First Oral Antiviral Approved to Treat COVID-19 Patients

The U.S. Food and Drug Administration (FDA) today approved Pfizer Inc.'s oral antiviral Paxlovid™ for treating mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is the fourth drug, but the first oral antiviral approved to treat COVID-19 in adults.

Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by the FDA's approval on May 25, 2023.

"While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives," said Patrizia Cavazzoni, M.D., director for the FDA's Center for Drug Evaluation and Research, in today's press release.

"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity."

"The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19." 

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis to prevent COVID-19.