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） (37 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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Safety- Events of Clinical Interest from Other
Studies
Additional safety data from Studies 101 (Part 1/2), 302, and 501 (pre-crossover
only) was reviewed, including serious adverse events and adverse events of
special interest.
• One event of Guillain-Barré syndrome was reported by a 65-year-old female
NVX recipient who experienced progressive neuropathy starting 9 days
following Dose 1.
• There were no other new SAEs, AESIs or PIMMCs in studies 101, 302, or
501 that were considered at least possibly related by FDA that were not
previously identified in study 301.
36
Studies
Additional safety data from Studies 101 (Part 1/2), 302, and 501 (pre-crossover
only) was reviewed, including serious adverse events and adverse events of
special interest.
• One event of Guillain-Barré syndrome was reported by a 65-year-old female
NVX recipient who experienced progressive neuropathy starting 9 days
following Dose 1.
• There were no other new SAEs, AESIs or PIMMCs in studies 101, 302, or
501 that were considered at least possibly related by FDA that were not
previously identified in study 301.
36