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

doi:10.1016/j.lanwpc.2022.100442

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.

Authors

Toshihiro Yamaguchi¹, Masao Iwagami^{2

3}, Chieko Ishiguro⁴, Daisuke Fujii⁵, Norihisa Yamamoto¹, Manabu Narisawa¹, Takashi Tsuboi¹, Hikari Umeda⁶, Natsumi Kinoshita⁶, Toyotaka Iguchi⁶, Tatsuya Noda⁷, Shinya Tsuruta¹, Akira Oka⁸, Tomohiro Morio⁹, Kiyohito Nakai⁵, Shuichiro Hayashi¹

Affiliations

¹ Immunisation Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan.
² Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
³ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
⁴ Section of Clinical Epidemiology, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
⁵ Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan.
⁶ Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
⁷ Department of Public Health, Health Management and Policy, Nara Medical University, Nara, Japan.
⁸ Saitama Children's Medical Center, Saitama, Japan.
⁹ Department of Pediatrics, Tokyo Medical and Dental University Graduate School, Tokyo, Japan.

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.

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

Publication types

Review