FDA staff said Pfizer’s clinical trial results on its COVID antiviral pill Paxlovid support its use in adults at high risk of progressing to severe disease
The FDA staff reviewed Pfizer's mid-to-late stage clinical trials of Paxlovid. In one trial called EPIC-HR, Paxlovid showed an 86% reduction in the risk of hospitalization or death in high-risk adults who hadn't received a Covid vaccine. No deaths were observed in the trial.
Paxlovid has been plagued by reports of"rebound" Covid infections, where patients see their Covid symptoms or a positive test return after finishing a five-day course of the oral drug. Last year, both Presidentand his former chief medical advisor Dr. Anthony Fauci experienced rebound cases after taking Paxlovid.
But FDA staff highlighted trial data that showed overall rates of rebound ranged from 10% to 16%,"with no evidence of a higher rate of symptom rebound or moderate symptom rebound" in patients who received Paxlovid compared to a placebo. That was also regardless of patients' risk of severe disease, or whether Covid's omicron variant or an earlier strain was dominant, according to the staff.
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