[PROVE] Health alert issued on meningitis vaccine

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http://www.fda.gov/bbs/topics/NEWS/2005/NEW01238.html

FDA News

FOR IMMEDIATE RELEASE

P05-66

September 30, 2005

Media Inquiries:

Zawisza ,

Consumer Inquiries:

888-INFO-FDA

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 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 <http://www.vaers.hhs.gov> or by phone at 1-.

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.

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http://www.chron.com/cs/CDA/ssistory.mpl/metropolitan/3380789

Oct. 3, 2005, 9:26PM

Health alert issued on meningitis vaccine

By LEIGH HOPPER

Copyright 2005 Houston Chronicle

Five reports of a serious neurological disorder in teens vaccinated

against bacterial meningitis have prompted a consumer health alert and

an investigation by federal health officials.

In the meantime, the U.S. Food and Drug Administration is recommending

that parents continue to vaccinate their children against bacterial

meningitis, a terrifying illness that can kill within hours of the

onset.

The teens, all 17 or 18 years old, developed weakness or abnormal

sensations in the arms or legs two to four weeks after vaccination.

Diagnosed with Guillain Barre Syndrome ? a disease that causes

progressive weakness or paralysis ? all are recovering or have

recovered.

More than 2.5 million doses of the vaccine, Menactra, have been

distributed, and statistically, the five cases could be coincidental.

" However, the timing of the events is of concern, " the FDA and the

Centers for Disease Control and Prevention said in a statement. " Also,

vaccine-adverse events are not always reported to FDA, so there may be

additional cases of which we are unaware at this time. "

Menactra, approved by the FDA in January, protects against

meningococcal meningitis. The shot is recommended for 11- and

12-year-olds, and high school and college freshmen.

Both meningococcal disease and Guillain Barre are rare, striking about

one person in 100,000 annually. Up to 5 percent of those with Guillain

Barre die, but twice that many ? 10 percent ? of meningococcal

meningitis cases are fatal.

Dr. Carol Baker, a pediatric infectious-disease expert with Baylor

College of Medicine, called the health alert " confusing " for parents

and urged them not to forego the vaccine.

" Both (diseases) are relatively rare, but I'd rather take my chance

with Guillain Barre. "

leigh.hopper@...

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