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U.S. Department of Health and Human Services

Molnupiravir (MK-4482)

Important Updates

December 23, 2021 - The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.  Learn More >>

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On December 23, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to Merck for its oral antiviral drug Molnupiravir to treat COVID-19. Molnupiravir is now authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate.

The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) will oversee the fair and equitable allocation of Molnupiravir to state and territorial health departments and, select Health Resources and Services Administration (HRSA)-funded health centers.

HHS has purchased about 3 million courses of Molnupiravir. An initial 300,000 courses of Molnupiravir has been made available for shipment to states and territories and will begin arriving at dispensing sites by the end of December. Initial allocations of Molnupiravir were determined on a pro rata basis and will be provided to state and territorial health departments for free.

State and territorial health departments will allocate product to dispensing sites across their jurisdictions, and the distributor will ship product directly to sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments.

Equity remains a top priority in the nation’s COVID-19 response. As part of our commitment to equitable access, HHS will identify a subset of 200 Health Resources and Services Administration (HRSA)-funded health centers across all 50 states to receive a direct allotment of Molnupiravir each distribution cycle. This allotment will equal about 15% of the total product available to HHS in a given distribution period, and allocation of product to these centers will be separate from the pool of product allocated to states and territories. Health departments will have insight into selected HRSA-funded health centers and their product allocations and reporting. This effort will complement the focus health departments are already placing on equity by helping ensure Molnupiravir is accessible to some of the most vulnerable communities and hard-hit populations around the country.

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  • This page last reviewed: January 12, 2022