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writing across the curriculum
Aventis Submits Application for FDA Licensure of Adacel Vaccine for Preventionof Tetanus, Diphtheria and Pertussis in Adolescents and Adults

- Vaccine Leader Looks to Introduce Pertussis Booster in United States -

SWIFTWATER, Pa., August 11, 2004 -- Aventis (NYSE:AVE) today announced thesubmission of a Biologics Licensing Application (BLA) to the U.S writing across the curriculum. 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 writing across the curriculum. 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 writing across the curriculum. In 2002, 9,771 cases were reported to the U.S writing across the curriculum. Centersfor Disease Control and Prevention (CDC), the highest number of such reportsin more than 30 years writing across the curriculum. Preliminary counts of pertussis reports for 2003 exceed10,000, while reporting thus far in 2004 is at an even faster pace writing across the curriculum. 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 writing across the curriculum. Johnson, MD, MPH, director, scientific and medical affairs, AventisPasteur writing across the curriculum. "We've already had great success in the prevention of tetanusand diphtheria in the U.S writing across the curriculum. 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 writing across the curriculum. The diphtheria, tetanus and pertussis (DTaP) vaccine is generallyadministered in five doses between the ages of 2 months and 6 years of age writing across the curriculum. However, the vaccine does not offer lifelong protection against pertussis, andit is believed that immunity wanes by adolescence writing across the curriculum. While a tetanus and diphtheriabooster immunization is available starting at age 11, a pertussis booster isnot writing across the curriculum. 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 writing across the curriculum. in 2002.

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

Risk of Pertussis
Pertussis is a highly contagious, respiratory disease marked by severe coughing writing across the curriculum. 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 writing across the curriculum. There are both severe and mild forms of pertussis writing across the curriculum. 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 writing across the curriculum. 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 writing across the curriculum. 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 writing across the curriculum. 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 writing across the curriculum. Johnson writing across the curriculum. "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) writing across the curriculum. 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 writing across the curriculum. "Lockjaw," asthe disease is sometimes called, is often the first symptom, followed by stiffnessin the neck and difficulty swallowing writing across the curriculum. Muscle spasms may occur frequently, lastingfor several minutes and persisting for up to a month writing across the curriculum. 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 writing across the curriculum. The bacteria that cause tetanus are widespread and are found in soiland in the intestinal tracts of animals and humans writing across the curriculum. It usually enters the bodythrough a wound or opening in the skin writing across the curriculum. Virtually all of the cases of tetanusdisease occurring in the U.S writing across the curriculum. 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 writing across the curriculum. 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 writing across the curriculum. It can also be spread by handling used tissues or bydrinking from a glass used by an infected person writing across the curriculum. Symptoms usually appear twoto five days after infection and begin very much like a common cold writing across the curriculum. However,symptoms can progress as a membrane grows and covers anywhere from a small patchto most of the throat, potentially blocking the airway writing across the curriculum. 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 writing across the curriculum. Diphtheria occurs rarely in this country, but is occasionally importedfrom countries where it is endemic writing across the curriculum. 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 writing across the curriculum. Pertussis is primarily spread by direct contactwith discharge from the nose or throat of infected individuals writing across the curriculum. 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 writing across the curriculum. Mild pertussisis any laboratory-confirmed pertussis disease that is less than classic disease.

Pertussis can occur at any age writing across the curriculum. More than half the cases occur in adolescentsand adults, while the majority of the remaining cases affect children under1 year of age writing across the curriculum. 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 writing across the curriculum. 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 writing across the curriculum. Aventis corporateheadquarters are in Strasbourg, France.
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