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      Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events

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          Abstract

          Objective

          To identify the risks of myocarditis or pericarditis after vaccination with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines in Japan.

          Methods

          We conducted an observed-to-expected analysis (OE analysis) of spontaneous reports of suspected adverse events from pharmaceutical companies, calculating rate ratios with myocarditis and pericarditis after the vaccination of the mRNA vaccines Comirnaty (BNT162b2) and Spikevax (mRNA-1273) and expected rate of myocarditis and pericarditis in the population before the COVID-19 pandemic. These reports dated from 17/2/2021 to 14/11/2021 and from 22/5/2021 to 14/11/2021 for Comirnaty and Spikevax, respectively. The observed-to-expected ratios (OE ratios) for each vaccine were estimated by age groups and sex.

          Results

          We identified 281 and 195 cases of myocarditis or pericarditis for Comirnaty and Spikevax, respectively, which were administrated 163,059,502 and 31,768,352 doses for Comirnaty and Spikevax until the 14th of November 2021, respectively. The OE ratios were statistically significantly higher in adolescent and young adult males in their age of teens and twenties after the second dose in a two-dose series [Comirnaty in teens male: 6.15 (95% CI, 2.26–21.98), Comirnaty in twenties male: 2.86 (95% CI, 1.13–8.38), Spikevax in teens male: 41.59 (95% CI, 5.64–43,281.94), Spikevax in twenties male: 16.84 (95%CI, 6.77–57.49)].

          Conclusions

          Risks of myocarditis and pericarditis following SARS-CoV-2 mRNA vaccines in Japan seems to be significantly elevated for adolescent and young adult males.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s43441-022-00466-1.

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          Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel

          Dror Mevorach, Emilia Anis, Noa Cedar … (2021)
          Background Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance. Methods We retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons. Results Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637. Conclusions The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.
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            Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases

            Hui-Lee Wong, Mao Lin Hu, Cindy Ke Zhou … (2022)
            Background Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after COVID-19 mRNA vaccination, especially in young men. We used active surveillance from large health-care databases to quantify and enable the direct comparison of the risk of myocarditis or pericarditis, or both, after mRNA-1273 (Moderna) and BNT162b2 (Pfizer–BioNTech) vaccinations. Methods We conducted a retrospective cohort study, examining the primary outcome of myocarditis or pericarditis, or both, identified using the International Classification of Diseases diagnosis codes, occurring 1–7 days post-vaccination, evaluated in COVID-19 mRNA vaccinees aged 18–64 years using health plan claims databases in the USA. Observed (O) incidence rates were compared with expected (E) incidence rates estimated from historical cohorts by each database. We used multivariate Poisson regression to estimate the adjusted incidence rates, specific to each brand of vaccine, and incidence rate ratios (IRRs) comparing mRNA-1273 and BNT162b2. We used meta-analyses to pool the adjusted incidence rates and IRRs across databases. Findings A total of 411 myocarditis or pericarditis, or both, events were observed among 15 148 369 people aged 18–64 years who received 16 912 716 doses of BNT162b2 and 10 631 554 doses of mRNA-1273. Among men aged 18–25 years, the pooled incidence rate was highest after the second dose, at 1·71 (95% CI 1·31 to 2·23) per 100 000 person-days for BNT162b2 and 2·17 (1·55 to 3·04) per 100 000 person-days for mRNA-1273. The pooled IRR in the head-to-head comparison of the two mRNA vaccines was 1·43 (95% CI 0·88 to 2·34), with an excess risk of 27·80 per million doses (–21·88 to 77·48) in mRNA-1273 recipients compared with BNT162b2. Interpretation An increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18–25 years after a second dose of the vaccine. However, the incidence was rare. These results do not indicate a statistically significant risk difference between mRNA-1273 and BNT162b2, but it should not be ruled out that a difference might exist. Our study results, along with the benefit–risk profile, continue to support vaccination using either of the two mRNA vaccines. Funding US Food and Drug Administration.
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              Age and sex-specific risks of myocarditis and pericarditis following Covid-19 messenger RNA vaccines

              Stéphane Le Vu, Marion Bertrand, Marie-Joëlle Jabagi … (2022)
              Cases of myocarditis and pericarditis have been reported following the receipt of Covid-19 mRNA vaccines. As vaccination campaigns are still to be extended, we aimed to provide a comprehensive assessment of the association, by vaccine and across sex and age groups. Using nationwide hospital discharge and vaccine data, we analysed all 1612 cases of myocarditis and 1613 cases of pericarditis that occurred in France in the period from May 12, 2021 to October 31, 2021. We perform matched case-control studies and find increased risks of myocarditis and pericarditis during the first week following vaccination, and particularly after the second dose, with adjusted odds ratios of myocarditis of 8.1 (95% confidence interval [CI], 6.7 to 9.9) for the BNT162b2 and 30 (95% CI, 21 to 43) for the mRNA-1273 vaccine. The largest associations are observed for myocarditis following mRNA-1273 vaccination in persons aged 18 to 24 years. Estimates of excess cases attributable to vaccination also reveal a substantial burden of both myocarditis and pericarditis across other age groups and in both males and females.
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                Author and article information

                Contributors
                Hidetaka Kobayashi:
                ORCID: http://orcid.org/0000-0002-8889-7144
                kobayashi-hidetaka@pmda.go.jp
                Journal
                Journal ID (nlm-ta): Ther Innov Regul Sci
                Journal ID (iso-abbrev): Ther Innov Regul Sci
                Title: Therapeutic Innovation & Regulatory Science
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 2168-4790
                ISSN (Electronic): 2168-4804
                Publication date (Electronic): 30 October 2022
                Pages: 1-14
                Affiliations
                [1 ]GRID grid.490702.8, ISNI 0000000417639556, Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency (PMDA), ; Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013 Japan
                [2 ]GRID grid.490702.8, ISNI 0000000417639556, Office of OTC/Quasi-Drugs, Pharmaceuticals and Medical Devices Agency (PMDA), ; Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013 Japan
                [3 ]GRID grid.410814.8, ISNI 0000 0004 0372 782X, Department of Public Health, , Health Management and Policy, Nara Medical University, ; 840 Shijo-Cho, Kashihara, Nara, 634-8521 Japan
                [4 ]Immunization Office, Health Service Division, Health Service Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo, 100-8916 Japan
                Author information
                http://orcid.org/0000-0002-8889-7144
                Article
                Publisher ID: 466
                DOI: 10.1007/s43441-022-00466-1
                PMC ID: 9618301
                PubMed ID: 36310329
                SO-VID: dda331cb-f512-476c-a223-acdd73661514
                Copyright © © The Author(s), under exclusive licence to The Drug Information Association, Inc 2022, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
                License:

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                Date received : 16 May 2022
                Date accepted : 30 September 2022
                Categories
                Subject: Original Research

                Keywords: covid-19,myocarditis,pericarditis,mrna vaccines,observed-to-expected analysis
                Data availability:
                Keywords: covid-19, myocarditis, pericarditis, mrna vaccines, observed-to-expected analysis

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