Myocarditis and pericarditis have rarely been reported. The benefit of vaccination against COVID-19 outweighs the potential risk of myocarditis and pericarditis. Learn about the four phases of clinical research, what questions researchers try to answer in each, and how a vaccine is developed, approved, and manufactured. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Hamedi KR, Loftus G, Traylor L, Goodwin R, Arce S. Vaccines (Basel). According to the TGA, the current overall estimated rates for the entire population of myocarditis for Pfizer and Moderna are similar - 1.4 cases per 100,000 Pfizer doses versus 1.8 cases per 100,000 Moderna doses. 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. endorsement of these organizations or their programs by CDC or the U.S. The ACIP COVID-19 Vaccines Work Group, comprising experts in infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings since April 2020 to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccination programs. It is estimated there are around 2 more cases per 100,000 second vaccine doses in people under 40 who received Moderna original formulation than Pfizer original formulation. Supportive therapy is a mainstay of treatment, with targeted cardiac medications or interventions as needed. There were no cases. Men under 40 who received a second dose of the Moderna vaccine had a higher risk of myocarditis following vaccination. CDC and its partners are actively monitoring reports of myocarditis and pericarditis after COVID-19 vaccination. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. mRNA Vaccine Technology: A Promising Idea for Fighting HIV, Testing of mRNA HIV vaccines in humans is underway. 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. Cookies used to make website functionality more relevant to you. The known risks of COVID-19 illness and its related, possibly severe complications, such as long-term health problems, hospitalization, and even death, far outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis or pericarditis. Reported cases of the rare heart . ACIP emphasized the importance of informing vaccination providers and the public about the benefits and the risks, including the risk for myocarditis after COVID-19 vaccination, particularly for males aged 1229 years. Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases. They also recover normal heart function sooner.12. In addition, CDC has updated patient education and communication materials reflecting this information for the Pfizer-BioNTech and Moderna****** COVID-19 vaccines; these are important to ensure that vaccine recipients, especially males aged 1229 years, are aware of increased risk for myocarditis and to seek care if they develop symptoms of myocarditis. Side effects of COVID-19 vaccination are generally mild discomfort at the injection site, fatigue, and muscle aches and go away in a few days. The https:// ensures that you are connecting to the MMWR. Cookies used to make website functionality more relevant to you. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. A recent study classifying Long COVID into four types can help health care providers better target treatments for a patients specific symptoms. endobj https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 76% were classified as mild and 22% intermediate. Were currently supporting two large studies looking at long-term effects of COVID-19, including myocarditis and other heart conditions. Baseline incidence rates (IRs), and vaccine- and dose-specific IRs and rate differences were calculated from the cohort The SCRI calculated calendar time-adjusted IR ratios (IRR), using a 60-day pre-vaccination control period and dose-specific . Getting vaccinated to prevent severe COVID-19 cuts your risk of myocarditis. Corresponding author: Sara E. Oliver, yxo4@cdc.gov. Incidence of multisystem inflammatory syndrome in children among US persons infected with SARS-CoV-2. To assess the benefit-risk balance of mRNA vaccines in adolescents and young adults, ACIP reviewed an individual-level assessment that compared the benefits (i.e., COVID-19 infections and severe disease prevented) to the risks (number of cases of myocarditis) of vaccination, using methods similar to those described previously. Specifically, the benefits per million second doses administered (i.e., the benefits of being fully vaccinated in accordance with the FDA EUA) were assessed, including 1) COVID-19 cases prevented based on rates the week of May 29, 2021; 2) COVID-19 hospitalizations prevented based on rates the week of May 22, 2021; and 3) COVID-19 intensive care unit (ICU) admissions and deaths prevented based on the proportion of hospitalized patients who were admitted to the ICU or died. 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. Most people (95%) who develop myocarditis after receiving a COVID-19 mRNA vaccine have only mild symptoms that go away within a few days. Of the 323 persons meeting CDCs case definitions, 309 (96%) were hospitalized. Reporting rates of adverse events following COVID-19 vaccination, including those from booster doses, are very stable. Am J Cardiol 2021;149:95102. Some people may have minimal or no symptoms. Between 2001 and 2020, the Institute has funded 139 myocarditis studies at a cost of $43.6 million. Expected vs. Myocarditis linked with COVID-19 illness may also be more severe because these patients are usually older and have other health conditions that increase their risk of complications. An elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed, particularly in males aged 1229 years. Your health care provider can provide more information thats specific to your situation. COVID-19 vaccines lower the risk of life-threatening heart problems and other serious health issues. Higher levels of vaccination coverage can reduce community transmission, which can protect against development and circulation of emerging variants. An official website of the United States government. Case Description and Clinical Course a. . Please enable it to take advantage of the complete set of features! Among persons with reported myocarditis after mRNA vaccination, the median age was 26 years (range=1294 years), with median symptom onset interval of 3 days after vaccination (range=0179). Acta Paediatr 2021;110:220811. Exposures were first and second dose of Pfizer, AstraZeneca, Moderna, and Janssen COVID-19 vaccines. 2021 Oct 1;6(10):1202-1206. doi: 10.1001/jamacardio.2021.2833. When reported, the cases have especially been in adolescents and young adult males within several days after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna). Autopsy cases may be classified as confirmed clinical myocarditis on the basis of meeting histopathologic criteria if no other identifiable cause. To meet the ECG or rhythm monitoring criterion, a probable case must include at least one of 1) ST-segment or T-wave abnormalities; 2) Paroxysmal or sustained atrial, supraventricular, or ventricular arrhythmias; or 3) AV nodal conduction delays or intraventricular conduction defects. Using either the original or the revised Lake Louise criteria. %PDF-1.7 "If you're focused on heart inflammation, the safer bet is to take the vaccine," said Mendel Singer at Case Western Reserve University in Ohio, who helped carry out the study. mmwrq@cdc.gov. The risk of myocarditis linked with COVID-19 illness is several times greater than the risk from vaccination, and it is often more serious.3,5,8 This is because the SARS-CoV-2 virus invades cells of the heart, plus the body generates an overactive immune response to the infection. FLEG: Myocarditis is an uncommon complication of SARS-CoV-2 infection. Most had other health conditions, such as high blood pressure, diabetes, or obesity, that raised their risk for serious COVID-19 illness.4. Chary M, Barbuto AF, Izadmehr S, Tarsillo M, Fleischer E, Burns MM. Information on v-safe is available at https://www.cdc.gov/vsafe. The estimated incidence of myocarditis was 2 per 100,000 individuals, with the highest reported rate in males aged 16 to 29. One thing we don't know is the real rate of myocarditis with the original two-dose primary series of Pfizer and Moderna. The CONNECTS-Collaborative Cohort of Cohorts for COVID-19 Research (CONNECTS-C4R) trial is enrolling 50,000 people to determine factors that may predict disease severity and long-term side effects of COVID-19. SARS-CoV-2 can cause serious heart problems by infecting heart cells and by causing inflammation that injures the heart muscle. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Its clear that vaccination can protect you from myocarditis by protecting you from COVID-19 infection. Jerome Fleg, M.D. 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. Those who have been diagnosed with myocarditis should consult with their cardiologist (heart doctor) about return to exercise or sports. 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 Reporting rates of myocarditis > background rates for males (12-49 years, depending upon dose and manufacturer) and females (after dose 2, 12-29 . Pillay J, Gaudet L, Wingert A, Bialy L, Mackie AS, Paterson DI, Hartling L. BMJ. If you have already gotten the first dose of Pfizer-BioNTech or Moderna vaccine, or if your child has already gotten the first dose of the Pfizer-BioNTech vaccine, its important to get the second dose unless a vaccination provider or your doctor tells you not to get it. CDC continues to recommend that everyone ages 6 months and older get vaccinated for COVID-19. The Researching COVID to Enhance Recovery (RECOVER) Initiative is taking place at 80 centers across the country. Buchan SA, Seo CY, Johnson C, Alley S, Kwong JC, Nasreen S, Calzavara A, Lu D, Harris TM, Yu K, Wilson SE. In a comprehensive analysis of 1,626 myocarditis cases in the U.S. VAERS, Oster, et al., concluded the highest rates of VAM are concentrated in young males, as follows: 6 70.6 per million in males 12-15 years 105.9 per million in males 16-17 years 52.4 per million for Pfizer-BioNTech and 56.3 million for Moderna per million in males 18-24 years. DOI: http://dx.doi.org/10.15585/mmwr.mm7027e2external icon. 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. Researchers added together cases after first and second doses to reach a total rate of 77 cases per million in this male age group triggered by vaccination, a sixth that seen after infection. What are the implications for public health practice? Because these studies are in their early phases, the results are not ready yet. Viruses. Among all participants aged 16 to 24, myocarditis rates were 18.8 and 4.4 per 100,000 person-years for males and females, respectively. However, the balance of benefits and risks varied by age and sex because cases of myocarditis were primarily identified among males aged <30 years, and the risks of poor outcomes related to COVID-19 increase with age. 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 1215 years; ACIP recommends that all persons aged 12 years receive a COVID-19 vaccine. Canadian public health authorities also found that the rate of myocarditis was higher for both Moderna. 8600 Rockville Pike 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. Bethesda, MD 20894, Web Policies An analysis of 51 patients with possible or confirmed myocarditis showed that 70% were male, and the average age was 56. Data were used for the most recent week not subject to reporting delays prior to the ACIP meeting. You will be subject to the destination website's privacy policy when you follow the link. The reports to the Vaccine Adverse Event Reporting System met the case definition of myocarditis (reported cases). Abbreviations: AV = atrioventricular; cMRI=cardiac magnetic resonance imaging; ECG or EKG=electrocardiogram. The study showed males younger than 40 years old who received the Moderna vaccine were shown to have the highest rates of myocarditis, which according to the authors, may have implications for choosing specific vaccines for certain populations. All EUA documents for COVID-19 vaccines, including fact sheets, are available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccinesexternal icon. Vaccine 2015;33:4398405. Unable to load your collection due to an error, Unable to load your delegates due to an error. Comparison of COVID-19 Vaccine-Associated Myocarditis and Viral Myocarditis Pathology. Department of Health and Human Services. *** Data collection for race/ethnicity of myocarditis cases is ongoing. This outside group of experts, many of them physicians at academic medical centers, advises the CDC, but doesn't represent the agency itself.The CDC has not said if the number of cases of the . Severe myocarditis can cause long-lasting heart damage or even death. This site needs JavaScript to work properly. According to the CDC, as of June 23, 2021, more than 177 million people had received at least one dose of a COVID-19 vaccine in the U.S. CDC also encourages reporting of any additional clinically significant adverse event, even if it is not clear whether a vaccination caused the event. Moderna said the majority of the infections were mild. An analysis of almost 400 patients with myocarditis linked with COVID-19 illness found that about 15% died within 6 months.9. 23) cases per 100 000 person-days for the Pfizer-BioNTech Hromi-Jahjefendi A, Barh D, Uversky V, Aljabali AA, Tambuwala MM, Alzahrani KJ, Alzahrani FM, Alshammeri S, Lundstrom K. Vaccines (Basel). Key Points There have been more than 1,200 reported cases of a myocarditis or pericarditis mostly in people 30 and under who received Pfizer's or Moderna's Covid-19 vaccine, according to CDC. ** https://www.cdc.gov/mis/hcp/index.html, https://www.ahajournals.org/doi/10.1161/CIR.0000000000000239?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed#d3e785external icon. These cookies may also be used for advertising purposes by these third parties. myocarditis and pericarditis and the mRNA COVID-19 vaccines, made by Moderna and Pfizer-BioNTech, in some vaccine recipients. Diagnostic evaluation might reveal an elevated troponin level or abnormal findings on electrocardiogram, echocardiogram, or cardiac magnetic resonance imaging (Table 1). Vaccination with mRNA-1273 (Moderna) was associated with a significantly increased rate of myocarditis or myopericarditis, especially among individuals aged 12-39 years (adjusted hazard ratio 5.24 (95% confidence interval 2.47 to 11.12); absolute rate 5.7 (3.3 to 9.3) per 100 000 individuals aged 12-39 years within 28 days of vaccination) Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. 2023 Jan 17;11(2):208. doi: 10.3390/vaccines11020208. doi: 10.1001/jamanetworkopen.2022.18505. MMWR Morb Mortal Wkly Rep 2021;70:977982. The work group also reviewed a benefit-risk assessment of myocarditis events after receipt of mRNA COVID-19 vaccines, considering recent epidemiology of COVID-19 and sequelae of COVID-19, including myocarditis and multisystem inflammatory syndrome in children (MIS-C). Information about CDCs ongoing study of myocarditis after COVID-19 vaccination can be found here: Investigating Long-Term Effects of Myocarditis | CDC. The researchers found only 1 case per 71,400 vaccinated with Pfizer-BioNTech and 1 case per 23,800 vaccinated with Moderna. More information is available, Travel requirements to enter the United States are changing, starting November 8, 2021. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. Klamer, T. A., Linschoten, M., & Asselbergs, F. W. (2022). There might be a 2.5 times higher . COVID-19 Therapeutics: Use, Mechanism of Action, and Toxicity (Vaccines, Monoclonal Antibodies, and Immunotherapeutics). Epidemiology of Myocarditis and Pericarditis Following mRNA Vaccination by Vaccine Product, Schedule, and Interdose Interval Among Adolescents and Adults in Ontario, Canada. Among men ages 18 to 29 who received the Moderna vaccine, the rate was 22.9 per 100,000 doses. URL addresses listed in MMWR were current as of Health and Human Services. In cases of v-safe reports that include possible medically attended health events, CDCs v-safe call center follows up with the vaccine recipient to collect additional information for completion of a VAERS report. Active monitoring includes reviewing data and medical records and evaluating the relationship toCOVID-19vaccination. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes. The U.S. Food and Drug Administration on Friday added a warning to patient and provider fact sheets for the Pfizer and Moderna Covid-19 vaccines to indicate a rare risk of heart inflammation. FLEG: Tens of thousands of people participated in the clinical trials for the COVID-19 vaccines. JAMA. Overall, the investigators found 2.13 myocarditis cases per 100,000 peopleagain, about a 0.002% incidencewith the highest incidence in men 16 to 29 years old, where it was 10.69 cases per 100,000 people, or a 0.011% incidence (95% CIs, 1.56 to 2.70 and 6.93 to 14.46, respectively). NHLBI-supported research aims to identify the causes of lasting heart and lung symptoms of COVID-19, find ways to prevent these problems, and improve treatment to promote rapid healing. Seek medical care if you or your child have any of the specific or general symptoms of myocarditis or pericarditis especially if its within a week after COVID-19 vaccination. Buonsenso D, Munblit D, De Rose C, et al. 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. Some groups have a higher risk of developing myocarditis from COVID-19. Am J Cardiovasc Pathol 1987; 1:314). (Pfizer) or mRNA-1273 (Moderna) mRNA vaccine between December 14, 2020, and July 20, 2021. Its also possible that myocarditis linked with vaccination is less serious because of the younger average age and healthier status of people getting vaccinated. According to an analysis presented by a C.D.C. Parents should speak with their childrens health care providers regarding the benefits and risks of vaccination against COVID-19. Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Myocarditis rates from Vaccine Safety Datalink (VSD), based on electronic health records, were also evaluated. 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. <>/ExtGState<>/Pattern<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The Pfizer and Moderna mRNA vaccines are available in the U.S. Regarding health equity considerations, racial and ethnic minority groups have higher rates of COVID-19 and severe disease*****; potential changes in vaccine policy, or anything that would affect vaccination coverage for adolescents or young adults, might disproportionately affect those groups with the highest rates of poor COVID-19 outcomes. FOIA sharing sensitive information, make sure youre on a federal Most people (95%) who develop myocarditis after receiving a COVID-19 mRNA vaccine have only mild symptoms that go away within a few days.5 Vaccine-linked myocarditis is less likely to cause lingering heart problems than myocarditis due to COVID-19 illness. We dont know exactly how often this happens, but one study estimated that myocarditis affects about 40 people out of every 1,000,000 people who test positive for COVID-19.3 However, myocarditis is much more common in patients hospitalized for COVID-19 (226 per 100,000). The most common symptoms are chest pain, fever, fatigue, shortness of breath, and a rapid or irregular pulse. Accessibility The .gov means its official. Potential cases of postvaccine myocarditis were identified based on reports . Per million second doses of mRNA COVID-19 vaccine administered to males aged 1229 years, 11,000 COVID-19 cases, 560 hospitalizations, 138 ICU admissions, and six deaths due to COVID-19 could be prevented, compared with 3947 expected myocarditis cases after COVID-19 vaccination (Table 2). The researchers noted 9.7 myocarditis cases per 100,000 person-years for unvaccinated males and 4.3 per 100,000 for females. Last week, after reviewing data from a clinical . Bookshelf Broken down by age and sex, a second dose of the Moderna vaccine was associated with a higher rate of myocarditis or pericarditis compared with a second dose of the Pfizer/BioNTech vaccine among males ages 18 to 24 (adjusted rate ratio 6.6; 95% CI 3.3-13.2) and 25 to 39 (adjusted rate ratio 5.1; 95% CI 2.3-11.5), as well as females ages 18 to . . "In general, the rate of myocarditis or myopericarditis was about threefold to fourfold higher for mRNA-1273 (Moderna) vaccination than that for BNT162b2 (Pfizer-BioNTech) vaccination," the study said. Comparison of MIS-C Related Myocarditis, Classic Viral Myocarditis, and COVID-19 Vaccine related Myocarditis in Children. Although numbers were too small to show rates in all subgroups by age, VSD data indicated increased risk of myocarditis in the 7 days after receipt of dose 1 or dose 2 of an mRNA COVID-19 vaccine compared with the risk 2242 days after the second dose, particularly among younger males after dose 2 (5). 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. The cases have been most common in male adolescents and young adults, occurring most often after the second dose, and usually within several days of receiving the vaccine. This conversion might result in character translation or format errors in the HTML version. Unfortunately, inflammation in the heart muscle can lead to serious complications, including heart failure, shock, or death. Presence of 2 new or worsening of the following clinical features: new ST-elevation or PR-depression on EKG, new or worsening pericardial effusion on echocardiogram or MRI. The findings from the VaST and the ACIP COVID-19 Vaccines Work Group assessments, including a summary of the data reviewed, were presented to ACIP during its meeting on June 23, 2021. The y-axis range differs between panels A and B. Rates of myocarditis and pericarditis were higher with the Moderna vaccine in both males and . Myocarditisisinflammation of the heart muscle. You will be subject to the destination website's privacy policy when you follow the link. We spoke with Fleg about the risk of myocarditis linked with COVID-19 illness and with vaccines. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. Follow-up is ongoing to identify and understand longer-term outcomes after myocarditis occurring after COVID-19 vaccination. Myocarditis is a rare complication of COVID-19 vaccination. the rates per million doses were roughly 52 with the Pfizer shots and . The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Results: Incidence Rates and Rate Ratios of Myocarditis in Vaccinated Individuals Compared With Control Groups. Dr Lopes reported receiving personal fees from Bayer, Boehringer Ingleheim, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Portola, and Sanofi and receiving grants from Bristol Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. Overall myocarditis rates among males in this age group were 2.97 per 100,000, which rose to 2.27 per 100,000 after the second dose. A., & American Heart Association Pediatric Heart Failure and Transplantation Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young and Stroke Council (2021). On June 23, 2021, the Advisory Committee on Immunization Practices concluded that the benefits of COVID-19 vaccination to individual persons and at the population level clearly outweighed the risks of myocarditis after vaccination. Questions or messages regarding errors in formatting should be addressed to Learn how NIH has improved basic understanding of the SARS-CoV-2 virus and sped up the development of COVID-19 vaccines, treatments, and testing. 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. Cordero, A., Cazorla, D., Escribano, D., Quintanilla, M. A., Lpez-Ayala, J. M., Berbel, P. P., & Bertomeu-Gonzlez, V. (2022). of pages found at these sites. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. 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. Men and boys between the ages of 16 and 29 have been most often affected by COVID-19vaccine-related myocarditis, usually a few days after their second dose.5 Myocarditis may be due to their strong immune response to the vaccine. FDA has added information to the Pfizer-BioNTech and Moderna COVID-19 vaccine EUA and fact sheets regarding myocarditis cases that have been reported among vaccine recipients. Myocarditis typically occurs more commonly in males than in females, and incidence is highest among infants, adolescents, and young adults (1,2). Current guidelines from the American Heart Association and American College of Cardiology recommend exercise restriction until the heart recovers.. Design, setting, and participants: When reported, the cases have especially been in adolescents and young adult males within several days after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna). On July 6, 2021, this report was posted online as an MMWR Early Release. Among patients in a large Israeli health care system who had received at least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of myocarditis was 2.13 cases per 100,000 persons; the .