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Vaccines 2015, 3(1), 186-202; doi:10.3390/vaccines3010186

Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
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Author to whom correspondence should be addressed.
Academic Editor: Diane M. Harper
Received: 29 November 2014 / Accepted: 6 March 2015 / Published: 18 March 2015
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Abstract

Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region. View Full-Text
Keywords: regulation; guidelines; plasmid DNA vaccines; viral-vectored vaccines; gene therapy; genetically modified organism regulation; guidelines; plasmid DNA vaccines; viral-vectored vaccines; gene therapy; genetically modified organism
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Nakayama, Y.; Aruga, A. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan. Vaccines 2015, 3, 186-202.

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