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Boostrix

Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid & Acellular Pertussis Vaccine, Adsorbed

BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated FHA and PRN).

Advisory Board:

It was determined that presentation of data in the sBLA for Boostrix to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) was not required because of CBER’s experience with Boostrix. Furthermore, because our review of information submitted in the supplement, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion, it was agreed that review of this sBLA by the VRBPAC was not necessary.

Indications: For active booster immunization against tetanus, diphtheria and pertussis in individuals 10 years of age and older.
Key Regulatory Milestones:

05/2005 – Boostrix was licensed in the U.S. for active immunization against diphtheria, tetanus, and pertussis. At that time Boostrix was approved as a single booster dose for use in children and adolescents 10-18 years of age.

09/10/2020 – FDA approval date

Package Insert