Health

Advisory

MENACTRA MENINGOCOCCAL VACCINE

AND GUILLAIN BARRE SYNDROME

The Division of Public Health is forwarding this Health Advisory from the Centers for Disease Control and Prevention. To contact DPH

about this Health Advisory, call 1-888-295-5156. This number is answered during normal business hours, and during non-business hours for

emergencies.

This is an official

CDC Health Advisory

Distributed via Health Alert Network

September 30, 2005, 19:00 EDT (07:00 PM EDT)

CDCHAN-00237-05-09-30-ADV-N

FDA and CDC Issue Alert on Menactra Meningococcal

Vaccine and Guillain Barre Syndrome

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care

providers to five reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135

(trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are

coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its

potentially serious nature.

Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or

after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization.

Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis, affecting approximately 1 in 100,000 people

annually. The infection can be life threatening:

• 10-14 percent of cases are fatal and
• 11-19 percent of survivors may have permanent disability

According to Jesse Goodman, MD, Director of FDA’s Center for Biologics Evaluation and Research, at the present time there are no

changes in recommendations for vaccination; individuals should continue to follow their doctors’ recommendations. FDA and CDC are not

able to determine if any or all of the cases were due to vaccination. The current information is very preliminary and the two agencies

are continuing to evaluate the situation.

Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS

occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the

matter. Individuals can report to VAERS on the web at www.vaers.hhs.gov or by phone at

1-800-822-7967.

The five cases of GBS reported following administration of Menactra occurred in individuals living in NY, OH, PA, and NJ. All five

patients were 17 or 18 years of age and developed weakness or abnormal sensations in the arms or legs, two-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 GBS 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 the events is of concern. Also, vaccine

adverse events are not always reported to FDA so there may be additional cases of which we are unaware at this time.

Prelicensure studies conducted by Sanofi Pasteur of more than 7000 recipients of Menactra showed no GBS cases. CDC conducted a rapid

study using available health care organization databases and found that no cases of GBS have been reported to date among 110,000 Menactra

recipients.