よむ、つかう、まなぶ。
参考資料13 Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Presentation - FDA Review of Effectiveness and Safety of Novavax COVID-19 Vaccine in Adults > 18 Years of Age - Emergency Use Authorization Request（Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting FDA提出資料） (18 ページ)
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301: Secondary Efficacy Analyses
Secondary Efficacy Analysis
Efficacy Against COVID-19 Among Variants
Vaccine Efficacy in Protecting Against PCRConfirmed Moderate to Severe COVID-19
Subgroup Analyses of Vaccine Efficacy
Results
Of the 96 cases in the primary efficacy analysis, 75 had sequence
data available, the majority of which were Alpha (53%), Iota
(11%), or Epsilon (7%). Currently, none of the variants
identified in the primary efficacy analysis are considered
variants of concern (VOC)/variants of interest (VOI).
A total of 13 moderate to severe COVID-19 cases were reported
in the placebo arm, and none were reported in the NVX arm,
resulting in VE of 100% (95% CI 85.4, 100.0).
The point estimate of VE across the subgroups was comparable
to the overall study population; however, lower efficacy rates were
observed for participants of Hispanic or Latino ethnicity (VE=
77.0% [95% CI 48.7, 90.0]).
17
Secondary Efficacy Analysis
Efficacy Against COVID-19 Among Variants
Vaccine Efficacy in Protecting Against PCRConfirmed Moderate to Severe COVID-19
Subgroup Analyses of Vaccine Efficacy
Results
Of the 96 cases in the primary efficacy analysis, 75 had sequence
data available, the majority of which were Alpha (53%), Iota
(11%), or Epsilon (7%). Currently, none of the variants
identified in the primary efficacy analysis are considered
variants of concern (VOC)/variants of interest (VOI).
A total of 13 moderate to severe COVID-19 cases were reported
in the placebo arm, and none were reported in the NVX arm,
resulting in VE of 100% (95% CI 85.4, 100.0).
The point estimate of VE across the subgroups was comparable
to the overall study population; however, lower efficacy rates were
observed for participants of Hispanic or Latino ethnicity (VE=
77.0% [95% CI 48.7, 90.0]).
17