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） (15 ページ)
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| 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 Analyses
The primary efficacy endpoint was assessed until a participant received
the first blinded, crossover vaccination or until the data cutoff of September
27, 2021, whichever came first.
EUA
In the Per-Protocol Efficacy Set, during the pre-crossover period, 21.7% of
the participants who received placebo were additionally unblinded with the
intention to receive a COVID-19 vaccine under EUA as compared to 13.2%
of the participants who received NVX-CoV2373. Participants who were
unblinded to receive a COVID-19 vaccine under EUA were censored from
the efficacy analyses at the time of unblinding.
14
The primary efficacy endpoint was assessed until a participant received
the first blinded, crossover vaccination or until the data cutoff of September
27, 2021, whichever came first.
EUA
In the Per-Protocol Efficacy Set, during the pre-crossover period, 21.7% of
the participants who received placebo were additionally unblinded with the
intention to receive a COVID-19 vaccine under EUA as compared to 13.2%
of the participants who received NVX-CoV2373. Participants who were
unblinded to receive a COVID-19 vaccine under EUA were censored from
the efficacy analyses at the time of unblinding.
14