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child centered 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 child centered 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 child centered 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 child centered curriculum. In 2002, 9,771 cases were reported to the U.S child centered curriculum. Centersfor Disease Control and Prevention (CDC), the highest number of such reportsin more than 30 years child centered curriculum. Preliminary counts of pertussis reports for 2003 exceed10,000, while reporting thus far in 2004 is at an even faster pace child centered 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 child centered curriculum. Johnson, MD, MPH, director, scientific and medical affairs, AventisPasteur child centered curriculum. "We've already had great success in the prevention of tetanusand diphtheria in the U.S child centered 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 child centered curriculum. The diphtheria, tetanus and pertussis (DTaP) vaccine is generallyadministered in five doses between the ages of 2 months and 6 years of age child centered curriculum. However, the vaccine does not offer lifelong protection against pertussis, andit is believed that immunity wanes by adolescence child centered curriculum. While a tetanus and diphtheriabooster immunization is available starting at age 11, a pertussis booster isnot child centered 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 child centered curriculum. in 2002. The regulatory submission for Adacel vaccine is based on results of clinicalstudies involving more than 7,200 clinical trial participants child centered curriculum. The vaccine hasshown an excellent safety and immunogenicity profile child centered curriculum. Adacel vaccine is currentlyapproved and marketed in Canada and Germany. Risk of 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 child centered 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 child centered curriculum. Johnson child centered curriculum. "Increased outbreaksin this country are an all too common reminder that we need to bring this diseaseunder control." About Tetanus, Diphtheria, Pertussis 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 child centered 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 child centered curriculum. It can also be spread by handling used tissues or bydrinking from a glass used by an infected person child centered curriculum. Symptoms usually appear twoto five days after infection and begin very much like a common cold child centered curriculum. However,symptoms can progress as a membrane grows and covers anywhere from a small patchto most of the throat, potentially blocking the airway child centered 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 child centered curriculum. Diphtheria occurs rarely in this country, but is occasionally importedfrom countries where it is endemic child centered 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 child centered curriculum. Pertussis is primarily spread by direct contactwith discharge from the nose or throat of infected individuals child centered 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 child centered curriculum. Mild pertussisis any laboratory-confirmed pertussis disease that is less than classic disease. Pertussis can occur at any age child centered curriculum. More than half the cases occur in adolescentsand adults, while the majority of the remaining cases affect children under1 year of age child centered curriculum. For young children, pertussis disease can result in significantmorbidity, hospitalization, serious long-term complications, and death. About Aventis |
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