WASHINGTON (AP) — 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 it was approved by the FDA emergency use authorization In late 2021, the agency will have the final say on granting full approval to Pfizer’s drug, with a decision expected 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.
The panel’s positive vote was widely expected, given that paxlovid is the go-to treatment for COVID-19. Antibody drug Excluded because the virus mutated.
About 4,000 deaths and 35,000 hospitalizations continue to be reported each week in the United States, the FDA notes.
AP Photo/Stephanie Nano, File
The agency has asked a panel of independent medical experts to address some lingering questions about Pax Lovid. COVID-19 rebound cases.
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, a high-profile incident drew attention to the issue. 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 and recommended more than 20 million doses of Paxlovid to medical professionals. aggressively prescribe Helps 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 has reviewed Pfizer’s data showing Paxlovid. There was no meaningful difference In otherwise healthy adults with or without prior vaccination.
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.
The Associated Press’ Health Sciences Division is supported by the Scientific and Educational Media Group at the Howard Hughes Medical Institute. AP is solely responsible for all content.
