The Biden Administration today announced that the U.S. government will procure approximately 1.7 million courses of an investigational antiviral treatment, molnupiravir (MK-4482), for COVID-19 from Merck, pending emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA).
Molnupiravir (MK-4482) is designed to induce viral genome copying errors to prevent the virus from replicating in the human body, and evidence to date from clinical trials in patients with COVID-19 suggests that molnupiravir may reduce replication of the SAR-CoV-2 virus.
This treatment is being evaluated in an ongoing Phase 3 trial for its potential to reduce the risk of hospitalization or death in non-hospitalized patients who have symptoms for five days or less and are at high risk for severe illness. The trial plans to enroll a total of 1,850 patients globally with final data expected in the fall of 2021.
In studies, molnupiravir has demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus, although molnupiravir has not been approved by the FDA for treatment of these diseases.
This agreement is part of the Biden Administration’s whole-of-government approach to develop new COVID-19 treatments and to respond to the health needs of the public through unprecedented partnership between agencies including the U.S. Department of Health and Human Services and the Department of Defense. This approach leverages all expertise and resources available to respond to COVID-19 such as funding the development and manufacturing of therapeutics, including antivirals.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army Contracting Command, on the $1.2 billion purchase agreement for the 1.7 million 5-day treatment courses of molnupiravir to be procured only if FDA grants emergency use authorization (EUA) or approval.
Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics. Merck is scaling up manufacturing while clinical trials are underway to deliver molnupiravir as quickly as possible, pending FDA EUA or approval. If FDA grants EUA or approval, the federal government will allocate molnupiravir to states and U.S. territories, and healthcare providers will be able to order the product directly from the distributor within those allocations.
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 (MCMs) – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 60 FDA approvals, licensures or clearances. To learn more about BARDA's COVID-19 Portfolio and BARDA’s COVID-19 Response, visit www.medicalcountermeasures.gov.
About the JPEO-CBRND:
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.