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October 12, 2005
On September 30, 2005, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) alerted consumers and health care professionals to five case reports of Guillain-Barre Syndrome following the administration of a certain meningitis vaccine. The FDA and the CDC are specifically concerned about Meningococcal Conjugate Vaccine A, C, Y, and W135 (MENACTRA) sold by Sanofi Pasteur but produced by Aventis Pasteur Inc. of Swiftwater, PA.
Th...
October 12, 2005
On September 30, 2005, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) alerted consumers and health care professionals to five case reports of Guillain-Barre Syndrome following the administration of a certain meningitis vaccine. The FDA and the CDC are specifically concerned about Meningococcal Conjugate Vaccine A, C, Y, and W135 (MENACTRA) sold by Sanofi Pasteur but produced by Aventis Pasteur Inc. of Swiftwater, PA.
The FDA approved the Menactra vaccine to immunize adolescents and adults between the ages of 11 and 55 against a specific bacterium that causes meningitis. Bacterial meningitis is a potentially life threatening condition that is characterized by fever, headache, vomiting, malaise, and a stiff neck. If left untreated, symptoms may progress to include confusion, stupor, convulsions, coma, and death. It is estimated that between 10 and 14 percent of the cases are fatal. Eleven to 19 percent of survivors may have a permanent disability.
At this time, the FDA and the CDC do not know whether the five cases of Guillain-Barre Syndrome were caused by the Sanofi Pasteur vaccine or were merely coincidental to the administration of the vaccine.
Guillain-Barre Syndrome is a serious disorder of the nervous system that can occur either spontaneously or after certain infections, often in healthy individuals. There were also a number of cases in the late 1970s in people who had been immunized with the Swine Flu vaccine. It typically causes increasing weakness in the legs and arms that can be severe and may require hospitalization.
Because of the potentially serious nature of this matter, the FDA and the CDC have asked that any possible cases of Guillain-Barre Syndrome that occur after Menactra administration be reported to these agencies. Reports of any vaccine-related adverse events are encouraged from vaccine recipients, their parents or guardians, and healthcare professionals involved in vaccine administration.
The U.S. Department of Health and Human Services has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. Adverse events following immunization should be reported to VAERS. Forms and information about reporting requirements can be obtained from VAERS through a toll-free number: 1-800-822-7967. Reporting forms may also be obtained at the FDA web site at http://vaers.hhs.gov/.
The five cases of Guillain-Barre Syndrome reported following administration of Menactra occurred in people living in New York, Ohio, Pennsylvania, and New Jersey. All five patients were 17 or 18 years of age. Each developed weakness or abnormal sensations in the arms or legs two to 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 these events after vaccine administration is of concern. Also, vaccine adverse events are not always reported to FDA, so there may be additional cases of which the FDA and the CDC are unaware at this time.
The meningitis vaccine is a very important way to prevent a serious, potentially life threatening infection of the nervous system. It is important for the FDA and the CDC to discover, as quickly as possible, if Menactra is responsible for causing Guillain-Barre Syndrome in the five young individuals or if the illness occurred spontaneously.
What You Can Do
You should contact a physician immediately if you or a family member have recently received Menactra and are experiencing any of the symptoms characteristic of Guillain-Barre Syndrome.
Any suspected cases of Guillain-Barre Syndrome should be reported to the Vaccine Adverse Event Reporting System (VAERS) at http://vaers.hhs.gov/.
