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(CNN) --
Pfizer has begun a phase 2 and 3 clinical trial of its antiviral treatment for COVID-19, Paxlovid, in children ages 6 to 17, the company said in a statement Wednesday.
The study will assess the safety and efficacy of treatment in children who have symptoms of COVID-19 and a confirmed infection, who are not hospitalized, and who are at risk of severe illness.
Paxlovid is already approved by the US Food and Drug Administration (FDA) for high-risk people over the age of 12 who weigh at least 39 kilograms, but that decision was made based on trial data. clinical trials that did not include people under the age of 18.
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The most recent results from those adult trials showed that Paxlovid reduced the risk of hospitalization or death by 89% if given to high-risk adults within days of first symptoms, according to Pfizer.
If given within the first five days of symptoms, the efficacy was similar: 88%.
The authorization includes those over 12 years of age based on a model that shows it would have similar effects in children as in adults if they were of a certain weight, but Pfizer said in its statement that data from the new trial "will provide further support for dose recommendations in this population, as well as potentially expanding the indication to younger and lower weight age groups.
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The trial is enrolling about 140 participants and will test them in two cohorts to determine the effects of different doses based on weight.
The components of Paxlovid to treat children
Paxlovid combines two antiviral drugs: nirmatrelvir and ritonavir.
Participants in the first set, weighing at least 39 kg, will receive 300 milligrams (mg) of nirmatrelvir and 100 mg of ritonavir orally twice a day for five days.
This is the same dose that is authorized for people over 12 years of age who weigh at least 39 kg.
Participants in the second set weigh between 19 and 39 kilograms and will receive a smaller dose: 150 mg of nirmatrelvir and 100 mg of ritonavir orally twice a day for five days.
"There is a significant unmet need for outpatient treatments that children and adolescents can take to help prevent progression to serious illness, including hospitalization or death," said Dr. Mikael Dolsten, chief scientific officer and president of global research and development. of Pfizer, in the statement.
Although Pfizer's COVID-19 vaccine is licensed for people up to 5 years old, treatments for children remain limited.
"We're working with companies to amass pediatric data," the FDA's Dr. John Farley said during an American Medical Association webinar last month, acknowledging that doctors are eager for more treatment options.
Farley is director of the Office of Infectious Diseases at the Center for Drug Evaluation and New Drug Research.
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He added that getting safety data, as well as data on how drugs move through the body, would be important moving forward.
Children can get very sick from COVID-19, but they are less likely to be hospitalized than adults.
New Covid-19 cases among American children fell below 100,000 last week for the first time since early August, the American Academy of Pediatrics said Monday.
New cases were down nearly 46% last week from the previous week, with 68,841 new cases of Covid-19 reported among children in the United States last week.
It was the sixth consecutive weekly decline since the peak of more than 1.15 million new cases the week of January 20.
-- CNN's Jen Christensen contributed to this report.
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