FDA ( U.S. Food and Drug Administration ) and CDC ( Centers for Disease Control and Prevention ) are alerting consumers and health care providers to five reports of Guillain Barre syndrome ( GBS ) following administration of Menactra ( Meningococcal Conjugate Vaccine A, C, Y, and W135 ), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental.

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.

Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis, affecting approximately 1 in 100,000 people annually. The infection can be life threatening: 10-14 percent of cases are fatal and 11-19 percent of survivors may have permanent disability.

According to Jesse Goodman, director of FDA’s Center for Biologics Evaluation and Research, at the present time there are no changes in recommendations for vaccination; individuals should continue to follow their doctors' recommendations.
FDA and CDC are not able to determine if any or all of the cases were due to vaccination. The current information is very preliminary and the two agencies are continuing to evaluate the situation.

The five cases of Guillain Barre syndrome reported following administration of Menactra occurred in individuals aged 17-18 years and developed weakness or abnormal sensations in the arms or legs, two-four weeks after vaccination. All individuals are reported to be recovering or to have recovered.

More than 2.5 million doses of Menactra vaccine have been distributed to date. The rate of Guillain Barre syndrome based on the number of cases reported following administration of Menactra 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. Also, vaccine adverse events are not always reported to FDA so there may be additional cases of which we are unaware at this time.

Prelicensure studies conducted by Sanofi Pasteur of more than 7000 recipients of Menactra showed no Guillain Barre syndrome cases.
CDC conducted a rapid study using available health care organization databases and found that no cases of Guillain Barre syndrome have been reported to date among 110,000 Menactra recipients.

Source: FDA, 2005


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