VACCINEFACT BOOK2012

Preface“Prevention is better than cure” is a proverb in many other languages as well. This idea iscentral to the development of vaccines, which have transformed human health since the time ofEdward Jenner in the late 18th Century. Smallpox has been eradicated, polio largely controlledand measles and rubella have been targeted for elimination. Bacterial meningitis is becomingrare in countries that vaccinate their children. Acquisition of hepatitis B at birth can now beprevented. All of this and more has been accomplished by the development and deploymentof vaccines. Most of these advances occurred in the last 50 years.
More and more vaccines are being developed and brought into use. Japanese scientists
have contributed to the recent creation of powerful vaccines, notably against pertussis andchickenpox. These two vaccines are used throughout the world. It is, therefore, fitting thatJapan also takes advantage of other new vaccines such as rotavirus, pneumococcal conjugatesand human papillomavirus, which can, respectively, prevent infantile diarrhea and dehydration,
invasive infections and pneumonia, and various forms of cancer, particularly cancer of the cervix
in women. Japanese children and adults should share in the benefits of vaccination. Moreover,
governments have a reason to promote vaccination: better health of a general population
lowers medical costs and is associated with broad economic benefits. Therefore, the vaccine
industry has been growing in importance and in many countries, including Japan, governments
consider vaccine production as a precious resource, for example, to control epidemics of new
types of influenza and other emerging infections.
New techniques and strategies of vaccine development are being constantly discovered and
it is likely there will be more diseases that can be prevented. It will be challenging to educate
physicians and the public about vaccines and to find the best ways to implement vaccination.
Nevertheless, industrialized and poor countries will want their populations to have access topreventive measures that make life better and safer.
This book seeks to explain to non-specialists what vaccines do, how they are developed,
how they are given, and what results have been obtained when they are routinely used. It isa dramatic and impressive story, but unfortunately not well understood by the general public.
However, once people understand it is likely that they will demand that vaccines be madeavailable to them in sufficient quantity and at an affordable price.
I know that my dear student and friend, the late Hitoshi Kamiya, would have agreed with me.
Hitoshi studied in my laboratory at Philadelphia Children’s Hospital in 1981. After his returnto Japan, we kept in touch and I had the opportunity to visit him many times. I watched him
become the chief exponent of vaccines in Japan through his knowledge and the force of hispersonality. Hitoshi Kamiya’s untimely death was a tragedy and I miss him very much. I would
like to dedicate this book to his memory because he was a remarkable person and did muchgood for his country.

Stanley A Plotkin, MD
Emeritus Professor of Pediatrics
University of Pennsylvania

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Contents

1
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8

Basic Concept of Vaccination
Definition of Vaccines....................................................................................................... 4Survey of Vaccine Preventable Diseases ....................................................................... 12
Vaccine Efficacy and Safety........................................................................................... 18
Vaccine Safety Surveillance and Evaluation .................................................................. 25
Vaccine Injury Compensation Systems ......................................................................... 29
Cost-Effectiveness Analyses and Evaluation................................................................. 36
Vaccine Implementation Options ................................................................................... 40
National Immunization Recommendation Systems ....................................................... 43

22.1
2.2
2.2.1
2.3
2.3.12.42.5
2.5.1
2.5.2
2.5.3

Vaccine Development and Implementation
The Global Vaccine Market ............................................................................................ 53
Vaccine Development .................................................................................................... 54
Clinical Development ..................................................................................................... 55
Vaccine Manufacturing .................................................................................................. 57
Cost Trends in Vaccine Development and Manufacturing ............................................. 59
Vaccine Registration and Approval ................................................................................ 60
Vaccine Funding ............................................................................................................ 65
US Advisory Committee on Immunization Practices (ACIP) .......................................... 65
Australia ......................................................................................................................... 67
Other .............................................................................................................................. 68

33.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9

Public Health Effectiveness of Vaccine Implementation
Polio Eradication, Global ............................................................................................... 70
Haemophilus Influenzae Type B (Hib) ............................................................................ 73
Mumps ........................................................................................................................... 75
Measles Eradication, Global .......................................................................................... 76
Rotavirus ........................................................................................................................ 78
Human Papillomavirus (HPV) ......................................................................................... 82
Pneumococcal Disease ................................................................................................. 88
Varicella Zoster Virus (VZV) ............................................................................................ 92
Hepatitis B ..................................................................................................................... 94

44.1
4.2
4.3
4.4
4.5
4.5.1

Vaccines in Use
Globally .......................................................................................................................... 96
US .................................................................................................................................. 97
European Union ........................................................................................................... 100
Australia ....................................................................................................................... 101
Japan ........................................................................................................................... 102
Current Situation in Japan ........................................................................................... 103

5

Vaccines in Development .......................................................................................... 104

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