The Food and Drug Administration (FDA) on Friday expanded its emergency use authorization (EUA) of Eli Lilly and Co’s dual-antibody therapy for mild to moderate COVID-19 to all children, including newborns.
The treatment consists of bamlanivimab and etesevimab—two monoclonal antibodies that are administered by intravenous infusion. The two monoclonal antibodies are directed against the spike protein of SARS-CoV-2, to block the virus’s attachment and entry into human cells. They work by binding to different but overlapping sites on the spike protein.
The antibody treatment was first authorized for emergency use in February for people aged 12 years and older who weigh at least 88 pounds (40 kilograms), who have mild to moderate COVID-19 symptoms and are at high risk for progression to severe COVID-19, including hospitalization or death.
The FDA in September authorized use of the antibody therapy for post-exposure prevention of COVID-19 in the same population. The latest FDA authorization extends the treatment to all children, including newborns.
“Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
He asserted that the therapy “is not a substitute for vaccination.”
The FDA said a clinical trial including 125 children was conducted to assess the safety of the treatment, to support the authorization. Children weighing less than 88 pounds were administered doses of the monoclonal antibodies adjusted for their body weight.
“Serious adverse events including hypersensitivity, anaphylaxis, and infusion-related reactions have been observed with bamlanivimab with and without coadministration of etesevimab,” according to the FDA. “Possible side effects of bamlanivimab and etesevimab administered together include nausea, dizziness, pruritus, and rash.”