Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
Online ISSN : 1882-790X
Print ISSN : 1342-0445
ISSN-L : 1342-0445
Special Issue on “Safety Monitoring and Related Systems for COVID-19 Vaccine in Japan”
1 . Distribution Information and Systems as a Basis for Safety Assessment of COVID‒19 Vaccine in Japan
Yoshihiko INAZUMI
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JOURNAL FREE ACCESS

2022 Volume 27 Issue 2 Pages 62-70

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Abstract

The COVID-19 vaccines have been used under the special temporary vaccination based on the Immunization Act, which stipulates the same report framework of symptoms suspected to be caused by the routine or the special temporary vaccinations. As for the safety analysis, the results of these reports have been evaluated at Council meetings held more frequently than usual. In addition, a research group, established by the Ministry of Health, Labour and Welfare, collected information about the symptoms suspected to be caused by COVID-19 vaccination.

Focusing on the electronic system for the COVID-19 vaccines, during the period of the special temporary vaccination, the Vaccination Record System (VRS), established by the Digital Agency, is used for individual COVID-19 vaccination history, and the Vaccination-System (V-SYS) established by the Ministry of Health, Labour and Welfare is used for recording COVID-19 vaccines distribution, so that the number of vaccine recipients, lot numbers of delivered vaccine, etc., which are the basis for safety assessment, can be confirmed easily.

Looking ahead, further progress is expected in the development of the infrastructure for evaluating vaccine safety. For example, the online insurance eligibility confirmation system will be expanded to a nationwide platform for sharing and exchanging information on immunizations and electronic medical records, etc. After the platform is completed, we will be able to analyze in conjunction with the database of information on immunization and specific medical examinations, etc.

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© 2022 Japanese Society for Pharmacoepidemiology
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