Nirsevimab for Prevention of RSV in Healthy Late-preterm and Term Infants
L.L. Hammitt, R. Dagan, Y. Yuan, M. Baca Cots, M. Bosheva, Sabhir Madhi, W.J. Muller, H.J. Zar, D. Brooks, A. Grenham, Ulrika Wählby Hamrén, V.S. Mankad, P. Ren, T. Takas, M.E. Abram, Alexander Leach, M.P. Griffin, T. Villafana, MELODY Study Group
Abstract
( N Engl J Med . 2022;386:837–846. doi: 10.1056/NEJMoa2110275) Infants experience medically attended illness and hospitalization at elevated rates from respiratory syncytial virus (RSV) infection. As a monoclonal antibody with an extended half-life, Nirsevimab (N) is an emerging treatment that binds to the RSV fusion protein and has enhanced inhibitory potency for RSV in cell-culture and animal models over Palivizumab. Preterm (29 to <35 wk gestational age birth) infants receiving a single dose of N before RSV season showed 70.1% efficacy at protection against RSV with a favorable safety profile. The safety and efficacy of N in late-preterm and term infants entering their first RSV season is investigated in this phase 3 trial.