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
| Autor: | Lauri E. Markowitz, Gayle E Langley, Heather M. Scobie, Melinda Wharton, Megan J. Wallace, Julia W. Gargano, Tom T. Shimabukuro, Karen R. Broder, Stephen C. Hadler, H. Keipp Talbot, Matthew F. Daley, Julianne Gee, Sara E. Oliver, Eric Weintraub, John R. Su, Danielle Moulia, Matthew E. Oster, Veronica V. McNally, Jose R. Romero, Grace M. Lee |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Pediatrics medicine.medical_specialty COVID-19 Vaccines Health (social science) Myocarditis Adolescent Coronavirus disease 2019 (COVID-19) Epidemiology Health Toxicology and Mutagenesis Advisory committee Advisory Committees Young Adult Pericarditis Health Information Management medicine Adverse Drug Reaction Reporting Systems Humans Full Report Young adult Child Vaccines Synthetic business.industry COVID-19 General Medicine medicine.disease United States Vaccination Immunization Practice Guidelines as Topic Female Centers for Disease Control and Prevention U.S business Myopericarditis |
| Zdroj: | Morbidity and Mortality Weekly Report |
| ISSN: | 1545-861X 0149-2195 |
| DOI: | 10.15585/mmwr.mm7027e2 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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