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GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix

s 10-19 during a 10-year period would prevent up to 1.8 million cases of pertussis and save as much as $1.6 billion in direct and indirect costs.

"With nearly two million doses of Boostrix distributed worldwide since 1999, GlaxoSmithKline is extremely pleased that our efforts to develop a booster vaccine for pertussis in the U.S. have resulted in a favorable recommendation from the FDA Advisory Committee," said David M. Pernock, senior vice president Pharmaceuticals, Philadelphia & Vaccines, GlaxoSmithKline. "As a leader in combination vaccines, GlaxoSmithKline will be proud to introduce Boostrix as the first of a number of new and important candidate vaccines from our pipeline specifically targeted at preventing disease in adolescents."

Background on Diphtheria and Tetanus

Diphtheria is a serious disease that results in the death of approximately five to 10 percent of infected persons, with higher death rates (up to 20 percent) in persons younger than five and older than 40 years of age. Initial symptoms may include malaise, sore throat and low-grade fever. As the disease progresses, a membrane can form over the airway and result in respiratory obstruction which can lead to death. Other complications may include heart failure and paralysis. Most cases of diphtheria occur among unvaccinated or inadequately vaccinated persons.

Tetanus (lockjaw) is a severe, often fatal disease. The bacteria that cause tetanus are widely found in soil and the manure of many animals. Almost all reported cases of tetanus are in persons who have either never been vaccinated, or who completed a primary series, but have not had a booster in the preceding 10 years. Infants of unvaccinated mothers are at risk for neonatal tetanus. Early symptoms are lockjaw, stiffness in the neck and abdomen, and difficulty swallowing. Later symptoms may include fever, elevated blood pressure and severe muscle spasms.


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Contact: Amanda Foley
919-483-2839
Cohn & Wolfe
15-Mar-2005


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