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Umesh D. Parashar CDC, Atlanta, GA

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1 Umesh D. Parashar CDC, Atlanta, GA
Rotavirus Vaccines Umesh D. Parashar CDC, Atlanta, GA

2 2006 -- A Big Year for Rotavirus Vaccines
Jan Phase 3 trials published in NEJM Feb US FDA licenses RotaTeq Feb ACIP recommends RotaTeq for routine immunization of all US children Mar EMEA licenses Rotarix Mar-Aug Rotarix introduced in Brazil, Panama, Venezuela, and El Salvador Oct RotaTeq launched in Nicaragua Nov GAVI approves purchase of vaccine for Latin America and Eastern Europe

3 First rotavirus immunizations in Panama, Inaugurated by President Martin Torrijos and his wife, Viven de Torrijos March 14, 2006

4 RotaTeq launch in Nicaragua, Oct 2006

5 The face of rotavirus Tabasco, Mexico Jan 2005 Diarrhea Vomiting
Dehydration Shock Death Tabasco, Mexico Jan 2005

6 Rotarix (GSK) Human rotavirus G1P[8]

7 Efficacy of Rotarix against RVGE
Number of Cases Disease Severity HRV (N=9009) Placebo (N=8858) % Efficacy 95% CI Severe 12 77 84.7 71.7, 92.4 Hospitalized 9 59 85.0 69.6, 93.5 Ruiz-Palacios G. et al N. Engl. J. Med. 2006; 354: 11-22

8 Rotarix intussusception (IS) data
Number of IS Cases Vaccine group Placebo group N=31,673 N=31,552 6 7 Total 0  31 days Relative Risk = 0.85 (95% CI: 0.30 to 2.42) 1 2 0  31 days post dose 1 0  31 days post dose 2 5 5 Ruiz-Palacios G. et al N. Engl. J. Med. 2006; 354: 11-22

9 Bovine rotavirus with single human rotavirus gene substitution
RotaTeq (Merck & Co.) Bovine rotavirus with single human rotavirus gene substitution G1 G3 P[8] G2 G4

10 Efficacy of RotaTeq to reduce healthcare utilization for RVGE*
Number of Cases Type of Contact % Rate Reduction Vaccine Placebo 95% CI Hospitalizations† ED visits † Office visits†† 6 15 14 144 232 100 95.8 93.5 85.2 90.5, 98.2 88.6, 96.3 73.1, 91.9 This slide shows the efficacy of PRV to reduce health care utilization for rotavirus gastroenteritis. PRV reduced the rates of hospitalizations for rotavirus gastroenteritis by 95.8%, with confidence intervals ranging from 91 to 98 percent, the rates of emergency department visits for rotavirus gastroenteritis by 93.5%, with confidence intervals ranging from 89 to 96 percent, and the rates of office visits for rotavirus gastroenteritis by 85.2%, with 95% confidence intervals ranging from 73 to 92 percent. So, overall PRV demonstrated very high efficacy against severe rotavirus gastroenteritis. *Per protocol population (includes only cases that occurred at least 14 days after Dose 3) † N=34,035 vaccine and 34,003 placebo recipients †† N = 2,834 vaccine and 2839 placebo recipients

11 RotaTeq intussusception (IS) data
42 days of Any Dose - 6V:5P RR=1.2; 95% CI 0.3,5.0* * Unadjusted for multiplicity.

12 US Rotavirus Disease Burden and Vaccine Effectiveness Monitoring

13 New Vaccine Surveillance Network (NVSN)
Population-based surveillance in 3 counties: Vanderbilt University Medical Center University of Rochester Medical Center Cincinnati Children’s Hospital Medical Center First year from Jan to June 2006 Children with acute gastroenteritis (AGE) enrolled and stool specimen tested for rotavirus Data collected: Parental interviews Medical chart abstractions Clinical outcomes (Inpatient, Emergency Department (ED), Outpatient) Laboratory test results (EIA and typing)

14 Rotavirus Detection Rates by Setting NVSN, Jan-June 2006
Number Enrolled with Specimens (n=517) Percent Rotavirus Positive (by EIA) Hospital 182 50% Emergency Department 201 Outpatient Clinic 134 27% P<0.0001

15

16 US Post-Licensure Monitoring of Intussusception with RotaTeq
.

17 Intussusception (IS) Reports to VAERS, March 2006-Feb 15, 2007
35 IS confirmed reports through 2/15/07 17 reports 1-21 days 11 of 17 were within 1-7 days No deaths

18 IS Reports by Onset-Interval—days after vaccination (N=35)
Reports as of February 15, 2007;

19 Do the Reported Number of VAERS Intussusception Cases Exceed Expected?
Observed: VAERS cases Expected: Baseline intussusception rate (age-stratified) Number of vaccine doses administered (age-stratified)

20 Background Intussusception Rates by Week of Age 1993-2004
* Source: Tate et al. unpublished data using Healthcare Utilization Project (HCUP) database

21 Observed versus Expected
1 to 21 Days* Age Group VAERS Cases Expected Cases* 6-14 7 21 15-23 9 24-35 1 10 Total 17 52 Exact Poisson—Stratified by age group Rate Ratio Lower Upper P-Value 0.32 0.17 0.55 <0.0001 * Source: VSD for background and age of vaccine administration; Merck distribution data

22 Observed versus Expected
1 to 7 Days* Age Group VAERS Cases Expected Cases* 6-14 5 7 15-23 6 24-35 3 Total 11 17 Exact Poisson—Stratified by age group Rate Ratio Lower Upper P-Value 0.61 0.29 1.18 0.153 * Source: VSD for background and age of vaccine administration; Merck distribution data

23 Data Assumptions VAERS reporting completeness
Doses of vaccine administered versus distributed

24 VSD Data, February 14, 2007 28,377 RotaTeq doses given
No intussuception reports within 30 days following RotaTeq vaccination

25 Conclusions Available post-marketing data do not suggest that RotaTeq is associated IS However, because of data assumptions with VAERS and limited VSD data to date, it is not possible to exclude risk CDC and FDA are continuing to carefully monitor IS and other adverse effects

26 An incredible year for rotavirus And great promise for the future!
2006 An incredible year for rotavirus And great promise for the future!

27 The biggest challenge for live oral rotavirus vaccines today is whether they will work in the developing world!

28 Estimated global distribution of the 600,000 annual deaths caused by rotavirus
1 dot = 1000 deaths

29 Who is interested in supporting rotavirus vaccines today ?
The International Finance Facility

30 Acknowledgements (NVSN)
Cincinnati Children’s Hospital Medical Center: Mary Staat, Gerry Fairbrother, Michol Holloway, and other CCHMC surveillance staff Vanderbilt University Medical Center: Kathryn Edwards, Marie Griffin, Diane Kent, and other Vanderbilt University surveillance staff University of Rochester Medical Center: Peter Szilagyi, Caroline Hall, Geoff Weinberg, Gerry Lofthus, and other University of Rochester surveillance staff Centers for Disease Control and Prevention: Dan Payne, Jim Alexander, Jon Gentsch, Marika Iwane, Aaron Curns, Lauren Stockman, and other CDC staff

31 Acknowledgements (Safety)
Jacquelyn Tate (CDC/NCIRD) Jon Gentsch (CDC/NCIRD) Elaine Miller (CDC/ISO) Bob Davis (CDC/ISO) John Iskander (CDC/ISO) VSD investigators Greg Wallace (CDC/NCIRD) Diana Bartlett (CDC/NCIRD) Jane Seward (CDC/NCIRD) Larry Anderson (CDC/NCIRD) Penina Haber (CDC/ISO) Manish Patel (CDC/NCIRD) James Baggs (CDC/ISO) Hector Izuerieta (FDA/CBER) Eric Weintraub (CDC/ISO) Paul Gargiullo (CDC/ISO) Miles Braun (FDA/CBER) Robert Ball (FDA/CBER) Margaret Cortese (CDC/NCIRD)

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