THIS WEDNESDAY, the US FDA shared that people have to know that using the Paxlovid pill has “no evidence of benefit at this time for a longer course of treatment” in patients with recurrent C-19 symptoms. This statement directly contradicts the claims of Pfizer’s CEO, Albert Bourla.
The Gateway Pundit reported that there were numerous reports of patients taking Pfizer’s antiviral pill and experiencing a second round of C-19 right after recovering.
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Where virus levels rebound, “then you give a second course like you do with antibiotics, and that’s it,” Pfizer CEO Albert Bourla said.
The FDA issued a statement that contradicts Pfizer’s chief executive claims that people can take more Paxlovid pills for recurring symptoms.
“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 FDA’s Office of Infectious Diseases.
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.
One month ago, Pfizer shared that it failed to reduce the risk of confirmed C-19 infections among adults living with someone 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.