GSK's Boostrix approved by US FDA

8 May 2005

UK drug giant GlaxoSmithKline says that its booster vaccine, Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]), has obtained marketing approval from the US Food and Drug Administration.

The FDA has cleared Boostrix, a similar formulation to that which is available in Australia and a number of countries in Europe, South America and Asia as a vaccination against diphtheria, tetanus and pertussis (Marketletters passim), for people aged 10-18 years, thereby adding a pertussis component to the routine tetanus/diphtheria booster currently administered to teenagers, the group noted.

This marks the first pertussis vaccine approved for use in the USA in children over seven years old and, considering that immunity from childhood vaccination generally begins to weaken after five-10 years, provides an added defense for many adolescents which are susceptible to this highly-contagious disease.

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