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Abstract
Technologies for making active vaccines fall into 3 general groups: live, subunit
(killed or inactivated) and genetic. Each of these groups is further divisible into
multiple categories, which include recombinant-derived antigens as well as native
microorganisms and their components. In addition, there are new enabling technologies
such as delivery systems and vectors which can be applied to these approaches. Most
disease targets, whether infectious or noninfectious in origin, can be approached
by the application of several different vaccine technologies, as can be tested during
the discovery phase of research. The criteria for choosing early in a development
program which of the vaccine technologies are likely to ultimately be most fruitful
for a given application include: knowledge of the pathogenesis of the given infection/disease;
technical feasibility; immunobiology and associated mechanisms; preclinical efficacy
profile; anticipated clinical safety; regulatory; manufacturing; and marketing. All
of these criteria should be considered together in making selections for an R&D program.
This paper is reviewing the major vaccine technologies and relevant examples of how
these criteria are used to make decisions in vaccine development.