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News From the Centers for Disease Control and Prevention
November 2, 2011

FDA Approval of Expanded Age Indication for a Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine

JAMA. 2011;306(17):1856-1857. doi:

MMWR. 2011;60:1279-1280

On July 8, 2011, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Originally, Boostrix was licensed in 2005 for persons aged 10 through 18 years, but in 2008, FDA approved an expanded age indication for Boostrix to include persons aged 19 through 64 years.1 FDA has now expanded the age indication to include persons aged 65 years and older. Boostrix is now licensed for use in persons aged 10 years and older as a single-dose booster vaccination.2 This notice summarizes the indications for use of Boostrix. Recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been published previously.3-6 Publication of revised Tdap recommendations within the next year is anticipated.