The U.S. government has purchased 10 million treatment courses of Pfizer’s antiviral COVID-19 medication, PAXLOVID, President Joe Biden announced.
Assuming the U.S. Food and Drug Administration (FDA) grants emergency use authorization (EUA) for the treatment, delivery of the medication will begin at the end of 2021 and continue throughout 2022, Biden said.
“My administration is making the necessary preparations now to ensure these treatments will be easily accessible and free,” he said.
Earlier this week, Pfizer announced that it was seeking EUA approval for PAXLOVID, an oral antiviral for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.
The submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the FDA in October 2021, Pfizer said.
If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness, which can lead to hospitalization and death, Pfizer has said.