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） (40 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。
Foreign Postmarketing Safety Data
The sponsor submitted postmarketing safety data as of April 30, 2022
(744,235 doses administered in Australia, Canada, European Union, New Zealand, and South Korea)
Sponsor reported a “potential safety signal” for myocarditis and pericarditis
• 37 reports identified, 2 duplicates (n=35 valid reports representing 36 AEs)
•
Pericarditis (n=29)*
Myocarditis (n=4)
Myopericarditis (n=2)
Carditis (n=1)
Observed-to-expected (O/E) rate ratios† elevated:
Dose
O/E Rate Ratio (95% CI) Assuming Sensitivity of 50%
Assuming Sensitivity of 25%
All doses
4.95 (3.50 - 6.79)
19.79 (14.01 – 27.17)
9.90 (7.00 – 13.58)
*Includes 5 reports of pericarditis in individuals with a history of pericarditis after mRNA COVID-19 vaccine.
†Does not include adjudication of individual cases by sponsor. Includes 2 duplicate reports.
39
The sponsor submitted postmarketing safety data as of April 30, 2022
(744,235 doses administered in Australia, Canada, European Union, New Zealand, and South Korea)
Sponsor reported a “potential safety signal” for myocarditis and pericarditis
• 37 reports identified, 2 duplicates (n=35 valid reports representing 36 AEs)
•
Pericarditis (n=29)*
Myocarditis (n=4)
Myopericarditis (n=2)
Carditis (n=1)
Observed-to-expected (O/E) rate ratios† elevated:
Dose
O/E Rate Ratio (95% CI) Assuming Sensitivity of 50%
Assuming Sensitivity of 25%
All doses
4.95 (3.50 - 6.79)
19.79 (14.01 – 27.17)
9.90 (7.00 – 13.58)
*Includes 5 reports of pericarditis in individuals with a history of pericarditis after mRNA COVID-19 vaccine.
†Does not include adjudication of individual cases by sponsor. Includes 2 duplicate reports.
39