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Monoclonal Antibody Therapeutic Treatment

Emergency Use Authorizations

FDA Emergency Use Authorizations

Fully FDA Approved

Fully FDA Approved

About Monoclonal Antibody Therapeutic (mAb) Treatment

The monoclonal antibody therapeutics (mAb) are laboratory-made proteins that mimic the immune system in response to SARS-CoV-2 (the infection that causes COVID-19). The FDA extended the potential application of monoclonal antibody therapy for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Three monoclonal antibody products currently have Emergency Use Authorizations (EUAs) from the Food and Drug Administration (FDA). These products are:

● Casirivimab plus imdevimab (Regen-COV): These are recombinant human monoclonal antibodies that bind to nonoverlapping epitopes of the spike protein RBD of SARS-CoV-2. Subcutaneous injection is an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment. For post-exposure prophylaxis, either subcutaneous injection or intravenous infusion can be administered.

● Bamlanivimab plus etesevimab (Bam-Ete): These are neutralizing monoclonal antibodies that bind to different but overlapping epitopes in the spike protein RBD of SARS-CoV-2.

● Sotrovimab: This monoclonal antibody was originally identified in 2003 from a SARS-CoV survivor. It targets an epitope in the RBD of the spike protein that is conserved between SARS-CoV and SARS-CoV-2.

The FDA updated the EUA for Regen- COV and Bam/Ete as post-exposure prophylaxis for certain individuals who are at high risk of acquiring SARS-CoV-2 infection and, if infected, are at high risk of progressing to serious illness.

The three monoclonal antibody therapeutics have shown effectiveness against the Delta variant.

See the NIH’s COVID-19 Treatment Guidelines Statement on Emergency Use Authorizations of Anti-SARS-CoV-2 Monoclonal Antibodies for the treatment of COVID-19 for further info and clinical data.

How to Order Monoclonal Antibody Treatments

Orders for Regen-COV, Bamlanivimab / Etesevimab and Etesevimab, and Sotrovimab can be placed directly from San Bernardino County via Monoclonal Antibody Treatment Request Form.

DPH will confirm your facility’s request and the preferred distribution service. Please see the
Monoclonal Antibody Treatment Request Guide for scheduling and further
ordering details.

Reporting Requirements

Providers receiving REGEN-COV and/or Bamlanivimab/Etesevimab and/or Sotrovimab will be required to submit a weekly COVID-19 therapeutics utilization report to the Department of Health and Human Services every Wednesday by 11:59 PM ET. The submission of these utilization reports will determine future allocations of monoclonal antibody therapies to the county. The portal used to submit your weekly utilization report will depend on your facility type, so please visit the following link for further guidance on therapeutics tracking.