※ 引述《Makubex82 ()》之铭言：
: 标题: [问卦] 时钟说 很多知名的厂牌 都没有做完三期
: 时间: Sun May 30 14:48:35 2021
:
: 时钟刚才说 很多知名的厂牌
: 都没有做完三期 就开始EUA 施打了
:
: 哪些知名的厂牌
: https://i.imgur.com/tpMEtQQ.png
: AZ?
: Moderna?
: BNT?
: 还是???
:
: 我上网查 连科兴都有三期
: 是哪间知名厂牌 可以分享一下吗
这个就话术啊！昨天的讨论串讲过了，我整理一下：
## 被列在 WHO 的 EUL 里的那些疫苗，都有做三期临床试验，但还有后续追踪，
所以严格上说“没做完三期”是可以接受的。
"The EUL pathway involves a rigorous assessment of late phase II and phase III
clinical trial data as well as substantial additional data on safety,
efficacy, quality and a risk management plan. These data are reviewed by
independent experts and WHO teams who consider the current body of evidence
on the vaccine under consideration, the plans for monitoring its use, and
plans for further studies."
<REF>
WHO, WHO lists two additional COVID-19 vaccines for emergency use and COVAX
roll-out
https://reurl.cc/gW79bX
## 辉瑞疫苗或者说 BNT 疫苗是做完有效性最终分析的

"Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that,
after conducting the final efficacy analysis in their ongoing Phase 3 study,
their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’
s primary efficacy endpoints."
"The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled
43,661 participants to date, 41,135 of whom have received a second dose of
the vaccine candidate as of November 13, 2020. Approximately 42% of global
participants and 30% of U.S. participants have racially and ethnically
diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85
years of age. A breakdown of the diversity of clinical trial participants can
be found here from approximately 150 clinical trials sites in United States,
Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue
to collect efficacy and safety data in participants for an additional two
years."
<REF>
Pfizer, PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE,
MEETING ALL PRIMARY EFFICACY ENDPOINTS
https://reurl.cc/Lb3Yr7
## 美国 FDA 针对 Covid-19 疫苗的紧急使用授权(EUA)标准，必须具备三期临床
试验的期中分析或最终报告，安全性部分, 必须完成一二期的所有安全性数据
以及三期最少两个月的追踪
"For an EUA to be issued for a vaccine, for which there is adequate
manufacturing information to ensure quality and consistency, FDA must
determine that the known and potential benefits outweigh the known and
potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be
submitted to FDA based on a final analysis of a phase 3 clinical efficacy
trial or an interim analysis of such trial, i.e., an analysis performed
before the planned end of the trial once the data have met the pre-specified
success criteria for the study’s primary efficacy endpoint.
From a safety perspective, FDA expects an EUA submission will include all
safety data accumulated from phase 1 and 2 studies conducted with the
vaccine, with an expectation that phase 3 data will include a median
follow-up of at least 2-months (meaning that at least half of vaccine
recipients in phase 3 clinical trials have at least 2 months of follow-up)
after completion of the full vaccination regimen. In addition, FDA expects
that an EUA request will include a phase 3 safety database of well over 3,000
vaccine recipients, representing a high proportion of participants enrolled
in the phase 3 study, who have been followed for serious adverse events and
adverse events of special interest for at least one month after completion of
the full vaccination regimen."
<REF>
U.S. FDA, Emergency Use Authorization for Vaccines Explained
https://reurl.cc/nozkG8
## 懒人总结
- 二期临床试验是安全性, 确保打了安全, 不会因为打疫苗就暴毙或
引发并发症
- 三期临床试验是有效力, 确保疫苗对病毒有防护力, 不会打了像是
吃保健食品心安，而是知道他能够对抗病毒
- 多数受国际认可的疫苗都有三期试验, 即使柯兴国药备受质疑批评,
但他们正在做三期临床试验
- 目前国产只知道做完二期, 目前我比较废找不到正在做三期的资讯,
国家生技菁英的资料都是写正在协商，要嘛就是很神奇的二三期一
起做, 可能是贯彻抠死当的精神, 省时省力, 赞啦!