What are the indications for Respiratory Syncytial Virus (RSV) immunization in children?

From the Guidelines

RSV immunization is recommended for all infants under 8 months of age born during or entering their first RSV season, and for certain high-risk children up to 24 months, as stated in the most recent guidelines from 2023 1. The indications for RSV immunization in children include:

• Infants under 8 months of age born during or entering their first RSV season
• Infants and children aged 8–19 months who are at increased risk for severe RSV disease and entering their second RSV season
• Premature infants born at less than 29 weeks gestation
• Infants with chronic lung disease of prematurity requiring medical support
• Infants with hemodynamically significant congenital heart disease
• Children aged 19-24 months with severe immunocompromise or neuromuscular disorders Nirsevimab (Beyfortus), a long-acting monoclonal antibody, is given as a single intramuscular injection at a dose of 50mg for infants weighing less than 5kg and 100mg for those weighing 5kg or more, as recommended by the Advisory Committee on Immunization Practices (ACIP) 1. The American Academy of Pediatrics (AAP) also provides guidelines for RSV prophylaxis, including the use of palivizumab for high-risk infants, such as those with congenital heart disease, chronic lung disease, and premature infants born at 32 weeks of gestation or earlier 1. However, the most recent and highest quality studies support the use of nirsevimab for RSV immunization in children, as it provides passive immunity against RSV and reduces the risk of lower respiratory tract infections, hospitalizations, and associated complications 1. Key considerations for RSV immunization include:
• Gestational age and chronologic age at the start of the RSV season
• Presence of underlying medical conditions, such as congenital heart disease or chronic lung disease
• Risk factors for severe RSV disease, such as child care attendance, school-aged siblings, and exposure to environmental air pollutants
• The importance of careful hand hygiene and avoiding exposure to tobacco smoke
• The need for individualized decisions regarding RSV immunization, taking into account the specific risks and benefits for each child.

From the FDA Drug Label

1 INDICATIONS AND USAGE BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:

• Neonates and infants born during or entering their first RSV season. • Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

1 INDICATIONS AND USAGE Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:

with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season

The indications for RSV immunization in children are:

• Neonates and infants born during or entering their first RSV season
• Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season
• Premature infants (less than or equal to 35 weeks gestational age) who are 6 months of age or younger at the beginning of RSV season
• Children with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season
• Children with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season 2, 3, 3

From the Research

Indications for RSV Immunization in Children

• The indications for RSV immunization in children include:
  • Preterm infants (<29 and ≤31 weeks gestational age) 4, 5
  • High-risk infants (≤9 and ≤6 months of age, respectively) 4, 5
  • Former preterm children ≤24 months with chronic lung disease/bronchopulmonary dysplasia 5
  • Children ≤24 months with significant congenital heart disease 5, 6
  • Other high-risk populations, such as children ≤24 months with Down syndrome, pulmonary/neuromuscular disorders, immunocompromised, and cystic fibrosis 5
• Palivizumab is the only licensed intervention for prevention of RSV infection and is recommended for use in high-risk infants and children 4, 5, 6, 7, 8
• The American Academy of Pediatrics (AAP) recommends palivizumab use for a limited population of pediatric patients, including preterm infants and those with certain underlying health conditions 4
• Other organizations, such as the National Perinatal Association, recommend a broader use of palivizumab for RSV prevention in high-risk pediatric populations 4

High-Risk Groups

• Preterm infants are at higher risk for severe RSV disease due to their immature lungs and immune systems 4, 5, 6
• Children with chronic lung disease or congenital heart disease are also at higher risk for severe RSV disease 4, 5, 6
• Other high-risk groups include children with immunodeficiencies, pulmonary or neuromuscular disorders, and those with a history of premature birth 5, 6

Prevention Strategies

• Palivizumab is currently the only available prevention strategy for RSV infection in high-risk infants and children 4, 5, 6, 7, 8
• Other prevention strategies, such as maternal immunization and immunization of infants with long-acting monoclonal antibodies, are being explored as potential options for protecting all infants against RSV 7