October 6, 2005
To: VFC (Vaccines for Children) Providers
Re: Menactra® Meningococcal Conjugate Vaccine and Guillain Barré Syndrome (Advisory 2005-1)
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are alerting customers and healthcare providers to five reports of Guillain Barré Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra®), manufactured by Sanofi Pasteur. It is not yet known if these cases of GBS were caused by the vaccine or are coincidental.
GBS is a serious neurological disorder that can occur either spontaneously or after certain infections. GBS typically causes weakness in the legs and arms, which can progress to weakness of muscles used for respiration, and often requires hospitalization.
The five cases of GBS reported following administration of Menactra® occurred in New York, Ohio, Pennsylvania, and New Jersey. All five patients were 17 or 18 years old and developed weakness or abnormal sensations in their arms or legs two to four weeks after vaccine administration. All affected persons are recovering or have recovered. The rate of GBS, based on the number of cases reported following the administration of Menactra®, is similar to what might have been expected to occur by coincidence, that is, even without vaccination. However, the timing of the events is of concern. Also, vaccine-related adverse events are not always reported to FDA, so there may be additional cases.
CDC recommends:
- Increased vigilance for Guillain Barré Syndrome in patients who have received Meningococcal Conjugate Vaccine A, C, Y and W135 (Menactra®).
- Report cases of possible vaccine-associated Guillain Barré Syndrome to the Vaccine Adverse Event Reporting System (VAERS) by telephone at (800) 822-7967 or on the web at www.vaers.hhs.gov.
- At this time, there are no changes in recommendations for vaccination. The current information is preliminary, and the FDA and CDC are continuing to investigate the situation.
If you suspect GBS in a patient who has recently received Menactra®, please report the case to the Vaccine Adverse Event Reporting System (VAERS) by telephone at (800) 822-7967 or on the web at www.vaers.hhs.gov.
MMWR Update: Guillian-Barre Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine -- United States, June-July 2005, October 6, 2005 (pdf)
|
