Macquarie150 wrote:
藍教徒與白黃粉完全消...(恕刪)
狗頭哥你是看不懂「預期」這兩個字嗎？
個人積分：652分
文章編號：83248890
個人積分：434分
文章編號：83248906
個人積分：1745分
文章編號：83249095
Macquarie150 wrote:
目前國際法規聯盟 ICMRA，以及由澳洲、加拿大等五國所組成的 Access Consortium，正積極倡議新冠肺炎疫苗的免疫橋接試驗，期刊除了可藉統計方式外推高端新冠疫苗的保護力預測數據，藉由原始數據發表，更可對全球新冠疫苗免疫橋接提供具體參考基礎。
又再節錄或是扭曲國際機構的論點來誤導國人！
高端6/15申請用二期免疫橋接通過EUA，可是，ICMRA在6/24才發布說他們在討論免疫橋接的可行性，而且有許多問題要被釐清。
衛服部在ICMRA之前獨步全球做了舉世創舉，不要怪國人為何對高端如此不信任，是他自己砸自己的鍋。
ICMRA 6/24新聞如下，節錄部分章節
ICMRA說可能需要進行免疫原性橋接研究，結果台灣一堆媒體說「ICMRA建議免疫橋接」，直接把疑問句改成肯定句！
ICMRA COVID-19 Vaccine development: Future steps Workshop
4. Discussion
There was consensus that immunogenicity bridging studies may be needed if an assessment of effectiveness of 2nd generation COVID-19 vaccines in clinical endpoint efficacy studies are no longer feasible. These could be designed as non-inferiority immunogenicity studies if the comparator vaccine has demonstrated high efficacy in clinical diseases endpoint efficacy trials and/or superiority designs if the comparator vaccine has demonstrated modest efficacy. The selection of immune markers to predict effectiveness (e.g. neutralizing antibody titre using WHO certified reference standard), identification of meaningful endpoints and statistical criteria, choice of appropriate vaccine comparators (e.g. platform) and population comparator groups (e.g. matched by age, gender, prior vaccination status) were also highlighted as critical factors to agree upon.
Other challenges for regulators included defining approaches to demonstrate effectiveness for 2nd generation vaccines that will be solely developed as booster vaccines, e.g. administered as heterologous boost following a primary series with another vaccine (potentially comparing the immunogenicity of booster responses induced by the 2nd generation vaccine to the homologous boost afforded by the primary series vaccines), and practical aspects of interpreting trial data with different dosing regimens or second-dose intervals. Sharing the responses to sponsors with other regulators would help building global convergence.
<翻譯>
一致認為，如果在臨床終點療效研究中評估第二代 COVID-19 疫苗的有效性不再可行，則可能需要進行免疫原性橋接研究。如果比較疫苗在臨床疾病終點功效試驗中表現出高功效，則可以將這些設計為非劣效免疫原性研究和/或如果比較疫苗表現出適度的功效，則可以設計為優效性設計。選擇免疫標誌物以預測有效性（例如使用 WHO 認證參考標準的中和抗體滴度）、確定有意義的終點和統計標準、選擇合適的疫苗比較器（例如平台）和人群比較器組（例如按年齡、性別、既往史匹配）疫苗接種狀態）也被強調為達成一致的關鍵因素。
監管機構面臨的其他挑戰包括定義方法來證明將單獨開發為加強疫苗的第二代疫苗的有效性，例如與另一種疫苗在初級系列後作為異源加強接種（可能比較第二代疫苗誘導的加強反應的免疫原性與初級系列疫苗提供的同源加強），以及解釋不同給藥方案或第二次試驗數據的實際方面- 劑量間隔。與其他監管機構分享對發起人的回應將有助於建立全球融合。
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9/16 European pharmaceutical review 才發布說同意ICMRA免疫橋接的論點，而且是有條件的！
Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The members of the Access Consortium, a medium-sized coalition of regulatory authorities including those from the UK, Australia, Canada, Singapore and Switzerland, agreed with the ICMRA conclusion that well-justified and appropriately designed immunobridging studies are an acceptable approach for authorising COVID-19 vaccines.
The Access Consortium stated that they consider the weight of evidence from studies with authorised COVID-19 vaccines is sufficient to support using neutralising antibody titers as a primary endpoint in cross-platform immuno-bridging trials. Though applicants must provide a clear rationale for the suitability of neutralising antibody as a primary endpoint in immuno-bridging studies, considering data that support the mechanism of action for the candidate vaccine. The consortium also recommends that applicants follow World Health Organization (WHO) standards in neutralisation assays and consult with the relevant authority early on in the study process.
In addition, applicants must provide non-clinical and clinical data, including a characterisation of comparative immunogenicity profiles, such as cell-mediated immunity; characterisation of comparative in vitro neutralisation against variants of concern; a safety database of at least 3,000 study participants vaccinated with the dosing regimen intended for authorisation; and a commitment for safety and immunogenicity follow-up for at least 12 months, among other
<翻譯>
Access Consortium 是一個中等規模的監管機構聯盟，包括來自英國、澳大利亞、加拿大、新加坡和瑞士的監管機構聯盟，其成員同意 ICMRA 的結論，即合理且設計合理的免疫橋接研究是批准 COVID 的可接受方法-19 疫苗。
Access Consortium 表示，他們認為來自授權 COVID-19 疫苗研究的證據的權重足以支持使用中和抗體滴度作為跨平台免疫橋接試驗的主要終點。儘管申請人必須提供明確的理由說明中和抗體是否適合作為免疫橋接研究的主要終點，但要考慮支持候選疫苗作用機制的數據。該聯盟還建議申請人在中和試驗中遵循世界衛生組織 (WHO) 標準，並在研究過程的早期諮詢相關機構。
此外，申請人必須提供非臨床和臨床數據，包括比較免疫原性特徵的特徵，例如細胞介導的免疫；對關注的變體進行比較體外中和的表徵；至少有 3,000 名研究參與者的安全數據庫，其中接種了用於授權的給藥方案；並承諾對安全性和免疫原性進行至少 12 個月的隨訪，以及其他因素。
個人積分：91分
文章編號：83249743
下面這一大段英文就是高端自己的paper寫在一堆帶著偏見只想內宣的政府、媒體跟［…各位自己腦補…］的傢伙特意標示出來什麼預估保護力80%到90%的描述後的第二段，是那個章節的最後一段。中文算我送你們的翻譯不跟你們收錢！
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We acknowledge the limitations of our study.
我們理解我們這份研究報告有其侷限性。
The low viral transmission rate in Taiwan at the time of the study, together with the small size of the placebo group, hindered observation of both vaccine efficacy as the exploratory endpoint and the risk of vaccine-associated enhanced disease.
研究進行中的時間點是台灣處於低病毒傳播率的狀態，而且安慰劑組的量小，這阻礙了我們對包含最終探究目標的疫苗防護力以及疫苗相關疾病增強風險的觀察。
The short duration of follow-up before the interim analysis prevented us from assessing the durability of immune responses after day 57;
因為中期分析前的追蹤持續時間短，使我們無法確認57天後免疫反應的耐久度；
the long-term follow-up analysis will be available on completion of this phase 2 trial in October, 2021. In addition, the racial diversity of study participants is restricted to ethnicities in Taiwan.
長期的追蹤分析會在2021年10月這個二期試驗結束後取得結果，另外，受試者的種族多樣性則是受限於台灣的族群。
We currently have no available data to draw conclusions about the immune response and safety of MVC-COV1901 in children aged younger than 20 years or in pregnant or lactating women.
我們目前無法取得可以讓我們做出20歲以下孩童、懷孕或泌乳中女性有關免疫反應以及MVC- COV1901安全性結論的資料
High-risk participants and those with one or more uncontrolled comorbidities were also excluded at baseline;
高風險受試者以及有一個或多個未控制的合併症的人也被排除在基準線之外。
therefore, the efficacy of MVC-COV1901 in these individuals cannot be established.
因此，MVC-COV1901在這些個體的保護力數據無法被建立。
These limitations will be addressed in the ongoing study in adolescents (NCT04951388) or our phase 3 trials, which will be done in regions outside Taiwan where the prevalence of COVID-19 infection is high.
上述這些限制將會在持續進行中的青少年研究(NCT04951388)或是我們的三期試驗中處理，我們的三期試驗會在台灣以外新冠病毒感染盛行率高的區域完成。
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我說你們這些人可以再不要臉一點，高端這間公司就算有點爭議也不敢在國際期刊上說謊。你們就這樣大剌剌的斷章取義無視實際結論，問題不在高端這間公司！在你們這些從上到下都在玩弄片面資訊的OOO！
什麼消聲匿跡，說得好像真正會去釐清資訊的人都欠你們的…
沒本事看懂就愛造謠胡說八道！
沒有睜眼說瞎話的本事，還不夠資格被叫做塔綠班呢
個人積分：980分
文章編號：83249775
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文章編號：83250438
