- Menactra Vaccine is Safe and Effective in Preventing Potentially
Deadly Meningococcal Disease
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
announced today that the U.S. Food and Drug Administration (FDA) has
licensed Menactra(TM) (Meningococcal [Groups A, C, Y and W-135]
Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for protection
against meningococcal disease in adolescents and adults aged 11-55
Menactra vaccine is the first quadrivalent conjugate vaccine
licensed in the U.S. for the prevention of meningococcal disease and
is designed to offer protection against four serogroups of Neisseria
meningitidis (A, C, Y, W-135), the bacterium that causes
A supplemental licensure application in the U.S. for use of
Menactra vaccine in children younger than 11 years is planned for
early 2005. Additional submissions for licensures are planned for
Canada in 2005 and submission in Europe at a future date.
The U.S. Centers for Disease Control and Prevention's (CDC)
Advisory Committee on Immunization Practices (ACIP) has formed a
working group that is updating the recommendations for the prevention
and control of meningococcal disease, including routine meningococcal
vaccination of one or more birth cohorts (e.g., 11-12 year olds) and
of selected college students. The ACIP is expected to approve any
changes in recommendations during the February 2005 committee
Although meningococcal disease rates are highest in infants, rates
begin to rise again in early adolescence and peak between the ages of
15 and 24. During the 1990s, one study reported substantially
increased incidence among 15- to 24-year-olds. In addition to the
increased incidence, the fatality rate was over 22 percent in this
age group, over five times that seen in younger persons. Up to 83
percent of the cases reported in this study were caused by the
potentially vaccine-preventable serogroups that are included in
"Adolescents and young adults are at increased risk for
contracting meningococcal disease. I'm very pleased that
pediatricians and family physicians in the United States now have a
new tool to reduce the number of cases among this age group," said
Michael Pichichero, MD, professor of microbiology/immunology,
pediatrics and medicine, University of Rochester Medical Center. "The
FDA licensure of Menactra vaccine, if it is coupled with wide-spread
meningococcal immunization, represents a significant step toward
eradicating this devastating disease."
"In 2001, members of the CDC's Active Bacterial Core Surveillance
Team called upon the pharmaceutical industry to create a conjugate
vaccine for protection against multiple serogroups of Neisseria
meningitidis to combat the increased risk for disease in the
adolescent population," said Michael Decker, MD, MPH, vice president,
scientific and medical affairs at sanofi pasteur. "We are pleased to
respond to their challenge with the licensure of Menactra vaccine.
All evidence indicates that widespread use of Menactra vaccine will
help to reduce invasive meningococcal disease in the United States,
thereby preventing many deaths and anguish for thousands of
The FDA's decision to license Menactra vaccine was based on safety
and immunogenicity data from six pivotal studies, which included more
than 7,500 adolescents and adults receiving Menactra vaccine.
Menactra vaccine induced the production of functional antibodies
specific to the capsular polysaccharides of the four serogroups (A,
C, Y and W-135) found in the vaccine. All vaccine immunogenicity
measurements demonstrated strong immune responses to a single dose of
Menactra vaccine that were equivalent to a single dose of sanofi
pasteur's Menomune(R)-A/C/Y/W-135 (Meningococcal Polysaccharide
Vaccine, Groups A, C, Y and W-135 Combined). Additional findings
demonstrated 98 to 100 percent of seronegative adolescents were found
to elicit four-fold increases in antibody titers to all four
meningococcal serogroups. In seronegative adults, this range was 91
to 100 percent.
There are risks associated with all vaccines. The most common
adverse reactions to Menactra vaccine may include pain, redness, and
induration at the site of injection, headache, fatigue and malaise.
Menactra vaccine is contraindicated in persons with known
hypersensitivity to any component of the vaccine or to latex, which
is used in the vial stopper.
Sanofi pasteur will work closely with the CDC in an effort to
ensure production schedules that will support an orderly
implementation of the anticipated new immunization recommendations.
Additionally, the company is building a state-of-the-art production
facility at its U.S. site in Swiftwater, Pennsylvania, to increase
the production of Menactra vaccine to meet anticipated demand.
About Conjugate Vaccine Technology
In general, the benefits of a successful conjugate vaccine include
improved duration of protection, induction of immunologic memory,
booster responses and reduction in nasopharyngeal bacterial carriage.
In 1987, sanofi pasteur licensed in the U.S. the first conjugate
vaccine for protection against Hib -- ProHIBiT(R) (Haemophilus
influenza type b and diphtheria conjugate vaccine [diphtheria
toxoid-conjugate]). Since the introduction of Hib conjugate vaccines,
such as ProHIBit, the incidence of Hib invasive disease among
children aged 4 years or younger has declined by 98 percent.
Additionally, a U.K. national campaign to immunize 15 million
children under age 17 with a monovalent conjugate vaccine against
serogroup C meningococci resulted in an 81 percent overall decline in
cases and 90 percent reduction in deaths from meningococcal serogroup
C disease within one year. Another result of the U.K. campaign was
herd immunity which resulted from the monovalent vaccine's ability to
prevent carriage of the meningococcal bacteria in the nose and
throat, thereby reducing disease transmission.
Because four serogroups predominate in the U.S. (C, Y, W-135 and
B) versus two predominant strains in the U.K. (C and B), obtaining
similar public health benefits in the U.S. would require a vaccine
that protects against multiple serogroups of meningococcal bacteria
and a broad recommendation for its use. Currently there is no vaccine
available in the U.S. or the U.K. against meningococcal disease
caused by the B serogroup, and Menactra does not protect against this
About Meningococcal Disease
Meningococcal disease is a rare but serious bacterial infection
that strikes between 1,500 and 3,400 Americans every year, causing
meningitis or sepsis in the majority of cases. Approximately 10
percent of individuals who contract meningococcal disease will die.
Of those who survive, up to one in five suffer permanent disabilities
such as hearing loss, neurological damage and limb amputations.
Meningococcal disease often begins with symptoms that can be mistaken
for common viral illnesses, such as the flu. But unlike more common
infections, meningococcal disease can progress very rapidly and kill
an otherwise healthy young person in 48 hours or less.
About sanofi-aventis Group
The sanofi-aventis Group is the world's third-largest
pharmaceutical company, ranking number one in Europe. Backed by a
world-class R&D organization, sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular disease,
thrombosis, oncology, diabetes, central nervous system, internal
medicine, vaccines. The sanofi-aventis Group is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
produced 1.4 billion doses of vaccine in 2003, making it possible to
protect 500 million people across the globe, which is about 1.4
million per day. The company offers the broadest range of vaccines,
providing protection against 20 bacterial and viral diseases.
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are statements that are not historical
facts. These statements include financial projections and estimates
and their underlying assumptions, statements regarding plans,
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are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of and sanofi-, that could cause actual results
and developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include those discussed or
identified in the public filings with the SEC and the AMF made by
sanofi- and, including those listed under "Forward-Looking
Statements" and "Risk Factors" in sanofi-'s annual report on Form
20-F for the year ended December 31, 2003 and those listed under
"Cautionary Statement Regarding Forward-Looking Statements" and "Risk
Factors" in 's annual report on Form 20-F for the year ended December
31, 2003. Other than as required by applicable law, does not
undertake any obligation to update or revise any forward-looking
information or statements.
ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.newsaktuell.ch
Len Lavenda, sanofi pasteur US Media Relations, +1-570-839-4446,
Len.Lavenda@.com; or Michel Joly, sanofi-aventis Communications,