COVID-19 Pill Paxlovid Moves Closer to Full FDA Approval

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COVID-19 Pill Paxlovid Moves Closer to Full FDA Approval
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Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers Thursday, clearing the way for its full regulatory approval by the Food and Drug Administration.

A panel of outside experts voted 16-1 that Paxlovid remains a safe and effective treatment for high-risk adults with COVID-19 who are more likely to face hospitalization and death due to the virus.

The panel’s positive vote was widely expected, given that Paxlovid has been the go-to treatment against COVID-19, especially since an entire group of antibody drugs has been sidelined as the virus mutated.The agency asked its panel of independent medical experts to address several lingering questions involving Paxlovid, including which people currently benefit from treatment and whether the drug plays a role in cases of COVID-19 rebound.

The federal government has purchased more than 20 million doses of Paxlovid and encouraged health professionals to prescribe it aggressively to help prevent severe COVID-19. But that’s led to concerns of overprescribing and questions of whether some patients are needlessly getting the drug.

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