[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-specified interim analysis announced on Monday 22 March 2021.

These results have been presented to the independent Data Safety Monitoring Board. The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug 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 previously announced interim analysis. Participants were randomised on a 2:1 ratio between 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 receiving 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 and older. A key secondary endpoint, preventing severe or critical disease and hospitalisation, demonstrated 100% efficacy. There were eight cases of severe COVID-19 observed in the primary analysis with all of those cases in the placebo group.

The vaccine was well tolerated, and no safety concerns related to the vaccine were 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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