Boostrix receives FDA approval as treatment for pertussis

May 3 2005

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.

Pertussis, commonly known as "whooping cough," is a highly contagious bacterial infection of the respiratory system that causes spasms of severe coughing. Up to 90 percent of non-vaccinated susceptible household members may develop the disease when exposed to people infected with pertussis. It is spread through airborne droplets of an infected person's cough or sneeze. The first symptoms of pertussis are similar to the "common cold" with a mild fever, runny nose and a cough. Symptoms generally progress to more severe coughing episodes, often with a high-pitched "whoop," followed by vomiting. Adolescents generally exhibit different symptoms of the disease, often without the classic "whoop," making it difficult to diagnose. However, for these older pertussis sufferers, severe coughing episodes can lead to vomiting, a hernia, or even a broken rib. These severe coughing episodes can last more than 100 days. While pertussis is threatening to all, this highly contagious disease can be deadly in infants who are too young to be fully immunized.