It is not known yet whether these cases were caused by the vaccine or are coincidental.
Guillain Barre Syndrome (GDS) 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.
Menactra protects against bacterial meningitis, and the vaccine is recommended for college students living in dormitories because close contact is the biggest risk factor for the spread of bacterial meningitis.
Because the FDA and the DCD are not able to determine if any or all of the cases were due to the vaccination, The FDA is recommending that individuals continue to follow their doctors’ recommendations with regard to receiving Menactra.
The five reported cases of GBS followed administration of Menactra in individuals living in New York, Ohio, Pennsylvania and New Jersey. All five patients were 17 or 18 years of age and developed symptoms two to four weeks after being vaccinated. All individuals are in recovery.
More than 2.5 million doses of Menactra vaccine have been distributed to date, and the rate of GBS following administration of the vaccine is what might have been expected to occur by coincidence, that is, even without the vaccination. However the timing of the events is of concern, stated the FDA, and vaccine adverse events are not always reported, so there may be additional cases that have occurred.
Prior to the licensing of Menactra, Sanofi Pasteur studied more then 7000 recipients of Menactra. No GBS cases were found. The CDC also conducted a rapid study using available health care organization databases and found no cases of GBS to have been reported among 110,000 Menactra recipients.
The Centers for Disease Control and Prevention has recommended that wider use be made of a new meningitis vaccine known as Menactra and manufactured by Sanofi Pasteur. The following categories of young people are the ones the CDC is most interested in seeing vaccinated: all 11- and 12-year-olds; high school freshmen or children under 15, whichever comes earlier, and college freshmen living in dormitories.
Each year about 3,000 people in the United States contract meningococcal disease. About 10% of these people die and another 15% may suffer serious permanent disabilities including loss of hearing, brain damage, or the loss of a limb. .
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