Pcv 10 v/ pcv 13   india scenario
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Pcv 10 v/ pcv 13 india scenario

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IAP Annual meet Chandigarh, PGI presentation

IAP Annual meet Chandigarh, PGI presentation

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  • Key Points As per the O’Brien report in Lancet 2009, India tops the countries with the greatest number of pneumococcal deaths in children under 5 years, ahead of China which has a higher population.
  • Key Points The Millennium Development Goal 4 aims to reduce mortality in children younger than 5 years by two-thirds between 1990 and 2015. However looking at this graph for 60 priority countries (including India), it seems we are still far away from that goal.
  • Although 91 serotypes have been isolated only a few of these serotypes are responsible for invasive pneumococcal disease. According to Johnson et al published in 2010, only 10 serotypes cause 75% of IPD in children under 5 years of age.
  • Based on a compilation paper written by Murphy et al in 2009, NTHi is one of the leading othopathogens and is responsible more than 30% AOM cases in children under 5 years of age.

Transcript

  • 1. PCV 10 v/s PCV 13 – IndianScenario Dr Gaurav Gupta 18th March, 2012
  • 2. Overview Pneumococcal Disease Burden – Indian Context Studies from India & abroad NTHi Recommendations & Comparison
  • 3. Overview Pneumococcal Disease Burden – Indian Context Studies from India & abroad NTHi Recommendations & Comparison
  • 4. Description of PCV vaccines PCV 7 (Prevenar) 4, 6B, 9V, 14, 18C, 19F, 23F CRM197 Diphtheria carrier proteinPCV 10 (Synflorix) 4, 6B, 9V, 14, 23F, 18C, 19F 1, 5, 7F NTHi protein D TT DT NTHi protein DPCV 13 (Prevenar13) 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 5, 7F 3, 6A, 19A CRM197 Diphtheria carrier protein 4
  • 5. Strep Pneumoniae in developing countries
  • 6. Pneumococcal Disease BurdenCountries with the greatest number of pneumococcal deaths among children under 5 years TOP TENO,Brien K, et al. Lancet. 2009;374:893-902.
  • 7. Pneumonia & India Pneumonia remains the leading killer of children1 410,000 children < 5 die of pneumonia every year1,2 25% of all child deaths are due to pneumonia3 Meta-analysis of 4 CTs suggest 30-40% of all severe pneumonia in children is pneumococcal. In Indian context, around 123,000 to 164,000 children <5 years die annually from pneumococcal pneumonia11. Levine OS et al Indian Pediatrics 2007; 44:491-4962. Pneumonia – The forgotten killer of children, WHO, UNICEF, 20063. Thacker N. IPD burden - An Indian Perspective. Pediatrics Today 2006; 9(4): 208-213
  • 8. Strep Pneumoniae & Pneumonia – Indian Disease Burden  Pneumonia is the single most important cause of death among children in the postneonatal period, contributing as much as 27.5% of total under-five mortality  It appears that about 10-15% of childhood pneumonias are caused by H. influenzae and RSV each; and 12-35% by pneumococcus. ** Mathew J et al. ARI & Pneumonia in India – A systematic review . Indian Pediatrics, March2011
  • 9. We are missing the target (Millennium Development Goal 4) Under-five mortality ratio (U5MR) projections 60 priority countries U5MR in 2015 85 at current AAR 38 MDG Target U5MR in 2015 AAR =average annual rate of reduction MDG=millennium development goalSource: UN Population Division World Population Prospects, 2004. 9
  • 10. Overview Pneumococcal Disease Burden – Indian Context Studies from India & abroad NTHi Recommendations & Comparison
  • 11. Epidemiology of Pneumococcal Serotypes in India inChildren under 5 yrs : An overview of available data 1999 : IBIS study (Invasive Bacterial Infection Surveillance) 2006-07 :SAPNA network (South Asia Pneumococcal Alliance) 2008 : Asian Network for Surveillance Of Resistant Pathogens ( ANSORP 2008 ) 1992-07 : S. Pneumoniae Surveillance for Serotype distribution in Bangladesh: 2008 : KIMS Study (PneumoNET) 2009 :Pneumo ADIP (Pneumococcal vaccine Accelerated Development and Introduction Plan ) 2011 : Alliance for Surveillance of Invasive Pneumococci (ASIP) 11
  • 12. Burden of Disease –Pneumonet Data* 2 year prospective study Age No. of No. in Incidence Based in 3 Bengaluru group cases group rate per (months) 1,00,000 hospitals population Study of IPD (culture of 1 to 6 3 8,186 36.35 S. pneumoniae from a 6 to 12 6 13,040 46.01 normally sterile site) and 12 to 24 3 22,777 13.17 pneumonia as defined 24 to 36 4 22,470 17.80 clinically and on X-ray 36 to 60 1 46,010 2.17 Interim data for 1 year Overall 17 112,483 15.10 Poster at ESPID- June Incidence of IPD in children < 2 years is 2011 15.91(pn) + 6.82(pyomen) + 5.55(bact) = 28.28/1,00,000 population * Study Funded by Wyeth, a division of Pfizer Inc.
  • 13. Burden of Disease –Pneumonet DataAge Clinical Incidence X-ray Incidencegroup Pneumonia rates per Pneumonia rates per(months) No. of cases 1,00,000 pop. No. of cases 1,00,000 pop.1 to 6 393 4,800.88 145 1,771.326 to 12 499 3,826.69 214 1,641.1012 to 24 627 2,752.78 318 1,396.1524 to 36 384 1,708.95 175 778.8236 to 60 468 1,017.17 254 552.05Overall 2,371 2,107.87 1,106 983.26 These are total pneumonia cases. Incidence of Pneumococcal pneumonia has to be by extrapolation on possible fraction of S. pneumonae as a cause of pneumonia in this age groups
  • 14. CMC CNBC Study CentresLudhiana Delhi • PAN India Safdar Network Jung Delhi • 12 Institutes KEM KEM • 48 SentinelMumbai Pune Pediatricians BVP SRMC • 7 Sentinel Pune Chennai local labs MGIMS Wardha Pushpagiri TiruvallaLTMMCMumbai Central Monitoring Lab CMC, AIMS Kochi Vellore St. Johns Bengaluru 19
  • 15. Indian Data – A brief SynopsisStudy Total number Top 3 Isolates of IsolatesIBIS – 1999 307 6, 1, 19SAPNA 4 1, 6 BPneumonet * 17 6 A, 5, 1/ 3/ 14ASIP * 35 10, 19 F/ 6, 23F/ 5
  • 16. A limited number of serotypes cause IPD in young Children ~ 10 Serotypes causes 75% of IPD in children under 5 years of ageJohnson et al PLOS Medicine 2010
  • 17. PCV 7 - CoverageReferences: 1. Johnson et al. Plos Medicine 2010
  • 18. PCV 10 - CoverageReferences: 1. Johnson et al. Plos Medicine 2010
  • 19. PCV 13 - CoverageReferences: 1. Johnson et al. Plos Medicine 2010
  • 20. PCV7: PCV7: <5 >8 PC V7 : PCV10 0% 1 PCV10 0% 1 ~7 :>70% 1 :~85% 1 PCV10 0% 1 PC V1 3 PC V1 3 :~ : 75% 1 :~90% 1 PCV13 80% 1 :<90% 1 Europe Asia North America PCV7: <5 PCV10 0% 2 :7 PCV13 5% 2 : 75% 2 PCV7: Africa <6 PC V1 0 0 % 1 :<80% 1 PCV13 PCV7: :~80% 1 <5 PCV10 0% 1 PC V7 : <7 :>7 PCV13 0% 1 PCV10 0% 1 : 75% 1 :~75% 1 PCV13 Latin America :~80% 1 oceaniaReferences: 1. Johnson et al. Plos Medicine 2010 2.Nitin k. shah et al. summary of invasive pneumococcal disease burden among children in Asia-Pacific region. Vaccine 28(2010) 7589-7605
  • 21. Ongoing clinical trials COMPAS study  Being conducted in 24,000 children in 3 Latin American Countries; 4 year follow-up  Aim is to study the efficacy in preventing clinical and radiological pneumonia in study group  PCV10 (with NTHi D protein) in study arm with control (Hep. B and Hep. A)  Interim data – vaccine efficacy rate of 22% (clinical pneumonia i.e. features of LRTI with CRP > 40 mg/L) and 25.7% (Consolidation on X-ray Chest)  Likely to be officially published in June 2012
  • 22. PCV 10 IPD Effectiveness II: Pneumococcal Meningitis in Brazil, in <2 yr olds 1998-2011Cumulative number of Pneumococcal meningitis cases in children <2 years of age by month of occurrence, Brazil,2007-10 PCV 10 introduction March-June 2010. 2009 UMV, 3+1 schedule 2010 ~48% reduction any Pn. meningitis 2011 Jun11 vs Jun10 Brazil National Pneumococcal menigitis reporting. MoH - SAUDE : http://portal.saude.gov.br/portal/saude/profissional/visualizar_texto.cfm?idtxt=37811 accessed 21Nov2011
  • 23. Acute Bacterial Core surveillance data (US)*  Rates of IPD with all serotypes per 1,00,000 pop. In children < 2 years of age (Total 15980 cases)  Effect of switch to PCV13 in Feb 2010 All Vaccine serotypes serotypes Quarter/Year Baseline 2010 Baseline 2010 2006-2008 2006-2008 Jan-Mar 43.4 48.4 27.0 31.8 Apr-Jun 37.1 27.8 22.9 18.4 Jul-Sept 22.0 17.5 10.7 11.2 Oct-Dec 40.3 18.8* 24.1 8.5* * P < 0.0001 Conclusion: These preliminary findings are consistent with early effects of PCV13 on IPD among young children *Presented at ICAAC of ASM at Chicago Sept. 2011
  • 24. Overview Pneumococcal Disease Burden – Indian Context Studies from India & abroad NTHi Recommendations & Comparison
  • 25. NTHi is one of the leading pathogen in Otitis MediaThe 3 predominant pathogens in otitis media: S. pneumoniae, NTHi and M. catarrhalis (from 8 different studies involvingtympanocentesis and culture of middle ear fluid from 1990–2007).9–16Murphy et al The Pediatric Infectious Disease Journal • Volume 28, Number 10, October 2009
  • 26. Indian data on NP carriage of NTHi in children under 2yrs of age
  • 27. Overview Pneumococcal Disease Burden – Indian Context Studies from India & abroad NTHi Recommendations & Comparison
  • 28. New recommendations for PCV 10 Iceland – PCV10 April 20111 EMA(CMPH) – PCV10 June 20112 (extension of use for 2 to 5 year age group) Brazil, Chile, Mexico, Colombia Finland, Sweden, Netherlands Albania, Bulgaria, Austria, Cyprus Kenya1. EPI-ICE 7:2 Apr-Jun 2011 2. NELM News Service June 2011
  • 29. New recommendations – PCV10 vs PCV13 Switch from PCV 10 to PCV 13  Hong Kong Nov 20111  Australia Aug 20112  Canada Sep 20103 Simultaneous use of PCV10 and PCV 13  Korea Apr 20114  No comment of superiority or otherwise of either vaccine  No special recommendation for use of either vaccine in any specific group  New Zealand May 20115  Use of PCV10 routinely and PCV13 for “high-risk” group1. Press Release: Health Dept. HK. Nov 29, 2011. 2. Dept. Memo dated 30th Aug, 20113. CCDR: Nov 2010. 4. Korean J Pediatr 2011;54(4):146-151 5. IAC – Univ. of Auckland
  • 30. PCV 10 v/s PCV 13Criteria Comment WinnerEffectiveness – IPD 2 - 8 % difference likely PCV 13Effectiveness – AOM 6 % v/s 34 % PCV 10Cost Almost 50 % difference PCV 10Convenience & Support No difference TieSafety No serious concerns Tie
  • 31. Conclusion High Pneumococcal disease burden in India, excellent safety and improved efficacy profile, pneumococcal vaccine should be offered to all affording children. PCV 13 is better in protecting against IPD, the main raison dêtre for pneumococcal vaccination. 19 – A coverage may offer potential benefits. PCV 10 offers good protection at better price, with additional significant benefit of protecting against AOM due to NTHi.