Medscape 2005. © 2005 WebMD Inc.

Oct. 4, 2005 — The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have launched an investigation into 5 reports of Guillain-Barre Syndrome (GBS) in patients administered meningococcal conjugate vaccine A, C, Y, and W 135 (Menactra, made by Sanofi Pasteur).

The 5 individuals, aged 17 or 18 years and residing in NY, OH, PA, and NJ, developed weakness or abnormal sensations in the arms or legs two to four weeks after receiving the vaccine. All individuals are reported to be recovering or to have recovered.

The causal role of the vaccine remains unclear, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting system. Although the rate of GBS reported following vaccine administration is similar to that which may be expected by coincidence, the timing of these events remains of concern. Moreover, additional unreported cases may exist.

Approximately 2.5 million doses have been distributed to date. No GBS cases were reported in the company's pre-licensure studies, and none have been reported thus far in a rapid review by the CDC of healthcare organization databases. The studies and review included 7,500 and 110,000 vaccine recipients, respectively.

The quadrivalent vaccine is indicated for the prophylaxis of meningococcal disease in adolescents and adults aged 11 to 55 years

Due to the potentially serious nature of the syndrome, the FDA and CDC have requested that possible cases of vaccine-related GBS be reported to the Vaccine Adverse Event Reporting System (VAERS) by phone at 1-800-822-7967 or online at http://www.vaers.hhs.gov.

Reviewed by Gary D. Vogin, MD