Kawasaki Disease After Vaccination Reports to the Vaccine Adverse Event Reporting System 1990-2007

Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Rockville, MD 20852-1448, USA.
The Pediatric Infectious Disease Journal (Impact Factor: 2.72). 09/2009; 28(11):943-7. DOI: 10.1097/INF.0b013e3181a66471
Source: PubMed


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.
To describe and assess KD reported to Vaccine Adverse Event Reporting System (VAERS) for all US licensed vaccines.
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.
Through October 14, 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.
Our review does not suggest an elevated KD risk for RotaTeq or other vaccines. Continued postmarketing monitoring for KD is ongoing.

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    ABSTRACT: Background The etiology of Kawasaki disease (KD) is unknown. Recently, the vaccination for prevention of gastroenteritis caused by rotavirus has been associated with it. Material, methods and results A “structured query language” (SQL) search for the term “Kawasaki disease” and vaccination with RotaTeq® or Rotarix® was performed and all German KD cases reported since enactment (2001) of the IfSG (German law for protection against infections) through 30 June 2010 – a total of four KD cases after vaccination with RotaTeq® and no case after vaccination with Rotarix®, respectively – were reviewed. The four KD cases after vaccination with RotaTeq® revealed no clustering regarding age, gender and time to onset of the adverse drug reaction (ADR). Conclusions Currently, the analysis of spontaneously reported cases of suspected KD from Europe and the USA as well as data emerging from a prospective post-licensure observational study do not support an increased KD risk after vaccination against gastroenteritis caused by rotavirus. Nevertheless, it is essential to thoroughly monitor the detected association. Physicians are encouraged to reasonably soon report all KD cases occurring after a vaccination to the German regulatory authority.
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