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1 Introduction: From Smallpox to SMART Vaccines
Pages 11-26

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From page 11...
... In a pamphlet, On the Origin of the Vaccine Inoculation, published in 1801, Jenner famously articulated the vision of immunizing people against smallpox: An hundred thousand persons, upon the smallest computation, have been inoculated in these realms. The numbers who have partaken of its benefits throughout Europe and other parts of the Globe are incalculable: and it now becomes too manifest to admit of controversy, that the annihilation of the Small Pox, the most dreadful scourge of the human species, must be the final result of this practice.
From page 12...
... For example, in 2011 the Indian government released its national vaccine policy aimed at strengthening the country's framework, infrastructure, and decision-making practices for immunization policies and programs (Government of India, 2011)
From page 13...
... Priorities A Develop a catalogue of priority vaccine targets of domestic and global health importance.
From page 14...
... Study scope and process The first goal of the 2010 National Vaccine Plan is to "develop new and improved vaccines," and the first implementation priority is "to develop a catalogue of priority vaccine targets of domestic and global health impor tance." To accomplish this task the National Vaccine Program Office (NVPO)
From page 15...
... The committee engaged several consultants to assist in achieving its goal: two consultants to help with modeling, two for software development, and eleven experts for evaluating the concept of SMART Vaccines Beta. SMART Vaccines Beta is a result of a modeling effort intended ultimately to help users in making decisions relating to setting vaccine priorities.
From page 16...
... . Industrial sources have recently suggested that in 2011 the worldwide vaccine market was around $23 billion, with continued sale growth expected between 5 and 15 percent annually, with the total market possibly reaching $32 billion by 2017.
From page 17...
... Prioritization efforts in the vaccine enterprise Investment in vaccination as well as in the associated research and production aspects has grown rapidly. The investments are expected to increase
From page 18...
... Poverty Travelers People with Chronic People with Emerging Diseases HIV Infection Infections Cholera Cholera Cytomegalovirus AIDS Influenza Dengue Dengue Influenza Anthrax Pneumococcus Enterotoxigenic Enterotoxigenic Fungal Infections Avian Influenza Pneumocystis Escherichia Coli Escherichia Coli Pseudomonas Cholera Tuberculosis Hepatitis A Virus Hepatitis A Virus Aeruginosa Diphtheria Hepatitis B Virus Hepatitis B Virus Parainfluenza Dengue Influenza Influenza Respiratory Syncytial Ebola Japanese Japanese Virus Enterovirus 71 Encephalitis Virus Encephalitis Virus Staphylococcus Malaria Malaria Malaria Tuberculosis Meningococcal X Meningococcal A Meningococcal A Severe Acute Paratyphoid Parasitic Infections Respiratory Syndrome Rabies Paratyphoid Smallpox Shigella Rabies Tuberculosis Tuberculosis Rotavirus West Nile Typhoid Fever Salmonella Enterica Yellow Fever Salmonella Typhimurium Shigella Tuberculosis Typhoid Fever Yellow Fever FIGURE 1-5 Special target groups for vaccination in the 21st century with a listing of important representative vaccines for each group. Figure 1-5.eps SOURCE: Rappuoli et al., 2011.
From page 19...
... (1955) Human papillomavirus recombinant quadrivalent (2006)
From page 20...
... Very few published prioritization efforts exist, and organizations' internal mechanisms to set priorities are not well known or publicized. Yet, given the vibrancy of the vaccine enterprise, the need for prioritization plans is tremendous.
From page 21...
... But the price of the vaccine will typically decrease over the next decade, and future generations will inevitably benefit from the reduction of disease by having lower health costs, better quality of life, and longer life expectancy. One way to think about this scenario is as follows: If a prioritization model had computed the cost–benefit of the smallpox vaccine before the eradication of the disease, it would have included costs saved only during the first few years following the vaccination, whereas the value for future generations of a world without smallpox would not be included.
From page 22...
... In 2000 the IOM released another consensus study report which contained an updated vaccine prioritization framework and also assessed the barriers to vaccine research and development and recounted the progress that had been made since the 1985–1986 report. That study's focus was on vaccine candidates that had the potential to be developed and used within the next two decades within the United States, so it did not consider the global burden of diseases.
From page 23...
... IVR's efforts have principally focused on identifying diseases that are of highest public health importance for vaccine development. Together with disease impact and burden, IVR has also considered economic restraints on developing and using vaccines as well as the ability to contain or prevent diseases through alternative measures.
From page 24...
... While Pasteur's injunction to "isolate, inactivate, and inject" the microorganism causing the disease is still the mainstay of vaccine development, modern vaccines are also being developed through a number of novel techniques. The combination of genomics, systems biology, the structure-based design and optimization of immunogens, small molecule adjuvants targeting specific receptors, and sophisticated assays to monitor the immune response is transforming the traditional field of vaccinology into one of today's most dynamic areas of research.
From page 25...
... Private Sector: • Development of desired product profiles that clearly Vaccine and describe target population and subpopulation biopharmaceutical segments, potential indications, and key product industry. attributes.
From page 26...
... Systems biology and the adap tive design of clinical trials may help reduce development time by allowing more rapid identification of vaccine candidates and making it possible to conduct the exhaustive and monitored Phase I and Phase II trials in paral lel (Rappuoli and Aderem, 2011)


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