Health and Global Policy Institute (HGPI) presented a policy proposal entitled, “Recommendations for Truly Strengthening the Vaccine R&D and Production Pipeline.”

In June 2021, HGPI presented, “A Life Course Approach to Immunization and Vaccination Policy – Five Perspectives and Recommended Actions” and appointed the vaccine R&D and production pipeline as one of the five important perspectives in immunization and vaccination policy in Japan. In FY2021, we gathered volunteer experts who possess a shared sense of caution toward this issue for discussions aiming to establish a domestic vaccine R&D and production pipeline. This proposal summarizes those discussions. Discussion points have been arranged in three perspectives on initiatives that require rapid responses during the ongoing COVID-19 pandemic or require action during ordinary times for emergency preparedness: strengthening the vaccine R&D and production pipeline, improving the clinical trial environment, and reforming the pharmaceutical affairs system for vaccines. Through these recommendations, we hope specific measures are taken to advance Japan’s immunization and vaccination policies and expand discussions among industry, Government, academia, and civil society so a system for protecting the health and safety of citizens from vaccine preventable diseases (VPDs) and maintaining socioeconomic activities can be created.

On April 25, in the World Immunization Week, we also held a non-partisan diet member briefing to enhance the tangible strengthening of the vaccine R&D and production pipeline in Japan.

 

■Executive Summary

1 Reinforce the Vaccine R&D and Production Pipeline
  1.1 The need for a true command center in the vaccine R&D and production pipeline and to rapidly establish that system

• Reinforce collaborative ties among industry, Government, academia, and civil society centered around a command center so infectious disease countermeasures can be coordinated during ordinary times and so vaccine R&D and production can proceed rapidly during emergencies
• Establish a system to focus resources on the most promising vaccine candidates based on cross-disciplinary discussions when resources are strained during emergencies, and improve transparency when doing so
• Designate a command center for pharmaceutical regulations and clinical trials and establish a strategic clinical trial environment

  1.2 Taking steps during non-emergencies to strengthen the domestic vaccine R&D and production ecosystem and to promote international collaboration

• Enhance emergency preparedness during non-emergencies by developing and producing prototype vaccines
• Take steps during non-emergencies to consider highly feasible, dual-use manufacturing facilities and to develop systems for operating manufacturing facilities
• Strengthen support for academia with promising basic research assets to improve the research environment
• Increase support for venture companies and similar organizations involved in innovative fields of R&D
• Strengthen pull incentives to make the domestic vaccine market more sustainable, such as by making routine vaccinations during non-emergencies more predictable or through Government purchase of vaccines during emergencies
• Strengthen partnerships with global organizations, national Governments, and international funding agencies
  
  

2 Create an Environment for Vaccine Clinical Trials
  2.1 Establishing a domestic clinical trial environment during non-emergencies

• Conduct high-quality clinical trials efficiently, such as by establishing a large-scale public facility for clinical trials
• Harmonize Japan’s system for conducting clinical trials with international standards to facilitate participation in global clinical trials
• Build a system to prevent the hollowing out of clinical trials for certain populations, such as children
• Reinforce communication strategies that contribute to fostering public understanding toward the need for clinical trials assessing innovative science and technology as well as toward the sound ethics and safety of those trials

  2.2 Establishing a system during non-emergencies for conducting clinical trials abroad

• Reinforce global partnerships against infectious diseases using diplomatic frameworks
• Establish arrangements and procedures that are harmonized with international Good Clinical Practices (GCPs) and Good Manufacturing Practices (GMPs)
  
  

3 Reform Vaccine Regulations
  3.1 Enacting emergency pharmaceutical regulations rapidly in times of crisis

• Establish a Japanese emergency authorization system for domestically-produced vaccines
• Provide support to help vaccines authorized for emergency use in Japan acquire use authorization overseas
• Build a system for the continuous monitoring of safety and effectiveness after special approval or emergency use authorization has been granted

  3.2 Collaboration between the vaccine R&D and production pipeline and pharmaceutical affairs system during non-emergencies as a form of emergency preparedness

• Examine pharmaceutical regulations with surrogate endpoints in areas with no endemic diseases
• Strengthen collaboration with overseas regulatory authorities for global clinical trials initiated by Japan and for simultaneous multi-country submissions

  3.3 Establishing systems during non-emergencies for examination and approval authorities to provide exemptions

• Consider an exemption system based on public discussions on the risks and benefits of vaccinations

 

 

■Working Group 5 “Vaccine R&D and Production Pipeline” Members (Titles omitted; in alphabetical order by last name)

Members

• Ken J. Ishii (Professor, Division of Vaccine Science, Institute of Medical Science, The University of Tokyo/ Director, International Vaccine Design Center, Institute of Medical Science)
• Masayuki Imagawa (Chief Executive, Japan Vaccine Industry Association/ Vice President & Head, Japan Vaccine Business Unit, Takeda Pharmaceutical Co., Ltd.)
• Hiroshi Kasanuki (Specially Appointed Professor, Waseda University/ Advisor, Institute for Medical Regulatory Science, Waseda University)
• Kengo Sonoda (General Manager, Development Department, R&D Division, KM Biologics Co., Ltd.)
• Hideki Hasegawa (Director, Center for Influenza and Respiratory Virus Research, National Institute of Infectious Diseases)
• Yoshiharu Matsuura (Director, Center for Infectious Disease Education and Research (CiDER))
• Shinji Matsumoto (Chair, Vaccines Working Team, EFPIA Japan)
• Isao Miyairi (Professor, Faculty of Pediatrics, Hamamatsu University School of Medicine)
• Yoshiaki Yamagishi (Associate Professor, Medical Center of Translational Research, Department of Medical Innovation, Osaka University)

Observer

• Yasuhiro Araki (Director, Office of Vaccine and Blood Products, Pharmaceuticals and Medical Devices Agency)

Special Advisors

• Keizo Takemi (Member, House of Councilors; Chairperson, Association for the Promotion of Improved Public Health through Vaccinations, Parliamentary Group for Vaccines and Prevention)
• Noriko Furuya (Member, House of Representatives; Acting Chairperson, Association for the Promotion of Improved Public Health through Vaccinations, Parliamentary Group for Vaccines and Prevention)

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■Related contents held as part of the project

– November 4, 2021 The First Meeting of Working Group 5 on Vaccine Research and Development, “Next Actions for the Development and Implementation of Immunization and Vaccination Policies”
– January 17, 2022 The Second Meeting of Working Group 5 on Vaccine Research and Development, “The Next Actions to Ensure the Development and Implementation of Immunization and Vaccine Policies”
– February 21, 2022 Expert Meeting “The Pursuit of Better Immunization and Vaccination Policy Measures – Developing Infrastructure and Utilizing Information to Contribute to Research on Long-Term Vaccine Safety”
– March 9, 2022 The Meeting of Working Group 1 on Life Course Approach, “The Next Actions to Ensure the Development and Implementation of Immunization and Vaccine Policies”
– March 14, 2022 The Meeting of Working Group 2 on Communication Approach, “The Next Actions to Ensure the Development and Implementation of Immunization and Vaccine Policies”
– March 16, 2022 The Meeting of Working Group 4 on Multi-Stakeholder Engagement Approach, “The Next Actions to Ensure the Development and Implementation of Immunization and Vaccine Policies”
– March 24, 2022 Working Group 3 Meeting on Information Systems that Contribute to the Long-Term Safety of Vaccines, “Next Actions for the Development and Implementation of Immunization and Vaccination Policies”