The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are investigating five reports of Guillain Barre Syndrome (GBS) in teenagers who have taken Menactra, a new vaccine for meningitis. The vaccine’s name is Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra) and is manufactured by Sanofi Pasteur.
It is not yet known whether these cases were caused by Menactra or are coincidental. The FDA and CDC have been informing the public and are investigating the situation. The FDA and CDC are asking that anyone with information of any possible cases of Guillain Barre Syndrome occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter.
Guillain Barre Syndrome (GBS) is a severe neurological disorder that may occur frequently in healthy individuals, either spontaneously or after certain infections. Guillain Barre Syndrome generally causes increasing weakness in the legs and arms that can require hospitalization. Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis. Bacterial meningitis affects approximately 1 in 100,000 people annually. The infection can be life threatening: 10-14% of cases are fatal, and 11-19% of survivors can have permanent disability.
The five cases of GBS reported following administration of Menactra occurred in individuals living in New York, Ohio, Pennsylvania and New Jersey. All five patients were 17 or 18 years old and developed weakness or abnormal sensations in the arms or legs two to four weeks after vaccination. More than 2.5 million doses of Menactra vaccine have been distributed to date. The rate of GBS based on the number of cases reported following administration of Menactra is comparable to what might have been expected to occur by coincidence, even without vaccination. However, the timing of the events is also a major concern. Additionally, vaccine adverse events are not always reported to the FDA, which can potentially skew the data due to unknown cases. The government advises that adolescents and college students living in dormitories receive the vaccine.
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