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FDA approves first antiviral pill for treatment of COVID

Pfizer’s Paxlovid pill is designed for the treatment of mild-to-moderate cases of COVID-19 in patients 12 and older.

Closeup of Pfizer sign and logo on the side its corporate building in New York City.

Federal regulators on Wednesday approved the first antiviral pill for treating COVID-19, as numbers of the fast-spreading omicron variant continue to climb nationwide.

Pfizer’s Paxlovid pill is designed for the treatment of mild-to-moderate cases of COVID-19 in patients 12 and older who are at high risk for severe cases of COVID-19 due to age or pre-existing health conditions, according to the U.S Food and Drug Administration.

The treatment, administered as three tablets taken together twice a day for five days, significantly reduces hospitalization and death by nearly 90 percent in patients with a positive COVID-19 diagnosis, according to a clinical trial conducted by Pfizer.

The pill would allow patients to receive the treatment courses and administer it themselves at home and would be the first approved treatment for COVID-19 not given intravenously — as with monoclonal antibody treatment, which isn’t usable with the omicron variant in the currently available form of the treatment.

“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, the 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.”

The FDA stressed in the announcement Wednesday that Paxlovid is not a substitute for vaccination and is not authorized for pre-exposure or post-exposure prevention. In addition, it is not authorized for use longer than five days.

According to a statement from the U.S Department of Health and Human Services, the federal government has purchased a total of 10 million courses of Paxlovid, a limited amount that will ramp up in the coming months.

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“An initial 65,000 courses of Paxlovid will be made available for shipment to states and territories, and select HRSA funded health clinics, and will begin arriving in states and territories during the first week of January,” HHS wrote in a statement to the Alabama Department of Public Health Wednesday. “Initial allocations of Paxlovid were determined on a pro rata basis and will be provided to state and territorial health departments for free.”

In a statement to APR Wednesday, Rachel Kiefer, Assistant State Pharmacy Director for the Alabama Department of Public Health, said Alabama will receive 780 patient courses, with a 20 course minimum per site, on the first federal allocation of Paxlovid. This initial amount will be enough for approximately 39 sites, Kiefer said.

“Our goal is to prioritize the equitable distribution and access to oral antivirals across Alabama,” Kiefer said. “Because of this, we will initially partner with a Federal Retail Pharmacy Partner, using a pharmacy dispensing model. This partner has the broadest reach of pharmacy partners in the state of Alabama, helping us to reach our goal of equitable distribution and access of products. Once allocation increases, we will begin to expand sites and/or providers.”

Meanwhile, the number of Alabamians hospitalized with COVID-19 has increased by 16.75 percent over the past two weeks. The seven-day average of new daily cases increased from 564 cases on Dec. 6 to 722 cases per day by Dec. 20, an increase of 28 percent.

According to the CDC, the state of Alabama has the third-lowest percentage of residents fully vaccinated against COVID-19 in the U.S, with the second-highest death rate per capita.

John is a reporter at the Alabama Political Reporter. You can contact him at [email protected] or via Twitter.

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