Public Health Emergency - Leading a Nation Prepared
Distribution of bamlanivimab/etesevimab has been paused to Rhode Island in addition to Arizona, California, Florida, Indiana, Oregon, Washington, Illinois and Massachusetts. Please see updates below for additional information.
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. The Centers for Disease Control and Prevention (CDC) has identified that the combined frequencies of the P.1 (Gamma) variant (first identified in Brazil) and the B.1.351 (Beta) variant (first identified in South Africa) now exceed 10% in Rhode Island and are trending upward (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html). Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against either the P.1 (Gamma) or B.1.351 (Beta) variants. These assays use “pseudo-virus particles” that help determine likely susceptibility of the live virus.REGEN-COV and
sotrovimab are alternative monoclonal antibody therapies that are currently authorized for the same use as
bamlanivimab and etesevimab administered together and, based on similar in vitro assay data currently available, REGEN-COV and sotrovimab are likely to retain activity against the P.1 (Gamma) or B.1.351 (Beta) variants. All treatment delivery sites can continue ordering REGEN-COV from the authorized distributer by following the existing ordering and reporting procedures. All treatment sites may also find information on the availability and ordering of sotrovimab by visiting GlaxoSmithKline’s website at
www.sotrovimab.com. 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 Rhode Island until further notice. The FDA recommends that health care providers in Rhode Island use the alternative authorized monoclonal antibody therapies as described above. As detailed in our prior communications (May 7, May 21, and May 26, 2021), the P.1 (Gamma) and B.1.351 (Beta) variants have also been elevated at a combined frequency exceeding 10% in Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington. The FDA recommends using REGEN-COV or sotrovimab as alternative monoclonal antibody therapies in these states. The shipping restrictions of bamlanivimab and etesevimab together and etesevimab alone to these states still remain in effect. Other states, except those noted above, are not impacted by today’s announcement. All health care providers should monitor information from the CDC and state and local health authorities regarding the frequency of the P.1 (Gamma) and B.1.351 (Beta) variants in their region.Healthcare providers should 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 (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html) 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 at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs. 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. Please contact
COVID19Therapeutics@hhs.gov with any questions. We thank you for your continued support and efforts in the fight against COVID-19.
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