Cited by 587Viral Infections and Immunology ResearchSARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research Studies

Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the advisory committee on immunization practices — United States, June 2021

Open access
Gargano, Julia W., Wallace, Megan, Hadler, Stephen C., Langley, Gayle, Su, John R., Oster, Matthew E., Broder, Karen R., Gee, Julianne +12 more·2021·MMWR. Morbidity and Mortality Weekly Report

Abstract

which predominantly occurred in young males after the second dose, an ACIP meeting was rapidly convened to review reported cases of myocarditis and pericarditis and discuss the benefits and risks of mRNA COVID-19 vaccination in the United States. Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis. On June 23, 2021, after reviewing available evidence including that for risks of myocarditis, ACIP determined that the benefits of using mRNA COVID-19 vaccines under the FDA's EUA clearly outweigh the risks in all populations, including adolescents and young adults. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. The EUA fact sheets should be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis.

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Crossref · 10.15585/mmwr.mm7027e2

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  • Our study confirms findings of previously identified rare cases of myocarditis and pericarditis following first and second doses of mRNA vaccines.

    “However, our study confirms findings of previ­ ously identified rare cases of myocarditis and pericarditis following first and second doses of mRNA vaccines [21 -23,34].”

    From COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals (2024) · cites this paper as [23]

    The main text reports rare myocarditis cases after mRNA vaccination and says Vaccine Safety Datalink data indicated increased risk after either dose 1 or dose 2. Table 2 (Reporting of Vaccine Adverse Events; page unavailable) includes pericarditis in estimates for second doses, but the passages do not establish pericarditis cases after first doses. The paper therefore supports most, but not all, of the attributed finding. (LLM, conf=0.82)

    Experimental — accuracy not yet measured
  • In women aged 18-24, mRNA COVID-19 vaccination would prevent 1127 hospitalisations, 93 ICU admissions and 13 deaths, while causing 4-5 myocarditis cases.

    “In women aged 18–24, mRNA COVID-19 vaccination would prevent 1127 hospitalisations, 93 ICU admissions and 13 deaths, while causing 4–5 myocarditis cases. 25”

    From Vaccine mandates for healthcare workers beyond COVID-19 (2023) · cites this paper as [25]

  • The CDC estimates that in men aged 18-24, 1 million mRNA COVID-19 vaccination doses would prevent 936 hospitalisations, 215 intensive care unit admissions and 13 deaths, while simultaneously leading to 15-18 vaccine-associated myocarditis cases.

    “1 million mRNA COVID-19 vaccination doses would prevent 936 hospitalisations, 215 intensive care unit (ICU) admissions and 13 deaths, while simultaneously leading to 15–18 vaccine-associated myocarditis cases.”

    From Vaccine mandates for healthcare workers beyond COVID-19 (2023) · cites this paper as [25]

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Authors
Gargano, J. W., Wallace, M., Hadler, S. C., Langley, G., Su, J. R., Oster, M. E., Broder, K. R., Gee, J., Weintraub, E., Shimabukuro, T., Scobie, H. M., Moulia, D., Markowitz, L. E., Wharton, M., McNally, V. V., Romero, J. R., Talbot, H. K., Lee, G. M., Daley, M. F., & Oliver, S. E.
Affiliations
Kaiser Permanente (US)
Corresponding author
Gargano, Julia W.
Venue
MMWR. Morbidity and Mortality Weekly Report
Published
2021-07-09
Volume
70
Issue
27
Pages
977-982
ISSN
  • 0149-2195 (ISSN-L)
  • 1545-861X
OpenAlex
W3178327314
Cited by
587
References
7
Citations by year
2026: 18 · 2025: 33 · 2024: 66 · 2023: 138 · 2022: 239 · 2021: 92
FWCI
89.67
Type
journal article
Language
en
Open access
Locations
  • MMWR Morbidity and Mortality Weekly Report (publishedVersion)
  • PubMed Central (publishedVersion, public-domain)
  • PubMed (publishedVersion)
Funders
  • U.S. Department of Defense
  • U.S. Department of Health and Human Services
  • Minnesota Department of Health
  • Council of State and Territorial Epidemiologists
  • Kaiser Permanente
  • Vanderbilt University
  • Emory University
  • George Washington University
  • Nationwide Children's Hospital
  • University of Washington
  • Johns Hopkins University (COVID-19)
  • Drexel University
  • American Pharmacists Association
  • Saint Louis University
  • Public Health Agency of Canada
  • Marshfield Clinic Research Institute
  • Kaiser Permanente Washington Health Research Institute
  • Northwell Health
  • Public Health Agency
  • National Institutes of Health (COVID-19)
  • Centers for Disease Control and Prevention
  • School of Medicine, Vanderbilt University
  • University of California, Los Angeles
  • College of Medicine, Drexel University
  • Wake Forest School of Medicine
  • Research Institute, Nationwide Children's Hospital
  • Biomedical Advanced Research and Development Authority
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
COVID-19 mRNA vaccine, myocarditis, pericarditis, myopericarditis, vaccine safety, Advisory Committee on Immunization Practices, emergency use authorization, adolescents and young adults, patient and provider education
MeSH terms
COVID-19, COVID-19 Vaccines, mRNA Vaccines, Adolescent, Adult, Centers for Disease Control and Prevention, U.S., Child, Female, Humans, Immunization, Male, Myocarditis, United States, Vaccines, Synthetic, Adverse Drug Reaction Reporting Systems, Practice Guidelines as Topic, Advisory Committees, Young Adult

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