1887
Research article Open Access
Like 0

Abstract

Introduction

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. We compare the number of prevented hospitalisations for RVGE to the number of vaccine-induced hospitalised intussusceptions in France. 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. The benefit–risk ratio in France is similar to that of other European countries.

Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2017.22.50.17-00041
2017-12-14
2024-12-22
/content/10.2807/1560-7917.ES.2017.22.50.17-00041
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/22/50/eurosurv-22-50-5.html?itemId=/content/10.2807/1560-7917.ES.2017.22.50.17-00041&mimeType=html&fmt=ahah

References

  1. Tate JE, Burton AH, Boschi-Pinto C, Steele AD, Duque J, Parashar UDWHO-coordinated Global Rotavirus Surveillance Network. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12(2):136-41.  https://doi.org/10.1016/S1473-3099(11)70253-5  PMID: 22030330 
  2. Patel MM, Steele D, Gentsch JR, Wecker J, Glass RI, Parashar UD. Real-world impact of rotavirus vaccination. Pediatr Infect Dis J. 2011;30(1) Suppl;S1-5.  https://doi.org/10.1097/INF.0b013e3181fefa1f  PMID: 21183833 
  3. Patel MM, López-Collada VR, Bulhões MM, De Oliveira LH, Bautista Márquez A, Flannery B, et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N Engl J Med. 2011;364(24):2283-92.  https://doi.org/10.1056/NEJMoa1012952  PMID: 21675888 
  4. Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, Platt R, et al. Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med. 2014;370(6):503-12.  https://doi.org/10.1056/NEJMoa1303164  PMID: 24422676 
  5. Tate JE, Yen C, Steiner CA, Cortese MM, Parashar UD. Intussusception Rates Before and After the Introduction of Rotavirus Vaccine. Pediatrics. 2016;138(3):e20161082.  https://doi.org/10.1542/peds.2016-1082  PMID: 27558938 
  6. Velázquez FR, Colindres RE, Grajales C, Hernández MT, Mercadillo MG, Torres FJ, et al. Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico. Pediatr Infect Dis J. 2012;31(7):736-44.  https://doi.org/10.1097/INF.0b013e318253add3  PMID: 22695189 
  7. Haber P, Patel M, Pan Y, Baggs J, Haber M, Museru O, et al. Intussusception after rotavirus vaccines reported to US VAERS, 2006-2012. Pediatrics. 2013;131(6):1042-9.  https://doi.org/10.1542/peds.2012-2554  PMID: 23669521 
  8. Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014;370(6):513-9.  https://doi.org/10.1056/NEJMoa1311738  PMID: 24422678 
  9. Carlin JB, Macartney KK, Lee KJ, Quinn HE, Buttery J, Lopert R, et al. Intussusception risk and disease prevention associated with rotavirus vaccines in Australia’s National Immunization Program. Clin Infect Dis. 2013;57(10):1427-34.  https://doi.org/10.1093/cid/cit520  PMID: 23964090 
  10. Clark A, Jit M, Andrews N, Atchison C, Edmunds WJ, Sanderson C. Evaluating the potential risks and benefits of infant rotavirus vaccination in England. Vaccine. 2014;32(29):3604-10.  https://doi.org/10.1016/j.vaccine.2014.04.082  PMID: 24814524 
  11. Ledent E, Lieftucht A, Buyse H, Sugiyama K, Mckenna M, Holl K. Post-Marketing Benefit-Risk Assessment of Rotavirus Vaccination in Japan: A Simulation and Modelling Analysis. Drug Saf. 2016;39(3):219-30.  https://doi.org/10.1007/s40264-015-0376-7  PMID: 26748506 
  12. Patel MM, Clark AD, Sanderson CFB, Tate J, Parashar UD. Removing the age restrictions for rotavirus vaccination: a benefit-risk modeling analysis. PLoS Med. 2012;9(10):e1001330.  https://doi.org/10.1371/journal.pmed.1001330  PMID: 23109915 
  13. World Health Organization (WHO). Weekly Epidemiological Record (WER): 1 February 2013, vol. 88, 5 (pp. 49–64). Geneva: WHO. [Accessed 25 Jan 2017]. Available from http://www.who.int/wer/2013/wer8805/en/
  14. World Health Organization (WHO). Estimated rotavirus deaths for children under 5 years of age: 2013, 215 000. [Accessed 25 Jan 2016]. Available from http://www.who.int/immunization/monitoring_surveillance/burden/estimates/rotavirus/en/
  15. Desai R, Parashar UD, Lopman B, de Oliveira LH, Clark AD, Sanderson CFB, et al. Potential intussusception risk versus health benefits from rotavirus vaccination in Latin America. Clin Infect Dis. 2012;54(10):1397-405.  https://doi.org/10.1093/cid/cis191  PMID: 22431803 
  16. Desai R, Cortese MM, Meltzer MI, Shankar M, Tate JE, Yen C, et al. Potential intussusception risk versus benefits of rotavirus vaccination in the United States. Pediatr Infect Dis J. 2013;32(1):1-7.  https://doi.org/10.1097/INF.0b013e318270362c  PMID: 22929172 
  17. Karafillakis E, Hassounah S, Atchison C. Effectiveness and impact of rotavirus vaccines in Europe, 2006-2014. Vaccine. 2015;33(18):2097-107.  https://doi.org/10.1016/j.vaccine.2015.03.016  PMID: 25795258 
  18. Sabbe M, Berger N, Blommaert A, Ogunjimi B, Grammens T, Callens M, et al. Sustained low rotavirus activity and hospitalisation rates in the post-vaccination era in Belgium, 2007 to 2014. Euro Surveill. 2016;21(27):30273.  https://doi.org/10.2807/1560-7917.ES.2016.21.27.30273  PMID: 27418466 
  19. Vesikari T, Uhari M, Renko M, Hemming M, Salminen M, Torcel-Pagnon L, et al. Impact and effectiveness of RotaTeq® vaccine based on 3 years of surveillance following introduction of a rotavirus immunization program in Finland. Pediatr Infect Dis J. 2013;32(12):1365-73.  https://doi.org/10.1097/INF.0000000000000086  PMID: 24051998 
  20. Marlow R, Muir P, Vipond B, Lyttle M, Trotter C, Finn A. Assessing the impacts of the first year of rotavirus vaccination in the United Kingdom. Euro Surveill. 2015;20(48):30077.  https://doi.org/10.2807/1560-7917.ES.2015.20.48.30077  PMID: 26675375 
  21. Haut Conseil de Santé Publique. Vaccination des nourrissons contre les infections à rotavirus Recommandations. [Vaccination of newborns against rotavirus infections. Recommendations]. Paris: Haut Conseil de Santé Publique; 2013. French. Available from: http://www.hcsp.fr/Explore.cgi/avisrapportsdomaine?clefr=404
  22. Haut Conseil de Santé Publique. Avis relatif à la vaccination des nourrissons vis-à-vis des gastroentérites à rotavirus. [Opinion on vaccination of newborns against rotavirus infections]. Paris: Haut Conseil de Santé Publique; 21 Apr 2015. French. Available from: http://www.hcsp.fr/Explore.cgi/avisrapportsdomaine?clefr=501
  23. World Health Organization (WHO). Global Vaccine Safety: Statement on risks and benefits of rotavirus vaccines Rotarix and RotaTeq. Geneva: WHO. [Accessed 20 Dec 2016]. Available from: http://who.int/vaccine_safety/committee/topics/rotavirus/rotarix_and_rotateq/statement_May_2015/en/
  24. Larson HJ, de Figueiredo A, Xiahong Z, Schulz WS, Verger P, Johnston IG, et al. The State of Vaccine Confidence 2016: Global Insights Through a 67-Country Survey. EBioMedicine. 2016;12:295-301.  https://doi.org/10.1016/j.ebiom.2016.08.042  PMID: 27658738 
  25. INSEE. Bilan démographique 2015. [2015 Population report]. Paris: INSEE. [Accessed 25 Jan 2017]. French. Available from: https://www.insee.fr/fr/statistiques/1912926
  26. Tuppin P, de Roquefeuil L, Weill A, Ricordeau P, Merlière Y. French national health insurance information system and the permanent beneficiaries sample. Rev Epidemiol Sante Publique. 2010;58(4):286-90.  https://doi.org/10.1016/j.respe.2010.04.005  PMID: 20598822 
  27. Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23-33.  https://doi.org/10.1056/NEJMoa052664  PMID: 16394299 
  28. Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007;370(9601):1757-63.  https://doi.org/10.1016/S0140-6736(07)61744-9  PMID: 18037080 
  29. Jit M, Bilcke J, Mangen M-JJ, Salo H, Melliez H, Edmunds WJ, et al. The cost-effectiveness of rotavirus vaccination: Comparative analyses for five European countries and transferability in Europe. Vaccine. 2009;27(44):6121-8.  https://doi.org/10.1016/j.vaccine.2009.08.030  PMID: 19715781 
  30. Kamdem AF, Vidal C, Pazart L, Leroux F, Savet C, Cornet C, et al. Epidémiologie de l’invagination intestinale aigüe chez l’enfant de moins de 1 an. Résultats préliminaires de l’étude Epistudy. [Epidemiology of acute intussusception in infants under the age of twelve months. Preliminary results of the Epistudy trial]. Saint Maurice: Sante Publique France. [Accessed 11 Dec 2017]. French. Available from: http://invs.santepubliquefrance.fr/Publications-et-outils/BEH-Bulletin-epidemiologique-hebdomadaire/Archives/2012/BEH-n-10-11-2012/Version-francaise/Epidemiologie-de-l-invagination-intestinale-aigue-chez-l-enfant-de-moins-de-1-an.-Resultats-preliminaires-de-l-etude-Epistudy
  31. INSEE. Naissances et décès domiciliés, 2007-2016. [2007-2016 Births and deaths]. Paris: INSEE. [Accessed 29 Nov 2017]. French. Available from https://www.insee.fr/fr/statistiques/3135214?geo=FE-1#tableau-RFD_G1
  32. Jiang J, Jiang B, Parashar U, Nguyen T, Bines J, Patel MM. Childhood intussusception: a literature review. PLoS One. 2013;8(7):e68482.  https://doi.org/10.1371/journal.pone.0068482  PMID: 23894308 
  33. Celtipharm. Le panel temps réel de 3 004 pharmacies, représentatif des 22 458 pharmacies de France métropolitaine. [The panel of 3,004 pharmacies representative of the 22,22458 French pharmacies]. Paris: Celtipharm. [Accessed 25 Jan 2017]. French. Available from: https://www.xpr-so.net/pages/Public/Accueil.aspx
  34. Pivette M. Surveillance des maladies infectieuses à partir des ventes de médicaments en pharmacies [thesis]. [Surveillance of infectious diseases from drug sales in pharmacies]. Paris: Université Paris Descartes; 2015.
  35. Stowe J, Andrews N, Ladhani S, Miller E. The risk of intussusception following monovalent rotavirus vaccination in England: A self-controlled case-series evaluation Ref. No: JVAC-D-16-01124. Vaccine. 2016;34(50):6115.  https://doi.org/10.1016/j.vaccine.2016.10.014  PMID: 27899199 
  36. Atchison CJ, Stowe J, Andrews N, Collins S, Allen DJ, Nawaz S, et al. Rapid Declines in Age Group-Specific Rotavirus Infection and Acute Gastroenteritis Among Vaccinated and Unvaccinated Individuals Within 1 Year of Rotavirus Vaccine Introduction in England and Wales. J Infect Dis. 2016;213(2):243-9.  https://doi.org/10.1093/infdis/jiv398  PMID: 26232438 
/content/10.2807/1560-7917.ES.2017.22.50.17-00041
Loading

Data & Media loading...

Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error