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90 years of History in vaccine development resulting in several “Japan First” approved vaccines

The Birth of BIKEN

The Research Foundation for Microbial Diseases of Osaka University (now known as the BIKEN Foundation) was established. Its unique model of combining basic research with vaccine development, production, supply and testing was groundbreaking at that time.

Exterior view of the Research Institute in June 1934

Obtained manufacturing licenses for seven vaccines, including cholera and pertussis vaccines, and began clinical laboratory testing.

Supplied large quantities of vaccines, including cholera and smallpox vaccines, contributing to the rebuilding of public health in postwar Japan.

Establishment of Kanonji Institute

Shortly after the end of World War II, we established the Kanonji Research Institute in Kagawa Prefecture in response to the growing need for a domestically produced epidemic typhus vaccine.

Group photo of the original 18 staff members at the establishment of the Kanonji Institute

Approval of Japan’s First Inactivated Polio Vaccine

Polio was widespread worldwide in 1957, followed by an unprecedented outbreak in Japan in 1960. In 1961, the BIKEN Foundation began supplying Japan’s first domestically produced inactivated polio vaccine, receiving a surge of requests from across the country. This experience highlighted the vital role BIKEN played in protecting public health.

Establishment of the Taniguchi Scholarship Program

Established as a scholarship program in the spirit of BIKEN’s first chairman, Dr. Tenji Taniguchi, who emphasized the importance of nurturing future generations.

Relief portrait of Dr. Tenji Taniguchi / Portrait relief of Dr. Tenji Taniguchi

Approval of Japan's First Oral Poliovirus Vaccine
(the former Japan Poliomyelitis Research Institute)

Following a polio outbreak in Japan, oral live polio vaccines were urgently imported from overseas due to insufficient domestic supply. In response, several domestic vaccine manufacturers, including the BIKEN Foundation, joined forces to establish the Japan Live Polio Vaccine Research Institute in 1962, leading to the development of Japan’s first domestically produced oral live polio vaccine.

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Relocated the headquarters to Yamadaoka, Suita, following the relocation of the Research Institute for Microbial Diseases at the University of Osaka.

Approval of Japan’s First Freeze-Dried Live Attenuated Measles Vaccine

Approval of Japan’s First Freeze-Dried Live Attenuated Rubella Vaccine

Approval of Japan’s First Freeze-Dried Live Attenuated Varicella Vaccine

BIKEN developed World first live attenuated Varicella vaccine.
The live attenuated Varicella virus strain developed by BIKEN (OKA strain) is the only WHO-approved strain for Varicella vaccine production. This strain is currently used to produce vaccines worldwide. In 2014, Varicella vaccine was added to the children routine vaccination in Japan.

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Suspended pharmaceutical manufacturing operations for 50 days due to violations of the Pharmaceutical Affairs Law in the manufacture of mumps vaccine.

Approval of Japan’s First Freeze-Dried Live Attenuated Measles, Rubella Combined Vaccine

Approval of Japan’s First Freeze-Dried Cell Culture-Derived Japanese Encephalitis Vaccine

Conventional mouse brain-derived vaccines had limitations in quality control. We successfully developed a safer vaccine using Vero cells, a cell line derived from African green monkey kidney cells.

Transitioned to a General Incorporated Foundation following Japan’s public interest corporation reform.

Completion of Phase I Construction at the Kanonji Institute Seto Center

Completed nine facilities, including research, development, and administrative buildings, on a 165,165-square-meter site with strong support from Seto-cho, Kagawa Prefecture, and Kanonji City.

Exterior of the Seto Center at Kanonji Institute

Approval of Japan’s First Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivated Polio (Sabin strain) Combined Vaccine

Contribution to the efforts for global polio eradication

We developed the world’s first inactivated polio vaccine using attenuated poliovirus.
We transferred our vaccine production technologies to developing countries, which contributed to the global polio eradication.

Merger with the Japan Polio Research Institute

Merged with the Japan Polio Research Institute, which had been solely responsible for polio vaccine research and manufacturing in Japan since .

Opening of the BIKEN Innovative Vaccine Research and Development Center

Approval of an Additional Indication for the Freeze-Dried Live Attenuated Varicella Vaccine

Varicella vaccine was additionally approved in Japan for the prevention of herpes zoster in adults aged 50 and older

Establishment of BIKEN Co., Ltd.

Spun off the Foundation’s vaccine production division and established BIKEN Co., Ltd. as a joint venture between the BIKEN Foundation and Mitsubishi Tanabe Pharma Corporation (now Tanabe Pharma Corporation).

Approval of Japan’s First Adsorbed Diphtheria-purified Pertussis-Tetanus-Inactivated Polio-Hib Combined Vaccine

Establishment of BIKEN-RIMD NGS laboratory

Established the BIKEN-RIMD NGS laboratory jointly with the Research Institute for Microbial Diseases (RIMD) at the University of Osaka. The laboratory aims to develop and apply advanced genomic analysis technologies by combining BIKEN Foundation’s clinical laboratory testing expertise with RIMD’s genetic analysis technologies.

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BIKEN Foundation Acquires Full Ownership of BIKEN Co., Ltd.

Terminated the joint venture agreement with Tanabe Pharma Corporation after achieving progress in strengthening the production base for stable vaccine supply.

"First domestic product approved" includes cases where other companies' products were approved on the same day.