American Journal of Epidemiology Advance Access published online on January 4, 2007
American Journal of Epidemiology, doi:10.1093/aje/kwk045
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ORIGINAL CONTRIBUTIONS |
Risks of Convulsion and Aseptic Meningitis following Measles-Mumps-Rubella Vaccination in the United Kingdom
1 Immunisation Department, Centre for Infections, Health Protection Agency, London, United Kingdom
2 Statistics Unit, Centre for Infections, Health Protection Agency, London, United Kingdom
3 Centre for Community Child Health, Royal Free and University College Medical School, London, United Kingdom
Reprint requests to Dr. Elizabeth Miller, Immunisation Department, Centre for Infections, Health Protection Agency, 61 Colindale Avenue, London NW9 5EQ, United Kingdom (e-mail: liz.miller{at}hpa.org.uk).
Measles-mumps-rubella (MMR) vaccines containing the Urabe strain of mumps were withdrawn in the United Kingdom in 1992 following demonstration of an increased risk of aseptic meningitis 15–35 days after vaccination.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.
adverse drug reaction reporting systems; measles-mumps-rubella vaccine; meningitis, aseptic; seizures; vaccines
Abbreviations: CI, confidence interval; ICD, International Classification of Diseases; MCC, meningococcal serogroup C conjugate; MMR, measles-mumps-rubella; RI, relative incidence
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