GlaxoSmithKline's booster vaccine candidate, Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received a favourable recommendation from the Vaccines and Related Biological Products Advisory Committee of the US FDA.
Currently, there is no pertussis vaccine approved for use in the US for children seven years of age or older. Immunity from childhood vaccination generally wears off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease.
If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently recommended for adolescents. The
committee's recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for Boostrix, the GSK release states.
According to the Centres for Disease Control and Prevention (CDC), there were almost 20,000 cases of pertussis in 2004 - the highest number of reported cases in more than 40 years. In addition, 39 per cent of cases reported to the CDC in 2003 occurred in adolescents 10-19 years of age. Adolescents, in whom classic signs and symptoms of pertussis are often absent, may go undiagnosed and be the source of infection for susceptible infants and other family members.