Report Research & Recommendations

[Recommendations] Recommendations on the Development of Information Infrastructure and System Maintenance for Long-term Safety Assessment of Immunizations and Vaccines (August 5, 2022)

[Recommendations] Recommendations on the Development of Information Infrastructure and System Maintenance for Long-term Safety Assessment of Immunizations and Vaccines (August 5, 2022)

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.

*Recommendations will be available in English in due course.


■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 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 adverse reaction suspicion reporting system

  • Promote use of the 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 adverse reaction suspicion reporting application, electronic reporting system, etc.

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

  • Appropriate and prompt use of information based on the functional limitations of passive surveillance
  • Institutional design of active surveillance based on the functional limitations of passive surveillance

  2.3 Utilization of insurance user databases and development 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 insurance user databases that are based on medical expense statements

3 Development of Information Infrastructure that Supports Surveillance during Non-emergency Periods and Collaboration with Local Governments

  3.1 Maintenance and further promotion of immunization records

  • Promote the digitalization and compilation of immunization records in data bases within information sharing networks

  3.2 Utilization of information sharing network systems

  • Consider the compatibility between decentralized management as a security measure within information sharing network systems as well as the sharing of statistical information that contributes to safety assessments of immunizations and vaccines
  • Accelerate better information coordination and digitalization 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 that contributes to the safety assessment of immunizations and vaccines, aimed at the linkage of national health insurance and other insurance user databases with immunization information
  • Promote trial efforts by local governments regarding information sharing within insurance user databases, the development of good practices, and the acceleration of studies on handling personal information
  • Utilize combined information from immunization 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 judgement

  • 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 Utilization of information sharing network systems

  • 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)
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