Public Health Emergency - Leading a Nation Prepared
October 8, 2021 - Effective, 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 - Effective, 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.
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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.
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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.
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