Paxlovid Gets FDA Panel Backing For Full Approval; Combating Rebound Misperception Urged

Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.

Paxlovid box and pills — FDA panel finds Paxlovid benefit-risk is favorable for treatment of COVID-19 in those at high-risk of progresing to severe illness • Source: Shutterstock

An advisory committee of the US Food and Drug Administration agreed that clinical trial data support full approval of Pfizer Inc.’s Paxlovid while suggesting additional studies be done in immunocompromised patients and that the agency publish its analyses of COVID-19 rebound to dispel misperceptions.

At its 16 March meeting, the Antimicrobial Drugs Advisory Committee voted 16-1 that the overall benefit-risk assessment is favorable for...