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Accounting for indirect protection in the benefit-risk ratio estimation of rotavirus vaccination in children under the age of 5 years, France, 2018.

ABSTRACT: BackgroundRotavirus is a major cause of severe gastroenteritis in children worldwide. The disease burden has been substantially reduced in countries where rotavirus vaccines are used. Given the risk of vaccine-induced intussusception, the benefit-risk balance of rotavirus vaccination has been assessed in several countries, however mostly without considering indirect protection effects.AimWe performed a benefit-risk analysis of rotavirus vaccination accounting for indirect protection in France among the 2018 population of children under the age of 5 years.MethodsTo incorporate indirect protection effects in the benefit formula, we adopted a pseudo-vaccine approach involving mathematical approximation and used a simulation design to provide uncertainty intervals. We derived background incidence distributions from quasi-exhaustive health claim data. We examined different coverage levels and assumptions regarding the waning effects and intussusception case fatality rate.ResultsWith the current vaccination coverage of < 10%, the indirect effectiveness was estimated at 6.4% (+/-?0.4). For each hospitalisation for intussusception, 288.2 (95% uncertainty interval: (173.8-480.0)) hospitalisations for rotavirus gastroenteritis were prevented. Should 90% of infants be vaccinated, indirect effectiveness would reach 57.9% (+/-?3.7) and the benefit-risk ratio would be 297.6 (95% uncertainty interval: 179.4-497.3). Indirect protection accounted for almost half of the prevented rotavirus gastroenteritis cases across all coverage levels. The balance remained in favour of the vaccine even in a scenario with a high assumption for intussusception case fatality.ConclusionsThese findings contribute to a better assessment of the rotavirus vaccine benefit-risk balance.

SUBMITTER: Escolano S

PROVIDER: S-EPMC7441603 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Accounting for indirect protection in the benefit-risk ratio estimation of rotavirus vaccination in children under the age of 5 years, France, 2018.

Escolano Sylvie S Mueller Judith E JE Tubert-Bitter Pascale P

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 20200801 33

Background Rotavirus is a major cause of severe gastroenteritis in children worldwide. The disease burden has been substantially reduced in countries where rotavirus vaccines are used. Given the risk of vaccine-induced intussusception, the benefit–risk balance of rotavirus vaccination has been assessed in several countries, however mostly without considering indirect protection effects. Aim We performed a benefit–risk analysis of rotavirus vaccination accounting for indirect protection in Franc ...[more]

PMID: 32820718

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Project description:Early observations from countries that have introduced rotavirus vaccination suggest that there may be indirect protection for unvaccinated individuals, but it is unclear whether these benefits will extend to the long term. Transmission dynamic models have attempted to quantify the indirect protection that might be expected from rotavirus vaccination in developed countries, but results have varied. To better understand the magnitude and sources of variability in model projections, we undertook a comparative analysis of transmission dynamic models for rotavirus. We fit five models to reported rotavirus gastroenteritis (RVGE) data from England and Wales, and evaluated outcomes for short- and long-term vaccination effects. All of our models reproduced the important features of rotavirus epidemics in England and Wales. Models predicted that during the initial year after vaccine introduction, incidence of severe RVGE would be reduced 1.8-2.9 times more than expected from the direct effects of the vaccine alone (28-50% at 90% coverage), but over a 5-year period following vaccine introduction severe RVGE would be reduced only by 1.1-1.7 times more than expected from the direct effects (54-90% at 90% coverage). Projections for the long-term reduction of severe RVGE ranged from a 55% reduction at full coverage to elimination with at least 80% coverage. Our models predicted short-term reductions in the incidence of RVGE that exceeded estimates of the direct effects, consistent with observations from the United States and other countries. Some of the models predicted that the short-term indirect benefits may be offset by a partial shifting of the burden of RVGE to older unvaccinated individuals. Nonetheless, even when such a shift occurs, the overall reduction in severe RVGE is considerable. Discrepancies among model predictions reflect uncertainties about age variation in the risk and reporting of RVGE, and the duration of natural and vaccine-induced immunity, highlighting important questions for future research.

Project description:Abstract Background Vaccines may play a role in controlling the spread of antibiotic resistance. However, it is unknown if rotavirus vaccination affects antibiotic use in the United States (US). Methods Using data from the IBM MarketScan Commercial Database, we conducted a retrospective cohort of US children born between 2007 and 2018 who were continuously enrolled for the first 8 months of life (N = 2 136 136). We followed children through 5 years of age and compared children who completed a full rotavirus vaccination series by 8 months of age to children who had not received any doses of rotavirus vaccination. We evaluated antibiotic prescriptions associated with an acute gastroenteritis (AGE) diagnosis and defined the switching of antibiotics as the prescription of a second, different antibiotic within 28 days. Using a stratified Kaplan-Meier approach, we estimated the cumulative incidence for each study group, adjusted for receipt of pneumococcal conjugate vaccine, provider type, and urban/rural status. Results Overall, 0.8% (n = 17 318) of participants received an antibiotic prescription following an AGE diagnosis. The 5-year adjusted relative cumulative incidence of antibiotic prescription following an AGE diagnosis was 0.793 (95% confidence interval [CI], .761–.827) among children with complete rotavirus vaccination compared to children without rotavirus vaccination. Additionally, children with complete vaccination were less likely to switch antibiotics (0.808 [95% CI, .743–.887]). Rotavirus vaccination has averted an estimated 67 045 (95% CI, 53 729–80 664) antibiotic prescriptions nationally among children born between 2007 and 2018. Conclusions These results demonstrate that rotavirus vaccines reduce antibiotic prescribing for AGE, which could help reduce the growth of antibiotic resistance. In this retrospective study of commercially insured children, vaccination against rotavirus appeared to reduce the inappropriate prescribing of antibiotics for acute gastroenteritis and subsequently may contribute to reduced antibiotic resistance among children.

Dataset Information

Accounting for indirect protection in the benefit-risk ratio estimation of rotavirus vaccination in children under the age of 5 years, France, 2018.

Publications

Accounting for indirect protection in the benefit-risk ratio estimation of rotavirus vaccination in children under the age of 5 years, France, 2018.

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