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Pfizer's COVID-19 pill, Paxlovid, has been authorized by FDA

Initial supply of the antiviral drug will be limited.
/ Source: NBC News

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-19 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.

“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,” she said.

While the pill from Pfizer is not a replacement for vaccinations, they add an easily administered treatment to help keep people at high risk of severe illness out of the hospital.

The new treatment could help ease the burden on hospitals as infections are expected to continue to surge this winter with the emergence of the omicron variant, already the dominant strain in the U.S. Initially, the supply of the drug is likely to be extremely limited, experts say.

The agency did not seek the advice of its independent advisory panel, called the Antimicrobial Drugs Advisory Committee, when reviewing data on Pfizer’s pill.

The agency did convene its advisory group to review the application for another antiviral treatment, a pill called molnupiravir, from Merck. The panel last month voted narrowly in favor of recommending that drug for emergency use authorization. The agency hasn’t announced a decision yet on that drug.

Pfizer has said a final analysis of its clinical trials found its drug to be 89% effective at preventing high-risk people from being hospitalized or dying from COVID-19, which was consistent with the results of the interim analysis the company released early last month. By comparison, clinical trials found Merck’s treatment reduced the risk of hospitalization and death among high-risk COVID-19 patients by 30%.

A full course of Pfizer’s treatment is 30 pills — taken as three pills twice daily for five days. The treatment includes a low dose of ritonavir, a commonly used HIV drug, along with an antiviral developed by Pfizer called nirmatrelvir.

The treatment needs to be taken early to be effective — within five days of first symptoms, according to the FDA.

Dr. David Boulware, an infectious disease physician at the University of Minnesota Medical School, said getting tested for COVID-19 as soon as possible will be essential to getting access to the antivirals.

Pfizer has said the pill should work against the omicron variant, which is the dominant variant in the U.S.

The initial supply of the drugs will be limited.

Pfizer CEO Albert Bourla has said the company expects to have 180,000 courses of the treatment available by the end of the year and as many as 80 million courses by the end of next year. The Biden administration said last month it plans to purchase 10 million courses of Paxlovid.

This story was originally published on NBC News.