COVID-19 tracker: Pfizer seeks full approval for Paxlovid

After running six months on an emergency use authorization for Paxlovid, Pfizer is now seeking a full FDA approval for the COVID antiviral in patients who are at high risk for progression to severe illness regardless of their vaccination status. When taken within five days of symptom onset, Paxlovid cut the risk of hospitalization or death from any cause by 86% in non-hospitalized, high-risk patients, according to final results from the phase 2/3 EPIC-HR study. Pfizer's application package also includes data from the EPIC-SR study, which didn't hit its goal in vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID.