※ 引述《Makubex82 ()》之銘言：
: 標題: [問卦] 時鐘說 很多知名的廠牌 都沒有做完三期
: 時間: Sun May 30 14:48:35 2021
:
: 時鐘剛才說 很多知名的廠牌
: 都沒有做完三期 就開始EUA 施打了
:
: 哪些知名的廠牌
: https://i.imgur.com/tpMEtQQ.png
: AZ?
: Moderna?
: BNT?
: 還是???
:
: 我上網查 連科興都有三期
: 是哪間知名廠牌 可以分享一下嗎
這個就話術啊！昨天的討論串講過了，我整理一下：
## 被列在 WHO 的 EUL 裡的那些疫苗，都有做三期臨床試驗，但還有後續追蹤，
所以嚴格上說「沒做完三期」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
## 輝瑞疫苗或者說 BNT 疫苗是做完有效性最終分析的

"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
## 美國 FDA 針對 Covid-19 疫苗的緊急使用授權(EUA)標準，必須具備三期臨床
試驗的期中分析或最終報告，安全性部分, 必須完成一二期的所有安全性數據
以及三期最少兩個月的追蹤
"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
## 懶人總結
- 二期臨床試驗是安全性, 確保打了安全, 不會因為打疫苗就暴斃或
引發併發症
- 三期臨床試驗是有效力, 確保疫苗對病毒有防護力, 不會打了像是
吃保健食品心安，而是知道他能夠對抗病毒
- 多數受國際認可的疫苗都有三期試驗, 即使柯興國藥備受質疑批評,
但他們正在做三期臨床試驗
- 目前國產只知道做完二期, 目前我比較廢找不到正在做三期的資訊,
國家生技菁英的資料都是寫正在協商，要嘛就是很神奇的二三期一
起做, 可能是貫徹摳死當的精神, 省時省力, 讚啦!