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Important Update

Shipment to Hawaii Paused for Bamlanivimab/etesevimab Monoclonal Antibody Therapeutic

October 8, 2021

Monoclonal Antibody Therapeutic Updates

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 Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services are committed to ensuring timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic.

Effective immediately, ASPR will pause distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) to Hawaii because the Centers for Disease Control and Prevention (CDC) has identified that the Delta plus variant (B.1.617.2 sublineage AY.1) (originally identified in India) is circulating with a frequency exceeding 5% in Hawaii (CDC COVID Data Tracker). Results from in vitro assays that are used to assess the susceptibility of viral variants of SARS-CoV-2 to a particular monoclonal antibody therapy suggest that bamlanivimab and etesevimab administered together are not active against this variant. These assays use “pseudo-virus particles” that help determine likely susceptibility of the live virus.

Hawaii is not among the states FDA has listed in which use of bamalanivimab and etesevimab administered together is authorized.

REGEN-COV and sotrovimab are alternative monoclonal antibody therapies that are currently authorized for treatment of mild to moderate COVID-19 in adults and certain pediatric patients who are at high risk for progression to severe disease. Additionally, REGEN-COV is an alternative monoclonal antibody therapy that is authorized for post-exposure prophylaxis of COVID-19 in adults and certain pediatric individuals who are at high risk for progression to severe COVID-19. Based on similar in vitro assay data currently available, REGEN-COV and sotrovimab retain activity against the Delta plus variant. FDA recommends that health care providers in Hawaii use these alternative authorized monoclonal antibody therapies, consistent with their authorized uses, until further notice.

Other states and territories are not impacted by today’s announcement. Health care providers should also review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under an EUA for details regarding specific variants and resistance. Health care providers should also refer to the CDC website and information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

Monoclonal antibody therapies available under an EUA must be used in accordance with the terms and conditions for the respective authorization, including the authorized labeling. The Letters of Authorization may be accessed here.

ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available.