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） (43 ページ)
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Adverse Event (AE) Reporting Under the EUA
Vaccine Recipients
Voluntary Reporting
• Spontaneous reports
• Solicited reports from V-SAFE
program
Vaccination Providers
Vaccine EUA Sponsor
Mandatory Reporting
Monthly Periodic Safety
Reports
• Analysis of aggregate AE data
• Newly identified safety
concerns
• Vaccination administration errors
(providers only)
• Serious adverse events (SAEs)
• Multisystem Inflammatory
Syndrome in adults
• Cases of COVID-19 that result in
hospitalization or death
• Review of all Adverse Events of
Special Interest (AESI)
• Data Abstraction
Coordination
Data Sharing
•
•
•
•
Screening of all incoming SAEs
Literature review
Data Mining
Potential safety signals will be
further evaluated
42
Vaccine Recipients
Voluntary Reporting
• Spontaneous reports
• Solicited reports from V-SAFE
program
Vaccination Providers
Vaccine EUA Sponsor
Mandatory Reporting
Monthly Periodic Safety
Reports
• Analysis of aggregate AE data
• Newly identified safety
concerns
• Vaccination administration errors
(providers only)
• Serious adverse events (SAEs)
• Multisystem Inflammatory
Syndrome in adults
• Cases of COVID-19 that result in
hospitalization or death
• Review of all Adverse Events of
Special Interest (AESI)
• Data Abstraction
Coordination
Data Sharing
•
•
•
•
Screening of all incoming SAEs
Literature review
Data Mining
Potential safety signals will be
further evaluated
42