The U.S. Department of Health and Human Services (HHS) has announced a pause in allocations of two currently available monoclonal antibody treatments for COVID-19 as they are unlikely to be effective in diffusing the Omicron variant.
Only one option, sotrovimab, appears to be effective against this variant, but its supply is limited. Nationwide shipments have begun, and an additional 300,000 doses of sotrovimab will be available for distribution in January. Sotrovimab is approved for intravenous treatment only.
The U.S. Food and Drug Administration updated Health Care Provider Fact Sheets for the monoclonal antibodies bamlanivimab and etesevimab administered together, REGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant. These data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant.
HHS does not prohibit the use of these products whose distribution has been paused, but advises prescribers to evaluate the extent to which the Omicron variant is present in their community and the clinical presentation of the patient.
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