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AFRICASEPTIC s.a.r.l.
VACCINES and
BIOLOGICALS PRODUCTS
How Africa Will Manage its Own
Healthlcare
National Conference For Clinical Reseaerch (NCCR 2010)
Vaccines And Biologics Summit 2010
Kuala Lumpur , 30 May -04 june 2010
AFRICASEPTIC s.a.r.l.
AFRICASEPTIC s.a.r.l.
Outline Of Presentation
Introduction
Situation analysis
Main Challenges/Constraints
Main Innovations and references
Priorities, perspectives and way forward.
AFRICASEPTIC s.a.r.l.
AFRICASEPTIC s.a.r.l.
34 MILLION CHILDREN ARE NOT FULLY IMMUNIZED FROM VACCINE-PREVENTABLE DISEASES
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IMMUNIZATION SAVES LIVES
PREVENTION is better than CURE
Immunization is one of the most cost-effective health interventions
Immunization is among the safest of modern medical interventions
Immunization is the foundation of the public health system
AFRICASEPTIC s.a.r.l.
2008
Reported DPT3 Coverage African Region,
2007 & 2009
2007 2009
AFRICASEPTIC s.a.r.l.
Measles vaccination coverage in AFR. 2008. (Source: JRF 2008)
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Countries’ Progress Towards
MNT Elimination - African Region
Jan 2005 May 2009Potentially Eliminated
With POAs
No POAs
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Polio in the WHO Africa Region.
2005 - 2009
2005 2009
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Main VPD Priorities In AFRO Region for 2005-2010
Strengthen immunization
systems
Accelerate disease controlIntroduce innovations
1. Strategic Plans
2. Increase coverage to
80%
3. Increase Government
funding
1. Polio-free certification
2. Measles control /
elimination
3. NNT elimination
4. YF control
1. Hep B & Hib&YFV into
routine
2. Vit A in routine
3. New technologies, new
policies & energies
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KEY REFERENCES
Millennium Development Goals (MDGs), especially MDGs-4 &5
Global Immunization Vision and Strategy (GIVS) 2006-2015 as a reference framework
Country plans in line with GIVS
AFRO Strategic orientations 2005-2009
AFRICASEPTIC s.a.r.l.
MDGs-4 & 5
Three out of eight goals, eight of the 16 targets and 18 of the 48 indicators
relate directly to health. Health is also an important contributor to several
other goals
MDG-4 : Reduce under-five child mortality by two thirds by 2015,
compared to 1990
Improve maternal health
AFRICASEPTIC s.a.r.l.
Global Immunization Vision and
Strategy 2006-2015
•Strategic Area 1: Protecting more
people in a changing environment
• Strategic Area 2: Introducing new
vaccines and technologies
• Strategic Area 3: Integrating
immunization and other interventions in
health systems context
• Strategic Area 4: Immunizing in the
context of global inter-dependance
•
AFRICASEPTIC s.a.r.l.
WHO/AFRO STRATEGIC ORIENTATIONS FOR 2005-2009
During these five years, the Regional Office was focus on five priorities:
Strengthening the WHO country offices
Improving and expanding partnerships for health
Supporting the planning and management of district health systems
Promoting the scaling up essential health interventions related to priority health problems
Enhancing awareness and response to key determinants of health.
AFRICASEPTIC s.a.r.l.
PRIORITIES FOR 2006-2009(1)
Strengthening immunization functions and managerial capacity especially at district level
Effective monitoring and assessment of VPD burden
Sustainable supply and quality of vaccines
Safe immunization practices
Introduction of new and underutilized vaccines
Effective VPD control interventions based on available information
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PRIORITIES FOR 2006-2009(2)
Eradicate polio and certify eradication
90% reduction in measles mortality in C and W blocks, elimination in E and S blocks
Implement strategies for MNTE
Reduce frequency and size of YF outbreaks
Translate/adapt/monitor global vaccine norms and strengthen NRAs
Research and development of vaccines and immunization technologies.
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LONG TERM GOALS/VPD
For routine immunization: see GIVS 2006-2015
For polio: Eradicate polio
For measles: Eliminate measles
For MNT: Eliminate MNT
For YF: Achieve control of YF
outbreaks
For other: Control VPDs
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Perspectives for 2006 and beyond (1)
Routine EPI
•Consolidate and expand R.E.D. implementation – using GAVI and other resources
•Focus support on Nigeria and Central Africa block
•High-level advocacy for Hib vaccine uptake using surveillance data
Polio Eradication
•Interrupt WPV transmission by implementing 6 rounds of high quality SIAs in priority
•countries. Further improve AFP surveillance in all districts.
•Sustain high population immunity in polio-free countries (routine)
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Perspectives for 2006 and beyond (2)
Accelerated disease control
•Mobilise resources and support measles SIAs in the remaining countries incl. Nigeria
•Advocacy and resource mobilisation for MNTE
•Implement the YF Strategic Plan approved by TFI in 2004
Integration
•Continue efforts in integrating surveillance and linking SIAs with other
interventions
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WAY FORWARD FOR CB
Develop regional and country CB strategic plans 2006-2010 in line with MDGs, GIVS and
Regional EPI strategic Plan 2006-2010 as well as with Regional and country HR plans
Revise/update EPI norms and standards as well as job descriptions in line with GIVS
Review and standardize existing guidelines, tools and training materials accordingly
Develop a coordinated HR development plan with staffing plans (including deployment plan for
polio staff).
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Recommendations/Training-1
Strengthen the teaching of EPI in the basic training of health personnel to equip the new graduates with recent developments in the programme. The curriculum of pre-service training schools need regular updating on modern EPI policies.
Consideration should be given to institutionalization of the MLM course in three public health training centers in the Region for English, French and Portuguese speaking countries.
AFRO should be encouraged (and supported) to complete entire MLM course by developing the remaining modules.
In view of cost efficiency of the in-country training, partners should increase their support to MLM training at country level. Countries should develop a reliable database on MLM training .
AFRO should continue its strategy to involve more participants from the host country in inter-country workshops with an aim to build up a large pool of national facilitators and to.
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Recommendations/Training-2
Countries should be encouraged to integrate EPI training at district level harmonizing training content, materials, approaches and methods with other programmes providing training in related content (IMCI, RBM, etc.).
There should be a specific follow up of the implementation of the TNA recommendations both at AFRO and country level.
AFRO should maintain an inventory of all training materials produced by the Regional Office, ICPs, partners and countries and share them with schools.
All EPI pre-service and in-service training activities should be linked to supportive supervision activities
AFRO should conduct further operational research on impact of training.
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Recommendations
HR are central to managing and delivering immunization services
The overall challenge in the area of HR for immunization is to ensure relevance of
health personnel to national needs through notably a reorientation of planning,
training and utilization of health personnel.
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Recommendations
It is essential to ensure a health workforce sufficient in numbers, well educated and trained, adequately deployed, managed and motivated.
To progress towards achievement of MDGs, an effective framework is offered by GIVS , WHO/AFRO Strategic Orientations and the Regional EPI Strategic Plan 2006-2009.
Crystal,
the Closed Vial Technology
A Revolution in Vaccine Supply in Africa
National Conference For Clinical Reseaerch (NCCR 2010)
Vaccines And Biologics Summit 2010
Kuala Lumpur , 30 May -04 june 2010
AFRICASEPTIC s.a.r.l.
AFRICASEPTIC s.a.r.l.
Key messages on Africaseptic
•Will manufacture vaccines in Senegal to supply West-Africa
•Is leveraging a revolutionary innovation in aseptic filling: the Crystal technology
•Aims to provide to African people vaccines:
–With the highest quality
–At affordable price
–In due time
–In a container adapted to African constraints
Africaseptic
AFRICASEPTIC s.a.r.l.
Agenda
•Driver of the project
•Overview of Crystal® technology
•Crystal® technology: the vial
•Crystal® technology: the filling line
•Crystal® technology: the key advantages
•Africaseptic concept
AFRICASEPTIC s.a.r.l.
Key issues driving Africaseptic project
•Supply of vaccines is highly depending on good will from large pharmaceutical companies
•Stock-outs are frequent
•Gavi is aiming that Africa will take in its own hands the vaccine supply
Ideal is that vaccines are manufactured in Africa
But…
AFRICASEPTIC s.a.r.l.
Challenges of Aseptic Technologies
Aseptic filling is currently
Still risky
More and more complex
How to make it
EASIER?
SAFER?
Hardly feasible in Africa FEASIBLE?
AFRICASEPTIC s.a.r.l.
Agenda
•Driver of the project
•Overview of Crystal® technology
•Crystal® technology: the vial
•Crystal® technology: the filling line
•Crystal® technology: the key advantages
•Africaseptic concept
AFRICASEPTIC s.a.r.l.
Agenda
•Driver of the project
•Overview of Crystal® technology
•Crystal® technology: the vial
•Crystal® technology: the filling line
•Crystal® technology: the key advantages
•Africaseptic concept
AFRICASEPTIC s.a.r.l.
Vial format
1 ml 2 ml 5 ml 10 ml 20 ml 50 ml
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Vial properties
Vial = isolator at item level
Right angle non return
snap-fits
V-pressure rib
Stopper designed to minimize residual volume of liquid
Resistant to damages
Large piercing area secured by V-pressure rib
Elevated bottom to facilitate particle
inspection
Hydrophobic material to
prevent electrostatic
interactions and siliconization
Anti-counterfeiting
possibilities
AFRICASEPTIC s.a.r.l.
Agenda
•Driver of the project
•Overview of Crystal® technology
•Crystal® technology: the vial
•Crystal® technology: the filling line
•Crystal® technology: the key advantages
•Africaseptic concept
AFRICASEPTIC s.a.r.l.
Closed vial filling line
Production lineUnder construction for GSK Biologicals, monoformat 1 ml, 600 vials/min
AFRICASEPTIC s.a.r.l.
Agenda
•Driver of the project
•Overview of Crystal® technology
•Crystal® technology: the vial
•Crystal® technology: the filling line
•Crystal® technology: the key advantages
•Africaseptic concept
AFRICASEPTIC s.a.r.l.
Key advantages of Crystal® Technology
• For your regulatory team
• For your supply chain team
• For your manufacturing team
• For your QA/QC team
• For your marketing team
• For your financial team
• For your manufacturing team
• For your sales team
For whom?
• Provide a top-class sterility assurance level thanks to a closed ready to fill container
• Secure the products inside an unbreakable and coded container
• Simplify entire filling process (lean manufacturing)
• Quicker initial validation and less follow-up validation work
• Facilitate handle by healthcare specialists
• Reduce capital expenses
• Reduce operating expenses despite vials more expensive than unclean non-sterile glass vials
• Boost sales thanks to better perception by end-users
Why?
SAFER
EASIER
INCREASE
PROFIT
AFRICASEPTIC s.a.r.l.
Agenda
•Driver of the project
•Overview of Crystal® technology
•Crystal® technology: the vial
•Crystal® technology: the filling line
•Crystal® technology: the key advantages
•Africaseptic concept
AFRICASEPTIC s.a.r.l.
Africaseptic concept
•Set up a facility in Senegal able to fill vials with the Crystal® technology
•Buy the bulk from pharmaceutical companies
•Fill the vials in Senegal
•Deliver the vaccines to large organizations (WHO, Unicef, GAVI) but also local governments
•Cover all West-Africa
•Develop filling activities with other injectables such as antibiotics, hormones,…
AFRICASEPTIC s.a.r.l.
Key advantages of Africaseptic concept
•Supply vaccines made with the safest technology
•Ensure supply chain and on-time delivery from Africa to Africa
•Technology transfer from large pharmaceutical companies to Africa
•High value employment in Africa
•Faciliated and simplified supply chain compared to production in other countries
AFRICASEPTIC s.a.r.l.
THANK YOU FOR YOUR
ATTENTION