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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） (16 ページ)
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301: Primary Efficacy Analysis
Vaccine Efficacy in Protecting Against PCR-Confirmed Mild, Moderate, or Severe
COVID-19 With Onset From 7 Days After Second Injection, Per-Protocol Efficacy Set
Age Group
All participants
18 to <65 years
≥65 years
NVX-CoV2373
n/N (%)
(Mean Incidence Rate/
1000 Person-Years)
17/17272 (0.098)
(4.34)
15/15228 (0.099)
(5.70)
2/2044 (0.098)
(5.76)
NVX-CoV2373
cases
Placebo
cases
Mild
17
66
Moderate
0
9
Severe
0
4
Placebo
n/N (%)
(Mean Incidence Rate/
1000 Person-Years)
79/8385 (0.942)
(45.25)
75/7417 (1.011)
(63.69)
4/968 (0.413)
(26.52)
Vaccine Efficacy
(95% CI)
90.41
(83.81, 94.32)
91.06
(84.44, 94.87)
78.63
(-16.64, 96.08)
VE(%) =100 × (1-RR); RR is ratio of incidence rates of active group relative to the
placebo arm (NVX-CoV2373/placebo) with first occurrence of event with onset during a
surveillance period from 7 days after second injection up to censor date.
15
Vaccine Efficacy in Protecting Against PCR-Confirmed Mild, Moderate, or Severe
COVID-19 With Onset From 7 Days After Second Injection, Per-Protocol Efficacy Set
Age Group
All participants
18 to <65 years
≥65 years
NVX-CoV2373
n/N (%)
(Mean Incidence Rate/
1000 Person-Years)
17/17272 (0.098)
(4.34)
15/15228 (0.099)
(5.70)
2/2044 (0.098)
(5.76)
NVX-CoV2373
cases
Placebo
cases
Mild
17
66
Moderate
0
9
Severe
0
4
Placebo
n/N (%)
(Mean Incidence Rate/
1000 Person-Years)
79/8385 (0.942)
(45.25)
75/7417 (1.011)
(63.69)
4/968 (0.413)
(26.52)
Vaccine Efficacy
(95% CI)
90.41
(83.81, 94.32)
91.06
(84.44, 94.87)
78.63
(-16.64, 96.08)
VE(%) =100 × (1-RR); RR is ratio of incidence rates of active group relative to the
placebo arm (NVX-CoV2373/placebo) with first occurrence of event with onset during a
surveillance period from 7 days after second injection up to censor date.
15