FDA authorizes Pfizer's pill to treat COVID-19: 'A major step forward'

The Food and Drug Administration has officially authorized the first antiviral pill to treat COVID-19 in the United States.

The FDA announced Wednesday it has approved Paxlovid, an oral antiviral COVID-19 treatment from Pfizer, for emergency use to treat mild-to-moderate COVID-19 for patients at "at high risk for progression to severe" COVID-19.

"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 Dr. Patrizia Cavazzoni, director of the FDA 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."

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Pfizer previously announced that the antiviral pill in a trial reduced the risk of hospitalization or death among high-risk COVID-19 patients by 89 percent when it was given within three days of symptoms first emerging. "It is a game changer," Pfizer CEO Albert Bourla told ABC News. "But at the same time, I want to emphasize that no one should use the existence of the pill as an excuse to avoid vaccination." The FDA in its Wednesday announcement also noted that the pill "is not a substitute for vaccination."

Another COVID-19 pill could soon be authorized by the FDA, as well, as Bloomberg reported that an antiviral pill from Merck could receive approval this week.