※ 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
: 加油~
: ※ 引述《femlro (既得此生當盡其用)》之銘言：
: : 你用後面的Omicron數據反推前面Alpha跟Delta病毒珠
: : 我都不知道說什麼了
: : 如果這邏輯會通
: : 那就不用開發Xbb跟Omicron疫苗了
: : 衛福部選的時間點非常正確
: : 就是證明高端在Omicron以前的死亡率高於BNT
: : RCTs高端沒有做
: : 所以當初根本沒有VE數據
: : 更別提年齡層問題
: : 不做RCTs你跟我說這是科學還是政治呢？
: : 我是不懂拉
: : 要拿EUA出來解釋使用Immunobridging來做為數據
: : 那怎麼解釋BNT、AZ、Moderna、Novavax通通都做了RCTs?
: : 還不講嬌生因為沒過被打槍
: : RCTs沒有做高端怎樣都沒辦法擺脫這個污名
: : 因為這是全球的共識
: : 所以至今高端也只有臺灣跟烏拉圭承認
: : 高端想去歐盟作RCTs也沒有人要
: : 因為早就覆蓋率都夠了
: : 為什麼？
: : 因為次蛋白本來就要比mRNA更久
: : 他一開始就不是一個適合EUA的技術
: : 真的要為臺灣好
: : 不是替高端護航
: : 是深刻檢討臺灣怎樣發展mRNA
: : 郭台銘把mRNA開始合作引入Biotech進臺灣
: : 為臺灣癌症作長期研究發展
: : 這次疫情過了
: : 請問民進黨臺灣的mRNA發展方案在哪裡？
: : 要怎樣在下次疫情可以有足夠說服國際我們臺灣的mRNA 不會只能賣烏拉圭
: : 能有國際的peer review？
: : 沒有這些不要講數據
: : 那些都是自我安慰而已