Government council recommends formulating MCM strategy for infectious disease countermeasures

While vaccines can prevent infectious diseases and reduce the risk of serious illness, they are insufficient to address infectious disease crises alone. A multilayered response using medical countermeasures (MCM) is therefore necessary. Promoting research and development, building manufacturing infrastructure, and accelerating the practical application of MCMs starting in normal times are important investments in crisis management. The Infectious Disease Committee of the Headquarters for Healthcare Policy has compiled recommendations calling for a review of the vaccine strategy and its revision to form a strategy covering MCMs more broadly.

In addition to the nine perspectives included in the vaccine strategy, the recommendations incorporate measures to enhance the effectiveness of emergency response. The measures are implemented for continuously conducting drills and simulations with the support of SCARDA and other bodies to confirm readiness for rapid response in infectious disease emergencies, and for considering areas for improvement.

Regarding the formation of world-leading research and development hubs, the recommendations call for establishing cross-disciplinary R&D centers capable of responding to infectious disease emergencies with a focus on therapeutics and diagnostics for priority infectious diseases (including the recruitment and development of skilled personnel). The Japan Institute for Health Security (JIHS), which is strong in a wide range of infectious disease and MCM research and development, will collaborate with academia, research institutions, and industry to build an integrated system running from seed development through clinical trials, thereby providing support for MCM research and development.

Regarding research funding, the recommendations call for the continuous promotion of research and development for necessary therapeutics and diagnostics starting in normal times, including R&D through the use of SCARDA program funds. Research into applying Japan's foundational vaccine modalities to a variety of infectious diseases—so they can be deployed in emergencies—and the accompanying R&D support are also to be carried out in normal times.

Regarding the development of manufacturing sites, the recommendations call for promoting collaboration and matchmaking among businesses with a focus on vaccine manufacturing facilities and component materials, and for considering continuous surveys of the actual state of raw materials and supplies that depend on overseas manufacturing, with the goal of strengthening supply chain resilience. The domestic biopharmaceutical manufacturing system (including vaccines) that was built up to respond to the COVID-19 pandemic is to be maintained. To enable a rapid response in infectious disease emergencies, the recommendations also call for examining the necessary legal and regulatory frameworks to build sustainable production systems at manufacturing facilities established through the Emergency Development Project for Vaccine Production Systems and the Project for Developing Biopharmaceutical Manufacturing Sites to Strengthen Vaccine Production. The appropriate form of support needed to respond to crises, including for therapeutics and diagnostics, is likewise to be examined.

In order to nurture and promote development and the manufacturing industry with a view of encouraging continuous corporate participation and promoting science, technology, and innovation, the recommendations call for considering and introducing pull-type R&D support to sustain manufacturing environments after commercialization in addition to push-type R&D support that directly funds research and development, working toward building an MCM ecosystem.

In response to these recommendations, the government plans to revise the vaccine strategy in the near future and adopt it by Cabinet decision.