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news.GlaxoSmithKline's booster vaccine, Boostrix, has become the first whooping cough vaccine available for children aged over seven in the US after receiving approval from the FDA.
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Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed, or Tdap) is indicated to be given as a single dose to individuals aged ten to 18 years, thereby adding a pertussis (whooping cough) component to the routine tetanus/diphtheria booster currently administered to teens.
In making its decision, the FDA reviewed several clinical trials which included safety and immunogenicity data from one pivotal phase III trial, which showed Boostrix to be comparable to a US-licensed Td vaccine (tetanus and diphtheria toxoids for adult use) with regard to overall safety and immunogenicity.
According to study results, in both treatment groups, greater than or equal to 99.9% of subjects had anti-diphtheria and anti-tetanus concentrations greater than or equal to 0.1 IU/ml, indicating seroprotection against diphtheria and tetanus
“The introduction of Boostrix marks a milestone in the fight against pertussis in the US, particularly among adolescents who are an important reservoir for the disease and often the source of infection for infants,” said Dr Gary Marshall, professor of pediatrics at the University of Louisville School of Medicine in Kentucky.