Reports of myocarditis and pericarditis following mRNA COVID-19 vaccines: A systematic review of spontaneously reported data from the UK, Europe, and the US and of the literature
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Abstract
Objectives
To bring together spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 mRNA vaccines.
Design
Systematic review of spontaneously reported data from United Kingdom (UK), United States (US), and European Union/European Economic Area (EU/EEA) and of the literature.
Data sources
UK Yellow Card scheme, Vaccine Adverse Event Reporting System (VAERS), EudraVigilance were searched from date of vaccine launch to 14-16 March 2022. PubMed/MEDLINE and Embase were searched to 15 March 2022.
Eligibility criteria
We included publicly available spontaneous reporting data for “Myocarditis” and “Pericarditis” from UK, US, and EU/EEA following COVID-19 mRNA vaccines. Pharmacoepidemiological observational studies investigating myocarditis/pericarditis following mRNA COVID-19 vaccines were included (no restrictions on language or date). Critical Appraisal Skills Programme (CASP) tools assessed study quality.
Data extraction and synthesis
Two researchers extracted data. Spontaneously reported events of myocarditis and pericarditis were presented for each data source, stratified by vaccine, age, sex, and dose (where available). Reporting rates were calculated for myocarditis and pericarditis for each population. For published pharmacoepidemiological studies, design, participant characteristics, and study results were tabulated.
Results
Overall, 18,204 myocarditis and pericarditis events have been submitted to the UK, US, and EU/EEA regulators during the study period. Males represented 62.24% (n=11,331) of myocarditis and pericarditis reports. Most reports concerned vaccinees aged <40 years and were more frequent following a second dose. Reporting rates were consistent between the data sources. Thirty-two pharmacoepidemiological studies were included; results were consistent with our spontaneous report analyses.
Conclusions
Younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines than older vaccinees. Results from published literature supported the results of our analyses.
Strengths and Limitations of the Study
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This is the first study to bring together spontaneously reported data from the United Kingdom, United States, and Europe on myocarditis and pericarditis following mRNA COVID-19 vaccines.
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Results from this study provide evidence on the frequency of reported events of myocarditis and pericarditis following mRNA vaccines in different age groups, and by sex and vaccine dose; analyses of spontaneous reports were consolidated with results of published literature, identified by systematic review.
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Results may have been influenced by biases including different vaccination policies in each region examined, and publicity on events of myocarditis and pericarditis following mRNA vaccines.
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The study relied on outputs from spontaneous reporting systems in which the level of detail differed between the systems examined; furthermore, it is not possible to estimate incidence rates using spontaneous reports due to the lack of data on the exposed population, and there is no unvaccinated comparison group.
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There is an urgent need for further pharmacoepidemiological studies to be conducted to provide more accurate estimates of the frequency, clinical course, long term outcome, effects of treatment and impact on quality of life, to address many of the limitations of spontaneous reporting.
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SciScore for 10.1101/2021.09.09.21263342: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:4.1 Limitations: Vaccination policies in the three regions may have biased the results towards a higher numbers of adverse events reports myocarditis and pericarditis from younger vaccinees compared with older vaccinees. In each of these regions, younger …
SciScore for 10.1101/2021.09.09.21263342: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:4.1 Limitations: Vaccination policies in the three regions may have biased the results towards a higher numbers of adverse events reports myocarditis and pericarditis from younger vaccinees compared with older vaccinees. In each of these regions, younger people were more likely to have received mRNA vaccines, which may have contributed to higher reporting rates of myocarditis and pericarditis in younger vaccinees. The frequency of reported events per age group was presented as a crude number, and reporting rates could only be calculated as an overall estimate rather than stratified by age; based on the data available for vaccinations administered, it was not possible to determine the proportion of all vaccinees per age group who reported an event of myocarditis or pericarditis. This is very important, because it is likely that the reporting rate of myocarditis and pericarditis with mRNA COVID-19 vaccines will be higher in young people and even higher in young men if the reporting rates are stratified by age and sex. The regulatory authorities and Marketing Authorisations Holders (MAHs) need to follow up reports of these conditions with reporters to obtain as much information and make this information available publicly. Myocarditis and pericarditis following mfRNA COVID-19 vaccines is an area which requires further research. The data sources for this study were spontaneous reporting systems of the UK, US, and EEA. All spontaneous reporting systems have well-known limitations ...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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