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

Vaccines
Yoshikazu Nakayama, Atsushi Aruga

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.

References

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Citations

Dec 28, 2018·Biotechnology & Genetic Engineering Reviews·Armando Tejeda-MansirPatricia Guerrero-Germán
Apr 11, 2019·Human Gene Therapy. Clinical Development·Vaishali ShuklaRosa Rodriguez-Monguio
Aug 31, 2020·Clinical and Experimental Vaccine Research·Sandeep Divate SathyanarayanaRavi Gundadka Shriram

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