Oct. 4, 2005 -- The FDA, CDC, and vaccine company Sanofi Pasteur are alerting doctors and patients about a possible side effect of Menactra, a new meningitis vaccine.
Five American teens reportedly developed a serious neurological condition called Guillain-Barré syndrome after being vaccinated with Menactra, which is made by Sanofi Pasteur.
Guillain-Barré syndrome often strikes healthy people, either spontaneously or after certain infections. It typically causes increasing weakness in the legs and arms that can be severe and require hospitalization.
However, the FDA isn't changing its vaccine recommendations, since it's not yet known if Menactra caused the reported Guillain-Barré syndrome cases.
"Individuals should continue to follow their doctors' recommendations," states an FDA news release.
All Patients Recovered or Recovering
All five reported cases occurred in 17- or 18-year-olds living in four states: New York, Ohio, Pennsylvania, and New Jersey.
The five teens have all reportedly recovered or are recovering. They had developed weakness or abnormal sensations in their arms or legs between two and four weeks after getting the Menactra vaccine, says the FDA.
About Menactra & Meningitis
The infection can spread among people living in close quarters, such as college dorms. Kissing an infected person or sharing food can also spread the infection.
Most people recover from bacterial meningitis, but the disease can be disabling or fatal. Bacterial meningitis kills 10% to 14% of patients and permanently disables 11% to 19% of survivors, according the FDA.
No Guillain-Barré syndrome cases were seen in prelicensure studies of more than 7,000 people who had taken Menactra, says the FDA. The CDC also did a quick check of available health care organization databases and found no reported cases among 110,000 Menactra recipients.
Vaccination is the most effective way to reduce the risk of death and permanent disability caused by bacterial meningitis.
In a news release, Sanofi Pasteur pledges to keep working with the FDA and CDC to thoroughly investigate the reported cases of Guillain-Barré syndrome (GBS).
"No causal relationship has been established between Menactra vaccination and GBS, and there remain several possible explanations for the reported cases of GBS," states the Sanofi Pasteur news release.
"More than 2.5 million doses of Menactra vaccine have been distributed, and the rate of GBS based on the number of cases reported following administration is in the range that might be seen, regardless of vaccination, in a population of that size," the news release states.
Report Side Effects
Sanofi, the FDA, and the CDC are urging doctors and patients to report any side effects from Menactra, including possible Guillain-Barré syndrome cases.
Contact the Vaccine Adverse Event Reporting System (VAERS) at www.vaers.hhs.gov, or call (800) 822-7967.