The treatment is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, given together by intravenous infusion. It was previously licensed for pediatric patients 12 years of age and older weighing at least 88 pounds.
Treatment is now permitted for all pediatric patients who test positive for COVID-19 or have been exposed to someone with COVID-19, who are at high risk of progression to severe COVID-19, including hospitalization or death.
The treatment was initially authorized in February and has been used in more than 700,000 patients.
“Now all patients at high risk of severe COVID-19, including children and newborns, have an option for post-exposure treatment and prevention,” said Patrizia Cavazzoni, director of the Center for Drug Evaluation and FDA Research. “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 meets the medical needs of this vulnerable population. “
Therapy, however, does not replace vaccination, Cavazzoni said.
The expanded clearance comes amid questions about the effectiveness of treatment against the newly emerged omicron variant. Lilly said he was working quickly to study the impact. Early reports from South Africa, which first warned the world about the variant, show an increase in infections in children under five, although scientists point out that all that is known currently is preliminary.
All of the major vaccine companies are also in the process of determining whether their vaccines are effective against omicron.