1. Burden of Rotavirus Disease & Impact of Rotavirus Vaccination Umesh D. Parashar, MBBS, MPH Lead, Viral Gastroenteritis Epidemiology Team Centers for Disease Control Prevention Atlanta, GA TM 1

2. Rotavirus is the Leading Cause Of Severe Gastroenteritis in Children <5 Years 2 Other Bacterial Rotavirus Developed CountriesDeveloping Countries Unknown Rotavirus A. Kapikian, Fields Virology 2003

3. The face of rotavirus Diarrhea Vomiting Dehydration Shock Death

4. 4 Burden of Rotavirus in the US in 2006 20-60 Deaths 55-70,000 Hospitalizations 500,000 Outpatient visits 3.2 Million episodes Cost: $300 M medical; >$1 B total CDC, MMWR, 2006

5. 5 1 dot = 250 deaths Global Distribution of 527,000 Annual Rotavirus Deaths in Young Children Parashar et al, JID, 2009

6. 2006 -- Phase 3 Trials of Two Rotavirus Vaccines 6 Trials of 60-70,000 infants No increased risk of intussusception or other SAE Efficacy of 85%-98% against severe disease Vesikari et al and Ruiz-Palacios et al, NEJM 2006

7. Countries in the Americas with Rotavirus Vaccine Programs Rotarix only No program Rotateq & Rotarix Rotateq only

8. 8 Rotavirus Vaccines in USA Feb 2006 – RotaTeq recommended June 2008 – Rotarix recommended

9. National Rotavirus Laboratory Surveillance Network of 67 laboratories reporting since 2000 Weekly reporting: – # specimens tested for rotavirus – # positive tests

10. * 3-week moving averages Vaccine introduced Total and Positive Rotavirus Tests, July 2000-Mar 2010 Tate et al, Pediatrics 2009 and CDC unpublished data

11. 11 Active Rotavirus Surveillance Payne et al, PAS 2009

12. 12 Total AGE and Rotavirus AGE Hospitalizations NVSN, 2006-2008 50 % Rota + 45 % Rota + 6 % Rota + National reduction of 45,000-62,000 hospitalizations in 2008

13. 13 AgeDecline in rotavirus hospitalization rate (2008 vs. 2006) Rotavirus vaccine coverage in 2008 (>=1 dose) < 1 year66%56% 1 -< 2 years95%44% 2 -< 3 years85%<1% This age cohort was ineligible to receive rotavirus vaccine Age-Specific Rotavirus Hospitalization Rate Reduction and Vaccine Coverage, NVSN

14. 14 Rotavirus Vaccination in El Salvador October 2006 – Rotarix recommended

15. 15 Reduction in Rotavirus Admissions in Children < 5 Years after Rotarix Introduction, El Salvador 70-80% reduction in rotavirus hospitalizations children < 5 years In press, BMJ, 2010

16. 16 Richardson et al, NEJM 2010

17. 17 Marked Decline in Childhood Diarrhea Deaths After Rotarix Introduction, Mexico Vaccine Introduction (May 2007) 2008 2009

18. 18 Winter Blunting of Diarrhea Deaths Suggests Effect Against Rotavirus

19. 19 1 dot = 250 deaths Global Distribution of 527,000 Annual Rotavirus Deaths in Young Children

20. 20 Rotarix Trial in Malawi & So. Africa Region Vaccine Efficacy 95% CI No. of rotavirus cases prevented per 100 vaccinated Malawi 49%19, 686.7 South Africa77%40, 884.1 Madhi, S et al. NEJM 2010

21. 21 2006-2010 Incredible years for rotavirus vaccines!.... And great promise for the future!!

22. 22 Acknowledgements