Pfizer's Paxlovid only helped seniors avoid hospitalization and death, new NEJM study finds
Usage of Pfizer’s Covid-19 treatment Paxlovid has spiked across the US in recent months, with more than 2 million courses administered during this latest Omicron wave since June, potentially saving many from hospitalization or death.
But a new observational study published in the New England Journal of Medicine on Wednesday evening found that Paxlovid only worked among patients 65 years of age or older, with no evidence of benefit found in younger adults.
The Israel-based study, which didn’t evaluate the current Omicron variant, looked at almost 43,000 Covid-19 patients who were 65 or older, and found hospitalization occurred in 11 patients treated with Paxlovid (14.7 cases per 100,000 person-days) and in 766 untreated patients (58.9 cases per 100,000 person-days).
But among the more than 66,000 Covid patients who were 40 to 64 years old, hospitalization occurred in seven treated patients (15.2 cases per 100,000 person-days) and in 327 untreated patients (15.8 cases per 100,000 person-days), which wasn’t a significant difference.
Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing, who’s unaffiliated with the study, told Endpoints News, “We need to rethink how we are using this drug, given these findings, and those of Epic-SR [primary endpoint not met]. We are over treating [sic] relatively healthy boosted people under 50 who might be eligible for Paxlovid because of one minor risk factor but who are not truly at high risk of developing severe disease.”
Pfizer did not immediately respond to a request for comment on the study, but Paxlovid’s authorization is based on final results from Pfizer’s Epic-HR study, showing an 86% reduction in relative risk of hospitalizations or death from any cause. Pfizer expects Paxlovid to bring in more than $20 billion this year.
While other trials have since shown that Paxlovid may not work as well in the vaccinated population, Gellad noted that this Israeli study, first posted as a pre-print in June, “does show benefit of the drug in older vaccinated and prior infected individuals who are older and at high risk of progression, and everyone who fits that bill should be offered treatment. Same with younger high risk who are unvaccinated or not previously infected, in my view.”
But given the rise of Paxlovid’s usage, many experts are also raising concerns about resistance.
“The government is pushing this drug too hard to be used at the drop of a hat in everyone without enough evidence that it has sufficient benefit to outweigh known and unknown risks, including the continued uncertainty around rebound and the theoretical risks of resistance,” Gellad added, noting that “what we really need is a randomized trial in vaccinated younger people, which the British will eventually give us, because FDA did not require it here.”