Re: [問卦] 時鐘說 很多知名的廠牌 都沒有做完三期
紐約時報有個網站對主要COVID-19疫苗的測試時程及使用技術有詳細的介紹。
The New York Times Coronavirus Vaccine Tracker
https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
https://tinyurl.com/nkcycrxj
根據這篇,"知名的廠牌沒有做完三期"的情況的確存在:
還完全未取得詳細三期測試資料就施打疫苗的國家包含中國和俄羅斯。
端看台灣要不要加入這個行列;
這篇也引述專家說法,警告可能有嚴重風險。
"JHU的Dr. Daniel Salmon及其他專家說(俄羅斯當初)跳過三期是危險的程序,三期實驗
得以決定該疫苗[比食鹽水]有效且不會傷害被施打者。"(2020/08報導)
原文:The Vaccine Testing Process章節
PHASE 2 EXPANDED TRIALS: Scientists give the vaccine to hundreds of people
split into groups, such as children and the elderly, to see if the vaccine
acts differently in them. These trials further test the vaccine's safety.
PHASE 3 EFFICACY TRIALS: Scientists give the vaccine to thousands of people
and wait to see how many become infected, compared with volunteers who
received a placebo. These trials can determine if the vaccine protects
against the coronavirus, measuring what's known as the efficacy rate. Phase 3
trials are also large enough to reveal evidence of relatively rare side
effects.
EARLY OR LIMITED APPROVAL: Many countries have procedures for providing
emergency authorizations for vaccines, based on preliminary evidence that they
are safe and effective. In addition, some countries such as China and Russia
began administering vaccines before detailed Phase 3 trial data was made public
. Experts have warned of serious risks from jumping ahead of these results.
^^^^^^^^^^^^^^^^^^^^^^^
順帶一提,前幾篇提到的疫苗正式許可(Full approvel; c.f. EUA)和同時做
不同期(Combined Phase),此文都有介紹。
另外,各大疫苗的資訊也都整理在這篇
比如說:
Pfizer-BioNTech ( https://tinyurl.com/3pk72p38 )
On July 27 [2020], the companies ... launch of a Phase 2/3 trial w/ 30,000
volunteers. On Sep 12, ... seek to expand the trial to 44,000 participants.
... on Nov 9, Pfizer and BioNTech released their preliminary analysis ...
Over the next month, Pfizer and BioNTech released more data on more cases.
On Dec 8 the FDA released their independent analysis of the clinical trials.
They determined that Comirnaty has an efficacy rate of 95 percent.
On Dec 2, the United Kingdom gave EUA, followed by many more countries.
...
--
Moderna (https://tinyurl.com/s6cpx2tj )( https://tinyurl.com/49b3mb6h )
July 27 [2020] ... Moderna and the N.I.H. begin Phase 3 testing on 30,000
volunteers across the US. ...
On Nov 16, Moderna announced the first preliminary data from the trial,
followed by the complete data on Nov 30. The researchers estimated that the
vaccine had an efficacy rate of 94.1 percent. ...
Nov 30 Moderna applies for emergency use authorization from the F.D.A.
Dec 18 The F.D.A. authorizes the Moderna vaccine for emergency use. ...
--
Johnson & Johnson ( https://tinyurl.com/ea439b97 )
... J&J launched a Phase 3 trial in September [2020] using just one dose ...
On Jan 29 [2021], J&J announced that the trial had proven that the vaccine was
safe and effective, and the F.D.A. released a similar analysis on Feb 24. ...
Bahrain ... first country to authorize the vaccine for emergency use on Feb 25.
On Feb 27, the F.D.A. issued an emergency use authorization for J&J's vaccine,
... the first to be shown to be safe and effective w/ just one dose ...
--
Oxford-AstrazZeneca ( https://tinyurl.com/49mxcsaj )
In early 2020, Oxford researchers developed the vaccine ... Teaming up with
AstraZeneca, they followed up w/ a Phase 1/2 trial. ... AstraZeneca and Oxford
then embarked on late-stage trials in the UK, South Africa, and elsewhere.
On Dec 8 [2020], AstraZeneca and Oxford published the 1st scientific paper on
a Phase 3 clinical trial ...demonstrated that the vaccine can protect people,
from COVID-19, but it left many questions unresolved about the results. ...
The UK and Argentina were the first countries to give the vaccine emergency
authorization, on Dec 30.
In March 2021 ... European medical regulators became concerned about a small
number of cases of blood clots in younger people who received Vaxzevria. The
European Medicines Agency concluded that the vaccine had a very rare side
effect ... is effective and the benefits ... outweighed the small risk ...
In response some countries chose to ... restricting the vaccine to older
people. In May, Norway permanently removed Vaxzevria ...
--
至於高端的話 ( https://tinyurl.com/d9seb6ha )
目前紐約時報上面還是列在Phase 2。
--
TL;DR 給直接end的人
最後來提Novavax ( https://tinyurl.com/eu9tyrew )
和高端相似(protein-based)的疫苗運作,( https://tinyurl.com/v672vvve )
我想他們的時程應該具有一點參考價值。
... launched a Phase 2 trial on 2,900 people in South Africa in August [2020],
and the next month it launched a Phase 3 trial with up to 15,000 volunteers in
the UK. A 30,000-person Phase 3 trial in the US ... launched on Dec 28 ... On
March 11 [2021], Novavax reported that their UK trial determined an efficacy
rate of 96% against the original coronavirus. But in South Africa, where ...
variant B.1.351, the efficacy was only 49%. In March, the chief executive of
Novavax said their vaccine might get authorized by the F.D.A. in May.
Novavax疫苗去年9月開始做第三期測試;今年3月開始揭開實驗結果;
根據紐約時報,至今(2021/05/30)疫苗仍未被授權核可使用。
--
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※ 文章網址: https://www.ptt.cc/bbs/Gossiping/M.1622371816.A.1C5.html
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去年9月是開始做第三期。
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※ 編輯: stwxk (137.83.219.6 美國), 05/30/2021 19:18:38
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完整討論串 (本文為第 9 之 9 篇):