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Introducing New Vaccines: An International Perspective Elizabeth T. Luman, PhD Epidemiologist, Global Immunization Division Centers for Disease Control and Prevention Acknowledgements Stephen Hadler Jon Andrus Vance Dietz Ciro de Quadros Karen Wilkins WHO NIP/CDC

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introducing new vaccines an international perspective

Introducing New Vaccines:An International Perspective

Elizabeth T. Luman, PhD

Epidemiologist, Global Immunization Division

Centers for Disease Control and Prevention

acknowledgements
Acknowledgements
  • Stephen Hadler
  • Jon Andrus
  • Vance Dietz
  • Ciro de Quadros
  • Karen Wilkins
  • WHO
  • NIP/CDC
slide3

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
slide4

Vaccination: Where are we now?

  • Vaccination has controlled 10 major diseases, at least in some parts of the world
slide5

Comparison of 20th Century Annual Morbidity and Current Morbidity, Vaccine-Preventable Diseases, United States

Percent

Decrease

20th Century

Annual Morbidity

2001

48,164

175,885

503,282

152,209

147,271

16,316

47,745

823

1,314

20,000

100

99.99

99.99

99.99

95

100

99.99

99.99

97

99.99

Smallpox

Diphtheria

Measles

Mumps

Pertussis

Polio (paralytic)

Rubella

Congenital Rubella Syndrome

Tetanus

H. influenzae,

type b and unknown (<5 yrs)

0

2

116

266

7,580

0

23

3

37

181

slide6

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
slide7

Global Deaths Due to Vaccine Preventable Diseases - 2000

4.0 million deaths

World Health Organization, 2001

slide8

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
slide9

Key Issues

  • Maintaining equity
  • Reducing morbidity and mortality
  • Strengthening public health infrastructure
slide10

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
slide11

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
slide12

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
slide13

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
slide14

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

slide15

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
introducing new vaccines 3 stages
Introducing New Vaccines: 3 Stages
  • Making a decision
  • Implementing the decision
  • Monitoring the impact
slide17

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

Wait for introduction

Introduce the vaccine

slide18

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
slide19

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?
slide20

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
slide21

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
slide22

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)
slide23

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
slide24

Implementing the Decision

  • Conduct training at all levels
  • Advocacy, social mobilization and communication
  • Conduct supportive supervision
  • Update the health information system
slide25

Monitoring the Impact

Disease Surveillance

Vaccination Coverage Assessment

Adverse Events (AEFI) Surveillance

Special Studies

Post-introduction Program Evaluation

slide26

WHO’s 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?

slide27

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-documents/DocsPDF05/777_screen.pdf

Copies may be requested from:

World Health Organization

Department of Immunization, Vaccines and Biologicals

CH-1211 Geneva 27, Switzerland

Fax: + 41 22 791 4227 Email: vaccines@who.int