Pfizer COVID pill showed no benefit in younger adults

Pfizer COVID pill showed no benefit in younger adults

WASHINGTON (AP) — Pfizer’s COVID-19 pill appears to offer little to no benefit to younger adults, while still reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday.

Results from an Israeli study of 109,000 patients will likely renew questions about the US government’s use of Paxlovid, which has become the main treatment for COVID-19 due to its convenience at home. The Biden administration spent more than $10 billion buying the drug and making it available in thousands of pharmacies through its test and treatment initiative.

The researchers found that Paxlovid reduced hospitalizations among people aged 65 and over by about 75% when given soon after infection. This is consistent with previous results used to authorize 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 compiled data from a large Israeli healthcare system rather than enrolling patients in a randomized control 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 risk 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 against the virus.

“Paxlovid will continue to be important for people at increased risk of severe COVID-19, such as the elderly and people with compromised immune systems,” said David Boulware, a researcher and physician at the University of Minnesota who was not involved in the study. “But for the vast majority of Americans who are now eligible, it really doesn’t do much good.”

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 authorized Paxlovid late last year for adults and children age 12 and older who are considered to be at high risk due to 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 decision, there were no options for treating COVID-19 at home, and Paxlovid was deemed critical to stemming hospitalizations and deaths during the pandemic’s second winter outbreak. The drug’s results were also much stronger than a competing pill from Merck.

The FDA made its decision based on a Pfizer study of 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 already been vaccinated or infected,” Boulware said.

Pfizer reported earlier this summer that a separate study of Paxlovid in healthy adults — vaccinated and unvaccinated — did not 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 authorized, according to federal records. A course of treatment is three tablets twice a day for five days.

A White House spokesperson on Wednesday pointed to several recent documents suggesting that Paxlovid helps reduce hospitalizations among people aged 50 and over. Studies have not been published in peer-reviewed journals.

“The risk of severe COVID outcomes is on a gradient, and the growing body of evidence shows that individuals between the ages of 50 and 64 may also benefit from Paxlovid,” Kevin Munoz said in an emailed statement.

Government officials have been working for months to increase the use of Paxlovid, opening thousands of places where patients who test positive can fill out a prescription. Last month, US officials further expanded access, allowing pharmacists to prescribe the drug.

The White House recently signaled that it may soon stop buying vaccines, drugs and tests for COVID-19, shifting responsibility to the private insurance market. In this scenario, insurers could set new criteria for when they would pay patients to receive Paxlovid.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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The Associated Press Department of Health and Science receives support from the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.

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