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US approves Pfizer pill for COVID treatment

December 22, 2021

The pill is the first at-home treatment for COVID-19, and marks a major milestone in the pandemic. Pfizer said it was ready to start immediate delivery of the oral drug.

Paxlovid pills in little white boxes on the factory floor assembly line
The Paxlovid pill has a high rate of efficacy against the virusImage: Thomas Hansmann/Pfizer/dpa/picture alliance

US drug regulators approved Pfizer's pill for treating COVID-19 on Wednesday. 

A pill to treat the deadly coronavirus marks a major breakthrough as the pandemic enters its third year.

The US Food and Drug Administration's (FDA) authorization paves the way for another significant tool in the fight against the omicron variant. The EU had already previously approved the pill.

US President Joe Biden said the pill was a "significant step forward" on the path towards ending the pandemic, and his administration would work towards ensuring equitable distribution. He also said a law would be invoked to ensure Pfizer could ramp up production.

Pfizer's clinical trial showed the antiviral pill was 90% effective in preventing extreme sickness requiring hospitalization and potential death in patients where there is a grave risk of severe illness.

Recent lab results suggest it is effective against the fast-spreading omicron variant.

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What did the US regulator say?

The US authorized the Pfizer pill for treating mild-to-moderate COVID-19 in adults and children 12 years of age and older who weigh a minimum of 40 kilos (88 pounds) and are at high risk of developing severe symptoms of the disease.

In a statement, Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said, "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 drug will be administered by prescription only and should be taken within the first five days of a COVID-19 diagnosis. It is recommended to take the pills every 12 hours over the course of five days beginning as soon as possible with the onset of symptoms.

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What has Pfizer said?

Pfizer is prepared to begin immediate deliveries in the US. The company raised its production projections from 80 million pills to 120 million in 2022.

The US government has a contract for 10 million courses of the treatment at $530 (€468) per treatment course.

The company plans to file a fresh patent next year in a bid to earn full regulatory approval from the FDA.

ar/wd (AFP, AP, Reuters)