Pfizer Stops Enrollment in Paxlovid Trial in Standard-Risk Population

By Reuters Staff

June 15, 2022

(Reuters) - Pfizer Inc said on Tuesday it would halt enrollment in a trial for its COVID-19 antiviral drug, Paxlovid, in standard-risk patients after data analysis showed a non-significant reduction in hospitalizations and deaths.

The drug has emergency use authorization for high-risk groups in which it has been effective in reducing hospitalizations and deaths.

The new data, however, showed a 51% relative risk reduction in standard-risk groups, which the company said was not statistically significant.

The standard-risk population usually includes people who do not have health conditions that put them at risk of severe disease and who can recover without the drug.

The low rates of hospitalization and death in this population is the reason the company gave in a press release for discontinuing the trial (https://bit.ly/3HpDACH).

Another pre-specified secondary endpoint, however, "resulted in a nominally significant 62% decrease in COVID-19-related medical visits per day across all patients, relative to placebo," the company said.

Pfizer said it will include the new data in the company's upcoming application to the U.S. Food and Drug Administration seeking full approval for the drug's use in high-risk groups.

Data from a study in Israel earlier this month showed the drug reduces COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, but was not found to prevent severe illness among younger adults.

More than 1.2 million courses of Paxlovid have been administered in the United States, according to data from the Assistant Secretary for Preparedness and Response under the U.S. Department of Health & Human Services.

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