【讨论】世卫组织关注和支持对疑似预防接种异常反应的调查

清歌一曲月如霜

WHO shares concern and supports investigation of suspected vaccine adverse reactions
2013年12月27日 发布

　　中国北京 | 2013年12月27日 - 世界卫生组织（世卫组织）同中国政府一样，也在关注最近报道的几起疑似新生儿接种乙肝疫苗致死事件。中国国家卫生和计划生育委员会（国家卫生计生委）和国家食品药品监督管理总局（食品药品监管总局）正在调查是否因疫苗导致这七起死亡事件。

　　BEIJING, China | 27 December 2013 - The World Health Organization (WHO) shares China government’s concerns over reports of recent suspected infant deaths following administration of the hepatitis B vaccine in several newborns. The National Health and Family Planning Commission (NHFPC) and China Food and Drug Administration (CFDA) are investigating the seven deaths to determine whether they were caused by the vaccine.
　　另一名新生儿已康复出院。这八个病例发生在三个不同省份，但是疫苗来自同一家生产企业。这几起病例已促使食品药品监管总局与国家卫生计生委做出暂停使用该疫苗企业的乙肝疫苗的决定，事件正在调查过程中。世卫组织支持这一决定。
　　One additional newborn has recovered and has been discharged from hospital. The eight cases occurred in three different Provinces, but the vaccine came from one manufacturer. The recent events prompted CFDA and NHFPC to temporarily suspend the use of the hepatitis B vaccine from the vaccine maker, while investigating the cases. WHO supports this decision.
　　发生这些死亡事件，我们深感不幸，但同时我们也看到政府对这件事情的快速报告和调查，体现了整个卫生和药品监管系统发现异常反应并采取行动预防更多问题出现的实力。”世卫组织驻华代表施贺德博士说。
　　These deaths are very unfortunate, but the rapid reporting and investigation of the Government speaks to the strength of the health and drug regulatory system to identify adverse events quickly and take action to prevent additional problems," says Dr. Bernhard Schwartl�0�1nder, WHO Representative in China.
　　乙型肝炎是一种可能致命的肝脏感染。乙肝病毒可引发慢性肝病及慢性感染，增加肝硬化和肝癌的死亡风险。接种乙肝疫苗是预防感染的最佳方式。
　　Hepatitis B is a potentially life-threatening liver infection. The virus can cause chronic liver disease and chronic infection, and increases the risk of death from cirrhosis of the liver and liver cancer. Hepatitis B vaccination is the best way to prevent infection.
　　按照世卫组织的指南，中国每一名新生儿在出生后24小时内接种第一剂乙肝疫苗，在1月龄和6月龄分别接种另两剂乙肝疫苗。
　　In China, and based on the guidance of WHO, every infant receives the first dose of the hepatitis B vaccine within 24 hours of birth, with two additional doses at one month and six months respectively.
　　总的来说，乙肝疫苗是安全、有效的。中国的乙肝疫苗免疫规划项目已使5岁以下儿童的乙肝病毒感染率从乙肝免疫规划项目实施前的超过9%，降低到了现在的不到1%。
　　In general, the hepatitis B vaccine is known to be safe and effective. The hepatitis B vaccine program in China was responsible for the reduction of the prevalence of hepatitis B to less that 1.0% among children less than 5 years old, down from over 9% in the pre-vaccine era.
　　食品药品监管总局告知，在中国大陆地区，除深圳康泰生物制品有限公司外，还有5家企业生产乙肝疫苗，疫苗不存在短缺风险。
　　The Government reports that the vaccines used in these infants came from one vaccine maker, Shenzhen Kangtai Biological Products. The hepatitis B vaccine produced by other 5 manufacturers in mainland China is still available therefore, there is no risk of shortage.
　　免疫规划对健康有着巨大的影响。我们应在确保疫苗安全的同时，继续全力实施免疫规划项目，” 施贺德博士说。
　　The health gains of the vaccination program are enourmous and all the efforts should be directed towards the continuation of the vaccination program while ensuring the safety of the vaccines," says Dr.Bernhard Schwartl�0�1nder.
　　世卫组织将继续与国家卫生计生委和食品药品监管总局保持密切合作，根据需要支持此事件调查工作，并确保在事件调查期间，为家长们提供免疫的最佳指南和建议。
　　The WHO will continue to work very closely with NHFPC and CFDA to support the investigation as needed, and to ensure that, during this period, the best guidance and advice on immunization can be provided to parents.

清歌一曲月如霜

国家食品药品监管总局向世卫组织通报乙肝疫苗有关情况

2013年12月27日 发布

　　12月27日上午，国家食品药品监督管理总局正式向世界卫生组织通报了近日在我国发生的疑似乙肝疫苗预防接种异常反应的有关情况。世卫组织驻华代表施贺德博士对中国政府及时有效的报告和调查等工作给予了充分肯定，并表示愿意为调查这一事件提供中国所需的各项支持和帮助。目前，事件发生的原因正在积极调查当中，总局将邀请世卫组织的专家参加相关调查分析等工作。

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