The Academy has revised its guidance for use of palivizumab (Synagis) for respiratory syncytial virus (RSV) prophylaxis based on a systematic review of recent and older peer-reviewed literature. The focus of the review by the AAP Committee on Infectious Diseases and the Clinical Practice Guideline Subcommittee on Bronchiolitis Evidence Working Group has been on publications that delineate children at risk of serious RSV disease.

Palivizumab was licensed by the Food and Drug Administration in June 1998, largely on the basis of results of the IMpact-RSV trial conducted during the 1996-’97 RSV season. A second randomized, double-blind, placebo-controlled trial conducted between 1998-2002 evaluated prophylaxis among children with hemodynamically significant congenital heart disease.

The palivizumab package insert states, “Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease.” In the absence of a specific definition of “high risk,” the...

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