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Review
. 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  1 , Masao Iwagami  2   3 , Chieko Ishiguro  4 , Daisuke Fujii  5 , Norihisa Yamamoto  1 , Manabu Narisawa  1 , Takashi Tsuboi  1 , Hikari Umeda  6 , Natsumi Kinoshita  6 , Toyotaka Iguchi  6 , Tatsuya Noda  7 , Shinya Tsuruta  1 , Akira Oka  8 , Tomohiro Morio  9 , Kiyohito Nakai  5 , Shuichiro Hayashi  1
Affiliations
Review

Safety monitoring of COVID-19 vaccines in Japan

Toshihiro Yamaguchi et al. Lancet Reg Health West Pac. .

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.

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Conflict of interest statement

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.

Figures

Fig 1
Figure 1
Governmental structure for vaccine safety monitoring in Japan. AEFIs = adverse events following immunisation, JADER= Japanese Adverse Drug Event Report database, ICH = International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
Fig 2
Figure 2
Trend in the cumulative number of people receiving second dose in 2021.
Fig 3
Figure 3
Trend in the cumulative number of individual case safety reports in 2021. MAH=marketing authorisation holder.
Fig 4
Figure 4
Result of observed-to-expected ratio analysis of myocarditis and pericarditis by age and sex. The risk period was set as seven days (i.e., observed cases in each subgroup were counted only during the risk window of seven days from the date of each vaccination). The background incidence rate in each subgroup was calculated using the National Database of Health Insurance Claims data (NDB), including the International Classification of Diseases 10th revision codes suggesting myocarditis/pericarditis and the population census data. The expected cases were calculated by multiplying the background incidence rate by the follow-up period (calculated by multiplying the total number of COVID-19 vaccinations by seven days).
See this image and copyright information in PMC

References

    1. WHO Coronavirus disease (COVID-19) dashboard; 2020. https://covid19.who.int/. Accessed 10 January 2022.
    1. Ritchie H, Mathieu E, Rodés-Guirao L, et al. Coronavirus Pandemic (COVID-19); 2020. published online March 5. https://ourworldindata.org/covid-vaccinations?country=JPN. Accessed 10 January 2022.
    1. Ministry of Health, Labour and Welfare. Revision of Precautions. Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection); 2021. https://www.pmda.go.jp/files/000243865.pdf. Accessed 10 January 2022.
    1. Ministry of Health, Labour and Welfare. Revision of Precautions. Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (COVID-19 Vaccine Moderna Intramuscular Injection); 2021. https://www.pmda.go.jp/files/000243866.pdf. Accessed 10 January 2022.
    1. Ministry of Health, Labour and Welfare. Health Sciences Council (the Immunization and Vaccination committee - the committee on Adverse Reactions) [in Japanese]. https://www.mhlw.go.jp/stf/shingi/shingi-kousei_284075.html. Accessed 4 March 2022.

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