FDA ADVISERS RECOMMEND SANOFI PASTEUR'S PEDIATRIC VACCINE

Sanofi pasteur, the vaccines arm of sanofi-aventis, announced that the FDA's Vaccines and Related Biological Products Advisory Committee decided that the company's pentavalent combination vaccine is safe and efficacious for use in pediatric patients.

The vaccine, Pentacel, protects against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b. According to the current recommended childhood and adolescent immunization schedule from the Centers for Disease Control and Prevention, up to 23 injections are needed from birth through 18 months of age. The use of Pentacel could reduce that number of shots by seven, according to sanofi pasteur.

The application for Pentacel is based on results of clinical studies involving more than 5,000 children in multicenter trials conducted in the U.S. and Canada. Pentacel is licensed for pediatric use in nine countries, including Canada, where it has been used in infants and young children since 1998.

The diphtheria, tetanus and pertussis components of Pentacel are based on the formulation in Daptacel, which was introduced by sanofi pasteur in the U.S. in 2002.