WHO Vaccine incident voice doubts over alleged "shanzhai" _ | | vaccines World Health Organization news

　　Representative Office of the World Health Organization has its own Web site, we represent on behalf of WHO and vaccine information posted on our official website, official micro-blog, micro-signals, are true

Three-time response to vaccines World Health Organization (hereinafter "the WHO"), recently embarrassed.

Embarrassing is the cause, WHO believe that vaccines that are not properly kept or handled, especially live attenuated hepatitis a vaccine, if vaccine vial or prefilled syringe of vaccine was not damaged and the possibility of pollution caused by improper storage of vaccines "minimal". However, this statement was questioned by some network media. Some netizens think, WHO published a statement of the site is fake "shanzhai".

So, whether the statement is true? The first financial daily yesterday on confirmation of the Organization's spokesman. "The representative office of the World Health Organization has its own Web site, we represent on behalf of WHO and vaccine information posted on our official website, official micro-blog, micro-signals, are true. "The WHO representative in China said Wu Linlin, public information officer.

"The information issued by the Office in Beijing, China, headquarters is known and agreed. "One project manager, WHO representative in China, told reporters.

　　Know WHO

"Vaccines should be properly stored and managed, otherwise it will lose effectiveness or reduce effectiveness. But it is important to note, incorrect storage or expired vaccine does not cause toxic reactions, so in this case, vaccine safety risks may be very low. Specifically, if a child is vaccinated against outdated or improperly stored vaccines, the risks they face is the lack of ability to prevent the diseases targeted by the vaccine. "The WHO released on March 22 statement.

WHO also said that "incorrect storage or expired vaccine does not cause toxic reactions." But "no toxic response" does not mean harmless, such harm is that if the vaccine ineffective due to expiration or improper processing, the lack of vaccines for disease prevention in children, may in future infections and damage. Similar to the consequences of this situation have not been vaccinated.

WHO is divided into three levels, namely at Headquarters, regional offices and representative offices. The Organization's headquarters in Geneva, the regional office is divided into the African region, region of the Americas, East Asia, Europe region, East Eastern Mediterranean region and the Western Pacific [1.6% funds research report] (601099, unit). China belongs to the Western Pacific region, WHO have representative offices in China.

WHO Regional Office for the Western Pacific English name is WesternPacificRegionalOffice, known as WPRO.

Enter the WHO Representative Office in China is the most authoritative sources, WHO certified the official website click on searching the Web, find regional offices in the Western Pacific region website, and then click the Office links.

According to the WHO website, since the Organization was founded on April 7, 1948, at the beginning, China is a member, has been more than 60 years of history.

One of the expanded programme on immunization is a major and WHO.

The expanded programme on immunization (EPI) Group's mission is to support the Chinese Government in China through timely immunization, effective monitoring and strengthen routine immunization programmes of prevention and control of vaccine-preventable diseases.

Expanded programme on immunization in China, the Group has three major goals: in front of the global polio eradication certification and maintaining polio-free status by 2015 to eliminate measles by 2012, children under 5 years of age with chronic hepatitis b infection rates to below 2%.

In June 2012, China officially confirmed it was to control the regional objective of hepatitis b, that is, children with chronic hepatitis b infection rate above 7% to below 2%. China had overfulfilled the task actually, infection rates to below 1%.

In November 2012, was certified to eliminate maternal and neonatal tetanus.

　　Understanding vaccines

Recalling the history of mankind can be seen, constantly plagued by diseases of mankind, but also never stopped fighting and disease, already has a method of using immunization to treat disease, such as the 1796, United Kingdom doctors Vaccinia vaccine to patients for the first time. Practice shows that the vaccine is the best way to prevent infectious diseases.

The so-called vaccine, WHO is the definition of intention is given immunity by stimulating the production of antibodies on the formation of a disease of any preparation.

"Many types of vaccines, inactivated vaccines, attenuated, live, but from peptide, composed of human serum proteins and vitamins, saline, which belongs to the protective agents of human serum protein, and also aluminum hydroxide as adjuvant. Qualified vaccine is free of bacteria, if kept at a high temperature packaging is not damaged, will not have bacterial contamination. "Original by the Chinese Center for disease control viral disease control and prevention researcher Hang Changshou told the newspaper reporter, said in an interview.

In his view, protein hydrolysis at high temperature in the vaccine composition and hydrolysis into small peptides, amino acids and the like, which from the point of view of biochemical reactions, cannot become toxic substances injected into the human body has no toxic side effects.

Shandong "problem vaccine" after the incident, experts and relevant organizations keep the public about science, industry experts said they were most concerned about was, the practical effect of public panic will make the vaccine were down and even exclusion.

Shanghai bio-industry experts said, because of the widespread use of the vaccine in the early 1960 of the 20th century, China vaccinated smallpox the eradication of smallpox, the objectives for the year 2000 polio-free, 2012 the Elimination of neonatal tetanus, control of diseases such as measles, diphtheria, pertussis, tetanus, hepatitis b infection rates among children were significantly reduced. National immunization program has created enormous economic benefits and lasting social benefits, protecting children's health, increasing average life expectancy has played an important role. In 2009, the global swine flu pandemic, China lead in influenza vaccine research and development, inhibit the spread of the epidemic.

Clearly, precisely because of the vaccine's contribution to human life and health, WHO in order to avoid the vaccine-safety event triggered public panic, respond to the third degree.

　　Cannot tolerate is not vaccinated

"For operating a vaccine, should not be tolerated. State regulations, vaccines must be transported under conditions of cold chain storage. Out of the cold chain conditions for transport and storage, which is a serious offence, this behavior is intolerable in itself, is not allowed. "The State food and Drug Administration drug supervision Department director Li guoqing said on March 24.

The "problem of vaccine" cannot be tolerated, is not equal to other normal vaccine cannot be vaccinated.

Li guoqing is of prime concern to the public in connection with the vaccines out of the cold chain transport and bring safe and effective storage problems are explained. Before any vaccine approved in China, are strict registration and approval system, vaccines of validity of, have been long-term stability test, and the long-term effectiveness tests in accordance with the relevant technical requirements, stability testing must lose at least 6 months can be taken as it is valid. If a drug is it valid for the two years, actual stability must be more than 2.5 years, States it will be for two years.

Other vaccine products after approval, each batch of products are subject to regulatory and inspection review issued for sale, some temperature-sensitive vaccines, each batch of vaccine enterprises are challenged to test before they go out, that is, in extreme conditions of heat stability test, depending on the product, 1-4 week 37 ℃ placed under high temperature conditions. If storage 1-4 week, unqualified, that the vaccine will not be shipped.

"The effectiveness of vaccines out of the cold chain for a long time, may be some effects. From the General rules on speaking, security should not have a big impact in the past five years, Chinese Center for disease control, the national health planning Commission and the food and Drug Administration has a national vaccination adverse reaction monitoring system reports through the system over the past five years is no exception, especially in Shandong and Henan provinces, the reported data were within the normal range. "Li guoqing said.

Responsible editor: Wang Hao

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WHO就中国疫苗事件发声遭质疑 被指“山寨”|疫苗|世界卫生组织_新闻资讯

　　世界卫生组织驻华代表处有自己的官网，我们代表处就代表WHO，而且关于疫苗的信息就发布在我们的官网、官方微博、微信号上，都是真的

　　三度回应中国疫苗事件的世界卫生组织（下称“WHO”），近日遭遇尴尬。

　　尴尬的起因是，WHO认为，未经适当保存或处理的疫苗，尤其是减毒活疫苗，如果疫苗瓶或者预充疫苗的注射器未损坏，不当储存而导致疫苗发生污染的可能性“微乎其微”。但这一声明遭到部分网络媒体的质疑。部分网友认为，刊登WHO声明的网站系仿冒的“山寨版”。

　　那么，声明到底是否为真？《第一财经日报》记者昨日就此求证了该组织的新闻发言人。“世界卫生组织驻华代表处有自己的官网，我们代表处就代表WHO，而且关于疫苗的信息就发布在我们的官网、官方微博、微信号上，都是真的。”WHO驻华代表处新闻官吴琳琳表示。

　　“中国驻华代表处发布的信息，总部都是知晓并同意的。”一位WHO驻华代表处项目经理告诉记者。

　　认识WHO

　　“疫苗应该正确储存和管理，否则将失去效力或降低效力。但必须注意的是，不正确储存或过期的疫苗几乎不会引起毒性反应，因此在本事件中，疫苗安全风险可能非常低。确切地说，若儿童接种了过期或不当储存的疫苗，其面临的风险在于缺乏对该疫苗所针对疾病的预防能力。”WHO在3月22日发布如此声明。

　　WHO同时称，“不正确储存或过期的疫苗几乎不会引起毒性反应”。但是“无毒性反应”并不意味着无害，这种危害就是：如果疫苗由于过期或不当处理失去效力，儿童将缺乏疫苗所针对疾病的预防能力，可能在未来感染疾病，对其造成伤害。这种情况跟未接种疫苗的后果相似。

　　WHO分为三个组织层级，即总部、区域办事处和代表处。该组织总部在日内瓦，区域办事处分为非洲区域、美洲区域、东南亚区域、欧洲区域、东地中海区域和西太平洋[1.60% 资金 研报](601099,股吧)区域。中国属于西太平洋区域，WHO在中国设有代表处。

　　WHO西太平洋区域办事处的英文全称是WesternPacificRegionalOffice，简称WPRO。

　　进入WHO中国代表处的最权威渠道是，点击搜索网站认证的WHO官网，找到区域办事处中的西太平洋区域官网，然后再点击中国代表处链接。

　　据WHO网站介绍，自1948年4月7日该组织成立伊始，中国就是其会员国，至今已有60多年历史。

　　扩大免疫是WHO的重大行动规划之一。

　　扩大免疫规划（EPI）组在华的使命是支持中国政府通过及时免疫接种、有效监测和加强常规免疫规划来防控疫苗可预防性疾病的工作。

　　扩大免疫规划组在华有三个重要目标：在全球消灭脊髓灰质炎并获得认证前保持无脊髓灰质炎状态；到2015年消除麻疹；到2012年，将5岁以下儿童慢性乙肝感染率降至2%以下。

　　2012年6月，中国被正式证实已达到控制乙肝的区域目标，即，将幼儿的慢性乙肝感染率从7%以上降至2%以下。中国实际上已超额完成了任务，将感染率降至1%以下。

　　2012年11月，中国被证实已消除了孕产妇和新生儿破伤风。

　　认识疫苗

　　回顾人类的发展历史可以看出，人类无时无刻不在受到疾病的困扰，同时也始终没有停止过与疾病的抗争，很早就已经有了用免疫接种来治疗疾病的方法，比如1796年，英国医生第一次为病人接种牛痘疫苗。实践表明，疫苗对一些传染性疾病是目前最好的预防方式。

　　所谓疫苗，WHO给出的定义是意图通过刺激产生抗体对一种疾病形成免疫力的任何制剂。

　　“疫苗分很多种类，有灭活、减毒、活疫苗等，但是它多由多肽类、人体血清蛋白以及维生素类、生理盐水等组成，其中人体血清蛋白属于保护剂，也有用氢氧化铝作为佐剂。合格的疫苗是不含细菌的，在高温下如果保持包装不破坏，不会产生细菌污染。”中国疾控中心病毒病预防控制所原研究员杭长寿在接受《第一财经日报》记者采访时表示。

　　在他看来，疫苗成分中的蛋白质在高温下会水解，水解之后变成小多肽、氨基酸之类，它们从生化反应的角度，无法变成有毒的物质，注射到人体也不会发生有毒的副反应。

　　在山东“问题疫苗”事件发生后，不断有专家和有关机构站出来对公众进行科普，业内专家表示，他们最担心的问题是，公众的恐慌情绪会让疫苗的实际作用遭到贬低，甚至被排斥。

　　上海生物界的一位专家表示，正是由于疫苗的广泛使用，20世纪60年代初，中国通过接种牛痘消灭了天花、2000年实现了无脊髓灰质炎目标、2012年消除了新生儿破伤风，控制了麻疹、白喉、百日咳、破伤风等疾病，显著降低了儿童的乙肝感染率。国家免疫规划创造了极大的经济效益和持久的社会效益，在保障儿童健康、增加人均期望寿命等方面发挥了重要作用。2009年，全球甲型H1N1流感大流行，我国率先成功研发甲型H1N1流感疫苗，有效抑制了疫情扩散。

　　显然，正是由于疫苗对人类生命健康的贡献，WHO为避免此次疫苗安全事件引发公众的过度恐慌，三度作出回应。

　　不能容忍不等于不接种

　　“对于非法经营疫苗，一支都不能容忍。国家规定，疫苗必须在冷链条件下运输储存。脱离冷链条件进行运输储存，这就是严重的违法行为，这个行为本身是不可容忍的，是不能允许的。”国家食品药品监督管理总局药化监管司司长李国庆3月24日表示。

　　对“问题疫苗”不能容忍，不等于其他正常疫苗不能接种。

　　李国庆对于公众最关心的涉案疫苗脱离冷链运输和储存带来的安全有效问题也作出了解释。中国的任何一种疫苗在批准上市前，都实行严格的注册审批制度，疫苗有效期的确定，都经过了长期稳定性试验，而且这个长期有效性试验按照有关技术的要求，稳定性试验的要求至少要减掉6个月，才能作为它的有效期。假如一个药物有效期是两年的话，实际做稳定性的时间一定要超过两年半，国家才给它定两年。

　　另外疫苗产品批准上市之后，每一批产品都要经过监管部门检验审核后签发上市销售，温度比较敏感的一些疫苗，每批疫苗在出厂前企业都要进行挑战试验，即在极端条件下的热稳定性试验，根据不同的产品，在37℃高温条件下放置1到4周的时间。如果储存1到4周，质量不合格了，那这个疫苗就不能出厂。

　　“长时间脱离冷链的疫苗的有效性，可能会受到一些影响。从一般规律上来讲，安全性应该不会有大的影响，近五年，中国疾控中心、国家卫计委和食药监总局设有国家疫苗预防接种异常反应监测系统，通过系统报告来看，过去五年也未见异常，特别是山东、河南两个省，报告数据也都在正常范围内。”李国庆表示。

责任编辑：王浩成

文章关键词：
疫苗 世界卫生组织

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