Biden administration plans to purchase 1.7 million courses of Merck’s antiviral treatment

President Biden’s administration committed on Wednesday to procuring nearly 2 million courses of the pharmaceutical company Merck’s COVID-19 antiviral treatment, pending the Food and Drug Administration’s (FDA) emergency authorization or approval.

The Department of Health and Human Services (HHS) announced the $1.2 million agreement to obtain 1.7 million of five-day treatment courses of the drug molnupiravir. 

So far, clinical trials involving the oral drug have shown it could slow the replication of the COVID-19 virus in the human body, but the FDA has not yet granted emergency use authorization or approval for it to be used in the U.S. 

Merck is currently conducting a phase 3 trial involving molnupiravir to determine whether it reduces the risk of hospitalization or death for non-hospitalized patients who are diagnosed with COVID-19 and are considered at high risk of serious illness. 

The pharmaceutical company said in a release that it plans to potentially apply for an emergency use authorization from the FDA in the second half of this year, if the trial results show a reduction of hospitalization and death risk. 

Merck, which developed the drug with Ridgeback BioTherapeutics, also intends to apply for approval from other regulatory groups in other countries and is discussing similar advance procurement deals with other governments as well.

The company is also boosting its production of the antiviral drug, predicting to have more than 10 million courses of treatment ready by the end of this year. If the FDA gives its authorization or approval of molnupiravir, the federal government said it will distribute the drug to states and territories.

“Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir — an investigational oral therapy being studied for outpatient use early in the course of disease — if it is authorized or approved,” Merck President Rob Davis said in a statement.

HHS said in a release that the deal is part of the 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.”