Vaccine Preventable Diseases: Pneumococcal Vaccine

1. Vaccine Preventable Diseases: Pneumococcal Vaccine An Opening Wedge for New Vaccine Introduction and Development Presented by: Christopher W. Woods Slides Prepared by Orin Levine Executive Director, International Vaccine Access Center Professor, International Health Johns Hopkins Bloomberg School of Public Health

3. Other Remedies of the Time

4. Vaccine History • 1794-Dr. Edward Jenner • 1952-Polio vaccine • 1963-Measles vaccine • 1974-Expanded Program on Immunization • Measles, Polio, DPT • 1980-Smallpox Eradication • 20??-Polio Eradication

5. Expanded Program on Immunization

6. Why is new vaccine introduction important? • Child mortality rates remain unacceptably high in many countries • Injustice • Expensive • Destabilizing

7. Why is new vaccine introduction important? A Global Forecasting Model of Political Instability by Goldstone et al. “lower-income countries showed a higher risk of instability. This is one of the best-established results in the conflict literature, of course, so we sought to improve on it. … Yet no model, no matter how complex, performed significantly better than models that simply used infant mortality (logged and normalized) as a single indicator of standard of living.”

8. Why is new vaccine introduction important? Causes of 8.8M child deaths, 2008 (Black et al. Lancet 2010) Pneumonia Pertussis Measles Meningitis Malaria Diarrhea 1.58M pneumonia deaths among children < 5 years AIDS

9. Annual deaths & deaths averted by vaccines 2.5mil deaths averted 2.5mil deaths Source: W. Orenstein, Gates Foundation; WHO, Burden of Disease 2004, released 2008

10. Why is new vaccine introduction important? • Vaccines can contribute to improving child survival, economic development, & national security • Vaccines available vs leading killers of children • New vaccines available shortly • Substantial existing delivery program

11. Consider Hib conjugate vaccine Hib – a leading cause of childhood meningitis and pneumonia worldwide Safe, effective vaccine used since 1990 in USA and other rich countries

12. If you build it, they will come… It worked in the movie but does it work for new vaccine introduction?

13. Global Hib Vaccine Uptake High and Low Income Countries

14. Vicious Cycle That Delayed Hib Vaccines 1) Uncertainty about demand in developing countries leads industry to limit investments in capacity Uncertain demand Limited supply Higher price 3) Higher prices keep developing countries uncertain about demand and donors uncertain about financing needs 2) Limited vaccine supply keeps prices relatively high

15. Industry willing to supply Donors & countries willing to pay Countries willing & able to introduce Saving lives requires finding “solution space” Solution space where lives are saved

16. Pneumococcal conjugate vaccine • Licensed in 2000 • Leading cause of childhood pneumonia & meningitis deaths • Proven safe, effective 7 deaths prevented per 1000 vaccinated in African trial of 9v vaccine Cutts F et al Lancet 2005

17. Global Alliance for Vaccines and Immunisation (GAVI): PneumoADIP Mission: To improve child health and reduce mortality by accelerating the evaluation of and access to new, life-saving pneumococcal vaccines for the world’s children.

18. PneumoADIP strategic goals Strategic Goal 1: Provide information that enables national decision-makers, the GAVI board and its partners to make an evidence-based decision regarding the use of vaccine. Strategic Goal 2: Accelerate the availability of affordable, new vaccines appropriate for use in developing countries.

19. Supply limited; just enough for rich countries • Vaccines $60/dose; doesn’t include vial sizes countries want Industry Willing to Supply • No WHO recommendation • No WHO disease burden estimates by country Countries Willing to Introduce “Solution space” status: 2003 Donors/ Countries Willing to Finance No financing for vaccine purchase “Too expensive to manufacture/Never affordable”

20. Surveillance documents disease patterns

21. Epidemiology, effectiveness, & economics ?How much pneumococcal disease do we have in children? WHO Disease Burden Estimates by Country Serotype Distribution by Region ?How well with the vaccine match our serotypes?

22. Epidemiology, effectiveness, & economics ?How cost-effective will the vaccine be in our country? Cost-Effectiveness & Health Impact Estimates by Country On-line web tool for national estimates using local data

23. Global Vaccine Policy at WHO

24. Pneumonia attention does not equate with disease burden

25. World Pneumonia Day Coalition http://worldpneumoniaday.org/

26. Illustrative

27. Illustrative

28. Investment case Approved! By GAVI Board Nov 2006

29. Major PneumoADIP accomplishments “GAVI’s efforts have truly accelerated the demand for pneumococcal vaccines.” • GAVI Phase 2 Independent Evaluation

30. WHO recommends pneumococcal vaccine in routine immunization programs • 8 approvals, 3 conditional approvals & 34 expressions of interest Countries Willing to Introduce “Solution space” status: 2008 Donors/ Countries Willing to Finance • Multinational & emerging manufacturers now committed to supply GAVI countries • Vaccines will have high serotype coverage, affordable price, and good vial size Industry Willing to Supply GAVI Board endorsed Investment Case for Pneumococcal Vaccines $1.5 billion for an Advance Market Commitment for pneumococcal vaccines

31. GAVI Pneumo: actual, recommended and forecasted introductions (Sept. 2010) Pakistan Gambia Mali Yemen Honduras Guyana Ethiopia Nicaragua Sierra Leone Kenya Cameroon Burundi Benin Rwanda CAR Malawi DR Congo Madagascar Number of Countries per year Actual Recommended Forecast Slide courtesy Lauren Franzel, PATH

32. Pneumococcal Vaccine Access Accelerated, Compared to Hib

33. The value of accelerated vaccine introduction Source: GAVI website

34. COI Results - Health Impact of Vaccine Scale-up 426 million Cases Averted 6.4 million Deaths Averted 63,000 Disabilities Averted Due to meningitis prevention 72 GAVI Countries; 2011-2020 (inclusive) Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028.

35. Immediate Economic Benefits Preventing illness could save $6.2 billion($4.8-9.1 b) in treatment costs and $1.2 billion ($0.7-1.4 b) in lost output of caretakers Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028.

36. Long-term Economic Benefits Immediate Benefits = Treatment costs + Caretaker Productivity Long-term Benefits = Morbidity Productivity + Mortality Productivity Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028. Future economic output increased by $144 billion ($120-168B) - Totaling $151 billion ($131-176B) in immediate & long-term benefits

37. Main takeaways • Dedicated team • Team that “sweats the details” every day • Use evidence to set consensus & policies • Need “push” to move into implementation • Strategic demand forecast • Lays out “what will it take” for each stakeholder

38. Evidence to policy to implementation Levine OS et al. Curr Op Infect Dis 2010

39. Moving from policy to implementation Can feel like it’s a lot to handle http://www.youtube.com/watch?v=8NPzLBSBzPI

40. Opportunities & Challenges Opportunities Challenges Biggest ever coordination needed Maintaining focus in face of competing priorities Economic setbacks • Impact on child health & economies • Success breeds success • Improved equity

41. Thank you! For more information, please visit www.jhsph.edu/ivac www.preventpneumo.org www.sabin.org/PACE

42. Global Pneumococcal Vaccine Uptake High & Low Income Countries

43. Historical Hib Introduction by Income Group Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).

44. Global PCV Introduction Status Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).

45. GAVI Countries PCV Introduction Status Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).

46. Pneumococcal is learning from Hib Significant acceleration of “evidence”, recommendations, advocacy and financing but little improvement in access to supply and Unicef procurement

47. More than 40 countries by 2015 Following the May 2011 round, almost 70% of GAVI countries have sought support for PCV introduction. A total of 37 GAVI-eligible countries have been approved for GAVI support to introduce pneumococcal conjugate vaccine into their national immunisation programmes. With an additional 18 countries approved as of September 2011, pneumococcal vaccines will soon be administered in more than half of GAVI eligible countries. This is an unprecedented rapid ramp up. To date, 14 countries in the developing world have begun the introduction of pneumococcal vaccines. By rapidly scaling up the number of countries and the number of children receiving the vaccines, GAVI and its partners can avert over 650,000 deaths by 2015 and up to seven million deaths by 2030.

48. Supplier perspective: Volumes / yr

49. Country/donor perspective: $ / year Illustrative