Coronavirus Disease 2019 (COVID-19) Outbreak, Update # 24 Bamlanivimab

On November 13, 2020, NH DHHS issued health alert COVID-19 outbreak update #24 regarding use of Bamlanivimab.

NH DPHS Health AlertsKey Points and Recommendations:

  • The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for use of bamlanivimab to treat mild to moderate COVID-19. Medication has been purchased by the federal government and will be distributed proportionally to NH hospital pharmacies (based on COVID-19 hospitalization numbers) through AmerisourceBergen. 
  • Bamlanivimab is an investigational neutralizing monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2, the virus that causes COVID-19. 
    • Bamlanivimab is administered as a single intravenous infusion. 
    • Limited study data shows that a lower proportion of bamlanivimab-treated patients with mild to moderate COVID-19 progressed to hospitalization or emergency room visits when compared to placebo, and benefit was greater in patients at higher risk for severe disease and hospitalization. 
  • The EUA permits the use of bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive viral SARS-CoV-2 test results, and all the following criteria must apply. Patient must be: 
    • 12 years of age and older, 
    • Weighing at least 40 kg, and 
    • High risk for progressing to severe COVID-19 and/or hospitalization (see FDA Fact Sheet for Health Care Providers for definition of “high risk”) 
  • Bamlanivimab is NOT authorized for use in the following patients: 
    • Adults or pediatric patients hospitalized due to COVID-19. 
    • Adult or pediatric patients who require oxygen therapy due to COVID-19. 
    • Adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in patients on chronic oxygen therapy due to an underlying non-COVID-19 related comorbidity. 
  • Clinicians managing patients for whom bamlanivimab is appropriate under the FDA EUA, and who have access to bamlanivimab through their hospital pharmacies, must review the following information and requirements before treating patients: 
  • The Fact Sheet for Health Care Providers contains important information about who may receive bamlanivimab under the FDA EUA, preparation and storage information, dosing and administration instructions, and other specific instructions for health care providers and mandatory requirements for administration.
  • For any questions regarding this notification, please call the NH DHHS, DPHS, Bureau of Infectious Disease Control at (603) 271-4496 during business hours (8:00 a.m. – 4:30 p.m.). 
  • If you are calling after hours or on the weekend, please call the New Hampshire Hospital switchboard at (603) 271-5300 and request the Public Health Professional on-call. 
    Full DHHS Alert