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） (28 ページ)
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301: Safety- Fatal Serious Adverse Events
Pre-Crossover
(through September 27, 2021)
Post-Crossover
(through September 27, 2021)
Novavax
N= 11 (<0.1%)
Cardiac arrest (n=5)
Myocardial infarction, cerebrovascular accident
(CVA), gunshot wound, septic shock, drug
toxicity, drug overdose (n=1 each)
N= 6 (<0.1%)
Cardiac arrest, traumatic rupture of vertebral artery
aneurysm, septic shock, drug toxicity (n=1 each)
Motor vehicle accident (n=2)
Placebo
N= 5 (<0.1%)
Cardiac arrest (n=3)
Myocardial infarction, COVID-19 pneumonia
(n=1 each)
N= 10 (<0.1%)
Myocardial infarction, ischemic stroke, suicide, opiate
toxicity, alcoholic liver disease, alcoholic cardiomyopathy
(n=1 each)
End stage chronic obstructive pulmonary disease (n= 2)
Death of unknown cause (n= 2)
Additional data through February 17, 2022: All deaths had a time to onset of 140 days or more following Dose 4 in the
crossover period.
27
Pre-Crossover
(through September 27, 2021)
Post-Crossover
(through September 27, 2021)
Novavax
N= 11 (<0.1%)
Cardiac arrest (n=5)
Myocardial infarction, cerebrovascular accident
(CVA), gunshot wound, septic shock, drug
toxicity, drug overdose (n=1 each)
N= 6 (<0.1%)
Cardiac arrest, traumatic rupture of vertebral artery
aneurysm, septic shock, drug toxicity (n=1 each)
Motor vehicle accident (n=2)
Placebo
N= 5 (<0.1%)
Cardiac arrest (n=3)
Myocardial infarction, COVID-19 pneumonia
(n=1 each)
N= 10 (<0.1%)
Myocardial infarction, ischemic stroke, suicide, opiate
toxicity, alcoholic liver disease, alcoholic cardiomyopathy
(n=1 each)
End stage chronic obstructive pulmonary disease (n= 2)
Death of unknown cause (n= 2)
Additional data through February 17, 2022: All deaths had a time to onset of 140 days or more following Dose 4 in the
crossover period.
27