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 the National Institutes of Health (NIH) clinical guidelines published on Dec. 30, 2021, and the significant variability in prevalence of the Omicron Variant of Concern, 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. Learn More >>
December 30, 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.
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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 >>
December 21, 2021: FDA and ASPR are announcing the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together. Learn More >>
December 3, 2021 - The U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.
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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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