The FDA reviewed Pfizer's mid-to-late stage clinical trials of Paxlovid and found "no evidence of a higher rate of symptom rebound or moderate symptom rebound."
In Pfizer's clinical trial, Paxlovid showed an 86 percent reduction in risk of hospitalization or death in high-risk adults who had not received a COVID-19 vaccine, according to a March 14 article from CNBC. The trial data showed overall rates of rebound ranged from 10 percent to 16 percent regardless of the strain or patients' risk of severe disease.
The FDA briefing documents were submitted ahead of the agency's Antimicrobial Drugs Advisory Committee meeting, which will determine whether to recommend full approval of Paxlovid for treatment of mild to moderate COVID-19 in high-risk adults.
The FDA authorized emergency use of Paxlovid in December 2021, and Pfizer submitted an application for full approval in June 2022. The agency is set to complete its review in May, according to CNBC.