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  • Title: Assuring the quality, safety, and efficacy of DNA vaccines.
    Author: Robertson JS, Griffiths E.
    Journal: Mol Biotechnol; 2001 Feb; 17(2):143-9. PubMed ID: 11395863.
    Abstract:
    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.
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