Introducing New Vaccines: An International Perspective

1. Introducing New Vaccines:An 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 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

6. 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

14. 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

15. 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

16. Introducing New Vaccines: 3 Stages • Making a decision • Implementing the decision • Monitoring the impact

17. 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

18. 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

19. 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?

20. 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

21. 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

22. 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)

23. 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

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

25. Monitoring the Impact Disease Surveillance Vaccination Coverage Assessment Adverse Events (AEFI) Surveillance Special Studies Post-introduction Program Evaluation

26. 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?

27. 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

28. Thank You!