Introduction Understanding the balance between the benefits and risks of vaccination is essential to ensure informed and adequate public health decision making. Quantitative benefit–risk models (qBRm) represent useful tools to help decision makers with supporting benefit–risk assessment throughout the lifecycle of a medical product. However, few initiatives have been launched to harmonise qBRm approaches, specifically for vaccines. Objectives The aim of this paper was to identify publications about qBRm applied to vaccines through a systematic literature review, and to describe their characteristics. Methods Medline, Scopus and Institute for Scientific Information Web of Knowledge databases were searched to identify articles in English, published from database inceptions up to December 2019. The search strategy included the combination of three key concepts: ‘benefit–risk’, ‘modelling’ and ‘vaccines’. Data extracted included the modelling context and the methodological approaches used. Results Of 3172 publications screened, 48 original publications were included. Most of the selected studies were published over the past decade and focused on rotavirus (15), dengue (10) and influenza (6) vaccines. The majority (30) of studies reported analyses related to high-income countries. The methodology of the studies differed, particularly in modelling techniques, benefit–risk measures, and sensitivity analyses. The present work also pointed out a high level of variability in the quality of reporting across studies, with particular regard to input parameters and methodological approaches. Conclusions This review provides an extensive list of qBRm applied to vaccines. Discrepancies across studies were identified during our review. While the number of published qBRm studies is increasing, no reporting guidance for qBRm applied to vaccines is currently available. This may affect decision makers’ confidence in the results and their benefit–risk assessment(s); therefore, the development of such reporting guidance is highly needed. Electronic supplementary material The online version of this article (10.1007/s40264-020-00984-7) contains supplementary material, which is available to authorized users.
IntroductionTwo vaccines against rotavirus gastroenteritis (RVGE) in young children, Rotarix and RotaTeq, have been available in Europe since 2006. Vaccination against rotaviruses significantly reduces the burden of RVGE, but it is also associated with a very small increased risk of intussusception. In a benefit–risk analysis, the prevented RVGE burden is weighed against the possible excess of intussusception.PurposeThe aim was to compare the estimated benefits and risks of Rotarix vaccination in France.MethodsWe estimated the benefits (vaccine-preventable RVGE hospitalizations and deaths) and risks (vaccine-caused intussusception hospitalizations and deaths) following two doses of Rotarix in a birth cohort of 791,183 followed for 3–5 years in France. We used data from peer-reviewed clinical and epidemiological studies or publications, and government statistics.ResultsWithin the total number of French children below 5 years of age, we estimate vaccination could prevent a median 11,132 [95% credible interval (CI) 7842–14,408] RVGE hospitalizations and 7.43 (95% CI 3.27–14.68) RVGE deaths. At the same time, vaccination could cause an average of 6.86 (95% CI 2.25–38.37) intussusception hospitalizations and 0.0099 (95% CI 0.0024–0.060) intussusception deaths in the entire French birth cohort of infants below 1 year of age. Therefore, for every intussusception hospitalization and every intussusception death caused by vaccination, 1624 (95% CI 240–5243) RVGE hospitalizations and 743 (95% CI 93–3723) RVGE deaths are prevented, respectively, by vaccination.ConclusionsThe vaccine-prevented RVGE hospitalizations and deaths (benefit) greatly outweigh the excess potentially vaccination-related cases of intussusception (risk), indicating a favorable benefit–risk balance for Rotarix in France.Electronic supplementary materialThe online version of this article (10.1007/s40259-018-0273-6) contains supplementary material, which is available to authorized users.
Background Although 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 hospitalizations and deaths prevented versus the ones induced. Method In this study, our objective was to provide a complete overview of qBRm used for rotavirus vaccination. We systematically searched 3 medical literature databases to identify relevant articles, in English, that were published between 2006 and 2019. Results Of the 276 publications screened, 14 studies using qBRm for rotavirus vaccination were retained, based on preselected criteria. Four were performed in low- and middle-income countries. Almost all (13 of 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 and/or exit the model over time), and aggregated level (no tracking of individual’s behavior). Most of the models were probabilistic (9 of 14) and reported sensitivity and/or scenario analyses (12 of 14). Input parameter values varied across studies. Selected studies suggest that, depending on the models used, for every IS hospitalization and death induced, vaccination would prevent, respectively, 190–1624 and 71–743 RVGE-related hospitalizations and deaths. Conclusions The benefits of rotavirus vaccination were shown to largely exceed the increased risk of IS, across all studies. Future research aiming to harmonize qBRm for rotavirus vaccination should ensure the comparability of studies and provide additional information for regulatory authorities, physicians, and patients.
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