Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.
Published
Journal Article
PURPOSE: A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain-Barré syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases. METHODS: Retrospective cohort study among 12.6 million 11- to 21-year-old members of five US health plans with a total membership of 50 million. Automated enrollment and medical claims data from March 2005 through August 2008 were used to identify the population, the vaccinations administered, and the medical services associated with possible GBS. Medical records were reviewed and adjudicated by a neurologist panel to confirm cases of GBS. The study used distributed data analysis methods that minimized sharing of protected health information. RESULTS: We confirmed 99 GBS cases during 18,322,800 person-years (5.4/1,000,000 person-years). More than 1.4 million MCV4 vaccinations were observed. No confirmed cases of GBS occurred within 6 weeks after vaccination. The upper 95% CI for the attributable risk of GBS associated with MCV4 is estimated as 1.5 cases per 1,000,000 doses. CONCLUSIONS: Among members of five US health plans, MCV4 vaccination was not associated with increased GBS risk.
Full Text
Duke Authors
Cited Authors
- Velentgas, P; Amato, AA; Bohn, RL; Chan, KA; Cochrane, T; Funch, DP; Dashevsky, I; Duddy, AL; Gladowski, P; Greenberg, SA; Kramer, JM; McMahill-Walraven, C; Nakasato, C; Spettell, CM; Syat, BL; Wahl, PM; Walker, AM; Zhang, F; Brown, JS; Platt, R
Published Date
- December 2012
Published In
Volume / Issue
- 21 / 12
Start / End Page
- 1350 - 1358
PubMed ID
- 22807266
Pubmed Central ID
- 22807266
Electronic International Standard Serial Number (EISSN)
- 1099-1557
Digital Object Identifier (DOI)
- 10.1002/pds.3321
Language
- eng
Conference Location
- England