FDA Issues EUA for First Oral Antiviral Pill for COVID-19

The long-awaited home remedy for one of the worst pandemics in history has just arrived. Well, it’s not exactly a remedy, but the US Food and Drug Administration (FDA) approved a pill by Pfizer that promises to head off the worst of COVID-19’s effects.

The FDA’s emergency use authorization (EUA) of the pill comes the same week that the Omicron variant of COVID-19 became the dominant variant in the United States, and President Joe Biden announced plans to help hospitals fighting off surges of both Delta and Omicron.

The timeliness of the announcement was not lost on Patrizia Cavazzoni, MD, 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,” she said in a statement.

Paxlovid is being touted as a faster and cheaper way to treat COVID-19 infections in their early stages. It’s the first therapy that can be taken orally; the previous therapies were administered through either IV or injection.

“It checks all the boxes,” said Gregory Poland, MD, who studies the immunogenetics of vaccine response in adults and children. Poland tells the Associated Press that those boxes include high efficiency and side effects that are low. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group—that’s stunning,” Poland tells the AP.

The FDA stresses that the pill is not to be seen as a substitute for vaccination or booster shots. “The FDA urges the public to get vaccinated and receive a booster if eligible,” the agency said in its statement.

This article originally appeared on Infection Control Today.