AFRICASEPTIC s.a.r.l. - cismed-inov.orgAFRICASEPTIC s.a.r.l. WHO/AFRO STRATEGIC ORIENTATIONS FOR...

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



Outline Of Presentation

Introduction

Situation analysis

Main Challenges/Constraints

Main Innovations and references

Priorities, perspectives and way forward.



34 MILLION CHILDREN ARE NOT FULLY IMMUNIZED FROM VACCINE-PREVENTABLE DISEASES


























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


2008

Reported DPT3 Coverage African Region,

2007 & 2009

2007 2009


Measles vaccination coverage in AFR. 2008. (Source: JRF 2008)


Countries’ Progress Towards

MNT Elimination - African Region

Jan 2005 May 2009Potentially Eliminated

With POAs

No POAs


Polio in the WHO Africa Region.

2005 - 2009

2005 2009




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


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


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


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

•


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.


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


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.


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



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)


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


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).


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.


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.


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.


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



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


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


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…


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?


Agenda








Agenda








Vial format

1 ml 2 ml 5 ml 10 ml 20 ml 50 ml


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


Agenda








Closed vial filling line

Production lineUnder construction for GSK Biologicals, monoformat 1 ml, 600 vials/min


Agenda








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


Agenda








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,…


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


THANK YOU FOR YOUR

ATTENTION

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