Adacel Receives Expanded Indication
January 14, 2019 – The U.S. FDA has approved an expanded indication for Adacel® [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed], manufactured by Sanofi. Under the expanded indication, the vaccine may now be repeated in individuals 10 through 64 years of age to help prevent tetanus, diphtheria, and pertussis (whooping cough).
Adacel first received FDA approval in 2005, and is indicated for use as a booster vaccine. It can be given at least five years following an initial Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccination series or a Tetanus and Diphtheria Toxoids Adsorbed (Td) vaccination. It can also be used to provide tetanus prophylaxis for wound management. Under the new indication, Adacel administration can now be repeated at least eight years after the first dose to further extend protection against tetanus, diphtheria, and pertussis. It is the first Tdap vaccine approved for repeat vaccination in the United States.
The U.S. Centers for Disease Control and Prevention (CDC) recommends that children receive a Tdap vaccination at age 11 or 12, and individuals who have not received the vaccine by 12 years of age do so as soon as possible. The CDC notes that Tdap vaccination is especially important for individuals who will have close contact with babies who are less than 12 months old, and that women should receive a Tdap vaccine during every pregnancy to protect the newborn from pertussis.