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. 2022 Dec 1;150(6):e2022058789.
doi: 10.1542/peds.2022-058789.

Kawasaki Disease Following the 13-valent Pneumococcal Conjugate Vaccine and Rotavirus Vaccines

Satoshi Kamidani  1   2 , Lakshmi Panagiotakopoulos  2 , Charles Licata  2 , Matthew F Daley  3 , W Katherine Yih  4 , Ousseny Zerbo  5 , Hung Fu Tseng  6 , Malini B DeSilva  7 , Jennifer C Nelson  8 , Holly C Groom  9 , Joshua T B Williams  10 , Simon J Hambidge  10 , James G Donahue  11 , Ermias D Belay  12 , Eric S Weintraub  2
Affiliations

Kawasaki Disease Following the 13-valent Pneumococcal Conjugate Vaccine and Rotavirus Vaccines

Satoshi Kamidani et al. Pediatrics. .

Abstract

Background: Temporal associations between Kawasaki disease (KD) and childhood vaccines have been reported. Limited data on KD following 13-valent pneumococcal conjugate (PCV13) and rotavirus vaccines are available.

Methods: We conducted a self-controlled risk interval study using Vaccine Safety Datalink electronic health record data to investigate the risk of KD following PCV13 and rotavirus vaccines in children <2 years of age who were born from 2006 to 2017. 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 were confirmed by manual chart review.

Results: During the study period, 655 cases of KD were identified by International Classification of Diseases codes. Of these, 97 chart-confirmed cases were within risk or control intervals. In analyses, the age-adjusted relative risk for KD following any dose of PCV13 was 0.75 (95% confidence interval, 0.47-1.21). Similarly, the age-adjusted relative risk for KD following any dose of rotavirus vaccine was 0.66 (95% CI, 0.40-1.09). Overall, there was no evidence of an elevated risk of KD following PCV13 or rotavirus vaccines by dose. In addition, no statistically significant temporal clustering of KD cases was identified during days 1 to 70 postvaccination.

Conclusions: PCV13 and rotavirus vaccination were not associated with an increased risk of KD in children <2 years of age. Our findings provide additional evidence for the overall safety of PCV13 and rotavirus vaccines.

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Conflict of interest statement

CONFLICT OF INTERST DISCLOSURES: Dr Kamidani’s institution, Emory University, has received funding from the National Institutes of Health to conduct clinical trials of Moderna and Janssen COVID-19 vaccines and funding from Pfizer to conduct clinical trials of Pfizer-BioNTech coronavirus disease 2019 vaccines. Dr Yih has received research support from GlaxoSmithKline and Pfizer for unrelated studies. Dr Tseng has received research support from Moderna, GlaxoSmithKline, and Janssen for unrelated studies. Dr DeSilva has received research support from National Institutes of Health for unrelated studies. Dr Nelson reported receiving payments from Moderna, Southern California Permanente Medical Group, Elsevier, and Harvard Pilgrim Health Care outside the submitted work. The other authors have indicated they have no potential conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Self-controlled risk interval design to compare the occurrence of Kawasaki disease between a risk interval and a control interval. Dose 1 and 2: RV1, RV5, and PCV13; dose 3: RV5 and PCV13; dose 4: PCV13.
FIGURE 2
FIGURE 2
Flowchart of Kawasaki disease cases confirmed by manual chart review, Vaccine Safety Datalink, 2006 to 2017.
FIGURE 3
FIGURE 3
Temporal distribution of chart-confirmed Kawasaki Disease during days 1 to 70 postvaccinations (PCV13 and rotavirus vaccines), Vaccine Safety Datalink, 2006 to 2017.
See this image and copyright information in PMC

References

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