Nirsevimab, sold under the brand name Beyfortus, is a human recombinant monoclonal antibody with activity against respiratory syncytial virus (RSV).
[15] Alternatively, in October 2023 the CDC recommended maternal RSVpreF vaccination during pregnancy, though both are not needed in most infants.
[6][15] Alternatively, in October 2023 the CDC recommended maternal RSVpreF vaccination during pregnancy, though administration of both is not needed in most infants.
[12] The opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) was based on data from two randomized, double-blind, placebo-controlled multicenter clinical trials that investigated the efficacy and safety of nirsevimab in healthy preterm (premature) and full-term infants entering their first RSV season.
[15] MA RSV LRTI included all health care provider visits (physician office, urgent care, emergency room visits and hospitalization) for lower respiratory tract disease with worsening clinical severity and a positive RSV test.
[15] The safety and pharmacokinetic data from Trial 05 provided evidence for the use of nirsevimab to prevent MA RSV LRTI in this population.
[10][11] The MELODY study is an ongoing, randomized, double-blind, placebo-controlled to evaluate the safety and efficacy of nirsevimab in late preterm and term infants.
Initial results were promising, with nirsevimab reducing LRTI (lower respiratory tract infections) by 74.5% compared to placebo in infants born at term or late preterm.