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世卫组织呼吁中国加强自费疫苗的监管

世界卫生组织驻华代表施贺德博士发表评论文章:《疫苗事件表明中国需加强自费疫苗的监管》世界卫生组织驻华代表施贺德博士疫苗在公共卫生领域扮演特殊的角色:健康的儿...

世界卫生组织驻华代表施贺德博士发表评论文章:《疫苗事件表明中国需加强自费疫苗的监管》

世卫组织呼吁中国加强自费疫苗的监管

世界卫生组织驻华代表施贺德博士

疫苗在公共卫生领域扮演特殊的角色:健康的儿童通过接种疫苗来预防乙肝、白喉、百日咳和细菌性脑膜炎等严重的疾病。自上世纪引入和广泛使用现代疫苗以来,挽救了全球数亿人的生命。许多国家已经完全消除了麻疹、风疹和脊髓灰质炎等疾病。

疫苗已成为现代公共卫生的中心话题,以致于人们视之为理所当然。但是疫苗是复杂的生物产品,需要有力的监督和管理,以保障正确的生产方式和从工厂到接种点再到儿童的过程中得到正确处理。不当处理的疫苗可能失去部分效力和有效性。

上周,某犯罪团伙在中国转售疫苗事件揭露出疫苗供应链其中一个环节出现了问题:自费疫苗的分发环节。

中国疫苗的生产并没有问题。世卫组织与国家疫苗监管部门紧密合作了 15 年之久,对中国所有国产疫苗都有信心。世卫组织于 2010 年和 2014 年就中国疫苗监管系统开展深入独立的评估,结果均表明中国监管系统符合或超越世卫组织/国际标准。

中国政府扩大免疫规划项目中免费向儿童提供的疫苗以及市场上销售的自费疫苗均应在同一套严格监管机制中生产的。因此,中国所有疫苗的起点是一样的,其生产流程均得到世卫组织考核通过,能够生产安全、纯净和有效的疫苗。

问题是在疫苗出厂后出现的。政府分发的免费疫苗是通过严格管理的冷链系统分发的。世卫组织和联合国儿童基金会在 2014 年和 2015 年评估了中国扩大免疫规划的管理系统,结果表明中国具备很强的有效管理疫苗的能力。上周疫苗事件揭露的问题起因于自费疫苗的分发未遵循相同的高标准。不幸的是,该缺陷遭到不法分子的猖狂利用,他们为了获得暴利丝毫不顾及对儿童健康的危害。

中国扩大免疫规划系统是全球最好的系统之一。这是有事实依据的:由于接种乙肝疫苗,超过 99% 的中国儿童避免感染慢性乙肝。16 年前,中国消除了脊髓灰质炎。麻疹的发病率比疫苗前时代降低了 99%。这些成就应能提振公众的信心。

自费市场流通的疫苗对于儿童健康也是至关重要的。部分疫苗实际上仅在中国自费疫苗市场上流通。世卫组织建议国家免疫规划能涵盖这些疫苗,包括肺炎/脑膜炎疫苗、肺炎球菌疫苗和轮状病毒疫苗。这既确保中国儿童受益于这些疫苗本身,又能将此类疫苗纳入严格管理的政府分发系统。

中国有关卫生部门和警方正在调查这起疫苗转售事件,表明中国政府对本事件的重视程度。世卫组织与开展调查的有关卫生部门始终保持紧密联系,并为其提供全力支持。尽管如此,本次事件说明中国需着力加强疫苗管理法规的全面实施。具体来说,自费疫苗的分发应严格遵守与扩大免疫规划疫苗同样的严格标准,杜绝引起此类事件再次发生。

本次疫苗事件引发的问题之一是,中国父母可能对免疫失去信心而减少其子女的常规免疫。这将导致非常严重的后果,因为疫苗是防止一系列致病和致死儿童疾病的唯一途径。改善中国自费疫苗的管理、监测和监督将有力保障所有疫苗的安全和效力。必须采取紧急行动恢复公众对疫苗的信心,保障儿童的身体健康。

—— 世界卫生组织驻华代表施贺德博士

以下为原文全文:

Vaccines incident highlights the need for stronger regulation of private vaccines in China

Opinion piece by 

Dr Bernhard Schwartländer, 

WHO Representative in China 

Vaccines have a special role in public health – they are given to healthy children, to prevent serious diseases like hepatitis B, diphtheria, pertussis (whooping cough), and bacterial meningitis.  Since the introduction and widespread use of modern vaccines over the last century, hundreds of millions of lives have been saved all over the world. In many countries, diseases like measles, rubella, and poliomyelitis have been eliminated completely.  

Vaccines have become so central to modern public health it would be easy to take them for granted. But vaccines are complex biologic products, requiring strong regulation and management to ensure that they are manufactured properly, and handled correctly at every step from factory door, to clinic, to child. Without careful handling, vaccines can lose some of their potency and effectiveness.

Last week’s exposure of a criminal ring re-selling vaccines across China has revealed problems in one part of this supply chain – the distribution of vaccines available for purchase on the private market.

The production of vaccines in China is not at issue here. WHO is confident in the manufacturing of all Chinese vaccines, based on over 15 years of working closely with the national vaccine regulators. WHO conducted in-depth, independent assessment of China’s vaccine regulation in 2010 and 2014, finding both times that China’s regulatory system meets or exceeds WHO/international standards. 

oth the vaccines that are distributed for free to all children through the Government’s Expanded Program on Immunization (EPI), and vaccines available for private purchase, are subject to the same stringent regulations on manufacturing. Thus, all vaccines in China start life the same way – through a process that WHO has certified will produce safe, pure, and effective vaccines.

The issue is what happens once the vaccines leave the factory. The government-distributed, free (EPI) vaccines are distributed through a tightly managed, cold chain system. A WHO-UNICEF evaluation of the EPI management system in 2014 and 2015 concluded that capacity to effectively manage vaccines is very strong. The problem that last week’s events have brought to light, is that distribution of vaccines for the private market do not follow the same high standards. And sadly, this weakness in the system has been exploited by an unscrupulous few intent on making some quick cash, without any apparent regard for the implications for children’s health.  

China’s EPI system is one of the best in the world. The results speak for themselves: over 99% of Chinese children are now free for life from chronic hepatitis B as a result of use of hepatitis B vaccination. Poliomyelitis was eliminated 16 years ago.  The incidence of measles is 99% lower than during the pre-vaccine era. These accomplishments should inspire confidence.

Vaccines available for private purchase are also important for children’s health. In fact, there are some vaccines currently only available on the private market in China, which WHO recommends be included in the national immunization program – including for pneumonia/meningitis, pneumococcal, and rotavirus. This would ensure that all children in China would benefit from the use of these vaccines, and have the benefit of bringing them into the more tightly managed government distribution system.

The ongoing investigation by health authorities and the police into China’s vaccine reselling ring shows how seriously the Chinese Government is taking this incident. WHO is in close contact with the health authorities as they conduct their investigation, and have offered our full support. Ultimately, though, this incident has highlighted the need for much stricter enforcement of vaccine management regulations across the board. Specifically, the same high standards used to distribute EPI vaccines should be used in the distribution of privately-purchased vaccines. This would ensure that the activities which sparked the current investigation would never be able to happen again.

One of the problems with the current events is the risk that parents』confidence in immunization will be diminished, and they will decline routine vaccination of their children. This would be a terrible outcome – because vaccines are the only way to prevent a range of debilitating, deadly childhood diseases. Improving management, monitoring and oversight of privately purchased vaccines in China is crucial to ensure the safety and effectiveness of all vaccines. Urgent action to achieve is needed to restore the public’s trust and confidence in vaccines in China, and to keep China’s children healthy. 

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