Guillain-Barré syndrome reported in five people after MCV4 administration

October 2005

The FDA and CDC announced five reports of Guillain-Barré syndrome (GBS) following administration of the quadrivalent meningococcal conjugate vaccine A, C, Y and W135 (MCV4; Menactra, Sanofi Pasteur).

It is unknown yet if the vaccine caused the cases, or if they were coincidental. The FDA and CDC are actively investigating the situation.

The five cases occurred in individuals living in New York, Ohio, Pennsylvania and New Jersey. All five people were 17 or 18 years of age and developed weakness or abnormal sensations in their arms or legs, two to four weeks post-vaccination. All individuals are recovering or have recovered.

There are no changes in vaccine recommendations, according to Jesse Goodman, MD, director of the FDA’s Center for Biologics Evaluation and Research. Individuals should continue to follow their doctor’s recommendations. To date, physicians have distributed more than 2.5 million doses of MCV4.

“Physicians should be aware of this,” Samuel L. Katz, MD, the Wilburt Cornell Davison Professor and chairman emeritus of pediatrics at Duke University, told Infectious Disease News. “In meeting with parents and children, they should offer the vaccine but also offer them the information about Guillain-Barré syndrome, so that they can make informed affirmative or negative responses.”

The rate of GBS based on the number of cases reported following administration of MCV4 is similar to what might have been expected to occur by coincidence, that is, even without vaccination. However, the timing of the events is of concern, the two agencies said in a press release. Also, vaccine adverse events are not always reported to the FDA, so there may be additional cases the agency is unaware of at this time.

About GBS

GBS is a serious neurological disorder that can occur often in healthy individuals, either spontaneously or after certain infections.

Meningococcal infection, prevented by MCV4, is a major cause of bacterial meningitis. It affects approximately one in 100,000 people annually and can be life threatening. Ten percent to 14% of cases are fatal, and 11% to 19% of survivors may have permanent disability.

Among the 7,000 MCV4 recipients in prelicensure studies conducted by Sanofi Pasteur, there were no cases of GBS reported.

Due to the serious nature of the situation, the FDA and CDC asked people with knowledge of any GBS cases occurring after administration of MCV4 to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the government agencies further evaluate the matter. Individuals can report to VAERS on the Internet at www.vaers.hhs.gov or by telephone at 1-800-822-7967.