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Important Update

Updated Guidelines Regarding Allocation of Bamlanivimab/etesevimab and REGEN-COV Therapeutics States and Territories can Continue to Order Both Products

December 31, 2021

Monoclonal Antibody Therapeutic Updates

The following statement is an update to our announcements from December 23, 2021 and December 29, 2021.

The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s updates related to COVID-19 monoclonal antibody therapeutics, please see our full list of updates.

The prevalence of COVID-19 variants remains dynamic, and the U.S. Department of Health and Human Services (HHS) actively assesses data on a continuous basis to adjust COVID-19 therapeutics allocation guidelines as required.

In light of recent National Institutes of Health (NIH) clinical guidelines published on Dec. 30, 2021, and the significant variability in prevalence of the Omicron Variant of Concern (VOC), all states and territories can continue to order both Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products from HHS based on allocated amounts for clinically appropriate use.

Additionally, jurisdictions, providers and patients should be aware that there are a number of alternative therapeutics, including oral and IV antivirals in addition to the GSK/Vir (sotrovimab) monoclonal antibody that are effective in the face of the Omicron variant.

If the Delta VOC still represents a significant proportion of infections in a region and other options are not available or are contraindicated, eligible patients can be offered bamlanivimab plus etesevimab or casirivimab plus imdevimab, with the understanding that these treatments would be ineffective if the patients are infected with the Omicron VOC. This concern can be mitigated if virus-specific diagnostic testing1 in a given patient indicates infection with the Omicron VOC is unlikely.

The next allocation of COVID-19 monoclonal antibody therapeutics will occur on Monday, Jan. 3.

  1. See: Tests with Detection Patterns that May Be Associated with the SARS-CoV-2 Omicron Variant (as of 12/22/2021)