Regulatory aspects of quality and safety for live recombinant viral vaccines against infectious diseases in Japan

Akira Sakurai; Takashi Ogawa; Jun Matsumoto; Tetsunari Kihira; Shinji Fukushima; Ippei Miyata; Hideaki Shimizu; Shigeyuki Itamura; Kazunobu Ouchi; Atsuro Hamada; Kenzaburo Tani; Nobuhiko Okabe; Teruhide Yamaguchi

doi:10.1016/j.vaccine.2019.08.031

Regulatory aspects of quality and safety for live recombinant viral vaccines against infectious diseases in Japan

Vaccine. 2019 Oct 8;37(43):6573-6579. doi: 10.1016/j.vaccine.2019.08.031. Epub 2019 Sep 7.

Authors

Affiliations

¹ Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg., 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: sakurai-akira@pmda.go.jp.
² Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg., 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: ogawa-takashi@pmda.go.jp.
³ Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg., 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: matsumoto-jun@pmda.go.jp.
⁴ Office of Vaccines and Blood Products, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg., 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: kihira-tetsunari@pmda.go.jp.
⁵ Travellers' Medical Center, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan. Electronic address: fuku789@tokyo-med.ac.jp.
⁶ Department of Pediatrics, Kawasaki Medical School, 577 Matsushima, Kurashiki-Shi, Okayama 701-0192, Japan. Electronic address: miyata.kkcl@gmail.com.
⁷ Kawasaki City Institute for Public Health, Life Science and Environment (LiSE) Research Center 2F, 3-25-13 Tono-Machi, Kawasaki-Ku, Kawasaki-City, Kanagawa 210-0821, Japan. Electronic address: shimizu-h@city.kawasaki.jp.
⁸ National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama-Shi, Tokyo 208-0011, Japan. Electronic address: sitamura@nih.go.jp.
⁹ Department of Pediatrics, Kawasaki Medical School, 577 Matsushima, Kurashiki-Shi, Okayama 701-0192, Japan. Electronic address: kouchi@med.kawasaki-m.ac.jp.
¹⁰ Travellers' Medical Center, Tokyo Medical University Hospital, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan. Electronic address: a-hamada@tokyo-med.ac.jp.
¹¹ Project Division of ALA Advanced Medical Research, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-Ku, Tokyo 108-8639, Japan. Electronic address: k-tani@ims.u-tokyo.ac.jp.
¹² Kawasaki City Institute for Public Health, Life Science and Environment (LiSE) Research Center 2F, 3-25-13 Tono-Machi, Kawasaki-Ku, Kawasaki-City, Kanagawa 210-0821, Japan. Electronic address: okaben-n@city.kawasaki.jp.
¹³ Divison of Pharmacology, Nihon Pharmaceutical University, 10281 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806, Japan. Electronic address: t-yamaguchi@nichiyaku.ac.jp.

PMID: 31506194
DOI: 10.1016/j.vaccine.2019.08.031

Abstract

Recombinant viral vaccines expressing antigens of pathogenic microbes (e.g., HIV, Ebola virus, and malaria) have been designed to overcome the insufficient immune responses induced by the conventional vaccines. Our knowledge of and clinical experience with the new recombinant viral vaccines are insufficient, and a clear regulatory pathway is needed for the further development and evaluation of recombinant viral vaccines. In 2018, the research group supported by the Ministry of Health, Labour and Welfare, Japan (MHLW) published a concept paper to address the development of recombinant viral vaccines against infectious diseases. Herein we summarize the concept paper-which explains the Japanese regulatory concerns about recombinant viral vaccines-and provide a focus of discussion about the development of recombinant viral vaccines.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Animals
Contraceptive Agents, Male / pharmacology
Disease Models, Animal
Drug Evaluation, Preclinical
Drug and Narcotic Control / legislation & jurisprudence*
Humans
Immunocompromised Host
Japan
Microorganisms, Genetically-Modified
Quality Control
Tissue Distribution
Vaccines, Synthetic / pharmacology
Vaccines, Synthetic / standards*
Viral Vaccines / pharmacokinetics
Viral Vaccines / standards*
Virus Replication / physiology
Virus Shedding

Substances

Contraceptive Agents, Male
Vaccines, Synthetic
Viral Vaccines