3. Contributions of Databases for Vaccines Pharmacovigilance

Pharmacovigilance for vaccines has different considerations from other drugs. In this article, contributions of databases for vaccines pharmacovigilance are discussed, such as spontaneous case reporting databases and medical information databases (claims databases and electronic health record databases). Regarding spontaneous case reporting databases, some databases such as in-house databases and Japanese Adverse Drug Event Report database (JADER) have been already established, and can be utilized for detection of a vaccination failure, a vaccine quality defect-related issue and a statistical safety signal. In the future, a pharmacovigilance activity for vaccines with spontaneous case reporting databases will be expected to become more robust by integrating data which pharmaceutical companies and regulators respectively accumulate and by compiling data from current regulatory programs. Regarding medical information databases, while there is a critical limitation that vaccination information cannot be captured, some points can be utilized, for example, to understand background incidence/trend of events or infections. Also there is a possibility that an assessment by using medical information databases can be alternative means of current regulatory programs. In the future, a paradigm shift will be expected through establishment of further medical information databases, for example, by standardization of vaccine code on the electronic medical record and by linkage of vaccine data to the medical information databases.