GlaxoSmithKline has submitted a Biologics License Application (BLA) for Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)], to the US FDA, a company release said.
According to GSK, they are seeking US marketing approval for the booster vaccine candidate, a similar formulation of which is available in Australia and a number of countries in Europe, South America and Asia, as a vaccination against the diseases diphtheria, tetanus and pertussis. Currently, pertussis vaccination in the US is available only to children below the age of seven. Boostrix was developed to offer extended protection against pertussis to adolescents between the ages of 10 and 18 by combining a pertussis vaccine with the routine tetanus/diphtheria booster.
"We are delighted that our efforts to develop a Tdap vaccine have resulted in filing a BLA with the FDA. GlaxoSmithKline is seeking approval for this new booster vaccine which would help address a large unmet need and offer important protection against pertussis where the disease is growing the most - the adolescent population," said Barbara Howe, vice president, Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline.
Whooping Cough Cases Reach Highest Level in 35 Years Pertussis, commonly known as "whooping cough," is a highly contagious bacterial infection of the respiratory system that causes spasms of severe coughing. 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 dry cough. Symptoms generally progress to more severe coughing episodes, often with a high-pitched whoop, followed by vomiting. These severe coughing spells can last for more than two months.
"As a leader in combination vaccines, GlaxoSmithKline is extremely pleased that our efforts to develop a booster vaccine for pertussis have resulted in filing a BLA with the FDA," said Jo LeCoulliard, vice president, Vaccines Business Unit, GlaxoSmithKline. He added, "Boostrix is the first of a number of new and important candidate vaccines from our pipeline specifically targeted at preventing disease in adolescents."
Cases of pertussis have increased since the mid-1970s. In fact, pertussis is the only disease for which children are routinely vaccinated that is currently on the rise in the US, with approximately 10,000 cases in 2003 - the highest number of cases reported to the Centres for Disease Control and Prevention (CDC) in more than 35 years. According to the CDC, from 1997 to 2000, about one -third of all reported pertussis cases occurred in adolescents 10 years of age or older. 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.