[其他] AZ更新美國第三期臨床數據：保護力約76%
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76% vaccine efficacy against symptomatic COVID-19
100% efficacy against severe or critical disease and hospitalisation
85% efficacy against symptomatic COVID-19 in participants aged 65 years and over
Positive high-level results from the primary analysis of the Phase III trial of
AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specif
ied interim analysis announced on Monday 22 March 2021.
These results have been presented to the independent Data Safety Monitoring Boar
d. The primary analysis is pre-specified in the protocol and will be the basis f
or a regulatory submission for Emergency Use Authorization to the US Food and Dr
ug Administration in the coming weeks.
This primary efficacy analysis included the accrual of 190 symptomatic cases of
COVID-19 from the 32,449 trial participants, an additional 49 cases to the previ
ously announced interim analysis. Participants were randomised on a 2:1 ratio be
tween the vaccine and placebo group.
The primary endpoint, vaccine efficacy at preventing symptomatic COVID-19 was 76
% (confidence interval (CI): 68% to 82%) occurring 15 days or more after receivi
ng two doses given four weeks apart. In addition, results were comparable across
age groups, with vaccine efficacy of 85% (CI: 58% to 95%) in adults 65 years an
d older. A key secondary endpoint, preventing severe or critical disease and hos
pitalisation, demonstrated 100% efficacy. There were eight cases of severe COVID
-19 observed in the primary analysis with all of those cases in the placebo grou
p.
The vaccine was well tolerated, and no safety concerns related to the vaccine we
re identified.
https://bit.ly/2PvsrJO
被美國監管單位刁了一下
更新了數據
針對有症狀的保護力：76%
針對預防重症跟住院的保護力：100%
針對65歲以上有症狀的保護力：85%
與禮拜一公布的期中報告接近
總共32499位參與者
有190位有症狀者
比期中報告中的人數增加49位
AZ疫苗安全有效
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