FDA Authorizes Pfizer's Anti-Viral COVID Treatment

By Bill Galluccio

December 22, 2021

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Photo: Getty Images

The U.S. Food and Drug Administration has granted an emergency use authorization for Pfizer's new COVID-19 antiviral pill. The drug, called Paxlovid, is authorized for adults and children over the age of 12 who have tested positive for COVID-19 and are at a high risk of severe complications from the virus.

"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

Clinical trials showed that Paxlovid had an efficacy of 89% at preventing patients from developing a severe case of COVID when given within three days of showing symptoms. The treatment requires taking 30 pills over five days.

"This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems," Pfizer Chairman and CEO Albert Bourla said in a statement. "Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible."

According to the Washington PostPfizer will be able to provide enough pills for 180,000 patients by the end of the year and hopes to ramp up production to deliver 120 million pill packs in 2022.

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