FDA expands age indication of Sanofi Pasteur’s Adacel Tdap vaccine

The approval is based on the data from an open label, multi-center Phase IV trial designed to evaluate the safety and immunogenicity of a single dose of Adacel vaccine in persons 10 years of age compared with those in persons 11 years of age.

The company said that antibody responses to all of the vaccine antigens and rates of adverse reactions were similar in the two age groups.

Sanofi Pasteur vice president of US Scientific and Medical Affairs David Greenberg said the company is happy that the FDA has expanded the age indication for Adacel vaccine, especially in a time when it has seen increases in reports of pertussis, commonly referred to as whooping cough.

"This approval not only reinforces the safety profile of Adacel, but importantly provides an additional opportunity to vaccinate a younger age group to help prevent this highly contagious disease," Greenberg said.

In order to reduce pertussis morbidity in adolescents and adults as well as maintain the standard of care for tetanus, diphtheria, and pertussis protection, the US Centers for Disease Control and Prevention has recommended that persons in these age groups should receive a single dose of a Tdap vaccine because immunity from early childhood vaccination wanes over time.

The US FDA had licensed Adacel vaccine in June 2005 to address pertussis protection for people 11 through 64 years of age.