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Standard Risk Study Enrollment Stopped

Pfizer has halted enrollment into its study of its COVID-19 treatment Paxlovid for standard-risk individuals after finding it does not reduce symptoms, Reuters reports.

Previously, the US Food and Drug Administration granted emergency use authorization for Paxlovid to treat COVID-19 among individuals at high risk of severe disease or death from COVID-19. Pfizer had previously reported that the antiviral treatment led to an 89 percent reduction in risk of COVID-19-related hospitalization or death among such high-risk individuals.

But Reuters reports that in this study of standard-risk individuals, the company found a 51 percent reduction in relative risk, which it says is not statistically significant.

Stat News adds that because there were few hospitalizations overall in the study, it was also unable to determine whether vaccinated individuals who received Paxlovid were less likely to be hospitalized. It notes that some real-world data have suggested Paxlovid might confer some benefits on lower-risk groups.

According to Reuters, Pfizer will include this new data in its application to the FDA for full approval of Paxlovid to treat COVID-19 among high-risk individuals.

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