Pfizer Study Shows Therapeutic Paxlovid 89% Effective Preventing Hospitalization and Death — FDA Still Sitting on It

Huh, it’s almost like they don’t want a therapeutic. That’s weird.

Additional data from Pfizer’s clinical trial of its oral Covid-19 antiviral drug confirm the treatment’s high level of effectiveness, the company said in a news release Tuesday.

In the final analysis of its Phase 2/3 clinical trial, the antiviral, called Paxlovid, was found to be 89 percent effective at preventing high-risk people from being hospitalized or dying from Covid, the company said.

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The findings are consistent with the results of the interim analysis the company released last month, although the full data have not been made public for scientists to review. Pfizer halted its clinical trial based on the interim results and submitted an application to the Food and Drug Administration for emergency use authorization several weeks later.

The FDA has not scheduled a meeting of its advisory committee to review the application.

Experts say an antiviral pill for Covid would have a major impact on the pandemic by making treatment available at home. Current treatments are available only by injection or IV.

“For many, many people this will be a really important drug,” said Ronald Swanstrom, a biochemistry professor at the University of North Carolina School of Medicine.

If authorized, the question becomes availability, said Dr. David Boulware, an infectious disease physician at the University of Minnesota Medical School. 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 said. “Is this something where Pfizer needs to partner with others to scale up manufacturing?”

Effectiveness of Pfizer’s Covid pill confirmed in further analysis, company says (