Oral antiviral drugs meant to prevent or treat COVID-19 could be essential pandemic-fighting weapons — something Biden stressed in his statement hours before the coronavirus death toll exceeded 800,000 in the U.S.
Biden announced that he's "encouraged" by Pfizer's Phase 2/3 data on its Paxlovid pill, which the company has shared with the FDA as part of its continuous rolling submission for Emergency Use Authorization.
"Getting vaccinated and getting your booster shot remain the most important tools we have to save lives," he stated.
"But if this treatment is indeed authorized — and once the pills are widely available — it will mark a significant step forward in our path out of the pandemic."
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Data from Pfizer's clinical trial of its oral COVID-19 antiviral drug confirm the treatment's high level of effectiveness, the company announced in a news release on Tuesday.
In the final analysis of its Phase 2/3 clinical trial, the company said the antiviral, called Paxlovid, was discovered to be 89 percent effective at preventing high-risk people from being hospitalized or dying from the virus.
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The findings are consistent with the interim analysis results the company published last month, yet, the complete data has not been published for scientists to examine. Pfizer halted its clinical trial based on the interim findings and submitted an application to the Food and Drug Administration for emergency use authorization several weeks later.
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The FDA has not scheduled a conference of its advisory committee to address the application.
Specialists explain that an antiviral pill for COVID would make treatment available at home. Current therapies are available only by injection or IV.
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"For many, many people this will be a really important drug," announced Ronald Swanstrom, a biochemistry professor at the University of North Carolina School of Medicine.
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If authorized, the question becomes availability. How quickly will Pfizer be able to ramp up production of the drug so that people can fill prescriptions?
"Should the U.S. government do something with production to help?" he asked. "Is this something where Pfizer needs to partner with others to scale up manufacturing?"
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A full course of Pfizer's treatment is three pills taken twice daily for five days. Two of the pills are an experimental antiviral called Nirmatrelvir; the third is an existing HIV drug called Ritonavir.
The treatment works by preventing the coronavirus from making copies of itself in the body. Paxlovid worked best when given within three days of the onset of symptoms, the company announced.
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