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Appendix B
PATHOGENIC AGENTS FOR WHICH ACCELERATED VACCINE DEVELOPMENT DOES NOT APPEAR APPROPRIATE

Judging the Feasibility of Accelerated Vaccine Development

The selection of candidates for accelerated vaccine development depends in part on the mechanisms used to promote development. In the broadest sense, accelerated development could refer to any increase in emphasis or funding at any point along the continuum from disease definition and basic research through clinical trials to licensure.

In the early phases of vaccine development, the questions that need to be answered and the methods most appropriate for answering them may be difficult to define. A diversity of approaches may be desirable until a scientific consensus emerges on the research directions most likely to be productive. Once the pathways for development have been set, however, the tasks needed to bring the vaccine to licensure are easier to identify and place in a uniform framework.

The National Institute of Allergy and Infectious Diseases’ (NIAID) influence to accelerate development is most likely to be effective in the latter stages of the continuum, probably through the contract mechanism. One of the committee’s first responsibilities was to identify vaccine candidates “ready” for this type of support. Candidates were included in the ranking exercise described in Chapter 3 if committee members and knowledgeable consultants believed that their successful development was probable within ten years. Candidates excluded from the analysis are described briefly, in alphabetical order, later in this appendix. (In several cases, reasonable vaccine candidates were excluded because they do not have a significant disease burden in the United States. These will be included in a separate report on vaccine development for technologically less developed countr ies.)

The knowledge required to determine the feasilibity of accelerated development covers a wide spectrum, from characteristics of the pathogen to the composition of the target population. The latter is important not only for cost-effective vaccine delivery, but also to determine whether there is sufficient motivation to achieve reasonable utilization. No checklist can replace experienced judgment in assessing vaccine feasibility, but it is possible to identify certain factors that generally facilitate vaccine development (although all may not be essential):



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