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Global Advisory Committee on Vaccine Safety

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Menactra meningococcal vaccine and Guillain-Barré syndrome

Over 5.4 million doses of tetravalent conjugated meningococcal vaccine were distributed in the United States since its introduction in 2005 through September 2006. During this time 17 cases of Guillain-Barré Syndrome (GBS) were reported among vaccinated persons. Analysis of these data suggests that there may be a small increased risk of GBS associated with vaccination (1.25 cases per million doses distributed [95%CI 0.058-5.993]), although there is substantial uncertaintly regarding this risk estimate (MMWR 55(41),2006 link see below). US authorities are continuing to monitor the situation and have not recommended changes to vaccination policy. Additional studies are being planned to provide a more definitive assessment. Based on these reports, the GACVS concluded that there should be no change in vaccination policies at the present time.

References

CDC Morbidity and Mortality Weekly Report

- CDC. Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006. MMWR 55(41):1120-1124, 2006.

- CDC. Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine - United States, June-July 2005. MMWR 54(40):1023-1025, 2005.

FDA statements

- FDA and CDC Update Information on Menactra Meningococcal Vaccine and Guillain Barre Syndrome (20 October 2006).

- FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome. FDA News (online) Sept 30 2005.

CDC fact sheet

- CDC Fact Sheet for Healthcare Professionals: GBS and Menactra Meningococcal Vaccine. Guillain-Barré Syndrome Among Persons who Received Meningococcal Conjugate Vaccine

Committee reports

- Appears in WER on 19 January 2007
- Appears in WER on 13 January 2006

Page last updated: 19 January 2007


New in August 2009
Report of Committee meeting [pdf 254kb]


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