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August 27, 2021August 27, 2021 – The Assistant Secretary for Preparedness and Response (ASPR) and the U.S. FDA have announced updates to emergency use authorization (EUA) for bamlanivimab and etesevimab to be used together to treat COVID-19.
- On June 25, 2021, the ASPR and FDA called for an immediate pause to distribution and use of bamlanivimab and etesevimab to treat COVID-19. The decision was made because the treatment was potentially ineffective against certain variants of the SARS-CoV-2 virus that causes COVID-19. At the time, these variants were becoming more common in the United States.
- As of August 27, 2021, the drugs' updated EUA specifies they can be used together to treat COVID- 19 in states, territories, and U.S. jurisdictions where the prevalence of resistant variants is 5% or less, as determined by recent data.
- The FDA maintains a list on its website of areas where the treatment can be used. The list is updated periodically based on the most recent data available.
- The treatment, which is given as a one-time intravenous infusion, is authorized for mild to moderate COVID-19 in adults and pediatric patients (at least 12 years of age and weighing at least 40kg, or about 88 pounds). Under the EUA, patients must be at high risk for progression to severe COVID-19, including hospitalization or death, and must have positive results of direct viral testing for SARS-CoV-2.
- Bamlanivimab and etesevimab, which are manufactured by Eli Lily, first received an EUA on February 9, 2021, to treat COVID-19. Neither drug currently holds full FDA approval.