WASHINGTON (AP) — Pfizer’s COVID-19 pill appears to offer little or no benefit to younger adults while still reducing the risk of hospitalization and death in at-risk older adults, according to a large study published Wednesday.
Results from a study of 109,000 Israeli patients could reignite questions about the U.S. government’s use of Paxlovid, which has become the treatment of choice for COVID-19 due to its convenience at home. The Biden administration has spent more than $10 billion on the drug and made it available in thousands of pharmacies through its testing and treatment program.
The researchers found that giving Paxlovid shortly after infection reduced hospitalization rates by about 75 percent in people 65 and older. This is consistent with early results used to authorize the drug in the United States and other countries.
But people between the ages of 40 and 65 saw no clear benefit, according to an analysis of medical records.
The study was limited by its design, which collected data from Israel’s large health system, rather than enrolling patients in a randomized study versus a control group — 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 from the virus as a result of vaccination or prior infection. Especially for young people, this greatly reduces their risk of serious complications from COVID-19. The Centers for Disease Control and Prevention recently estimated that 95 percent of Americans 16 and older have acquired some degree of immunity to the virus.
“Paxlovid remains important for those at highest risk for severe COVID-19, such as the elderly and those with compromised immune systems,” said University of Minnesota researcher and physician Dr. David Boulware, who was not involved in the study. “But for those who are now eligible. For most Americans, it really doesn’t do much good.”
A Pfizer spokesman declined to comment on the results, published in the New England Journal of Medicine.
Late last year, the U.S. Food and Drug Administration authorized Paxlovid for use in adults and children 12 and older who are considered high-risk for conditions such as obesity, diabetes and heart disease. According to the Centers for Disease Control and Prevention, more than 42 percent of U.S. adults are considered obese, representing 138 million Americans.
At the time of the FDA’s decision, there was no option to treat COVID-19 at home, and Paxlovid was seen as critical to curbing hospitalizations and deaths during the pandemic’s second winter surge. The drug was also far more effective than Merck’s competing pills.
The FDA’s decision was based on Pfizer’s study of high-risk patients with unvaccinated or untreated prior COVID-19 infection.
“These people do exist, but they are relatively few because most people are now either vaccinated or infected,” Boulware said.
Pfizer reported earlier this summer that separate studies of Paxlovid in healthy adults (vaccinated and unvaccinated) failed to show a significant benefit. These results have not been published in a medical journal.
According to federal records, more than 3.9 million Paxlovid prescriptions have been written since the drug was approved. A course of treatment is three capsules twice a day for five days.
A White House spokesman on Wednesday pointed to several recent papers showing that Paxlovid could help reduce hospitalizations for people 50 and older. The studies have not yet been published in a peer-reviewed journal.
“There is a gradient in the risk of severe COVID-19 consequences, and there is growing evidence that individuals between the ages of 50 and 64 can also benefit from Paxlovid,” Kevin Munoz said in an emailed statement.
Government officials have been working to increase the use of Paxlovid for months, opening thousands of sites where patients who test positive can fill out prescriptions. Last month, U.S. officials further expanded access to allow pharmacists to prescribe medication.
The White House recently said it may soon stop buying COVID-19 vaccines, drugs and tests, shifting responsibility to the private insurance market. In this case, insurers could set new criteria for when to pay patients for Paxlovid.