Vaccine safety implications of Ontario, Canada's switch from DTaP-IPV to Tdap-IPV for the pre-school booster

Vaccine. 2014 Nov 12;32(48):6360-3. doi: 10.1016/j.vaccine.2014.09.017. Epub 2014 Sep 22.

Abstract

Ontario, Canada, replaced the 4-6 year old diphtheria (D, d), tetanus (T), acellular pertussis (aP, ap) and polio (IPV) booster from DTaP-IPV to Tdap-IPV in May 2012. We assessed the impact of this replacement on the rate and types of reported adverse events following immunization (AEFIs). We used AEFIs reported among 4-6 years olds, through the provincial surveillance system, following administration of DTaP-IPV or Tdap-IPV from 2009 to 2013. Reporting rates per 100,000 doses distributed were calculated using publicly funded doses distributed as the denominator. A total of 204 AEFIs were reported (DTaP-IPV, n=182; Tdap-IPV, n=22). AEFI reporting rates were 33.1 and 6.3 per 100,000 doses distributed for DTaP-IPV and Tdap-IPV, respectively. Injection site reaction rate was lower for Tdap-IPV compared with DTaP-IPV (1.7 vs 20.6 per 100,000 doses). The replacement resulted in a decline in the number of reports and AEFI reporting rates, most notably a substantial decrease in injection site reactions.

Keywords: AEFI; Adverse effects; Diphtheria–tetanus–acellular pertussis vaccines; Safety.

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Child
  • Child, Preschool
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
  • Diphtheria-Tetanus-Pertussis Vaccine / adverse effects
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage*
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / adverse effects
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Humans
  • Immunization Programs
  • Immunization, Secondary / adverse effects*
  • Ontario / epidemiology
  • Poliovirus Vaccine, Inactivated / administration & dosage*
  • Poliovirus Vaccine, Inactivated / adverse effects

Substances

  • Boostrix
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Poliovirus Vaccine, Inactivated
  • adacel