FDA authorizes treating younger patients with monoclonal antibody combo

The Food and Drug Administration Friday authorized administering bamlanivimab and etesivimab together to treat or prevent COVID-19 in all pediatric patients exposed to or testing positive for the virus who are at high risk for progressing to severe disease. The emergency use authorization previously authorized the combination therapy to treat patients age 12 and older who weigh at least 40 kilograms (about 88 pounds).  
  
“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention,” said Patrizia Cavazzoni, M.D., director of FDA’s Center for Drug Evaluation and 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 addresses the medical needs of this vulnerable population. 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.”