GlaxoSmithKline submits Biologics License Application for Boostrix
GlaxoSmithKline has submitted a Biologics License Application (BLA) for Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)], to the US FDA.
GlaxoSmithKline has submitted a Biologics License Application (BLA) for Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)], to the US FDA.
The company is seeking US marketing approval for the booster vaccine candidate, a similar formulation of which is available in Australia and a number of countries in Europe, South America and Asia, as a vaccination against diphtheria, tetanus and pertussis.
Currently, pertussis vaccination in the US is available only to children below the age of seven. Boostrix was developed to offer extended protection against pertussis to adolescents between the ages of 10 and 18 by combining a pertussis vaccine with the routine tetanus/diphtheria booster.
Pertussis is the only disease for which children are routinely vaccinated that is currently on the rise in the US, with approximately 10,000 cases in 2003. According to the Centers for Disease Control and Prevention (CDC), from 1997 to 2000, about one-third of all reported pertussis cases occurred in adolescents 10 years of age or older.
'GlaxoSmithKline is seeking approval for this new booster vaccine which would help address a large unmet need and offer important protection against pertussis where the disease is growing the most -- the adolescent population,' said Dr Barbara Howe, vice president, clinical r&d and medical affairs, vaccines North America, GlaxoSmithKline.