Myocarditis and Pericarditis following COVID-19 Vaccination: Rapid Systematic Review of Incidence, Risk Factors, and Clinical Course

Pillay, Jennifer; Bialy, Liza; Gaudet, L.; Wingert, Aireen; Mackie, Andrew S.; Paterson, D. Ian; Hartling, Lisa

doi:10.1101/2021.11.19.21266605

Cited by 7 publications

(15 citation statements)

References 44 publications

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“…The most common symptoms are chest pain, followed by myalgia/ body aches and fever. These findings matched with Pillay et al (2021) [15], who reported in a systematic review observation that the majority of myocarditis cases had a short symptoms onset of 2 to 4 days after a second dose, and the majority presented with chest pain. These findings matched with Oster et al (2022) [12], who mentioned myocarditis was diagnosed within days of vaccination.…”

Section: Discussionsupporting

confidence: 90%

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Global Reports of Myocarditis Following COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Ahmed¹,

Mohamed

Essa³

et al. 2022

Preprint

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In December 2020, the FDA granted emergency approval to Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) COVID-19 vaccines. There have been recent media reports of myocarditis after receiving COVID-19 vaccines, particularly the messenger RNA (mRNA) vaccines, causing public concern. This review summarizes information from published case series and case reports, with a strong emphasis on reporting patient and disease characteristics, investigation, and clinical outcome, to provide a comprehensive picture of the condition. Forty studies, including 147 cases, participated in this systematic review. The median age was 28.9 years; 93.9% were male and 6.1% were female. 72.1% of patients received the Pfizer-BioNTech (BNT162b2) vaccine, 24.5% of patients received the Moderna COVID-19 Vaccine (mRNA-1273), and the rest of the 3.3% received other types of vaccines. Furthermore, most myocarditis cases (87.1%) occurred after the second vaccine dose, after a median time interval of 3.3 days. The most frequently reported symptoms were chest pain, myalgia/body aches and fever. Troponin levels were consistently elevated in 98.6%. The admission ECG was abnormal in 88.5% of cases, and the left LVEF was lower than 50% in 26.5% of cases. The vast majority of patients (93.2%) resolved symptoms and recovered, and only 3 patients died. These findings may help public health policy to consider myocarditis in the context of the benefits of COVID-19 vaccination as well as to assess the cardiac condition before the choice of vaccine, which is offered to male adults. In addition, it must be carefully weighed against the very substantial benefit of vaccination.

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Section: Discussionsupporting

confidence: 90%

“…Moreover, Patone et al (2022) [14] mentioned that the incidence of myocarditis was among England males younger than 40 years old. Similarly, a systematic review study found that the Incidence of myocarditis following mRNA vaccines is low but probably highest in males aged 12-29 years old [15].…”

Section: Discussionmentioning

confidence: 99%

Global Reports of Myocarditis Following COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Ahmed¹,

Mohamed

Essa³

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…(2022) [ 14 ] mentioned that the incidence of myocarditis was among England males younger than 40 years old. Similarly, a systematic review study found that the Incidence of myocarditis following mRNA vaccines is low but probably highest in males aged 12–29 years old [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

Global reports of myocarditis following COVID-19 vaccination: A systematic review and meta-analysis

Ahmed

Mohamed

Essa³

et al. 2022

Diabetes & Metabolic Syndrome: Clinical Research & Revi

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“…Forty-six studies were included in this update ( Figure 1 ). Findings from 12 studies from the original review 15 were carried forward (Q1=5 25–29 , Q2=2 29 30 , Q3b. 25–28 31–36 ).…”

Section: Resultsmentioning

confidence: 99%

“…Our original reviews (literature search October 6, 2021) on incidence rates, risk factors, and case presentation and short-term outcomes of myo- and/or pericarditis after COVID-19 vaccination across all vaccines, ages and sexes indicated that incident rates were little-to-none after non-mRNA vaccines and in adults 40 years and older, that rates after mRNA vaccination varied by sex, age, and dose, and that the case characteristics and clinical course of myocarditis and pericarditis differ. 15 There were no data on children aged <12 years or for people after receiving a third dose. For our review update reported herein, we refined the questions to focus on gaps and stakeholder/decision-maker priorities, specifically, mRNA vaccines, priority age and risk groups, and cases after a third vaccine dose.…”

Section: Introductionmentioning

confidence: 99%

Myocarditis and Pericarditis following COVID-19 Vaccination: Evidence Syntheses on Incidence, Risk Factors, Natural History, and Hypothesized Mechanisms

Pillay

Gaudet

Wingert

et al. 2022

Preprint

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ObjectivesMyocarditis and pericarditis are adverse events of special interest after vaccination for COVID-19. Evidence syntheses were conducted on incidence rates, risk factors for myocarditis and pericarditis after COVID-19 mRNA vaccination, clinical presentation and short- and longer-term outcomes of cases, and proposed mechanisms and their supporting evidence.DesignSystematic reviews and evidence reviews.Data sourcesMedline, Embase and the Cochrane Library were searched from October 2020 to January 10, 2022; reference lists and grey literature (to January 13, 2021).Review methodsLarge (>10,000) or population-based/multisite observational studies and surveillance data (incidence and risk factors) reporting on confirmed myocarditis or pericarditis after COVID-19 vaccination; case series (n≥5, presentation, short-term clinical course and longer-term outcomes); opinions/letters/reviews/primary studies focused on describing or supporting hypothesized mechanisms. A single reviewer completed screening and another verified 50% of exclusions, using a machine-learning program to prioritize records. A second reviewer verified all exclusions at full text, extracted data, and (for incidence and risk factors) risk of bias assessments using modified Joanna Briggs Institute tools. Team consensus determined certainty of evidence ratings for incidence and risk factors using GRADE.Results46 studies were included (14 on incidence, 7 on risk factors, 11 on characteristics and short-term course, 3 on longer term outcomes, and 21 on mechanisms). Incidence of myocarditis after mRNA vaccines is highest in male adolescents and young adults (12-17y: range 50-139 cases per million [low certainty] and 18-29y: range 28-147 per million [moderate certainty]). For 5-11 year-old males and females and females 18-29 years of age, incidence of myocarditis after vaccination with Pfizer may be fewer than 20 cases per million (low certainty). There was very low certainty evidence for incidence after a third dose of an mRNA vaccine. For 18-29 year-old males and females, incidence of myocarditis is probably higher after vaccination with Moderna compared to Pfizer (moderate certainty). Among 12-17, 18-29 and 18-39 year-olds, incidence of myocarditis/pericarditis after dose 2 of an mRNA vaccine may be lower when administered ≥31 days compared to ≤30 days after dose 1 (low certainty). Data specific to males aged 18-29 indicated that the dosing interval may need to increase to ≥56 days to substantially drop incidence. For clinical course and short-term outcomes only one small series (n=8) was found for 5-11 year olds. In cases of adolescents and adults, the majority (>90%) of myocarditis cases involved 20-30 year-old males with symptom onset 2 to 4 days after second dose (71-100%). Most cases were hospitalized (≥84%) for a short duration (2-4 d). For pericarditis, data is limited but more variation has been reported in patient age, sex, onset timing and rate of hospitalization. Case series with longer-term (3 mo; n=38) follow-up suggest persistent ECG abnormalities, as well as ongoing symptoms and/or a need for medications or restriction from activities in >50% of patients. 16 hypothesized mechanisms are described, with little direct supporting or refuting evidence.ConclusionsAdolescent and young adult males are at the highest risk of myocarditis after mRNA vaccination. Pfizer over Moderna and waiting more than 30 days between doses may be preferred for this population. Incidence of myocarditis in children aged 5-11 may be very rare but certainty was low. Data on clinical risk factors was very limited. Clinical course of mRNA related myocarditis appears to be benign although longer term follow-up data is limited. Prospective studies with appropriate testing (e.g., biopsy, tissue morphology) will enhance understanding of mechanism(s).Funding and Registration noThis project was funded in part by the Canadian Institutes of Health Research (CIHR) through the COVID-19 Evidence Network to support Decision-making (COVID-END) at McMaster University. Not registered.Summary boxWhat is already known about this topic?Case reports and surveillance signals of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the two-layered sac surrounding the heart) after COVID-19 vaccination appeared as early as April 2021.These have prompted ongoing surveillance and research of these complications to investigate their incidence, possible attribution to the vaccines, and clinical course.What this study addsThis review critically appraises and synthesizes the available evidence to-date on the incidence of and risk factors for myocarditis and pericarditis after COVID-19 vaccination in multiple countries. It summarizes the presentation and clinical course of over 8000 reported cases and describes some initial reports of longer term outcomes. Further, many possible mechanisms are outlined and discussed.Though low, the incidence of myocarditis is probably the highest in young males aged 12-29 years and is probably higher with Moderna than Pfizer mRNA vaccines. Longer dosing intervals may be beneficial. Most cases are mild and self-limiting, though data in 5-11 year-olds is very limited. Continued active surveillance with longer term follow-up is warranted.

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Myocarditis and Pericarditis following COVID-19 Vaccination: Rapid Systematic Review of Incidence, Risk Factors, and Clinical Course

Cited by 7 publications

References 44 publications

Global Reports of Myocarditis Following COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Global Reports of Myocarditis Following COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Global reports of myocarditis following COVID-19 vaccination: A systematic review and meta-analysis

Myocarditis and Pericarditis following COVID-19 Vaccination: Evidence Syntheses on Incidence, Risk Factors, Natural History, and Hypothesized Mechanisms

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