小中大cuturl('http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm')
FDA已经批准了四家H1N1疫苗厂家。看看详细的报道吧,我觉得FDA在这次的批准中并不比SFDA做的高明:
FDA仅仅采纳了一剂免后10天的数据,而SFDA是两剂免后21天(当然其实10天以后GMT已经够高);
FDA批准的疫苗中也有添加防腐剂的,这也并不比国内疫苗先进多少;
FDA的甲流疫苗批准后四周内可以批签发,而SFDA在批准的第二天就可以批签发出。
应该说两者都遵照了WHO关于甲流疫苗的意见,而且都把甲流疫苗定性为季节性流感疫苗更换毒株,但是明显国内的反应速度和举国体制这次又领先了。
另外,不要说什么政绩不政绩,国内大家看的是政绩,难道国外FDA就没有来自国会、议会和群众团体的压力?
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FDA是批准了四家疫苗厂商(鼎鼎有名),我看了详细报道,我的结论是FDA和SFDA一样果断
您从哪里看出FDA仅仅采纳了一剂免后10天的数据?从Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine? 人家只是说明其诱导的免疫应答与季节性流感疫苗相似,而不是之前很多人推测由于人群处于免疫空白状态,其需要两针才会诱导有效免疫应答,人家的临床试验数据这么清晰明了,为什么不好好看看?关于中国临床数据,你自己算算时间,SFDA根据两剂免后21天,可能么?第二针的结果未出科兴都通过审批了,还两剂免后21天,这是个笑话!
现在的流感疫苗大多都汗防腐剂,怎么了?影响其使用了?再说,人家FDA批准的也有不含防腐剂的,您视而不见?As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.
什么叫批准后四周批签发?您从哪里看出FDA的四周内可以批签发?是不是这句话?The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.人家的意思FDA已经审批通过(The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus),四周内可获得首批大量疫苗吧
天,我以为我们看的不是同一篇文章,my god