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FDA approves Boostrix a new US vaccine for adolescents against pertussis

PHILADELPHIA, PA, May 3, 2005 GlaxoSmithKline (NYSE: GSK) today announced that its booster vaccine, Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received approval from the United States (U.S.) Food and Drug Administration (FDA). Boostrix is indicated to be given as a single dose to individuals aged 10 to 18 years thereby adding a pertussis component to the routine tetanus/diphtheria booster currently administered to teens. Previously, there was no pertussis vaccine approved for use in the United States in children seven years of age or older. Immunity from childhood vaccination generally begins to wear off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease.

"The introduction of Boostrix marks a milestone in the fight against pertussis in the United States, particularly among adolescents who are an important reservoir for the disease and often the source of infection for infants," said Gary Marshall, M.D., professor of Pediatrics, University of Louisville School of Medicine, Louisville, Kentucky. "Adding pertussis to the current tetanus and diphtheria booster shot for teens is a logical strategy to prevent this disease in adolescents without additional injections."

Reported cases of pertussis have risen nearly 20-fold since 1976. According to the Centers for Disease Control and Prevention (CDC), there were almost 20,000 cases in 2004 the highest number of reported cases in more than 40 years.

In addition, experts believe the disease is underreported and estimate that the true incidence of the disease in the United States may be greater than one million cases per year. Adolescents aged 10 19 are being hit particularly hard, with almost 40 percent of cases reported to the CDC in 2004 occurring in this age group. Alarmingly, there was a 743 percent increase in reported adolescent pertussis cases in the last decade. Teens, in whom c
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Contact: Amanda Foley
919-483-2839
Cohn & Wolfe
3-May-2005


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