- Pentacel(R) vaccine is the first 5-in-1 pediatric combination for immunization against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib) - SWIFTWATER, Pa. and LYON, France, June 23
SWIFTWATER, Pa. and LYON, France, June 23 /PRNewswire/ -- Sanofi Pasteur,
the vaccines division of the sanofi-aventis Group, announced today that the
U.S. Food and Drug Administration (FDA) has licensed Pentacel(R), Diphtheria
and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus
and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine. Pentacel(R)
vaccine is indicated for active immunization against diphtheria, tetanus,
pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae
type b (Hib). Pentacel(R) vaccine is approved for use in infants and children
6 weeks through 4 years of age (prior to fifth birthday).
Pentacel(R) vaccine is the first and only four-dose diphtheria, tetanus,
and acellular pertussis (DTaP)-based combination vaccine for use in infants
and young children in the U.S. that includes both poliovirus and Hib antigens.
Pentacel(R) vaccine is approved for administration as a four-dose series
at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6
weeks of age. According to the current Recommended Childhood Immunization
Schedule of the U.S. Centers for Disease Control and Prevention (CDC), up to
23 injections are needed by the time a child reaches 18 months of age with
single-entity vaccines. The use of Pentacel(R) vaccine could reduce that
number of shots by seven.
"Pentacel(R) vaccine will help simplify the immunization schedule by
reducing the number of injections infants and young children will receive in
their first two years of life," said Wayne Pisano, President and Chief
Executive Officer, sanofi pasteur. Pentacel(R) vaccine has been used in Canada
for a decade and is licensed in seven other countries. "We are pleased that
the U.S. FDA has now taken this important step, to make the convenience of
Pentacel(R) vaccine available to health-care providers and parents in the
U.S.," Pisano added.
"The FDA approval of Pentacel(R) vaccine is great news for parents and
pediatricians who want to reduce the stress of well-baby visits," said Tina Q.
Tan, M.D., infectious disease specialist, Children's Memorial Hospital,
Chicago. "Pertussis disease continues to remain a threat to young infants, who
are at the highest risk for severe complications and death. With a four-dose
primary series of Pentacel(R) vaccine, pediatricians can reduce the number of
vaccination shots while providing protection against five diseases, including
pertussis."
Pentacel(R) vaccine is also the first five-component (pentavalent)
pediatric combination vaccine in the U.S. to contain sanofi pasteur's five
acellular pertussis antigens, which are also used in its DTaP vaccine for
children (DAPTACEL(R)(a) vaccine, licensed in 2002) and its tetanus,
diphtheria, and acellular pertussis (Tdap) vaccine for adults and adolescents
(Adacel(R)(b) vaccine, licensed in 2005). Pertussis is commonly known as
whooping cough because of the sound some patients -- especially children --
make while gasping for air during coughing spells.
The FDA licensure of Pentacel(R) vaccine is based on the results of
multi-center clinical studies conducted in the U.S. and Canada involving more
than 5,000 children who received at least one dose of Pentacel(R) vaccine. The
immunogenicity of Pentacel(R) vaccine was compared to separately administered
DAPTACEL, IPOL(R)(c) and ActHIB(R)(d) vaccines (studies P3T06 and M5A10), as
well as to other single-entity vaccine formulations (study 494-01). The safety
of Pentacel(R) vaccine was compared both to separately administered DAPTACEL,
IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine
formulations (study 494-01).
In clinical studies, local and systemic reactions following administration
of Pentacel(R) vaccine were reported at rates consistent with those of the
separately administered vaccines used in each trial. The most common local and
systemic adverse reactions to Pentacel(R) vaccine include injection site
redness, swelling and tenderness; fever, fussiness and crying. Other adverse
reactions may occur. Known systemic hypersensitivity reaction to any component
of Pentacel(R) vaccine or a life-threatening reaction after previous
administration of the vaccine or a vaccine containing the same substances are
contraindications to vaccination.
The decision to give Pentacel(R) vaccine should be based on the potential
benefits and risks; if Guillain-Barre syndrome has occurred within 6 weeks of
receipt of a prior vaccine containing tetanus toxoid; or if adverse events
have occurred in temporal relation to receipt of pertussis-containing vaccine.
Encephalopathy within 7 days of administration of a previous dose of a
pertussis-containing vaccine or a progressive neurologic disorder is a
contraindication. Vaccination with Pentacel(R) vaccine may not protect all
individuals.
Before administering Pentacel(R) vaccine, please see accompanying full
Prescribing Information.
The full Prescribing Information for Pentacel(R) vaccine is available on
www.pentacel.com and www.vaccineshoppe.com. More than 14 million doses of
Pentacel(R) vaccine have been distributed in Canada since 1997. Pentacel(R)
vaccine is expected to be available for distribution in the U.S. this summer.
Sanofi Pasteur's U.S. operations in Swiftwater, PA have long been
committed to providing vaccines to prevent childhood diseases. In 1987, it
licensed the first Hib conjugate vaccine. And in 1996, it was the first
company to license a DTaP vaccine for use in infants (Tripedia(R)(e) vaccine).
In 2005, sanofi pasteur continued its tradition of innovation by introducing
Menactra(R)(f) vaccine to protect against meningococcal disease, and Adacel
vaccine as a booster dose for protection against tetanus, diphtheria and
pertussis in both adults and adolescents 11-64 years of age.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT PARIS: SAN) and in New
York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided
more than 1.6 billion doses of vaccine in 2007, making it possible to immunize
more than 500 million people across the globe. A world leader in the vaccine
industry, sanofi pasteur offers the broadest range of vaccines protecting
against 20 infectious diseases. The company's heritage, to create vaccines
that protect life, dates back more than a century. Sanofi Pasteur is the
largest company entirely dedicated to vaccines. Every day, the company invests
more than EUR1 million in research and development. For more information,
please visit: www.sanofipasteur.com or www.sanofipasteur.us.
Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions. Although sanofi-aventis'
management believes that the expectations reflected in such forward-looking
statements 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
sanofi-aventis, 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-aventis, including those listed under "Risk Factors"
and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2007. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information
or statements.
(a) The true name for DAPTACEL vaccine is: Diphtheria and Tetanus Toxoids
and Acellular Pertussis Vaccine Adsorbed.
(b) The true name for Adacel vaccine is: Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed.
(c) The true name for IPOL vaccine is: Poliovirus Vaccine Inactivated.
(d) The true name for ActHIB vaccine is: Haemophilus b Conjugate Vaccine
(Tetanus Toxoid Conjugate).
(e) The true name for Tripedia vaccine is: Diphtheria and Tetanus Toxoids
and Acellular Pertussis Vaccine Adsorbed.
(f) The true name for Menactra vaccine is: Meningococcal (Groups A, C, Y
and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine.
SOURCE Sanofi Pasteur
