[爆卦] H1N1疫苗人體試驗樣本數

看板medache (醫療心酸)作者CKun (溫水煮青蛙)時間16年前 (2009/09/03 19:18)推噓1(1推 0噓 1→)

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※ [本文轉錄自 Gossiping 看板] 作者: CKun (溫水煮青蛙) 看板: Gossiping 標題: [爆卦] 新流感疫苗人體試驗樣本數時間: Wed Sep 2 10:08:28 2009 摘錄新聞 : 國光生技新流感疫苗只進行二百人的人體臨床試驗，未達一定規模， : 恐有安全疑慮。國光生技總經理魏逸之表示，世界衛生組織（ＷＨＯ） : 認定，Ｈ１Ｎ１新流感是流感的一種，所以新流感疫苗也是一種流感 : 疫苗，不是新藥，同意各國可進行人數較少的人體試驗。 : : 國光生技強調，二百人是歐盟對新流感疫苗人體實驗樣本數的規定， : 澳洲為二四○人，並非媒體報導的一千人，各國對新流感疫苗製備步 : 驟均與國光類似。 WHO的說法 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. 歐盟核准的四款疫苗 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. 可以減少H1N1疫苗人體試驗樣本數的前題是在同一個製造廠曾經生產過(已經試驗完畢)已核准的季節性流感疫苗但台灣國光生技以前未曾製造過季節性流感疫苗, 僅是由日本進口原液, 然後自行充填包裝出售工廠是今年新落成啟用, 哪裡來8000個H5N1疫苗的人體試驗資料再說澳洲CSL僅試驗240人, 國光可不曉得CSL在美國同時進行1300成人+450孩童的測試? CSL的H1N1疫苗試驗總人數高達3640人我們來看看各家廠商的H1N1疫苗人體試驗的樣本數吧廠商樣本數台灣國光 Adimmune 350 成人100+老人100+兒童150 中國科興 Sinovac 1614 老年101+成人706+少年404+兒童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) % 資料來源 * 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 台灣國光比大陸還不如不能因為國光有政府股份,有前署長支持, 是台灣第一家疫苗廠, 就可以放水這根本是拿人民的健康做賭注! 今日新聞, 衛生署另外進口500萬劑疫苗是明智的作法! -- ※ 發信站: 批踢踢實業坊(ptt.cc) ◆ From: 138.26.234.72

[爆卦] H1N1疫苗 人體試驗樣本數

[爆卦] H1N1疫苗人體試驗樣本數