DNA Vaccines: Regulatory Considerations and Safety Aspects
DNA vaccines have great potential as preventive or therapeutic vaccines against viral, bacterial, or parasitic diseases as well as cancer, and may also be used as gene therapy products. Although many human and veterinary DNA vaccines have been investigated in laboratory trials, only four of these ha...
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| Veröffentlicht in: | Current Issues in Molecular Biology 2017, Vol.22, p.79-88 |
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| container_title | Current Issues in Molecular Biology |
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| creator | Myhr, Anne Ingeborg |
| description | DNA vaccines have great potential as preventive or therapeutic vaccines against viral, bacterial, or parasitic diseases as well as cancer, and may also be used as gene therapy products. Although many human and veterinary DNA vaccines have been investigated in laboratory trials, only four of these have been approved for commercial use. In this paper an overview of the regulatory requirements for the development of DNA vaccines is given. The regulatory process in EU and USA is described. A discussion concerning the relevance of national regulations on gene technology is included. In addition the main safety concerns associated with DNA vaccines, relating to unwanted side effects in the vaccinated mammal or fish, are presented. Finally, the need for greater openness regarding the assessment information is discussed. |
| doi_str_mv | 10.21775/cimb.022.079 |
| format | Article |
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| fulltext | fulltext |
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| ispartof | Current Issues in Molecular Biology, 2017, Vol.22, p.79-88 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Animals Humans Legislation, Medical Safety Vaccines, DNA - adverse effects Vaccines, DNA - standards |
| title | DNA Vaccines: Regulatory Considerations and Safety Aspects |
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