The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Pfizer’s pill, Paxlovid, to treat COVID-19 Wednesday, Dec. 22.
The antiviral pill is the first authorized to treat people with COVID-19 at home before they need to be hospitalized.
According to an FDA news release, Paxlovid treats mild-to-moderate cases of COVID-19 in adults and children, who are at least 12 years old and weigh at least 88 pounds.
The pill is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
Paxlovid is not authorized for pre- or post-exposure prevention of the disease nor is it a substitution for vaccination and the FDA still recommends the public get vaccinated and receive a booster if eligible.
Paxlovid treatment is administered as three tablets taken twice daily, for a total of 30 tablets. It is not authorized for use for longer than five days.
“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.”