Re: [爆卦] AZ BNT moderna都是做完三期才緊急授權！

Tianmu 發表於 2021/5/29 下午9:01:15

看板Gossiping標題Re: [爆卦] AZ BNT moderna都是做完三期才緊急授權！作者

(TianMu)時間May 29 21:01:15 2021推噓 5 推:5 噓:0 →:4

美國緊急授權 EUA 的 guideline 就在網路上都可以查到
緊急授權都需要看到第三期的資料。
絕對沒有可以有第二期資料就給發 EUA緊急授權的：

2020/10 EUA of FDA 版本網址
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 版本網址
https://www.fda.gov/media/142749/download

擷取內文如下
內文如下（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.）

以輝瑞 pfizer - BNT為例已經做完phase 3 研究
直接準備申請 EUA緊急授權也同步進行論文發表第3期報告

2020 11/20 美國EUA 核准 Pfizer 緊急使用。
2020/12/10 NEJM 發表文章 https://www.fda.gov/media/144416/download
我相信FDA已經看到資料才緊急同意使用

※ 引述《mongi (大體老屍)》之銘言：
: 看那些側翼又在那邊造謠亂講
: 說國外疫苗都是二期做完就申請緊急授權（EUA)
: 所以台灣也可以是這樣嗎
: 我上網看了個藥廠的聲明
: 1. AZ (AstraZeneca)
: https://i.imgur.com/9cud1YE.jpg