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• W4385331569 abstract "We read with great interest the research article by Suzuki et al.1 Although it is very useful to understand the utilization of the Japanese Adverse Drug Event Report (JADER) database for vaccine-induced adverse events (VAEs), there are major questions about this process, as outlined below. A new finding presented in this article is that the JADER database, unlike the Vaccine Adverse Event Reporting System (VAERS) maintained by the US Food and Drug Administration and Centers for Disease Control and Prevention, may be able to detect VAE signals earlier, even though it contains information on adverse events without distinguishing between vaccines and other drugs. Miyazaki reported that the vaccine spontaneous report databases that can be used for signal detection from the standpoint of companies are “in-house databases” and “JADER.”2 Although spontaneous reporting databases from other countries, such as VAERS, are accessible to companies, the report states that not only are there differences in immunization systems and vaccine production lots in each country, but also there are many additional interpretive considerations that must be noted. As the results of detecting VAE signals by JADER are used in revising package inserts (ie, the signal is one of the triggers for revising package inserts), it is not surprising that VAE signals are often detected earlier than the revision of the package inserts. On the other hand, as the authors also stated, the signals detected contain potential reporting bias and cannot be used to determine causality.1 That is, the detected positive signals will lead to a validation step and, if necessary, to the revision of package inserts.3 However, you must remember that even a negative signal may well result in revising the package inserts as a result of the comprehensive pharmacological review. In fact, 3 exceptions were observed that were not detected before revising package inserts.1 With this in mind, the signal is one of the triggers for the revision of package inserts but is not essential. When vaccine case information is stored in the same spontaneous reporting database as other drug case information, the question of whether the entire database should be analyzed or whether a subset of vaccine cases should be created and analyzed has been discussed widely in other countries,4 and is also the case in this study.2 It is known that signal detection using the entire database may mask unknown safety signals arising from vaccines.2 Therefore, signal detection using a subset of vaccine cases should also be performed in this study. Y.N. and T.Y. both wrote the article. Y.N. and T.Y. declare that they have no conflicts of interest associated with this work. This study was supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI (Grants-in-Aid for Scientific Research) grant number 22K12890. Not applicable." @default.
• W4385331569 created "2023-07-29" @default.
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• W4385331569 date "2023-08-24" @default.
• W4385331569 modified "2023-09-24" @default.
• W4385331569 title "Comment: Detection of Vaccine Adverse Events Before Package Insert Revisions Using a Japanese Spontaneous Reporting System" @default.
• W4385331569 cites W2713736781 @default.
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• W4385331569 doi "https://doi.org/10.1002/jcph.2324" @default.
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