4 ． Early Post-marketing Phase Vigilance and Post-marketing Survey of SARS‒CoV‒2 Vaccine Under COVID‒19 Situation

Epidemic of SARS-CoV-2 affected the human society, with multidimensional impact. COVID-19 vaccine was developed as an important tool for public health which can change epidemic situation. In early 2021, products got an approved and become available in Japan also. Several difficulty from development to approval which was overcame by collaborative work of several stakeholders, have been already known. As same as this, in post-marketing phase, there were several challenging situation. MR visit to health care institute was quite restricted. The duration from product approval to product use, was quite short. Vaccine distribution was controlled by government to keep nationwide optimization, and vaccination was done based on prioritization. To expand vaccination site, large scale vaccination sites and occupational vaccination sites which differed from usual health care institute, was opened. Under these situation, we made various effort to do several actions aligned with several related rules like pharmaceutical and Medical Device acts. For timely information delivery and information collection, internet technology was utilized. Post-marketing survey plan was revised from usual survey to database survey, because product used basically at occupational vaccination site. In this material, we would like to report what we did as Early Post-marketing Phase Vigilance (EPPV), safety monitoring and post-marketing survey under COVID-19 situation. We hope this report can be utilized to discuss what we should do under resemble situation.