WASHINGTON (AP) — Pfizer’s COVID-19 pill offers little or no benefit for young adults, while reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday. does.
The results of a 109,000-patient Israeli study are likely to re-emerge questions about the US government’s use of Paxlovid, which has become a treatment for COVID-19, due to its in-house facility. Biden Administration It has spent more than $10 billion to buy the drug and make it available in thousands of pharmacies through its test-and-treat initiative.
Researchers found that Paxlovid reduced hospitalization by about 75% in people 65 and older when given soon after infection. This is in line with earlier results used to authorize the drug in the US and other countries.
But people between the ages of 40 and 65 saw no measurable benefit, according to an analysis of medical records.
The study has limitations due to its design, which compiles data from a large Israeli health system rather than enrolling patients in a randomized study with a control group — the gold-standard for medical research.
The findings reflect the changing nature of the pandemic, with most people already vaccinated or having some protection against the virus due to prior infection. For young adults, in particular, it greatly reduces their risk of serious COVID-19 complications. The Centers for Disease Control and Prevention recently estimated 95% of Americans age 16 and older have acquired some level of immunity against the virus.
“PaxLovid will remain important for people at highest risk of severe COVID-19, such as seniors and those with weakened immune systems, who were not involved in the study,” said Dr. David Boulware, a researcher and physician at the University of Minnesota. “But for the majority of Americans who are eligible now, it really doesn’t have much of a benefit.”
A Pfizer spokesperson declined to comment on the results, which were published in the New England Journal of Medicine.
The US Food and Drug Administration has Paxlovid. authorized to Late last year for adults and children 12 years of age and older who are considered high risk because of conditions such as obesity, diabetes and heart disease. According to the CDC, more than 42% of American adults are considered obese, representing 138 million Americans.
There were no alternatives to treating COVID-19 at home at the time of the FDA’s decision, and Paxlovid was seen as key to preventing hospitalizations and deaths during the pandemic’s second winter surge. The drug’s results were also stronger than those of Merck’s competing pill.
The FDA made its decision based on the Pfizer study in high-risk patients who had not previously been vaccinated or treated for COVID-19 infection.
“Those people do exist but they are relatively rare because most people have now either been vaccinated or they have become infected,” Boulware said.
Pfizer reported earlier this summer that a separate study of paxlovid in healthy adults — vaccinated and unvaccinated — failed to show a significant benefit. Those results have not yet been published in a medical journal.
According to federal records, more than 3.9 million prescriptions for Paxlovid have been filled since the drug was authorized. a treatment course There are three tablets twice a day for five days.
A White House spokeswoman pointed to several recent letters Wednesday saying that PaxLovid helps reduce hospitalizations among people 50 and older. The studies have not been published in peer-reviewed journals.
“The risk of serious consequences from COVID has a gradient, and a growing body of evidence suggests that individuals aged 50 to 64 may also benefit from Paxlovid,” Kevin Munoz said in an emailed statement.
Administration officials have been working for months to increase the use of Paxlovid, opening thousands of sites where patients who test positive can fill a prescription. Last month, US officials further expanded access By allowing pharmacists to prescribe medicine.
The White House recently indicated that it may soon stop buying vaccines, drugs and tests for COVID-19, shifting responsibility to the private insurance market. Under that scenario, insurers can set new criteria for patients to pay to receive Paxlovid.
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