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POSTED: March 26th, 2021
POSTED IN: Forum Topic, HHS and CMS Updates, Resources,

The U.S. Department of Health & Human Services announced an updated on COVID-19 variants and impact on bamlanivimab distribution.

Given the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company, has stopped the distribution of bamlanivimab on March 24, 2021.

FDA recently updated the authorized Fact Sheet for Healthcare Providers for the bamlanivimab emergency use authorization (EUA). This update advised healthcare providers to consider the use of alternative authorized monoclonal antibody therapies that are expected to retain activity against circulating viral variants. Using an alternative authorized monoclonal antibody therapy may reduce the risk of treatment failure should a patient be infected with a SARS-CoV-2 viral variant that is resistant to bamlanivimab alone. Alternative monoclonal antibody therapies that are currently authorized for the same use include bamlanivimab and etesevimab administered together and REGEN-COV.

Health care 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 Centers for Disease Control and Prevention (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.

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