Tous Actualités
Suivre
Abonner sanofi-aventis Group

sanofi-aventis Group

U.S. FDA Licenses Sanofi Pasteur's ADACEL(TM) Vaccine for Combined Protection Against Tetanus, Diphtheria and Pertussis

Swiftwater, Pennsylvania and Lyon, France (ots/PRNewswire)

- First and Only Booster in the U.S. for Protection Against
Pertussis  from Adolescence through Adulthood
Sanofi pasteur, the vaccines business of the sanofi-aventis Group
(NYSE: SNY), announced today that the U.S. Food and Drug
Administration (FDA) has licensed ADACEL(TM) (Tetanus Toxoid and
Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed)
Vaccine for protection against tetanus, diphtheria and pertussis from
adolescence through adulthood. ADACEL vaccine is the first booster to
address pertussis - or whooping cough - protection across a wide
range of ages (11 through 64 years), and the first and only such
booster licensed for adults in the U.S. It is a licensed product in
Canada and Germany.
The number of reported cases of pertussis continues to rise across
the United States at a rate of great concern to the public health and
medical communities. Pertussis immunity from early childhood
vaccinations wears off, leaving adults and adolescents susceptible to
the disease which they can then transmit to others. At particular
risk are newborns who have not yet been fully vaccinated against
pertussis(i), are more vulnerable to severe pertussis, and face the
possibility of serious complications and even death. Over the last
decade, 80% of pertussis deaths have occurred in infants under six
months of age(ii).
Adults often are the source of pertussis for infants and young
children. A 2004 study conducted by the U.S. Centers for Disease
Control and Prevention (CDC) reported that in cases where the source
of the disease was identifiable, adults were responsible for over
half of pertussis cases in infants, with parents the source for 47
percent and grandparents for 8 percent of cases(iii). Health-care
workers are of special concern for acquiring and transmitting the
disease because of their exposure to both infected and susceptible
individuals.
"Pertussis, or whooping cough, is a family disease. Adults and
adolescents are at risk of contracting and transmitting the infection
because the protection from childhood immunization appears to
diminish over time," said Russell Steele, MD, professor and vice
chairman of the Department of Pediatrics at Louisiana State
University School of Medicine in New Orleans.
"Over the last several years, the proportion of pertussis cases
reported in the U.S. occurring among adolescents and adults has
increased considerably, to nearly two thirds in 2003."
The U.S. CDC's Advisory Committee on Immunization Practices (ACIP)
will meet in upcoming months to update recommendations for the
prevention and control of pertussis, including vaccination of adults
and adolescents. The announcement today of the licensure of ADACEL
vaccine follows a unanimous recommendation on March 15 by the
Vaccines and Related Biological Products Advisory Committee (VRBPAC)
of the U.S. FDA to recommend the vaccine's licensure.
Growing Threat
Preliminary data from the U.S. CDC indicate that there were nearly
19,000 case reports of pertussis in 2004, a 63 percent increase over
2003 and the highest number of case reports in four decades. In
particular, adolescents and adults have experienced a five-fold
increase over the past 14 years. Among adults aged 20 years and
older, the number of reported cases of pertussis nearly doubled to
5,365 cases in 2004 from 2,854 cases in 2003(iv).
Pertussis also has a financial impact on the family. One study
found that the average medical costs for an infant with pertussis was
more than  US$2,800, while parents lost an average of six days of
work to care for an  ill child. This loss of productivity cost
families an average of US$767(v).  Another study, published in 2004,
found that the majority of adults missed an  average of 9.8 days of
work due to their disease, while adolescents missed an  average of
5.5 days of school(vi).
Studies Support Safety and Immunogenicity
The U.S. FDA reviewed the results of four principle clinical
studies that included more than 7,200 individuals. The studies
concluded that the safety profile of ADACEL vaccine was very similar
to that of Td vaccine when administered to adults and adolescents. In
these studies, ADACEL vaccine stimulated robust antibody responses
nearly identical to those from Td vaccine for protection against
tetanus and diphtheria, and exceeding those following three doses of
the analogous diphtheria-tetanus-acellular pertussis given to infants
for protection from pertussis.
In addition, studies were conducted that demonstrated that ADACEL
vaccine can be administered concomitantly with two other common
adolescent and adult vaccines - Hepatitis B (HB) and trivalent
inactivated influenza.
In clinical studies, the adverse events associated with ADACEL
vaccine were very similar to those from the current Td vaccine and
consisted primarily of transient pain, swelling or redness at the
injection site, and low-grade fever of short duration. The most
common systemic adverse events include headache, body ache, and
tiredness. ADACEL vaccine is contraindicated in persons with known
systemic hypersensitivity to any component of ADACEL vaccine or a
life-threatening reaction after previous administration of the
vaccine or a vaccine containing the same substances. Because
intramuscular injection can cause injection site hematoma, ADACEL
vaccine should not be given to persons with any bleeding disorder,
such as hemophilia or thrombocytopenia, or to persons on
anticoagulant therapy unless the potential benefits clearly outweigh
the risk of administration. If the decision is made to administer
ADACEL vaccine in such persons, it should be given with caution, with
steps taken to avoid the risk of hematoma formation following
injection.
ADACEL Vaccine - Development
The development of a pertussis booster vaccine for use from
adolescence through adulthood was not possible before the advent of
acellular vaccines in the mid-1990s. Before then, only whole cell
pertussis vaccine was available which carried an increased risk of
adverse events in individuals over 7 years of age. A children's
diphtheria, tetanus and acellular pertussis (DTaP) vaccine currently
is recommended by the U.S. CDC for administration in a five-dose
series between the ages of 2 months and 6 years.
ADACEL vaccine was licensed in Canada in May 1999 for use in
persons 11 to 54 years of age, and in Germany in July 2001 as
COVAXiS(TM) (TdcP Vaccine; Tetanus and Diphtheria Toxoids Adsorbed
Combined with Component Pertussis Vaccine) for use in persons 10
years and older.
In Canada, ADACEL vaccine is recommended for adolescents and
adults. Adolescent pertussis immunization programs were recently
implemented countrywide. In several regions, including the Northwest
Territories and Newfoundland, use of ADACEL vaccine started earlier
than elsewhere in the country, with reductions in pertussis disease
noted within just a few years of the vaccine's adoption. Following
the introduction of ADACEL vaccine, pertussis incidence in the
Northwest Territories decreased from 7.9 cases per 10,000 in the late
1990s to just 0.2 cases per 10,000 in 2004(vii). In Newfoundland, no
person vaccinated with ADACEL vaccine has been diagnosed with the
disease to date(viii). Sanofi pasteur intends to submit ADACEL
vaccine for licensure in other countries.
About sanofi-aventis
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, metabolic diseases, central nervous system,
internal medicine, and 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,
sold nearly a billion doses of vaccine in 2004, making it possible to
protect more than 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. For more information, please visit: www.sanofipasteur.com
Forward Looking Statement
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,
objectives and expectations with respect to future operations,
products and services, and statements regarding future performance.
Forward-looking statements are generally identified by the words
"expect," "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, 2004. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise
any forward-looking information or statements.
Note to Editors:
Prescribing information and Fact Sheets about ADACEL vaccine and
pertussis are available upon request
(i) Centers for Disease Control and Prevention. Outbreaks of
Pertussis Associated with Hospitals - Kentucky, Pennsylvania, and
Oregon, 2003. MMWR 2004;54 (3):67-71.
(ii) Vitek CR, Pascual FR, Baugham, AL, Murphy TV. Increase in
deaths from pertussis from young infants in the United States in the
1990s, Pediar Infect Dis J. 2003:22:628:634.6.
(iii) Bisgard KM, et al. Infant Pertussis: Who Was the Source?
Pediatric Infectious Disease Journal. 2004; 23(11):985-989.
(iv) Centers for Disease Control and Prevention. Division of
Bacterial and Mycotic Diseases. Pertussis Disease Information.
Available at:
http://www.cdc.gov/incidod/dbmd/diseaseinfo/pertussis_t.htm. Accessed
April 8, 2005.
(v) Lee HL, Pichichero ME. Costs of Illness Due to Bordetella
pertussis in Families. Arch Fam Med. 2000;9:989-996.
(vi) Lee GM, et al. Societal Costs and Morbidity of Pertussis in
Adolescents and Adults. Clin Infect Dis. 2004;39(11):1572-1580.
(vii) Kandola, K. Abstract in Can J Infect Dis Med Microbiol.
2004;15:351. Manuscript in preparation.
(viii) O'Keefe, C. Pertussis in Newfoundland and Labrador,
1991-2004. Manuscript in preparation.
Contact :
    SANOFI PASTEUR
    Len Lavenda
    sanofi pasteur U.S. Media Relations
    Tel.: +1-570-839-4446
     Len.Lavenda@sanofipasteur.com
    SANOFI AVENTIS
    France : Michel Joly
    Tél : +33-(0)1-53-77-47-86
    Mobile : +33-(06)-73-19-51-19

Contact:

Contact : SANOFI PASTEUR, Len Lavenda, sanofi pasteur U.S. Media
Relations, Tel.: +1-570-839-4446, Len.Lavenda@sanofipasteur.com;
SANOFI AVENTIS, France : Michel Joly, Tél : +33-(0)1-53-77-47-86,
Mobile : +33-(06)-73-19-51-19

Plus de actualités: sanofi-aventis Group
Plus de actualités: sanofi-aventis Group