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The incidence of Kawasaki disease after vaccination within the UK pre-school National Immunisation Programme: an

Gillian C Hall1, Robert Mr Tulloh2, Louise E Tulloh3

  • 1Grimsdyke House, London, UK. gillian.hall@gchall.com.

Pharmacoepidemiology and Drug Safety
|September 22, 2016
PubMed

Insights

Kawasaki disease incidence following routine childhood vaccinations is low. This study provides crucial data for interpreting vaccine safety in clinical trials and surveillance programs.

Area of Science:

  • Pediatric immunology
  • Vaccine safety research
  • Epidemiology

Background:

  • Kawasaki disease is a significant concern in pediatric health.
  • Understanding potential vaccine associations is vital for public health.
  • The pre-school National Immunisation Programme (NIP) involves multiple vaccination stages.

Purpose of the Study:

  • To determine the incidence of Kawasaki disease following vaccinations within the UK pre-school National Immunisation Programme (NIP).
  • To establish expected incidence rates in routine clinical practice.
  • To inform vaccine safety assessments and clinical trial interpretations.

Main Methods:

  • Utilized The Health Improvement Network (THIN) database of UK primary care records (2008-2012).
  • Included immunisation records for children under 6 years, linked to validated Kawasaki disease cases.
  • Defined a 28-day post-immunisation risk period for disease onset analysis.

Main Results:

  • Analyzed 642,170 immunisation stages from 275,986 children.
  • Observed 6 Kawasaki disease cases in the risk period after NIP vaccination, yielding an incidence of 12.8 per 100,000 person-years.
  • Incidence varied by vaccination stage, ranging from 0 to 27.4 per 100,000 person-years.

Conclusions:

  • Few Kawasaki disease cases occurred in the defined risk period after NIP vaccinations.
  • The low incidence rates are valuable for interpreting clinical trial data.
  • Findings support ongoing post-marketing surveillance of new vaccines.
Abstract

Keywords:
childrenincidencekawasaki diseasenational immunisation programmepharmacoepidemiology

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