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Monday, June 14th, 2021

U.S. federal government to acquire 1.7 million doses of Merck’s molnupiravir COVID-19 antiviral following FDA authorization

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A new agreement struck between the Biden administration and Merck & Co. will provide the U.S. government with 1.7 million courses of the company’s investigational COVID-19 antiviral treatment, molnupiravir.

This agreement is contingent upon either emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA). Still, the treatment has performed well in previous studies, which investigated its capabilities against influenza, Ebola, and Venezuelan Equine Encephalitis virus — though it has not been approved for the treatment of any of them. However, an ongoing phase three trial has used it against COVID-19, with data from 1,850 patients expected in the fall.

Molnupiravir, also known as MK-4482, was created to induce viral genome copying errors that keep viruses from replicating in the human body. Current evidence suggests it has the potential for reducing replication of the SARS-CoV-2 virus that causes COVID-19. Merck has been developing the treatment in collaboration with Ridgeback Biotherapeutics and is actively scaling up manufacturing during clinical trials.

The Biomedical Advanced Research and Development Authority (BARDA), Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), and Army Contracting Command will pay out $1.2 billion for the five-day treatment courses once FDA decides on them. At that point, the federal government would begin allocating molnupiravir to states and U.S. territories. Healthcare providers would then be able to order the product directly from the appropriate distributor.