Yamaguchi T, Iwagami M, Ishiguro C, Fujii D, Yamamoto N, Narisawa M, Tsuboi T, Umeda H, Kinoshita N, Iguchi T, Noda T, Tsuruta S, Oka A, Morio T, Nakai K, and Hayashi S
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., Competing Interests: AO receives grants from Eisai Co., Ltd, SHIONOGI & CO., LTD., Takeda Pharmaceutical Co, Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., and Pfizer Japan Inc. All other authors declare no competing interests., (© 2022 The Author(s).)