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） (26 ページ)
出典
| 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》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
301: Safety- Unsolicited Events
Key Findings in Pre-crossover Period
• No adverse event preferred term (PT) reported by more than 1% of participants in either group.
• Imbalances in the SOC of General disorders and administration site conditions and Blood and lymphatic
system disorders were noted, largely due to AEs associated with reactogenicity (including chills, injection
site pruritis, and influenza-like illness) and lymphadenopathy.
• Lymphadenopathy were reported by a higher proportion of participants in the NVX arm for Dose 1 and
Dose 2 (0.06% and 0.2%, respectively) than in the placebo arm (0.03% and 0.02%, respectively).
• The most commonly reported (≥0.1% of participants) severe unsolicited event in the NVX arm was
fatigue (n=10, 0.1%).
Through September 27, 2021 data cutoff
25
Key Findings in Pre-crossover Period
• No adverse event preferred term (PT) reported by more than 1% of participants in either group.
• Imbalances in the SOC of General disorders and administration site conditions and Blood and lymphatic
system disorders were noted, largely due to AEs associated with reactogenicity (including chills, injection
site pruritis, and influenza-like illness) and lymphadenopathy.
• Lymphadenopathy were reported by a higher proportion of participants in the NVX arm for Dose 1 and
Dose 2 (0.06% and 0.2%, respectively) than in the placebo arm (0.03% and 0.02%, respectively).
• The most commonly reported (≥0.1% of participants) severe unsolicited event in the NVX arm was
fatigue (n=10, 0.1%).
Through September 27, 2021 data cutoff
25