Sanofi Announces FDA Approval Of Adacel Expanded Age Indication

Sanofi vaccines division Sanofi Pasteur announced that it has won approval from the U.S. Food and Drug Administration (FDA) for the expansion of the approved age indication of Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; Tdap) for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose. Adacel can now be used to treat patients 10 years old through 64 years old.

David P. Greenberg, VP of U.S. Scientific and Medical Affairs at Sanofi Pasteur, said, “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. 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.”

Pertussis is a highly contagious and often serious disease especially in pediatric patients caused by Bordetella pertussis. The disease often presents it as a severe and episodic cough lasting from weeks to months in adolescents and adult patients. Pertussis is also known as whooping cough. It is estimated to affect up to 3 million patients in the U.S. alone in any given year.

Adacel vaccine is administered in a single dose to patients 10 to 64 years of age for the prophylaxis of tetanus (lockjaw), diphtheria, and pertussis.

“The FDA approval was based on data from a Phase IV, open label, multi-center trial 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. Antibody responses to all of the vaccine antigens (tetanus, diphtheria, and pertussis) and rates of adverse reactions were similar in the two age groups,” the company stated in its press release.

Previous FDA approval of Adacel in June 2005 only addressed pertussis protection in patients from 11 to 64 years old.