, 26th in Lanzhou reported a suspected abnormal deaths of infants after immunization with hepatitis b vaccine disease cases are coupled.
Expert Group think, vaccination vaccine Hou suspected exception reaction death child care was born may exists throat spasms, and choke milk to inhalation sexual pneumonia, and cranial hemorrhage, illness, its by vaccination vaccine, and syringe sources clear, vaccine has national food drug prison Council issued of certificate, vaccine storage, and transport cold chain conditions meet requires, vaccination process specification, vaccination with batch vaccine children no similar phenomenon appeared, expert group think no directly evidence proved child care death and vaccine related, belonging to coupled syndrome.
By coincidence mean such vaccination is in some sort of incubation period of this disease or prodromal period, inoculated coupling affected was not part of abnormal reactions after vaccination.
The investigation, the Dalian Chinese production of early childhood vaccination with recombinant hepatitis b vaccine lot number, total receipted warehousing 112,530 in Gansu province as of December 26, the province with the batches of vaccine were reported suspected adverse reaction after vaccination in 40 cases, including 39 cases in General, 1 case of abnormal reaction (urticaria), does not include this.
(Original title: all hepatitis b vaccines many years single source tender)
早报记者 陆玫 陈斯斯 龚菲
疑似接种乙肝疫苗后死亡的浙江永嘉男婴张嘉悦的遗体解剖27日开始，预计30个工作日后得出死因鉴定，并确定是否与注射乙肝疫苗有关。
张嘉悦在去世前一天接种的是大连汉信生物制药有限公司(以下简称“大连汉信”)生产、批号为201205037的乙肝疫苗。据浙江省疾控介绍，该省所有乙肝一类疫苗(免费疫苗)均为大连汉信生产，逐级下拨至各接种点。早报记者从浙江政府采购网查阅发现，该省疾控中心多次以“单一来源”方式向大连汉信采购乙肝疫苗。
有媒体此前报道“大连汉信乙肝疫苗车间停产”。对此，大连汉信市场部孙经理在接受早报记者采访时表示：“公司目前生产经营秩序一切正常。”他说，国家《药品生产质量管理规范(2010年修订)》(下称新版GMP)规定，药品生产企业疫苗等无菌药品的生产应在今年12月31日前达到新版GMP要求，“乙肝疫苗车间停产是为了GMP认证，不会影响乙肝疫苗的正常供应。”
均“单一来源”招标
早报记者在中国政府采购网、浙江政府采购网发现，在可查询范围内，浙江近几年乙肝一类疫苗招标均以“单一来源”方式进行，供货商为大连汉信。
浙江政府采购网上，一则12月23日定标的《浙江省政府采购中心关于一类疫苗的成交结果公示》显示，大连汉信以“单一来源采购”方式中标浙江省疾控一类疫苗集中采购。昨天，浙江省政府采购中心人员向早报记者证实，该标项为乙肝疫苗。
中国政府采购网12月6日挂出的《关于浙江省政府采购中心一类疫苗的单一来源采购公示》显示，浙江省疾控需采购的该批一类疫苗只有唯一供应商，因此，申请单一来源采购。其中，10μg乙肝疫苗拟定供应商为大连汉信。
采购公示还显示：9月3日，大连汉信以93万元中标该省疾控乙肝疫苗，采购方式为“单一来源”；2012年11月，该省疾控申请以“单一来源”方式向大连汉信采购乙肝疫苗；2011年11月，该中心以93万元、“单一来源”方式采购大连汉信的乙肝疫苗。
“采购方式由采购人提出申请，经评审专家小组论证，再由财政厅审批。以乙肝疫苗为例，省疾控要在申请中阐述选择采购方式的理由，评审专家小组由各市疾控组成，财政厅根据论证意见审批。”浙江财政厅工作人员告诉早报记者，其他供应商如有异议，可在3个工作日内提出。
2012年，江苏省对儿童免疫疫苗规划用疫苗进行公开招标采购，其规格为3支/人份的10ug乙肝疫苗(酵母)中标候选人分别为北京天坛生物制品股份有限公司、大连汉信生物制药有限公司及深圳康泰生物制品股份有限公司三家公司。而今年第一包规格为10ug乙肝疫苗，3支/人份的中标候选人则只有北京天坛生物制品股份有限公司这一家公司。
孙经理表示，“我们也在等浙江卫生部门的鉴定。大连汉信乙肝疫苗自2004年上市已累计供应2亿多剂，没有发生过1例异常反应致死。”
申请理由表述不同
根据《政府采购法》，采用单一来源方式采购需符合3种情形之一：只能从唯一供应商处采购；发生不可预见的紧急情况，不能从其他供应商处采购；必须保证原有采购项目一致性或服务配套的要求，需要继续从原供应商处添购，且添购资金额不超过原合同采购额的10%。
根据公示，浙江省疾控近年在拟采用单一来源方式采购大连汉信乙肝疫苗的申请理由中有两种表述。
一种是“只能从唯一供应商处采购”。如2013年申请理由为“10μg乙肝疫苗只有唯一供应商，特申请单一来源采购”；2012年申请理由为“乙肝疫苗标项只能从唯一供应商处取得”；2009年为“15岁以下人群使用的10μg酵母乙肝疫苗，国内生产企业仅大连汉信”。
第二种表述在2011年出现，该省疾控当时拟以“单一来源”方式向大连汉信采购183万剂10ug乙肝疫苗(酵母)，申请理由是“只有大连汉信所投产品为国产且报价尚在预算内，经专家论证，建议单一来源采购”。
资料显示，乙肝疫苗分为一类(国家免疫计划，免费)和二类 (自费)；自1992年列入免疫计划苗后，市场基本为一类疫苗垄断。乙肝疫苗目前有4个规格：5μg、10μg、20μg、60μg，前3个规格为免疫计划范畴。由于乙肝疫苗有不同的生产工艺，每家生产企业生产的注射剂规格也有所不同。
框定“汉逊酵母”疫苗
早报记者试图向浙江省疾控了解“为何在2013年的采购项目内规定需汉逊酵母乙肝疫苗，因此缩小供应商范围”以及其他年份申请“单一来源”方式采购疫苗的具体情况，但未得到答复。
据北京生物制品所研究员赵铠介绍，国内使用疫苗分3种，一种是酿酒酵母，如深圳康泰、北京天坛生产的；一种是大连汉信的汉逊酵母疫苗；另一种是CHO细胞疫苗。
浙江省疾控人员告诉早报记者，该省已使用大连汉信乙肝疫苗多年，未出现过严重的异常情况。
关于浙江省疾控多次以“单一来源”方式采购大连汉信乙肝疫苗。孙经理解释，大连汉信是国内唯一生产适用全人群的10μg乙肝疫苗的企业，疫苗有更高的抗体阳转率、抗体滴度、母婴阻断率、细胞免疫水平，具有可靠的安全性，“最符合浙江省疾控心对产品的要求，且多年合作一直没有出现问题。”
◎ 相关新闻
甘肃：兰州幼儿接种
疫苗后死亡属偶合症
据新华社电 甘肃省卫计委29日通报，经联合调查诊断专家组分析，26日兰州市报告的一例幼儿接种乙肝疫苗后疑似异常反应死亡疾例属偶合症。
专家组认为，接种疫苗后疑似异常反应死亡幼儿生前可能存在喉痉挛、呛奶致吸入性肺炎、颅内出血等病症，其所接种疫苗、注射器来源明确，疫苗具有国家食药监局签发的合格证，疫苗存储、运输冷链条件符合要求，接种过程规范，接种同批次疫苗儿童无类似现象出现，专家组认为无直接证据证明幼儿死亡与疫苗相关，属于偶合症。
所谓偶合症是指受种者在接种时正处于某种疾病的潜伏期或者前驱期，接种后偶合发病，不属于预防接种异常反应。
经查，该幼儿接种的大连汉信生产的同批号重组乙肝疫苗，甘肃省共计到货入库112530支，截至12月26日，全省同批次疫苗共报告疑似预防接种异常反应40例，其中一般反应39例、异常反应1例(为荨麻疹)，不包括此例。
(原标题：浙乙肝疫苗多年单一来源招标)
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