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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 : 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.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. Methods To 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. Results With 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. Conclusions These findings contribute to a better assessment of the rotavirus vaccine benefit-risk balance.
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Submitted on : Friday, January 29, 2021 - 4:17:05 PM
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Sylvie Escolano, Judith E. Mueller, Pascale Tubert-Bitter. Accounting for indirect protection in the benefit–risk ratio estimation of rotavirus vaccination in children under the age of 5 years, France, 2018. Eurosurveillance, European Centre for Disease Prevention and Control, 2020, 25 (33), ⟨10.2807/1560-7917.ES.2020.25.33.1900538⟩. ⟨hal-02921347⟩

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