AP
Washington, August 25
Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults, while reducing the risk of hospitalization and death for high-risk older adults, according to a large study published Wednesday.
The results of an Israeli study of 1,09,000 patients are likely to renew questions about the US government’s use of Paxlovid, which has become the go-to treatment for COVID-19 due to your comfort at home. The Biden administration has spent more than $10 billion buying the drug and making it available to thousands of pharmacies through its test-and-treat initiative.
Researchers found that Paxlovid reduced hospitalizations among people age 65 and older by about 75% when given soon after infection. This is consistent with previous results used to license the drug in the US and other nations.
But people between the ages of 40 and 65 saw no measurable benefit, according to the medical record analysis.
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 age 16 and older have acquired some level of immunity to the virus.
“Paxlovid will continue to be important for people at higher risk of severe COVID-19, such as the elderly and those with compromised immune systems,” said Dr. David Boulware, a researcher and physician at the University of Minnesota, who did not participate in the 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 age 12 and older who are considered high-risk because of conditions such as obesity, diabetes, and heart diseases. More than 42 percent of American 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 slowing hospitalizations and deaths during the pandemic’s second winter surge. The drug’s results were also much stronger than those of 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 have now been vaccinated or infected,” Boulware said.
Pfizer reported earlier this summer that a separate study of Paxlovid in healthy, vaccinated and unvaccinated adults showed no significant benefit. These results have not yet been published in a medical journal.
More than 3.9 million prescriptions have been filled for Paxlovid since the drug was authorized, according to federal records. A course of treatment is three tablets twice a day for five days.
A White House spokesman on Wednesday pointed to several recent papers suggesting 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 is a gradient, and the growing body of evidence shows that people aged 50 to 64 may also benefit from Paxlovid,” Kevin Muñoz 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 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 set new criteria for when they would pay for patients to receive Paxlovid.