The U.S. Food and Drug Administration has authorized the emergency use of Pfizer’s antiviral pill for adults and children older than 12 who have tested positive for COVID-19 and are at high risk of severe disease. The drug—which has been shown to reduce the risk of hospitalization and death—is the first of its kind to be approved for use in the United States.
It’s unclear how effective the drug will be against the new Omicron variant. But health officials hailed the FDA authorization as one more tool available to doctors and patients who are fighting the disease.
“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, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
As National Geographic has previously reported, these drugs work by interfering with the virus’s genome as it multiples, creating mutations that disrupt replication and ultimately kill the virus. In clinical trials, Pfizer says its pill, called Paxlovid, was shown to reduce the risk of hospitalization and death by 89 percent. The drug is administered as three tablet dose taken twice a day, for five days.
The drug will be available for use after it receives a final signoff from the Centers for Disease Control and Prevention, which is expected shortly.