Introducing New Vaccines: An International Perspective

1
Introducing New VaccinesAn International
Perspective

• Elizabeth T. Luman, PhD
• Epidemiologist, Global Immunization Division
• Centers for Disease Control and Prevention

2
Acknowledgements

• Stephen Hadler
• Jon Andrus
• Vance Dietz
• Ciro de Quadros
• Karen Wilkins
• WHO
• NIP/CDC

3
Vaccination Where are we now?

• Over 300 infectious agents recognised
• More infectious agents becoming recognised as
  causal or triggering agents for many chronic
  conditions
• Vaccines against 25 infectious diseases available
• 1 billion being spent on vaccine research and
  development annually

4
Vaccination Where are we now?

• Vaccination has controlled 10 major diseases, at
  least in some parts of the world

5
Comparison of 20th Century Annual Morbidity and
Current Morbidity, Vaccine-Preventable Diseases,
United States
Percent Decrease
20th Century Annual Morbidity
2001
Smallpox Diphtheria Measles Mumps Pertussis Pol
io (paralytic) Rubella Congenital Rubella
Syndrome Tetanus H. influenzae, type b and
unknown (lt5 yrs)
48,164 175,885 503,282 152,209 147,271 16,316 47,7
45 823 1,314 20,000
100 99.99 99.99 99.99 95 100 99.99 99.99 97 99.99
0 2 116 266 7,580 0 23 3 37 181
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Vaccination Where are we now?

• Vaccination has controlled 10 major diseases, at
  least in some parts of the world
• Over 90 of global birth cohort can be reached,
  but only an average of 80 are vaccinated with
  six basic paediatric vaccines (BCG, DTP, Polio,
  measles), and under 50 in many sub-Saharan
  countries
• About 3 million lives saved per year
• But 4 million more deaths preventable with
  existing vaccines

7
Global Deaths Due to Vaccine Preventable Diseases
- 2000
4.0 million deaths
World Health Organization, 2001
8
Vaccination Where are we now?

• Vaccination has controlled 10 major diseases, at
  least in some parts of the world
• Over 90 of global birth cohort can be reached,
  but only an average of 80 are vaccinated with
  six basic paediatric vaccines (BCG, DTP, Polio,
  measles), and under 50 in many sub-Saharan
  countries
• About 3 million lives saved per year
• But 4 million more deaths preventable with
  existing vaccines
• Infectious diseases still principal cause of
  death world-wide, with 15-17 million deaths
  mostly in developing countries

9
Key Issues

• Maintaining equity
• Reducing morbidity and mortality
• Strengthening public health infrastructure

10
What should we do in the 21st century?

• Complete polio eradication
• Strengthen delivery infrastructure where systems
  are weakest
• Ensure funding for programs in the poorest
  countries
• Create new vaccination financing mechanisms and
  increased allocation of resources

11
What should we do in the 21st century?

• Achieve wider adoption of under-utilised
  vaccines
• Introduce recently-licensed vaccines
• Develop new vaccines and demonstrate their
  utility earlier in developing countries
• Develop simplified and safer methods of
  vaccination delivery
• Expand demand for vaccination through increased
  public confidence and political commitment

12
The Global Immunization Vision and Strategy
(GIVS) 2006-2015 (WHO/UNICEF)
http//www.who.int/vaccines/GIVS/

• Reduce illness and death due to VPDs by 2/3
• Four strategic areas
• Protecting more people in a changing world
• Introducing new vaccines and technologies
• Integrating immunization, other linked
  interventions and surveillance in the health
  systems context
• Immunizing in a context of global interdependence

13
The Global Immunization Vision and Strategy
(GIVS) 2006-2015 (WHO/UNICEF)
http//www.who.int/vaccines/GIVS/

• Reduce illness and death due to VPDs by 2/3
• Four strategic areas
• Protecting more people in a changing world
• Introducing new vaccines and technologies
• Integrating immunization, other linked
  interventions and surveillance in the health
  systems context
• Immunizing in a context of global interdependence

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Status of Vaccine Development and Introduction,
2000
Widespread Use
in National
Programs
Basic
Animal
Phase I
Phase II
Phase III
Licensed
EPI
6
Research
Models
133
79
48
28
8
286
249
Source The Jordan Report
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Approximately 40 new or improved vaccinesare
anticipated by 2015

• Anthrax
• C. trachomatis
• Cholera
• Epstein-Barr virus
• ETEC
• Dengue
• DTaP (with two P antigens)
• Enterotoxigenic Escherichia coli (ETEC)
• Group A streptococcus
• H. pylori
• Hepatitis B improved
• Hepatitis C
• Hepatitis E
• Herpes simplex type 2
• HIV/AIDS
• Hookworm disease
• Human papilloma virus
• Influenza for pandemic response
• Japanese encephalitis (improved)

• Leishmaniasis
• Malaria
• Measles (aerosol)
• Meningococcus A (multi-serotype conjugate)
• New combinations of existing vaccines
• Parainfluenza
• Plague
• Pneumococcus (improved conjugate or
  protein-based)
• Polio (inactivated Sabin strains/monovalent OPV)
• Respiratory syncytial virus
• Rotavirus
• Severe acute respiratory syndrome (SARS)
• Schistosomiasis
• Shigellosis
• Streptococcus (Group A and B)
• Tuberculosis
• Typhoid (conjugate)
• West Nile fever

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Introducing New Vaccines 3 Stages

• Making a decision
• Implementing the decision
• Monitoring the impact

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Making a Decision
Policy Issues
Public health priority
Other interventions (including other vaccines)
Disease burden
Vaccine X
Efficacy, quality and safety
Economic and financial issues
Programmatic Issues
Vaccine presentation
Programmatic strength
Supply availability
Introduce the vaccine
Wait for introduction
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8 Factors to be EvaluatedBefore Making a Decision

• Policy issues
• Is the introduction of the vaccine a public
  health priority in the country?
• What is the burden of disease that the vaccine
  protects against?
• Disease surveillance
• Morbidity, mortality
• Special studies
• Global/regional estimates

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8 Factors to be EvaluatedBefore Making a Decision

• Policy issues
• Is the introduction of the vaccine a public
  health priority in the country?
• What is the burden of disease that the vaccine
  protects against?
• Is there an efficacious and safe vaccine of
  assured quality?
• Are there any other interventions that could be
  more feasible in controlling the disease?
• Is the introduction of vaccine economically and
  financially feasible and sustainable?

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8 Factors to be EvaluatedBefore Making a Decision

• Programmatic issues
• Are the available presentations of the vaccine
  suitable to the needs of the country programme?
• Is there enough vaccine supply in the global
  market to sustain the introduction?
• Is the national immunization program strong
  enough to benefit from an additional vaccine?
• Impact on existing programs
• Impact on distribution system
• Training needs
• Cultural Acceptance

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Implementing the Decision

• Update the multi-year immunization plan
• Choose the right vaccine formulation and
  presentation (vial size, monovalent/combined,
  liquid/lyophilized)
• Decide on the extent of introduction
• (phased, countrywide, only in selected areas)
• Forecast and procure the vaccine and associated
  needs

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Implementing the Decision

• Assure the quality of the vaccine
• Decide on the immunization strategy (routine
  infant immunization, catch-up, high-risk groups)
• Ensure adequate cold chain capacity
• Ensure immunization safety (vaccine management,
  safe injections, waste disposal, AEFI
  surveillance)

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Implementing the Decision

• Conduct training at all levels
• Vaccines
• indications
• contraindications
• administration techniques
• complications
• cold chain requirements
• vaccine injection safety
• How to monitor usage
• Disease reporting
• Supervision

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Implementing the Decision

• Conduct training at all levels
• Advocacy, social mobilization and communication
• Conduct supportive supervision
• Update the health information system

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Monitoring the Impact
Disease Surveillance
Vaccination Coverage Assessment
Adverse Events (AEFI) Surveillance
Special Studies
Post-introduction Program Evaluation
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WHOs Vaccine Introduction Guidelines

• To assist decision-making
• To ensure successful introduction
• To strengthen the program

Why?

• Before Introduction
• During Introduction
• After introduction

When?

• Country decision-makers
• Immunization program managers
• Technical assistance providers

Who?
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Vaccine Introduction Guidelines are produced by
the Expanded Programme on Immunization of the
Department of Immunization, Vaccines and
Biologicals Ordering code WHO/IVB/05.18 Printed
November 2005 This publication is available on
the Internet at http//www.who.int/vaccines-docum
ents/DocsPDF05/777_screen.pdf Copies may be
requested from World Health Organization Departme
nt of Immunization, Vaccines and
Biologicals CH-1211 Geneva 27, Switzerland Fax
41 22 791 4227 Email vaccines_at_who.int
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• Thank You!