Safety monitoring of COVID-19 vaccines in Japan
Toshihiro Yamaguchi, Masao Iwagami, Chieko Ishiguro, Daisuke Fujii, Norihisa Yamamoto, Manabu Narisawa, Takashi Tsuboi, Hikari Umeda, Natsumi Kinoshita, Toyotaka Iguchi, Tatsuya Noda, Shinya Tsuruta, Akira Oka, Tomohiro Morio, Kiyohito Nakai, Shuichiro Hayashi
Abstract
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.