FDA Expands Authorization for Bamlanivimab and Etesevimab for Younger Pediatric Population

The Food and Drug Administration announced it has expanded the authorization of the 2 monoclonal antibodies bamlanivimab and etesevimab so that younger children and even newborns could be administered the therapy who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.

“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention. 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, MD, director of the FDA’s Center for Drug Evaluation and Research, said.

In February, the FDA authorized bamlanivimab and etesevimab administered together to treat mild-to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progressing to severe COVID-19 and/or hospitalization.

In September, the agency authorized its use for post-exposure prevention of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high-risk for progression to severe COVID-19, including hospitalization or death.

“While today’s authorization includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination. Vaccines remain our best tool in the fight against the virus and there is a COVID-19 vaccine authorized for children 5 years of age and above,” Cavazzoni, said.