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The Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) for bamlanivimab plus etesevimab to state that the combination should only be administered in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab is less than or equal to 5%.
In February 2021, the FDA granted EUA to bamlanivimab plus etesevimab for the treatment of mild to moderate COVID-19 in patients 12 years of age and older weighing at least 40kg who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19 and/or hospitalization. In June 2021, the distribution of bamlanivimab plus etesevimab and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) were paused due to increasing prevalence of the Gamma (P.1) and Beta (B.1.351) variants, which are resistant to the combination therapy.
With the updated EUA, the Assistant Secretary for Preparedness and Response will resume distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility) to the following states, territories, and US jurisdictions:
- Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Maine, Massachusetts, New Hampshire, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, Rhode Island, South Dakota, Utah, Vermont, Wisconsin, and Wyoming.
The combination of bamlanivimab plus etesevimab is not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab with etesevimab exceeds 5%. Health care providers should refer to the Fact Sheet for Health Care Providers.
According to in vitro assays, the administration of bamlanivimab and etesevimab together is expected to retain activityagainst the Delta variant (B.1.617.2), but is not expected to retain activity against the Gamma (P.1), Beta (B.1.351), Delta plus (AY.1 and AY.2), and B.1.621 variants.
Monoclonal antibody therapies REGEN-COV (casirivimab and imdevimab) and sotrovimab are also currently authorized for emergency use by the FDA in all states, territories, and US jurisdictions for the treatment of mild to moderate COVID-19 in patients 12 years of age and older weighing at least 40kg who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19, including hospitalization or death.
According to in vitro assays, REGEN-COV and sotrovimab are likely to retain activity against the Gamma, Beta, Delta plus, B.1.621, and Delta variants. At this time, the use and distribution of REGEN-COV and sotrovimab are not impacted by the circulating variants.
References
- Resumption in use and distribution of bamlanivimab/etesevimab in certain states. News release. US Department of Health and Human Services. Accessed August 30, 2021. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/resumption-in-distribution-bamlanivimabetesevimab.aspx?utm_medium=email&utm_source=govdelivery.
- Pause in the distribution of bamlanivimab/etesevimab. News release. US Department of Health and Human Services. Accessed August 30, 2021. https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/bamlanivimab-etesevimab-distribution-pause.aspx.
