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An Improved and High Throughput Respiratory Syncytial Virus (RSV) Micro-neutralization Assay
Published on: January 26, 2019
Palivizumab: new indication. Moderate reduction in hospitalisation rate
Insights
Palivizumab is a preventive treatment that reduces hospitalizations for respiratory syncytial virus (RSV) infections in high-risk infants. However, it does not impact intensive care needs or overall mortality rates.
Area of Science:
- Pediatrics
- Immunology
- Infectious Diseases
Background:
- Respiratory syncytial virus (RSV) is a common cause of infant respiratory illness, particularly severe in high-risk infants.
- Palivizumab, a monoclonal antibody, is the first preventive treatment for RSV approved in France.
- Recent license extensions in France include infants under two years with hemodynamically significant congenital heart disease.
Purpose of the Study:
- To evaluate the efficacy and safety of palivizumab in preventing RSV hospitalizations in high-risk infants.
- To assess the impact of palivizumab on intensive care, mortality, and overall hospitalization rates.
- To review available data on adverse effects and treatment costs.
Main Methods:
- Analysis of follow-up data from Spanish cohorts of premature infants and those with bronchopulmonary dysplasia.
- Review of a randomized double-blind placebo-controlled trial involving 1287 infants with hemodynamically significant heart disease.
- Assessment of reported adverse events and treatment cost data.
Main Results:
- Palivizumab reduced RSV hospitalization risk (3.95% vs. 13.25%) in Spanish cohorts but had no impact on intensive care or mortality.
- In infants with heart disease, palivizumab reduced RSV-related hospitalizations (5.3% vs. 9.7%) and all-cause hospitalizations (54.9% vs. 62.3%), with no effect on mortality.
- Few adverse effects reported, with anaphylaxis risk <1/100,000; second-season risks are poorly documented.
Conclusions:
- Palivizumab appears beneficial for specific high-risk infant groups, including premature infants with bronchopulmonary dysplasia, those with pulmonary sequelae, and infants with significant heart disease.
- The treatment primarily reduces hospitalization rates for RSV infection and all causes, without affecting mortality or intensive care needs.
- Cost-effectiveness and long-term safety, particularly for second-season use, require further consideration.
Abstract:
(1) Respiratory syncytial virus (RSV) infection is common in infants; it is usually mild except in high risk children. (2) Palivizumab, a monoclonal antibody against RSV, was the first preventive treatment to be marketed in France. The licence was recently extended in France to cover children under 2 years of age who have haemodynamically significant congenital heart disease. (3) Follow-up data from Spanish cohorts of premature infants and infants with bronchopulmonary dysplasia are now available. The data tend to agree, albeit with different levels of evidence, that palivizumab reduces the risk of hospitalisation for RSV infection (3.95% of infants treated with palivizumab, 13.25% of untreated infants), but has no impact on the need for intensive care or on overall mortality. There are no data on the overall risk of hospitalisation. (4) In a randomised double-blind placebo-controlled trial in 1287 infants under 2 years of age with haemodynamically significant heart disease, palivizumab had no effect on mortality. But it did reduce the rate of hospitalisation both for RSV infection (5.3% versus 9.7%) and for all causes (54.9% versus 62.3%). (5) Few adverse effects have been reported after five years of use. The estimated risk of anaphylactic reactions is less than 1 per 100 000 infants. The risk of adverse effects when an infant is treated during a second season is poorly documented. (6) Treatment costs about 5000 euros per season for a 6 kg child. (7) In practice, palivizumab seems useful for the following categories of infants: those aged less than 6 months who were born with a gestational age of less than 32 weeks and who had bronchopulmonary dysplasia at birth; formerly premature infants under 2 years of age who are receiving long-term treatment for pulmonary sequelae; and infants with haemodynamically significant heart disease.
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