Paxlovid is nearing full FDA approval

WASHINGTON – Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from US health advisers on Thursday, clearing 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 approval in late 2021. The agency has the final say on whether to give Pfizer’s drug full approval and is expected to make a decision by May.

The 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 from the virus.

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

The FDA says that using Paxlovid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospitalizations per week.

The committee’s positive vote was widely expected, given that Paxlovid has been a mainstay in the fight against COVID-19, especially since an entire class of antibody drugs has been sidelined by the mutation of the virus.

The U.S. continues to report about 4,000 deaths and 35,000 hospitalizations per week, the FDA said.

read more: Why Not Everyone Should Take Paxlovid

The agency asked its panel of independent medical experts to address several lingering questions about Paxlovid, including which people are currently benefiting from the treatment and whether the drug is playing a role in cases of COVID-19 recovery.

The panel agreed with assessments by both the FDA and Pfizer, which found no clear link between Paxlovid use and returning symptoms, but said more information is needed from studies and medical record data. High-profile cases last year brought attention to the issue, including President Joe Biden and First Lady Jill Biden.

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

The federal government has purchased more than 20 million doses of Paxlovid and encouraged healthcare 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 receiving the drug inappropriately.

Pfizer initially studied Paxlovid in the highest-risk patients with COVID-19 — unvaccinated adults with other health conditions and no evidence of prior coronavirus infection. But that doesn’t reflect the US population today, where about 95% of people are protected by at least one vaccine dose, previous infection, or both.

The FDA reviewed data from Pfizer showing that Paxlovid did not make a significant difference in otherwise healthy adults, whether or not they had been previously vaccinated.

But when the FDA released data for high-risk adults, regardless of their vaccination or infection history, Paxlovid still showed significant benefit, reducing the chance of hospitalization or death by 60% to 85%, depending on individual circumstances. Patients in that group included the elderly and those with serious health conditions such as diabetes, obesity, lung disease and immune system disorders.

With so many different factors at play, experts said prescribing Paxlovid will remain an individual decision.

Dr. Sankar Swaminathan of the University of Utah and other experts emphasized the importance of managing potentially dangerous drug interactions between Paxlovid and other commonly used drugs.

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