Bernd Benninghoff

New vaccination programs measure economic success through cost-effectiveness analysis (CEA) based on an outcome evaluated over a certain time frame. The reimbursement price of the newly approved vaccine is then often reliant on a simulated ideal effect projection because of limited long-term data availability. This optimal cost-effectiveness result is later rarely adjusted to the observed effect measurements, barring instances of market competition-induced price erosion through the tender process. However, comprehensive and systematic monitoring of the vaccine effect (VE) for the evaluation of the real long-term economic success of vaccination is critical. It informs expectations about vaccine performance with success timelines for the investment. Here, an example is provided by a 15-year assessment of the rotavirus vaccination program in Belgium (RotaBIS study spanning 2005 to 2019 across 11 hospitals). The vaccination program started in late 2006 and yielded sub-optimal outcomes. Long-term VE surveillance data provided insights into the infection dynamics, disease progression, and vaccine performance. The presented analysis introduces novel conceptual frameworks and methodologies about the long-term economic success of vaccination programs. The CEA evaluates the initial target vaccination population, considering vaccine effectiveness compared with a historical unvaccinated group. Cost-impact analysis (CIA) covers a longer period and considers the whole vaccinated and unvaccinated population in which the vaccine has direct and indirect effects. The economic success index ratio of CIA over CEA outcomes evaluates long-term vaccination performance. Good performance is close to the optimal result, with an index value ≤1, combined with a low CEA. This measurement is a valuable aid for new vaccine introductions. It supports the establishment of robust monitoring protocols over time.

New vaccination programs need a method to measure success based on pre-defined outcomes evaluated over pre-specified time frames. Reimbursement of newly approved vaccines is often reliant on simulated projections that approximate real-world scenarios, due to limited long-term data availability. Adjustments to reimbursement prices are infrequent, barring instances of market competition-induced price erosion through tender processes. Consequently, comprehensive monitoring of the vaccine effect (VE) for an adequate duration to evaluate the success of vaccination programs remains rare. Such data are essential to inform expectations of vaccine effect and the timeline for measurable success of the investment. An example is provided here by the 15-year assessment of the rotavirus vaccination program in Belgium (RotaBIS study spanning 2005 to 2019 across 11 hospitals). The vaccination program started in late 2006 and yielded sub-optimal outcomes. Long-term VE surveillance data provided insights into infection dynamics, disease progression, and vaccine performance. The presented analysis introduces novel conceptual frameworks and methodologies. Cost-effectiveness analysis (CEA) evaluates the initial target vaccination population, considering the effectiveness of direct and indirect effects of the vaccine, compared with a historical group that is unvaccinated. Cost-impact analysis (CIA) covers a longer period and considers the whole vaccinated and unvaccinated population in which the vaccine has direct and indirect effects. The success index ratio of CIA over CEA outcomes evaluates the vaccination performance. Good performance has ≤ 1 index value combined with a low CEA. This measure is therefore a valuable aid for new vaccine introductions. It supports the establishment of robust monitoring protocols.

Observational data over 15 years of rotavirus vaccine introduction in Belgium have indicated that rotavirus hospitalisations in children aged <5 years plateaued at a higher level than expected, and was followed by biennial disease peaks. The research objective was to identify factors influencing these real-world vaccine impact data. We constructed mathematical models simulating rotavirus-related hospitalisations by age group and year for those children. Two periods were defined using different model constructs. First, the vaccine uptake period encompassed the years required to cover the whole at-risk population. Second, the post-uptake period covered the years in which a new infection/disease equilibrium was reached. The models were fitted to the observational data using optimisation programmes with regression and differential equations. Modifying parameter values identified factors affecting the pattern of hospitalisations. Results indicated that starting vaccination well before the peak disease season in the first year and rapidly achieving high coverage was critical in maximising early herd effect and minimising secondary sources of infection. This, in turn, would maximise the reduction in hospitalisations and minimise the size and frequency of subsequent disease peaks. The analysis and results identified key elements to consider for countries initiating an optimal rotavirus vaccine launch programme.

Rotavirus infection causes a significant proportion of diarrhea disease burden in children <5 years of age in Asia and the Pacific regions. The World Health Organization recommends that rotavirus v...

Robust scientific evidence related to two rotavirus (RV) vaccines available worldwide demonstrates their significant impact on RV disease burden. Improving RV vaccination coverage may result in better RV disease control. To make RV vaccination accessible to all eligible children worldwide and improve vaccine effectiveness in high-mortality settings, research into new RV vaccines continues. Although current and in-development RV vaccines differ in vaccine design, their common goal is the reduction of RV disease risk in children <5 years old for whom disease burden is the most significant. Given the range of RV vaccines available, informed decision-making is essential regarding the choice of vaccine for immunization. This review aims to describe the landscape of current and new RV vaccines, providing context for the assessment of their similarities and differences. As data for new vaccines are limited, future investigations will be required to evaluate their performance/added value in a real-world setting. The disease What is new? We reviewed the current, recently launched and soon-to-be-launched rotavirus vaccines and found that: What is the impact?

Rotavirus (RV) disease remains a prominent cause of disease burden in children <5 years of age worldwide. However, implementation of RV vaccination has led to significant reductions in RV mortality...

Rotavirus (RV) is one of the leading causes of severe childhood gastroenteritis in children <5 years of age. Several countries have successfully implemented vaccination against RV disease; however, hesitancy to include RV vaccination in the national immunization program exists and relates, among other reasons, to the results of international post-licensure studies of RV vaccines that established an increased risk of intussusception (IS) in infants following immunization. IS is one of the major causes of bowel obstruction in infants between 4 and 10 months of age. Some studies have investigated the etiology of IS, including the role of natural RV infection and available evidence suggests that RV disease may be an independent risk factor for IS. In this regard, the benefit-risk profile of RV vaccination, which is recognized as positive, could potentially turn out to be even more favorable in preventing IS cases triggered by RV disease. However, further research is prompted to quantify the IS risk attributable to RV disease.

This study is aimed to review the published evidence on safety, immunogenicity, and efficacy of rotavirus vaccines when co-administered with meningococcal vaccines in infants. A systematic literature search was performed in four databases containing peer-reviewed articles and conference abstracts. In total, twelve articles were included in the review; 11 provided information on safety and five on the immunogenicity of rotavirus vaccines following co-administration. No paper was found on efficacy. Additional routine vaccines were administered in all studies. The safety analysis was mainly focused on fever, vomiting, diarrhea, intussusception, and changes in eating habits. Overall, safety profiles and immune responses associated with rotavirus vaccination were comparable between infants co-administered with rotavirus and meningococcal vaccines and infants receiving rotavirus vaccines without meningococcal vaccines. Although data are limited, co-administration of rotavirus and meningococcal vaccines does not appear to interfere with the safety or immunogenicity of rotavirus vaccines.