The US Food and Drug Administration appears comfortable with the safety and efficacy profiles presented in filings for GlaxoSmithKline and Sanofi Pasteur’s diphtheria, tetanus and whooping cough vaccines, Boostrix and Adacel, according to documents released ahead of today’s advisory committee meeting.
The manufacturers are seeking slightly different indications for their vaccines. GSK is hoping to win the green light for Boostrix as a single-dose booster immunisation in individuals 10-18 years of age [[08/07/04f]], while Sanofi Pasteur is looking for approval of Adacel for active immunisation in adolescents and adults 11-64 years of age [[12/08/04h]].
The products are intended to address the growing incidence of whooping cough in the US – cases have been on the increase since the mid-1970s. It is currently vaccinated against, but around 10,000 cases were reported in the USA in 2003, which is the highest number of cases in more than 35 years. Around one third of all cases occur in those aged ten years or older – whooping cough vaccine is currently only available to children below the age of seven in the USA. Tetanus and diphtheria are also severe diseases, which can often prove to be fatal.