The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021. The agency has the final say on giving
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.
“We still have many groups that stand to benefit from Paxlovid, including unvaccinated persons, under-vaccinated persons, the elderly and the immuno-compromised,” said Dr.
The FDA said using Paxlovid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospitalizations per week.
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
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 panel agreed with assessments by both the FDA and
Between 10% and 16% of patients across multiple
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.
The FDA reviewed
But when FDA teased out data for high-risk adults — regardless of their vaccination or infection history — Paxlovid still showed a significant benefit, reducing the chance of hospitalization or death between 60% and 85%, depending on individual circumstances. Patients in that group included seniors and those with serious health problems, such as diabetes, obesity, lung disease and immune-system disorders.
With so many different factors, panelists said prescribing Paxlovid will remain a case-by-case decision.
Dr.
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