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Effectiveness of palivizumab prophylaxis in infants and children in Florida
Almut G Winterstein1, Christian Hampp, Arwa Saidi
1Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA. Almut@cop.ufl.edu
Insights
Palivizumab significantly reduced severe respiratory syncytial virus (RSV) hospitalizations in a real-world setting. The protective effect of this RSV immunization may last longer than current dosing guidelines suggest.
Area of Science:
- Pediatric infectious diseases
- Immunization effectiveness
- Public health research
Background:
- Existing data on palivizumab effectiveness for respiratory syncytial virus (RSV) infections are primarily from clinical trials and vary across high-risk populations.
- There is a need to evaluate palivizumab's real-world effectiveness in a broader, community-based setting.
Purpose of the Study:
- To assess the effectiveness of palivizumab in preventing RSV-related hospitalizations within a community-based sample of high-risk children.
- To compare palivizumab use (first, subsequent, and former) against non-use in a Medicaid population.
Main Methods:
- A cohort study was conducted using Florida Medicaid data (1998-2004) of children with continuous eligibility.
- Children were followed from the start of the RSV season until age two, or earlier if hospitalized, lost eligibility, or died.
- Cox regression models were used to compare palivizumab exposure (defined by dosing schedule) with non-use, adjusting for confounders and using non-RSV hospitalizations as a secondary endpoint.
Main Results:
- Palivizumab use was associated with reduced hazard ratios for RSV hospitalizations: 0.89 for first use, 0.56 for subsequent use, and 0.71 for former use.
- Hazard ratios for hospitalizations due to non-RSV infections indicated residual confounding for first-use but not for subsequent or former use.
- These findings suggest that palivizumab provides significant protection against severe RSV disease in a community setting.
Conclusions:
- Palivizumab demonstrated effectiveness in reducing severe RSV infections in a community-based cohort, with results comparable to clinical trial efficacy estimates.
- The observed protection suggests that the benefits of palivizumab may extend beyond the standard monthly dosing interval.
- This study supports the use of palivizumab for preventing severe RSV disease in eligible pediatric populations.
Purpose:
Palivizumab effectiveness data on respiratory syncytial virus (RSV) infections are limited to trial settings and vary considerably between selected high-risk populations. This study aimed to evaluate effectiveness in a community-based sample.
Methods:
We conducted a cohort study of children with ≥ 3 months Florida Medicaid fee-for-service eligibility between 1998 and 2004 who also had matching birth certificates. Children entered the cohort at the beginning of the RSV season, after a minimum of 60 days in ambulatory care, and were followed until the earliest of the following: season end, second birthday, loss of eligibility, hospitalization, or death. Study endpoint was the first RSV-related hospitalization. To evaluate the presence of confounding, a second endpoint, hospitalizations for pneumonia or bronchiolitis secondary to specified bacterial or viral pathogens other than RSV, was used. Palivizumab exposure defined as first use (day 1-30 of first dose), subsequent use (days 1-30 of each subsequent dose), and former use (days 31-60 after any dose if delays or no readministration occurred) was compared with non-use with a Cox regression model, adjusting for confounders.
Results:
Hazard ratios (HRs) for RSV hospitalizations were 0.89 (95%CI, 0.71-1.12), 0.56 (95%CI, 0.46-0.69), and 0.71 (95%CI, 0.51-0.97) for first, subsequent, and former use, respectively. HRs for hospitalization because of non-RSV infections were 1.31 (95%CI, 1.04-1.65), 1.03 (95%CI, 0.86-1.23), and 1.05 (95%CI, 0.78-1.41), indicating residual confounding for first but not for subsequent and former use.
Conclusion:
In this community-based study, palivizumab was associated with a reduction in severe RSV infections of a magnitude comparable to the lower clinical trial efficacy estimates. Protection appears to extend beyond the currently recommended monthly dosing schedule.
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