Obtaining marketing authorization for nucleic acid vaccines in the European Union.
Nucleic acid vaccines are promising candidates for easy-to-handle and cost-effective vaccines that combine the safety of subunit vaccines with the efficacy of live virus vaccines. In order to obtain marketing authorization for a nucleic acid vaccine in all member states of the European Union, a single application dossier has to be filed with the European Agency for the Evaluation of Medicinal Products. Notes for Guidance on the data necessary to support applications are available. The preclinical development of nucleic acid vaccines has to follow procedures of contained use according to the relevant EC directives which were translated into the German Gene Law. Clinical trials in Germany would follow the known procedures defined in the German Drug Law, whereas the Gene Law is not applicable. Clinical trials should be started only after having obtained consent of the Commission for Gene Therapy Trials formed under the auspices of the Federal Chamber of Physicians. Experience in intramuscular nucleic acid inoculation of animals has been gained using expression constructs comprising single and multiple genes of simian immunodeficiency virus. Specific antibodies were induced against multiple antigens. No adverse effects of nucleic acid inoculations were found, but more rigorous testing of specific safety problems will have to be performed.
Department of Medical Biotechnology, Paul-Ehrlich-Institute, Langen, Germany.
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D016915:AIDS Vaccines; D000818:Animals; D016665:Cercocebus atys; D002986:Clinical Trials as Topic / Q000592:standards; D003264:Containment of Biohazards; D004274:DNA, Recombinant / Q000008:administration & dosage / Q000009:adverse effects; D005060:Europe; D005062:European Union; D005858:Germany; D007273:Injections, Intramuscular; D008253:Macaca mulatta; D051379:Mice; D008807:Mice, Inbred BALB C; D012449:Safety; D015302:Simian Immunodeficiency Virus / Q000276:immunology; D014611:Vaccination / Q000331:legislation & jurisprudence*; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects
D016915:AIDS Vaccines; D004274:DNA, Recombinant; D014614:Vaccines, Synthetic