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） (7 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: Safety Data Collection
CROSSOVER
Dose 1
Solicited
local and
systemic ARs
(7 days)
Dose 2
Dose 3
Dose 4
Solicited
local and
systemic ARs
(7 days)
Unsolicited and medically attended AEs
(through 28 days post-Dose 2)
Unsolicited and medically attended AEs
(through 28 days post-Dose 2)
Medically attended AEs attributed to study vaccine, serious AEs, and AEs of special interest (defined as
COVID-related AEs and potential immune mediated medical conditions) for the duration of the study in all
participants
6
CROSSOVER
Dose 1
Solicited
local and
systemic ARs
(7 days)
Dose 2
Dose 3
Dose 4
Solicited
local and
systemic ARs
(7 days)
Unsolicited and medically attended AEs
(through 28 days post-Dose 2)
Unsolicited and medically attended AEs
(through 28 days post-Dose 2)
Medically attended AEs attributed to study vaccine, serious AEs, and AEs of special interest (defined as
COVID-related AEs and potential immune mediated medical conditions) for the duration of the study in all
participants
6