FDA approves first therapy to protect infants from RSV
UCI Health pediatrician calls antibody injection a ‘game-changer’
July 19, 2023
IN THE NEWS: In a long-awaited move, the U.S. Food and Drug Administration this week approved the first drug developed to shield children under age 2 from respiratory syncytial virus (RSV), the leading cause of U.S. infant hospitalizations.
Widespread adoption of nirsevimab-alip, an injectable monoclonal antibody therapy to be available under the name Beyfortus, could significantly reduce the number of babies and toddlers hospitalized every year with RSV, UCI Health pediatric infectious disease specialist Dr. Coleen K. Cunningham told NBC4 News.
This would be a game-changer. Right now, we have nothing to give to otherwise healthy kids in the first six months of life to protect them. The injections are very safe and they've been very well-tolerated by thousands of babies [who] have been studied.
Cunningham, who is renowned for her work on HIV and AIDS, is the author of more than 130 published manuscripts. She has led many multicenter clinical trials aimed at treating and preventing HIV infection in children. She also has been awarded several competitive research grants and served on National Institutes of Health review panels. Her focus as an educator has been the training of pediatric infectious diseases physician-scientists. She is professor and chair of Pediatrics at the UCI School of Medicine and pediatrician-in-chief at CHOC Children's Hospital of Orange County.