University of Tokyo to Launch Facility to Produce Vaccines for Clinical Trials

The Yomiuri Shimbun

6:00 JST, July 20, 2023

The University of Tokyo plans to launch a facility to produce vaccines developed by domestic research institutes and biotech ventures for clinical trials in preparation for future pandemics, it has been learned.

Set to open as early as next fiscal year, the facility will be the nation’s first vaccine production site operated by a university.

The initiative is aimed at promoting the use of domestic vaccines by establishing a system to swiftly confirm the safety and efficacy of vaccines through clinical trials, even in normal times.

A four-story facility will be constructed on an about 1,000-square-meter site at the university’s campus in Kashiwa, Chiba Prefecture. The university plans to complete the construction by the end of this fiscal year, working together with industry and the government.

Clinical trials are usually conducted in three stages — the first stage to confirm the safety with several dozen people; the second stage with several hundred people; and the third and final stage involving tens of thousands of people.

According to sources, the new facility is expected to have the capacity to produce vaccines for several hundred people for second-stage clinical trials.

The University of Tokyo plans to start operating the site in fiscal 2024, after safety standards for the production of drugs have been confirmed.

The university is a key part of a government program aimed at developing vaccines in normal times.

While flu vaccines are typically manufactured by domestic pharmaceutical companies, vaccines for new infectious diseases are mainly developed by universities and biotech ventures, which do not have the facilities to produce sufficient quantities for clinical trials.

The University of Tokyo plans to make the new facility available to such research institutions and companies, in the event of emergencies and allow vaccines produced there to be used by hospitals participating in clinical trials.

Before the COVID-19 pandemic, it was said to take at least 10 years to develop new vaccines and put them into practical use. The new facility is expected to shorten the development period.

In normal times, the facility is likely to be used for manufacturing drugs and training personnel.

“We want joint efforts involving industry, government and academia to increase in preparation for future pandemics,” said Masahiko Kikuchi of University of Tokyo, who is in charge of the initiative.