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） (8 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》 |
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301: Efficacy Assessments
Efficacy was assessed through daily surveillance of symptoms suggestive of
COVID-19 throughout the study follow-up
Symptoms of COVID-19 experienced by participants during post-vaccination
follow-up prompted an unscheduled illness visit and nasopharyngeal swab.
Molecular confirmation of SARS-CoV-2 infection (using the Abbott Real Time
SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) assay)
by the central laboratory was required to meet the primary and secondary
efficacy endpoint case definitions.
7
Efficacy was assessed through daily surveillance of symptoms suggestive of
COVID-19 throughout the study follow-up
Symptoms of COVID-19 experienced by participants during post-vaccination
follow-up prompted an unscheduled illness visit and nasopharyngeal swab.
Molecular confirmation of SARS-CoV-2 infection (using the Abbott Real Time
SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) assay)
by the central laboratory was required to meet the primary and secondary
efficacy endpoint case definitions.
7