Progress in the field of passive immunoprophylaxis for protection of high-risk infants and children against respiratory syncytial virus (RSV) infection has achieved remarkable success. Palivizumab was licensed by the United States Food and Drug Administration (FDA) in 1998 for monthly intramuscular administration for prevention of RSV lower respiratory tract infections in high-risk infants and children. The annual rate of hospitalization due to RSV infection among infants in high-risk groups who do not receive immunoprophylaxis varies between 10% and 20%, a figure that is ∼5 times higher than the hospitalization rate among non–high-risk infants. Results from 2 blinded, randomized, placebo-controlled trials involving 2789 infants and children with prematurity, chronic lung disease, or congenital heart disease demonstrated a reduction in RSV hospitalization rates of between 39% and 78% in different groups.1,2  Results from postlicensure, observational studies suggest that monthly immunoprophylaxis with palivizumab may reduce rates of RSV-induced hospitalization to...

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