FDA Authorizes Pfizer’s COVID-19 Pill Weeks After Landing $5 Billion Deal With Biden Administration

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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.

By Jack Phillip

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