Immunization summit pneumo finalr

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Immunization summit pneumo finalr

  1. 1. Presentation at the Immunization Summit 2011 Pneumococcal Conjugated Vaccine (PCV) : Is the introduction to the National Immunization Program in Sri Lanka justified ? Dr. Pushpa Ranjan Wijesinghe, MD Consultant Epidemiologist
  2. 2. Is introduction of PCV a dilemma for National EPI managers ? • Need for achieving MDGs and role of immunization • Opportunities for introduction of appropriate new vaccines to the NPI • Are we going to use these opportunities ? • Inequity • public sector responsibility • If so, will there be a place for pneumococcal vaccines? • Is scientific evidence available for such a decision ? • If the decision is made, is it self- sustainable in the longer run ?
  3. 3. Consensus statement The immunization stake holder's meeting -2007 • Pneumococcal vaccines : • Current disease burden (2007) is inadequate for decision making • Due to high pneumonia specific morbidity, mortality and high AB resistance of S.pneumoniae, consideration of the pneumococcal vaccine in future given the financial feasibility and GAVI support • Extension of surveillance activities to more sentinel sites to represent different geographical regions, further strengthening and revisit in 2008
  4. 4. Does the disease burden warrant health intervention ? • Consensus statement –The immunization stake holder's meeting -2007 “Current disease burden (2007) is inadequate for decision making “ • Is the situation different in 2010 ? “ High AB resistance of S.pneumonia “ • Is this real in the Sri Lankan context ?
  5. 5. Pneumococcal Surveillance 2004-2008) • Syndromic surveillance of PMS patients aged 2-60 months at the LRH Type of testing No. tested (n) positivity rate for S.pneumoniae Blood cultures 2275 0.68% ( range - 0.57%-0.69%) CSF cultures 9495 0.65% ( range – 0.23% - 1.1%) Latex agglutination tests 1861 1 .9% ( range – 0.88% - 2.5%) Higher detection by latex antigen test from CSF than CSF cultures *Diminished growth of S.pneumoniae in cultures due to probable prior use of antibiotics Source : SAPNA
  6. 6. Incidence rate /100000 and estimates of PMS for Colombo district and Sri Lanka Syndrome Incidence rate * (per 100000) Estimate for Colombo district * Estimate for Sri Lanka All cause pneumonia 1342 2227 23551 All cause meningitis 519 866 9030 All cause sepsis 390 651 6786 3759 39167 All cause PMS 2251 •Epidemiological and economic analysis of pneumococcal disease in Sri Lanka conducted by Dr. S.Kularatne for the Epidemiology Unit - 2009
  7. 7. Annual incidence rates of IPD/100000 in under 5 children Country Pneumococcal meningitis Pneumococcal sepsis Pneumococcal pneumonia IPD Sri Lanka ( Colombo) 31.1 (95% CI= 20-42) 18.0 (95% CI= 10-26) 34.2 (95% CI= 23-46) 83.3 (95% CI= 65-101) Spain 90.0 Germany 14.0 USA Gambia 250 (500 - < I yr) Kenya 597
  8. 8. Annual incidence rate/100000 and estimates of IPD for Colombo district and Sri Lanka Syndrome Incidence rate * (per 100000) Estimate for Colombo * Estimate for Sri Lanka Pneumococcal pneumonia 34.2 (95% CI -23-46) 57 (95% CI- 38-76) 595 (95% CI- 400 -800) Pneumococcal meningitis 31.1 (95% CI -20-42) 51 (95% CI - 33-70) 539 (95% CI -348 – 730) Pneumococcal sepsis 18 (95% CI -10-26) 30 (95% CI-17-4) 313 (95% CI -174-452) 83.3 (95% CI- 65-101) 139 (95% CI -108-169) 1449 (95% CI -1131-1757) IPD * Epidemiological and economic analysis of pneumococcal disease in Sri Lanka conducted by Dr. S.Kularatne for the Epidemiology Unit - 2009
  9. 9. Pneumococcal surveillance ( 2004-2009) Antibiotic sensitivity of Pneumococcal isolates ( n=125) Antibiotic Sensitive Intermediate resistant Resistant Penicillin 53 (42%) 41(33%) 31(25%) Co-trimaxazole 33 (26%) 21(17%) 71(57%) Chlorampenicol 99(79%) 00 26 (21%) Erythromycin 42(33%) 01(1%) 82(66%) Cefotaxime 94(75%) 25(20%) 06(5%) Source : SAPNA
  10. 10. Is there an appropriate vaccine? • PCV 7 – contains 7 sero -types – 4, 6b,9v,14,18C, 19F, 23F – a licensed product • PCV 9 – Contains additional serotypes – 1 & 5 – unlicensed product • PCV 10 – contains additional serotype - 7 • PCV 13 – contains additional serotypes- 3,6A,9A
  11. 11. Is there an appropriate vaccine? Type of vaccine No. of Serotypes contained Serotypes PCV 7 7 PCV 9 9 1 & 5 (additionally) PCV 10 10 7(additionally) In production PCV 13 13 3,6A,9A(additionally) In production 4, 6b,9v,14,18C, 19F, 23F Status licensed product unlicensed product
  12. 12. Pneumococcal surveillance ( 2004-2009) Distribution of serotypes in Sri Lanka ( LRH & 5 sites) 35 30 Coverage of PCV 7 = 62.2% Coverage of PCV 7 = 62.2% Coverage of PCV 10=63.1% Coverage of PCV 10=63.1% Coverage of PCV 13= 69.7% Coverage of PCV 13= 69.7% 29 25 20 15 11 8 9V 9N 19c 6B 18F 1 6A 18A 5 4 1 47f 17f Type 1 0 35,42 1 33b 1 4 23f 1 23a 1 22 1 19f 1 16a 1 15c 20 1 15b 16 0 11c 15 2 11a 1 38 1 23 1 14 1 13 0 1 3 1 5 4 4 4 5 7 NT 10 1 Number 22
  13. 13. Are the globally available safety and efficacy data conclusive ? Is there a need for local immunogenicity/efficacy and safety data ?
  14. 14. End points evaluated Individual randomized (direct effect) Cluster randomized ( + herd immunity) Individually RCT Individual Efficacy (95% CI) Efficacy (95% CI) Efficacy (95% CI) Efficacy (95% CI) IPD –vaccine sero types 94% (80-99%) 83% (21-96%) 71%(46-86%) IPD-all pneumococal types 89% ( 74-96%) 52 % (-7-79%) 45%(19-62%) Radiologically confirmed pneumonia 26% ( 7-41%) -21% ( -62-9%) 35%(26-43%) Well defined clinical pneumonia 6% ( 1-11%) Severe clinical pneumonia - Hospital admissions 13% (6-19%) Mortality (all cause) 14%(2-24%) Vaccine type acute Otitis media All cause acute otitis media 54% (41-64%) 6%(4-9%) 6% ( -4-16%) Source : WHO
  15. 15. Safety – key points • Generally safe and well tolerated • even among children infected with HIV • Post marketing surveillance • No significant serious AE among 30 million users in USA • Most common reported adverse events • Injection site reactions (slight soreness and swelling) • Transient fever above 38.5 C • Rare adverse events • Febrile seizures • Hypotonic-Hypo responsive Episodes (HHE) • Very rare adverse events • Urticarea, angioneurotic oedema, erythema multiforme and hypersensitivity including anaphylaxis
  16. 16. Preventable number of cases by PCV 7 in Sri Lanka Non vaccinated scenario Vaccinated – vaccine recipients (90%) Vaccinated – vaccine non recipients (10%) Total cases prevented by vaccine IPD 1444 120 25 1299 Non Pnc PMS 38280 25417 5206 7657 Efficacy – 83% for IPD
  17. 17. Can the vaccine be incorporated in to the current EPI schedule ? • Currently 2 recommended schedules of 3 doses – 6 weeks, 10 weeks and 14 weeks – 2 months, 4 months and 6 months • Compatible with pentavalent 3 doses • No need for an additional clinic visit
  18. 18. What are the costs involved ? Approximate cost for vaccines 5$ per a dose (376843 X 5 $ X 3) 56 52645 $ per year Treatment cost in a non vaccinated scenario Per Pnc PMS & other PMS cases (25714 RS X1444) + (12495 Rs X 38280) 45 56221 $ per year Treatment cost in a vaccinated scenario Per Pnc PMS & other PMS cases (25714 Rs X 145) + (12495 Rs X 30623) 34 49668 $ per year Treatment cost saved from vaccination Additional space due Volume per to increasing Cold dose chain requirements 59.7cm3/dose * 11 06553 $ per year (1130529 X 59.7) 67.5 m3
  19. 19. Is the suggested vaccine cost effective ? GAVI’s economic analysis GAVI’s estimated Cost effectiveness ratio for Sri Lanka Estimated Cost effectiveness ratio based on Sri Lankan study Cost effective in 71/72 GAVI eligible countries ( including Sri Lanka ) 4211 $ per DALY averted 7397 Rs per DALY averted Benchmark – WHO CHOICE
  20. 20. Where are we compared to the previous summit ? • Availability of an estimate of the disease burden for the Colombo district as a model for decision making • Availability of an estimate of treatment cost • More comprehensive collection of sero types from LRH and 5 other hospitals • Wide representativeness • Antibiotic resistance data • Circulating serotypes ( n=125)
  21. 21. Where are we compared to the previous summit ? • Availability of a vaccine ( 7,10,13 valent) with a high coverage for available serotypes • Comprehensive data on safety and immunogenicity of the intended vaccine • Availability of results of an economic analysis as a guiding tool for decision making • Established infra structure ,expertise on and experience in post introduction surveillance of new vaccines • Availability and delivery of the intended vaccine in the private sector • WHO support for continued surveillance ( disease and laboratory)
  22. 22. Points for the discussion • • • • • Is – – – introduction of pneumococcal vaccine justifiable ? Disease burden, economic burden Competing priorities (MMR, typhoid) Financial sustainability • SL- no longer being GAVI eligible • Self financing potential Can a tentative timeline be determined ? – consideration of the pneumococcal vaccine in future given the financial feasibility and GAVI support – immunization stake holder's meeting 2007 What are the other constraints ? How can we overcome them? Any concerns of participants ?
  23. 23. Acknowledgement • • • • • • • • • • • • • • Dr. Nihal Abeysinghe for vision and guidance Dr. Paba Palihawadana and Dr T.S.R.Pieris for continued vision & support Dr.Ranjit Batuwanthdawe for the pioneering work Dr. Malka Dissanayake & Dr.Kumudu Karunaratne for enabling information generation Dr.Sanjeewa Kuaratne for initiating epidemiological and economic analysis All microbiologists at the SPnSN for their contributions MLTs at the LRH microbiology lab for the excellent work All pediatricians at the LRH for their precious contributions Dr. Mark Stein Hoff, Prof. Kurian Thomas, Professor Lalitha Kesewan Microbiology team @ the Christian Medical College , Vellore, Tamil Nadu GAVI’s Pneumo ADIP, John Hopkins University, USA International Clinical Epidemiological Network (INCLEN) All research assistants of the SAPNA ( Sri Lanka) for the hard work Iresha, Roshan, Priyangika for coordinating all the work

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