tetano
Editor, Senior Moderator
Lancet Reg Health West Pac
. 2022 Mar 29;23:100442.
doi: 10.1016/j.lanwpc.2022.100442. eCollection 2022 Jun.
Safety monitoring of COVID-19 vaccines in Japan
Toshihiro Yamaguchi[SUP] 1 [/SUP], Masao Iwagami[SUP] 2 3 [/SUP], Chieko Ishiguro[SUP] 4 [/SUP], Daisuke Fujii[SUP] 5 [/SUP], Norihisa Yamamoto[SUP] 1 [/SUP], Manabu Narisawa[SUP] 1 [/SUP], Takashi Tsuboi[SUP] 1 [/SUP], Hikari Umeda[SUP] 6 [/SUP], Natsumi Kinoshita[SUP] 6 [/SUP], Toyotaka Iguchi[SUP] 6 [/SUP], Tatsuya Noda[SUP] 7 [/SUP], Shinya Tsuruta[SUP] 1 [/SUP], Akira Oka[SUP] 8 [/SUP], Tomohiro Morio[SUP] 9 [/SUP], Kiyohito Nakai[SUP] 5 [/SUP], Shuichiro Hayashi[SUP] 1 [/SUP]
Affiliations
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.
. 2022 Mar 29;23:100442.
doi: 10.1016/j.lanwpc.2022.100442. eCollection 2022 Jun.
Safety monitoring of COVID-19 vaccines in Japan
Toshihiro Yamaguchi[SUP] 1 [/SUP], Masao Iwagami[SUP] 2 3 [/SUP], Chieko Ishiguro[SUP] 4 [/SUP], Daisuke Fujii[SUP] 5 [/SUP], Norihisa Yamamoto[SUP] 1 [/SUP], Manabu Narisawa[SUP] 1 [/SUP], Takashi Tsuboi[SUP] 1 [/SUP], Hikari Umeda[SUP] 6 [/SUP], Natsumi Kinoshita[SUP] 6 [/SUP], Toyotaka Iguchi[SUP] 6 [/SUP], Tatsuya Noda[SUP] 7 [/SUP], Shinya Tsuruta[SUP] 1 [/SUP], Akira Oka[SUP] 8 [/SUP], Tomohiro Morio[SUP] 9 [/SUP], Kiyohito Nakai[SUP] 5 [/SUP], Shuichiro Hayashi[SUP] 1 [/SUP]
Affiliations
- PMID: 35359913
- PMCID: PMC8960038
- DOI: 10.1016/j.lanwpc.2022.100442
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.