Objective: The Palivizumab Outcomes Registry contains data on infants and young children who received palivizumab for the prevention of respiratory syncytial virus (RSV) that causes serious lower respiratory tract illness.Study Design: Prospective observational registry enrolling those who received X1 dose of palivizumab during any RSV season (2000 to 2004) at participating US sites.Result: Of 19 548 subjects enrolled, 40% were born before 32 weeks', 48% between 32 and 35 weeks' and 12% after 35 weeks' gestation. Risk factors included child-care attendance, prematurity, chronic lung disease (CLD) and congenital heart disease (CHD). The RSV hospitalization rate of palivizumab recipients was 1.3%. Gender, gestational age <32 weeks, CLD, CHD, congenital airway abnormality, severe neuromuscular disease, Medicaid insurance and >2 children in household were associated with significantly higher rates. Home-care prophylaxis with palivizumab was associated with reduced hospitalization rates.Conclusion: Data on the use of palivizumab prophylaxis in primarily high-risk infants confirm low RSV hospitalization rates.

BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children, accounting for approximately 75,000-125,000 hospitalizations per year. It is estimated that in 2000, RSV infection accounted for 1.7 million office visits, 402,000 emergency room visits, and 236,000 hospital outpatient visits per year for children younger than 5 years of age. Palivizumab, a humanized monoclonal antibody directed against RSV, is the only immunoprophylaxis therapy approved by the FDA for prevention of serious lower respiratory tract disease caused by RSV in infants (up to 2 years of age) who meet 1 or more of the following criteria for high risk: (a) gestational age up to 35 weeks; (b) diagnosis of chronic lung disease (CLD, formerly bronchopulmonary dysplasia [BPD]); or (c) diagnosis of cyanotic or complex congenital heart disease. The RSV season typically occurs between November and March but may vary by region. During the period of our review, depending on local duration of the RSV season, infants usually required 5 monthly (every 28-30 days) intramuscular injections of palivizumab. Infants born in the middle of the season received their palivizumab doses from the time of birth to the end of the season and, therefore, may have required less than 5 doses. It is unclear if compliance with monthly doses is a problem and whether noncompliance increases the risk of RSV hospitalizations in routine clinical practice.

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Children are the most prevalent vulnerable population in US society and have unique needs during the response to and recovery from public health emergencies. The physiological, behavioral, developmental, social, and mental health differences of children require specific attention in preparedness efforts. Despite often being more severely affected in disasters, children's needs are historically underrepresented in preparedness. Since 2001, much progress has been made in addressing this disparity through better pediatric incorporation in preparedness planning from national to local levels. Innovative approaches, policies, and collaborations contribute to these advances. However, many gaps remain in the appropriate and proportional inclusion of children in planning for public health emergencies. Successful models of pediatric planning can be developed, evaluated, and widely disseminated to ensure that further progress can be achieved.

BackgroundPalivizumab has been shown to decrease the incidence of hospitalization due to respiratory syncytial virus (RSV) in infants at risk of severe RSV disease. We examined the association between compliance with palivizumab dosing throughout the RSV season and risk of RSV-related hospitalization in clinical practice.MethodsSubjects who were born and discharged from the hospital before the RSV season and received ≥1 palivizumab dose during their first RSV season were identified from a large US commercial health insurance database between 01/01/03 and 12/31/09. Subjects were deemed compliant if they received ≥5 palivizumab doses without gaps (>35 days) and their first dose was received by November 30. RSV-related hospitalizations were identified using ICD-9-CM diagnosis codes and examined over 2 observation periods: post-index dose and RSV season. A Cox proportional hazard model was used to evaluate the association between non-compliance and RSV-related hospitalization.ResultsOf the 5,003 subjects who received palivizumab, 62% were deemed non-compliant. Non-compliant subjects had significantly higher unadjusted rates of RSV-related hospitalizations compared to compliant subjects during both observation periods (post-index: 6.1 vs. 2.8 per 100 infant seasons, p < 0.001; RSV season: 5.9% vs. 2.3%; p < 0.001). In multivariate analyses, non-compliance was significantly associated with higher risk of RSV-related hospitalization (HR = 2.01; p < 0.001). Of the 225 RSV-related hospitalizations observed during the RSV season, 61 (27%) occurred before the first dose of palivizumab.ConclusionsSubjects who did not receive monthly dosing of palivizumab throughout the RSV season had significantly higher rates of RSV-related hospitalizations. The RSV-related hospitalizations prior to the first dose of palivizumab suggest some dosing was started too late.