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U.S. Department of Health and Human Services

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Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135)

Audience: Neurological and Pediatric healthcare professionals, and consumers
[Posted 10/23/2006] FDA and CDC updated an October 2005 alert to consumers and health care providers regarding reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135, manufactured by Sanofi Pasteur. To date a total of 15 confirmed cases of GBS among individuals 11-19 years of age occurring within six weeks of vaccination with Menactra have been reported to the Vaccine Adverse Event Reporting System (VAERS). Two additional cases have been confirmed in persons 20 years of age and older. All individuals are reported to be recovering or have recovered.

While the cases reported suggest a small increased risk of GBS following immunization with Menactra, the limitations in VAERS, and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. At this time, CDC and FDA cannot determine with certainty whether Menactra does increase the risk of GBS in persons who receive the vaccine and, if so, to what degree. At the present time, there are no changes in recommendations for vaccination and individuals should continue to follow their doctors' recommendations. FDA asks any persons with knowledge of possible cases of GBS occurring after receiving Menactra to report them to VAERS at http://www.vaers.hhs.gov or by phone at 1-800-822-7967.

[October 20, 2006 - Statement - FDA]
[October 20, 2006 - MMWR Update - CDC]

Previous MedWatch alert:

[October 03, 2005]