Rotavirus: advocacy slides
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Rotavirus: advocacy slidesThese 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.
Rotavirus Vaccines
Rotavirus vaccines: provide best protection
benefits
saves lives
improves health
cost effective
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 useRotaTeq (Merck) Rotarix (GSK)
Formulation Pentavalent, bovine-human reassortant
Monovalent, human
Orally administered, doses 3 2Safety: clinical trials (intussusception risk)
No difference1 No difference1
Safety: post-introduction(intussusception risk)
Low-level risk in some countries, not others2,4,5,6
Low-level risk in some countries, not others2,3
Efficacy: against severe rotavirus diarrhea in children < 1 (developed countries)
98%7 85%-96%8,9
Efficacy: against severe rotavirus diarrhea in children < 1(developing countries)
51%-64%10,11 59%13
1Soares-Weiser, Cochrane Review, 20122Buttery, PID, 20113Patel, NEJM, 20114Shui, JAMA, 20125Cortese, PID, 20106Haber, Pediatrics, 2008
Shown to be safe and effective in large-scale clinical studies and real-world use
7Vesikari, NEJM, 20068Ruiz-Palacios, NEJM, 20069Vesikari, Lancet, 2007
10Armah, Lancet, 201011Zaman, Lancet, 201013Mahdi and Cunliffe, NEJM, 2010
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
WHO. Rotavirus vaccines: WHO position paper – January 2013NIP status as of August 2013
But only 47
countries have
introduced
rotavirus vaccines
into their NIPs
5
47 countries have introduced rotavirus vaccines into their NIPs
Rotavirus vaccine: introduction status47 countries have introduced rotavirus vaccines into their
national immunization programs as of August 2013
WHO, 2013
Africa Botswana, Ghana, Malawi, Rwanda, South Africa, Tanzania, The Gambia
Americas Bolivia, Brazil, Cayman Islands, Colombia, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, USA, Venezuela
Eastern Mediterranean
Bahrain, Iraq, Morocco, Qatar, Saudi Arabia, Sudan, Yemen
Europe Armenia, Austria, Belgium, Finland, Georgia, Israel, Luxembourg, Moldova, United Kingdom
Southeast Asia Philippines
Western Pacific Australia, Fiji, Marshall Islands, Micronesia, Palau
*Canada, Thailand, United Arab Emirates, Zambia have introduced regionally
Diarrhea: comprehensive approachRotavirus vaccines are key to a comprehensive approach to fighting diarrheal disease
Protect• Exclusive
Breastfeeding• Appropriate
complementary feeding
Treat• Rehydration therapy
(oral rehydration solution [ORS], home available or IV fluids)
• Zinc supplementation
Prevent• Rotavirus vaccines• Improved drinking
water, hygiene, sanitation
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
Impact: reductions in hospitalizations
Patel, Lancet, 2012
Impact: reduction in rotavirus hospitalizations
Country (Nationwide)
Vaccine Used Age Group Eligible to Receive Vaccine
Yearly Reductions in Hospitalizations(Across Studies and Age Groups)
Australia RotaTeq & Rotarix 0-1 years old 87%
Austria RotaTeq & Rotarix 0-2 years old 74-79%
Belgium RotaTeq & Rotarix 0-2 years old 50-77%
Bolivia Rotarix 0-1 years old ~70%US RotaTeq 0-2 years old 66-86%
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.
Hospitalizations: documented reductions of 50% or more
Impact: reduction in rotavirus hospitalizations
Belgium50-77%
RotaTeq & Rotarix
US66-86%RotaTeq
Bolivia70%
RotarixAustria 74-79%RotaTeq & Rotarix
Australia87%
RotaTeq & Rotarix
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.
Hospitalizations: documented reductions of 50% or more in children 0-2 years old following rotavirus vaccination
Impact: reduction in all causes of diarrhea hospitalizations
Country (Nationwide)
Vaccine Used Age Group Eligible to Receive Vaccine
Yearly Reductions in Hospitalizations(Across Studies and Age Groups)
Mexico Rotarix 0-2 years old 40%
Belgium RotaTeq & Rotarix 0-2 years old 33%
USA RotaTeq 0-2 years old 29-52%
El Salvador Rotarix 0-2 years old 28-37%
Brazil Rotarix 0-2 years old 17-48%
Hospitalizations: documented reductions of nearly 20% 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.
Impact: reduction in all causes of diarrhea hospitalizations
Brazil17-48%
Rotarix
El Salvador28-37%RotarixUSA
29-52%RotaTeq Belgium
33% RotaTeq & Rotarix
Mexico40%
Rotarix
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.
Hospitalizations: documented reductions of nearly 20% or more in children 0-2 years old following rotavirus vaccination
Impact: herd immunity/indirect benefits of vaccination
Rotavirus related hospitalizations reduced
Country (nationwide)
Children age-eligible for vaccine
Children NOT age-eligible for vaccine
El Salvador 79-86% 41-81%
Austria 76-79% 35%
USA 74-85% 41-80%
Belgium 65-80% 20-64%
Country (regional)
Sao Paulo, Brazil 56-69% 24%
Queensland, Australia 50-70% 30-70%
Significant reductions in hospitalization observed for non-vaccinated children
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.
Impact: herd immunity/indirect benefits of vaccination
Belgium65-80%
USA74-85%
Austria 76-79%
El Salvador79-86%
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.
Belgium20-64%
USA41-80%
Austria 35%
El Salvador41-81%
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
Rotavirus vaccines: cross-strain protectionRotavirus vaccines provide broad protection against rotavirus–even against strains of the
virus not included in the vaccine.
Rotarix Efficacy Against Vaccine and Non-Vaccine Type Rotavirus
Vaccine Type Efficacy Non-Vaccine Type Efficacy
G1 64.1% G12 55.5%
G8 64.6%
P8 59.1% P[4] 70.9%
P[6] 55.2%
Steele, BMCID, 2012
Real world impact: Mexico and Brazil
1Richardson V, et al.3Lanzieri, IJID, 20114Carmo, PLOS, 2011
Post-introduction impact in Mexico and Brazil comparable to phase 3 clinical trial efficacy data
Mexico• Widespread introduction in 2007
• In 2008, diarrhea deaths declined by 35%1
• In 2009, diarrhea deaths declined by more than 65%
Brazil• Widespread introduction in 2006
• In 2007, diarrhea deaths declined by 30%3
• In 2008, diarrhea deaths declined by 39%3
• Sustained reduction of 22% over 3 years (2007-2009)4
Hospitalizations for rotavirus and all-cause diarrhea decline
Impact: Mexico
1Gastañaduy, Pediatrics, 20132Richardson, 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 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
Atherly, Vaccine, 2012
If used in all GAVI-eligible countries, rotavirus vaccines
could…
Prevent an estimated 180,000 deaths
annually
Avert 6 million clinic and hospital visits
annually
Save US $68 million annually
Cost-effectiveness: GAVI countries
Slide from Debbie Atherly Source: GAVI Investment Case
Cost per DALY averted, 2011-2030 Compared to GDP per capita
(Very cost effective when cost per DALY averted < 1x GDP)
Rotavirus vaccines: cost effectiveCost 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
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 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
WHO, 2012
Risk: 288 potential deaths from vaccine-associated intussusception,an intestinal obstruction
Real world observations: intussusception risk
Post-licensure StudiesAustralia• Low-level risk• 5-6 excess cases of
intussusception/100,000 children vaccinated
Mexico• Low-level risk• 1st dose: 2 excess cases of
intussusception/100,000 children vaccinated
• 2nd dose: no excess risk observed so far
Brazil • Low-level risk• 1st dose: no excess risk
observed so far• 2nd dose: 1-2 excess cases
of intussusception/ 100,000 children vaccinated
US• Low-level risk• 1-5 excess cases of
intussusception/100,000 children vaccinated
Buttery, Vaccine, 2011Patel, NEJM, 2011CDC, 2013FDA, 2013
Benefits outweigh risk, but surveillance remains essential
References • Ansari SA, Springthorpe VS, 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.• Armah G, 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.
• Cortese MM, 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.
• 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.
References
References • Parashar UD, 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, Parashar UD. 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.• Rheingans RD, 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.• Shui IM, Baggs J, Patel M, Parashar UD, Rett M, Belongia EA, Hambidge SJ, Glanz JM, Klein NP, Weintraub E. Risk of
intussusception following administration of a pentavalent rotavirus vaccine in US infants. JAMA; 2012: 307(6):598-604.
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.
• 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.
• 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. Wkly Epidemiol 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/• Zaman K, 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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