Postlicensure epidemiology of childhood vaccination: the Danish experience

Expert Rev Vaccines. 2006 Oct;5(5):641-9. doi: 10.1586/14760584.5.5.641.


The efficacy, the ability to confer protection against a target disease and the safety of a vaccine are assessed in great detail before licensure. However, inherent limitations in the prelicensure assessment necessitate continued epidemiological evaluations of efficacy and safety issues after the introduction of vaccines into use. In Denmark, the opportunities available for epidemiological research are unique. In 2001, an initiative was undertaken to take advantage of these opportunities to study the postlicensure epidemiology of childhood vaccination with respect to effectiveness and safety. First, we describe the unique opportunities for postlicensure research in Denmark with respect to the data sources available and the epidemiological and statistical methods used. We then describe a number of recent postlicensure studies of effectiveness and safety that took advantage of these opportunities. Specifically, studies on the effectiveness of Haemophilus influenzae type b vaccination, the effectiveness of pertussis vaccination, the impact of a preschool pertussis booster on infant pertussis, measles-mumps-rubella vaccine and autism, thimerosal-containing vaccine and autism, measles-mumps-rubella vaccine and febrile seizures, childhood vaccination and Type 1 diabetes, and childhood vaccination and nontargeted infectious disease are discussed.

Publication types

  • Review

MeSH terms

  • Autistic Disorder / etiology
  • Bacterial Capsules
  • Child
  • Child, Preschool
  • Communicable Diseases / epidemiology
  • Communicable Diseases / etiology
  • Denmark / epidemiology
  • Diabetes Mellitus, Type 1 / etiology
  • Haemophilus Vaccines / adverse effects
  • Humans
  • Immunization Programs / trends
  • Immunization Schedule
  • Immunization, Secondary
  • Incidence
  • Infant
  • Infant, Newborn
  • Measles-Mumps-Rubella Vaccine / adverse effects
  • Meningitis, Haemophilus / epidemiology
  • Meningitis, Haemophilus / prevention & control*
  • Pertussis Vaccine / adverse effects
  • Polysaccharides, Bacterial / adverse effects
  • Preservatives, Pharmaceutical / adverse effects
  • Product Surveillance, Postmarketing*
  • Registries
  • Risk Factors
  • Seizures, Febrile / etiology
  • Thimerosal / adverse effects
  • Vaccination / adverse effects*
  • Vaccines / adverse effects*
  • Whooping Cough / epidemiology
  • Whooping Cough / prevention & control*


  • Haemophilus Vaccines
  • Haemophilus influenzae type b polysaccharide vaccine
  • Measles-Mumps-Rubella Vaccine
  • Pertussis Vaccine
  • Polysaccharides, Bacterial
  • Preservatives, Pharmaceutical
  • Vaccines
  • Thimerosal