netSPEAR Foundation Meeting

1
netSPEAR Foundation Meeting

• November 17, 2003
• Nairobi, Kenya

2
Why do we have a PneumoADIP?

• Because.
• Pneumococcus is a major cause of deaths worldwide
• Effective pneumococcal vaccines exist
• Affordable pricing of these vaccines is possible
• Without an ADIP, 15-20 years will pass before
  these vaccines save lives in the countries least
  able to purchase them

3
ARI is a huge disease burden even if global
leaders have trouble seeing the problem
4
Pneumococcus is a major cause of deaths due to.

• Acute Respiratory Infections
• ARI is the leading infectious killer globally
• Most ARI deaths are due to bacterial pneumonia
• S. pneumoniae is the leading cause of bacterial
  pneumonia
• Meningitis and Sepsis
• Pneumococcal meningitis kills or disables over
  50 of patients
• Sepsis deaths often undetected

5
Leading infectious causes of mortality, 2000
estimates
70 of all childhood ARI deaths occur in
sub-Saharan Africa and South Asia
3.5
gt 5 years old
3.0
2.5
Deaths (millions)
2.0
1.5
1.0
0.5
0
Source WHO
6
Evidence for higher case-fatality rate in
bacterial vs. viral pneumonia
7
Lung puncture studies of infants and children
with pneumonia demonstrate role of pneumococcus
8
Pneumococcal Meningitis Results in Significant
Mortality and Longterm Morbidity
0-12 year old, Gambian children with meningitis,
1990-95
Goetghebuer T. Trop Health and Intern Med 2000
9
Pneumococcal Infections Can Be Prevented
10
Effective pneumococcal vaccines exist

• Invasive disease endpoint
• Pneumonia endpoint
• Otitis media endpoint
• Nasopharyngeal carriage endpoint
• Reduction in antibiotic use
• Indirect effects

11
Pneumococcal Conjugate Vaccine Prevents VT
Invasive Disease
Refs Black et al PIDJ 2000 OBrien et al
Lancet 2003 Klugman et al NEJM 2003
12
Pneumococcal Conjugate Vaccine Prevents CXR
Confirmed Pneumonia
Refs Black et al PIDJ 2001 Klugman et al NEJM
2003
13
Pneumococcal Conjugate Vaccine Reduces
Pneumococcal Disease in Unvaccinated People
(Indirect Effect)
2002 vs 1998/99
65 years
- 29
40-64 yrs
- 20
20-39 yrs
- 46
5-19 yrs
- 23
C. Whitney, CDC unpublished ABCspreliminary data
14
Success Requires a Rational Process for Vaccine
Introduction
15
Without an ADIP, even a great offer like free or
cheap vaccine may not be accepted
16
Breaking the Vicious CircleAccelerated
Development Introduction Plan (ADIP)
Increased supply
Limited supply
Lower price
Higher price
Uncertain demand
Predictable demand
17
(No Transcript)
18
ADIP is focusing on earlier, faster uptake for
the worlds poorest children
ESTIMATE
GAVIs objective is to prevent deaths sooner by
shifting the uptake curve to the left by
increasing its slope
Million doses
HepB all developing countries
Hib all developing countries
Years from availability
19
GAVIs PneumoADIP at Johns Hopkins
Mission To improve child health by accelerating
the evaluation of and access to new, life-saving
pneumococcal vaccines for the worlds poorest
children.
20
GAVIs PneumoADIP Primary Aim
To provide sufficient information to.. GAVI,
Vaccine Fund, Donors, Regions and
Countries.. about the investment case in
pneumococcal conjugate vaccines that a rational
decision can be made about its introduction and
funding.
Identify key drivers of the investment case
Identify missing pieces of key data
Fill those key voids
21
PneumoADIP team and its relationship to GAVI,
JHSPH WHO
JHSPH Dept. of International Health
Key Strategic Partner
PneumoADIP Team
WHO (MOU with IVR)
22
ADIP team is structured to address demand and
supply issues
Communicate value
Deliver value

• Assure adequate supply
• Secure sustainable funding
• Continuously refine demand forecasts
• Assure delivery system

• Improve awareness of disease burden vaccine
  effectiveness
• Education, meetings, key messages

Reliable supply of affordable vaccine and assured
financing
Generate political will to prioritize disease
prevention and vaccine introduction
23
Establish Value
RESEARCH Maria Knoll, Director Kate OBrien,
Deputy Dir. Farzana Muhib, Coordinator
24
ADIPs Establish Value Activities

• GOAL
• By 2007, prepare target countries for realizing
  national vaccine demand by providing core
  information on disease burden vaccine impact to
  enable local decision-makers, GAVI, and its
  partners to prioritize pneumococcal vaccine
  introduction.

Disease burden (country level emphasis)
Economics (country/regional)
Vaccine safety and efficacy (regional/representati
ve)
Pneumonia (hospital and population
based) Serotype distribution Other outcomes (e.g.
antimicrobial resistance, otitis media, invasive
disease)
Cost of illness/death Cost-effectiveness of
vaccination
Trials (immunogenicity, alternate regimens,
efficacy?) Demonstration projects
25
ADIPs Establish Value Activities

• CORE DATA
• Pneumonia burden
• Serotype distribution

Invasive Pneumococcal Disease
Each country will have Core Data PLUS 1 or more
of the following disease outcomes -Countries
select most appropriate data for their
individual situation
Mortality
Otitis Media
Antimicrobial resistance
Meningitis
Additional data
26
Working through networks

• ADIP strategy built on working through networks
  wherever possible
• Networks
• Improve comparability across sites
• Provide peer to peer interaction to improve
  quality
• Assure communication of findings across borders
• Promotes sharing of best practices and
  south-south collaborations

27
ADIP sponsored surveillance sites

Funded Countries 8 Total Population gt300
million
Proposed for 2004 Number of Countries gt20 Total
population gt3 Billion
28

Will current clinical trials provide data
representative of all VF eligible countries?
?
?
?

Phil
Gambia
SA
Eligible for new vaccines
Not eligible for new vaccines
October 2001
29
Communicate Value

• Hans Kvist
• Director, Communications

30
PneumoADIP Communications

• Develop a global communication plan outlining
  strategic long term objectives
• Containing
• Overall objectives
• Target audiences
• Key messages
• Communication channels
• Communication activities
• Milestones

31
Deliver Value

• Angeline Nanni
• Director, Vaccine Supply Financing

32
Deliver value activities

• Develop an actionable proposal for procuring an
  affordable, sustainable supply of pneumococcal
  vaccine sufficient to meet projected demand in
  the worlds poorest countries by 2007.

Assess Demand
Assess Supply
Finance / Deliver
Coordinate demand forecast process for
Vaccine-Fund eligible countries develop strategy
for country prioritization
Draft price / volume agreement for consideration
by manufacturers and donors address regulatory
obstacles
Evaluate potential financing options match
vaccine infrastructure with requirements build
investment case, including risk assessments
33
New vaccines are not going to cost what old
vaccines do
However..

• An affordable price for the international
  community and countries is possible
• ADIP attempting to anticipate and influence the
  decline in price
• Major determinant is a clear indication by
  countries of willingness to use and finance
  vaccine
• Necessitates a demand driven not a supply driven
  introduction

34
What makes GAVIs pneumococcal ADIP different
from past efforts?
35
Value of Pneumococcal Surveillance to East
African Countries

• Burden of disease
• Serotype distribution
• Antibiotic resistance profiles
• Cost effectiveness analyses
• Baseline measures will enable assessment of
  vaccine impact following introduction

36
Successful introduction of conjugate pneumococcal
vaccine could potentially prevent thousands to
millions of deaths globally
160,000 deaths prevented 20062012
1.9 million deaths prevented 20132020 (300,000
without ADIP)
2006
2008
2010
2012
2014
2016
2018
2020
ESTIMATE
660,000 deaths estimated for 2006 (1.7 million
ARI deaths, 38 Pneumococcal share). Not expected
to decline over time (TBC). Source Article
(Estimates of world wide distribution of child
deaths from acute respiratory infections (Lancet
2002Williams)) team analysis