※ 引述《femlro (既得此生当尽其用)》之铭言：
: ※ 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
前面烙那么多术语结果只是只会数一二三的情弱仔
该不会你不知道他们全都是三期免疫桥接啊？
https://i.imgur.com/sZqdvg4.jpeg
SK的结果是 2.9倍AZ
https://i.imgur.com/c3vPyHm.jpeg
VLA2001 是1.39倍
https://i.imgur.com/kwoFiyl.jpeg
一样都是采3000ー4000人左右
这些都谷歌的到欸
就说高端别取名什么扩大二期
没命名天分
: : 加油~