Re: [問卦] 國產疫苗萬一解盲失敗怎麼辦？

※ 引述《mongi (大體老屍)》之銘言：
: 台灣的國產疫苗現在二期臨床試驗
: 應該就快解盲了
: 但我一直納悶 萬一解盲失敗
: 國外疫苗又沒有到位怎麼辦
: 台灣緊急授權還能強行通過嗎
: 好如果順利成功
: 但台灣市場就兩千萬人口
: 第三期臨床試驗受試者超過萬元
: 補貼也要幾萬美金
: 以台灣的市場根本沒有經濟效益
: 那既然沒有可能做第三期
: 台灣打的那麼開心國外憑什麼承認台灣疫苗
: 且全球的疫苗加工廠只會越來越多
: 供過於求 價格下降
: 那台灣疫苗的優勢還在哪
: 所以合理懷疑講炒股有什麼錯

每種藥物的臨床試驗成功率如下圖

https://imgur.com/a/MAxhXh8.jpg

我們可以看到疫苗臨床二期成功解盲進入臨床三期的機率是58%

一旦進入臨床三期成功機率更是高達85.4%

但是臨床試驗的成功與否

是看這個試驗有沒有達到一開始設定的"Primary Outcome Measures"

這個primary outcome有達成再來看看是否有"Secondary Outcome"

若達到統計上的顯著差異就可以說這個算成功了可進入下一關

高端的臨床試驗代號如下

ClinicalTrials.gov Identifier: NCT04695652

Primary Outcome Measures :

Incidence of Adverse Event within 28 days post the second study intervention
(Safety of MVC-COV1901) [ Time Frame: Day 1 to 28 days after second
vaccination ]

To evaluate the safety and tolerability of MVC-COV1901 from Visit 2 (Day 1)
to Visit 7 (28 days after the second dose of study intervention) in terms of
the number and percentage of participants with the occurrence of:

Solicited local AEs (up to 7 days after each dose of study intervention)

Solicited systemic AEs (up to 7 days after each dose of study intervention)
Unsolicited AEs (up to 28 days after each dose of study intervention)

AE of Special Interest (AESI)
Vaccine-Associated Enhanced Disease(VAED)
Serious adverse events (SAEs)

Immunogenicity of MVC-COV1901 [ Time Frame: Day 1 to 28 days after second
vaccination ]

To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in
terms of neutralizing antibody titers

Secondary Outcome Measures :

Incidence of Adverse Event throughout study conduct (Safety of MVC-COV1901) [Time Frame: Day 1 to 180 days after second vaccination ]

To evaluate the safety of MVC-COV1901 over the study period in terms of the
number and percentage of participants with the occurrence of:
>= Grade 3 AE

AE of Special Interest (AESI)

Vaccine-Associated Enhanced Disease(VAED)

Serious adverse events (SAEs)

lot to lot consistency [ Time Frame: Day 1 to 28 days after second
vaccination ]

To evaluate the lot-to-lot consistency of MVC-COV1901 in participants of
20 to 65 years age group

安全性大概不會有什麼問題

就看Immunogenicity是否有達到標準值，有達到就算成功

可是要證明群體保護效力可以到多少 %

那就是要等到大規模施打之後才能算出來

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