※ 引述《askacis (ASKA)》之铭言：
: To 已知用火的femlro :
: 你知道法国Valneva的疫苗是做免疫桥接三期拿到欧盟EMA的药证吗?
: 要知道打Valneva产生的中和抗体效价只是一般般而已喔
: https://www.trade.gov.tw/Pages/Detail.aspx?nodeID=45&pid=745412
ㄜ
请看以下2023年9月的杂志
https://www.sciencedirect.com/science/article/pii/S0163445323003675
Valneva的灭活疫苗是有做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
韩国也是有做三期的
你的文章是2022年9月2日
早在2022年6月29日SK就有自己发新闻稿了
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闻的比较对呢？
还是日本、韩国原厂给出的新闻稿和法国的杂志比较对呢？
我还真的不知道原来免疫桥接3期还有受测者做RCTs呢？
哈哈哈
快笑死我了！
不知道你那边的火是哪种火？
中央社新闻替代原厂新闻稿的火吗？
WHO把Chinese Hamster Ovary (CHO) cell-derived spike protein (subunit) COVID-19
vaccine高端的中国中国仓鼠卵巢 (CHO) 细胞衍生的刺突蛋白（亚基）COVID-19 疫苗这个技术
纳入了C-TAP，为什么呢？
https://www.who.int/initiatives/covid-19-technology-access-pool/medigen-license-to-c-tap
想想看为什么？
全球那些药厂都没有把自己的Covid-19疫苗技术授权给C-TAP平台
高端却给了
原因很简单阿
高端没有打算再继续生产这项疫苗来获利了
看最新的XBB1.5疫苗台湾也只剩下Novavax跟Moderna了
剩下的药厂都还有要继续玩
高端可不是政府100%持股的是私人公司
私人公司放弃了自己关键的疫苗专利与技术授权给WHO
不继续开发Xbb疫苗
真是太佛心了
感恩高端股东贡献全世界
ICMRA进行中和抗体neutralising antibodies的研讨会
https://icmra.info/drupal/en/covid-19/30june2022
这是最后一次
https://www.icmra.info/drupal/en/covid-19/icmra_who_vaccines_confidence_statement_for_hcps_2
为什么ICMRA后来对 immuno-bridging 有针对在研究
原文写得非常清楚
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.
就是因为RCTS找不到受试者，但不是免疫桥接都一样
ICMRA的原文写得很清楚
要有以下条件：
vaccine comparators, statistical criteria and population comparator groups
(for example, matched by age, gender, prior vaccination/infection status).
我对国产疫苗完全没有意见
但世界主流就是RCTs三期试验
然后台湾要针对下一次疫情作准备就是做mRNA的投资跟研发
我看上面一堆推文除了谩骂和护航高端免去RCTs一直在帮免疫桥接做护航
却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
你举的例子我也全部打脸都有做
不是中央社新闻中文的拿来就能说服我这种看原文资料的人～
台湾平时不投资结果遇到事情不先以RCTs做过三期认证的正统疫苗为主
先采购
而是用免疫桥接这种不成熟的开发方法
要知道当初EUA已经是略过很多程序了
美国FDA当初给BNT等都还是没有略过RCTs程序
台湾一直讲自己民主却与美国相差甚远
在现在安逸的时候也不思国发基金有要投资 以mRNA技术的公司吗？
结果是Moderna美国公司来台湾继续招募生医人才
跟中研院与其他公司合作
这相关的授权能技转像是当初工研院一样成立台积电等公司吗？
如果不行
下次疫情Moderna如果又遇到是不是又优先供应欧洲美国？
是爱台湾还是爱高端？
这我可不会搞混
: 你知道韩国SK的疫苗也是做免疫桥接拿到韩国的EUA吗?
: https://www.cna.com.tw/news/aopl/202209020275.aspx
: 你知道日本第一三共的疫苗做免疫桥接拿到日本厚生劳动省的批准上市吗?
: https://www.cna.com.tw/news/aopl/202311280271.aspx
: 高端当年也有一个计画是做免疫桥接三期，这个有得到欧盟EMA允许，
: 但最后计画不知道是否有跑完。
: https://www.cna.com.tw/news/firstnews/202109220304.aspx
: 扣掉这个计画，高端的免疫桥接三期在泰国跟巴拉圭都做过，
: 巴拉圭也有给EUA
: https://www.rti.org.tw/news/view/id/2124522
: https://www.medigenvac.com/news_view.php?id=222
: 更别说WHO技转高端的疫苗技术，
: 什么~~你说没做vaccine efficacy不行?
: 好啦，人家WHO拿着几百万美金帮高端免费做，
: 免费做的原因就是因为他的中和抗体效价够高才有这个价值
: https://www.cna.com.tw/news/ahel/202308290345.aspx
: 更别说ICMRA 早在2021就有提到要用免疫桥接作为新疫苗实验设计的基础
: https://www.roc-taiwan.org/be/post/12576.html
: 怎么你的世界跟真实的世界不一样呢?
: 还是你比欧盟EMA/ICMRA/日本厚生劳动省更厉害呢?
: 今天我好心陪你复习旧知识，希望你有学到东西
: 加油~
: ※ 引述《femlro (既得此生当尽其用)》之铭言：
: : 你用后面的Omicron数据反推前面Alpha跟Delta病毒珠
: : 我都不知道说什么了
: : 如果这逻辑会通
: : 那就不用开发Xbb跟Omicron疫苗了
: : 卫福部选的时间点非常正确
: : 就是证明高端在Omicron以前的死亡率高于BNT
: : RCTs高端没有做
: : 所以当初根本没有VE数据
: : 更别提年龄层问题
: : 不做RCTs你跟我说这是科学还是政治呢？
: : 我是不懂拉
: : 要拿EUA出来解释使用Immunobridging来做为数据
: : 那怎么解释BNT、AZ、Moderna、Novavax通通都做了RCTs?
: : 还不讲娇生因为没过被打枪
: : RCTs没有做高端怎样都没办法摆脱这个污名
: : 因为这是全球的共识
: : 所以至今高端也只有台湾跟乌拉圭承认
: : 高端想去欧盟作RCTs也没有人要
: : 因为早就覆蓋率都够了
: : 为什么？
: : 因为次蛋白本来就要比mRNA更久
: : 他一开始就不是一个适合EUA的技术
: : 真的要为台湾好
: : 不是替高端护航
: : 是深刻检讨台湾怎样发展mRNA
: : 郭台铭把mRNA开始合作引入Biotech进台湾
: : 为台湾癌症作长期研究发展
: : 这次疫情过了
: : 请问民进党台湾的mRNA发展方案在哪里？
: : 要怎样在下次疫情可以有足够说服国际我们台湾的mRNA 不会只能卖乌拉圭
: : 能有国际的peer review？
: : 没有这些不要讲数据
: : 那些都是自我安慰而已