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U.S. Department of Health and Human Services

Safety

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

Audience: Neurological and other Healthcare Professionals, and Consumers
[Posted 10/03/2005] FDA and CDC notified consumers and health care providers of five reports of Guillain Barre Syndrome following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature. Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization. Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter.

[September 30, 2005 - News Release - FDA]