FDA ( Food and Drug Administration ) has received five reports of Guillain Barre syndrome, following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 ( Menactra ), manufactured by Sanofi Pasteur.
It is not known yet whether these cases were caused by the vaccine or are coincidental.
FDA and CDC ( Centers for Disease Control and Prevention ) are actively investigating the situation because of its potentially serious nature.
Guillain Barre syndrome is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections.
The syndrome 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 FDAs 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.
Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of Guillain Barre syndrome occurring after Menactra to report them to the Vaccine Adverse Event Reporting System ( VAERS ).
The five cases of Guillain Barre syndrome reported following administration of Menactra occurred in individuals 17 or 18 years of age.
They 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.
Source: FDA, 2005