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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 [email protected] .

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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 [email protected]

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.



Rotavirus vaccines provide best protection
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.


Two vaccines licensed for global use
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


Rotavirus vaccines recommended by who

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



Rotavirus vaccine introduction status
Rotavirus vaccine: introduction status NIPs

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


Diarrhea comprehensive approach
Diarrhea: comprehensive approach NIPs

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


Impact reductions in hospitalizations
Impact NIPs: 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


Impact reduction in rotavirus hospitalizations
Impact: NIPsreduction 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.


Impact reduction in rotavirus hospitalizations1
Impact: reduction in rotavirus hospitalizations NIPs

  • 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.


Impact reduction in all causes of diarrhea hospitalizations
Impact: NIPsreduction 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.


Impact reduction in all causes of diarrhea hospitalizations1
Impact: reduction in NIPsall 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.


Impact herd immunity indirect benefits of vaccination
Impact: NIPsherd 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.


Impact herd immunity indirect benefits of vaccination1
Impact: NIPsherd 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.


Rotavirus vaccines: NIPscross-strain protection

  • Rotavirus vaccines provide broad protection against rotavirus–even against strains of the virus not included in the vaccine.

Steele, BMCID, 2012


Real world impact mexico and brazil
Real world impact: Mexico and Brazil NIPs

Hospitalizations for rotavirus and all-cause diarrhea decline

  • 1Richardson V, et al.

  • 3Lanzieri, IJID, 2011

  • 4Carmo, PLOS, 2011


I mpact mexico
I NIPsmpact: 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


Impact bolivia
Impact NIPs: 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


Rotavirus vaccines cost effective
Rotavirus vaccines: cost effective NIPs

Atherly, Vaccine, 2012


C ost effectiveness gavi countries
C NIPsost-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


Rotavirus vaccines cost effective1
Rotavirus vaccines: cost effective NIPs

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.


Rotavirus vaccination benefits outweigh risks
Rotavirus vaccination: benefits outweigh risks NIPs

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


Rotavirus vaccines: benefits outweigh risks NIPsIf 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


Real world observations intussusception risk
Real NIPsworld observations: intussusception risk

Benefits outweigh risk, but surveillance remains essential

Buttery, Vaccine, 2011

Patel, NEJM, 2011

CDC, 2013

FDA, 2013


References
References NIPs

  • 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.


References1
References NIPs

  • 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.


References2
References NIPs

  • 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.


References3
References NIPs

  • 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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