MMWR. 2009;58:374-375
On December 4, 2008, 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). Boostrix is now licensed for use in persons aged 10-64 years as a single-dose booster immunization; the vaccine initially was licensed for persons aged 10-18 years. This announcement summarizes the indications for use of Boostrix. Complete recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been described previously.1,2,3
On October 23, 2008, ACIP was presented data on the safety and immunogenicity of Boostrix in adults aged 19-64 years and notified of the impending expanded age indication for Boostrix. Guidance for the use of Boostrix is the same as for Adacel (Sanofi Pasteur, Toronto, Canada), another Tdap vaccine licensed for use in adults.
Data were reviewed by ACIP from two clinical trials conducted . . . [Full Text of this Article]
Indications and Guidance for Use