From the Guidelines
The CDC recommends RSV immunization for all infants younger than 8 months born during or entering their first RSV season, using either nirsevimab (a monoclonal antibody) as a single dose or the maternal RSV vaccine if the mother received it during pregnancy (between 32-36 weeks gestation).
RSV Immunization Guidelines
The guidelines for RSV immunization in pediatrics, as recommended by the CDC, prioritize the use of nirsevimab for infants under 8 months of age, with a dose of 50 mg for those weighing less than 5 kg and 100 mg for those weighing 5 kg or more 1. For higher-risk infants and children aged 8-19 months entering their second RSV season, a dose of 200 mg of nirsevimab is recommended, administered as two 100 mg injections at different sites 1.
Maternal RSV Vaccine
Alternatively, the maternal RSV vaccine can be administered to pregnant individuals between 32-36 weeks of gestation to provide protection to infants against RSV-associated lower respiratory tract disease 1. The CDC recommends using either the maternal RSV vaccine or nirsevimab, but not both, to prevent RSV-associated lower respiratory tract infection in infants 1.
Key Points
- Infants under 8 months of age should receive RSV immunization using nirsevimab or the maternal RSV vaccine.
- Higher-risk infants and children aged 8-19 months should receive nirsevimab if entering their second RSV season.
- The dose of nirsevimab varies by weight, with 50 mg for infants under 5 kg and 100 mg for those 5 kg or heavier.
- The maternal RSV vaccine can be administered to pregnant individuals between 32-36 weeks of gestation.
From the FDA Drug Label
The provided drug labels do not mention CDC guidelines for pediatrics regarding the RSV vaccine. The FDA drug label does not answer the question.
From the Research
CDC Guidelines for Pediatrics Regarding the RSV Vaccine
The Centers for Disease Control and Prevention (CDC) provides guidelines for the prevention of serious lower respiratory tract infections caused by Respiratory Syncytial Virus (RSV) in high-risk infants.
- The American Academy of Pediatrics (AAP) recommends palivizumab prophylaxis for certain high-risk infants, including those with a history of premature birth, bronchopulmonary dysplasia, or hemodynamically significant congenital heart disease 2, 3, 4, 5.
- Palivizumab is administered in a series of monthly injections during the RSV season, typically from November to March 2, 3, 4.
- The CDC guidelines also consider the cost-effectiveness of palivizumab prophylaxis, as it can be expensive, with an estimated cost ranging from $3,500 to $10,700 per infant per season 5.
- Recently, nirsevimab, a highly potent, long-acting, human, recombinant monoclonal antibody, has been approved for the prevention of RSV infection in newborns and infants during their first RSV season 6.
High-Risk Infants
High-risk infants who may benefit from RSV prophylaxis include:
- Preterm infants (<29 and ≤31 weeks gestational age) 4
- Former preterm children ≤24 months with chronic lung disease/bronchopulmonary dysplasia 4
- Children ≤24 months with significant congenital heart disease 4
- Other high-risk populations, such as children ≤24 months with Down syndrome, pulmonary/neuromuscular disorders, immunocompromised, and cystic fibrosis 4
Effectiveness and Safety
- Palivizumab has been shown to reduce RSV-related hospitalizations by 55% in high-risk infants 2, 3, 5.
- Nirsevimab has also demonstrated positive results in Phase 2b and 3 clinical trials, with a single dose covering a typical RSV season in regions with temperate climates 6.
- Both palivizumab and nirsevimab have been found to be generally well-tolerated, with common adverse events including injection site reaction, fever, and diarrhea 2, 3, 6.