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） (23 ページ)
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301: Safety- Solicited systemic reactogenicity
Frequency of Solicited Systemic Reactions Within 7
Days After Each Dose, Safety Analysis Set Participants
≥65 Years of Age
Frequency of Solicited Systemic Reactions Within 7 Days After Each
Dose, Safety Analysis Set Participants 18 to <65 Years of Age
Solicited Systemic
Reaction
Any solicited systemic
reaction, (%)
Any (Grade ≥1)
Grade 3
Grade 4
Fatigue/malaise, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Headache, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Muscle pain (myalgia), (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
NVXCoV2373
Dose 1
N=15884
-49.7
2.4
0.1
-30.8
15.1
14.1
1.6
0.1
-26.2
19.9
5.5
0.8
<0.1
-24.1
17.8
5.8
0.5
<0.1
--
NVXCoV2373
Dose 2
N=15148
--
41.2
2.2
0.1
-26.6
13.1
12.1
1.4
<0.1
-23.7
18.3
4.7
0.7
<0.1
-13.6
9.6
3.6
0.4
<0.1
72.1
13.0
0.1
-58.3
16.9
30.8
10.5
0.1
-47.1
24.9
18.8
3.3
<0.1
-50.7
22.9
22.5
5.3
<0.1
Placebo
Dose 1
N=7868
Placebo
Dose 2
N=7361
-36.9
2.1
0.1
-25.7
12.1
12.0
1.6
<0.1
-20.3
15.0
4.8
0.5
<0.1
-12.2
8.3
3.5
0.4
0.1
Solicited Systemic
Reaction
Any solicited systemic
reaction, (%)
Any (Grade ≥1)
Grade 3
Grade 4
Fatigue/malaise, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Headache, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Muscle pain (myalgia), (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
NVXCoV2373
Dose 1
N=2251
-32.2
1.6
<0.1
-19.7
10.9
7.8
1.0
0
-15.3
13.0
1..7
0.5
<0.1
-12.6
9.9
2.6
0.1
0
--
NVXCoV2373
Dose 2
N=2048
--
31.5
1.1
0
-18.1
9.4
8.3
0.5
0
-16.5
13.7
2.4
0.4
0
-11.2
7.9
3.0
0.4
0
48.7
4.4
0.1
-34.9
14.4
17.1
3.3
0
-24.5
18.5
5.1
0.9
0.1
-27.4
16.8
9.0
1.6
0
Placebo
Dose 1
N=1114
Placebo
Dose 2
N=978
-28.2
1.5
0
-18.6
9.8
7.5
1.3
0
-14.7
12.0
2.6
0.2
0
-10.4
7.0
3.3
0.2
0
22
Frequency of Solicited Systemic Reactions Within 7
Days After Each Dose, Safety Analysis Set Participants
≥65 Years of Age
Frequency of Solicited Systemic Reactions Within 7 Days After Each
Dose, Safety Analysis Set Participants 18 to <65 Years of Age
Solicited Systemic
Reaction
Any solicited systemic
reaction, (%)
Any (Grade ≥1)
Grade 3
Grade 4
Fatigue/malaise, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Headache, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Muscle pain (myalgia), (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
NVXCoV2373
Dose 1
N=15884
-49.7
2.4
0.1
-30.8
15.1
14.1
1.6
0.1
-26.2
19.9
5.5
0.8
<0.1
-24.1
17.8
5.8
0.5
<0.1
--
NVXCoV2373
Dose 2
N=15148
--
41.2
2.2
0.1
-26.6
13.1
12.1
1.4
<0.1
-23.7
18.3
4.7
0.7
<0.1
-13.6
9.6
3.6
0.4
<0.1
72.1
13.0
0.1
-58.3
16.9
30.8
10.5
0.1
-47.1
24.9
18.8
3.3
<0.1
-50.7
22.9
22.5
5.3
<0.1
Placebo
Dose 1
N=7868
Placebo
Dose 2
N=7361
-36.9
2.1
0.1
-25.7
12.1
12.0
1.6
<0.1
-20.3
15.0
4.8
0.5
<0.1
-12.2
8.3
3.5
0.4
0.1
Solicited Systemic
Reaction
Any solicited systemic
reaction, (%)
Any (Grade ≥1)
Grade 3
Grade 4
Fatigue/malaise, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Headache, (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
Muscle pain (myalgia), (%)
Any (Grade ≥1)
Grade 1
Grade 2
Grade 3
Grade 4
NVXCoV2373
Dose 1
N=2251
-32.2
1.6
<0.1
-19.7
10.9
7.8
1.0
0
-15.3
13.0
1..7
0.5
<0.1
-12.6
9.9
2.6
0.1
0
--
NVXCoV2373
Dose 2
N=2048
--
31.5
1.1
0
-18.1
9.4
8.3
0.5
0
-16.5
13.7
2.4
0.4
0
-11.2
7.9
3.0
0.4
0
48.7
4.4
0.1
-34.9
14.4
17.1
3.3
0
-24.5
18.5
5.1
0.9
0.1
-27.4
16.8
9.0
1.6
0
Placebo
Dose 1
N=1114
Placebo
Dose 2
N=978
-28.2
1.5
0
-18.6
9.8
7.5
1.3
0
-14.7
12.0
2.6
0.2
0
-10.4
7.0
3.3
0.2
0
22