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） (41 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。
Summary of Benefits/Risks
Known and Potential
Benefits
Uncertainties in Benefits
Known and Potential
Risks
• Vaccine efficacy: 90.41%
(95% CI 83.81, 94.32)
• Vaccine efficacy estimates
from study 301 are
generally consistent
across subgroups
stratified by demographic
variables (including age,
race, and ethnicity) and
risk for severe COVID-19.
•
• Safety in certain
• Local and systemic
reactogenicity
subpopulations
• Myocarditis/pericarditis • Adverse reactions that
are uncommon or that
• Guillain-Barré
require longer follow-up
syndrome
to be detected,
including imbalances
observed in study 301:
biliary events,
neurovascular events,
cardiac events, uveitis
•
•
Effectiveness against:
currently circulating SARSCoV-2 variants, long term
effects of COVID-19
disease
Effectiveness in: certain
populations at higher risk
of severe COVID-19,
individuals previously
infected with SARS-CoV-2
Duration of protection
Uncertainties in Risks
40
Known and Potential
Benefits
Uncertainties in Benefits
Known and Potential
Risks
• Vaccine efficacy: 90.41%
(95% CI 83.81, 94.32)
• Vaccine efficacy estimates
from study 301 are
generally consistent
across subgroups
stratified by demographic
variables (including age,
race, and ethnicity) and
risk for severe COVID-19.
•
• Safety in certain
• Local and systemic
reactogenicity
subpopulations
• Myocarditis/pericarditis • Adverse reactions that
are uncommon or that
• Guillain-Barré
require longer follow-up
syndrome
to be detected,
including imbalances
observed in study 301:
biliary events,
neurovascular events,
cardiac events, uveitis
•
•
Effectiveness against:
currently circulating SARSCoV-2 variants, long term
effects of COVID-19
disease
Effectiveness in: certain
populations at higher risk
of severe COVID-19,
individuals previously
infected with SARS-CoV-2
Duration of protection
Uncertainties in Risks
40