Public Health Emergency - Leading a Nation Prepared
The Trump Administration, through the Department of Health and Human Services (HHS) and the Department of Defense (DoD), today announced the purchase of 650,000 additional treatments courses of Eli Lilly and Company’s investigational monoclonal antibody therapeutic, bamlanivimab, to be delivered in December and January for treatment of non-hospitalized COVID-19 patients. This latest purchase brings the total to 950,000 treatment courses.
Each treatment course is a single dose. Under the agreement announced October 28 and to meet Operation Warp Speed goals, the company is in the process of delivering the first 300,000 doses, and on November 10, HHS began allocating these doses to state and territorial health departments which, in turn, are determining which healthcare facilities receive the infusion drug.
“With COVID-19 cases on the rise, treating people with mild or moderate infections can help prevent hospitalizations, which will reduce that burden on healthcare systems,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, MD. “To ensure equitable and efficient distribution, we will continue coordinating with Lilly, its distributor, and state and territorial health departments to get these additional therapeutics into the hands of healthcare providers quickly, with a focus on areas of the country currently hardest hit by the pandemic.”
A data-driven system is ensuring fair and equitable distribution of these new products. Weekly allocations to state and territorial health departments are based proportionally on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data hospitals and state health departments enter into the HHS Protect data collection platform. To date, more than 215,000 treatment courses of bamlanivimab have been allocated.
The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) worked with state and territory partners to refine the process based on experience with previous therapeutics and diagnostics; shipments now occur within hours of pulling the weekly data. These government-purchased doses are available at no cost to patients, although healthcare facilities could charge for administering the medicine – as is customary with such government-purchased products. The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, funded the purchase of the product working in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Army Contracting Command.
Lilly received emergency use authorization (EUA) for bamlanivimab from the U.S. Food and Drug Administration November 9 for use in treating non-hospitalized patients with mild or moderate confirmed cases of COVID-19. Under the EUA, bamlanivimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Facilities also must have space available to administer the medication in a manner that minimizes infection transmission.
The company developed the medicine without federal support. Bamlanivimab currently is being evaluated in ongoing clinical trials funded by Lilly in addition to a clinical trial as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership led by the National Institutes of Health with funding and other support from the BARDA. ACTIV is part of a coordinated research strategy to prioritize and speed development of the most promising treatments and vaccines.
To find out how much bamlanivimab has been allocated to specific states, territories, and jurisdictions, visit the allocation dashboard. This dashboard will be updated each distribution week until the FDA issues a revised EUA indicating the U.S. government involvement in the allocation and distribution process is no longer needed. This may occur when the supply of the product meets the demand from the commercial marketplace.
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 56 BARDA-supported products have achieved FDA approval, licensure or clearance. For more on BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments and about partnering with BARDA, visit medicalcountermeasures.gov. To learn more about federal support for the all-of-America COVID-19 response, visit coronavirus.gov.
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.
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