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Rota Vaccines in review (Developments last 6 Months) Dr.Sanjay Srirampur [email protected] 5/24/2017 IAPCOI - DEC 2011 1 Rota Vaccines in review (Developments last 6 Months) Agenda 1. Real World Impact of Vaccine 2. Efficacy of Vaccine 3. Indirect Effects 4. Intussusception Increased incidence? 5. Strain Replacement 6. Epidemiology Update 2011 5/24/2017 IAPCOI - DEC 2011 2 Real World Impact of Vaccine Effectiveness Impact Studies 5/24/2017 IAPCOI - DEC 2011 3 5/24/2017 IAPCOI - DEC 2011 4 5/24/2017 IAPCOI - DEC 2011 5 5/24/2017 IAPCOI - DEC 2011 6 5/24/2017 IAPCOI - DEC 2011 7 5/24/2017 IAPCOI - DEC 2011 8 Efficacy Studies 5/24/2017 IAPCOI - DEC 2011 9 5/24/2017 IAPCOI - DEC 2011 10 5/24/2017 IAPCOI - DEC 2011 11 Indirect Effect 5/24/2017 IAPCOI - DEC 2011 12 5/24/2017 IAPCOI - DEC 2011 13 5/24/2017 IAPCOI - DEC 2011 14 Safety of Rota Vaccines Intussusception 5/24/2017 IAPCOI - DEC 2011 15 Post Marketing surveillance •Increased incidence of intussusception •After the first dose and within one week •Risk substantially less than RRV •Mexico •Brazil •Australia •U.S.A •Benefit outweighs the risk 5/24/2017 IAPCOI - DEC 2011 16 Summary Recommendations •Evidence that small increase in rate of intussusception •Risk substantially less than that of RRV •In Africa and Asia studies regarding safety are wanting •In Africa and Asia data on Intussusception is wanting •Safety studies should run parallel to the introduction of vaccine 5/24/2017 IAPCOI - DEC 2011 17 Contraindications 1. Severe allergic reaction to a previous dose 2. Infants diagnosed with SCID 3. Infants with a H/O Intussusception 5/24/2017 IAPCOI - DEC 2011 18 Strain Replacement 5/24/2017 IAPCOI - DEC 2011 19 5/24/2017 The Pediatric Infectious Disease Journal • 20 Volume 30, Number 1, January 2011 IAPCOI - DEC 2011 Conclusions: Our data demonstrate the reemergence of RV-A genotype G2P4 in Brazil from 2005 to 2008, and that the rate of G2P4 detection decreased in 2009, probably reflecting natural oscillations of RV-A genotypes The Pediatric Infectious Disease Journal • Volume 30, Number 1, January 2011 5/24/2017 IAPCOI - DEC 2011 21 5/24/2017 IAPCOI - DEC 2011 22 Epidemiology Update - 2011 5/24/2017 IAPCOI - DEC 2011 23 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 Jacqueline E Tate, Anthony H Burton, Cynthia Boschi-Pinto, A Duncan Steele, Jazmin Duque, Umesh D Parashar, and the WHO-coordinated Global Rotavirus Surveillance Network* Findings Worldwide in 2008, diarrhoea attributable to rotavirus infection resulted in 453 000 deaths (95% CI 420 000–494 000) in children younger than 5 years—37% of deaths attributable to diarrhoea and 5% of all deaths in children younger than 5 years. Five countries accounted for more than half of all deaths attributable to rotavirus infection: Democratic Republic of the Congo, Ethiopia, India, Nigeria, and Pakistan; India alone accounted for 22% of deaths (98 621 deaths). wwwlancet online: Published Oct 25, 2011 5/24/2017 IAPCOI - DEC 2011 24 5/24/2017 IAPCOI - DEC 2011 25 Indian Rotavirus Surveillance Network (IRSN) • 10 representative hospitals in 7 cities. • 4 testing laboratories. • Technical co-ordination by Indian Council for Medical Research (ICMR) & US Centers for Disease Control and Prevention (US CDC). • Surveillance results available from Dec 2005-Nov 2007 for children aged <5 years who presented with acute gastroenteritis and required hospitalization with rehydration for at least 6 hr. IAPCOI - DEC 2011 Adapted 5/24/2017 from: Gagandeep Kang et al, Multicenter, Hospital-Based Surveillance of Rotavirus Disease and Strains among Indian Children Aged <5 Years, JID 2009; 200:S147–53. 26 5/24/2017 IAPCOI - DEC 2011 27 Projected impact and cost-effectiveness of a rotavirus vaccination program in India, 2008. Eposito et al RESULTS: With use of a vaccine that has an estimated effectiveness of 50%, a rotavirus vaccination program in India would prevent ~44,000 deaths, ~293,000 hospitalizations, and ~328,000 outpatient visits annually, which would avert $20.6 million in medical treatment costs. Vaccination would be cost-saving at the GAVI Alliance price of $0.15 per dose. At $1.00 per dose, a vaccination program would cost $49.8 million, which would result in an expenditure of $21.41 per DALY averted or $662.94 per life saved. Even at $7.00 per dose, vaccination would be highly cost-effective. In sensitivity analyses, varying efficacy against severe rotavirus disease and vaccine price had the greatest impact on cost-effectiveness. 5/24/2017 IAPCOI - DEC 2011 Clin Inf Dis: 2011 Jan 15;52(2):171-7. 28 Rota Vaccines in review (Developments last 6 Months) Agenda 1. Real World Impact of Vaccine 2. Efficacy of Vaccine 3. Indirect Effects 4. Intussusception Increased incidence? 5. Strain Replacement 6. Epidemiology Update 2011 5/24/2017 IAPCOI - DEC 2011 29 Thank You 5/24/2017 IAPCOI - DEC 2011 30