Important Update

State/Territory-Coordinated Distribution of Sotrovimab

December 17, 2021

In late November, the federal government paused shipment of the monoclonal antibody therapeutic sotrovimab in order to help ensure a more balanced portfolio of monoclonal antibody products and to allow more time to assess data regarding the effectiveness of sotrovimab against the Omicron variant.

Early in vitro data suggests sotrovimab retains activity against the Omicron variant. As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to your jurisdictions. Shipment of product will begin soon, and jurisdictions will see product arrive as early as Tuesday, December 21, 2021.

Allocation of sotrovimab to state and territorial health departments was determined using the same methodology as before, which takes into account COVID-19 incidence rates and hospitalizations.

Please note that the federal government’s current supply of sotrovimab is extremely limited, and additional doses of the product will not be available until the week of January 3rd. We recommend that jurisdictions continue use of the bam/ete and REGEN-COV monoclonal antibody products while reserving sotrovimab for treatment of eligible outpatients at highest risk who are either:

• diagnosed with a test that may identify a potential case of the Omicron variant (e.g., by S gene Target Failure in the ThermoFisher TaqPath assay); or
• are present in local settings where reported prevalence of Omicron is greater than 20%.

Until local prevalence of Omicron is greater than 20%, jurisdictions are encouraged to direct sotrovimab to sites that can provide IV treatment (within 48 hours of collection of a patient sample) to highest risk, eligible individuals diagnosed with a test that may identify a potential case of the Omicron variant.

Highest risk criteria for severe COVID-19 can be determined by local prioritization schemes, but criteria may include age ≥65 years, major immune suppression (e.g., recently diagnosed hematologic malignancy, cancer chemotherapy, solid organ transplant on immune suppression), obesity with BMI >35-40 kg/m2, cardiovascular disease (including hypertension), pregnancy, poorly controlled diabetes, significantly reduced kidney function, COPD, stroke, and two or more risk factors.

Jurisdictions should also take into consideration the NIH COVID-19 Treatment Guidelines Panel’s Statement on prioritization when there are logistical or supply constraints.

Distribution Determinations for Sotrovimab: December 17, 2021