FDA gives 1st emergency approval to antiviral pill to treat COVID-19 patients

People wait in line for COVID-19 tests at Farragut Square near the White House in Washington, D.C., on Wednesday. Photo by Ken Cedeno/UPI |

Dec. 22 (UPI) — For the first time on Wednesday, federal drug regulators gave emergency approval to an antiviral pill produced by Pfizer to treat COVID-19 in persons over the age of 12.

The Food and Drug Administration granted emergency use authorization to the pill, called Paxlovid, which has shown in clinical trials to dramatically reduce the likelihood of hospitalization and deaths in coronavirus patients.

Further, the clinical studies observed mostly only mild side effects from the drug.

The FDA authorization makes the pill available to adults and children who have tested positive for COVID-19 and are considered likely to become severely ill. That includes older adults and those with heart disease and obesity.

Under the FDA authorization, children must weigh at least 88 pounds to qualify to take the medication.

“Today’s authorization of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world,” Pfizer CEO Albert Bourla said in a statement.

“This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems.”

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said authorizing the pill is a “major step forward” in fighting the pandemic.

“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 in a statement.

Bourla added that Pfizer’s pill comes at a crucial time for COVID-19 treatments with the emergence of the Omicron variant.

An antiviral oral tablet in development at Merck is also expected to be authorized by the FDA in the near future.


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