FDA Debunks Pfizer’s Claim

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    U.S. Food and Drug Administration said on Wednesday that using Pfizer’s Paxlovid pill has “no evidence of benefit at this time for a longer course of treatment” in patients with recurrent Covid-19 symptoms, contradicting Pfizer’s CEO Albert Bourla’s comments.

    As the Gateway Pundit previously reported, there are more and more reports of patients who were taking Pfizer’s antiviral pill experiencing a second round of Covid-19 shortly after recovering and doctors were baffled.

    In cases where virus levels rebound, “then you give a second course, like you do with antibiotics, and that’s it,” Pfizer CEO Albert Bourla told Bloomberg on Tuesday.

    The FDA released a statement on Wednesday debunking Pfizer’s chief executive claims that patients can take more Paxlovid pills for recurring symptoms.

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    “We are continuing to review data from clinical trials and will provide additional information as it becomes available. However, 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,” according to John Farley, director of the Food and Drug Administration’s (FDA) Office of Infectious Diseases.

    Bloomberg reported:

    There is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help Covid-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea.

    Doctors and virologists have been struggling to understand a number of patient reports of viral rebounds after completion of a five-day course of the Covid treatment. In an interview Tuesday, Pfizer Chief Executive Officer Albert Bourla said doctors could prescribe a second course of treatment to patients who suffer a rebound.

    Some physicians have suggested a longer course of Paxlovid might prevent symptoms from returning.

    No data support a longer course of treatment or two separate five-day courses to treat or prevent relapse, John Farley said Wednesday in a post on the agency’s website.

    “We are continuing to review data from clinical trials and will provide additional information as it becomes available.”

    A Pfizer spokesman said Thursday that the Paxlovid emergency authorization label does not preclude a patient later being prescribed a second round of Paxlovid if the virus recurs after the first course is completed.

    Last month, Pfizer released a statement admitting that it failed to reduce the risk of confirmed and symptomatic COVID-19 infection in adults living with someone who had been exposed to the virus.

    “While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness, and we are pleased to see the growing global use of PAXLOVID in that population,” Bourla said in a statement.