當H1N1疫苗施打疑似造成多起死亡流產麻痺等恐慌事件大家質疑疫苗安全性時,對Anchi這個施打過的人倒是懷疑自製的國光疫苗是否跟633一樣是應急的安慰劑?
以下整理者為: 劉興政 Hsing-Cheng Liu
- 因H1N1疫情而讓臨床試驗人數減少,期限減短,這不是「情有可原」,當初衛生署大可以採購國外有經驗的廠牌,而不要急著讓國光生產。
- H1N1自1918年大流行後只有在1976年疑似流行,台灣製作疫苗是有史以來第一次,其實大家都沒經驗,不要再口口聲聲專家了啦!
- 當一個從沒貸過款的人到銀行申請貸款時,銀行的審核非常嚴格;當這個人的信用史建立起來時,標準有可能放鬆。國光就像那個第一次貸款的人,沒有信用紀錄。
- 更重要的是,衛生署核准一個新疫苗上市的標準何在?
- 國光臨床試驗到底做了幾個人,猶如一團迷霧,有台大醫師說國外也都只做幾百人,請見網站table 1,美國衛生機關NIH做的人體試驗大部分是採用Sanofi生產的疫苗,總試驗人數將近4,000人,對象包括孕婦,幼兒,氣喘病病童, 以及免疫不全患者.至於其他像GSK跟Norvatis這些藥廠的人體試驗人數都是動輒數千人,絕非只是幾百人http://www.upmc-biosecurity.org/website/focus/2009_H1N1_updates/isssue_briefs/2009-11-13-IssBrf_lcnsre_evl_advrse.html更何況
- 以上這些藥廠都有數十年生產流感疫苗的經驗, FDA核准是以「病毒株改變」(strain change)的標準,也就是說認可這些廠先前的經驗(貸過多次款,信用紀錄良好),今年只是做不同的病毒株,都還做這麼多人,台灣的專家、衛生署為什麼都睜眼說瞎話?
- 國光去函大話澄清試驗樣本,指出測試15毫克的人數為177人,其他的是打7.5毫克,現在打在台灣打的就是15毫克的,換言之,人體試驗只做了177人!
- 現在大家沒有在談暈針,可是暈針的比例遠高於國外,衛生署完全沒有解釋,還有先前統計出來的不良副作用,資料完整嗎?許多暈針或麻的各案雖然恢復 了,但還是有產生不良副作用,這些到底有沒有算?
- 1976年美國的H1N1也是倉卒上市,開始施打後,有三人死亡,都被認為是偶事件(就是「無關」啦!),結果後來所有疫苗回收,停打。台灣要死 幾個人才夠?先前五個加昨天以及胎死腹中的胎兒都快十個了,也才不過打一個半月!
- 要大家打H1N1疫苗,為何要侷限國光疫苗?政策為什麼只能打國光?打疫苗一訂立大於弊嗎?H1N1的死亡率低於季節性流感,去年衛生署怎麼沒有 動輒拿防疫法出來叫人去打國光?還是不能排除利益勾結!
- 國光這麼好,又急著要跟中國自由貿易,何不把國光疫苗銷到中國?
- 台灣不是WHO成員,請問哪一個單位供應試劑,確認無菌性?在國光量產前這個步驟是怎麼進行的?http://www.who.int/csr/disease/swineflu/notes/h1n1_vaccine_20090806/en/index.html Activities at vaccine manufacturers
1. Optimization of virus growth conditions: The vaccine manufacturer takes the hybrid vaccine virus that it has received from the WHO laboratories, and tests different growth conditions in eggs to find the best conditions. This process requires roughly three weeks.
2. Vaccine bulk manufacture: For most influenza vaccine production, this is performed in nine to twelve-days old fertilized hen’s eggs. The vaccine virus is injected into thousands of eggs, and the eggs are then incubated for two to three days during which time the virus multiplies. The egg white, which now contains many millions of vaccine viruses, is then harvested, and the virus is separated from the egg white. The partially pure virus is killed with chemicals. The outer proteins of the virus are then purified and the result is several hundred or thousand liters of purified virus protein that is referred to as antigen, the active ingredient in the vaccine. Producing each batch, or lot, of antigen takes approximately two weeks, and a new batch can be started every few days. The size of the batch depends on how many eggs a manufacturer can obtain, inoculate and incubate. Another factor is the yield per egg. When one batch has been produced, the process is repeated as often as needed to generate the required amount of vaccine.
3. Quality control: This can only begin once the reagents for testing the vaccine are supplied by WHO laboratories, as described above. Each batch is tested and the sterility of bulk antigen is verified. This process takes two weeks. ,當WHO的實驗室供應測試疫苗的試劑後才能開始上述生產流程,每批疫苗都需要測試並確認(verify)大量抗原的無菌性(sterility),這個過程需需兩星期
4. Vaccine filling and release: The batch of vaccine is diluted to give the desired concentration of antigen, and put into vials or syringes, and labeled. A number of these are then tested: