Myocarditis following mRNA Covid-19 vaccination: A pooled analysis

Bellos, Ioannis; Karageorgiou, Vasilios; Viskin, Dana

doi:10.1016/j.vaccine.2022.02.017

Cited by 22 publications

(23 citation statements)

References 74 publications

(65 reference statements)

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“…Similarly, one uncontrolled cohort study detected 54 myocarditis cases among 2.5 million BNT162b2 recipients, of which 76% cases were mild, 22% were moderate, and 2% were severe [ 67 ]. In a meta-analysis of 39 cohort or observational studies comprising 129 cases of post-mRNA vaccine myocarditis, 81% of cases fully recovered within the first week, 7% required intensive care unit admission, and 1.6% died [ 68 ].…”

Section: Discussionmentioning

confidence: 99%

Rare Adverse Events Associated with BNT162b2 mRNA Vaccine (Pfizer-BioNTech): A Review of Large-Scale, Controlled Surveillance Studies

Yong

Halim

et al. 2022

Vaccines

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Given the increasing anti-vaccine movements erroneously touting vaccine danger, this review has investigated the rare adverse events potentially associated with BNT162b2 (Pfizer-BioNTech), an mRNA vaccine against the severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2). Only real-world surveillance studies with at least 0.1 million BNT162b2-vaccinated participants and one unvaccinated control group were selected for review. A total of 21 studies examining the potential association of BNT162b2 with cardiovascular, herpetic, thrombotic or thrombocytopenic, neurological, mortality, and other miscellaneous rare adverse events were described in this review. Only myocarditis is consistently associated with BNT162b2. An unclear direction of association was seen with stroke (hemorrhagic and ischemic), herpes zoster, and paresthesia from BNT162b2, which may require more studies to resolve. Fortunately, most surveillance studies detected no increased risks of the remaining rare adverse events reviewed herein, further reassuring the safety of BNT162b2. In conclusion, this review has concisely summarized the current rare adverse events related and unrelated to BNT162b2, arguably for the first time in sufficient depth, to better communicate vaccine safety to the public.

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Section: Discussionmentioning

confidence: 99%

Rare Adverse Events Associated with BNT162b2 mRNA Vaccine (Pfizer-BioNTech): A Review of Large-Scale, Controlled Surveillance Studies

Yong

Halim

et al. 2022

Vaccines

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“…7 Previous studies reported largely favorable outcomes in adults with myocarditis following COVID-19 mRNA vaccination, demonstrating resolution of clinical symptoms, preservation of cardiac function, and no complications. [8][9][10][11] However, data on the clinical features and outcomes of myopericarditis after COVID-19 vaccination in adolescents and young adults are scarce compared with adults and often consist of small case series. Most large-scale studies on COVID-19 vaccine-associated myopericarditis among adolescents and young adults are derived from national population-based studies that contain homogeneous populations or from surveillance networks that rely on passive reporting.…”

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confidence: 99%

Myopericarditis After COVID-19 mRNA Vaccination Among Adolescents and Young Adults

et al. 2023

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ImportancePublished data on COVID-19 mRNA vaccine–associated myopericarditis in adolescents and young adults have been derived from small case series, national population-based studies, or passive reporting systems. Pooled evidence from a larger, international cohort is scarce.ObjectiveTo investigate the clinical features and early outcomes associated with myopericarditis after COVID-19 mRNA vaccination in a heterogeneous population of adolescents and young adults.Data SourcesPubMed and EMBASE were searched through August 2022. Language restrictions were not applied.Study SelectionObservational studies and case series describing COVID-19 vaccine–associated myopericarditis in adolescents and young adults aged 12 to 20 years and reporting clinical characteristics and early outcomes were included.Data Extraction and SynthesisTwo independent investigators extracted relevant data from each study. One-group meta-analysis in a random effects model was performed. The Preferred Reporting Items for Systematic Reviews and Meta-analysis and Meta-analysis of Observational Studies in Epidemiology reporting guidelines were followed.Main Outcomes and MeasuresThe primary outcomes were clinical features and early outcomes for COVID-19 mRNA vaccine–associated myopericarditis, including incident rate, cardiac findings, hospitalization, intensive care unit (ICU) admission, and in-hospital mortality.ResultsA total of 23 observational studies were identified, including 854 individuals (mean age, 15.9 [95% CI, 15.5-16.2] years) with COVID-19 vaccine–associated myopericarditis. Male sex was predominant, at 90.3% (95% CI, 87.3%-93.2%) of individuals. The incident rate was higher after the second dose than the first dose, with 74.4% (95% CI, 58.2%-90.5%) of events occurring after the second dose. Most patients (84.4% [95% CI, 80.5%-88.3%] of patients) had preserved left ventricular (LV) function. Of the 15.6% (95% CI, 11.7%-19.5%) of patients with LV systolic dysfunction (LV ejection fraction [LVEF] &lt;55%), most (14.1% [95% CI, 10.2%-18.1%]) were mild (ie, LVEF 45%-54%), and only 1.3% (95% CI, 0%-2.6%) of patients had severe LV systolic dysfunction (ie, LVEF&lt;35%). Interestingly, cardiac magnetic resonance imaging revealed late gadolinium enhancement in 87.2% (95% CI, 79.8%-94.7%) of patients. Although 92.6% (95% CI, 87.8%-97.3%) of patients were hospitalized and 23.2% (95% CI, 11.7%-34.7%) of patients required ICU admission, inotropes were used in only 1.3% (95% CI, 0%-2.7%) of patients, no patients died or required mechanical support, and the hospital length of stay was 2.8 (95% CI, 2.1-3.5) days.Conclusions and RelevanceThis systematic review and meta-analysis found low incidence rate and largely favorable early outcomes of COVID-19 mRNA vaccine–associated myopericarditis in adolescents and young adults from a wide range of populations. These findings are reassuring but continued follow-up is warranted.

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“…Certain vaccine‐induced AESI appears to have certain epidemiological patterns. mRNA vaccine‐induced perimyocarditis affects predominantly younger persons below the age of 30 years old, with no increased risk so far in the 5‐ to 11‐year‐old paediatric population 27,28 . Vaccine‐induced thrombotic thrombocytopenia (VITT), although predominant in recipients of adenovirus vector vaccines, 29 does not appear to recur with the second dose regardless of the type of vaccine and remains rarely, if at all, associated with mRNA vaccines 30 …”

Section: Discussionmentioning

confidence: 99%

“…mRNA vaccine-induced perimyocarditis affects predominantly younger persons below the age of 30 years old, with no increased risk so far in the 5-to 11-year-old paediatric population. 27,28 Vaccine-induced thrombotic thrombocytopenia (VITT), although predominant in recipients of adenovirus vector vaccines, 29 does not appear to recur with the second dose regardless of the type of vaccine and remains rarely, if at all, associated with mRNA vaccines. 30 Thirdly, diagnostic tests like antigen rapid tests (ART) 31 36,37 Pre-exposure prophylaxis using Tixagevimab and Cilgavimab (Evusheld) is now also available.…”

Section: Discussionmentioning

confidence: 99%

Asia Pacific perspectives on the second year of the COVID‐19 pandemic: A follow‐up survey

Pawankar

Thong

Tiongco‐Recto

et al. 2022

Clin Experimental Allergy

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BackgroundThe Coronavirus disease 2019 (COVID‐19) pandemic is currently in its third year. This follow‐up survey was commissioned by the Asia Pacific Association of Allergy Asthma and Clinical Immunology (APAAACI) Task Force on COVID‐19 to compare and contrast changes in the epidemiology, clinical profile, therapeutics and public health measures of the pandemic in the Asia Pacific region.MethodsA questionnaire‐based survey comprising 32 questions was electronically sent out to all 15 member countries of APAAACI using Survey Monkey® from 1 December 2021 to 28 February 2022.ResultsSeventeen responses were received from 14/15 (93.4%) member countries and 3 individual members. Mild‐to‐moderate COVID‐19 predominated over severe infection, largely contributed by COVID‐19 vaccination programmes in the region. The incidence of vaccine adverse reactions in particular anaphylaxis from messenger ribonucleic acid (mRNA) vaccines was no longer as high as initially anticipated, although perimyocarditis remains a concern in younger males. Novel therapeutics for mild‐to‐moderate disease including neutralizing antibodies casirivimab/imdevimab (REGEN‐COV®) and sotrovimab (Xevudy®), anti‐virals Paxlovid® (nirmatrelvir and ritonavir) and Molnupiravir pre‐exposure prophylaxis for high‐risk persons with Tixagevimab and Cilgavimab (Evusheld) are now also available to complement established therapeutics (e.g., remdesivir, dexamethasone and baricitinib) for severe disease. In the transition to endemicity, public health measures are also evolving away from containment/elimination strategies.ConclusionsWith access to internationally recommended standards of care including public health preventive measures, therapeutics and vaccines among most APAAACI member countries, much progress has been made over the 2‐year period in minimizing the morbidity and mortality from COVID‐19 disease.

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Myocarditis following mRNA Covid-19 vaccination: A pooled analysis

Cited by 22 publications

References 74 publications

Rare Adverse Events Associated with BNT162b2 mRNA Vaccine (Pfizer-BioNTech): A Review of Large-Scale, Controlled Surveillance Studies

Rare Adverse Events Associated with BNT162b2 mRNA Vaccine (Pfizer-BioNTech): A Review of Large-Scale, Controlled Surveillance Studies

Myopericarditis After COVID-19 mRNA Vaccination Among Adolescents and Young Adults

Asia Pacific perspectives on the second year of the COVID‐19 pandemic: A follow‐up survey

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