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FDA authorizes monoclonal antibody treatment for newborns, young children

US Births
Posted at 5:36 PM, Dec 03, 2021

Newborns and younger pediatric patients who have tested positive for COVID-19 can now receive monoclonal antibody treatments that were previously authorized for those 12 and older.

The Food and Drug Administration announced Friday that it had revised its emergency use authorization for bamlanivimab and etesevimab.

The FDA says the monoclonal antibodies can now be used for “treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.”

The FDA cautions that the treatment 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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA says it expanded the emergency use authorization following a clinical trial of 125 pediatric patients that showed the monoclonal antibodies were safe and effective.