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U.S. Department of Health and Human Services

Bamlanivimab/etesevimab

Important Updates

October 22, 2021 – FDA and ASPR are announcing the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, etesevimab, which is currently authorized for emergency use only when administered together with bamlanivimab.  Learn More >> 

October 21, 2021 -  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. Learn More >>

October 8, 2021 - 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 Hawaii because the Centers for Disease Control and Prevention (CDC) has identified that the Delta plus variant (B.1.617.2 sublineage AY.1) (originally identified in India) is circulating with a frequency exceeding 5% in Hawaii. Learn More >>

September 13, 2021 - The U.S. Department of Health and Human Services transitioned from a direct ordering process for COVID-19 monoclonal antibody therapeutics (mAbs) to a state/territory-coordinated distribution system. The new system will help ensure consistent availability of COVID-19 mAbs and provide health departments with the flexibility to get these critical drugs where they are needed most. Learn More >>

September 13, 2021 -  HHS Provides Pathway to Expand Access to COVID-19 Therapeutics: HHS Issues New PREP Act Declaration. Learn More >>

September 3, 2021 -  HHS is immediately implementing changes to help promote optimal and equitable use of the available supply of monoclonal antibodies while efforts to procure additional product.  Learn More >>

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Outpatient Monoclonal Antibody Treatment for COVID-19 Made Available under Emergency Use Authorization

On February 25, 2021, Eli Lilly and Company received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody treatment bamlanivimab/etesevimab. The EUA allows healthcare providers to administer bamlanivimab/etesevimab together to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. In alignment with the terms of the EUA for bamlanivimab/etesevimab, the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will coordinate distribution of this treatment.

Distribution Table. How to Receive Product

Emergency Use AuthorizationRelated Resources

  • This page last reviewed: October 22, 2021