adacel canada

SWIFTWATER, Pa., August 11, 2004 -- Aventis (NYSE:AVE) today announced thesubmission of a Biologics Licensing Application (BLA) to the U.S adacel canada. Food and DrugAdministration (FDA) for marketing approval of Adacel (Tetanus Toxoid and ReducedDiphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) for prevention oftetanus, diphtheria and pertussis in adolescents and adults aged 11 through64 years adacel canada. The BLA for this candidate vaccine was submitted by Aventis Pasteur,the vaccines business of Aventis.

Reported cases of pertussis, commonly known as whooping cough, clearly areon the rise in the U.S adacel canada. In 2002, 9,771 cases were reported to the U.S adacel canada. Centersfor Disease Control and Prevention (CDC), the highest number of such reportsin more than 30 years adacel canada. Preliminary counts of pertussis reports for 2003 exceed10,000, while reporting thus far in 2004 is at an even faster pace adacel canada. However,it is estimated that only 12 percent of pertussis cases are actually reportedand that under-reporting may be greatest among adolescents and adults.

"Pertussis continues to be an important public health issue, in part becauseadolescents and adults may not even be aware that they have the disease andthat they can transmit it to vulnerable infants and younger children,"said David R adacel canada. Johnson, MD, MPH, director, scientific and medical affairs, AventisPasteur adacel canada. "We've already had great success in the prevention of tetanusand diphtheria in the U.S adacel canada. and believe that the introduction of a combinationvaccine that also protects against pertussis in adults and adolescents willhelp to counter ongoing transmission of this disease."

A vaccine is currently available to protect children against pertussis up to7 years of age adacel canada. The diphtheria, tetanus and pertussis (DTaP) vaccine is generallyadministered in five doses between the ages of 2 months and 6 years of age adacel canada. However, the vaccine does not offer lifelong protection against pertussis, andit is believed that immunity wanes by adolescence adacel canada. While a tetanus and diphtheriabooster immunization is available starting at age 11, a pertussis booster isnot adacel canada. The Adacel tetanus, diphtheria and pertussis vaccine will be referred toas a "Tdap" vaccine; the children's vaccine to prevent these samediseases is known as "DTaP." The pertussis components in Adacel vaccineare based on the acellular pertussis formulation in DAPTACEL(R), Diphtheriaand Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine),which was successfully introduced by Aventis Pasteur in the U.S adacel canada. in 2002.

The regulatory submission for Adacel vaccine is based on results of clinicalstudies involving more than 7,200 clinical trial participants adacel canada. The vaccine hasshown an excellent safety and immunogenicity profile adacel canada. Adacel vaccine is currentlyapproved and marketed in Canada and Germany.

Risk of Pertussis
Pertussis is a highly contagious, respiratory disease marked by severe coughing adacel canada. Its common name, whooping cough, comes from the "whoop" sound childrenand adults make when they try to inhale during or after a severe coughing spell adacel canada. There are both severe and mild forms of pertussis adacel canada. Although pertussis can occurat any age, severe pertussis disease usually occurs in infants and young childrenwho are at higher risk for severe pertussis-related complications and even death adacel canada. While adults may not experience the debilitating effects of the disease thatinfants do, infected adults can easily transmit the illness to unimmunized andpartially immunized infants and young children adacel canada. Additionally, older adults (morethan 55 years of age) may also be at considerable risk for death associatedwith pertussis.

Mild pertussis disease is difficult to diagnose because its symptoms are notas distinctive; usually a prolonged cough is present, but without the "whoop."One reason for the incomplete identification of pertussis may be that diagnosisof the disease in adults and adolescents is sometimes difficult because symptomsare often atypical.

Although infants and young children may experience mild pertussis disease,it is more often associated with adolescents and adults adacel canada. Even in less severecases, infected adolescents and adults can easily transmit the illness to vulnerableinfants and young children who may experience complications associated withthe disease, such as pneumonia, encephalitis and pertussis- related seizures.

"While older patients are often spared the debilitating effects of thedisease, the fact that it may not be properly diagnosed and treated opens thedoor for spreading the disease," said Dr adacel canada. Johnson adacel canada. "Increased outbreaksin this country are an all too common reminder that we need to bring this diseaseunder control."

About Tetanus, Diphtheria, Pertussis
Tetanus is a severe, frequently fatal disease caused by an exotoxin producedby bacteria (Clostridium tetani) adacel canada. The disease, characterized by generalizedrigidity and convulsive spasms of skeletal muscles, causes paralysis, usuallystarts at the top of the body and works its way down adacel canada. "Lockjaw," asthe disease is sometimes called, is often the first symptom, followed by stiffnessin the neck and difficulty swallowing adacel canada. Muscle spasms may occur frequently, lastingfor several minutes and persisting for up to a month adacel canada. Symptoms of tetanus canappear anywhere from three days to three weeks after exposure to the bacteriaand may be accompanied by fever, sweating, elevated blood pressure and rapidheartbeat adacel canada. The bacteria that cause tetanus are widespread and are found in soiland in the intestinal tracts of animals and humans adacel canada. It usually enters the bodythrough a wound or opening in the skin adacel canada. Virtually all of the cases of tetanusdisease occurring in the U.S adacel canada. are in adults not up-to-date with booster vaccinations.

Diphtheria is a disease caused by exposure to airborne bacteria (Corynebacteriumdiphtheriae) from an infected person and usually affects the tonsils, throat,nose and/or skin adacel canada. It is passed from person to person by droplet transmission,usually by breathing in diphtheria bacteria after an infected person has coughed,sneezed or even laughed adacel canada. It can also be spread by handling used tissues or bydrinking from a glass used by an infected person adacel canada. Symptoms usually appear twoto five days after infection and begin very much like a common cold adacel canada. However,symptoms can progress as a membrane grows and covers anywhere from a small patchto most of the throat, potentially blocking the airway adacel canada. The infection releasesa toxin that can lead to heart failure and paralysis, and if enough toxin isabsorbed into the bloodstream, coma or even death can occur in as little asa week adacel canada. Diphtheria occurs rarely in this country, but is occasionally importedfrom countries where it is endemic adacel canada. Ongoing vaccination to protect against diphtheriacontinues to be recommended.

Pertussis, a highly contagious disease of the respiratory tract, is causedby exposure to bacteria (Bordetella pertussis) found in the mouth, nose andthroat of an infected person adacel canada. Pertussis is primarily spread by direct contactwith discharge from the nose or throat of infected individuals adacel canada. Classic, orsevere, pertussis, as defined by the World Health Organization, consists ofat least 21 days of cough illness (with the cough coming in spasms or paroxysms),associated whoops or post-cough vomiting, and culture confirmation adacel canada. Mild pertussisis any laboratory-confirmed pertussis disease that is less than classic disease.

Pertussis can occur at any age adacel canada. More than half the cases occur in adolescentsand adults, while the majority of the remaining cases affect children under1 year of age adacel canada. For young children, pertussis disease can result in significantmorbidity, hospitalization, serious long-term complications, and death.

About Aventis
Aventis is dedicated to treating and preventing disease by discovering and developinginnovative prescription drugs and human vaccines adacel canada. In 2003, Aventis generatedsales of euro 16.79 billion, invested euro 2.86 billion in research and developmentand employed approximately 69,000 people in its core business adacel canada. Aventis corporateheadquarters are in Strasbourg, France.

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