On Jun. 14 2022, Pfizer reported data from the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study evaluating the use of PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in patients who were at standard risk for developing severe COVID-19.

Treatment-emergent adverse events were comparable between PAXLOVID (23.1%) and placebo (23.4%), most of which were mild in intensity. Rates of serious adverse events (1.4% vs. 1.9%) and discontinuation of study drug due to adverse events (1.7% vs. 1%) were also comparable between PAXLOVID and placebo.

PAXLOVID is currently approved or authorized for conditional or emergency use in more than 65 countries across the globe to treat high-risk COVID-19 patients. Available safety data for PAXLOVID have been generally consistent in more than 3,500 PAXLOVID-treated participants across the EPIC-HR, EPIC-SR and EPIC-PEP studies, as well as in reported post-authorization safety experience.