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. 2011 May;127 Suppl 1(Suppl 1):S9-15.
doi: 10.1542/peds.2010-1722C. Epub 2011 Apr 18.

Integrating safety and efficacy evaluation throughout vaccine research and development

George Curlin  1 , Sarah Landry, Jessica Bernstein, Richard L Gorman, Barbara Mulach, Charles J Hackett, Stephanie Foster, Sarah E Miers, Patricia Strickler-Dinglasan
Affiliations

Integrating safety and efficacy evaluation throughout vaccine research and development

George Curlin et al. Pediatrics. 2011 May.
No abstract available

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Figures

FIGURE 1
FIGURE 1
Stages of vaccine research, development, and evaluation. Safety evaluation is integral to every stage of the product-development pathway. This pathway begins with basic research, which involves understanding the pathogen's mechanism of action, the interaction between pathogen and host, and the host response. Target identification entails studying the biological plausibility of particular strategies for creating a vaccine against the pathogen. In preclinical development, the candidate vaccine is tested in vitro and evaluated for safety and biological response in relevant animal models. If the vaccine candidate successfully passes all the preclinical stages, it is then evaluated in humans by using a phased clinical approach. The candidate vaccine can then be passed on to entities outside of the NIH, such as other federal agencies and industry, for advanced development, licensure, manufacturing, and postlicensure safety evaluation.
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