2021年6月20日 星期日

更正AZ緊急授權時機

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 LancetAZ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.

https://www.astrazeneca.com/media-centre/press-releases/2020/astrazenecas-covid-19-vaccine-authorised-in-uk.html 

[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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