SUNDAY, SEPTEMBER 25, 2016

Sanofi Pasteur receives FDA approval to use Adacel vaccine on 10-year-olds

Sanofi Pasteur said on Tuesday that it received approval from the U.S. Food and Drug Administration to expand the age indication of its tetanus, diphtheria and pertussis booster immunization to include people 10 years of age.


The Adacel Tdap vaccine was previously licensed for people 11 to 64 years of age by the FDA in June 2005.


"We are pleased the FDA has expanded the age indication for Adacel vaccine, especially in a time when we have seen increases in reports of pertussis, commonly referred to as whooping cough," Sanofi Pasteur Vice President of U.S. Scientific and Medical Affairs David Greenberg said. "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."


The approval was granted after a Phase IV open label, multi-center trial. The test showed the immunogenicity of a single dose of Adacel vaccine in people 10 years of age in contrast with patients 11 years of age. Results showed antibody response to the vaccine antigens and negative reactions were similar in both age groups.


The U.S. Centers for Disease Control and Prevention recommended that youth in these age groups receive the booster vaccine because protection from vaccines received in early childhood wanes over time.