The Food and Drug Administration on Friday approved Eli Lilly’s monoclonal antibody treatment for infants and children under the age of 12 with Covid-19 who are at high risk of developing the virus seriously because of a condition such as obesity or diabetes .
Previously, high-risk Covid patients aged 12 and over had the option of receiving the medication that is normally administered intravenously in a clinic or hospital and has been shown to reduce the risk of hospitalization and death.
Until now, “we had nothing for young children” with Covid to keep them away from the hospital, said Dr. Walid F. Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh Medical School.
The approval comes amid fears of a winter surge fueled by the new variant of Omicron coronavirus, which appears to be spreading due to a mix of contagiousness and its ability to evade 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 is less effective against it.
Hospital stays of children with Covid skyrocketed over the summer amid a surge in Delta cases. Among the states reporting the data, between 0.1 percent and 1.9 percent of all confirmed cases of Covid in children resulted in hospitalization, according to the American Academy of Pediatrics.
The FDA said weight-adjusted doses of Lilly’s treatment, a cocktail of two antibody drugs, were evaluated in a safety study of 125 pediatric patients.
“Parents of toddlers, especially high-risk toddlers, have had a difficult time because while their children are at lower risk, until recently the focus of vaccination was not on that age,” said Dr. Gellad. “It is always good to have another option, but it is always worth repeating that it does not replace vaccination.”