更正AZ緊急授權時機
先前我為文說:英國緊急授權AZ(AZD1222),僅完成二期,沒進入三期,因為按經驗研判,試驗從2020/4開始,12/30授權,才8個月,不可能進入三期。
剛查了AZ新聞稿[1],英國基於三期期中分析才給授權,該數據也在8 Dec. 2020刊於The Lancet。AZ三期試驗從2020/8/28開始,離2020/12/30授權,過4個月,三期預計2023/2完成[2]。
台灣擬比較AZ的中和抗體(免疫橋接)做為審查標準之一,目前WHO開會持正面態度,但還沒給出正式結論。台灣審查緊急授權共10個程序,就交給審查委員吧!
………..
[1] AZ發新聞稿30 Dec. 2020
The MHRA’s decision was based on independent advice from its Commission on Human Medicines following a rolling review of trial data that included an interim analysis of the Phase III programme led by the University of Oxford. The data were also published in The Lancet on 8 December 2020.
[2] AZD1222第三期試驗
試驗人數:32459 participants
實際開始:August 28, 2020
預計完成:February 14, 2023
https://clinicaltrials.gov/ct2/show/NCT04516746
eaton
2021/6/20
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