GlaxoSmithKline today announced that its booster vaccine, Boostrix received approval from the United States (U.S.) Food and Drug Administration (FDA).
Boostrix is indicated to be given as a single dose to individuals aged 10 to 18 years thereby adding a pertussis component to the routine tetanus/diphtheria booster currently administered to teens. Previously, there was no pertussis vaccine approved for use in the United States in children seven years of age or older. Immunity from childhood vaccination generally begins to wear off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease.
In making its decision, the FDA reviewed several clinical trials which included safety and immunogenicity data from one pivotal trial, which studied Boostrix in approximately 3,000 adolescents in the United States, aged 10 to 18. The Phase III clinical trial showed Boostrix to be comparable to a U.S.- licensed Td vaccine [Tetanus and Diphtheria Toxoids for Adult Use] with regard to overall safety and immunogenicity. In addition, the use of Boostrix induced anti-pertussis antibody levels which were non inferior to those observed in infants following a primary immunization series with a DTaP vaccine (Infanrix) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed] in whom efficacy against pertussis disease was demonstrated in a previous study. As compared to Infanrix, the ratio of geometric mean antibody levels to pertussis antigens following the use of Boostrix ranged from 1.9 to 7.3.