Most people recover fully with rest and a few days of supportive treatment while being monitored in a hospital. Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Myocarditis related to COVID-19 vaccines seems to be caused by the bodys immune response to vaccination. For Moderna's vaccine, rates of myocarditis or pericarditis overall were 23 cases per million first doses and 62.5 cases per million second doses. Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The median age of the 323 patients meeting CDCs case definitions was 19 years (range=1229 years); 291 were male, and 32 were female. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Cases of myocarditis and pericarditis, although rare, have occurred more often in younger men (adolescents or young adults) and after the second dose, typically within a few days after . Even in this group, though, heart inflammation is seven or eight times more common after SARS-CoV-2 infection.10 And the data suggest that young adults with myocarditis possibly linked with COVID-19 vaccines recover quickly with supportive care.11. Exposures were first and second dose of Pfizer, AstraZeneca, Moderna, and Janssen COVID-19 vaccines. The scientists are monitoring the health of a diverse group of people to learn about the long-term effects of COVID, including heart problems. Follow-up is ongoing to identify and understand longer-term outcomes after myocarditis occurring after COVID-19 vaccination. Using myocarditis cases reported to VAERS with onset within 7 days after dose 2 of an mRNA vaccine, crude reporting rates (i.e., using confirmed and unconfirmed cases) per million second dose recipients were calculated using national COVID-19 vaccine administration data as of June 11, 2021. Information on v-safe is available at https://www.cdc.gov/vsafe. This is a recognised risk with the Comirnaty (Pfizer) and Spikevax (Moderna) vaccines and we are closely monitoring these events. : Myocarditis is an inflammation of the heart muscle. Its clear that vaccination can protect you from myocarditis by protecting you from COVID-19 infection. and transmitted securely. The risk of getting myocarditis from a COVID-19 vaccine is less than 1%. US researchers say teenagers are more likely to get vaccine-related myocarditis than end up in hospital with Covid Skip to main content Skip to navigation Print subscriptions Mary Chamberland, Thomas Clark, Amanda Cohn, Frank DeStefano, Ruth Gallego, Alice Guh, Theresa Harrington, Fiona P. Havers, Lauri Hicks, Amelia Jazwa, Tara Johnson, Brian Kit, Paige Marquez, Sarah Mbaeyi, Elaine Miller, Hannah Rosenblum, Monica Parise, Kadam Patel, Pragati Prasad, David Shay, Jamila Shields, Christopher A. Taylor, Joshua Wong, CDC COVID-19 Response Team; Clinical Immunization Safety Assessment (CISA) Project; Vaccine Safety Datalink; Center for Biologics Evaluation and Research, Food and Drug Administration; Voting members of the Advisory Committee on Immunization Practices: Kevin A. Ault, University of Kansas Medical Center; Lynn Bahta, Minnesota Department of Health; Henry Bernstein, Zucker School of Medicine at Hofstra/Northwell Cohen Childrens Medical Center; Beth Bell, University of Washington, Seattle, Washington; Wilbur Chen, University of Maryland School of Medicine; Sharon E. Frey, Saint Louis University Medical School; Camille Kotton, Harvard Medical School; Sarah Long, Drexel University College of Medicine; Katherine A. Poehling, Wake Forest School of Medicine; Pablo J. Snchez, The Research Institute at Nationwide Childrens Hospital. Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. You can learn more about myocarditis symptoms, diagnosis, and treatment from the NHLBI. Hamedi KR, Loftus G, Traylor L, Goodwin R, Arce S. Vaccines (Basel). The Pfizer and Moderna mRNA vaccines are available in the U.S. The F.D.A. * These authors contributed equally to this work. Bethesda, MD 20894, Web Policies Vaccinating adolescents against SARS-CoV-2 in England: a risk-benefit analysis. From an analysis done on just 26 medical chart-confirmed cases of myocarditis in people ages 12 to 39, the CDC scientists estimated a rate of 12.6 cases per million second doses. https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Paul Burton, M.D., Ph.D., shared that data has found that there have been 13.3 cases of myocarditis per 100,000 people who received the Moderna vaccine compared to 2.7 cases per 100,000 people. Current guidelines from the American Heart Association and American College of Cardiology recommend exercise restriction until the heart recovers.. 2023 Feb 5;11(2):362. doi: 10.3390/vaccines11020362. This site needs JavaScript to work properly. Questions or messages regarding errors in formatting should be addressed to If you have any health problems after vaccination, report them to theVaccine Adverse Event Reporting System. Of the nearly 21 million women, 7.2 million (34%) were younger than age 40, and a slightly increased risk of myocarditis was found among this younger age group after receiving a second dose of the Moderna COVID-19 vaccine: 7 estimated extra cases of myocarditis for every one million women vaccinated. An analysis of 51 patients with possible or confirmed myocarditis showed that 70% were male, and the average age was 56. 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. Information about CDCs ongoing study of myocarditis after COVID-19 vaccination can be found here: Investigating Long-Term Effects of Myocarditis | CDC. They suggest the rates of myocarditis after the Moderna-NIAID vaccine may be two-and-a-half times higher. Reports of myocarditis and pericarditis after vaccination are rare. During the COVID-19 pandemic, Fleg turned his attention to the effects of SARS-CoV-2 infection on the heart, including myocarditis. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. COVID-19 Therapeutics: Use, Mechanism of Action, and Toxicity (Vaccines, Monoclonal Antibodies, and Immunotherapeutics). Cookies used to make website functionality more relevant to you. Severe problems linked with myocarditis include chest pain, arrhythmias, trouble breathing, ankle or leg swelling, and fainting. Reported cases of the rare heart . The benefits (prevention of COVID-19 disease and associated hospitalizations, ICU admissions, and deaths) outweighed the risks (expected myocarditis cases after vaccination) in all populations for which vaccination has been recommended. Annie, F. H., Alkhaimy, H., Nanjundappa, A., & Elashery, A. JAMA Netw Open 2021;4:e2116420. Baggs J, Gee J, Lewis E, et al. <>/Metadata 2557 0 R/ViewerPreferences 2558 0 R>> (2022). Viral infections, including COVID-19, are most often the cause,2 but other diseases, as well as some drugs and toxins, can also cause myocarditis. An analysis of almost 400 patients with myocarditis linked with COVID-19 illness found that about 15% died within 6 months.9. The 120-day period was selected because 1) no alternative vaccine options currently exist for persons aged <18 years or are expected to be available during this period, and 2) inputs regarding community transmission have high uncertainty beyond this period, particularly in the context of circulating variants.. In a press release, the authors said their findings "support the preferential use of the BNT162b2 (Pfizer-BioNTech . The Researching COVID to Enhance Recovery (RECOVER) Initiative is taking place at 80 centers across the country. Myocarditis typically occurs more commonly in males than in females, and incidence is highest among infants, adolescents, and young adults (1,2). View Large Download. (Pfizer) or mRNA-1273 (Moderna) mRNA vaccine between December 14, 2020, and July 20, 2021. <>/ExtGState<>/Pattern<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Su, J. R., McNeil, M. M., Welsh, K. J., Marquez, P. L., Ng, C., Yan, M., & Cano, M. V. (2021). JAMA Netw Open. Among males aged 30 years, 15,300 COVID-19 cases, 4,598 hospitalizations, 1,242 ICU admissions, and 700 deaths could be prevented, compared with three to four expected myocarditis cases after COVID-19 vaccination. sharing sensitive information, make sure youre on a federal More information is available, Travel requirements to enter the United States are changing, starting November 8, 2021. July 5, 2022, U.S. Department of Health and Human Services, Benefits of COVID-19 vaccines outweigh a very small risk of heart complications, You can learn more about myocarditis symptoms, diagnosis, and treatment from the NHLBI, Countermeasures Injury Compensation Program, Researching COVID to Enhance Recovery (RECOVER), CONNECTS-Collaborative Cohort of Cohorts for COVID-19 Research (CONNECTS-C4R), https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total, https://doi.org/10.1161/CIR.0000000000001001, https://doi.org/10.1038/s41591-021-01630-0, https://doi.org/10.1016/j.hrtlng.2020.08.013, https://doi.org/10.1007/s12471-022-01677-9, https://doi.org/10.1016/j.vaccine.2020.12.046, https://doi.org/10.1016/j.ijcard.2022.01.037, https://doi.org/10.1007/s00392-022-02007-0, https://doi.org/10.1016/j.mayocpiqo.2021.12.006, https://doi.org/10.1177/01410768211052589, https://doi.org/10.1101/2021.10.05.21264581. Case Description and Clinical Course a. . Learn more about, Feelings of having a fast-beating, fluttering, or pounding heart. Hromi-Jahjefendi A, Barh D, Uversky V, Aljabali AA, Tambuwala MM, Alzahrani KJ, Alzahrani FM, Alshammeri S, Lundstrom K. Vaccines (Basel). Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases. Reporting rates (per 1 million doses administered) of myocarditis among females after Moderna COVID-19 vaccination, days 0-7 after vaccination (through Jan 13, 2022 6 Moderna (Females) Ages (years) Dose 1 Dose 2 18-24 0.5 5.5 25-29 0.3 5.8 30-39 0.6 0.6 40-49 0.8 1.6 50-64 0.8 0.4 65+ 0.1 0.5 85,729,766 Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Your health care provider can provide more information thats specific to your situation. There were 13.3 cases of myocarditis per 100,000 in people 12 to 29 years old who got Moderna's vaccine compared to 2.7 cases per 100,000 people in that age group that got the Pfizer vaccine. Viruses. CDC has provided guidance regarding evaluation and management of myocarditis after mRNA COVID-19 vaccine (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html), as well as considerations for a second vaccine dose in persons who develop myocarditis after a first dose (https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html). Chou, O., Zhou, J., Lee, T., Kot, T., Lee, S., Wai, A., Wong, W. T., Zhang, Q., Cheng, S. H., Liu, T., Vassiliou, V. S., Cheung, B., & Tse, G. (2022). <> But the risk of myocarditis associated with the vaccine was lower than the risk associated with COVID-19 infection before or after vaccination - with one exception. Severe myocarditis can cause long-lasting heart damage or even death. Many people have no side effects at all. FLEG: Myocarditis is an uncommon complication of SARS-CoV-2 infection. Abbreviations: AV = atrioventricular; cMRI=cardiac magnetic resonance imaging; ECG or EKG=electrocardiogram. Importance: ACIP recommendations for all COVID-19 vaccines are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html. Since April, more than 1,000 cases of inflammation of the . CDC is not responsible for the content Pediatrics 2011;127(Suppl 1):S4553. The benefit-risk analysis can be updated as needed to reflect changes in the COVID-19 pandemic and additional information on the risk for and outcomes of myocarditis after COVID-19 vaccination. Reporting rates of adverse events following COVID-19 vaccination, including those from booster doses, are very stable. The FDA - which generally follows the recommendations of its advisers but is not obligated to do so - is likely to authorize the Moderna vaccine for ages 6-17 soon. Observed cases of myocarditis reported to VAERS after Moderna dose 2, 7-day risk period (N=216)* Age group, years Females Males Cases of myopericarditis, expected Cases of . scientist on Monday, every million doses of the Pfizer vaccine administered to 16- and 17-year-old boys would be expected to cause 73 cases of the . Moderna defended the use of its Covid vaccine, saying the protection it offers against severe disease, hospitalization and death outweighs the risk of myocarditis. At the time of this report, 323 of these 484 cases were determined to meet criteria in CDCs case definitions for myocarditis, pericarditis, or myopericarditis by provider interview or medical record review (Table 1). COVID-19 Vaccinations in the United States. Vaccine 2015;33:4398405. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. doi: 10.1001/jamanetworkopen.2022.18505. The y-axis range differs between panels A and B. Its also possible that myocarditis linked with vaccination is less serious because of the younger average age and healthier status of people getting vaccinated. Researchers Identify Four Long COVID Categories. Comparisons of the risk of myopericarditis between COVID-19 patients and individuals receiving COVID-19 vaccines: a population-based study. Cooper LT Jr. Myocarditis. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. B, For the mRNA-1273 vaccine, there were 116 reported cases of myocarditis with known date for symptom onset and dose after 78158611 first vaccination doses and 311 reported cases after 66163001 second vaccination doses. Within the Vaccine Adverse Event Reporting System (VAERS) (4), the national vaccine safety passive monitoring system, 1,226 reports of myocarditis after mRNA vaccination were received during December 29, 2020June 11, 2021. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Serious side effects are very uncommon. For children ages 6 months to 2 years, efficacy was 43.7 percent, and in children ages 2 to 6, it was only 37.5 percent. Among 1,194 reports for which patient age was known, 687 were among persons aged <30 years and 507 were among persons aged 30 years; of 1,212 with sex reported, 923 were male, and 289 were female. Among 1,094 patients with number of vaccine doses received reported, 76% occurred after receipt of dose 2 of mRNA vaccine; cases were reported after both Pfizer-BioNTech and Moderna vaccines. government site. The y-axis range differs between panels A and B. There were likely many cases that went unreported. Most had other health conditions, such as high blood pressure, diabetes, or obesity, that raised their risk for serious COVID-19 illness.4. Coronavirus-induced myocarditis: A meta-summary of cases. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Myocarditis Occurs Earlier, Pericarditis Later Several reports to date have shown a higher-than-expected rate of myocarditis or pericarditis following SARS-CoV-2 vaccination, particularly with the mRNA-based vaccines from Pfizer/BioNTech and Moderna. **** The risks were assessed as the number of myocarditis patients reported to VAERS that occurred within 7 days of receipt of a second dose of an mRNA COVID-19 vaccine per million second doses administered through the week of June 11, 2021. The benefit-risk assessment was stratified by age group and sex. Data from a government agency's safety monitoring system in that month suggested a rate of 12.6 cases of heart inflammation per million in 12-to 39-year-olds. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis. Incidence Rates and Rate Ratios of Myocarditis in Vaccinated Individuals Compared With Control Groups. FLEG: The bottom line is this: The benefits of getting vaccinated markedly outweigh the very small risk of vaccine-related myocarditis. 2023 Feb 13;11(2):432. doi: 10.3390/vaccines11020432. The most common symptoms are chest pain, fever, fatigue, shortness of breath, and a rapid or irregular pulse. endobj and/or the original MMWR paper copy for printable versions of official text, figures, and tables. Myocarditis usually goes away on its own with supportive care, including IV fluids, steroid therapy, and medicines to treat disorders of heart rhythm or pumping function. Thank you for taking the time to confirm your preferences. Myocarditis reporting rates were 40.6 cases per million second doses of mRNA COVID-19 vaccines administered to males aged 1229 years and 2.4 per million second doses administered to males aged 30 years; reporting rates among females in these age groups were 4.2 and 1.0 per million second doses, respectively. HHS Vulnerability Disclosure, Help MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services.