Monoclonal Antibody Treatment
Overview of Monoclonal Antibody Treatment for COVID-19 Made Available Under Emergency Use Authorization
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful viruses and bacteria which can cause disease. Currently there are two monoclonal antibody therapies approved for use under an Emergency Use Authorization.
Bamlanivimab plus Etesevimab
Bamlanivimab and etesevimab should be administered together under Emergency Use Authorization (EUA) 094. Specifically, the EUA now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. As of August 2021, IL is one such state where we can use bamlanivimab/etesevimab.
On November 21, 2020, Regeneron Pharmaceuticals, Inc. received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational treatment cocktail consisting of 2 monoclonal antibodies, casirivimab and imdevimab. The EUA allows healthcare providers to administer casirivimab/imdevimab to non-hospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization. It can also be used to prevent COVID-19 once you are exposed, especially if you are unvaccinated.
In alignment with the terms of the EUA for casirivimab/imdevimab, the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will oversee allocation of this therapeutic and coordinate its distribution.
Allocation and Distribution Process
Monoclonal antibody therapy is a prevention as well as treatment option for mild to moderate COVID-19 illness for non-hospitalized people and is a way to lower the chance of progression to severe illness or hospitalization. IDPH continues to encourage health care providers, such as primary care offices, outpatient clinics, urgent care centers, infusion centers, dialysis centers, home health services, and hospitals, to assess their capabilities to provide this treatment to their patients quickly after they have been identified as having COVID-19 and are determined to be high-risk for severe illness or hospitalization. On Monday, September 13, 2021, the U.S. Department of Health and Human Services moved from direct ordering by monoclonal antibody administration sites, to requiring orders for REGEN-COV and bamlanivimab/etesivimab to go through the state. HHS is determining each state's weekly amount of monoclonal antibody products based on COVID-19 case burden and monoclonal antibody utilization. Providers can submit requests for monoclonal antibody treatment to the State here.
The Illinois Department of Public Health is committed to the equitable and efficient distribution of monoclonal antibody therapy treatments throughout Illinois, no matter the location and regardless of income. IDPH is committed to distributing these therapies quickly in partnership with AmeriSource Bergen, the distributor of the therapeutics.
Individuals Seeking Treatment or Prevention
Individuals who have tested positive and are experiencing mild or moderate COVID-19 illness and symptoms and are considered “high risk” for progressing to severe COVID-19. Pediatric patients, 12 years of age or older weighing at least 40 kilograms (about 80 pounds), and adults included those 65 years of age or older with certain chronic medical conditions can be considered eligible to receive this treatment. Chronic medical conditions include, but are not limited to:
- Having a body mass index (BMI) greater than 35
- Chronic kidney disease
- Immunosuppressive disease
- Are currently receiving immunosuppressive treatment
Individuals who meet high risk criteria and test positive should contact their primary care physician about a referral for antibody treatment within three days of a positive test result and no later than 10 days after symptom onset.
Treatment for COVID-19 is limited at this time. Check with your health care provider about the use of monoclonal antibodies (bamlanivimab or casirivimab/imdevimab) or an antiviral (remdesiver).
If you have been exposed to COVID-19 and are either unvaccinated or have a weakened immune system, you could also get this medication to protect you from getting COVID-19. However you must get it within 7 days of being exposed to someone with COVID-19.