Vaccine Health Impact

Thousands of Lives Saved

As of May 2020, about 100 countries – home to a combined 78 million infants – have introduced rotavirus vaccines into their national immunization programs. As a result, there is a large and growing body of evidence demonstrating the impact of these critical vaccines in countries where they are used routinely. Rotavirus vaccines averted 800,000 to 900,000 future deaths from 2011 – 2020.^[1]

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Swift and significant declines in hospitalizations and deaths due to rotavirus and all-cause diarrhea have been observed in many countries routinely using rotavirus vaccines.

Both RotaTeq and ROTARIX were found in clinical trials in the U.S., Western European, and Latin American countries to provide 80-90% protection against severe rotavirus diarrhea in infants and young children.^[13,14]
Both vaccines cut the number of hospitalizations caused by rotavirus in children under 5 years of age by 45–94% in high-income countries, such as the U.S., Australia, Belgium, and Austria, and all hospitalizations from diarrhea in this age group by 25–54%.^{[10, 15-25]}
Latin American countries also saw declines in diarrheal hospitalizations ranging from 13% to as high as 48%, and several experienced a significant reduction in childhood deaths from diarrhea—from 16% in Honduras to 64% in Venezuela.^[26-33]
Clinical trials of rotavirus vaccines in low- and middle-income countries in Africa and Asia also found both vaccines to be effective in preventing rotavirus gastroenteritis, but at a somewhat lower level of efficacy than in the trials in high-income countries and Latin America.^[34-36]

Even moderate efficacy can translate to significant public health impact:

Efficacy is the measure of how a vaccine performs under ideal conditions, such as a clinical study. This is different from effectiveness, which measures how a vaccine performs in real-world conditions, and impact, which measures the number of lives saved or hospitalizations averted.

In Malawi, a low-income country, a study found ROTARIX to be 71% effective in preventing rotavirus-related hospitalizations in the first year of life. A recent, large population-based study also found that ROTARIX reduced infant diarrheal deaths by one-third. These studies demonstrate a similar impact to that seen in middle-income countries, such as Mexico
Some factors that may reduce the immune response of oral vaccines in low-income settings include higher rates of malnutrition and micronutrient deficiencies; interference from other infections in the gut, as well as from infections such as HIV, tuberculosis, and malaria; and higher levels of maternal antibodies.^[37-39]

References

^{1. Global vaccine action plan. (2013). Vaccine, 31, B5-B31. doi:10.1016/j.vaccine.2013.02.015}

^{2. Payne, D.C., et al., Direct and indirect effects of rotavirus vaccination upon childhood hospitalizations in 3 US Counties, 2006–2009. Clin Infect Dis, 2011. 53(3): p. 245–53.}

^{3. Tate, J.E., et al., Trends in National Rotavirus Activity Before and After Introduction of Rotavirus Vaccine into the National Immunization Program in the United States, 2000 to 2012. The Pediatric Infectious Disease Journal, 2013. 32(7): p. 741–744.}

^{4. Yen, C., et al., Diarrhea-associated hospitalizations among US children over 2 rotavirus seasons after vaccine introduction. Pediatrics, 2011. 127(1): p. e9–e15.}

^{5. Leshem, E., et al., Rotavirus vaccines and health care utilization for diarrhea in the United States (2007–2011). Pediatrics, 2014. 134(1): p. 15–23}

^{6. Tharmaphornpilas, P., et al., Evaluating the first introduction of rotavirus vaccine in Thailand: Moving from evidence to policy. Vaccine, 2017. 35: p. 796–801.}

^{7. Sánchez-Uribe, E., et al., Sustained Reduction of Childhood Diarrhea-Related Mortality and Hospitalizations in Mexico after Rotavirus Vaccine Universalization. Clinical Infectious Diseases, 2016.}

^{8. Costa, I., et al., Sustained decrease in gastroenteritis-related deaths and hospitalizations in children less than 5 years of age after the introduction of rotavirus vaccination a time-trend analysis in Brazil (2001–2010). Pediatric Infectious Disease Journal, 2016. 35(6): p. e180-e190.}

^{9. Gheorghita, S., et al., Impact of Rotavirus Vaccine Introduction and Vaccine Effectiveness in the Republic of Moldova. Clinical Infectious Diseases, 2016. 62(Suppl 2): p. S140-S146.}

^{10. Raes, M., et al., Reduction in pediatric rotavirus-related hospitalizations after universal rotavirus vaccination in Belgium. Pediatr Infect Dis J, 2011. 30(7): p. e120–5.}

^{11. Bar-Zeev, N., et al., Impact of monovalent rotavirus vaccine on diarrhoea-associated post-neonatal infant mortality in rural communities in Malawi: a population-based birth cohort study. The Lancet Global Health, 2018. 6(9): p. e1036-e1044.}

^{12. Ngabo, F., et al., Effect of pentavalent rotavirus vaccine introduction on hospital admissions for diarrhoea and rotavirus in children in Rwanda: a time-series analysis. The Lancet Global Health, 2016. 4(2): p. e129–e136.}

^{13. Ruiz-Palacios, G.M., et al., Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. New England Journal of Medicine, 2006. 354(1): p. 2725–2732.}

^{14. World Health Organization., Rotavirus vaccines WHO position paper: January 2013, in Weekly epidemiological record. 2013. p. 49–64}

^{15. Paulke-Korinek, M., et al., Herd immunity after two years of the universal mass vaccination program against rotavirus gastroenteritis in Austria. Vaccine, 2011. 29(15): p. 2791–2796.}

^{16. Paulke-Korinek, M., et al., Sustained low hospitalization rates after four years of rotavirus mass vaccination in Austria. Vaccine, 2013. 31(24): p. 2686–2691.}

^{17. Buttery, J.P., et al., Reduction in rotavirusassociated acute gastroenteritis following introduction of rotavirus vaccine into Australia’s National Childhood vaccine schedule. Pediatr Infect Dis J, 2011. 30(1 Suppl): p. S25–9.}

^{18. Pendleton, A., et al., Impact of rotavirus vaccination in Australian children below 5 years of age: a database study. Hum Vaccin Immunother, 2013. 9(8): p. 1617–1625.}

^{19. Braeckman, T., et al., Effectiveness of rotavirus vaccination in prevention of hospital admissions for rotavirus gastroenteritis among young children in Belgium: case-control study. BMJ, 2012. 345: p. e4752–e4752.}

^{20. Standaert, B., et al., Improvement in hospital Quality of Care (QoC) after the introduction of rotavirus vaccination: An evaluation study in Belgium. Hum Vaccin Immunother, 2015. 11(9): p. 2266–73.}

^{21. Payne, D.C., et al., Direct and indirect effects of rotavirus vaccination upon childhood hospitalizations in 3 US Counties, 2006–2009. Clin Infect Dis, 2011. 53(3): p. 245–53.}

^{22. Vesikari, T., 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: p. 1365–1373.}

^{23. Tate, J.E., et al., Trends in National Rotavirus Activity Before and After Introduction of Rotavirus Vaccine into the National Immunization Program in the United States, 2000 to 2012. The Pediatric Infectious Disease Journal, 2013. 32(7): p. 741–744.}

^{24. Yen, C., et al., Diarrhea-associated hospitalizations among US children over 2 rotavirus seasons after vaccine introduction. Pediatrics, 2011. 127(1): p. e9–e15.}

^{25. Leshem, E., et al., Rotavirus vaccines and health care utilization for diarrhea in the United States (2007–2011). Pediatrics, 2014. 134(1): p. 15–23.}

^{26. De Oliveira, L.H., et al., Temporal trends in diarrhea-related hospitalizations and deaths in children under age 5 before and after the introduction of the rotavirus vaccine in four Latin American countries. Vaccine, 2013. 31: p. C99–C108.}

^{27. Lanzieri, T.M., et al., Impact of rotavirus vaccination on childhood deaths from diarrhea in Brazil. Int J Infect Dis, 2011. 15(3): p. e206–10.}

^{28. do Carmo, G.M., et al., Decline in diarrhea mortality and admissions after routine childhood rotavirus immunization in Brazil: a time-series analysis. PLoS Med, 2011. 8(4): p. e1001024–e1001024.}

^{29. Yen, C., et al., Decline in rotavirus hospitalizations and health care visits for childhood diarrhea following rotavirus vaccination in El Salvador. Pediatr Infect Dis J, 2011. 30(1 Suppl): p. S6–S10.}

^{30. Quintanar-Solares, M., et al., Impact of rotavirus vaccination on diarrhea-related hospitalizations among children <5 years of age in Mexico. Pediatr Infect Dis J, 2011. 30(1 Suppl): p. S11–5.}

^{31. Becker-Dreps, S., et al., Community diarrhea incidence before and after rotavirus vaccine introduction in Nicaragua. Am J Trop Med Hyg, 2013. 89(2): p. 246–50.}

^{32. Bayard, V., et al., Impact of rotavirus vaccination on childhood gastroenteritisrelated mortality and hospital discharges in Panama. Int J Infect Dis, 2012. 16(2): p. e94–8.}

^{33. Molto, Y., et al., Reduction of diarrheaassociated hospitalizations among children aged <5 Years in Panama following the introduction of rotavirus vaccine. Pediatr Infect Dis J, 2011. 30(1 Suppl): p. S16–20.}

^{34. Madhi, S.A., et al., Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med, 2010. 362(4): p. 289–298.}

^{35. Armah, G.E., et al., Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebocontrolled trial. The Lancet, 2010. 376(9741): p. 606–614.}

^{36. Zaman, K., et al., Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, doubleblind, placebo-controlled trial. The Lancet, 2010. 376(9741): p. 615–623.}

^{37. Glass, R.I., et al., Rotavirus vaccines: Successes and challenges. Journal of Infection, 2014. 68: p. S9–S18.}

^{38. Tate, J.E., et al., Effectiveness of Pentavalent Rotavirus Vaccine Under Conditions of Routine Use in Rwanda. Clinical Infectious Diseases, 2016. 62(suppl 2): p. S208–S212.}

^{39. Patel, M., A.D. Steele, and U.D. Parashar, Influence of oral polio vaccines on performance of the monovalent and pentavalent rotavirus vaccines. Vaccine, 2012. 30(SUPPL. 1): p. 30–35.}