※ [本文转录自 Gossiping 看板] 作者: CKun (温水煮青蛙) 看板: Gossiping 标题: [爆卦] 新流感疫苗 人体试验样本数 时间: Wed Sep 2 10:08:28 2009 摘录新闻 : 国光生技新流感疫苗只进行二百人的人体临床试验，未达一定规模， : 恐有安全疑虑。国光生技总经理魏逸之表示，世界卫生组织（ＷＨＯ） : 认定，Ｈ１Ｎ１新流感是流感的一种，所以新流感疫苗也是一种流感 : 疫苗，不是新药，同意各国可进行人数较少的人体试验。 : : 国光生技强调，二百人是欧盟对新流感疫苗人体实验样本数的规定， : 澳洲为二四○人，并非媒体报导的一千人，各国对新流感疫苗制备步 : 骤均与国光类似。 WHO的说法 http://www.who.int/csr/disease/swineflu/notes/ h1n1_safety_vaccines_20090805/en/index.html Fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine. If the vaccine is made with the same processes as the seasonal influenza vaccine, and in the same manufacturing plant, regulatory approval can be very rapid. 欧盟核准的四款疫苗 http://www.emea.europa.eu/pdfs/human/press/pr/46856809en.pdf Four ‘mock-up’ vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the European Union based on earlier data generated with the H5N1 virus strain, which is similar to H1N1. These vaccines were developed in the knowledge that the virus strain would be changed in the event of a declared pandemic, to include the strain causing the pandemic. Altogether, they have been tested in more than 8,000 subjects. Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine, as will apply with the change from H5N1 to H1N1 in the mock-up vaccines, should not substantially affect the safety or level of protection offered. 可以减少H1N1疫苗人体试验样本数的前题是 在同一个制造厂曾经生产过(已经试验完毕)已核准的季节性流感疫苗 但台湾国光生技以前未曾制造过季节性流感疫苗, 仅是由日本进口原液, 然後自行充填包装出售 工厂是今年新落成启用, 哪里来8000个H5N1疫苗的人体试验资料 再说澳洲CSL仅试验240人, 国光可不晓得CSL在美国同时进行1300成人+450孩童的测试? CSL的H1N1疫苗试验总人数高达3640人 我们来看看各家厂商的H1N1疫苗人体试验的样本数吧 厂商 样本数 台湾国光 Adimmune 350 成人100+老人100+儿童150 中国科兴 Sinovac 1614 老年101+成人706+少年404+儿童403 GlaxoSmithKline 9000 * Sanofi 6370 # (850+450+800+650+650+650+150+120+850+300+450+450) CSL Biotherapies 3640 @ (450+800+240+400+1300+450) Novartis 6000 $ Baxter 1300 (phase 1) + 3500 (phase 3) % 资料来源 * http://triangle.bizjournals.com/triangle/stories/ 2009/08/10/daily72.html # http://www.clinicaltrials.gov/ @ http://money.aol.com/article/csl-biotherapies-announces-start -of-us/627699?icid=sphere_blogsmith_inpage_dailyfinance $ http://www.porkmag.com/swineflu.asp?ts=sfl&pgID=675&ed_id=7975 % http://www.news-medical.net/news/20090805/Baxter-completes- production-of-batches-of-CELVAPAN-AH1N1-pandemic-vaccine.aspx 台湾国光比大陆还不如 不能因为国光有政府股份,有前署长支持, 是台湾第一家疫苗厂, 就可以放水 这根本是拿人民的健康做赌注! 今日新闻, 卫生署另外进口500万剂疫苗是明智的作法! --

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