Public Health Emergency - Leading a Nation Prepared
January 24, 2022: The FDA today updated the Emergency Use Authorization (EUA) fact sheets for two COVID-19 monoclonal antibody treatments: Lilly’s bamlanivimab plus etesevimab and Regeneron’s casirivimab plus imdevimab (REGEN-COV). FDA now says these two treatments are not currently authorized for use anywhere in the U.S., due to the prevalence of Omicron. FDA is encouraging healthcare providers to choose authorized treatment options with activity against circulating variants in their state, territory, or U.S. jurisdiction. Learn More >>
December 31, 2021: In light of recent National Institutes of Health (NIH) clinical guidelines published on Dec. 30, 2021, and the significant variability in prevalence of the Omicron Variant of Concern (VOC), all states and territories can continue to order both Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products from HHS based on allocated amounts for clinically appropriate use.
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December 29, 2021: Based on recent data and assessment, HHS will pause allocations of bamlanivimab/etesevimab and REGEN-COV COVID-19 therapeutics to states or territories within regions of the country that have greater than 80% prevalence of the Omicron variant based on CDC NOWCAST data. These two products are not expected to be effective in patients infected with the Omicron variant, and other therapeutic options are available. The purpose of this pause is to ensure effective product is available in most sites. In regions that have less than 80% prevalence of the Omicron variant, states and territories will continue to receive allocations of the two products to use as clinically appropriate. Learn More >>
December 23, 2021: ASPR will pause any further allocation of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun. An additional 300,000 doses of sotrovimab will be available for distribution in January. 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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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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