Kawasaki Disease After Vaccination

Abstract

Our review does not suggest an elevated KD risk for RotaTeq or other vaccines. Continued postmarketing monitoring for KD is ongoing.

Two infants with tuberculid associated with Kawasaki disease

“…Previous reports have shown that K D was developed after the vaccinations of BCG, diphtheria–pertussis–tetanus (DPT), hepatitis A, hepatitis B, influenza, and rotavirus 4,13-18 . On the other hand, vaccinations do not increase the risk of K D 18,19 . In our infants, we could not prove the relationship between BCG inoculation and the onset of K D .…”

The incidence of Kawasaki disease after vaccination within the UK pre‐school National Immunisation Programme: an observational THIN database study

“…10 Spontaneous reports of Kawasaki disease after vaccination have been described, but the incidence cannot be estimated because of under-reporting. 9 The incidence of Kawasaki disease in the current population during the age groups when immunisation are routinely given are reported as 6.5 per 100 000 PY (95%CI 2.7, 15.7) at any time up to 6 months of age, 5.0 (2.1, 11.9) at 12 to 18 months and 12.0 (8.0, 17.8) at 36 to 48 months. 14 The immediate postimmunisation findings in this study are consistent with these data given the large confidence intervals.…”

“…A recent UK study reported an annual incidence of 9.1 per 100 000 person years in those aged less than 5 years and 2.8 per 100 000 when aged under 20 years. 6 Cases of Kawasaki disease have been reported immediately post-childhood vaccination during clinical trials and in case reports [7][8][9] although no causal association has been made. 9 In trials of RotaTeq (rotavirus vaccine, live, oral, pentavalent; Merck and Co. Inc., White House Station, NJ, USA), five cases were identified among vaccinated cases and one in the placebo group, crude relative risk 4.9 (95%CI 0.6, 239.1).…”

“…6 Cases of Kawasaki disease have been reported immediately post-childhood vaccination during clinical trials and in case reports [7][8][9] although no causal association has been made. 9 In trials of RotaTeq (rotavirus vaccine, live, oral, pentavalent; Merck and Co. Inc., White House Station, NJ, USA), five cases were identified among vaccinated cases and one in the placebo group, crude relative risk 4.9 (95%CI 0.6, 239.1). Across trials of Bexsero (meningitis B vaccine), the estimated annual incidence postvaccination was 72 (95%CI 23-169) per 100 000 person years after 4CMenB versus 56 (95%CI 1-311) after control vaccines.…”

“…10 Spontaneous reports of Kawasaki disease post-vaccination have been analysed, but incidence cannot be estimated because of under-reporting and limited exposure data. 9 Knowledge of the background incidence of the condition after routine vaccination combinations would allow comparison with observed rates during the development of new vaccinations. This will be of benefit in interpretation of clinical trials when the number of comparator patients may be too small to provide meaningful data on the background rate of a rare condition and in the interpretation of spontaneous reports and other data from routine clinical practice post-marketing.…”