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） (34 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
Embolic/Thrombotic
Pre- and post-crossover
• Non-cardiac, non-neurovascular embolic and thrombotic events were
balanced in the pre- and post- crossover periods.
• However, 8 participants in the NVX arm experienced thrombotic/embolic
events within 21 days of the most recent NVX dose, without plausible
alternative etiologies.
Cumulatively through February 17, 2022
• An imbalance in events of pulmonary embolism was noted for the postcrossover period (0.1% of participants who crossed over to receive NVX
compared to 0.05% of participants who crossed over to receive placebo).
• However, most events in both treatment arms had onset >90 days
following the most recent dose, and the proportion of events with onset <2
weeks was comparable.
Through September 27, 2021 data cutoff unless otherwise indicated.
33
Embolic/Thrombotic
Pre- and post-crossover
• Non-cardiac, non-neurovascular embolic and thrombotic events were
balanced in the pre- and post- crossover periods.
• However, 8 participants in the NVX arm experienced thrombotic/embolic
events within 21 days of the most recent NVX dose, without plausible
alternative etiologies.
Cumulatively through February 17, 2022
• An imbalance in events of pulmonary embolism was noted for the postcrossover period (0.1% of participants who crossed over to receive NVX
compared to 0.05% of participants who crossed over to receive placebo).
• However, most events in both treatment arms had onset >90 days
following the most recent dose, and the proportion of events with onset <2
weeks was comparable.
Through September 27, 2021 data cutoff unless otherwise indicated.
33