ArticleAmerican journal of epidemiology2025
A propensity score approach and a partitioned approach for the self-controlled case series design to evaluate safety of a 2-dose vaccine series: application to myocarditis/pericarditis following mRNA COVID-19 vaccination.
Article in American journal of epidemiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- A three-part model for the self-controlled case series design to estimate and characterize adverse event risk in an overlapping risk period after multiple vaccines: application to ischemic stroke following Pfizer-BioNTech bivalent COVID-19 vaccine and influenza vaccine.American journal of epidemiology · 2026Article
- GP Consultations for Venous Thromboembolism (VTE) After mRNA and Adeno-Vector-Based COVID-19 Vaccination-An Exposure-Anchored Self-Controlled Cohort Study Based on Primary Healthcare Data From the Netherlands.Pharmacoepidemiology and drug safety · 2026Article
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Authors and funding
8 authors.
Funding
Abstract
The assumption that serious adverse events (SAEs) do not affect subsequent exposure might not hold when evaluating 2-dose vaccine safety through a self-controlled case series (SCCS) design. To address this, we developed: (1) propensity score SCCS (PS-SCCS) using a propensity score model involving SAEs during the risk interval after dose 1 (${R}_1$), and (2) partitioned SCCS (P-SCCS) estimating relative incidence (RI) separately for doses 1 and 2. In simulations, both provided unbiased RIs. Conversely, standard SCCS overestimated RI after dose 2. We applied these approaches to assess myocarditis/pericarditis risks after 2-dose mRNA coronavirus disease 2019 (COVID-19) vaccination in 12- to 39-year-olds. For BNT162b2, PS-SCCS yielded RIs of 1.85 (95% CI, 0.75-4.59) and 11.05 (95% CI, 6.53-18.68) 14 days after doses 1 and 2 respectively; standard SCCS provided similar RI after dose 1 and RI of 12.92 (95% CI, 7.56-22.09) after dose 2. For mRNA-1273, standard SCCS showed RIs of 1.96 (95% CI, 0.56-6.91) after dose 1 and 7.87 (95% CI, 3.33-18.57) after dose 2. As no mRNA-1273 recipients with SAEs during ${R}_1$ received dose 2, P-SCCS was used, yielding similar RI after dose 1 and RI of 6.48 (95% CI, 2.83-14.83) after dose 2. mRNA vaccines were associated with elevated myocarditis/pericarditis risks following dose 2 in 12- to 39-year-olds.
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