WASHINGTON (AP) — Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults, while still reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday .
The results of an Israeli study of 109,000 patients are likely to raise new questions about the US government’s use of Paxlovid, which has become the best treatment for COVID-19 due to its convenience at home. The Biden Administration has spent more than $10 billion to buy the drug and make it available at thousands of pharmacies through its test-and-treat initiative.
The researchers found that Paxlovid reduced the number of hospitalizations in people over 65 by about 75% when given shortly after infection. That’s consistent with previous 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, the analysis of medical records shows.
The study has limitations because of its design, which collected data from a major Israeli health system rather than including patients in a randomized controlled trial — the gold standard for medical research.
The findings reflect the changing nature of the pandemic, with the vast majority of people already having some protection against the virus as a result of vaccination or previous infection. Especially for younger adults, that significantly reduces their risk of serious COVID-19 complications. The Centers for Disease Control and Prevention recently estimated: that 95% of Americans aged 16 and over have acquired some degree of immunity to the virus.
“Paxlovid will continue to be important for people at highest risk for severe COVID-19, such as seniors and those with compromised immune systems,” said Dr. David Boulware, a University of Minnesota researcher and physician who was not involved in the study. . “But for the vast majority of Americans who qualify now, this really doesn’t benefit much.”
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 late last year for adults and children ages 12 and older who are considered to be at high risk due to 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.
At the time of the FDA decision, there were no options to treat COVID-19 at home, and Paxlovid was considered critical in reducing hospitalizations and deaths during the second winter wave of the pandemic. The drug’s results were also much stronger than a competing pill from Merck.
The FDA made its decision based on a Pfizer study in high-risk patients who had not been vaccinated or treated for a previous COVID-19 infection.
“Those people do exist, but they’re relatively rare because most people have now been vaccinated or become infected,” Boulware said.
Pfizer reported earlier this summer that a separate study of Paxlovid in healthy adults — vaccinated and unvaccinated — showed no significant benefit. Those results have not yet been published in a medical journal.
According to federal data, more than 3.9 million prescriptions for Paxlovid have been filled since the drug was approved. A treatment course is three pills twice a day for five days.
A White House spokesperson pointed out several recent papers on Wednesday that suggest Paxlovid is helping to reduce hospitalizations in people 50 and older. The studies have not been published in peer-reviewed journals.
“The risk of serious consequences from COVID is along a gradient, and the growing body of evidence shows that individuals between the ages of 50 and 64 can 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 for patients who test positive to fill out a prescription. Last month, US officials further expanded access by allowing pharmacists to prescribe the drug.
The White House recently signaled that it may soon stop buying COVID-19 vaccines, drugs and tests, shifting responsibility to the private insurance market. In that scenario, insurers could establish new criteria for when they would pay for patients to receive Paxlovid.
Follow Matthew Perrone on Twitter: @AP_FDAwriter
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.