The U.S. Food and Drug Administration (FDA) on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects and protect against the severe disease.
Dr. Patrizia Cavazzoni, Director of the agency’s Center for Drug Evaluations and Research said in a statement, “The authorization marks a major step forward in the pandemic.”
The oral drug, called Paxlovid, is from Pfizer and is a faster way to treat early COVID-19 infections. It will be prescribed for use in adults and children ages 12 and up with mild to moderate COVID-19 who are at risk for severe disease or hospitalization, the FDA said in a statement.
The long-awaited Covid pill comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of an overwhelming number of new infections from the omicron variant, although initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an injection or an IV.
Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the United States. The company expects to have 250,000 available in the U.S. by the end of January, a spokesperson said.
The FDA authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 text and early symptoms who face the highest risks of hospitalization. That includes older people and those with conditions like obesity and heart disease, though the drug is not recommended for patients with severe kidney or liver problems. Children eligible for the drug must weigh at least 88 pounds (40 kilograms.
Dr. Gregory Poland of the Mayo Clinic said, “The efficiency is high, the side effects are low and it’s oral. It checks all the boxes. You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group and that’s stunning.”
An antiviral pill form Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred options because of its mild side effects and superior effectiveness.
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