The FDA on Friday authorized Eli Lilly monoclonal antibody treatment for infants and children under 12 with Covid-19 who are at high risk of serious illness from the virus due to diseases such as obesity or diabetes …
Previously, high-risk Covid patients aged 12 and over were eligible for medication, which is usually given intravenously in a clinic or hospital and has been shown to reduce the risk of hospitalization and death.
So far, “we haven’t had something for young children” with Covid to keep them from going to the hospital, ”said Dr. Walid F. Gellad, director of the Center for Pharmaceutical Policy and Prescriptions at the University of Pittsburgh. School of Medicine.
The permit was issued as concerns about the winter spike caused by a new variant of the Omicron coronavirus, which seem to be spreading due to a combination of its infectiousness and its ability to evade the body’s immune defenses, are mounting. It is not yet known how Omicron might affect young children compared to other versions of the virus, and whether Lilly’s treatment with antibodies against it may be less effective.
The number of hospitalizations for children with Covid soared over the summer during a spike in Delta cases. Among states that report data, 0.1% to 1.9% of all confirmed Covid cases in children end up in hospital admissions, according to the American Academy of Pediatrics.
The FDA said the weight-adjusted doses of Lilly (a mixture of two antibody-based drugs) were studied in a safety trial involving 125 pediatric patients.
“Parents of young children, especially those at high risk, have had a difficult time because, even though their children are at a lower risk, this age has been neglected until recently with vaccinations,” said Dr. Gellad. “It’s always good to have another option, but it’s always worth repeating that it is not a substitute for vaccination.”