FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Comagine Health

The Food and Drug Administration  issued an emergency-use authorization Dec. 22 for the first oral antiviral treatment for mild to moderate COVID-19 in adults and children over 12.

Pfizer's Paxlovid will be available by prescription only and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset, according to a press release from the FDA. The pill is designed for those who are high risk for progression to severe COVID-19, including hospitalization or death.

“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.  

Paxlovid is not a substitute for vaccination in those for whom COVID-19 vaccination and a booster dose are recommended, the FDA states.