【國際認證:英國等國採納免疫橋接核准新疫苗】
一、英國主管單位宣布採納免疫橋接作為批准 COVID-19 疫苗的檢測標準
英國政府,採納類似「台灣模式」核准新疫苗。國際藥物法規主管機構聯盟(ICMRA)於六月召開研討會,針對免疫橋接與保護關聯性達成多點共識,稍早跨國醫藥聯盟Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium(英國、澳洲、新加坡、加拿大、瑞士主管機關組成的聯盟)表示同意採用與現行疫苗比對中和抗體校價的「免疫橋接」,接著英國藥物及保健產品管理局(Medicines and Healthcare Products Regulatory Agency,簡稱 MHRA)接著宣布,可接受設計合理的免疫橋接作為批准 COVID-19 疫苗的檢測標準。
二、英國、澳洲、新加坡、加拿大、瑞士監管機構接納免疫橋接:
聯盟五國成員,同意論證充分設計良好的免疫橋接試驗,是武漢肺炎疫苗取得授權的可行途徑。
Access聯盟引述ICMRA會議有關免疫橋接的共識如下:
‧難以進行傳統安慰劑對照試驗,取得有效性實驗終點的狀況下,可使用免疫橋接。
‧實驗設計:若和高度有效的疫苗比較,應採不劣性(non-inferiority )設計;若和僅達一般標準的疫苗相比,應採優越性(superiority)設計。
‧中和抗體校價可作為預測疫苗有效性的免疫標記。
‧中和抗體校價試驗應使用WHO認證之標準方式。
‧須考慮:1.考慮疫苗平台來選擇合適的疫苗比較品;2.統計標準;3.校正不同組別間的族群特性差異。
‧各國監管機構分享資訊,有助「國際認證」的聚焦。
Access聯盟權衡已核准疫苗的研究實證後,認為中和抗體校價足以作為跨平台免疫橋接試驗的主要終點。
另外,申請者須提供各項資料,包含:
非臨床資料:
‧可證明抵抗變種病毒有效性的動物攻毒實驗
‧(動物實驗之)免疫生成性,包含抗體免疫與細胞免疫
臨床資料:
‧中和抗體校價比較資料
‧免疫生成性資料,包含細胞免疫
‧在體外試驗中,中和變種病毒的能力
‧至少3000名受試者的安全性資料
‧承諾至少追蹤受試者12個月的安全性與免疫生成性,並紀錄臨床有效性數據。
‧承諾進行授權使用後的真實世界有效性研究,研究方案需考慮現行WHO規範。
三、疫情病毒不斷變種,需要更經濟有效的疫苗實驗標準
當然傳統實驗設計方式,仍是最堅實的標準,但在時間和現實環境的雙重壓力問題,確保其有效性的前提下,讓疫苗研發的成本再降低,經過國際相關醫學公衛單位的嚴格討論,免疫橋接已被納入標準。這不是為了哪個特定品牌,而是面對病毒進程,國際公衛對於疫苗研發所做出的世界趨勢決定。
很多人拿免疫橋接來做攻擊,說不是國際標準,說國際上沒有人這麼做,說台灣這樣獨步全球不可思議,但其實免疫橋接在國際間一直都在討論。現在免疫橋接是國際認證的設計了,別的國家都跟在台灣後面做了,希望免疫橋接的紛爭到此為止。
我並不悲觀,相信民眾心裡都有一把尺,很清楚這些事情背後的出發點。台灣的未來比這些口水戰重要得太多,一起繼續努力。
其他相關原文細節,會把報導原文放在留言裡。
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- 關於access consortium 在 音樂政治上班族 Facebook 的最讚貼文
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access consortium 在 音樂政治上班族 Facebook 的最讚貼文
嗯嗯,「武漢肺炎疫苗」採取免疫橋接臨床試驗的方式,又一個醫藥聯盟認可囉~
由英國、澳洲、加拿大和新加坡、瑞士主管機關組成的跨國醫藥聯盟Access Consortium宣佈免疫橋接的臨床試驗方式 #是可以被接受的方式。
國際藥物法規主管機構聯盟(ICMRA),在6月24日有個工作小組討論武漢肺炎疫苗開發,他們把焦點放在「免疫橋接」的研究,就如我們以前說過的,很多國家想要再開發新的疫苗,不管是時間、金錢或是安慰劑組人數對照等諸多成本因素,都難以用傳統方式來研發。
因此只要是設計得當的免疫橋接方式,是可以被接受的!!
而Access Consortium也認同ICMRA的結論,利用已獲授權的疫苗來做中和抗體效價比較,來作為免疫橋接的評估指標。
簡單說,#高端研發武漢疫苗所使用的免疫橋接方式已獲得愈來愈多國家和國際醫藥聯盟所認可
#藍白巨嬰不懂就請閉嘴!!
.
相關連結:
https://reurl.cc/q1gkxD
https://news.ltn.com.tw/news/world/breakingnews/3676786
.
access consortium 在 我是台灣人.台灣是咱的國家 Facebook 的最佳貼文
取笑高端免疫橋接的國民黨、民眾黨、#高虹安 出來打球囉!
英國、澳大利亞、加拿大、新加坡和瑞士的監管聯盟 #AccessConsortium 宣布 #免疫橋接 研究可用於支持COVID-19疫苗權
再次證明大仁哥的說法是正確的,免疫橋接認證疫苗是世界未來趨勢,受到更多國際監管機構的支持,而我們的國產 #高端疫苗 正超前部署往這方向前進
Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.
原文報導:
https://www.europeanpharmaceuticalreview.com/news/162653/immuno-bridging-studies-are-sufficient-for-authorising-new-covid-19-vaccines-say-regulators/
#台灣加油
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I’ve known Dan Pena for more than 11 years now. Dan Pena is a personal mentor of mine. I’ve attended the Castle seminar.
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I’ve known Dan Pena for more than 11 years now. Dan Pena is a personal mentor of mine. I’ve attended the Castle seminar.
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