WHO shares concern and supports investigation of suspected vaccine adverse reactions

中國北京 | 2013年12月27日 - 世界衛(wèi)生組織(世衛(wèi)組織)同中國政府一樣，也在關(guān)注最近報道的幾起疑似新生兒接種乙肝疫苗致死事件。中國國家衛(wèi)生和計劃生育委員會(國家衛(wèi)生計生委)和國家食品藥品監(jiān)督管理總局(食品藥品監(jiān)管總局)正在調(diào)查是否因疫苗導(dǎo)致這七起死亡事件。

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.

另一名新生兒已康復(fù)出院。這八個病例發(fā)生在三個不同省份，但是疫苗來自同一家生產(chǎn)企業(yè)。這幾起病例已促使食品藥品監(jiān)管總局與國家衛(wèi)生計生委做出暫停使用該疫苗企業(yè)的乙肝疫苗的決定，事件正在調(diào)查過程中。世衛(wèi)組織支持這一決定。

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.

發(fā)生這些死亡事件，我們深感不幸，但同時我們也看到政府對這件事情的快速報告和調(diào)查，體現(xiàn)了整個衛(wèi)生和藥品監(jiān)管系統(tǒng)發(fā)現(xiàn)異常反應(yīng)并采取行動預(yù)防更多問題出現(xiàn)的實(shí)力。”世衛(wèi)組織駐華代表施賀德博士說。

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?nder, WHO Representative in China.

乙型肝炎是一種可能致命的肝臟感染。乙肝病毒可引發(fā)慢性肝病及慢性感染，增加肝硬化和肝癌的死亡風(fēng)險。接種乙肝疫苗是預(yù)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.

按照世衛(wèi)組織的指南，中國每一名新生兒在出生后24小時內(nèi)接種第一劑乙肝疫苗，在1月齡和6月齡分別接種另兩劑乙肝疫苗。

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.

總的來說，乙肝疫苗是安全、有效的。中國的乙肝疫苗免疫規(guī)劃項目已使5歲以下兒童的乙肝病毒感染率從乙肝免疫規(guī)劃項目實(shí)施前的超過9%，降低到了現(xiàn)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.

食品藥品監(jiān)管總局告知，在中國大陸地區(qū)，除深圳康泰生物制品有限公司外，還有5家企業(yè)生產(chǎn)乙肝疫苗，疫苗不存在短缺風(fēng)險。

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.

免疫規(guī)劃對健康有著巨大的影響。我們應(yīng)在確保疫苗安全的同時，繼續(xù)全力實(shí)施免疫規(guī)劃項目，” 施賀德博士說。

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?nder.

世衛(wèi)組織將繼續(xù)與國家衛(wèi)生計生委和食品藥品監(jiān)管總局保持密切合作，根據(jù)需要支持此事件調(diào)查工作，并確保在事件調(diào)查期間，為家長們提供免疫的最佳指南和建議。

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.