※ 引述《femlro (既得此生當盡其用)》之銘言：
: ※ 引述《askacis (ASKA)》之銘言：
: : To 已知用火的femlro :
: : 你知道法國Valneva的疫苗是做免疫橋接三期拿到歐盟EMA的藥證嗎?
: : 要知道打Valneva產生的中和抗體效價只是一般般而已喔
: : https://www.trade.gov.tw/Pages/Detail.aspx?nodeID=45&pid=745412
: ㄜ
: 請看以下2023年9月的雜誌
: https://www.sciencedirect.com/science/article/pii/S0163445323003675
: Valneva的滅活疫苗是有做3期的
: This interim analysis of an open-label extension of a randomized, controlled
: phase 3 trial assessed a single booster dose of an inactivated whole-virus
: COVID-19 vaccine (VLA2001) in healthy or medically stable adults aged 18
: years and above, recruited in 21 clinical sites in the UK, who had previously
: received two doses of either VLA2001 or ChAdOx1-S. Safety outcomes were
: frequency and severity of solicited injection site and systemic reactions
: within 7 days after booster vaccination as well as frequency and severity of
: any unsolicited adverse events (AE) after up to 6 months. Immunogenicity
: outcomes were the immune response to ancestral SARS-CoV-2 assessed 14 days
: post booster expressed as geometric mean titres (GMT), GMT fold ratios and
: seroconversion of specific neutralizing antibodies and S-protein binding IgG
: antibodies. Immunogenicity against the Delta and Omicron VoCs was assessed as
: a post-hoc outcome with a pseudovirus neutralization antibody assay. This
: study is registered with ClinicalTrials.gov, NCT04864561, and is ongoing.
: 也有
: A booster dose of VLA2001 was administered to 958 participants, of whom 712
: had been primed with VLA2001, and 246 with ChAdOx1-S. Within 7 days following
: these booster doses, 607 (63.4%) participants reported solicited injection
: site reactions, and 487 (50.8%) reported solicited systemic reactions. Up to
: 14 days post booster, 751 (78.4%) participants reported at least one adverse
: event. The tolerability profile of a booster dose of VLA2001 was similar in
: VLA2001-primed and ChAdOx1-S-primed participants. In VLA2001-primed
: participants, the GMT (95% CI) of neutralizing antibodies increased from 32.5
: (22.8, 46.3) immediately before to 521.5 (413.0, 658.6) 2 weeks after
: administration of the booster dose, this corresponds to a geometric mean fold
: rise (GMFR) of 27.7 (20.0, 38.5). Compared to 2 weeks after the second
: priming dose, the GMFR was 3.6 (2.8, 4.7). In the ChAdOx1-S primed group, the
: GMT (95% CI) of neutralizing antibodies increased from 65.8 (43.9, 98.4)
: immediately before to 188.3 (140.3, 252.8) 2 weeks after administration of
: the booster dose, a geometric mean fold rise (GMFR) of 3.0 (2.2, 4.0).
: Compared to 2 weeks after the second priming dose, the GMFR was 1.6 (1.1,
: 2.2). For S-protein binding IgG antibodies, the pre- versus post-booster GMT
: fold ratio (95% CI) was 34.6 (25.0, 48.0) in the VLA2001-primed group and 4.0
: (3.0, 5.2) in the ChAdOx1-S-primed group. Compared to 2 weeks after the
: second priming dose, the GMT fold rise of IgG antibodies was 3.8 (3.2, 4.6)
: in the VLA2001-primed group and 1.2 (0.9, 1.6) in the ChAdOx1-S-primed group.
: The GMT against Delta (B.1.617.2) and Omicron (BA.4/5) increased from 4.2 to
: 260, and from 2.7 to 56.7, respectively, when boosting subjects previously
: primed with VLA2001. Following the boost, 97% of subjects primed with VLA2001
: had detectable Delta- and 94% Omicron-neutralizing antibodies. In subjects
: primed with ChAdOx1-S, the GMT against Delta and Omicron titres increased
: from 9.1 to 92.5, and from 3.6 to 12.3, respectively. After boosting, 99% of
: subjects primed with ChAdOx1-S had detectable Delta- and 70%
: Omicron-neutralizing antibodies. In both VLA2001 and ChAdOx1-S primed
: subjects, the additional VLA2001 dose boosted T cell responses against
: SARS-CoV-2 antigens to levels above those observed before the booster dose.
: https://www.skbioscience.com/en/news/news_01_01?mode=view&id=132
: 韓國也是有做三期的
: 你的文章是2022年9月2日
: 早在2022年6月29日SK就有自己發新聞稿了
: The results of the Phase III clinical trial, collected in 4,037 adults over
: 18-year-old, showed that SKYCovione™ induced neutralizing antibody
: responses, against the SARS-CoV-2 parental strain. The neutralizing antibody
: titres increased about 33 times compared to before the injection and were 3
: times that of AstraZeneca′s Vaxzevria™, the control vaccine used in the
: study, 2 weeks after the second dose.
: 日本第一三共也做了三期
: https://www.daiichisankyo.com/files/news/pressrelease/pdf/202309/20230907_E1.pdf
: 不知道是引用中央社中文新聞的比較對呢？
: 還是日本、韓國原廠給出的新聞稿和法國的雜誌比較對呢？
: 我還真的不知道原來免疫橋接3期還有受測者做RCTs呢？
: 哈哈哈
: 快笑死我了！
: 不知道你那邊的火是哪種火？
: 中央社新聞替代原廠新聞稿的火嗎？
: WHO把Chinese Hamster Ovary (CHO) cell-derived spike protein (subunit) COVID-19
: vaccine高端的中國中國倉鼠卵巢 (CHO) 細胞衍生的刺突蛋白（亞基）COVID-19 疫苗這個技術
: 納入了C-TAP，為什麼呢？
: https://www.who.int/initiatives/covid-19-technology-access-pool/medigen-license-to-c-tap
: 想想看為什麼？
: 全球那些藥廠都沒有把自己的Covid-19疫苗技術授權給C-TAP平台
: 高端卻給了
: 原因很簡單阿
: 高端沒有打算再繼續生產這項疫苗來獲利了
: 看最新的XBB1.5疫苗臺灣也只剩下Novavax跟Moderna了
: 剩下的藥廠都還有要繼續玩
: 高端可不是政府100%持股的是私人公司
: 私人公司放棄了自己關鍵的疫苗專利與技術授權給WHO
: 不繼續開發Xbb疫苗
: 真是太佛心了
: 感恩高端股東貢獻全世界
: ICMRA進行中和抗體neutralising antibodies的研討會
: https://icmra.info/drupal/en/covid-19/30june2022
: 這是最後一次
: https://www.icmra.info/drupal/en/covid-19/icmra_who_vaccines_confidence_statement_for_hcps_2
: 為什麼ICMRA後來對 immuno-bridging 有針對在研究
: 原文寫得非常清楚
: For COVID-19 vaccines, it is becoming increasingly difficult to conduct
: placebo-controlled disease endpoint efficacy trials in some countries, as few
: individuals are willing and available to participate. Appropriately designed
: immuno-bridging studies are an acceptable alternative approach for
: authorising vaccines including for variants, boosters and paediatric
: populations. Neutralising antibody titres may be a suitable primary endpoint
: to predict vaccine effectiveness. The applicant for regulatory approval must
: also have justified the choice of appropriate vaccine comparators,
: statistical criteria and population comparator groups (for example, matched
: by age, gender, prior vaccination/infection status). Efficacy data should
: also include characterisation of comparative immunogenicity profiles,
: including cell-mediated immunity and characterisation of comparative in vitro
: neutralisation against Variants of Concern.
: 就是因為RCTS找不到受試者，但不是免疫橋接都一樣
: ICMRA的原文寫得很清楚
: 要有以下條件：
: vaccine comparators, statistical criteria and population comparator groups
: (for example, matched by age, gender, prior vaccination/infection status).
: 我對國產疫苗完全沒有意見
: 但世界主流就是RCTs三期試驗
: 然後臺灣要針對下一次疫情作準備就是做mRNA的投資跟研發
: 我看上面一堆推文除了謾罵和護航高端免去RCTs一直在幫免疫橋接做護航
: 卻完全忽略其他疫苗全部都有做
: 世界主流大家打最多的都有做
: 你舉的例子我也全部打臉都有做
: 不是中央社新聞中文的拿來就能說服我這種看原文資料的人～
: 臺灣平時不投資結果遇到事情不先以RCTs做過三期認證的正統疫苗為主
: 先採購
: 而是用免疫橋接這種不成熟的開發方法
: 要知道當初EUA已經是略過很多程序了
: 美國FDA當初給BNT等都還是沒有略過RCTs程序
: 臺灣一直講自己民主卻與美國相差甚遠
: 在現在安逸的時候也不思國發基金有要投資 以mRNA技術的公司嗎？
: 結果是Moderna美國公司來臺灣繼續招募生醫人才
: 跟中研院與其他公司合作
: 這相關的授權能技轉像是當初工研院一樣成立台積電等公司嗎？
: 如果不行
: 下次疫情Moderna如果又遇到是不是又優先供應歐洲美國？
: 是愛臺灣還是愛高端？
: 這我可不會搞混
: : 你知道韓國SK的疫苗也是做免疫橋接拿到韓國的EUA嗎?
: : https://www.cna.com.tw/news/aopl/202209020275.aspx
: : 你知道日本第一三共的疫苗做免疫橋接拿到日本厚生勞動省的批准上市嗎?
: : https://www.cna.com.tw/news/aopl/202311280271.aspx
: : 高端當年也有一個計畫是做免疫橋接三期，這個有得到歐盟EMA允許，
: : 但最後計畫不知道是否有跑完。
: : https://www.cna.com.tw/news/firstnews/202109220304.aspx
: : 扣掉這個計畫，高端的免疫橋接三期在泰國跟巴拉圭都做過，
: : 巴拉圭也有給EUA
: : https://www.rti.org.tw/news/view/id/2124522
: : https://www.medigenvac.com/news_view.php?id=222
: : 更別說WHO技轉高端的疫苗技術，
: : 什麼~~你說沒做vaccine efficacy不行?
: : 好啦，人家WHO拿著幾百萬美金幫高端免費做，
: : 免費做的原因就是因為他的中和抗體效價夠高才有這個價值
: : https://www.cna.com.tw/news/ahel/202308290345.aspx
: : 更別說ICMRA 早在2021就有提到要用免疫橋接作為新疫苗實驗設計的基礎
: : https://www.roc-taiwan.org/be/post/12576.html
: : 怎麼你的世界跟真實的世界不一樣呢?
: : 還是你比歐盟EMA/ICMRA/日本厚生勞動省更厲害呢?
: : 今天我好心陪你複習舊知識，希望你有學到東西
前面烙那麼多術語結果只是只會數一二三的情弱仔
該不會你不知道他們全都是三期免疫橋接啊？
https://i.imgur.com/sZqdvg4.jpeg
SK的結果是 2.9倍AZ
https://i.imgur.com/c3vPyHm.jpeg
VLA2001 是1.39倍
https://i.imgur.com/kwoFiyl.jpeg
一樣都是採3000ー4000人左右
這些都谷歌的到欸
就說高端別取名什麼擴大二期
沒命名天分
: : 加油~