The oral antiviral pill Paxlovid does not significantly reduce the risk of severe COVID-19 in patients at “standard risk” of poor outcomes from the disease, the drug’s maker reported.
An updated analysis of trial data from more than 1,100 of these patients enrolled through December 2021 “showed a non-significant 51% relative risk reduction” of hospitalization and death with Paxlovid, Pfizer announced Tuesday. The study subjects had at least one characteristic or underlying medical condition that would make them more vulnerable to severe COVID-19.
The company has stopped enrollment in that trial but will continue its testing its use in high-risk patients, for whom the drug has been shown to be effective, it said.
Paxlovid is the preferred therapy for managing nonhospitalized adults with COVID-19, according to the National Institutes of Health’s COVID-19 Treatment Guidelines. The Biden administration has worked to stockpile the drug and has campaigned to encourage its use.
“Anybody who is eligible, anybody who’s high risk, should be getting Paxlovid … as long as they meet the clinical criteria,” said COVID-19 Response Coordinator Ashish Jha, M.D., in an April statement to clinicians.
In a large, real-life study of seniors in Israel released in June, the drug was found to be effective at lowering rates of severe COVID-19 outcomes.
Pfizer’s ongoing studies in more vulnerable populations will include “longer treatment durations in immunocompromised individuals, as well as exploring other clinical development opportunities, such as its potential use in hospitalized patients with severe disease,” the company stated.