Status: approved; component of dTap vaccine

Organizations involved:

Novartis Vaccines and Diagnostics Ltd. – Manuf; R&D; Tech.

Chiron Corp. – Parent; Former

Novartis AG – Parent

Cross ref: See the Tetanus Toxoid Vaccines (#543), and the other Tetanus Toxoid entries. See the entry for dTpa booster/GSK or Boostrix (#436), a vaccine manufactured using this concentrate as a component.

Description: Tetanus Toxoid Concentrate (For Further Manufacturing Use) is a formulation of tetanus toxoid, i.e., inactivated Clostridium tetani toxin. This is exclusively manufactured for and provided to GlaxoSmithKline S.A. for incorporation at the tetanus component of its dTap booster vaccine, Boostrix (see related entry). The dating period is 48 months from the date of manufacture when stored at 2-80˚C, “defined as the date that the bulk purified toxoid [words redacted/censored by FDA] final product release testing.”

Nomenclature: Tetanus Toxoid/Chiron [BIO]; Tetanus Toxoid Concentrate (For Further Manufacturing Use) [FDA]

Companies.: The vaccine was developed and is manufactured by Chiron Behring GmbH & Co KG, CBER/FDA lic. no. 1222 (Marburg, Germany), now Novartis Vac-cines and Diagnostics Ltd., formerly a subsidiary of Chiron Corp., acquired by Novartis AG. It is exclusively shipped to GlaxoSmithKline Biologicals S.A. in a shared manufacturing arrangement for the production of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap; Boostrix).

FDA class: Biologic BLA

CBER class: Toxoids And Toxins For Immunization

Approvals: Date = 20050503; BLA (BL 125107/0)

Indications: = [From FDA approval letter]

“Under this license you are authorized to manufacture the product Tetanus Toxoid Concentrate (For Further Manufacturing Use) at Chiron Behring GmbH & Co KG, Marburg, Germany, to be shipped to GlaxoSmithKline Biologicals in a shared manufacturing arrangement for the production of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap).