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.
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Recent And Upcoming FDA Advisory Committee Meetings
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Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval
Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.