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SAM on the favorable recommendation by FDA Advisory Committee for Boostrix

BLUE SPRINGS, MO March 15, 2005 The Society for Adolescent Medicine supports the unanimous favorable recommendation of the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA) regarding the development of a vaccine to prevent the occurrence of pertussis in adolescents. We believe that the development of this vaccine will further the health and well-being of adolescents by helping to protect teens from this serious and highly contagious disease.

"We look forward to the anticipated approval of Boostrix for adolescents," said Vaughn I. Rickert, Psy.D., immediate past president of the Society for Adolescent Medicine. "Pertussis is a serious and growing public health threat, with outbreaks occurring nationwide. Pertussis among teens may cause severe coughing fits, which may last up to 100 days and significantly impact the teen's life at home and school."

"Currently, there is no pertussis vaccine approved for use in the United States for children seven years of age or older. Because immunity from childhood vaccination may wane after five to 10 years, many teens are left susceptible to this highly contagious disease. Since adolescents do not commonly exhibit the classic signs and symptoms of pertussis, the infection can go undiagnosed and may be the source of infection for infants who are too young to be fully immunized," added Dr. Rickert.

"If approved, BoostrixTM [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] would add a pertussis component to the routine tetanus/diphtheria booster currently administered to adolescents," noted Dr. Rickert.

"According to the Centers for Disease Control and Prevention (CDC), there were almost 20,000 pertussis cases in 2004 the highest number of reported cases in more than 40 years. Due to these alarming statistics, it is critical for adolescents to receive extended protection against pertussis.
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Contact: Amanda Foley
919-483-2839
Cohn & Wolfe
15-Mar-2005


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