TABLE 1

FDA emergency use authorization criteria for bamlanivimab and casirivimab-imdevimab

Patients must meet all 3 of the following:

  1. Positive SARS-CoV-2 viral test and symptoms for ≤ 10 days

  2. Do not require hospitalization or supplemental oxygen or do not require change in baseline oxygen

  3. Meet the patient criteria listed below

    • 65 years and older

    • 55 years and older AND at least 1 of the following risk factors for severe disease:

      1. Cardiovascular disease

      2. Hypertension

      3. Chronic obstructive pulmonary disease or other chronic respiratory disease

    • Patients 18 years and older AND at least 1 of the following:

      1. Body mass index of ≥ 35 kg/m2

      2. Chronic kidney disease

      3. Diabetes mellitus

      4. Currently receiving immunosuppressive therapy

      5. Immunosuppressive disease

    • Patients 12 to 17 years old AND weighing at least 40 kg AND at least 1 of the following:

      1. BMI 85th percentile or higher for their age and gender based on growth charts from the Centers for Disease Control

      2. Sickle cell disease

      3. Congenital or acquired heart disease

      4. Neurodevelopmental disorders including cerebral palsy

      5. Medical-related technological dependence such as tracheostomy, gastrostomy, or positive-pressure ventilation (not related to COVID-19)

      6. Asthma, reactive airway, or other chronic respiratory disease that requires daily medication control

  • Adapted from references 5 and 6.