Status: used as an intermediate; not marketed

Organizations involved:

Chiron Behring GmbH – Manuf.; R&D; Tech.

Chiron Corp. – Parent

Novartis AG – Parent

Behringwerke AG – Former

Cross ref: See the entries for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed or Infanrix (#433) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) or Boostrix (#436), which are manufactured using this intermediate/precursor product. See the Diphtheria & Tetanus and Pertussis Vaccine (DTP/DTaP) Products entry (#429), and the Tetanus Toxoid Vaccines (#543) and Diphtheria Toxoid Products (#418) entries.

Description: Diphtheria & Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) is an aqueous mixture of two aluminum hydroxide-adsorbed, formaldehyde-inactivated toxin (toxoid) component vaccines, Diphtheria Toxoid Adsorbed and Tetanus Toxoid Adsorbed. This bulk concentrate is used for further manufacture of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (Infanrix; DTaP vaccine) by GlaxoSmithKline Biologics S.A. With the May 2005 supplement approval, a new preservative-free (thimerosal-free; see entry #939) formulation is being used for manufacture of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) or Boostrix from GSK.

The dating period for the preservative-free Diphtheria and Tetanus Toxoids Adsorbed bulk formulation is 24 months from the date of manufacture when stored at 2-8˚C. The date of manufacture is defined as the date of blending of the diphtheria and tetanus toxoid bulk concentrates.

Nomenclature: Diphtheria & Tetanus Toxoids, conc. [BIO]; Diphtheria & Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) [FDA]; DT vaccine [SY]

Companies.: This intermediate is manufactured by Chiron Behring GmbH & Co., CBER/FDA est. 1222, formerly Beh-ring-werke AG, a joint venture of Chiron and Hoechst Marion Roussel, now a subsidiary of Chiron Corp., which merged into Novartis AG in Oct. 2005. The vaccine is exclusively provided to GlaxoSmithKline Biologics S.A. for manufacture of Infanrix (DTaP) and/or Boostrix (dTpa).

FDA class: Biologic PLA

CBER class: Multiple Antigen Preparations

Approvals: Date = 19970129; first approval, PLA

Date = 20050503; BLA supplement; Indication = approval of a new preservative-free formulation

Indications: [for original approval] = for further manufacture of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (Infanrix) by SmithKline Beecham S.A. [now GlaxoSmithKline Biologicals S.A.]

[for May 2005 supplemental approval] = for shipment to GlaxoSmithKline Biologicals, in a shared manufacturing arrangement for the production of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)

Status: In Dec. 2000, CBER/FDA reported that the Diphtheria Toxoid Adsorbed component of Infanrix was manufactured using bovine-derived materials from countries on the official USDA list of countries known to have cattle with BSE. This has been resolved, and the vaccine no longer appears on the USDA list. See the Vaccine Products entry (#400) for further information about bovine source materials and BSE/TSE.