The COVID-19 pill Paxlovid is nearing full FDA approval

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

Medicines have been used by millions of Americans since the FDA cleared them for use emergency use permit in late 2021. The agency has the final say on whether to fully approve Pfizer’s drug 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 be hospitalized and die 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 said using Paxlovid in high-risk patients could prevent 1,500 deaths from COVID-19 and 13,000 hospitalizations per week.

The group’s positive vote was expected given that Paxlovid was the main treatment for COVID-19, especially since the entire group drugs with antibodies was rejected because the virus was mutating.

The US continues to report 4,000 deaths and 35,000 hospitalizations each week, the FDA said.

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

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

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

The federal government has purchased more than 20 million doses of Paxlovid and urged health care providers to do so assign it aggressively to help prevent severe COVID-19. But that has led to concerns about overprescribing and questions about some patients getting the drug unnecessarily.

Pfizer initially studied Paxlovid in patients most at risk for COVID-19: unvaccinated adults with other health problems and no evidence of prior infection with the coronavirus. But this does not reflect the current US population, where an estimated 95% of people have protection from at least one dose of the vaccine, prior exposure, or both.

The FDA reviewed Pfizer’s data showing Paxlovid did not make a significant difference in healthy adults, regardless of whether they have been previously vaccinated.

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

With so many different factors to consider, panelists said prescribing Paxlovid will be decided on a case-by-case basis.

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