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免疫橋接 世界潮流 - 選擇高端 人財兩得

免疫橋接或許是新名詞, 但並不是新的方法.
已經行之有年, 如肺炎鏈球菌疫苗、 人類乳突疫苗(HPV疫苗)...

當年國光的流感疫苗, 只完成標準的二期. (約300人, 與高端、聯亞將近4000人的二期不同)
就由馬英九和朱立倫帶頭施打. 相較高端更是便宜行事.

特定媒體、名嘴, 針對高端不斷的提出各種質疑.
仿佛人人都是疫苗專家, 其實內容荒誕不經. 但也困惑迷惘多數對疫苗不熟悉的普羅大眾. (請守護口業)

隨著潮水退去, 許多真象終將逐一浮現.

放棄選擇最安全、副作用最低又效果佳的疫苗, 寧可挑戰高副作用又是全新的技術, 沒有經過完整實證的產品.
以投資的角度, 當然也錯失富作用非同小可的疫苗股.
這是人財兩失.

Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators

The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.

Vial of blue liquid with syringe drawing from it between two black and red SARS-CoV-2 particles - idea of COVID-19 vaccine

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced that, though placebo-controlled disease endpoint trials are the gold standard for authorising vaccines, well-justified and appropriately designed immuno-bridging studies are an acceptable approach for authorising COVID-19 vaccines.

Immuno-bridging studies are controlled trials, leveraging placebo or other controls and correlates of protection such as humoral and/or cellular immune parameters to establish whether an intervention is effective.

The MHRA’s decision to support immuno-bridging studies for authorising COVID-19 vaccines was based on a workshop in 24 June 2021, convened by the International Coalition of Medicines Regulatory Authorities (ICMRA), to consider the development of COVID-19 vaccines. They focused on immuno-bridging studies because in some countries it is difficult to conduct traditional, placebo-controlled efficacy trials for COVID-19 vaccines, as few candidates are willing and available to participate.

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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 factors.


國產高端疫苗8/23開打 免疫橋接有前例【專家講疫】
https://www.youtube.com/watch?v=JyaHAuDFf9M

各國解疫苗荒！「免疫橋接」成歐美研究主流

https://www.youtube.com/watch?v=YxmF3BBURAA 

高端成功解盲! 國產疫苗該打嗎? 還是政治騙局!? | 蒼藍鴿聊醫學EP154

https://www.youtube.com/watch?v=GF01dRGeBgw

#1
民眾被洗腦 醫生也抓狂！高端副作用最少是真的啦…

#2
免疫橋接授權疫苗 跨國醫藥聯盟證實可行

#3
研究：抗體濃度可測COVID-19疫苗保護力

#4
巴拉圭核准高端疫苗三期臨床試驗 免疫橋接比對AZ

#5
高端疫苗將啟動歐盟3期免疫橋接試驗　最快明年初取得認證

#6
高端COVID-19疫苗第3期試驗 獲歐盟EMA核准進行

#7
林氏璧專訪連加恩醫師！ 高端疫苗 免疫橋接進展 第三針 國際認證 次世代疫苗 產能 一次問到飽！
林氏璧孔醫師的新冠病毒討論會

#8
ICMRA：第二代疫苗需要「免疫橋接」日藥廠跟進！張鴻仁：「食藥署決定是對的！」

#9
免疫橋接認證COVID-19疫苗成趨勢 日、英都擬採用

#10
免疫橋接！南韓國產疫苗三期臨床較勁AZ中和抗體

#11
Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
https://valneva.com/press-release/valneva-reports-positive-phase-3-results-for-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/

...Valneva (VALN)  的疫苗 VLA2001, 採免疫橋接 4000人的臨床 

#12
高端新冠疫苗巴拉圭三期試驗 最快年底前取得數據
...文中提到法國藥廠 Valneva 採用免疫橋接試驗, 目前仍有多國如日、韓、英... 都有疫苗進行免疫橋接試驗.

#13
4大疫苗不良反應PK！人氣最低的這款表現最好　名醫揭謎底
...高端表現最佳, 真的不是意外

#14
高端入選WHO「團體試驗疫苗」計畫　宣布展開全球第三期臨床試驗

#15
高端可能打不完 外交部：多國想要台灣國產疫苗

#16
WHO團結試驗疫苗計畫納高端

#17
葉金川／期許高端成為公益疫苗

#18
高端將與CEPI共同出資 在台進行第三針混打試驗

#19
亞美尼亞疫苗試驗的免費途徑

#20
高端疫苗「WHO團結疫苗試驗」收案破萬人 預告擴大量產規模

#21
我贈索馬利蘭15萬劑高端「效期曝光」　莊人祥曝下波捐贈計畫

#22
【解盲修但幾勒】高端3期實驗先揭極少量不良反應 巴拉圭看好：期待振奮結果

#23
2021十大疫苗新聞出爐 「高端二期登國際期刊」獲TOP1

#24
腸病毒疫苗

#25
巴拉圭三期的期中報告

#26
快訊／高端疫苗通過第三期試驗！效價為「AZ的3.7倍」獲巴拉圭EUA

#27
高端WHO團結試驗結果本月有望出爐！李秉穎：若成功國產疫苗可遨遊全世界

#28
本土超過50人打3劑染疫！高端突破性感染最少　最多是「這款」

#29
高端腸病毒疫苗三期臨床結果 獲國際期刊刺胳針發表

#30
歐洲藥品局（EMA）啟動對Valneva藥廠研發之COVID-19疫苗 (VLA2001) 滾動式審查

法商Valneva新冠疫苗臨床3期數據出爐！ 效果與AZ相似副作用更少

#31
韓國首個新冠疫苗申請獲批
Approval requested for Korea's first Covid vaccine

#32
輝瑞公布實驗結果：Paxlovid口服藥無法預防感染

#33
Nature
CpG-adjuvanted stable prefusion SARS-CoV-2 spike protein protected hamsters from SARS-CoV-2 challenge

THE LANCET
Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901:
interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan

MedRxiv
Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in adolescents in Taiwan: A
double-blind, randomized, placebo-controlled phase 2 trial 

#34
高端疫苗WHO團結試驗將解盲，後續發展具想像

#35
高端次世代新冠疫苗完成試驗收案！動物攻毒數據由國際期刊審查發表

#36
快訊／高端「新冠疫苗」已正式向澳洲TGA　申請緊急使用許可！

#37
高端新冠疫苗申請澳洲緊急使用許可 估全球仍有百億劑需求量

#38
MDPI
An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901

#39
Clinical Infectious Diseases
Evaluating the Neutralizing Ability of a CpG-Adjuvanted S-2P Subunit Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Variants of Concern 

#40
瑞士科學期刊研究報告：高端疫苗「保護力84%」 科興、國藥僅65%
瑞士科學期刊刊出一份研究報告指出，高端疫苗的總體保護力84%，無嚴重不良反應。   

#41
medRxiv
An Evaluation of the Safety and Immunogenicity of MVC-COV1901: Results of an interim analysis of a phase III, parallel group, randomized, double-blind, active-controlled study

#42
高端疫苗巴國三期試驗結果出爐！亞松森大學：血清轉化率及中和抗體比值皆優於AZ

#44
「我很不喜歡mRNA疫苗」　李秉穎：全身亂竄、器官發炎

#45
高端新冠疫苗「高齡族數據」　獲國際期刊審查發表

#46
高端新冠肺炎疫苗泰國三期臨床試驗結果：安全性良好、免疫原性優於AZ

#47
高端腸病毒疫苗 向越南申請上市

#48
關於疫苗開發 / 矢板明夫

#49
Safety, Tolerability, and Immunogenicity of Booster Dose with MVC-COV1901 or MVC-COV1901-Beta SARS-CoV-2 Vaccine in Adults: A Phase I, Prospective, Randomized, Open-Labeled Study

https://www.mdpi.com/2076-393X/11/12/1798

5. Conclusions
In this study, we found that a booster dose with the MVC-COV1901-Beta vaccine after a primary series of MVC-COV1901 can generate a broad immune response that croos-reacts with various Omicron subvariants.

#50
高端保護力破9成 「與BNT疫苗相似」獲美CDC期刊刊登

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