Analysis of Myocarditis Among 252 Million mRNA-1273 Recipients Worldwide
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Abstract
Background: Growing evidence indicates a causal relationship between SARS-CoV-2 infection and myocarditis. Post-authorization safety data have also identified myocarditis as a rare safety event following mRNA COVID-19 vaccination, particularly among adolescent and young-adult males after dose 2. We further evaluated the potential risk by querying the Moderna global safety database for myocarditis/myopericarditis reports among mRNA-1273 recipients worldwide. Methods: Myocarditis/myopericarditis reports from 18 December 2020 to 15 February 2022 were reviewed and classified. The reported rate after any known mRNA-1273 dose was calculated according to age and sex, then compared with a population-based incidence rate to calculate observed-to-expected rate ratios (RRs). Results: During the study period, 3017 myocarditis/myopericarditis cases among 252 million mRNA-1273 recipients who received at least 1 dose were reported to the Moderna global safety database. The overall reporting rate was 9.23 per 100 000 person-years, which was similar to the expected reference rate (9.0 cases per 100 000 person-years; RR [95% confidence interval (CI)], 1.03 [.97–1.08]). When stratified by sex and age, observed rates were highest for males aged <40 years, particularly those 18–24 years (53.76 per 100 000 person-years), which was higher than expected (RR [95% CI], 3.10 [2.68–3.58]). When considering only cases occurring within 7 days of a known dose, the observed rate was highest for males aged 18–24 years after dose 2 (4.23 per 100 000 doses administered). Conclusions: Myocarditis/myopericarditis rates were not higher than expected for the overall population of mRNA-1273 recipients but were higher than expected in males aged 18–24 years, with most cases occurring 7 days after dose 2.
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The reported incidence of myocarditis or pericarditis varies widely depending on vaccine type and number of doses, with the highest levels reported for the Moderna mRNA vaccine, with an overall incidence of ≈10/100,000 and around 50/100,000 in men under 40 years of age.
“The reported incidence of myocarditis or pericarditis varies widely depending on the vaccine type and how many doses were administered, with the highest levels reported for the Moderna mRNA vaccine, with an overall incidence of ≈ 10/100 000 and around 50/100 000 in men under 40 years of age (Table 1). 91”
From COVID-19, Myocarditis and Pericarditis (2023) · cites this paper as [91]
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COVID-19, Myocarditis and Pericarditis
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- Authors
- Straus, W., Urdaneta, V., Esposito, D. B., Mansi, J. A., Sanz Rodriguez, C., Burton, P., & Vega, J. M.
- Affiliations
- Clinical Safety and Pharmacovigilance, Moderna, Inc., Cambridge, Massachusetts , USA
- Medical Affairs, Moderna, Inc., Cambridge, Massachusetts , USA
- Corresponding author
- Straus, Walter
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2022-08-08
- Volume
- 76
- Issue
- 3
- Pages
- e544-e552
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- PMC
- PMC9384217
- OpenAlex
- W4281722923
- Cited by
- 41
- References
- 9
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 10 · 2023: 15 · 2022: 9 · 2021: 1
- FWCI
- 6.44
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Infectious Diseases (publishedVersion, cc-by-nc-nd)
- medRxiv (acceptedVersion)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Moderna, Inc
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Viral Infections and Immunology Research
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- myocarditis, myopericarditis, mRNA-1273 vaccine, COVID-19 pandemic, Moderna vaccine, adolescent and young adult males, age and sex differences
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Adolescent, Adult, Humans, Male, Myocarditis, Vaccination
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