※ 引述《mongi (大体老尸)》之铭言：
: 台湾的国产疫苗现在二期临床试验
: 应该就快解盲了
: 但我一直纳闷 万一解盲失败
: 国外疫苗又没有到位怎么办
: 台湾紧急授权还能强行通过吗
: 好如果顺利成功
: 但台湾市场就两千万人口
: 第三期临床试验受试者超过万元
: 补贴也要几万美金
: 以台湾的市场根本没有经济效益
: 那既然没有可能做第三期
: 台湾打的那么开心国外凭什么承认台湾疫苗
: 且全球的疫苗加工厂只会越来越多
: 供过于求 价格下降
: 那台湾疫苗的优势还在哪
: 所以合理怀疑讲炒股有什么错
每种药物的临床试验成功率如下图
https://imgur.com/a/MAxhXh8.jpg
我们可以看到疫苗临床二期成功解盲进入临床三期的机率是58%
一旦进入临床三期成功机率更是高达85.4%
但是临床试验的成功与否
是看这个试验有没有达到一开始设定的"Primary Outcome Measures"
这个primary outcome有达成再来看看是否有"Secondary Outcome"
若达到统计上的显著差异就可以说这个算成功了可进入下一关
高端的临床试验代号如下
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
安全性大概不会有什么问题
就看Immunogenicity是否有达到标准值，有达到就算成功
可是要证明群体保护效力可以到多少 %
那就是要等到大规模施打之后才能算出来