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） (14 ページ)
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301: Efficacy Analysis Population: Demographics
NVX-CoV2373
N=17272
Placebo
N=8385
Total
N=25657
Sex
48% female
50% female
49%
Median age
47.0 years
47.0 years
47.0 years
>65 years
12%
12%
12%
Race/Ethnicity
76% White, 11% African
American, 6% American Indian
or Alaska Native, 4% Asian;
22% Hispanic
76% White, 11% African
American, 6% American
Indian or Alaska Native, 5%
Asian; 22% Hispanic
76% White, 11% African
American, 6% American
Indian or Alaska Native, 4%
Asian; 22% Hispanic
Countries
US (94%), Mexico (6%)
US (94%), Mexico (6%)
US (94%), Mexico (6%)
Co-morbidities
Obesity: 37%
Chronic kidney disease: 1%
Chronic lung disease: 14%
Cardiovascular disease: 1%
DM Type 2: 8%
Obesity: 40%
Chronic kidney disease: 1%
Chronic lung disease: 15%
Cardiovascular disease: 1%
DM Type 2: 8%
Obesity: 37%
Chronic kidney disease: 1%
Chronic lung disease: 15%
Cardiovascular disease: 1%
DM Type 2: 8%
High-risk*
95%
95%
95%
DM= Diabetes mellitus; Obesity= Body mass index >30 kg/m3
* High-risk adults were defined as 1) age ≥65 years with or without comorbidities and/or living or working conditions involving known frequent exposure to SARS-CoV-2 or to densely populated
circumstances; 2) age <65 years with comorbidities and/or living or working conditions involving known frequent exposure to SARS-CoV-2 or to densely populated circumstances
13
NVX-CoV2373
N=17272
Placebo
N=8385
Total
N=25657
Sex
48% female
50% female
49%
Median age
47.0 years
47.0 years
47.0 years
>65 years
12%
12%
12%
Race/Ethnicity
76% White, 11% African
American, 6% American Indian
or Alaska Native, 4% Asian;
22% Hispanic
76% White, 11% African
American, 6% American
Indian or Alaska Native, 5%
Asian; 22% Hispanic
76% White, 11% African
American, 6% American
Indian or Alaska Native, 4%
Asian; 22% Hispanic
Countries
US (94%), Mexico (6%)
US (94%), Mexico (6%)
US (94%), Mexico (6%)
Co-morbidities
Obesity: 37%
Chronic kidney disease: 1%
Chronic lung disease: 14%
Cardiovascular disease: 1%
DM Type 2: 8%
Obesity: 40%
Chronic kidney disease: 1%
Chronic lung disease: 15%
Cardiovascular disease: 1%
DM Type 2: 8%
Obesity: 37%
Chronic kidney disease: 1%
Chronic lung disease: 15%
Cardiovascular disease: 1%
DM Type 2: 8%
High-risk*
95%
95%
95%
DM= Diabetes mellitus; Obesity= Body mass index >30 kg/m3
* High-risk adults were defined as 1) age ≥65 years with or without comorbidities and/or living or working conditions involving known frequent exposure to SARS-CoV-2 or to densely populated
circumstances; 2) age <65 years with comorbidities and/or living or working conditions involving known frequent exposure to SARS-CoV-2 or to densely populated circumstances
13