Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.

View Abstract

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.

Abbreviation
Pharmacoepidemiol Drug Saf
Publication Date
2012-07-16
Volume
21
Issue
12
Page Numbers
1350-8
Pubmed ID
22807266
Medium
Print-Electronic
Full Title
Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.
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