Post on 18-Jan-2016
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Vaccine Preventable Diseases:Pneumococcal Vaccine
An Opening Wedge for New Vaccine Introduction and Development
Presented by:Christopher W. Woods
Slides Prepared by Orin LevineExecutive Director, International Vaccine Access Center
Professor, International HealthJohns Hopkins Bloomberg School of Public Health
Other Remedies of the Time
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
Expanded Program on Immunization
Why is new vaccine introduction important?
• Child mortality rates remain unacceptably high in many countries– Injustice– Expensive– Destabilizing
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.”
Why is new vaccine introduction important?
AIDS
Diarrhea
Pertussis
Measles
Meningitis
Malaria
Pneumonia
1.58M pneumonia deathsamong children < 5 years
Causes of 8.8M child deaths, 2008 (Black et al. Lancet 2010)
Annual deaths & deaths averted by vaccines
9
2.5m
il de
aths
ave
rted
Source: W. Orenstein, Gates Foundation; WHO, Burden of Disease 2004, released 2008
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
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
If you build it, they will come…
It worked in the movie but does it work for new vaccine introduction?
Global Hib Vaccine Uptake High and Low Income Countries
Vicious Cycle That Delayed Hib Vaccines
Limited supply
Higher price
Uncertain demand
3) Higher prices keep developing countries uncertain about demand and donors uncertain about financing needs
1) Uncertainty about demand in developing countries leads industry to limit investments in capacity
2) Limited vaccine supply keeps prices relatively high
Saving lives requires finding “solution space”
15
Solution space where
lives are saved
Industry willing to supply
Donors & countries willing to pay
Countries willing & able to introduce
Pneumococcal conjugate vaccine• Licensed in 2000• Leading cause of childhood pneumonia &
meningitis deaths• Proven safe, effective
7 deaths preventedper 1000 vaccinatedin African trial of 9v vaccineCutts F et al Lancet 2005
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.
Global Alliance for Vaccines and Immunisation (GAVI): PneumoADIP
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.
“Solution space” status: 2003
• 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
CountriesWilling toIntroduce
No WHO recommendation
No WHO disease burden estimates by country
Donors/CountriesWilling toFinance
Surveillance documents disease patterns
Epidemiology, effectiveness, & economics
WHO Disease Burden Estimates by Country
Serotype Distribution by Region
?How much pneumococcal disease do we have in children?
?How well with the vaccine match our serotypes?
Epidemiology, effectiveness, & economics
Cost-Effectiveness & Health Impact Estimates by Country?How cost-effective will the vaccine be in our country?
On-line web tool for national estimates using local data
Global Vaccine Policy at WHO
malaria
TB
HIV/AIDS
pneumonia (observed)
pneumonia (predicted)
0
100
200
300
400
500
600
700
800
900
0 0.5 1 1.5 2 2.5 3 3.5 4
Deaths (in millions)
Go
og
le h
its
(in
mil
lio
ns)
Pneumonia attention does not equate with disease burden
World Pneumonia Day Coalition
http://worldpneumoniaday.org/
Illustrative
Illustrative
Investment case
Major PneumoADIP accomplishments“GAVI’s efforts have truly accelerated the demand for
pneumococcal vaccines.”– GAVI Phase 2 Independent Evaluation
“Solution space” status: 2008
• GAVI Board endorsed Investment Case for Pneumococcal Vaccines
• $1.5 billion for an Advance Market Commitment for pneumococcal vaccines
Industry Willing to
Supply
Multinational & emerging manufacturers now committed to supply GAVI countries
Vaccines will have high serotype coverage, affordable price, and good vial size
CountriesWilling toIntroduce
WHO recommends pneumococcal vaccine in routine immunization programs
8 approvals, 3 conditional approvals & 34 expressions of interest
Donors/CountriesWilling toFinance
GAVI Pneumo: actual, recommended and forecasted introductions (Sept. 2010)
BurundiBenin
CAR
Cameroon
DR Congo
Ethiopia
Gambia
GuyanaHonduras
Kenya
Madagascar
Mali
Malawi
Nicaragua
Pakistan
Rwanda
Sierra Leone
Yemen
Forecast
ActualRecommended
Number of
Countries per year
Slide courtesy Lauren Franzel, PATH
Pneumococcal Vaccine Access Accelerated, Compared to Hib
The value of accelerated vaccine introduction
Source: GAVI website
COI Results - Health Impact of Vaccine Scale-up
6.4 million Deaths Averted 426 million Cases Averted
63,000 Disabilities AvertedDue to meningitis prevention
72 GAVI Countries; 2011-2020 (inclusive)Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028.
Immediate Economic BenefitsPreventing 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.
Long-term Economic BenefitsFuture economic output increased by $144 billion ($120-168B) -
Totaling $151 billion ($131-176B) in immediate & long-term benefits
Immediate Benefits = Treatment costs + Caretaker ProductivityLong-term Benefits = Morbidity Productivity + Mortality Productivity Source: Stack ML, et al. Health Aff (Millwood). 2011;30(6):1021-1028.
Main takeaways
1. Dedicated team1. Team that “sweats the details” every day
2. Use evidence to set consensus & policies1. Need “push” to move into implementation
3. Strategic demand forecast1. Lays out “what will it take” for each stakeholder
Evidence to policy to implementation
Levine OS et al. Curr Op Infect Dis 2010
Moving from policy to implementation
Can feel like it’s a lot to handlehttp://www.youtube.com/watch?v=8NPzLBSBzPI
Opportunities & Challenges
Opportunities• Impact on child health &
economies• Success breeds success• Improved equity
Challenges• Biggest ever coordination
needed• Maintaining focus in face of
competing priorities• Economic setbacks
Thank you!
For more information, please visit
www.jhsph.edu/ivac
www.preventpneumo.org
www.sabin.org/PACE
Global Pneumococcal Vaccine Uptake High & Low Income Countries
Historical Hib Introduction by Income Group
Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).
Global PCV Introduction Status
Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).
GAVI Countries PCV Introduction Status
Source: Johns Hopkins University IVAC. VIMS Report: Global Vaccine Introduction (August, 2011).
Pneumococcal is learning from Hib
Hibyrs since licensure Pneumo
yrs since licensure
Years accelerated
Licensure 1990 0 2000 0 0
Africa trial 1993 3 1998 -2 5
Asia trial 1998 8 2002 2 6
Financing 2000 10 2006 6 4
ADIP created 2005 15 2003 3 12
1st WHO rec 1998 8 2003 3 5
2nd WHO rec 2006 16 2007 7 9
Procurement 1998 8 2008 8 0
Significant acceleration of “evidence”, recommendations, advocacy and financing but little improvement in access to
supply and Unicef procurement
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.
Supplier perspective: Volumes / yr
Country/donor perspective: $ / yearIllustrative