Paxlovid isn't associated with COVID rebound, in which patients test positive or have symptoms days after a course of the drug is completed, FDA staff said in briefing documents.
Paxlovid isn't associated with COVID rebound, in which patients test positive or have symptoms days after a course of the drug is completed, Food and Drug Administration staff said inThis is the first time the FDA has publicly discussed if the phenomenon is actually due to the antiviral — a question that’s swirled around its use since Pfizer's drug was granted emergency use authorization in December 2021.
FDA staff said that Pfizer’s clinical trials support the notion that Paxlovid’s benefits outweigh its risks.Both the FDA and Pfizer concluded that rebound is likely part of the natural course of a COVID infection and that it does not lead to severe disease when it occurs. Rebound has also been observed in the absence of Paxlovid treatment, with potential rates ranging from 10% to 16%.
The likelihood of rebound was not significantly different between patients who were sick with the omicron variant compared to the delta variant.FDA regulators acknowledged more research is needed to determine whether a longer-term dosage than the customary five-day Paxlovid course could be needed for moderate-to-severely immunocompromised patients.
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