Vaccine Supply and Innovation (1985) / Chapter Skim
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2 Vaccines: Past, Present, and Future
2 Vaccines: Past, Present, and Future
Pages 14-26
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From page 14... ...
pathogens or components of a pathogen.] Examples of whole, inactivated vaccines include currently licensed pertussis vaccines, influenza vaccines, and the Salk poliovirus vaccine.
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From page 15... ...
It was repealed in 1822, after Congress decided that vaccine regulation should be left to local authorities. The apparent success of early smallpox vaccination efforts and the developing science of microbiology led to other attempts to control feared infectious diseases in the late nineteenth century.
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At first, warnings by responsible authorities went essentially unheeded.6 Concerns about uncontrolled production of smallpox vaccine and diphtheria antitoxin were expressed in editorials in the Journal of the American Medical Association late in 1894.7'8 The potential role of state governments in supervising the propagation of vaccine virus was discussed at the National Conference of State Boards of Health held that December.7 The recognized variability in the efficacy of different smallpox vaccines was attributed, at least in part, to defective preparations. On December 5, 1894, the New York City Board of Health instructed the Health Department to develop a plan that would assure the potency and purity of diphtheria anti-e Oxin preparations sold in New York City.8 Although antitoxin shipped in small amounts from two German manufacturers appeared to exhibit acceptable purity and efficacy, some antitoxins from the United States were never subjected to testing and at least one that was tested was inert.
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Increasing evidence in the early 1900s of the effectiveness of diphtheria antitoxin and smallpox vaccination led to the idea that many or all infectious diseases might be amenable to immunologic prevention and therapy. Tetanus antitoxin, prepared in horses, came into general use in the military during World War I
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, adenovirus infections, meningococcal disease, and others. It is clear that vaccines widely employed as public health measures in the United States and other industrialized countries have had an enormous impact on morbidity and mortality.
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, two state laboratories, and one university are licensed to produce one or more vaccines for use in the united States. Vaccines against 20 different infectious diseases are marketed, several in various combinations.
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Commercial manufacturers rarely consider the possibility of a specific vaccine until the groundwork has been laid, typically by academic or government researchers. The most basic technical requirement is the ability to consistently produce the organism (maintaining its immunogenicity)
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Phase 1 and 2 studies often overlap, and the results provide the basis for Phase 3 studies, which are controlled field trials with sufficient study subjects to develop reasonable estimates of safety and efficacy. Efficacy usually is measured in terms of protection against clinical disease.
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The license application process includes review of all records of production, testing, and clinical evaluation by the OBRR. The product itself is submitted to laboratory testing by appropriate scientists at the OBRR, who also conduct on-site inspection of the production facilities.
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The greatest advances have occurred in the area of viral vaccines, but it is expected that these techniques also will be applicable to the production of bacterial vaccines and, ultimately, parasitic vaccines. Among the approaches available are:22 Recombinant DNA Techniques In this approach, the genetic material responsible for production of the immunity-inducing antigen is incorporated into the genetic apparatus of another replicating virus, bacterium, yeast, or animal cell.
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The idiotype of an antibody molecule is a recognition site located at or near its antigen-binding site;22 the idiotype acts as an antigenic site when the body makes anti-antibody molecules (a natural immune system mechanism used to control the level of antibodies in the blood)
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that deter development of vaccines by traditional methods. These problems must be resolved before the full public health benefits of new approaches to vaccine development can be achieved.
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This report presents the findings of the Institute of Medicine's Committee on Issues and Priorities for New Vaccine Development, which was asked by the National Institute of Allergy and Infectious Diseases, NIH, to design a comprehensive approach to setting priorities for accelerated vaccine development. The method developed by the committee is based on a quantitative model in which vaccine candidates are ranked according to two principal characteristics: expected health benefits (reduction of morbidity and mortality)
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