Pfizer Required to Conduct Paxlovid Covid Rebound Trial

FDA has revised an emergency use authorization for Pfizer’s Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-moderate Covid-19 to require a post-authorization clinical trial in patients with “Covid-19 rebound” and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate Covid-19.

Reports about Covid-19 rebound following a treatment course of Paxlovid have been increasing. Last month, president Biden experienced a Covid rebound after completing his Paxlovid treatment course and testing negative.

According to the EUA revision, “Pfizer will conduct a randomized placebo-controlled trial in patients with Covid-19 rebound following an initial treatment course of Paxlovid to evaluate a subsequent five-day treatment course of Paxlovid. Pfizer will provide topline results by September 30, 2023.”