Risk benefit analysis to evaluate risk of thromboembolic events after mRNA COVID-19 vaccination and COVID-19
npj Vaccines·
- DOI
- 10.1038/s41541-024-00960-7
- PMID
- 39271677
- PMCID
- PMC11399239
- OpenAlex
- W4402508259
- Study type
- Case-control study
- Publisher
- Springer Science and Business Media LLC
- Article type
- journal-article
- Integrity
- current
Publication version
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Open linked preprint →Why this research matters now
The findings support vaccination strategies by demonstrating that despite modest increases in post-vaccination thromboembolic risk, the overall effect of mRNA COVID-19 vaccination reduces thromboembolic event burden through prevention of infection-associated events, with greater benefit during high transmission periods.
Structured evidence summary
Research question
The study evaluated the net risk-benefit profile of mRNA COVID-19 vaccination by comparing thromboembolic event risks following vaccination against the reduction in infection-associated thromboembolic risks conferred by vaccine protection.
Study design
The analysis combined a self-controlled case series design to assess post-vaccination thromboembolic event association and a case-control design to evaluate infection-associated thromboembolic risks, accounting for underreported infection data. Electronic health record data from Corewell Health included 16,640 subjects in the case series and 106,143 in the case-control component.
Population and setting
The study used electronic health record data from Corewell Health, a U.S. health system, encompassing over 100,000 subjects across both study components.
Main findings
Thromboembolic event risks increased modestly following the first dose (incidence rate ratio 1.19, 95% CI 1.08–1.31) and second dose (1.22, 95% CI 1.11–1.34) of mRNA COVID-19 vaccines. Vaccination reduced infection-associated thromboembolic risks, with vaccinated individuals showing lower odds ratios (2.77, 95% CI 2.40–3.24) compared to unvaccinated individuals (4.65, 95% CI 4.18–5.17). When vaccine efficacy and protection against infection-associated events were incorporated, vaccination resulted in a net decrease in thromboembolic event risk, particularly during periods of high infection prevalence.
Public-health relevance
The findings support vaccination strategies by demonstrating that despite modest increases in post-vaccination thromboembolic risk, the overall effect of mRNA COVID-19 vaccination reduces thromboembolic event burden through prevention of infection-associated events, with greater benefit during high transmission periods.
Important limitations
This summary relies on the supplied single-article abstract and metadata. Interpretation of causal pathway methodology, generalizability beyond the Corewell Health population, temporal applicability to current variants and vaccination schedules, and detailed sensitivity analyses require review of the full published paper.
GIDS interpretation
This article would be discoverable through GIDS disease classifiers for SARS and COVID-19, and topic classifiers for outbreak investigation, vaccination, and vaccine effectiveness. The study provides methodological context for interpreting thromboembolic event reports in vaccinated populations by quantifying both post-vaccination and infection-associated risks within a single analytical framework.
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 10 auditable classifier relationships to diseases, places, topics, and study design.