A ¥6.5 billion budget granted by the Ministry of Education, Culture, Sports, Science and Technology towards creating Vaccine Development Centers

Although Japan has fallen behind the rest of the world in terms of development of a new COVID-19 vaccine, world-class research and development centers will be created to carry out vaccine development quickly in preparation for the next potential infectious disease outbreak. The Ministry of Education, Culture, Sports, Science and Technology (MEXT) has included ¥6.55 billion in its next fiscal year's budget request for this activity. It will invest about ¥2 billion per year in a flagship center and about ¥1 billion per year in other centers with the expectation of generating synergies over the next 10 years that can strengthen and promote related research with an eye to exiting basic research. A new facility will also be established at the flagship center with a separate budget. Public solicitation is scheduled for April next year or later, but if the supplementary budget is moved forward, there is a possibility that it will take place earlier in the new year.

Five universities are leading candidates and support will be ongoing for 10 years in order to avoid future pitfalls.

The government's strategy for strengthening vaccine development and the production system points out the current weakness in infectious disease research in the country, which is ranked eighth in the world in terms of number of papers published, the lack of awareness that vaccine development is part of security policy, and the inadequate establishment of a network of industry, academia, and government collaboration in vaccine development. In response, nine concrete measures have been presented, including the creation of world-class research and development centers, the strengthening of funding functions, the improvement and expansion of the clinical trial environment, and acceleration of the regulatory approval process.

To address these measures, MEXT will develop world-class research and development centers (one flagship and up to four synergy centers) for the realization of domestic vaccine development. This will strengthen and promote related research with an eye on exiting from basic research during non-pandemic times. It will also promote basic and fundamental research in the field of infectious diseases.

A budget of ¥6.55 billion is required for the improvement and enhancement of the centers; ¥3.8 billion for the reinforcement of overseas research centers established by universities and in collaboration with the National Institute for Infectious Diseases, and the National Center for Global Health and Medicine, among others; and ¥1.1 billion for whole-genome analysis at Bio Bank Japan for multiple-factor diseases closely related to the serious risks discovered during COVID-19.

In terms of the centers, one flagship center and multiple synergy centers will be created. There are five practical candidates: the University of Tokyo's Institute of Medical Science, which has strengths in clinical and adjuvants; Osaka University's Research Institute for Microbiological Diseases, which has a proven track record in vaccine development and manufacturing; Nagasaki University's National Research Center for the Control and Prevention of Infectious Diseases, which will begin operations in the next fiscal year; Hokkaido University's International Institute for Zoonosis Control, which has a proven track record in research on common human and animal infectious diseases; and Kyoto University's Institute for Frontier Life and Medical Sciences, which is reputed for viral research.

The center will operate independently of the university itself, such as in the case of Japan's World Premier International Research Center Initiative. For example, it will recruit prominent researchers at high salaries and introduce a top-down management system. In addition, a certain number of foreign researchers will be recruited, and the official language will be English, thereby achieving an international research environment. In collaboration with core clinical research hospitals and industry, the center will establish laboratories for pharmaceutical companies and other organizations during the research period. It will also recruit private-sector personnel for its management team to build a system that facilitates a smooth transition from the research stage to development and production. By integrating human immunology, genome, AI, and epidemiology (mathematical modeling), which go beyond conventional infectious disease research, the centers can establish the fastest connection to clinical practice along with cutting-edge approaches. In addition, a research system for field integration will be established and promoted under one roof, along with clinical trials and commercialization through collaboration with core clinical research hospitals.

Each center will allocate roles based on respective characteristics and areas of expertise, focusing on the flagship center, and strengthen the collaboration network necessary for vaccine development as a whole in Japan, including overseas centers. In the flagship center, facilities that can test and manufacture vaccines will be established in a separate budget, and facilities and equipment at each center will be developed and strengthened.

Until now, Japan has launched a project each time an emerging or re-emerging infectious disease has occurred. However, the conclusion over the last few years is that the continuity of study, the sophistication of technology, and human resource development have not been sufficiently carried out. Learning from this, the centers will continue to receive support for 10 years. To strengthen monitoring, the budget will be increased to reinforce the research centers (Ghana, Congo, Zambia, India, Myanmar, Thailand, China, Vietnam, the Philippines, and Indonesia) in the overseas epidemic areas that the universities have already established. Overseas research centers have managed to maintain their slim budgets partly due to effective business arrangements. If this budget request goes through, the international network will also be revived.

In this vaccine strategy the Strategic Center of Biomedical Advanced R&D for Preparedness and Response (SCARDA) that can independently create allocable funds, will be established by AMED to provide strategic funding. However, since there are no SCARDA proprietary funds, it will be difficult to allocate funds according to the status of R&D or to conduct flexible funding in emergencies. Therefore, new funds that can be allocated independently by SCARDA are required.