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） (46 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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Additional Monitoring Activities for Events of Interest
Additional post-authorization safety monitoring will be performed for the previously described
adverse events of clinical interest
Active Surveillance
• U.S. and U.K. active surveillance safety studies will include assessment for
cardiac, neurovascular, embolic/thrombotic, and biliary events
Enhanced
Pharmacovigilance
• Sponsor to provide updated assessment of interval and aggregate data in
monthly periodic safety reports
• Targeted questionnaire for follow up of spontaneous reports of GBS
45
Additional post-authorization safety monitoring will be performed for the previously described
adverse events of clinical interest
Active Surveillance
• U.S. and U.K. active surveillance safety studies will include assessment for
cardiac, neurovascular, embolic/thrombotic, and biliary events
Enhanced
Pharmacovigilance
• Sponsor to provide updated assessment of interval and aggregate data in
monthly periodic safety reports
• Targeted questionnaire for follow up of spontaneous reports of GBS
45