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| In a highly anticipated decision, the Food and Drug Administration authorized the first antiviral pill to treat COVID-19 at home. |
| The pill, called Paxlovid, is made by Pfizer. It's taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral. |
| "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'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." |
| The Pfizer treatment could help keep people infected with the coronavirus from getting so sick that they need to be hospitalized. |
| The results from a Pfizer study involving more than 2,200 people at high risk for developing serious COVID-19 found Paxlovid reduced the risk of hospitalization or death by 89%, compared with a placebo, when taken within three days of first symptoms of illness. When taken within five days, the drug reduced the risk of hospitalization and death by 88%. |
| Early results from another Paxlovid study showed a 70% reduction in hospitalization risk among several hundred people at lower risk for severe disease. |
| Although it's not certain, Paxlovid's efficacy is unlikely to be reduced in treating people infected with the omicron variant of the coronavirus virus. The drug, which belongs to a family called protease inhibitors, doesn't target the virus's spike protein, as the vaccines do. |
| The federal government has a contract with Pfizer to buy 10 million courses of the treatment for $5.3 billion. But initial supplies of Paxlovid will be limited. The company says it will have 180,000 courses of treatment ready by the end of the year. |
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