Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A multi-database, self-controlled case series study
PLOS Medicine·
- DOI
- 10.1371/journal.pmed.1004056
- PMID
- 35900992
- PMCID
- PMC9333264
- OpenAlex
- W4288441808
- Study type
- Journal article
- Publisher
- Public Library of Science (PLoS)
- Article type
- journal-article
- Integrity
- current
Publication version
This article has a linked preprint
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Open linked preprint →Why this research matters now
The findings contribute to understanding the safety profile of mRNA COVID-19 vaccines in younger populations, with the authors noting that the public health implications should be weighed against proven vaccine effectiveness in preventing severe COVID-19 disease and death.
Structured evidence summary
Research question
The study examined the association between SARS-CoV-2 mRNA vaccines (BNT162b2 and mRNA-1273) and myocarditis or pericarditis in vaccinated individuals aged 12 to 39 years in Italy.
Study design
A self-controlled case series study was conducted using national COVID-19 vaccination data linked to emergency care and hospital discharge databases. The exposure risk period (0 to 21 days post-vaccination, divided into three intervals) was compared with a baseline period, and the model was adapted to event-dependent exposures using unbiased estimating equations.
Population and setting
The study included 2,861,809 persons aged 12 to 39 years who received mRNA vaccines in Italy between December 27, 2020, and September 30, 2021. Of these, 2,405,759 received BNT162b2 and 456,050 received mRNA-1273.
Main findings
The study identified 441 myocarditis or pericarditis cases, with increased risk observed after the second dose of BNT162b2 (RI 1.99) and after both doses of mRNA-1273 (RI 2.22 and 2.63). The highest risks occurred in males aged 12 to 39 years within 0 to 7 days after vaccination, particularly following mRNA-1273 doses (RI up to 12.28 after first dose and 11.91 after second dose). Excess cases per 100,000 vaccinated males after the second dose of mRNA-1273 was 8.8.
Public-health relevance
The findings contribute to understanding the safety profile of mRNA COVID-19 vaccines in younger populations, with the authors noting that the public health implications should be weighed against proven vaccine effectiveness in preventing severe COVID-19 disease and death.
Important limitations
The outcome was not validated through clinical record review, and information on hospitalization length and outcome severity was absent. This summary relies on the supplied single-article abstract and metadata; the original paper is required for decision-grade interpretation.
GIDS interpretation
This peer-reviewed journal article on vaccine safety surveillance would be discoverable through queries combining COVID-19 vaccination, myocarditis, pericarditis, mRNA vaccines, Italy, and age-specific adverse event monitoring. The methodological approach (self-controlled case series with national linkage) represents active pharmacovigilance design.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 12 auditable classifier relationships to diseases, places, topics, and study design.