U.S. health regulators approved Wednesday the first pill to combat COVID-19, a Pfizer medicine that Americans would be able to take at home to help prevent the virus's most severe symptoms from manifesting themselves.
Individuals at high risk for the infection who are 12 years old or older, weigh at least 88 pounds, and have a positive COVID-19 test are eligible for this medication, which must be recommended by a doctor.
Paxlovid, produced by Pfizer, was shown in clinical trials to lower the chance of severe disease by approximately 90% while also appearing to be safe.
It is indicated for adults at high risk for severe disease, such as those over 65, those with obesity or diabetes, and anyone with a weaker immune system, as well as high-risk children ages 12 and older.
The long-awaited achievement comes at a time when cases, hospitalizations, and fatalities in the United States are all on the rise, and health experts are warning of a deluge of new infections from the Omicron strain that might overwhelm medical facilities.
Paxlovid is a more rapid treatment for COVID-19 infections in the early stages, albeit initial supplies will be heavily restricted. All of the previously approved drugs to help the condition require administration through an IV or an injection.
According to the U.S. Food and Drug Administration, the pill should be started "as soon as feasible following diagnosis of COVID-19" and within five days of the initiation of symptom development.
Paxlovid is a combination of a new antiviral medicine known as nirmatrelvir and an older antiviral drug known as ritonavir. It is provided in the form of three pills taken twice a day for five days.
The U.S. government has purchased 10 million Paxlovid treatment courses, with 265,000 slated to be available to Americans in January, according to White House COVID-19 response coordinator Jeff Zients. Pfizer said the pills take 6-8 months to make.
Meanwhile, Merck's antiviral tablet is also likely to receive FDA approval soon. However, because of its low side effects and greater effectiveness, including a nearly 90% reduction in hospitalizations and fatalities among patients most likely to develop severe disease, Pfizer's medicine is almost guaranteed to be the favored alternative.
Pfizer revealed new results this week showing that if administered to high-risk patients within a few days after their initial symptoms, the medication reduced the chance of hospitalization or death by nearly 90%. The drug's effectiveness was similar when administered within the first five days of symptoms.
