Re: [爆卦] AZ BNT moderna都是做完三期才紧急授权!

楼主: Tianmu (TianMu)   2021-05-29 21:01:15
美国紧急授权 EUA 的 guideline 就在网络上 都可以查到
紧急授权都需要看到第三期的资料。
绝对没有可以有第二期资料就给发 EUA紧急授权的:
2020/10 EUA of FDA 版本网址
https://myscrs.org/wp-content/uploads/2021/01/Emergency-Use-Authorization-for-Vaccines-to-Prevent-COVID-19_Oct_2020.pdf
2021/5 EUA of FDA 版本网址
https://www.fda.gov/media/142749/download
撷取内文如下
内文如下(FDA acknowledges that an EUA for a COVID-19 vaccine may be requested to allow for the vaccine’s rapid and widespread deployment for administration to millions of individuals, including healthy people, potentially following interim results from one or more clinical trials meeting pre-specified success criteria described in the analysis plan submitted to FDA. In this scenario, for a COVID-19 vaccine for which there is adequate manufacturing information to ensure its quality and consistency,
issuance of an EUA would require a determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.)
以辉瑞 pfizer - BNT为例 已经做完phase 3 研究
直接准备申请 EUA紧急授权 也同步进行论文发表第3期报告
2020 11/20 美国EUA 核准 Pfizer 紧急使用。
2020/12/10 NEJM 发表文章 https://www.fda.gov/media/144416/download
我相信FDA已经看到资料才紧急同意使用
※ 引述《mongi (大体老尸)》之铭言:
: 看那些侧翼又在那边造谣乱讲
: 说国外疫苗都是二期做完就申请紧急授权(EUA)
: 所以台湾也可以 是这样吗
: 我上网看了个药厂的声明
: 1. AZ (AstraZeneca)
: https://i.imgur.com/9cud1YE.jpg
: 2020/12/8 发布第三期临床试验完成并发表在the lancet 期刊(impact factor:60.932)
: 2. Moderna(莫德纳)
: https://i.imgur.com/wXuHasw.jpg
: Moderna也是做完三期临床通过才紧急授权
: 3. BNT /Pfizer (辉瑞BNT)
: https://i.imgur.com/KcvnJLx.jpg
: BNT也是做完三期通过才紧急授权
: 这些公开资讯都在药厂网站 以及pubmed论文可找
: 根本没有和联亚高端疫苗一样二期临床之后
: 就紧急授权的
: 侧翼是在恶心
: 又想扭曲科学事实

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