FDA directs Pfizer to test second dose of Paxlovid for ‘rebound’ infections

FDA directs Pfizer to test second dose of Paxlovid for ‘rebound’ infections

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The U.S. Food and Drug Administration is directing U.S. biomedical company Pfizer to produce a second round of tests for its COVID antiviral drug in order to treat those who suffer from “rebound” infections of the disease.
The FDA said in a letter to Pfizer earlier this month that the company would be required to “conduct a randomized placebo-controlled trial in patients with ‘COVID-19 rebound’ following an initial treatment course of PAXLOVID to evaluate a subsequent 5-day treatment course of PAXLOVID.”
“Pfizer will provide topline results by September 30, 2023,” the agency said. 
“Rebound infections” have been reported among individuals...
Source: https://justthenews.com/politics-policy/coronavirus/fda-directs-pfizer-test-second-dose-paxlovid-rebound-infections?utm_source=justthenews.com&utm_medium=feed&utm_campaign=external-news-aggregators