The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care providers that five reports of Guillain Barre Syndrome (GBS) followed administration of Menactra, a new vaccine against meningitis that is manufactured by Sanofi Pasteur.
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.