Status: withdrawn from the market

Organizations involved:

BioPort Corp. – Manuf.; R&D; Tech.

Michigan Biologics Products Institute – Former

Cross ref: See the entries for the component vaccines, Diphtheria Toxoid Adsorbed (#419) and Tetanus Toxoid Adsorbed (#551) from BioPort. See the entry for Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed (DTP vaccine) (#448) manufactured by BioPort Corp., of which this DT vaccine is a component. See the Diphtheria & Tetanus and Pertussis Vaccines (DTP/DTaP) Products entry (#429). See the Tetanus Toxoid Vaccine (#543) and Diphtheria Toxoid Products entries (#418).

Description: Diphtheria & Tetanus Toxoids Adsorbed is a combination vaccine formulated by mixture of two vaccines – Tetanus Toxoid Adsorbed and Diphtheria Toxoid Adsorbed (see related entries).

Nomenclature: Diphtheria & Tetanus Toxoids/BioPort [BIO]; Diphtheria & Tetanus Toxoids Adsorbed [FDA]; Diphtheria & Tetanus Toxoids Aluminum Phosphate Adsorbed [FDA former]; DT Vaccine [SY]

Companies.: Diphtheria & Tetanus Toxoids Adsorbed was manufactured by the Michigan Department of Public Health (CBER/FDA est. no. 0099), later the Michigan Biologics Products Institute; later, now BioPort Corp. (CBER/FDA est. 1260).

SmithKline Beecham Corp. (now GlaxoSmithKline Inc.) previously marketed a Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) product in the U.S., using components manufactured by the Michigan Biologics Products Institute (now BioPort Corp.).

FDA class: Biologic PLA

CBER class: Multiple Antigen Preparations

Approvals: Date = 19510511; first approval granted to Michigan Dept. of Public Health, according to 1979 Office of Technology Assessment vaccines approvals list

Date = 19550000; first approval according to BioPort Web site (on 3/16/2000)

Date = 19700827; first approval granted to Michigan Department of Public Health, according to the CBER/FDA BRMS database. However, an FDA letter to the company on this date states that the product license was revoked and granted (reissued) using the current FDA proper name.

Date = 19981112; licenses (PLA/ELA) revoked and granted (reissued) to new owner, BioPort Corp.

Date = 20000803; license voluntarily revoked

Indications: product insert/labeling not available

Status: The product is no longer approved, manufactured, or marketed. License revocation was announced in the Federal Register, May 29, 2001, (66) 103, p. 29148-9.