COVID-19 pill Paxlovid moves closer to full FDA approval

WASHINGTON (AP) — Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers Thursday, paving the way for full regulatory approval from the Food and Drug Administration.

The drug has been used by millions of Americans since the FDA granted it emergency use authorization late 2021. The agency has the final say on full approval of Pfizer’s drug and is expected to make a decision in May.

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

“We still have many groups that could benefit from Paxlovid, including unvaccinated individuals, undervaccinated individuals, the elderly and the immunocompromised,” said Dr. Richard Murphy of the Department of Veterans Affairs.

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 mood was widely expected as Paxlovid has been the best treatment against COVID-19, especially since a whole group of antibody drugs has been sidelined because the virus has mutated.

The US continues to report about 4,000 deaths and 35,000 hospitalizations weekly, the FDA noted.

The agency asked its panel of independent medical experts to answer several lingering questions about 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 reviews by both the FDA and Pfizer that found no clear link between Paxlovid use and recurrent symptoms, but said more information is needed from studies and medical record data. High-profile cases drew attention to the issue last year, including President Joe Biden and First Lady Jill Biden.

Between 10% and 16% of patients in multiple Pfizer studies had symptoms return, whether they received Paxlovid or a dummy pill. Such cases “likely reflect the natural progression of COVID-19,” the FDA concluded.

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

Pfizer originally studied Paxlovid in the highest-risk COVID-19 patients: unvaccinated adults with other health conditions and no evidence of previous coronavirus infection. But that doesn’t reflect the current U.S. population, where an estimated 95% of people are protected from at least one vaccine dose, a previous infection, or both.

The FDA reviewed Pfizer data showing that Paxlovid made no significant difference in otherwise healthy adults, regardless of whether they were previously vaccinated.

But when the FDA leaked data for high-risk adults — regardless of their vaccination or infection history — Paxlovid still showed a significant benefit, reducing the chances of hospitalization or death by 60% to 85%, depending on individual circumstances. Patients in that group included seniors and people 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. Sankar Swaminathan of the University of Utah and other panelists stressed the importance of controlling potentially dangerous drug interactions between Paxlovid and other commonly used drugs.


The Associated Press Health and Science division is supported by the Science and Educational Media Group of the Howard Hughes Medical Institute. The AP is solely responsible for all content.


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