※ 引述《sincere77 (台湾会更好)》之铭言：
: 1.媒体来源:
: 自由时报
: 2.记者署名:
: 林惠琴
: 3.完整新闻标题:
: 5月底请辞国产疫苗审查委员 陈培哲：原因就是蔡总统
(内文恕删)
大家别太紧张
PJ也没说他审的是高端还是联亚或是两个都审
先来看看这两家的临床二期试验资讯
联亚
https://reurl.cc/rg1pRr
ClinicalTrials.gov Identifier: NCT04773067
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 3850 participants
Actual Study Start Date : January 30, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022
Primary Outcome Measures
1. Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody
[ Time Frame: Day 57 ] Evaluation of immunogenicity
2. Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody
[ Time Frame: Day 57 ] Evaluation of immunogenicity
3. Safety evaluation [ Time Frame: Day 1 to Day 197 ]
Local reactions and systemic events for up to 7 days following each dose
Unsolicited adverse events from Day 1 to Day 57
MAAEs, SAEs, AESIs and ADEs from Day 1 to Day 197
高端
https://reurl.cc/xGEdQZ
ClinicalTrials.gov Identifier: NCT04695652
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 3700 participants
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022
Primary Outcome Measures :
1. 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)
2. 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
简单来说
这两家的临床二期的Primary Outcome都有说要看Immunogenicity
也都是要看施打完疫苗的neutralizaing antibody titers
然后疫苗有没有产生免疫效果
在这试验阶段就要看这个neutralizaing antibody的表现是否很棒棒
去统计受试者打完过28天之后
体内所产生出来的中和抗体浓度是否仍能有效阻碍(中和)病毒感染细胞
然后计算统计上是否达到显著差异以及有效群体数量(%)等
至于中和抗体要到多少程度可以有效阻止SARS-CoV-2感染细胞
并且可以用来作为桥接试验的标准浓度
国外专家会议尚未有明确定论 (也就是俗称的：窝不知道)
但是也因为还没有明确定论
就决定要用中和抗体浓度来当效力标准
那titer是要用 (1：4) (1：8) (1：16) (1：32)还是 (1：64)当标准呢
https://imgur.com/a/pVjIQqt.jpg