The U.S. Food and Drug Administration approved the expanded use of Sanofi's Adacel to include repeat vaccination for tetanus, diphtheria and pertussis.
The French pharmaceutical giant said Adacel is the first and only vaccine in the U.S. approved for a repeat dose to protect people 10 to 64 years of age against the diseases eight years or more after their first vaccination.
Tetanus, also known as lockjaw, is caused by caused by the bacterium Clostridium tetani and leads to contraction of muscles, while Diphtheria is an infectious disease caused by the bacterium Corynebacterium diphtheria, which mainly infects the throat and upper airways and produces a toxin affecting other organs.
Pertussis, also known as whooping cough, is a highly contagious respiratory disease and is caused by the bacterium Bordetella pertussis.
David Greenberg, regional medical head of North America at Sanofi Pasteur, said a single immunization does not offer lifetime protection against pertussis due to waning immunity but Adacel's use as repeat vaccination will help patients manage their immunization.
The FDA's approval was based on data from a trial showing the safety and effectiveness of repeat Adacel vaccination in adults aged 18 through 64 years. The trial consisted of 1,300 people, who received either Adacel or a tetanus-diphtheria vaccine 8 to 12 years after a previous dose of Adacel, and showed that there were no significant differences in adverse events between the two vaccine groups.
Sanofi said the data of the trial has been provided to the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices for use in future recommendations.