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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.
MMWR Morb Mortal Wkly Rep. 2021 Jul 09; 70(27):977-982.MM

Abstract

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine,† and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively.§ In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine. Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a 2-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose. After reports of myocarditis and pericarditis in mRNA vaccine recipients,¶ 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.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

34237049

Citation

Gargano, Julia W., et al. "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." MMWR. Morbidity and Mortality Weekly Report, vol. 70, no. 27, 2021, pp. 977-982.
Gargano JW, Wallace M, Hadler SC, et al. 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. MMWR Morb Mortal Wkly Rep. 2021;70(27):977-982.
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. (2021). 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. MMWR. Morbidity and Mortality Weekly Report, 70(27), 977-982. https://doi.org/10.15585/mmwr.mm7027e2
Gargano JW, et al. 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. MMWR Morb Mortal Wkly Rep. 2021 Jul 9;70(27):977-982. PubMed PMID: 34237049.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Gargano,Julia W, AU - Wallace,Megan, AU - Hadler,Stephen C, AU - Langley,Gayle, AU - Su,John R, AU - Oster,Matthew E, AU - Broder,Karen R, AU - Gee,Julianne, AU - Weintraub,Eric, AU - Shimabukuro,Tom, AU - Scobie,Heather M, AU - Moulia,Danielle, AU - Markowitz,Lauri E, AU - Wharton,Melinda, AU - McNally,Veronica V, AU - Romero,José R, AU - Talbot,H Keipp, AU - Lee,Grace M, AU - Daley,Matthew F, AU - Oliver,Sara E, Y1 - 2021/07/09/ PY - 2021/7/8/entrez PY - 2021/7/9/pubmed PY - 2021/7/10/medline SP - 977 EP - 982 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 70 IS - 27 N2 - In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine,† and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively.§ In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine. Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a 2-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose. After reports of myocarditis and pericarditis in mRNA vaccine recipients,¶ 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. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/34237049/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_ L2 - https://doi.org/10.15585/mmwr.mm7027e2 DB - PRIME DP - Unbound Medicine ER -