Public Health Emergency - Leading a Nation Prepared
The Department of Health and Human Services (HHS) and the Department of Defense (DOD) today announced the purchase of 1.25 million additional treatment courses of Regeneron’s investigational monoclonal antibody therapeutic, a combination of casirivimab and imdevimab, to be delivered in the first half of 2021 to treat non-hospitalized, high-risk COVID-19 patients. This latest agreement brings the total supply of casirivimab and imdevimab purchased by HHS and DOD to over 1.5 million treatment courses.
Under the agreement announced in July to meet Operation Warp Speed goals, Regeneron is in the process of delivering the first approximately 300,000 doses of casirivimab and imdevimab. Following Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS began allocating these doses November 23 to state and territorial health departments which, in turn, direct which healthcare facilities receive the infusion drug. An HHS treatment locator is now available showing where antibody therapeutics have been delivered.
“With COVID-19 cases continuing to rise, treating people with mild or moderate infections can help prevent hospitalizations, which will reduce the burden on healthcare systems,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “To ensure equitable and efficient distribution, we will continue coordinating with 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.”
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 that hospitals and state health departments enter into the HHS Protect data collection platform. To date, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) has allocated more than 127,700 treatment courses of the therapeutic.
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, provided approximately $2.63 billion to purchase the additional treatment courses, working in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Army Contracting Command.
Regeneron’s therapeutic treatment received an EUA from the FDA on November 21, 2020, for use in treating high-risk, non-hospitalized patients with mild or moderate confirmed cases of COVID-19.
Regeneron developed the treatment, a combination of two monoclonal antibodies called casirivimab and imdevimab, with preclinical and clinical development funded in part through a long-standing partnership with BARDA. Regeneron previously used its same proprietary technology to develop a novel triple monoclonal antibody treatment for Ebola, which in 2020 became the first FDA-approved treatment for Zaire ebolavirus.
Antibodies are a component of the human immune system. Monoclonal antibodies developed by Regeneron are made outside of the body by a single clone of cells or a cell line producing identical antibody molecules, and then delivered to patients via infusion or injection. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.
To find out how much of the therapeutic treatment has been allocated to specific states, territories and jurisdictions, visit the allocation dashboard. This dashboard will be updated after each allocation while the U.S. government is engaged in the allocation and distribution process.
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, BARDA-supported products have achieved 57 FDA approvals, licensures or clearances. 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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