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Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature
OBJECTIVES: To combine spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 messenger RNA (mRNA) vaccines. DESIGN: Systematic review of spontaneously reported data from UK, USA and Europ...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9133727/ https://www.ncbi.nlm.nih.gov/pubmed/35613761 http://dx.doi.org/10.1136/bmjopen-2021-059223 |
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author | Lane, Samantha Yeomans, Alison Shakir, Saad |
author_facet | Lane, Samantha Yeomans, Alison Shakir, Saad |
author_sort | Lane, Samantha |
collection | PubMed |
description | OBJECTIVES: To combine spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 messenger RNA (mRNA) vaccines. DESIGN: Systematic review of spontaneously reported data from UK, USA and European Union/European Economic Area (EU/EEA) and of the scientific literature. DATA SOURCES: UK Yellow Card scheme, Vaccine Adverse Event Reporting System (VAERS), EudraVigilance were searched from date of vaccine launch to 14 March 2022–16 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, USA 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 tools assessed study quality. DATA EXTRACTION AND SYNTHESIS: Two researchers extracted data. 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 were submitted to the UK, USA and EU/EEA regulators during the study period. Males represented 62.24% (n=11 331) of myocarditis and pericarditis reports. In the UK and USA, most reports concerned vaccinees aged <40 years (59.7% and 47.3% of reported events, respectively); trends in age were less clear for EU/EEA. Reports were more frequent following a second dose (47.1% of reports, where data available). 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. |
format | Online Article Text |
id | pubmed-9133727 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-91337272022-05-26 Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature Lane, Samantha Yeomans, Alison Shakir, Saad BMJ Open Public Health OBJECTIVES: To combine spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 messenger RNA (mRNA) vaccines. DESIGN: Systematic review of spontaneously reported data from UK, USA and European Union/European Economic Area (EU/EEA) and of the scientific literature. DATA SOURCES: UK Yellow Card scheme, Vaccine Adverse Event Reporting System (VAERS), EudraVigilance were searched from date of vaccine launch to 14 March 2022–16 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, USA 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 tools assessed study quality. DATA EXTRACTION AND SYNTHESIS: Two researchers extracted data. 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 were submitted to the UK, USA and EU/EEA regulators during the study period. Males represented 62.24% (n=11 331) of myocarditis and pericarditis reports. In the UK and USA, most reports concerned vaccinees aged <40 years (59.7% and 47.3% of reported events, respectively); trends in age were less clear for EU/EEA. Reports were more frequent following a second dose (47.1% of reports, where data available). 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. BMJ Publishing Group 2022-05-25 /pmc/articles/PMC9133727/ /pubmed/35613761 http://dx.doi.org/10.1136/bmjopen-2021-059223 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Public Health Lane, Samantha Yeomans, Alison Shakir, Saad Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature |
title | Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature |
title_full | Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature |
title_fullStr | Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature |
title_full_unstemmed | Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature |
title_short | Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature |
title_sort | reports of myocarditis and pericarditis following mrna covid-19 vaccination: a systematic review of spontaneously reported data from the uk, europe and the usa and of the scientific literature |
topic | Public Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9133727/ https://www.ncbi.nlm.nih.gov/pubmed/35613761 http://dx.doi.org/10.1136/bmjopen-2021-059223 |
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