On December 22, 2021, the US Food and Drug Administration (FDA) issued emergency use
authorization (EUA) for the combination of nirmatrelvir and ritonavir tablets co-packaged
and sold by Pfizer (New York, NY) under the name Paxlovid for individuals over the
age of 12 years. Data supporting EUA comes from EPIC-HR, a randomized, double-blind,
placebo-controlled trial of adult patients with COVID-19 who had one or more risk
factors for progression to severe disease (Table).1-3 Crucially, none of the participants
had received a COVID-19 vaccine or had a prior documented infection with COVID-19.