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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.

Aim

We 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, 277.0 (95% uncertainty interval: (165.0–462.1)) 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 192.4 (95% uncertainty interval: 116.4–321.3). At a coverage level of 50%, indirect protection accounted for 27% of the prevented rotavirus gastroenteritis cases. 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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This work is licensed under a Creative Commons Attribution 4.0 International License.
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A corrected article has been published for this content:
Resolved: Expression of concern for Euro Surveill. 2020;25(32)
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A corrected article has been published for this content:
Authors’ correction for Euro Surveill. 2020;25(32)
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2020-08-20
2024-11-24
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2020.25.33.1900538
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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
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Sylvie+Escolano&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Escolano Sylvie</a>, <a href="/search?value1=Judith+E+Mueller&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Mueller Judith E</a>, <a href="/search?value1=Pascale+Tubert-Bitter&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Tubert-Bitter Pascale</a></span>. Accounting for indirect protection in the benefit–risk ratio estimation of rotavirus vaccination in children under the age of 5 years, France, 2018. <a href="/content/ecdc">Euro Surveill.</a> 2020;25(33):pii=1900538. <a href="https://doi.org/10.2807/1560-7917.ES.2020.25.33.1900538" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2020.25.33.1900538</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 23 Aug 2019;&nbsp;&nbsp; <span class="generated">Accepted</span>: 10 Jan 2020 </span> </p>
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