Health and Global Policy Institute (HGPI) has released policy recommendations entitled, “Recommendations on the Development of Information Infrastructure and System Maintenance for Long-Term Safety Assessment of Immunizations and Vaccines.”

The long-term safety assessment of immunizations and vaccines was considered an important issue in the policy recommendations released previously by the HGPI in June 2021 entitled, “A Life Course Approach to Immunization and Vaccination Policy – Five Perspectives and Recommended Actions.” The HGPI brought together experts with a shared sense of need to tackle this issue and summarized their discussions. The current recommendations are a summary of that discussion, including key points regarding future initiatives.

Through these recommendations, we hope that the safety evaluation of immunizations and vaccines will act as a safety net in immunization and vaccine policy, that discussions will expand in within the industry, government, academia and civil society to systematically promote the establishment of a system for safety evaluation, and that specific measures will be put into practice so that immunization and vaccine policies can create a mutual circle of benefit between individuals and society.

 

■Executive Summary

1 Establishing a Common Understanding of Immunization and Vaccine Safety Assessment

1.1 Establishing a common understanding of the necessary information for and current systems of immunization and vaccine safety assessment

• Establish a common understanding of the epidemiological information required to quantitatively and scientifically evaluate the safety of immunizations and vaccines and the systems required to collect such information
  
  

2 Enhancing the Function of Passive Surveillance and Institutional Design of Active Surveillance

2.1 Enhancing the function of the suspected adverse reaction suspicion reporting system

• Promote use of the suspected adverse reaction suspicion reporting system for the prompt detection of abnormal adverse events and abnormal signals that should be examined for causal relationships with immunizations and vaccines
• Enhance the function of passive surveillance through effective use of the suspected adverse reaction suspicion reporting application, electronic reporting system, etc.

2.2 Institutional design of active surveillance to complement the functions of passive surveillance

• Make a ppropriate and prompt use of information based on the functional limitations of passive surveillance
• Implement institutional designs for active surveillance based on the functional limitations of passive surveillance

2.3 Utilizing of insurer databases and developing of medical information for active surveillance

• Design and establish an active surveillance system that is aligned with the domestic healthcare system
• Promote active surveillance systems that use insurer databases that are based on medical claims data
• Examine analysis methods including self-controlled study designs to make effective use of active surveillance
• Accelerate discussions on linking vaccination information and medical information in a manner that uses insurer databases to go beyond active surveillance for more appropriate safety assessments
  
  

3 Supporting Surveillance Through Information Infrastructure Development During Non-emergency Periods and Collaboration With Local Governments

3.1 Maintenance and further promotion of vaccination ledgers

• Promote the digitalization and compilation of vaccination ledgers in data bases within information sharing network

3.2 Utilization of information sharing network systems

• Consider how to balance decentralized management as a security measure for information sharing network systems and the sharing of statistical information that contributes to safety assessments of immunizations and vaccine safety assessments
• Adopt the VRS to provide statistical information
• Accelerate better information coordination and digitalization practices in the future based on a review of lessons learned in response to past emergencies

3.3 Building a cooperative system among the national Government, local governments, and other related organizations

• Construct a cooperative system between the national Government and local governments for linking National Health Insurance and other insurer databases with vaccination information to contribute to immunization and vaccine safety assessments
• Promote trial efforts by local governments for information sharing among insurance user databases, to develop good practices, and to accelerate efforts to examine personal information handling
• Utilize combined information from vaccination information and health information and return such information to citizens through data visualization
  
  

4 Making Comprehensive Policy Decisions Based on Safety Assessments

4.1 Establishment of a system for comprehensive policy decisions

• Promote human resource development and the establishment of an assessment institution so that comprehensive policy decisions on immunization and vaccine policy can be made on a permanent basis

4.2 Achieving effective communication strategies for comprehensive policy decisions

• Promote human resource development and the dissemination of relevant and correct information, terminology, and the understanding of systems to contribute to effective communication with citizens regarding comprehensive policy decisions

 

■Working Group 3 “Information Systems” Members (Titles omitted; in alphabetical order by last name (as of 2021))

Working Group Members

• Mugen Ujie (Chief of Travel Clinic / Director of Vaccination Support Center)
• Hisashi Urushihara (Professor, Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University)
• Mizuho Oyama (Deputy Director, Planning and Finance Department and Chief Digital Office (CDO), Digital Strategy Office, Toda City; Advisor on Regional Informatization, Ministry of Internal Affairs and Communications
• Satoshi Kamidani (Physician, Division of Pediatric Infectious Diseases & Vaccine and Treatment and Evaluation Units, Emory University; Visiting Scholar, Immunization Safety Office, Centers for Disease Control and Prevention (CDC))
• Akinori Sugaya (Head Physician, Sugaya Children’s Clinic; Director, KNOW VPD Protect Our Children)
• Keiko Tanaka-Taya (Director, Immunization Group, Center for Surveillance, Immunization, and Epidemiologic Research, National Institute of Infectious Diseases)
  
  

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)