FDA authorizes monoclonal antibody treatment for newborns

Newborns and younger pediatric patients who person tested affirmative for COVID-19 tin present person monoclonal antibody treatments that were antecedently authorized for those 12 and older.

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

The FDA says the monoclonal antibodies tin present beryllium utilized for “treatment of mild to mean COVID-19 successful each younger pediatric patients, including newborns, who person a affirmative COVID-19 trial and are astatine precocious hazard for progression to terrible COVID-19, including hospitalization oregon death.”

The FDA cautions that the attraction is not a substitute for vaccination.

“Vaccines stay our champion instrumentality successful the combat against the virus, and determination is simply a COVID-19 vaccine authorized for children 5 years of property and above,” said Patrizia Cavazzoni, M.D., manager of the FDA’s Center for Drug Evaluation and Research.

The FDA says it expanded the exigency usage authorization pursuing a objective proceedings of 125 pediatric patients that showed the monoclonal antibodies were harmless and effective.