The FDA's Vaccines and Related Biological Products Committee voted unanimously to recommend that Sanofi Pasteur's Tetanus Toxoid and Reduced Diphtheria Toxoid and Accellular Pertussis Vaccine Adsorbed Vaccine (Adacel) be licensed by the FDA for protection against tetanus, diphtheria, and pertussis in adolecents and adults aged 11 to 64 years of age.
The vaccine is the first booster to address pertussis protection for a wide range of ages.
In recommending the approval of Adacel, the committee reviewed the results of four clinical trials that included more than 7,200 people who were evaluated for safety. Immunogenicity of the vaccine was documented in a randomized subgroup of 4,342 study subjects receiving Adacel and Td vaccine.