The Food and Drug Administration (FDA) on Dec. 22 granted emergency use authorization to Pfizer’s COVID-19 treatment pill—coming about a month after the federal government announced it would purchase 10 million courses of the drug.
The pill, Paxlovid, is taken twice per day for five days in combination with a second medicine called ritonavir, classified as a generic antiviral drug. The drug is aimed to help patients who are suffering from “mild-to-moderate” COVID-19 symptoms from becoming so sick that they need to be hospitalized, officials and Pfizer have said.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement about the agency’s approval.
The drug, available only via prescription, can be initiated as soon as possible following a positive diagnosis of COVID-19, the disease caused by the CCP (Chinese Communist Party) virus.
“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,” Cavazzoni said.
But the pill isn’t designed to be used for “pre-exposure or post-exposure prevention” of the CCP virus or for individuals who have been hospitalized due to severe or critical COVID-19, the FDA said in the statement.
The agency also stressed that the drug can’t be a substitute for vaccination and again recommended the common COVID-19 vaccines or booster shots.
The Biden administration has already purchased some 10 million courses of Paxlovid in a more than $5 billion agreement. In November, the White House announced that the federal government would work to ensure treatments are free and accessible for the general public.
Delivery will begin by the start of 2022 and will continue through the remainder of the year, according to the Department of Health and Human Services. Meanwhile, Pfizer CEO Albert Bourla told news outlets earlier this month that his firm already shipped the drug to the United States, saying it would be ready when the FDA granted an emergency use authorization.
“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,” Bourla said Dec. 22 in a statement.
The FDA decision comes about a week after Pfizer reported that its new oral drug is able to reduce the risk of death or hospitalization from the CCP virus by up to 89 percent if it is taken shortly after symptoms appear.
Before the FDA decision, the only COVID-19 antiviral treatment that had been granted emergency authorization by the FDA is remdesivir, a drug that’s being sold under the brand name Veklury.
In recent months, some severely sick COVID-19 patients and their family members have said that the cheaply produced anti-parasitic drug ivermectin produced positive results. An elderly patient in Illinois recovered following a court order that allowed him to use the medication, which the FDA hasn’t cleared for use for COVID-19, the man’s attorney said on Dec. 1.
The FDA, meanwhile, is weighing a COVID-19 pill from Merck and Ridgeback Biotherapeutics that—like Pfizer’s pill—is meant to be taken twice per day for five days.