U.S. FDA Authorizes First Antiviral Pill to Treat COVID-19 for Emergency Use

The United States Food and Drug Administration (FDA) authorized on Dec. 22 Pfizer’s Paxlovid for emergency use, becoming the first antiviral pill to treat COVID-19 in the country.

FDA granted emergency use authorization for Paxlovid to treat adults and children aged 12 and older weighing at least 40 kilograms with mild to moderate COVID-19 who are at risk of hospitalization or death.

FDA said that the pill “should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.”

FDA’s Center for Drug Evaluation and Research Director Patrizia Cavazzoni called the authorization “a major step forward in the fight against this global pandemic.”

“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,” Cavazzoni said.

The FDA did not seek advice from its independent advisory panel when it reviewed the data on the pill.

Paxlovid is administered as three tablets taken orally twice a day for five days, for a total of 30 tablets, according to the FDA.

FDA noted that the pill is not authorized for use for longer than five consecutive days and is not a substitute for vaccination for those who are recommended to take the vaccine and the booster dose.

In a statement, Pfizer Chairman and Chief Executive Officer Albert Bourla said that the company “stands ready to begin delivery in the U.S. immediately.”

Pfizer said in November 2020 that it agreed with the U.S. government to supply 10 million treatment courses of the pill, with delivery fulfillment expected to be completed in 2022.


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