GlaxoSmithKline and Sanofi-Aventis were celebrating yesterday after a US Food and Drug Administration advisory panel unanimously recommended that the agency approve their rival diphtheria, tetanus and whooping cough vaccines, Boostrix and Adacel,
There is currently no whooping cough vaccine approved for use in the US for children over the age of seven years. However, as immunity from childhood vaccination generally wears off after five to 10 years, many adolescents are susceptible to this highly contagious respiratory disease. Reported cases of whooping cough have been on the rise since the mid-1970s, with almost 20,000 cases reported in 2004 – the highest number for 40 years, and almost a 40% increase over 2003. Approximately two-thirds of all cases occur in adolescents and adults.
The manufacturers are seeking slightly different indications for their vaccines. GSK is hoping to win the final nod for Boostrix as a single-dose booster immunisation in individuals 10-18 years of age [[08/07/04f]], while Sanofi Pasteur is hoping to market Adacel for active immunisation in adolescents and adults 11-64 years of age [[12/08/04h]].