Updates are available Correction dated 2026-03-06

Article History

Received: 2 June 2025

Accepted: 3 December 2025

First Online: 26 January 2026

Change Date: 26 February 2026

Change Type: Update

Change Details: The conflict of interest statement has been revised.

Change Date: 6 March 2026

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s40264-026-01661-x

Declarations

:

: AKR reports membership on a data safety monitoring board (DSMB) for matters unrelated to the presented research. SGS reports consulting for Astra-Zeneca, GSK, Sanofi, Pfizer, Moderna, CSL Seqirus, Novavax, and Evo Health on work unrelated to the presented research. FMM is an investigator in pediatric studies of coronavirus disease 2019 vaccines for Pfizer and Moderna and for a pediatric remdesivir study conducted by Gilead Sciences; serves as investigator on projects supported by a National Institutes of Health (NIH) contract for a Vaccine Treatment and Evaluation Unit and the Centers for Disease Control and Prevention (CDC) New Vaccine Surveillance Network; serves as a member of the DSMB for clinical trials conducted by Pfizer, Dynavax, Moderna, Meissa Vaccines, Virometix, and the NIH; and is a member of the American Academy of Pediatrics Committee of Infectious Diseases and the Immunization Expert Group of the American College of Obstetrics and Gynecology and cochair of the COVAX Maternal Immunization Working Group. SLR reports consulting for CSL Seqirus on work unrelated to the presented research. All other authors report no potential conflicts.

: This study was determined not to be human subjects research because of the use of pre-existing, de-identified data and was therefore exempt from full Institutional Review Board review.

: De-identified secondary data were used in this study, and consent to participate was not obtained.

: Not applicable.

: During the conduct of the study, the first author (MMC) and AKR had full access to the study data and took responsibility for the integrity of the data and the accuracy of the data analysis. However, the authors do not have ongoing access to the data analyzed in this study, nor do they have permission to share the study data with other researchers.

: Code for the simulated implications on vaccine safety and effectiveness is available online: . Code for other components of the study that has been edited to comply with Optum Labs policy is available upon request.

: AKR conceptualized the study and secured funding for the research. MMC analyzed the data, interpreted the results, and wrote the article. AKR, SLR, SGS, FMM, and OAA provided critical feedback on study design and article content. All authors reviewed and approved the final version of the article.