WASHINGTON — Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers on Thursday, paving the way for full regulatory approval by the Food and Drug Administration.
The drug has been used by millions of Americans since the FDA granted emergency use authorization in late 2021. The FDA has the final say in granting full approval to Pfizer’s drug. We plan to make a decision by May.
A panel of outside experts voted 16 to 1 that paxlovid remains a safe and effective treatment for adults at high risk of COVID-19, who are likely to face hospitalization and death from the virus Did.
“There are still many groups that would benefit from Paxlovid, including unvaccinated, unvaccinated, elderly and immunocompromised individuals,” said Dr. Richard Murphy of the Department of Veterans Affairs. increase.
The FDA says use of paxlobid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospitalizations per week.
Given that paxlovid is the go-to treatment for COVID-19, the panel’s positive vote is widely expected, especially given that the virus has mutated, sidelining the entire group of antibody drugs. It was done.
About 4,000 deaths and 35,000 hospitalizations continue to be reported each week in the United States, the FDA notes.
read more: Why Everyone Shouldn’t Take Paxlovid
The agency has asked a panel of independent medical experts to address some lingering questions about Paxlovid. This includes which people are currently benefiting from treatment and whether the drug has a role in cases of COVID-19 rebound.
The panel agreed with evaluations by both the FDA and Pfizer, which found no clear link between paxlovid use and recurrence of symptoms, but needed more information from studies and medical record data. said it is. Last year, high-profile cases brought the issue to the fore, including President Joe Biden and First Lady Jill Biden.
In multiple Pfizer studies, symptoms recurred between 10% and 16% of patients, regardless of whether they received paxlobid or the dummy pill. Such cases “likely reflect the natural progression of COVID-19,” the FDA concludes.
The federal government has purchased more than 20 million doses of paxlobid and encouraged medical professionals to aggressively prescribe it to prevent severe COVID-19. However, it has led to concerns of overprescribing and the question of whether some patients are taking their medication unnecessarily.
Pfizer was initially studying paxlovid in the highest-risk COVID-19 patients. This is an unvaccinated adult with other health problems and no evidence of previous coronavirus infection. But that doesn’t reflect today’s US population. An estimated 95% of people are protected from at least one of her vaccinations, previous infections, or both.
The FDA reviewed the Pfizer data and showed that paxlovid made no significant difference in otherwise healthy adults, regardless of whether they had been previously vaccinated.
However, when the FDA pulled data in high-risk adults, paxlobid still showed significant benefits, regardless of vaccination or infection history, reducing the chances of hospitalization or death from 60% to 85%, depending on individual circumstances. % reduced. That group of patients included the elderly and those with serious health problems such as diabetes, obesity, lung disease, and compromised immune systems.
With so many different factors, panelists said the prescription of Paxlovid remains a case-by-case decision.
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.
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