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Lower respiratory tract infection caused by respiratory syncytial virus (RSV) infection is a leading cause of hospitalization among infants. Although RSV prophylaxis with palivizumab, given as a monthly injection, is recommended for certain high-risk preterm infants, no prophylaxis agent currently is approved for late-preterm or average-risk infants, despite the fact that most RSV-associated hospitalizations occur in these groups.
Nirsevimab (a monoclonal antibody against RSV that is not yet U.S. FDA-approved) previously was shown to be effective at limiting RSV-associated illness and hospitalization among preterm infants (NEJM JW Pediatr Adolesc Med Sep 2020 and N Engl J Med 2020; 383:415). In this new industry-funded multicenter trial, 149…