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。
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。
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.