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Containment of polioviruses after eradication and OPV cessation: characterizing risks to improve management.

The goal of the World Health Organization is to stop routine use of oral poliovirus vaccine shortly after interruption of wild poliovirus transmission. A key component of this goal is to minimize the risk of reintroduction by destruction of polioviruses except in an absolute minimum number of facilities that serve essential functions and implement effective containment. Effective containment begins with a complete facility risk assessment. This article focuses on characterizing the risks of exposure to polioviruses from the essential vaccine production, quality control, and international reference and research facilities that remain. We consider the potential exposure pathways that might lead to a poliovirus reintroduction, including para-occupational exposures and releases to the environment, and review the literature to provide available estimates and a qualitative assessment of containment risks. Minimizing the risk of poliovirus transmission from a poliovirus facility to increasingly susceptible communities is a crucial and ongoing effort requiring understanding and actively managing the potential exposure pathways.

Containment of Biohazards↗

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.

AIDS Vaccines↗