FDA authorizes first antiviral pill to treat COVID at home
The Pfizer treatment could help keep people infected with the coronavirus from getting so sick that they need to be hospitalized.
Updated December 23, 2021 at 3:37 PM ET
A federal agency has released the first allocations of Paxlovid, the new COVID-19 treatment from Pfizer, to states and territories. The federal government has a contract for 10 million courses of the treatment and is providing the medicine free to state and territorial health departments.
The government acknowledges that supplies will be tight to start.
"An initial 65,000 courses of Paxlovid will be made available for shipment to states and territories and will begin arriving at dispensing sites by the end of December," an HHS website says.
Only California, Florida, New York and Texas are receiving more than 3,000 treatment courses. By contrast, Washington, D.C., Alaska and North Dakota will each get only 120 for now. Federally funded health centers that serve low-income patients around the country will get enough Paxlovid for 9,750 patients.
The Food and Drug Administration authorized Paxlovid for emergency use on Wednesday.
The drug is an oral antiviral pill that can be taken at home to help keep high-risk patients from getting so sick that they need to be hospitalized. It's taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral.
When FDA authorized the pill, Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, called it "a major step forward in the fight against this global pandemic."
"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," she said.
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 course of treatment ready by the end of the year. It expects to have millions of doses available in 2022.
The FDA also authorized another antiviral COVID-19 pill Thursday, this one from Merck and Ridgeback Biotherapeutics that is also taken twice a day for five days.
There's more of this drug — molnupiravir — to go around. Merck says it will have 10 million packs available by the end of the month.
But the effectiveness of the Merck COVID-19 pill may make it less attractive. An interim analysis of a clinical study of the drug found that molnupiravir cut the risk of hospitalization or death in half. However, the final study analysis released a couple of days before a public meeting of advisers to the FDA, found only a 30% reduction in the risk of hospitalization or death.
But Nicholas Kartsonis, Merck's senior vice president of clinical research for infectious diseases and vaccines told NPR that among the 10 deaths in the study, nine were in people who got the placebo and only one was a patient who took the molnupiravir.
FDA didn't authorize molnupiravir for use in patients younger than 18 because the drug may interfere with bone and cartilage growth and doesn't recommend it for use during pregnancy because animal studies suggested it could harm the fetus.
The FDA's Cavazzoni said Thursday that molnupiravir is intended for situations "where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate."
That could include certain patients who can't take Paxlovid, which can interact badly with certain medications, including some commonly given for heart disease and cancer, according to Dr. John Farley with the FDA's office of infectious diseases. It is also not recommended for patients with severe kidney problems or cirrhosis of the liver, he said.
NPR's Joe Palca contributed to this report.
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