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An In vitro Model to Study Immune Responses of Human Peripheral Blood Mononuclear Cells to Human Respiratory Syncytial Virus Infection
Published on: December 10, 2013
Passive immunisation of preterm infants with palivizumab against RSV infection
Christian Harkensee1, Malcolm Brodlie, Nicholas D Embleton
1Newcastle Neonatal Service, Department of Child Health, University of Newcastle upon Tyne, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, UK.
Insights
Palivizumab shows clinical benefit for preventing respiratory syncytial virus (RSV) in preterm infants. However, current cost-effectiveness analyses do not support widespread use, recommending it only for high-risk infants.
Area of Science:
- Pediatrics
- Immunology
- Health Economics
Background:
- Respiratory syncytial virus (RSV) is a significant cause of infant hospitalization.
- Palivizumab is a monoclonal antibody developed for RSV prevention.
- Evidence on its efficacy, safety, and cost-effectiveness requires comprehensive review.
Purpose of the Study:
- To review the existing literature on the efficacy, safety, and cost-effectiveness of palivizumab for RSV prevention.
- To evaluate the clinical benefit and safety profile of palivizumab.
- To assess the economic viability of palivizumab immunization programs.
Main Methods:
- Literature review of randomized controlled trials and cost-effectiveness studies.
- Analysis of clinical trial data regarding palivizumab efficacy and safety.
- Examination of economic analyses comparing immunization costs with hospitalization savings.
Main Results:
- A randomized controlled trial demonstrated clinical benefit and a favorable safety profile for palivizumab in preterm infants.
- Further studies indicate that cost savings from reduced hospitalizations may not outweigh immunization costs.
- Cost-effectiveness analyses are complicated by variable healthcare costs and RSV incidence.
Conclusions:
- Palivizumab demonstrates efficacy and safety in specific high-risk infant populations.
- Current cost-effectiveness data do not support broad implementation of palivizumab.
- Recommendation is limited to infants at high risk for severe RSV bronchiolitis, such as those with chronic lung disease of prematurity.
Abstract:
Palivizumab is a monocloncal antibody used for prevention of respiratory syncytial virus infection. This study reviews the literature regarding evidence of efficacy, safety and cost-effectiveness. The only randomised controlled trial into efficacy of palivizumab in preterm infants demonstrates clinical benefit and suggests a favourable safety profile. Further studies, however, do not provide evidence that costs saved by the reduction in hospitalisation would outweigh actual costs of the immunization for the recommended indications. There is considerable controversy over which groups of patients to include in immunization programs and analyses of cost-effectiveness are complicated by the fact that incidence of RSV infection, rates of hospitalisation and ventilation, health care costs and economic resources are variable among different health care systems and settings. Studies of cost-analysis, despite their implicit weaknesses, do not currently support the widespread use of palivizumab. In the absence of high quality cost-benefit analysis, we currently only recommend the use of palivizumab in infants at high risk of severe bronchiolitis, such as those with active chronic lung disease of prematurity. To illustrate current practice we also present data from an audit of the use of palivizumab in a regional centre in the North-East of England.
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