A benefit–risk analysis of rotavirus vaccination, France, 2015

Two vaccines available for protection against rotavirus gastroenteritis (RVGE), Rotarix and RotaTeq, have contributed to a large decrease in the incidence of paediatric diarrhoea in countries where they have been used. However, they have also led to a small increase in the risk of intussusception. Methods: We compare the number of prevented hospitalisations for RVGE to the number of vaccine-induced hospitalised intussusceptions in France. Results: With 9.5% coverage (French 2015 estimation), vaccination was estimated to prevent, annually, a median of 1,074 hospitalisations (2.5th and 97.5th percentiles (2.5th–97.5th): 810–1,378) and 1.4 deaths (2.5th–97.5th: 1.2–1.6) from RVGE. It was also estimated to cause, annually, 5.0 hospitalisations (2.5th–97.5th: 3.2–7.7) and 0.005 deaths (2.5th–97.5th: 0.001–0.015) from intussusception. The benefit–risk ratio is therefore 214 (2.5th–97.5th: 128–362) for hospitalisations and 273 (2.5th–97.5th: 89–1,228) for deaths. Under a hypothetical 92% coverage, rotavirus vaccination with Rotarix would avoid 10,459 (2.5th–97.5th: 7,702–13,498) hospitalisations for RVGE and induce 47.0 (2.5th–97.5th: 25.1–81.4) hospitalisations for intussusception annually, thereby preventing 13.7 (2.5th–97.5th: 11.1–15.2) deaths and inducing 0.05 (2.5th–97.5th: 0.01–0.15) deaths. Conclusion: The benefit–risk ratio in France is similar to that of other European countries.