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
This is the reason for the delay – uncertain demand leads to limited supply which in turn keeps prices too high for developing countries to afford and demand, and donors uncertain about financing needs

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

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.
Research & Surveillance
Communications
Vaccine Access & Implementation
Project Administration
Improving child health by accelerating access to vaccines
To avoid history repeating it self, in 2003, GAVI created the PneumoADIP, a 5-year, $30M grant
( read )
The PnemoADIP is a small, dedicated team located at JHU that works in partnership with WHO

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. “Solution space” status: 2003
Donors/
Countries
Willing to
Finance
No financing for vaccine purchase
“Too expensive to manufacture/Never affordable”
Industry
Willing to
Supply
Supply limited; just enough for rich countries
Vaccines $60/dose; doesn’t include vial sizes countries want
Lets start with the money
– GAVI has committed 100 million to an investment in Pneumococcal vaccine, this includes vaccine purchase
Heavy weight donors in the G7 and Gates Foundation have pledged 1.5 billion in an advance market commitment to subsidize the purchase of Pneumococcal vaccines for GAVI countries
The supply outlook looks good
Routine use of pneumococcal conjugate vaccine, including the available 7-valent vaccine, should begin as soon as possible
Countries where 7-valent vaccine is expected to have substantial health impact include those with a high burden of pneumonia and evidence that the serotypes included in the vaccine are responsible for a large proportion of IPD.
Countries
Willing to
Introduce
No WHO recommendation
No WHO disease burden estimates by country

20. Surveillance documents disease patterns

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

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
Strategic Advisory Group of Experts

24. Pneumonia attention does not equate with disease burden
Volume of hits compared to number of child deaths per disease | Source: Projections based on Google Search, July 2006 and The World Health Report 2005 – Make Every Mother and Child Count
Pneumococcal disease coverage remained behind HIV/AIDS, TB, malaria and measles, despite the burden of pneumococcal disease being greater.
HIV/AIDS consistently dominated the media agenda, attracting almost twice as much coverage as all other diseases combined.

25. World Pneumonia Day Coalition

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
Research & Surveillance
>50 countries with quality surveillance
Disease burden, serotype, and cost-effectiveness estimates for every country
Successes in collaboration with WHO
Communications
Increased donor awareness
Increased country level recognition of vaccine value
Established new practices and standards
Access & Implementation
Strategic demand forecast
Affordable, sustainable vaccine supply
Better vaccines
Investment cases for >$1.6 billion

30. “Solution space” status: 2008
Donors/
Countries
Willing to
Finance
GAVI Board endorsed Investment Case for Pneumococcal Vaccines
$1.5 billion for an Advance Market Commitment for pneumococcal vaccines
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
Lets start with the money
– GAVI has committed 100 million to an investment in Pneumococcal vaccine, this includes vaccine purchase
Heavy weight donors in the G7 and Gates Foundation have pledged 1.5 billion in an advance market commitment to subsidize the purchase of Pneumococcal vaccines for GAVI countries
The supply outlook looks good
Routine use of pneumococcal conjugate vaccine, including the available 7-valent vaccine, should begin as soon as possible
Countries where 7-valent vaccine is expected to have substantial health impact include those with a high burden of pneumonia and evidence that the serotypes included in the vaccine are responsible for a large proportion of IPD.
Countries
Willing to
Introduce
WHO recommends pneumococcal vaccine in routine immunization programs
8 approvals, 3 conditional approvals & 34 expressions of interest

31. Number of Countries per year
GAVI Pneumo: actual, recommended and forecasted introductions (Sept. 2010)
Burundi
Benin
CAR
Cameroon
DR Congo
Ethiopia
Gambia
Guyana
Honduras
Kenya
Madagascar
Mali
Malawi
Nicaragua
Pakistan
Rwanda
Sierra Leone
Yemen
Without financial constraints
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
6.4 million Deaths Averted
426 million Cases Averted
To determine the economic benefit of introducing and scaling up coverage of the six vaccines, we first had to project the health impact:
6.4 million child deaths would be averted in the 72 GAVI eligible countries over 10 years
A majority of the averted deaths are due to pneumonia and diarrhea prevention primarily from the introduction and scale-up of PCV and rotavirus vaccines
Important to note that vaccines against pertussis, measles and certain causes of meningitis (hib) are already introduced in most countries, so the health impact of scaling their coverage up to 90% will be lower than vaccines that have yet to be introduced.
426 million cases averted
The share of cases prevented due to rotavirus vaccine is substantially larger than the share of deaths prevented due to the higher incidence and lower severity of diarrhea compared to other syndromes such as meningitis and pneumonia
63,000 severe disabilities due to meningitis sequelae would be prevented from hib and pcv introduction and scale-up
63,000 Disabilities Averted
Due to meningitis prevention
72 GAVI Countries; (inclusive)
Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):

35. Immediate Economic Benefits
Preventing illness could save $6.2 billion ($ b) in treatment costs and $1.2 billion ($ b) in lost output of caretakers
The health impact of vaccines directly results in both immediate and long-term economic benefits
The immediate savings that local governments and households would realize from vaccines could total $7.4 billion ($6.2 from averted treatment costs and $1.2 from lost wages of caretakers). – could total over $800 million annually when coverage of all vaccines reach 90%
A majority of these benefits are again from diarrhea and pneumonia prevention.
The substantial economic savings from a vaccine against malaria becomes apparent after it is introduced in 2015 and scaled up to 90% by 2020.
Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):

36. Long-term Economic Benefits
Future economic output increased by $144 billion ($ B) - Totaling $151 billion ($ B) in immediate & long-term benefits
However, the vast majority (95%) of the economic benefit of vaccines is realized over the long-term.
While $7.4 billion in immediate savings could be realized over the next ten years, reduced mortality and morbidity due to vaccine scale-up could result in $144 billion in increased income over the lifetime of those immunized between
The majority of these economic benefits are realized in three countries (India, Nigeria, Angola). This is not only due to the large populations of India and Nigeria, but also to the fact that both countries have yet to introduce Hib vaccine and that Angola has a relatively high average income.
Immediate Benefits = Treatment costs + Caretaker Productivity
Long-term Benefits = Morbidity Productivity + Mortality Productivity
Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):

37. Main takeaways Dedicated team Use evidence to set consensus & policies
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
Disease burden
Efficacy
Cost-effectiveness
Serotypes
Safety
Establish & organize evidence
Recommendations
Financing
Establish supportive global policies
Evidence-driven advocacy
Vaccine impact
Systems (including surveillance)
Translate policies into local action
Levine OS et al. Curr Op Infect Dis 2010

39. Moving from policy to implementation
Can feel like it’s a lot to handle

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

41. For more information, please visit
Thank you!
For more information, please visit
Thank you for your interest in helping us find Pneumo.

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
yrs since licensure
Pneumo
Years accelerated
Licensure
1990
2000
Africa trial
1993 3
1998 -2 5
Asia trial 8
2002 2 6
Financing 10
2006 4
ADIP created
2005 15
2003 12
1st WHO rec
2nd WHO rec 16
2007 7 9
Procurement
2008
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