Allocation of Bamlanivimab/etesevimab and REGEN-COV Therapeutics
December 29, 2021
Monoclonal Antibody Therapeutic Updates
The following statement is an update to our announcement on
December 23, 2021. An updated edition of this announcement was published on
December 31, 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 U.S. Department of Health and Human Services (HHS) continues to assess the COVID-19 environment to further inform the allocation and distribution of COVID-19 therapeutics.
Based on recent data and assessment, HHS will pause allocations of bamlanivimab/etesevimab and REGEN-COV COVID-19 therapeutics to states or territories within regions of the country that have greater than 80% prevalence of the Omicron variant based on
CDC NOWCAST data. These two products are not expected to be effective in patients infected with the Omicron variant, and other therapeutic options are available. The purpose of this pause is to ensure effective product is available in most sites. In regions that have less than 80% prevalence of the Omicron variant, states and territories will continue to receive allocations of the two products to use as clinically appropriate.
If monoclonal antibody treatment sites are able to utilize testing to distinguish between variants (i.e., infections caused by Omicron vs. Delta) and can subsequently treat those individuals within the appropriate treatment window, even in regions that have greater than 80% Omicron variant, states and territories will be able to continue requesting bamlanivimab/etesevimab and REGEN-COV provided by HHS. Sites that have the test and treat capability and wish to continue receiving bamlanivimab/etesevimab and REGEN-COV products should submit requests through their state or territorial health department. Health departments can then make the requests directly through their ASPR Regional Emergency Coordinator.
The Food and Drug Administration (FDA) updated Health Care Provider Fact Sheets for
REGEN-COV last week, as the Fact Sheets contain specific information regarding expected activity against the Omicron variant. Additionally, health departments and healthcare providers should continue to assess local data and review current
National Institutes of Health (NIH) guidelines to help inform treatment decisions.