Literature reports Temporal associations between Kawasaki disease (KD) and childhood vaccines. However, there are limited data on KD following 13-valent pneumococcal conjugate (PCV13) and rotavirus vaccines.
The present study conducted a self-controlled risk interval study using Vaccine Safety Datalink electronic health record data and investigated the risk of KD following PCV13 and rotavirus vaccines in children <2 years of age. It included all hospitalized KD cases identified by International Classification of Diseases diagnosis codes that fell within predefined risk (days 1–28 postvaccination) and control (days 29–56 for doses 1 and 2, and days 43–70 for doses 3 and 4) intervals.
The study identified 655 cases of KD by the International Classification of Diseases codes. Among these, 97 chart-confirmed cases were within risk or control intervals. Analyses showed the age-adjusted relative risk for KD following any dose of PCV13 as 0.75 and the age-adjusted relative risk for KD following any dose of the rotavirus vaccine as 0.66. Overall, the study observed no evidence of an elevated risk of KD following PCV13 or rotavirus vaccines by dose. Additionally, it identified no statistically significant temporal clustering of KD cases during days 1 to 70 postvaccination.
This study shows a non-association of PCV13 and rotavirus vaccination with an increased risk of KD in children <2 years of age. These findings provide additional evidence for the overall safety of PCV13 and rotavirus vaccines.
Kamidani S, Panagiotakopoulos L, Licata C, et al. Kawasaki Disease Following the 13-valent Pneumococcal Conjugate Vaccine and Rotavirus Vaccines. Pediatrics. 2022;150 (6): e2022058789. https://doi.org/10.1542/peds.2022-058789
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