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The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals. The drug, Paxlovid, is a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection. An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease. (Perrone, 12/22)

The pill ... is 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." (Hensley, 12/22)

Initial supplies of Paxlovid will be limited. Pfizer has said it expects to produce more than 180,000 courses of the treatment this year. The company said Wednesday it now expects to provide 120 million courses by the end of 2022, up from 80 million previously, thanks in part to new contract manufacturers. Pfizer has contracted with the U.S. government to provide 10 million courses by the end of 2022 at a cost of $5.29 billion. (Herper, 12/22)

Pfizer CEO Albert Bourla said in a statement Wednesday that the company is ready to begin delivery of the drug to the U.S. "immediately." "This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat Covid-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” he said. The FDA did not seek the advice of its independent advisory panel, called the Antimicrobial Drugs Advisory Committee, when it reviewed data on Pfizer's pill. (Lovelace Jr., 12/22)

The antiviral drug remdesivir can help keep unvaccinated people at risk of severe covid-19 out of hospitals, according to a study that found the treatment reduced hospitalization and death by 87 percent when given soon after diagnosis. (Goldstein, 12/22)