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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.
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This page
was originally posted on October 7, 2005.
This page
was last updated on
February 15, 2013
©
2013 Institute for Vaccine Safety |
