FDA and CDC officials issued a health advisory Sept. 30 alerting health professionals to reports of five cases of Guillain-Barre syndrome following vaccination with the tetravalent meningococcal conjugate vaccine, or MCV4. Sold as Menactra, the vaccine was approved earlier this year to prevent meningococcal infection in 11- to 55-year-olds.
The agencies are further asking all clinicians with knowledge of any possible cases of the syndrome occurring after administration of MCV4 to report them to the Vaccine Adverse Event Reporting System. Individuals can report such events to VAERS online or by phone at (800) 822-7967.
Federal health officials point out that based on the information currently available, this incidence of the syndrome is what normally would be expected in the general population. However, the timing of the events is cause for concern.
The five patients affected -- all 17 or 18 years old -- reported weakness or abnormal sensations in the arms or legs beginning within two to four weeks after vaccination. In each case, symptoms have now resolved or are resolving.
More than 2.5 million doses of Menactra have been distributed since the drug was approved in January.
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