Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.

  title={Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.},
  author={M. Pamela Griffin and Yuan Yuan and Therese Takas and Joseph B. Domachowske and Shabir Ahmed Madhi and Paolo Manzoni and Eric A. F. Sim{\~o}es and Mark T. Esser and Anis A. Khan and Filip Dubovsky and Tonya Villafana and John P. Devincenzo},
  journal={The New England journal of medicine},
  volume={383 5},
BACKGROUND Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose. METHODS In this trial conducted in both northern and southern hemispheres, we evaluated nirsevimab for the prevention of RSV-associated lower respiratory… 

Breakthrough therapy designation of nirsevimab for the prevention of lower respiratory tract illness caused by respiratory syncytial virus infections (RSV)

Nirsevimab will supplant the current standard of care for RSV prevention and requires a single dose to last the entire RSV season and may be given to term, preterm, and high-risk infants.

Monoclonal Antibodies for Prevention of Respiratory Syncytial Virus Infection.

A new generation of mAbs directed to new neutralizing epitopes and with prolonged half life are expected to provide adequate protection during the complete RSV season with a single intramuscular (IM) dose.

Nirsevimab reduces medically attended RSV-associated lower respiratory tract infection and hospitalisations in healthy pre-term infants

  • S. Murphy
  • Medicine
    Archives of Disease in Childhood
  • 2021
Infants without current indication for palivizumab, and without bronchopulmonary dysplasia, liver, renal or cardiac impairment who were currently aged <1 year and entering their first bronchiolitis season were studied, finding hospitalisation due to RSV LRTI during the same time frame was hospitalisation for RSV and adverse events.

New long‐acting monoclonal antibody reduces RSV infections in healthy preterm infants

  • Medicine, Biology
    Journal of paediatrics and child health
  • 2021
A randomised controlled trial of an extended half-life, RSVspecific mAb, nirsevimab, showed it was safe and efficacious in preterm infants (29–34 weeks gestation), and presents a new, more feasible possibility for RSV protection in infants.

The Future of Respiratory Syncytial Virus Disease Prevention and Treatment

Palivizumab, an RSV monoclonal antibody [immunoprophylaxis (IP)], has demonstrated effectiveness in disease prevention and is the only licensed IP for RSV disease in specific high-risk pediatric populations.

Palivizumab for preventing severe respiratory syncytial virus (RSV) infection in children.

Palivizumab reduces hospitalisation due to RSV infection at two years' follow-up and reduces the number of wheezing days, days of supplemental oxygen, intensive care unit length of stay and mechanical ventilation days.

Pranlukast treatment and the use of respiratory support in infants with respiratory syncytial virus infection

Pranlukast use was associated with a reduced likelihood of requiring respiratory support in infants aged <10 months with RSV infection, and the length of hospital stay and the GRSS did not differ significantly between propensity score-matched pairs.

Real-World Studies of Respiratory Syncytial Virus Hospitalizations among Moderate/Late Preterm Infants Exposed to Passive Immunoprophylaxis with Palivizumab

Exposure to palivizumab was associated with a reduction in RSVH rates that was comparable to the reduction seen in controlled clinical trials (weighed mean 4.0-fold reduction), and Immunoprophylaxis should be used in high-risk infants.

RSV Prevention in All Infants: Which Is the Most Preferable Strategy?

It is concluded that, based on current data, immunization of infants with long-acting mAbs might represent the most effective approach for protecting all infants entering their first RSV season.