Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes as the development of a novel vaccine could be problematic owing to the starting material often being developed in a research laboratory under ill-defined conditions. This paper examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations that must be addressed during preclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinees chromosomes, and the potential for the formation of anti-DNA antibodies.
CITATION STYLE
Robertson, J. S., & Griffiths, E. (2001). Assuring the quality, safety, and efficacy of DNA vaccines. Applied Biochemistry and Biotechnology - Part B Molecular Biotechnology. https://doi.org/10.1385/MB:17:2:143
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