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

The Lancet Regional Health. Western Pacific (Jun 2022)

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

Affiliations

Toshihiro Yamaguchi: Immunisation Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
Masao Iwagami: Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
Chieko Ishiguro: Section of Clinical Epidemiology, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan; Corresponding authors: Dr. Chieko Ishiguro, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan, Telephone: +81-3-3202-7181, Dr. Shuichiro Hayashi, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku Tokyo, 100-8916, Japan, Telephone: +81-3-5253-1111
Daisuke Fujii: Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
Norihisa Yamamoto: Immunisation Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
Manabu Narisawa: Immunisation Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
Takashi Tsuboi: Immunisation Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
Hikari Umeda: Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
Natsumi Kinoshita: Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
Toyotaka Iguchi: Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
Tatsuya Noda: Department of Public Health, Health Management and Policy, Nara Medical University, Nara, Japan.
Shinya Tsuruta: Immunisation Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
Akira Oka: Saitama Children's Medical Center, Saitama, Japan.
Tomohiro Morio: Department of Pediatrics, Tokyo Medical and Dental University Graduate School, Tokyo, Japan.
Kiyohito Nakai: Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan
Shuichiro Hayashi: Immunisation Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan; Corresponding authors: Dr. Chieko Ishiguro, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan, Telephone: +81-3-3202-7181, Dr. Shuichiro Hayashi, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku Tokyo, 100-8916, Japan, Telephone: +81-3-5253-1111

Journal volume & issue: Vol. 23
p. 100442

Abstract

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Summary: 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.

Published in The Lancet Regional Health. Western Pacific

ISSN: 2666-6065 (Online)
Publisher: Elsevier
Country of publisher: United Kingdom
LCC subjects: Medicine: Public aspects of medicine
Website: https://www.thelancet.com/journals/lanwpc/home

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