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） (10 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》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
301: COVID-19 Case Definitions
Mild
•
Fever (defined by subjective or
objective measure, regardless of
use of anti-pyretic medications)
•
New onset cough
OR ≥2 additional COVID-19
symptoms:
•
New onset or worsening of
shortness of breath or difficulty
breathing compared to baseline
•
New onset fatigue
•
New onset generalized muscle
or body aches
•
New onset headache
•
New loss of taste or smell
•
Acute onset of sore throat,
congestion, and runny nose
•
New onset nausea, vomiting, or
diarrhea
Moderate
•
•
High fever (≥38.4°C) for ≥3 days
(regardless of use of anti-pyretic
medications, need not be contiguous
days)
Any evidence of significant LRTI:
o Shortness of breath (or
breathlessness or difficulty
breathing) with or without
exertion (greater than
baseline)
o Tachypnea: 24 to 29 breaths
per minute at rest
o SpO2: 94% to 95% on room
air
o Abnormal chest X-ray or chest
computerized tomography
consistent with pneumonia or
LRTI
o Adventitious sounds on lung
auscultation crackles/rales,
wheeze, rhonchi, pleural rub,
stridor)
Severe
•
•
•
•
•
•
Tachypnea: ≥30 breaths per minute at rest
Resting heart rate ≥125 beats per minute
Oxygen saturation ≤93% on room air or ratio of the partial
pressure of arterial oxygen to the fraction of inspired
oxygen <300 mm Hg
High flow oxygen therapy or non-invasive ventilation/noninvasive positive pressure ventilation (e.g., continuous
positive airway pressure or bilevel positive airway pressure)
Mechanical ventilation or extracorporeal membrane
oxygenation
One or more major organ system dysfunction or failure
(e.g., cardiac/circulatory, pulmonary, renal, hepatic, and/or
neurological, to be defined by diagnostic testing/clinical
syndrome/interventions), including any of the following:
o Acute respiratory distress syndrome, renal failure,
hepatic failure, right or left heart failure, septic or
cardiogenic shock, stroke, thrombotic event,
myocardial infarction, deep vein thrombosis,
pulmonary embolism
o Requirement for: vasopressors, systemic
corticosteroids, or hemodialysis.
o Admission to an intensive care unit
o Death
9
Mild
•
Fever (defined by subjective or
objective measure, regardless of
use of anti-pyretic medications)
•
New onset cough
OR ≥2 additional COVID-19
symptoms:
•
New onset or worsening of
shortness of breath or difficulty
breathing compared to baseline
•
New onset fatigue
•
New onset generalized muscle
or body aches
•
New onset headache
•
New loss of taste or smell
•
Acute onset of sore throat,
congestion, and runny nose
•
New onset nausea, vomiting, or
diarrhea
Moderate
•
•
High fever (≥38.4°C) for ≥3 days
(regardless of use of anti-pyretic
medications, need not be contiguous
days)
Any evidence of significant LRTI:
o Shortness of breath (or
breathlessness or difficulty
breathing) with or without
exertion (greater than
baseline)
o Tachypnea: 24 to 29 breaths
per minute at rest
o SpO2: 94% to 95% on room
air
o Abnormal chest X-ray or chest
computerized tomography
consistent with pneumonia or
LRTI
o Adventitious sounds on lung
auscultation crackles/rales,
wheeze, rhonchi, pleural rub,
stridor)
Severe
•
•
•
•
•
•
Tachypnea: ≥30 breaths per minute at rest
Resting heart rate ≥125 beats per minute
Oxygen saturation ≤93% on room air or ratio of the partial
pressure of arterial oxygen to the fraction of inspired
oxygen <300 mm Hg
High flow oxygen therapy or non-invasive ventilation/noninvasive positive pressure ventilation (e.g., continuous
positive airway pressure or bilevel positive airway pressure)
Mechanical ventilation or extracorporeal membrane
oxygenation
One or more major organ system dysfunction or failure
(e.g., cardiac/circulatory, pulmonary, renal, hepatic, and/or
neurological, to be defined by diagnostic testing/clinical
syndrome/interventions), including any of the following:
o Acute respiratory distress syndrome, renal failure,
hepatic failure, right or left heart failure, septic or
cardiogenic shock, stroke, thrombotic event,
myocardial infarction, deep vein thrombosis,
pulmonary embolism
o Requirement for: vasopressors, systemic
corticosteroids, or hemodialysis.
o Admission to an intensive care unit
o Death
9