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.

Autor:	Xu S; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101.; Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA., Sy LS; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101., Han B; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101., Hong V; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101., Bruxvoort KJ; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101.; School of Public Health, University of Alabama at Birmingham, Birmingham, Al 35233., Lewin B; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101.; Department of Clinical Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA., Holmquist KJ; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101., Qian L; Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles Ave, 5th Floor, Pasadena, CA 91101.
Jazyk:	angličtina
Zdroj:	American journal of epidemiology [Am J Epidemiol] 2024 Jun 21. Date of Electronic Publication: 2024 Jun 21.
DOI:	10.1093/aje/kwae141
Abstrakt:	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 (${R}_1\Big)$, 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 COVID-19 vaccination in 12-39-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 12-39-year-olds. (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.)
Databáze:	MEDLINE
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