The Food and Drug Administration on Friday authorized Eli Lilly’s monoclonal antibody treatment for infants and children under age 12 with COVID-19 who are at high risk of becoming severely ill from the virus because they have a condition such as obesity or diabetes.
Previously, high-risk COVID patients 12 or older had been eligible to get the drugs, which are typically administered intravenously at a clinic or hospital and have been shown to lower the risk of hospitalization and death.
Until now, “we haven’t had something for young kids” with COVID that could keep them out of the hospital, said Dr. Walid F. Gellad, who is the director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh’s School of Medicine.
The authorization comes as fears are rising about a winter surge fueled by the new omicron coronavirus variant, which appears to be spreading because of a mix of its contagiousness and its ability to dodge the body’s immune defenses. It is not yet known how omicron may affect young children compared to other versions of the virus or whether Lilly’s antibody treatment may be less effective against it.
Hospitalizations of children with COVID soared over the summer during a surge in delta cases. Among the states that report the data, between 0.1% and 1.9% of all confirmed cases of COVID in children have resulted in hospitalization, according to the American Academy of Pediatrics.
The FDA said that body-weight-adjusted doses of Lilly’s treatment, a cocktail of two antibody drugs, were studied in a safety trial that enrolled 125 pediatric patients.
“Parents of young kids, especially high-risk young kids, have had a difficult time because even though their kids are at lower risk, the focus has not been on that age, until recently with the vaccinations,” Gellad said. “It’s always good to have another option, but it’s always worth reiterating it doesn’t take the place of vaccination.”