FDA panel favors GSK and Sanofi-Aventis vaccines

GlaxoSmithKline’s booster vaccine candidate, Boostrix, received a unanimous favorable recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). If approved, Boostrix would add a pertussis (whooping cough) component to the routine tetanus/diphtheria booster currently recommended for adolescents.

In making its recommendation, the FDA Advisory Committee reviewed several clinical trials which included safety and immunogenicity data from a pivotal trial that studied Boostrix in more than 3,000 adolescents in the US, aged 10 to 18.

Meanwhile, Sanofi-Aventis’ vaccines unit, Sanofi Pasteur, also received a unanimous vote from the VRBPAC to recommend licensure of Adacel vaccine for protection against tetanus, diphtheria and pertussis in adolescents and adults aged 11-64 years.

Adacel vaccine, which is already licensed and marketed in Canada and Germany, is the first booster to address pertussis protection across a wide range of ages, including adolescents and adults. These age groups are at a growing risk of contracting and transmitting the disease.

In making its recommendation, the Committee reviewed the results of four principle clinical studies that included more than 7,200 individuals who were evaluated for safety.

Currently, there is no pertussis vaccine approved for use in the US for children seven years of age or older. Immunity from childhood vaccination generally wears off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease.

Although the FDA is not bound by the Advisory Committee’s recommendation, the agency considers it carefully when deciding whether to license a vaccine for marketing.