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） (33 ページ)
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| 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》 |
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301: Safety- Events of Clinical Interest
Neurovascular
Pre-crossover
• Imbalance in events consistent with stroke in (0.06% in NVX arm and
0.02% in placebo arm), including 3 of 11 events occurring within 15 days
of the most recent dose of NVX
• Both events in the placebo arm occurred within 15 days of the most recent
dose of placebo
Cumulatively through February 17, 2022
• A total of 19 neurovascular events consistent with stroke were reported
following NVX in the pre- and post-crossover periods (N=26,106)
• Time to onset from last NVX dose: <30 days (N=3), 31-60 days (N=5), >61
days (N=11)
Through September 27, 2021 data cutoff unless otherwise indicated.
32
Neurovascular
Pre-crossover
• Imbalance in events consistent with stroke in (0.06% in NVX arm and
0.02% in placebo arm), including 3 of 11 events occurring within 15 days
of the most recent dose of NVX
• Both events in the placebo arm occurred within 15 days of the most recent
dose of placebo
Cumulatively through February 17, 2022
• A total of 19 neurovascular events consistent with stroke were reported
following NVX in the pre- and post-crossover periods (N=26,106)
• Time to onset from last NVX dose: <30 days (N=3), 31-60 days (N=5), >61
days (N=11)
Through September 27, 2021 data cutoff unless otherwise indicated.
32