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 released Wednesday.
Results from an Israeli study of 109,000 patients are likely to renew questions about the US government’s use of Paxlovid, which has become the go-to treatment for COVID-19 because of its convenience at home. The Biden administration has spent more than $10 billion to buy the drug and make it available to thousands of pharmacies through its test-and-treat initiative.
The researchers found that Paxlovid reduced hospitalizations in people 65 and older by about 75% when given shortly after infection. This is consistent with previous results used to approve the drug in the US and other nations.
But people between the ages of 40 and 65 saw no measurable benefit, according to the analysis of medical records.
The study has limitations due to its design, which collected data from a large Israeli health system rather than enrolling patients in a randomized controlled trial—the gold standard for medical research.
The findings reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus due to vaccination or previous infection. For younger adults, in particular, this greatly reduces the risks of serious complications from COVID-19. The Centers for Disease Control and Prevention recently estimated that 95% of Americans 16 and older have acquired some level of immunity to the virus.
“Paxlovid will remain important for people who are at the highest risk of severe COVID-19, such as the elderly and people with weakened immune systems,” said Dr. David Boulware, a University of Minnesota researcher and physician who was not involved in the study. study. “But for the vast majority of Americans who are now eligible, that really doesn’t have much benefit.”
A Pfizer spokesman declined to comment on the results, which were published in the New England Journal of Medicine.
The U.S. Food and Drug Administration approved Paxlovid late last year for adults and children 12 and older who are considered high-risk because of conditions such as obesity, diabetes and heart disease. More than 42% of US adults are considered obese, representing 138 million Americans, according to the CDC.
At the time of the FDA’s decision, there were no options for treating COVID-19 at home, and Paxlovid was seen as critical to limiting hospitalizations and deaths during the second winter outbreak of the pandemic. The drug’s effects 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.
“These people do exist, but they are relatively rare because most people now are either vaccinated or 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. These results have not yet been published in a medical journal.
More than 3.9 million prescriptions for Paxlovid have been filled since the drug was approved, according to federal records. A course of treatment is three pills twice a day for five days.
A White House spokesman on Wednesday pointed to several recent papers suggesting that Paxlovid helps reduce hospitalizations in people 50 and older. The studies have not been published in peer-reviewed journals.
“The risk for serious outcomes from COVID is on a gradient, and growing evidence suggests that people between the ages of 50 and 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 the drug.
The White House recently indicated it may soon stop buying vaccines, drugs and tests for COVID-19, shifting the blame to the private insurance market. Under this scenario, insurers could set new criteria for when they will pay for patients to take Paxlovid.
Follow Matthew Perrone on Twitter: @AP_FDAwriter
The Associated Press Health and Science Section is supported by the Howard Hughes Medical Institute Science Education Division. AP is solely responsible for all content.