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U.S. probes neurological problems, Sanofi vaccine

September 30, 2005

By Lisa Richwine

WASHINGTON (Reuters) – U.S. officials are investigating if
a Sanofi-Aventis meningitis vaccine may have caused five cases
of a rare neurological disorder that can paralyze its victims,
the government announced on Friday.

The patients — all 17 or 18 years old — developed
Guillain-Barre Syndrome, or GBS, after receiving Sanofi’s
Menactra vaccine, which was approved for sale in January. All
are recovering or have recovered, officials said.

The cases under investigation were reported in New York,
Ohio, Pennsylvania and New Jersey. All patients developed
weakness or abnormal sensations in their arms or legs within
two to four weeks after vaccination.

“It is not known yet whether these cases were caused by the
vaccine or are coincidental,” the U.S. Food and Drug
Administration and the federal Centers for Disease Control and
Prevention said in a joint statement.

Guillain-Barre Syndrome causes progressive weakness in the
legs and arms that can lead to paralysis in some instances.
Most patients recover, however, according to the National
Institutes of Health.

More than 2.5 million doses of Menactra have been
distributed, the FDA and the CDC said.

The Menactra vaccine has been distributed nationwide in the
United States, according to Sanofi-Aventis. The drug company
also said the vaccine is not sold in any other countries.

Menactra is approved for preventing bacterial meningitis,
an infection that can cause seizures, brain damage, memory loss
and even death in otherwise healthy people in less than 48
hours.

“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,” the agencies said.

Sanofi Pasteur, the vaccine unit of Sanofi-Aventis, said it
was working with U.S. health authorities on the investigation,
adding that “there remain several possible explanations for the
cases of GBS.

“It is important to keep in mind that Menactra vaccine
offers valuable protection against the severe health
consequences caused by meningococcal disease,” the company said
in a statement.

ON THE ALERT FOR MORE CASES

Officials said they were not changing their recommendations
for the vaccine. The CDC and the American Academy of Pediatrics
urge meningitis shots for pre-teens ages 11 and 12, as well as
newly enrolled high school and college students living in
dormitories.

In Sanofi’s tests of the vaccine before it was approved, no
cases of Guillain-Barre Syndrome were recorded, the FDA and the
CDC statement said.

More cases may have occurred that were not reported, health
officials said. They encouraged people to alert authorities to
any possible cases occurring after a Menactra injection.

The U.S. government agencies disclosed the news that five
patients have suffered neurological problems after receiving
the Sanofi vaccine in a statement released late Friday
afternoon, after the close of regular stock trading.

On Friday, the U.S.-listed shares of Sanofi-Aventis closed
on the New York Stock Exchange at $41.55, up 64 cents, or 1.6
percent.




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