Safety monitoring of COVID-19 vaccines in Japan

Lancet Reg Health West Pac. 2022 Mar 29:23:100442. doi: 10.1016/j.lanwpc.2022.100442. eCollection 2022 Jun.


The assessment of the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines in actual practice is extremely important, and monitoring efforts are being implemented worldwide. In Japan, a joint council in the Ministry of Health, Labour and Welfare is held every two to three weeks to summarise information on the adverse events following COVID-19 vaccination, with careful assessment of individual case safety reports and comparison with background incidence rates. In 2021, the joint council mainly reviewed anaphylaxis, death, myocarditis/pericarditis, and thrombosis with thrombocytopenia syndrome. These activities resulted in several safety-related regulatory actions, including the revision of vaccine package inserts with warnings about myocarditis/pericarditis. International sharing of vaccine safety information, as well as details of the evaluation systems, is important for international discussion and decision-making on better safety monitoring of COVID-19 vaccines.

Keywords: COVID-19; Epidemiology; Health policy; Pharmacovigilance; Vaccines.

Publication types

  • Review