Background: Kawasaki disease (KD) is a multisystemic vasculitis primarily affecting children <5 years. A review of RotaTeq (rotavirus vaccine live) clinical trial data revealed higher, though not statistically significantly, KD rates among RotaTeq vaccines than placebo recipients. In June 2007, the RotaTeq label was revised accordingly.
Objectives: To describe and assess KD reported to Vaccine Adverse Event Reporting System (VAERS) for all US licensed vaccines.
Methods: We reviewed all KD reports received by VAERS from 1990 through mid-October 2007. Cases were characterized by age, gender, onset interval, and vaccine type. Proportional reporting ratio (PRR) was used to evaluate KD reporting for each vaccine compared with all others. Reporting rates were calculated using number of doses distributed as denominator.
Results: Through October14, 2007, 107 KD reports were received by VAERS: 26 were categorized as classic cases, 19 atypical, 52 possible, and 10 were noncases. Of the 97 cases, 91% were children <5 years. There was no clustering of onset intervals after day 1 postvaccination. Before the RotaTeq label revision, the KD PRR was elevated only for Pediarix (DTaP, hepB, and IPV combined) but the KD reporting rate for Pediarix (0.59/100,000 person-years) was much lower than the background incidence rate (9–19/100,000 person-years) for children <5 years in the United States. After the revision, reporting of KD for RotaTeq was stimulated but the reporting rate for RotaTeq (1.47/100,000 person-years) was still much lower than the background rate.
Conclusions: Our review does not suggest an elevated KD risk for RotaTeq or other vaccines. Continued postmarketing monitoring for KD is ongoing.
From the *Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Rockville, MD; †Immunization Safety Office, Centers for Disease Control and Prevention (CDC), Atlanta, GA; ‡National Center for Zoonotic, Vector-Borne and Enteric Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA; and §Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Rockville, MD.
Accepted for publication March 20, 2009.
Address for correspondence Wei Hua, MD, PhD, Vaccine Safety Branch, Division of Epidemiology, OBE, CBER, FDA, 1401 Rockville Pike, Suite 264S, HFM-222, Rockville, MD 20852-1448. E-mail: firstname.lastname@example.org.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.pidj.com).