A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ During Pregnancy - O-STEREO

Inclusion Criteria

• - Female sex at LMP
• - Age 18-49 years at LMP
• - Continuous coverage/clinical activity (dependent on data source type) within the confounder ascertainment period
• - LMP date falls within the LMP eligibility period
• - Occurrence of at least one of the following high-risk conditions during the confounder ascertainment period
• - Immunocompromised conditions:
• * Cancer (active solid cancer, blood cancer, or receipt of chemotherapy, immunotherapy, or radiotherapy)
• * Solid organ transplant
• * HIV/AIDS
• * Prolonged systemic corticosteroid use (15–20 mg of prednisone equivalents for greater than 2 weeks)
• * Receipt of T or B cell depleting therapy, anti-Tumour Necrosis Factor (anti- TNF), or other immunosuppressive agents
• * Receipt of stem cell transplant
• * Receipt of gene cell therapy of the CAR-T cell type
• * Congenital immunodeficiency, primary immune deficiencies (treatment with subcutaneous or intravenous immunoglobulins - and/or immunodeficiency diagnosis codes), severe or combined immunodeficiency (including transplanted
• * Severe combined immunodeficiency [SCID] where immunoglobulin replacement is required)
• * Other autoimmune conditions and immune-mediated inflammatory disorders
• (such as systemic lupus erythematosus, Crohn's disease, ulcerative colitis).
• - Conditions that increase risk of COVID-19 disease progression
• * Severe risk of COVID-19 disease progression: sickle cell disease, chronic lung disease (ie, chronic bronchitis, Chronic obstructive pulmonary disease [COPD], cystic fibrosis, emphysema with dyspnoea on exertion), chronic kidney disease, cardiovascular diseases (ie, heart failure, coronary artery disease, cardiomyopathies), moderate to severe asthma, Down syndrome, rare neurological conditions (ie, multiple sclerosis, motor neurone disease,
• myasthenia gravis, Huntington’s disease), gestational diabetes requiring medication
• * Moderate risk of COVID-19 disease progression: type I or II diabetes, obesity, chronic liver disease, congenital heart disease