Public Health Emergency - Leading a Nation Prepared
Monoclonal antibody therapeutics (mAb) are authorized for treatment of non-hospitalized patients who have tested positive for COVID-19. Eligible patients with mild to moderate symptoms of COVID-19 include those 12 years and older with a high risk of progressing to severe forms of the virus or hospitalization. REGEN-COV is also authorized for post-exposure prophylaxis use. REGEN-COV can be administered through IV or subcutaneous injection. Healthcare facilities, long-term care facilities, dialysis centers, federally qualified health centers, correctional facilities, and urgent care centers, can provide mAb therapy. To learn more about deciding whether to offer mAbs therapy, see the
COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites.
If your facility would like to offer COVID-19 mAb therapy, you can evaluate your readiness by using the
COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sties (mAbs Calculator).The mAbs Calculator is a decision support tool for staffing and resource investment decisions. The tool can be used to:
Monoclonal Antibody Infusion Center Model offers examples for setting up a COVID-19 mAb infusion center at your site, including: facility layout; patient flow, stations and staffing; supplies; infection control and prevention; and reimbursement.
The U.S. Department of Health and Human Services transitioned to a state/territory-coordinated distribution system on September 13, 2021. Contact your state or territorial health department for guidance on requesting product. If you need help connecting with your state/territorial health department official, please send a request for information for your state or territory’s point of contact to
COVID19Therapeutics@HHS.gov. To learn more about the process for distributing and receiving product, see
How to Receive COVID-19 Monoclonal Antibody Therapeutics.
All sites that use monoclonal antibody therapeutics are required to report product utilization every Wednesday. To learn more about your facility’s reporting requirements and how to report, see the
process for tracking utilization of COVID-19 therapeutics.
Remember that all mAb products (except GSK/Vir Biotechnology’s Sotrovimab) are U.S. government property. Per the FDA EUA, infusion sites have the following options for product use:
Infusion sites are not allowed to donate excess monoclonal antibody products purchased by the U.S. government anywhere outside their site because they are considered government property.
Home | Contact Us | Accessibility | Privacy Policies | Disclaimer | HHS Viewers & Players | HHS Plain Language
Assistant Secretary for Preparedness and Response (ASPR), 200 Independence Ave., SW, Washington, DC 20201
U.S. Department of Health and Human Services | USA.gov |
HealthCare.gov in Other Languages