Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom

Am J Epidemiol. 2007 Mar 15;165(6):704-9. doi: 10.1093/aje/kwk045. Epub 2007 Jan 4.

Abstract

Measles-mumps-rubella (MMR) vaccines containing the Urabe strain of mumps were withdrawn in the United Kingdom in 1992 following demonstration of an increased risk of aseptic meningitis 15-35 days after vaccination. Following introduction of a replacement MMR vaccine (Priorix; GlaxoSmithKline, London, United Kingdom) in 1998, active surveillance of aseptic meningitis and convulsion was established to evaluate the risk associated with the new vaccine. No laboratory-confirmed cases of mumps meningitis were detected among children aged 12-23 months after administration of 1.6 million doses of Priorix (upper 95% confidence limit of risk: 1:437,000) in England and Wales. The upper 95% confidence limit excluded the risk found for mumps meningitis with Urabe vaccines (1:143,000 doses). No cases of aseptic meningitis were detected among children aged 12-23 months, who had received over 99,000 doses of Priorix (upper 95% confidence limit of risk: 1:27,000), in a regional database of hospital-admitted cases. This compares with an observed risk of 1:12,400 for Urabe vaccines. An elevated relative incidence of convulsion was found in the 6- to 11-day period after receipt of Priorix (relative incidence = 6.26, 95% confidence interval: 3.85, 10.18)-consistent with the known effects of the measles component of MMR vaccine-but not in the 15- to 35-day period (relative incidence = 1.48, 95% confidence interval: 0.88, 2.50) as occurred with Urabe-containing vaccines. This study demonstrates the power of active postmarketing surveillance to identify or exclude events too rare to be detected in prelicensure trials.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • England / epidemiology
  • Humans
  • Incidence
  • Infant
  • International Classification of Diseases
  • Measles-Mumps-Rubella Vaccine / adverse effects*
  • Measles-Mumps-Rubella Vaccine / supply & distribution
  • Medical Record Linkage
  • Medical Records Systems, Computerized
  • Meningitis, Aseptic / diagnosis
  • Meningitis, Aseptic / epidemiology*
  • Meningitis, Aseptic / etiology*
  • Mumps virus / classification
  • Patient Admission / statistics & numerical data
  • Population Surveillance
  • Product Surveillance, Postmarketing
  • Risk Factors
  • Seizures / diagnosis
  • Seizures / epidemiology*
  • Seizures / etiology*
  • Vaccination / adverse effects
  • Vaccination / statistics & numerical data
  • Wales / epidemiology

Substances

  • Measles-Mumps-Rubella Vaccine