中国批准首例H5N1禽流感疫苗
　　China approves its first human H5N1 vaccine

　　[北京]4月2日，中国国家食品与药品管理局批准生产国内首例针对H5N1禽流感病毒的人类疫苗。该疫苗由北京科兴公司与中国疾病预防控制中心共同研发，它是基于世界卫生组织（WHO）认定的H5N1病毒的完整灭活毒株开发的。

　　[BEIJING] China's State Food and Drug Administration approved production of the country's first human vaccine for the H5N1 virus last week (2 April).

　　Developed by Beijing Sinovac and the Chinese Center for Disease Control and Prevention (China CDC), the vaccine is based on whole, inactivated virus particles of a H5N1 strain identified by the WHO in Vietnam.

　　法国安万提·塞诺菲公司、英国葛兰素·史克公司以及瑞士的诺华公司也生产出了相类似的疫苗，这些公司是在2007年3月到2008年2月期间获得其生产许可的，然而他们目前还没有得到中国的许可。

　　Similar vaccines made by French pharmaceutical companies Aventis Sinofi, UK-based GlaxoSmithKline and the Swiss firm Norvatis received their production licences between March 2007 and February 2008, but have so far not been approved in China.

　　与这些西方公司一样，北京科兴公司的疫苗批准只经历了两个阶段的临床试验――参与试验的人员总共有402人――用以证实其安全且能引起免疫反应。

　　Like its Western counterparts, the Sinovac vaccine was approved after two phases of clinical trials ― enrolling a total of 402 participants ― showed its safety and ability to induce an immune response.

　　第三阶段临床试验用于测试该疫苗是否能够预防真正的传染，由于现在人群中还没有出现大规模的H5N1禽流感传染，所以该阶段还没有实施。由于没有第三阶段的临床试验，科兴公司的疫苗以及其他H5N1疫苗只是被批准进行生产而不是给人们直接接种。

　　The third phase, to test whether the vaccine prevents real infection, has not yet been carried out, as there has been no massive spread of H5N1 influenza in people.

　　Without the phase III clinical trial, approvals for the Sinovac vaccine and other H5N1 vaccines are currently for production only, rather than direct vaccination.

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