Shipment of Bamlanivimab/etesevimab Resumes to Hawaii
October 21, 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 COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.
On August 27, 2021, we
informed you of revisions to the authorized use of bamlanivimab and etesevimab, administered together, under
Emergency Use Authorization (EUA) 094. The EUA was revised to authorize the use of bamlanivimab and etesevimab, administered together, only in states, territories, and US jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%.
On October 8, 2021, we
informed you that 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 was paused because the Centers for Disease Control and Prevention (CDC) identified that the Delta plus variant (B.1.617.2 sublineage AY.1) (originally identified in India) was circulating with a frequency exceeding 5% in Hawaii. The Delta plus variant is expected to be resistant to bamlanivimab and etesevimab administered together. In addition, based on this information, FDA updated the list of
Bamlanivimab and Etesevimab Authorized States, Territories, and US Jurisdictions to reflect that use of bamlanivimab and etesevimab, administered together, was not authorized for use in Hawaii.
Today, based on FDA’s evaluation of the most recently available
SARS-CoV-2 variant frequency data, we are informing you that the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is now less than 5% in all U.S. states, territories, and jurisdictions, including Hawaii.
Bamlanivimab and etesevimab, administered together, can be used in all U.S. states, territories, and jurisdictions consistent with the terms and conditions of authorization for EUA 94. As such, ASPR will resume the 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 and will continue distribution to all other U.S. states, territories, and jurisdictions.
Since June 2021, there has been a sustained increase in the circulation of the Delta variant (B.1.617.2). Based on in vitro assays that are used to assess the susceptibility of viral variants to monoclonal antibodies, bamlanivimab and etesevimab, administered together, are expected to retain activity against the Delta variant (B.1.617.2), which is now the dominant variant in the United States. The increase in prevalence of Delta has been associated with a decrease at the same time in the frequency of identified variants that are expected to be resistant to bamlanivimab and etesevimab.
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.
