FDA

• Prevention of lower respiratory tract disease from respiratory syncytial virus (RSV) 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 in their second RSV season
• RSV is the leading cause of hospitalization among infants in the U.S.[1]
  • Most children are expected to be infected during their first year of life, and nearly all have been infected by the age of 2.
  • The incidence of RSV hospitalization is three times higher in infants born at or before 30 weeks of gestation compared to infants born at term. Premature infants are also more likely to be admitted to the ICU for RSV disease compared to term infants.
  • Most children (79%) under 24 months old hospitalized for RSV have no underlying medical conditions.