Quantitative Benefit-Risk Models Used for Rotavirus Vaccination: A Systematic Review

Abstract

While rotavirus vaccines have proven to prevent the risk of rotavirus gastroenteritis (RVGE) in children under 5 years old, they are also associated with an increased transient risk of intussusception (IS). Several quantitative benefit-risk models (qBRm) are performed to measure this balance in hospitalisations and deaths prevented versus the ones induced. To provide a complete overview of qBRm used for rotavirus vaccination. For this study, three medical literature databases were systematically searched to identify relevant articles, in English, published between 2006 and 2019. Of the 276 publications screened, 14 studies using qBRm for rotavirus vaccination were retained, based on pre-selected criteria. Four were performed in low-middle-income countries (LMICs). Almost all (13/14) displayed the following characteristics: force of infection assumed to be constant over time (static model), indirect effect of rotavirus vaccination (herd effect) not considered, closed model (individuals not allowed to enter/exit the model over time) and aggregated level (no tracking of individual's behaviour). Most of the models were probabilistic (9/14) and reported sensitivity/scenario analyses (12/14). Input parameter values varied across studies. Selected studies suggest that, depending on the models used; for every IS hospitalisation and death induced, vaccination would prevent, respectively, 190−1,624 and 71−743 RVGE-related hospitalisations and deaths. The benefits of rotavirus vaccination were shown to largely exceed the increased risk of IS, across all studies. Future research aiming to harmonise qBRm for rotavirus vaccination, should ensure the comparability of studies and provide additional information for regulatory authorities, physicians and patients.