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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 accessAbstract
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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“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]
Experimental — accuracy not yet measuredIn the citing paper
“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]
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“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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Cites
Cooper, L. T. (2009) · New England Journal of Medicine · doi:10.1056/nejmra0800028 · Cited by 1,325
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)
Shimabukuro, T. T., Nguyen, M., Martin, D., & Destefano, F. R. (2015) · Vaccine · doi:10.1016/j.vaccine.2015.07.035 · Cited by 627
Self-citationPreliminary evidence on long COVID in children
Buonsenso, D., Munblit, D., Rose, C. D., Sinatti, D., Ricchiuto, A., Carfì, A., & Valentini, P. (2021) · Acta Paediatrica · doi:10.1111/apa.15870 · Cited by 508
Incidence of Multisystem Inflammatory Syndrome in Children Among US Persons Infected With SARS-CoV-2
Payne, A. B., Gilani, Z., Godfred‐Cato, S., Belay, E. D., Feldstein, L. R., Patel, M. M., Randolph, A. G., Newhams, M. M., Thomas, D., Magleby, R., et al. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.16420 · Cited by 395
Self-citationThe Vaccine Safety Datalink: A Model for Monitoring Immunization Safety
Baggs, J. M., Gee, J. M., Lewis, E. M., Fowler, G. L., Benson, P. J., Lieu, T. A., Naleway, A. L., Klein, N. P., Baxter, R. P., Belongia, E. A., et al. (2011) · PEDIATRICS · doi:10.1542/peds.2010-1722h · Cited by 349
Self-citationThe effects of gender and age on occurrence of clinically suspected myocarditis in adulthood
Kytö, V., Sipilä, J., & Rautava, P. (2013) · Heart · doi:10.1136/heartjnl-2013-304449 · Cited by 124
Trends in Acute Myocarditis Related Pediatric Hospitalizations in the United States, 2007–2016
Vasudeva, R., Bhatt, P. J., Lilje, C., Desai, P., Amponsah, J. K., Umscheid, J., Parmar, N. G., Bhatt, N. S., Adupa, R., Pagad, S., et al. (2021) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2021.03.019 · Cited by 53
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Fiolet, T., Kherabi, Y., MacDonald, C.-J., Ghosn, J., & Peiffer-Smadja, N. (2022) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2021.10.005 · Cited by 911
The clinical progress of mRNA vaccines and immunotherapies
Barbier, A. J., Jiang, A. Y., Zhang, P., Wooster, R., & Anderson, D. G. (2022) · Nature Biotechnology · doi:10.1038/s41587-022-01294-2 · Cited by 823
Oster, M. E., Shay, D. K., Su, J. R., Gee, J. M., Creech, C. B., Broder, K. R., Edwards, K. M., Soslow, J. H., Dendy, J. M., Schlaudecker, E. P., et al. (2022) · JAMA · doi:10.1001/jama.2021.24110 · Cited by 686
Self-citationGluckman, T. J., Bhave, N. M., Allen, L. A., Chung, E. H., Spatz, E. S., Ammirati, E., Baggish, A. L., Bozkurt, B., Cornwell, W. K., Harmon, K. G., et al. (2022) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2022.02.003 · Cited by 431
Diagnosis and Treatment of Acute Myocarditis: A Review
Ammirati, E., & Moslehi, J. J. (2023) · JAMA · doi:10.1001/jama.2023.3371 · Cited by 379
Metadata
- 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.
- ORCID
- 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
- PMC
- PMC8312754
- 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
- diamond
- doi.org
- 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 › Infectious Diseases › 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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