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Rota Vaccines in review (Developments last 6 Months). Dr.Sanjay Srirampur sanjaysrirampur@yahoo.com. Rota Vaccines in review (Developments last 6 Months ) Agenda. Real World Impact of Vaccine Efficacy of Vaccine Indirect Effects Intussusception Increased incidence? Strain Replacement
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Rota Vaccines in review (Developments last 6 Months) Dr.SanjaySrirampur sanjaysrirampur@yahoo.com IAPCOI - DEC 2011
Rota Vaccines in review (Developments last 6 Months) Agenda Real World Impact of Vaccine Efficacy of Vaccine Indirect Effects Intussusception Increased incidence? Strain Replacement Epidemiology Update 2011 IAPCOI - DEC 2011
Real World Impact of Vaccine Effectiveness Impact Studies IAPCOI - DEC 2011
Efficacy Studies IAPCOI - DEC 2011
Indirect Effect IAPCOI - DEC 2011
Safety of Rota Vaccines Intussusception IAPCOI - DEC 2011
Post Marketing surveillance • Increased incidence of intussusception • After the first dose and within one week • Risk substantially less than RRV • Benefit outweighs the risk • Mexico • Brazil • Australia • U.S.A IAPCOI - DEC 2011
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 IAPCOI - DEC 2011
Contraindications Severe allergic reaction to a previous dose Infants diagnosed with SCID Infants with a H/O Intussusception IAPCOI - DEC 2011
Strain Replacement IAPCOI - DEC 2011
The Pediatric Infectious Disease Journal • 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 IAPCOI - DEC 2011
Epidemiology Update - 2011 IAPCOI - DEC 2011
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 IAPCOI - DEC 2011
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 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.
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. ClinInfDis: 2011 Jan 15;52(2):171-7. IAPCOI - DEC 2011
Rota Vaccines in review (Developments last 6 Months) Agenda Real World Impact of Vaccine Efficacy of Vaccine Indirect Effects Intussusception Increased incidence? Strain Replacement Epidemiology Update 2011 IAPCOI - DEC 2011
Thank You IAPCOI - DEC 2011