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） (20 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000208910_00043.html |
| 出典情報 | 第80回厚生科学審議会予防接種・ワクチン分科会副反応検討部会、令和4年度第5回薬事・食品衛生審議会薬事分科会医薬品等安全対策部会安全対策調査会（合同開催）（6／10）《厚生労働省》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
301: Safety Analysis Population: Demographics
Sex
NVX-CoV2373
N=19735
48% female
Placebo
N=9847
49% female
Total
N=29945
48% female
Median age
47.0 years
47.0 years
47.0 years
>65 years
13%
13%
13%
Race/Ethnicity
75% White, 12% African
American, 7% American Indian
or Alaska Native, 4% Asian;
22% Hispanic
75% White, 12% African
American, 7% American
Indian or Alaska Native, 4%
Asian; 22% Hispanic
75% White, 12% African
American, 7% 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: 14%
Cardiovascular disease: 1%
DM Type 2: 8%
High-risk
94%
93%
93%
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
19
Sex
NVX-CoV2373
N=19735
48% female
Placebo
N=9847
49% female
Total
N=29945
48% female
Median age
47.0 years
47.0 years
47.0 years
>65 years
13%
13%
13%
Race/Ethnicity
75% White, 12% African
American, 7% American Indian
or Alaska Native, 4% Asian;
22% Hispanic
75% White, 12% African
American, 7% American
Indian or Alaska Native, 4%
Asian; 22% Hispanic
75% White, 12% African
American, 7% 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: 14%
Cardiovascular disease: 1%
DM Type 2: 8%
High-risk
94%
93%
93%
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
19