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Rotavirus: advocacy slides

Rotavirus: advocacy slides. These slides are intended to support your advocacy efforts. Please incorporate those that may be useful to you in your presentations. For questions, please contact jen.farber@gmmb.com .

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Rotavirus: advocacy slides

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  1. Rotavirus: advocacy slides These slides are intended to support your advocacy efforts. Please incorporate those that may be useful to you in your presentations. For questions, please contact jen.farber@gmmb.com. Special thanks to the ROTA Council’s Partners: Johns Hopkins University, PATH, US Centers for Disease Control and Prevention and Bill & Melinda Gates Foundation for their technical guidance and expertise in developing these slides.

  2. Rotavirus Vaccines

  3. Rotavirus vaccines: provide best protection • A comprehensive approach to fighting diarrhea,including rotavirus vaccines and other proven preventions and treatments,can significantly reduce child illnesses and deaths.

  4. Two vaccines licensed for global use Shown to be safe and effective in large-scale clinical studies and real-world use 1Soares-Weiser, Cochrane Review, 2012 2Buttery, PID, 2011 3Patel, NEJM, 20114Shui, JAMA, 2012 5Cortese, PID, 2010 6Haber, Pediatrics, 2008 10Armah, Lancet, 2010 11Zaman, Lancet, 2010 13Mahdi and Cunliffe, NEJM, 2010 7Vesikari, NEJM, 2006 8Ruiz-Palacios, NEJM, 2006 9Vesikari, Lancet, 2007

  5. 5 Rotavirus vaccines: recommended by WHO • WHO recommends rotavirus vaccines in all national immunization programs (NIPs), particularly in south and south-eastern Asia and sub-Saharan Africa • Should be part of a comprehensive approach to control diarrhea • Vaccination age restriction may be relaxed in countries where delays in immunizations and deaths from rotavirus are common But only 47 countries have introduced rotavirus vaccines into their NIPs • WHO. Rotavirus vaccines: WHO position paper – January 2013 • NIP status as of August 2013

  6. 47 countries have introduced rotavirus vaccines into their NIPs

  7. Rotavirus vaccine: introduction status 47 countries have introduced rotavirus vaccines into their national immunization programs as of August 2013 • *Canada, Thailand, United Arab Emirates, Zambia have introduced regionally WHO, 2013

  8. Diarrhea: comprehensive approach Rotavirus vaccines are key to a comprehensive approach to fighting diarrheal disease • Prevent • Rotavirus vaccines • Improved drinking water, hygiene, sanitation • Treat • Rehydration therapy (oral rehydration solution [ORS], home available or IV fluids) • Zinc supplementation • Protect • Exclusive Breastfeeding • Appropriate complementary feeding

  9. Impact: reductions in hospitalizations Major reductions in hospitalizations for children under 5 observed within 2 years of rotavirus vaccine introduction • Hospital admissions for rotavirus reduced by half or more (49-89%) • Significant declines (17- 55%) in hospitalizations for all causes of diarrhea • Patel, Lancet, 2012

  10. Impact: reduction in rotavirus hospitalizations Hospitalizations: documented reductions of 50% or more Note: table derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious Diseases. 2012;12(7):561-570. Patel, British Medical Journal, 2013.

  11. Impact: reduction in rotavirus hospitalizations • Hospitalizations: documented reductions of 50% or more in children 0-2 years old following rotavirus vaccination Note: data derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious Diseases. 2012;12(7):561-570.

  12. Impact: reduction in all causes of diarrhea hospitalizations Hospitalizations: documented reductions of nearly 20% or more Note: table derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, ParasharUD. Fulfilling the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious Diseases. 2012;12(7):561-570.

  13. Impact: reduction in all causes of diarrhea hospitalizations • Hospitalizations: documented reductions of nearly 20% or more in children 0-2 years old following rotavirus vaccination Note: data derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious Diseases. 2012;12(7):561-570. Patel, British Medical Journal, 2013.

  14. Impact: herd immunity/indirect benefits of vaccination Significant reductions in hospitalization observed for non-vaccinated children Note: table derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, ParasharUD. Fulfilling the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious Diseases. 2012;12(7):561-570.

  15. Impact: herd immunity/indirect benefits of vaccination • Hospitalizations: documented reductions of more than 50% in children eligible for vaccination • Hospitalizations: documented reductions of more than 20% in children NOT eligible for vaccination Note: data derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious Diseases. 2012;12(7):561-570.

  16. Rotavirus vaccines: cross-strain protection • Rotavirus vaccines provide broad protection against rotavirus–even against strains of the virus not included in the vaccine. Steele, BMCID, 2012

  17. Real world impact: Mexico and Brazil Hospitalizations for rotavirus and all-cause diarrhea decline • 1Richardson V, et al. • 3Lanzieri, IJID, 2011 • 4Carmo, PLOS, 2011

  18. Impact: Mexico • 1Gastañaduy, Pediatrics, 2013 • 2Richardson, NEJM, 2010 • Reduction in deaths of more than 50% realized and sustained (2009-2011) across all regions1 • Reduction in deaths of 35%seen in just the first year.2

  19. Impact: Bolivia • Bolivia, first high-mortality country to introduce Rotarix® in 2008, with GAVI support • Study found vaccinated children 70% less likely to be hospitalized for rotavirus compared to unvaccinated children • Protection sustained through first 2 years of a child’s life, when risk of infection is greatest • Vaccination protected against wide variety of rotavirus strains, including those not found in the vaccine • Findings applicable to many other GAVI-eligible countries in Africa and Asia, especially those using Rotarix BMJ, 2013

  20. Rotavirus vaccines: cost effective Atherly, Vaccine, 2012

  21. Cost-effectiveness: GAVI countries Cost per DALY averted, 2011-2030 Compared to GDP per capita(Very cost effective when cost per DALY averted < 1x GDP) Slide from Debbie Atherly Source: GAVI Investment Case

  22. Rotavirus vaccines: cost effective Cost effectiveness is about more than the price of the vaccine. We must also consider: • Hospitalizations • Loss of income/productivity when taking care of a sick child • Child suffering Patel, Santosham, & Tate, Medscape, 2012.

  23. Rotavirus vaccination: benefits outweigh risks Benefits of rotavirus vaccination are substantial and include prevention of hospitalization and death Benefits far outweigh possible low-level risk of intussusception associated with the vaccine

  24. Rotavirus vaccines: benefits outweigh risksIf introduced into all national immunization programs at the same coverage levels of other routine vaccines administered by 15 weeks of age Benefit: 156,000 deaths related to rotavirus averted Risk: 288 potential deaths from vaccine-associated intussusception,an intestinal obstruction WHO, 2012

  25. Real world observations: intussusception risk Benefits outweigh risk, but surveillance remains essential Buttery, Vaccine, 2011 Patel, NEJM, 2011 CDC, 2013 FDA, 2013

  26. References • Ansari SA, SpringthorpeVS, Sattar SA. Survival and vehicular spread of human rotaviruses: possible relation to seasonality of outbreaks. Reviews of infectious diseases. 1991; 13(3): 448-61. • Atherly D, Lewis K, Tate J et al. Projected health and economic impact of rotavirus vaccination in GAVI-eligible • countries: 2011–2030. Vaccine. 30S (2012) A7– A14. • ArmahG, Sow S, Breiman R, et al. Efficacy of pentavalent human-bovine reassortant rotavirus vaccine against severe rotavirus gastroenteritis in sub-Saharan Africa: a randomized, double-blind, placebo-controlled trial. The Lancet. 2010;376(9741):606-614. • Buttery JP, Lambert SB, Grimwood K, et al. Reduction in rotavirus-associated acute gastroenteritis following introduction of rotavirus vaccine into Australia’s National Childhood vaccine schedule. Pediatric Infectious Disease Journal. 2011;30(suppl 1):S25–S29. • Buttery JP, Danchin MH, Lee KJ, Carlin JB, McIntyre PB, Elliott EJ, et al. Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia. Vaccine. 2011;29(16):3061-3066. • CDC. Rotavirus vaccines and intussusception in the Vaccien Safety Datalink (VSD). http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-jun-2013/02-Rotavirus-Weintraub.pdf. Published 2013. Accessed 29 July 2013. • CorteseMM, Tate JE, Simonsen L, Edelman L, Parashar UD. Reduction in gastroenteritis in United States children and correlation with early rotavirus vaccine uptake from national medical claims databases. Pediatric Infectious Disease Journal. 2010;29:489–494.

  27. References • do Carmo GM, Yen C, Cortes J, Siqueira AA, de Oliveira WK, Cortez-Escalante JJ, et al. Decline in diarrhea mortality and admissions after routine childhood rotavirus immunization in Brazil: a time-series analysis. PLoS Medicine. 2011;8(4):e1001024. • FDA. Risk of intussusception after rotavirus vaccination: results of a PRISM study. http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-jun-2013/04-Rotavirus-Yih.pdf. Published 2013. Accessed 29 July 2013. • Haber P, Patel M, Izurieta HS, Baggs J, Gargiullo P, Weintraub E, Cortese M, Braun MM, Belongia EA, Miller E, Ball R, Iskander J, Parashar UD. Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics; 2008:121(6):1206-12. • Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, et al. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013. • Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012; 379(9832): 2151-61. • Madhi S, Cunliffe N, Steele D et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. The New England Journal of Medicine. 2010;362(4):289-298. • Parashar U, Hummelman E, Bresee J, et al.Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases. 2003 May; 9(5):565–572.

  28. References • ParasharUD, Gibson CJ, Bresse JS, et al. Rotavirus and severe childhood diarrhea. Emerging Infectious Diseases. 2006;12:304–306. • Patel MM, Glass R, Desai R, Tate J, ParasharUD. Fulfilling the promise of rotavirus vaccines: how far have we come since licensure? Lancet Infect Dis 2012; 12; 561-70 • Patel M, Richardson V, et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. The New England Journal of Medicine. 2011;364(24):2283- 2292. • Patel MM, Patzi M, Pastor D, Nina A, Roca Y, Alvarez L, et al. Effectiveness of monovalent rotavirus vaccine in Bolivia: case-control study. BMJ. 2013;346:f3726 • Patel MM, Santosham M, Tate, J. Preventing Rotavirus Disease in the Developing World: Issues, Opportunities, and Challenges. Medscape, December 2012. http://www.medscape.org/viewarticle/776009 • Richardson V, Hernandez-Pichardo J, Quintanar-Solares M, et al. Effect of rotavirus vaccination on death from childhood diarrhea in Mexico. The New England Journal of Medicine. 2010;362(4):299–305. • RheingansRD, Antil L, Dreibelbis R, et al. Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries. JID 2009;200 (Supplement 1):S16–S27. • Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006; 354(1): 11-22. • Santosham M, Chandran A, Fitzwater S, et al. Progress and barriers for the control of diarrhoeal disease. The Lancet. 2010; 376: 63–67. • ShuiIM, Baggs J, Patel M, ParasharUD, Rett M, BelongiaEA, HambidgeSJ, GlanzJM, Klein NP, Weintraub E. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants. JAMA; 2012: 307(6):598-604.

  29. References • Soares-Weiser K, Maclehose H, Bergman H, Ben-Aharon I, Nagpal S, Goldberg E, Pitan F, Cunliffe N. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev.; 2012:11:CD008521. • Steele AD, Neuzil KM, Cunliffe NA, Madhi SA, Bos P, Ngwira B, et al. Human rotavirus vaccine Rotarix provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial. BMC Infect Dis. 2012; 12: 213. • Tate JE, Burton AH, Boschi-Pinto C, Steele D, et al. 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. The Lancet. Published online October 25, 2011. • VesikariT, 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. • WHO. Diarrhoeal disease. 2009 [cited 2011 September 28]; Available from: http://www.who.int/mediacentre/factsheets/fs330/en/index.html • WHO. Meeting of the immunization Strategic Advisory Group of Experts, April 2009 – conclusions and recommendations. Weekly Epidemiological Record. 2009; 84(23):232-236. • WHO. Rotavirus vaccines: WHO position paper – January 2013. WklyEpidemiol Rec. 2009; 88(50): 49-64. • WHO: Rotavirus vaccine update 2012. Available from: http://www.sabin.org/sites/sabin.org/files/Fatima%20Serhan.pdf • WHO. Estimated rotavirus deaths for children under 5 years of age. Available from: http://www.who.int/immunization_monitoring/burden/rotavirus_estimates/en/ • ZamanK, Dang DA, Victor J, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. The Lancet. 2010;376(9741):615-623.

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