Palivizumab 100mg/1ml solution for injection vials

BackgroundRespiratory syncytial virus (RSV) is the most common cause of pediatric acute lower respiratory tract infection worldwide. In Singapore, RSV substantially contributes to the morbidity and mortality of children aged Data sourcesA comprehensive literature review was conducted using Medline via PubMed, to identify relevant studies, including randomized controlled trials, observational studies, systematic reviews, and meta-analyses, related to RSV burden and prevention and nirsevimab. A multidisciplinary group of physicians with RSV expertise from leading institutions in Singapore reviewed the literature on RSV-related topics, convened to deliberate and formulate evidence-based recommendations, summarizing the overall disease burden, unmet needs, and the optimal implementation of an immunization strategy for all infant protection against RSV infections in Singapore. Premeeting and in-meeting surveys were conducted to guide the development of final consensus recommendations.ResultsEpidemiology and burden of RSV in Singapore, current protection against RSV infections in infants, implementations of nirsevimab, and optimization of nirsevimab implementation in Singapore were discussed in this study. Although RSV brings substantial burden with underestimated costs, palivizumab is the only approved product for RSV prevention in Singapore. Existing evidences reveal that nirsevimab has a good safety profile and is effective in preventing RSV lower respiratory tract infections. Seven statements were formulated on the epidemiology and burden of RSV in Singapore, with emphasis on its high incidence and associated healthcare cost, and the clinical efficacy and safety of nirsevimab as a basis of its implementation for all infant protection in Singapore.ConclusionsThe burden of RSV disease in young children is substantial, especially in those < 2 years old, accounting for up to 47% of bronchiolitis and pneumonia admissions in children < 6 months. The administration of a single dose of nirsevimab may be offered to infants at birth for the prevention of RSV in Singapore.

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IntroductionPremature infants are at increased risk of developing chronic respiratory diseases, predisposing them to severe infections, such as those caused by respiratory syncytial virus (RSV). Palivizumab reduces the severity of RSV infections in high-risk children; however, its relationship with asthma development in premature infants remains unclear.ObjectiveThis systematic review with meta-analysis aimed to review the literature and assess whether prophylaxis with palivizumab protects premature infants without congenital heart disease from developing asthma.ResultsIn total, 14 studies met the inclusion criteria, assessing 1,364,238 children; of these, 9232 received palivizumab. No significant difference in the chance of developing asthma between the groups (odds ratio (OR) of 0.84, 95% CI [0.62-1.13], p = 0.1968). Heterogeneity between studies was I² = 35.6%. Subgroup analysis for children with a family history of atopy showed no significant reduction in asthma risk (OR 0.78, 95% CI: 0.40-1.55, p = 0.3390). Sensitivity analysis confirmed result robustness. IgE levels were similar between the groups (standardized mean difference [SMD] -0.03 [95% CI: -0.30; 0.23], p = 0.8088). Children who received palivizumab were diagnosed younger (SMD -0.24 [95% CI: -0.38; -0.09], p = 0.0014), with lower gestational age (MD -0.75 [95% CI: -1.61; 0.12], p = 0.0915).ConclusionsPalivizumab prophylaxis does not reduce asthma risk in premature children without congenital heart disease. Its primary benefit lies in preventing severe RSV infections, with no direct impact on asthma developing.

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Background: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTI) in infants and young children, with significant morbidity, hospitalizations, and healthcare costs. Passive immunoprophylaxis has historically relied on palivizumab, while nirsevimab, a long-acting monoclonal antibody, has recently emerged as an alternative and has broader indications. Methods: We conducted a systematic review of randomized controlled trials, observational studies, real-world effectiveness analyses, and economic evaluations assessing the efficacy, safety, and cost-effectiveness of palivizumab and nirsevimab for RSV prevention in children under 24 months. Results: 41 studies were included in this review. Palivizumab demonstrated consistent efficacy in reducing RSV-related hospitalizations in high-risk infants, with relative risk reductions of approximately 45-55%. Nirsevimab showed higher relative efficacy, with reductions of 70-85% in RSV-associated lower respiratory tract infections and hospitalizations across randomized trials and real-world studies, including healthy term and late-preterm infants. Both monoclonal antibodies have favorable safety profiles, with adverse event rates comparable to the placebo. Economic analyses indicated that palivizumab is cost-effective primarily in narrowly defined high-risk populations, whereas nirsevimab may offer improved cost-effectiveness, particularly at lower acquisition prices and with seasonal administration strategies. Conclusions: Nirsevimab represents a promising advancement in RSV prevention, with broader protection, a simpler administration, and potential economic advantages compared to palivizumab.

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