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National Institutes of Health (NIH) researchers said they will investigate how often and why coronavirus levels rebound in some patients who complete a five-day course of Pfizer’s COVID-19 antiviral pill, Paxlovid.
“It is a priority,” Clifford Lane, deputy director for clinical research at the National Institute of Allergy and Infectious Diseases, told Bloomberg. It’s “a pretty urgent thing for us to get a handle on.”
Lane said the agency is discussing with scientists at the Centers for Disease Control and Prevention possible epidemiological and clinical studies to examine post-Paxlovid rebound.
In response to reports of patients relapsing after taking Paxlovid, Pfizer CEO Albert Bourla on Tuesday suggested they take more of the treatment, contrary to the established protocol.
Bourla’s comment prompted a U.S. Food and Drug Administration (FDA) official on Wednesday to contradict Bourla, FiercePharma reported.
John Farley, M.D., director of the Office of Infectious Diseases, in the FDA Updates on Paxlovid for Health Care Providers wrote:
“There is no evidence of benefit at this time for a longer course of treatment (e.g., 10 days rather than the 5 days recommended in the Provider Fact Sheet for Paxlovid) or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”