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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） (19 ページ)
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| 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》 |
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301: Safety Analysis Population
The safety analysis population included participants who received at least 1 dose of NVX-CoV2373
(data cutoff September 27, 2021)
NVX-CoV2373
N=19735
Placebo
N=9847
Total
N=29582
First vaccination series
--
--
--
Blinded
Crossover
NVX to
Placebo
N=15298
--
Completed 2 doses, n
19111
9416
28527
NA
NA
NA
Median follow up post-Dose 2,
months
2.5
2.5
2.5
NA
NA
NA
Completed at least 2 months
follow up post-Dose 21, n (%)
14825 (77.8)
6852 (72.8)
21677 (76.0)
NA
NA
NA
Crossover vaccination series
--
--
--
--
--
--
Completed 4 doses, n
NA
NA
NA
15084
6303
21387
Median follow up post-Dose 4,
months
NA
NA
NA
4.4
4.4
4.4
Completed at least 2 months
follow up post-Dose 42, n (%)
NA
NA
NA
14934 (99.0)
6244 (99.1)
21178 (99.0)
Population
Blinded
Crossover
Placebo to
NVX
N=6371
--
Blinded
Crossover
Total
N=21669
--
At FDA’s request, the Sponsor provided additional safety data through an extraction date of February 17, 2022, for evaluation of clinically
important adverse events (median post-crossover follow-up duration of 8.4 months after the completion of the 2-dose crossover series)
18
The safety analysis population included participants who received at least 1 dose of NVX-CoV2373
(data cutoff September 27, 2021)
NVX-CoV2373
N=19735
Placebo
N=9847
Total
N=29582
First vaccination series
--
--
--
Blinded
Crossover
NVX to
Placebo
N=15298
--
Completed 2 doses, n
19111
9416
28527
NA
NA
NA
Median follow up post-Dose 2,
months
2.5
2.5
2.5
NA
NA
NA
Completed at least 2 months
follow up post-Dose 21, n (%)
14825 (77.8)
6852 (72.8)
21677 (76.0)
NA
NA
NA
Crossover vaccination series
--
--
--
--
--
--
Completed 4 doses, n
NA
NA
NA
15084
6303
21387
Median follow up post-Dose 4,
months
NA
NA
NA
4.4
4.4
4.4
Completed at least 2 months
follow up post-Dose 42, n (%)
NA
NA
NA
14934 (99.0)
6244 (99.1)
21178 (99.0)
Population
Blinded
Crossover
Placebo to
NVX
N=6371
--
Blinded
Crossover
Total
N=21669
--
At FDA’s request, the Sponsor provided additional safety data through an extraction date of February 17, 2022, for evaluation of clinically
important adverse events (median post-crossover follow-up duration of 8.4 months after the completion of the 2-dose crossover series)
18