Public Health Emergency - Leading a Nation Prepared
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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Regeneron Pharmaceuticals, Inc. received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal treatment REGEN-COV (casirivimab/imdevimab). The EUA allows healthcare providers to administer casirivimab/imdevimab 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.
REGEN-COV is also authorized for post-exposure prophylaxis use. In alignment with the terms of the EUA for casirivimab/imdevimab, 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.
As of September 13,2021, COVID-19 monoclonal antibody therapeutics are being made available through a state/territory-coordinated distribution system. State and territorial health departments know best where product is needed in their areas. Transitioning to a state/territory-coordinated distribution system gives health departments maximum flexibility to get these critical drugs where they are needed most.
HHS will determine the weekly amount of mAb products each state and territory receives based on COVID-19 case burden and mAb utilization. State and territorial health departments will subsequently identify which sites in their respective jurisdictions receive product as well as the amount each site receives.
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