Pfizer has begun a Phase 2 and 3 clinical trial of its Covid-19 antiviral treatment, Paxlovid, in children ages 6 to 17, the company said Wednesday in a news release.
The study will evaluate the safety and efficacy of the treatment in children who have Covid-19 symptoms and a confirmed infection, who are not hospitalized and who are at risk of severe disease.Paxlovid is already authorized by the US Food and Drug Administration for high-risk people 12 and older who weigh at least 88 pounds, but that decision was made based on data from clinical trials that did not include people under the age of 18.
"We're working with companies to accrue pediatric data," the FDA's Dr. John Farley said during an American Medical Association webinar last month, acknowledging that physicians are eager for more treatment options. Farley is director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research of New Drugs. He added that getting safety data, as well as data on how the drugs move through the body, would be important to move forward.
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