Status: approved in U.S.; not marketed

Organizations involved:

Sanofi Pasteur Ltd. – Manuf.; R&D; Tech.; Former

Sanofi Pasteur Inc. – USA mark.

Sanofi Pasteur S.A. – Intl. mark.; Parent

Cross ref: See the Tetanus Toxoid Vaccines (#543) and Diphtheria Toxoid Products entries (#418); and the DTP and DTaP vaccines from Sanofi Pasteur Inc. that may incorporate this vaccine as a component. See the Diphtheria & Tetanus and Pertussis Vaccines (DTP/DTaP) Products entry (#429). See the entry below for DT vaccine manufactured by Sanofi Pasteur, Inc. (U.S.A.) (#424).

Description: Diphtheria & Tetanus Toxoids Adsorbed or DT vaccine is an aqueous formulation combining suspensions of aluminum potassium sulfate (alum) adjuvant-adsorbed, formaldehyde-inactivated toxins (toxoids) – Diphtheria Toxoid Adsorbed and Tetanus Toxoid Adsorbed. This vaccine is approved but not currently marketed in the U.S., and details are not available. A comparable DT vaccine is manufactured and marketed in the U.S. by Sanofi Aventis Inc., and is presumed to be the one marketed in the U.S..

Nomenclature: Diphtheria & Tetanus Toxoids/Sanofi Canada. [BIO]; Diphtheria & Tetanus Toxoids Adsorbed [FDA]; Diphtheria & Tetanus Toxoids Adsorbed USP (For Pediatric Use) [FDA]; DT vaccine [SY]

Companies.: This vaccine was developed and is approved for manufacture by Sanofi Pasteur Ltd., CBER/FDA est. no. 1726, formerly a subsidiary of Aventis Pasteur S.A. now a subsidiary of Sanofi Pasteur S.A. If marketed in the U.S., this would have been performed by Connaught Inc., later Pasteur Merieux Connaught, later Aventis Pasteur, now Sanofi Pasteur Inc. Aventis merged into Sanofi Aventis S.A. in late 2004.

FDA class: Biologic PLA

CBER class: Multiple Antigen Preparations

Approvals: Date = 19970411; first approval, PLA

Date = 20000224; PLA supplement; license transferred from Connaught to Aventis Pasteur

Indications: product insert/labeling not available

Status: This DT vaccine is approved. It may be used as an intermediate in the manufacture of U.S.-approved DTaP vaccine by Sanofi Pasteur Ltd. (Canada) or Sanofi Pasteur Inc. (U.S.). This divalent vaccine is not currently marketed in the U.S. Sanofi Pasteur Inc. (U.S.) manufactures an equivalent DT vaccine (see entry below) and, presumably, this DT vaccine is the one marketed in the U.S.

There are no currently approved non-adsorbed monovalent Diphtheria Toxoid products. This establishment does not hold approvals for either monovalent diphtheria or tetanus toxoid products, so the sources for the approvals of the two toxoid components of this vaccine are unclear.