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

Wei Hua, MD, PhD; Hector S. Izurieta, MD, MPH; Barbara Slade, MD; Ermias D. Belay, MD; Penina Haber, MPH; Rosemary Tiernan, MD, MPH; Emily Jane Woo, MD, MPH; John Iskander, MD, MPH; M. Miles Braun, MD, MPH; Robert Ball, MD, MPH, ScM

Disclosures

Pediatr Infect Dis J. 2009;28(11):944-947. 

In This Article

Results

Through October 14, 2007, a total of 239,535 reports were received by VAERS. Of those, 107 were reported as KD: 26 were categorized as classic cases, 19 as atypical, 52 as possible, and 10 were noncases and excluded from further analysis. As Figure 1 illustrates, the number of KD reports gradually increased after 1990 but spiked after the FDA-approved RotaTeq label revision for KD was published on June 15, 2007. During June 15-October 14, 2007, a total of 20 KD reports were received by VAERS, compared with a total of 7 reports during the first half of 2007 (January 1-June 14, 2007) and 80 total reports during 1990–2006 (Fig. 1).

Figure 1.

Demographic Characteristics

Table 1 summarizes the demographic characteristics of 97 (classic, atypical, and possible) KD cases received by VAERS through October 14, 2007. The majority of cases were children <5 years of age, male, and reported in the United States. Most (75%) non-US cases were reported from Europe, mainly France. Eight (20%) non-US cases were reported from Asia, including 3 from Japan, 2 from Singapore, and 1 each from Indonesia, Malaysia, and China.

Vaccines

The KD cases were reported for 22 types of FDA licensed vaccines. The most common vaccine types were Haemophilus influenzae type b (31 cases), pneumococal 7-valent conjugate (29 cases), measles, mumps, and rubella virus (22 cases), diphtheria and tetanus toxoids and acelluar pertussis (21 cases), inactivated polio (17 cases), rotavirus (16 cases), diphtheria and tetanus toxoids, acelluar pertussis, hepatitis B, and inactivated polio combined (16 cases), and hepatitis B (13 cases); vaccines commonly had simultaneous administration of multiple vaccines.

Time to Onset

Of the 97 KD cases, 88 (91%) had onset within 30 days after vaccination and 6 (6%) beyond 30 days after vaccination (range 35 to 488 days); the onset interval of 3 cases was not reported. Figure 2 shows onset intervals of 85 KD cases with onset within 0 to 30 days postvaccination and age <18 years, for all vaccines and for RotaTeq, Pediarix (diphtheria and tetanus toxoids and acellular pertusis vaccine adsorbed, hepatitis B recombinant, and inactivated poliovirus vaccine combined; GlaxoSmithKline Biologicals, Rixensart, Belgium), and Prevnar (pneumococcal 7-valent conjugate vaccine; Wyeth Pharmaceuticals Inc., Philadelphia, PA). Overall, 30 cases (35%) had onset within 0 to 1 days postvaccination. Of the RotaTeq, Pediarix, and Prevnar cases, 2/12(17%), 8/14(57%), and 12/24 (50%), respectively, had onset within 0 to 1 days postvaccination.

Figure 2.

Proportional Reporting Ratio

PRR for KD was calculated for all vaccine types; only 3 vaccines met the conventional criteria for elevated PRR. For cases <5 years old, the PRR was elevated for RotaTeq and Pediarix for all cases, and for RotaTeq, Pediarix, and Prevnar for confirmed cases. The PRR values were essentially unchanged after the analysis was extended to cases <18 years old or was restricted to the US cases. Stratifying based on whether reports were received before or after the FDA RotaTeq label revision revealed that, before the label revision, the PRR was elevated only for Pediarix; after the label revision, the PRR for RotaTeq increased greatly and RotaTeq became the only vaccine that met the criteria for elevated PRR.

Reporting Rates for RotaTeq and Pediarix

Using a 30-day postvaccination risk window, the reporting rates of KD for RotaTeq and Pediarix were 0.65 and 0.37 per 100,000 person-years, respectively, for reports received before the June 15, 2007 RotaTeq label revision, and 2.78 and 2.44 per 100,000 person-years, respectively, after the label revision through October 14, 2007.

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