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） (45 ページ)
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Sponsor Surveillance Studies
The sponsor has proposed five post-authorization surveillance studies:
Pregnancy Exposure
Registry
To evaluate obstetric, neonatal, and infant outcomes among women vaccinated
during pregnancy with the Novavax COVID-19 vaccine.
US Active Follow-Up for
Safety Study
To evaluate the risk of select Adverse Events of Special Interest (AESIs) in
association with administration of the Novavax COVID-19 vaccine in adults aged 18
years and older in the real-world setting in the United States (US).
UK Active Follow-Up for
Safety Study
To evaluate the risk of select AESIs in association with administration of the Novavax
COVID-19 vaccine in adults aged 18 years and older in the real-world setting in the
United Kingdom (UK).
US Real World
Effectiveness Study
To assess the effectiveness of the Novavax COVID-19 vaccine in preventing
symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
infection in adults aged 18 years and older in the US.
European Real World
Effectiveness Study
To assess the effectiveness of the Novavax COVID-19 vaccine against
hospitalization due to laboratory confirmed SARS-CoV-2 in adults aged 18 years and
older in multiple European countries.
44
The sponsor has proposed five post-authorization surveillance studies:
Pregnancy Exposure
Registry
To evaluate obstetric, neonatal, and infant outcomes among women vaccinated
during pregnancy with the Novavax COVID-19 vaccine.
US Active Follow-Up for
Safety Study
To evaluate the risk of select Adverse Events of Special Interest (AESIs) in
association with administration of the Novavax COVID-19 vaccine in adults aged 18
years and older in the real-world setting in the United States (US).
UK Active Follow-Up for
Safety Study
To evaluate the risk of select AESIs in association with administration of the Novavax
COVID-19 vaccine in adults aged 18 years and older in the real-world setting in the
United Kingdom (UK).
US Real World
Effectiveness Study
To assess the effectiveness of the Novavax COVID-19 vaccine in preventing
symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
infection in adults aged 18 years and older in the US.
European Real World
Effectiveness Study
To assess the effectiveness of the Novavax COVID-19 vaccine against
hospitalization due to laboratory confirmed SARS-CoV-2 in adults aged 18 years and
older in multiple European countries.
44