UMass Chan researchers studying Paxlovid dosing for children with COVID-19

Photo | Timothy Doyle UMass Chan Medical School in Worcester

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By Timothy Doyle

Researchers at UMass Chan Medical School are teaming up with pharmaceutical giant Pfizer and the U.S. Food and Drug Administration to study the effects of the COVID-19 drug Paxlovid on patients aged 18 and under.

“The number of pediatric cases really spiked with the Omicron wave, particularly in late 2021 through early 2022, and the number of reported cases remains high, with approximately 350,000 reported cases over the past four weeks,” said site principal investigator Katherine Luzuriaga, the UMass Memorial Health Care chair in biomedical research, vice provost for clinical and translational research, professor of molecular medicine, pediatrics and medicine; and director of the UMass Center for Clinical and Translational Science, in a Sept. 12 report by UMass Chan.

According to the report, patients 12 and older were included with adults in the FDA’s emergency use authorization of Paxlovid in December. In March, Pfizer initiated a Phase II/III study to evaluate the safety and efficacy of Paxlovid for treatment of nonhospitalized, symptomatic pediatric participants who have a confirmed case of COVID-19 and are at risk of progression to severe disease. Now researchers have begun to enroll children aged 6 to 11, as well as continuing to enroll teens to continue to monitor the effects on that group. Following the assessment of this group, the effects on younger patients will be studied.

“We have seen many children hospitalized with COVID who develop respiratory and other complications, including several very ill teens who have required pediatric ICU care,” said William Durbin, professor of pediatrics and division chief of pediatric infectious diseases, in the Sept. 12 report. “These children would have benefitted from an oral antiviral such as Paxlovid to avoid these complications.”