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

Nakayama Y, Aruga A - Vaccines (Basel) (2015)

Bottom Line: 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.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 Article: PubMed Central - PubMed

Affiliation: 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. yoshi-nakayama@fuji.waseda.jp.

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.

No MeSH data available.


Related in: MedlinePlus

Simplified regulatory pathway from preclinical to the marketing authorization.
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vaccines-03-00186-f005: Simplified regulatory pathway from preclinical to the marketing authorization.

Mentions: In the U.S., an applicant who plans to start clinical trials has to submit an application for the clinical trial, an Investigational New Drug application (IND), which provides the information to assess whether the product is reasonably safe for initial testing in humans by FDA, the manufacturing, the result of animal pharmacology and toxicology studies, and clinical protocols and investigator information. If applicable, the applicant may be able to consult with the FDA as Pre-IND consultation in which the FDA advise the requirements for the IND [32,33]. Then, phase I studies are carried out to assess safety and immunogenicity in a small number of subjects, phase II studies to assess the dosage and the vaccination schedule and phase III studies to verify the protective efficacy of the vaccine in a large number of subjects are typically conducted. After the success of these clinical trials, the applicant can submit a biologics license application (BLA) to the FDA and the application is reviewed by the multidisciplinary FDA reviewer team (i.e., medical officers, microbiologists, chemists, biostatisticians) to make a risk/benefit assessment lead to the recommendation or opposition of the approval of a vaccine. Following the review, the sponsor and the FDA present their findings to the vaccines and related biological products advisory committee (VRBPAC) consists of a non-FDA expert (i.e., scientists, physicians, biostatisticians and a consumer representative) who provides advice to the FDA regarding the safety and efficacy of the vaccine for the proposed indication [34] (Figure 5).


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

Nakayama Y, Aruga A - Vaccines (Basel) (2015)

Simplified regulatory pathway from preclinical to the marketing authorization.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4494244&req=5

vaccines-03-00186-f005: Simplified regulatory pathway from preclinical to the marketing authorization.
Mentions: In the U.S., an applicant who plans to start clinical trials has to submit an application for the clinical trial, an Investigational New Drug application (IND), which provides the information to assess whether the product is reasonably safe for initial testing in humans by FDA, the manufacturing, the result of animal pharmacology and toxicology studies, and clinical protocols and investigator information. If applicable, the applicant may be able to consult with the FDA as Pre-IND consultation in which the FDA advise the requirements for the IND [32,33]. Then, phase I studies are carried out to assess safety and immunogenicity in a small number of subjects, phase II studies to assess the dosage and the vaccination schedule and phase III studies to verify the protective efficacy of the vaccine in a large number of subjects are typically conducted. After the success of these clinical trials, the applicant can submit a biologics license application (BLA) to the FDA and the application is reviewed by the multidisciplinary FDA reviewer team (i.e., medical officers, microbiologists, chemists, biostatisticians) to make a risk/benefit assessment lead to the recommendation or opposition of the approval of a vaccine. Following the review, the sponsor and the FDA present their findings to the vaccines and related biological products advisory committee (VRBPAC) consists of a non-FDA expert (i.e., scientists, physicians, biostatisticians and a consumer representative) who provides advice to the FDA regarding the safety and efficacy of the vaccine for the proposed indication [34] (Figure 5).

Bottom Line: 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.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 Article: PubMed Central - PubMed

Affiliation: 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. yoshi-nakayama@fuji.waseda.jp.

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.

No MeSH data available.


Related in: MedlinePlus