On Nov. 16, 2021, Pfizer announced it had submitted an Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.

This submission to the U.S. Food and Drug Administration (FDA) included 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.

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.