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FDA/CDC Alert on New Meningococcal Vaccine

 

The FDA and CDC are investigating reports of 5 cases of Gullain Barre Syndrome following receipt of Menactra, a new conjugate meningococcal vaccine [link to FDA announcement]. CDC and FDA are investigating these cases and asking health care providers to report any additional cases to VAERS (Vaccine Adverse Event Reporting System) [link to reporting form | link to VAERS site].
In the October 6, 2005 MMWR, case reports and further information is provided about the 5 cases of GBS: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine --- United States, June--July 2005. MMWR 2005;54(Dispatch);1-3.
 
Details of the five reports, which have been described as cases of GBS, have not yet been made public. Their occurrence following vaccination with Menactra may have been by chance. Additional studies are needed to determine if this vaccine results an increased risk of GBS.

GBS is a rare condition associated with progressive weakness starting in the legs and moving up the body. Most affected people recover completely after a period of several weeks or months.

Most cases of GBS are preceded by an infection; it is believed that GBS is the result of an abnormal immune response to certain infectious agents. Campylobactor jejuni infection of the gastrointestinal tract has been documented in about 1/3 of all cases of GBS in the United States. In most of the other cases, no known trigger is identified, but the preceding infection or immune stimulus is suspected of contributing to the disease.

Some influenza vaccines have been demonstrated to increase the risk of GBS. In 1976-7, the swine influenza vaccine was associated with an increased risk of GBS at a rate of approximately 1 in 110,000 vaccine recipients. In 1992-3 and 1993-4 there was a small increased risk associated with influenza vaccination at a rate of approximately 1 in 1 million vaccine recipients [ACIP 2005]. Studies in other years did not reveal any significant association between influenza vaccine and GBS.

In 1994 the Institute of Medicine Vaccine Safety Committee concluded that tetanus toxoid can cause GBS, based primarily on a single person who had repeated episodes after sequential doses of tetanus toxoid. However, the committee was unable to conclude that there was an increased risk above the expected background rate in the community following tetanus toxoid containing vaccines [IOM 1994].
The IVS is unaware of any recognized increased risk of GBS associated with diphtheria toxoid, the protein included in Menactra.

 

This page was originally posted on October 7, 2005.

This page was last updated on November 21, 2013

© 2013 Institute for Vaccine Safety