Abstract
DNA vaccines combine the biotechnological manufacturing aspects of a subset of gene therapeutic medicinal products with the mode of action of a classical vaccine. Due to this hybrid state, the regulation of DNA vaccines requires the expertise from both gene therapy and vaccine experts. This chapter will provide an overview of the regulatory status and requirements for DNA vaccines intended for human use. We first introduce the regulatory process in Europe and in the USA and then highlight the most relevant aspects of the already existing guidance documents for DNA vaccines.DNA vaccines combine the biotechnological manufacturing aspects of a subset of gene therapeutic medicinal products with the mode of action of a classical vaccine. Due to this hybrid state, the regulation of DNA vaccines requires the expertise from both gene therapy and vaccine experts. This chapter will provide an overview of the regulatory status and requirements for DNA vaccines intended for human use. We first introduce the regulatory process in Europe and in the USA and then highlight the most relevant aspects of the already existing guidance documents for DNA vaccines.
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Klug, B., Reinhardt, J., Robertson, J. (2012). Current Status of Regulations for DNA Vaccines. In: Thalhamer, J., Weiss, R., Scheiblhofer, S. (eds) Gene Vaccines. Springer, Vienna. https://doi.org/10.1007/978-3-7091-0439-2_14
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DOI: https://doi.org/10.1007/978-3-7091-0439-2_14
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