The U.S. Food and Drug Administration has authorized the emergency use of Pfizer’s COVID-19 pill, the agency announced Wednesday.
Paxlovid now becomes the first FDA-authorized oral antiviral for use in adults with mild-to-moderate coronavirus infection. It’s only available to patients ages 12 and over who are particularly vulnerable to severe illness.
“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
Pfizer released final data last week showing its pill remains 89% effective at preventing hospitalizations and death. Studies also show the drug will likely work against the omicron variant, which now accounts for about 73% of new cases in the U.S.
“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 added.
An entire treatment course of Paxlovid requires taking 30 pills over five days: two of Pfizer’s pills and one low-dose H.I.V drug known as ritonavir, which helps keep Pfizer’s drug active.
The feds have ordered a supply of pills to treat about 10 million people, the New York Times reported. Initially, New York-based Pfizer will deliver drugs for about 65,000 Americans with another 200,000 expected to arrive in January, according to the news outlet.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.