FDA Authorizes Pfizer's COVID-19 Antiviral Pill

Headline Roundup December 22nd, 2021

On Wednesday, the Food and Drug Administration authorized Pfizer’s antiviral pill to treat mild-to-moderate COVID-19. 

The pill, Paxlovid, is the first authorized at-home prescription treatment for the disease. The authorization is limited to patients 12 and older who test positive and “are at high risk for progression to severe COVID-19.” “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. 

Coverage was widespread and featured prominently across the spectrum. Coverage was mostly balanced on all sides, with some outlets calling the pill “highly anticipated” or a “long-awaited milestone.”

From the Left

The Food and Drug Administration on Wednesday authorized the first Covid-19 antiviral pill in the United States to protect against severe disease.

The oral drug, called Paxlovid, from Pfizer will be prescribed for use in adults and children ages 12 and up with mild to moderate Covid who are at risk for severe disease or hospitalization, the FDA said in a statement.

The authorization marks "a major step forward" in the pandemic, Dr. Patrizia Cavazzoni, director of the agency’s Center for Drug Evaluation and Research, said in a statement.


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From the Center

The Food and Drug Administration on Wednesday authorized Pfizer's antiviral pill for the treatment of individuals at high risk of severe illness from COVID-19.

Why it matters: At-home COVID-19 treatments, especially Pfizer's Paxlovid, are seen as possible game-changers for the pandemic. The emergency use authorization comes as the U.S. sees a surge in new COVID-19 cases and hospitalizations largely driven by the Omicron variant.

Driving the news: Pfizer released new data last week confirming Paxlovid reduced the risk of hospitalization or death by 89% in high-risk adults, Axios' Tina Reed reports.

An interim analysis of a second study of...

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From the Right

The Food and Drug Administration authorized the first oral antiviral treatment for COVID-19, Pfizer's Paxlovid drug.

Emergency use authorization was granted Wednesday for Pfizer's Paxlovid – nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use – for the treatment of mild-to-moderate coronavirus disease in adults and children 12 years of age or older weighing at least 40 kilograms or about 88 pounds. 

It applies only to those who meet those qualifications, have tested positive for SARS-CoV-2 testing and "who are at high risk for progression to severe COVID-19, including hospitalization or death,"...

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