Status: withdrawn from the U.S. market

Organizations involved:

BioPort Corp. – Manuf.; R&D; Tech.; Former

Emergent BioSolutions Inc. – Parent; Former

Michigan Biologics Products Institute – Former

Cross ref: See the entries for component vaccines – Tetanus Toxoid Adsorbed (#551), Diphtheria Toxoid Adsorbed (#419), and Pertussis Vaccine Adsorbed (#510), from BioPort Corp. See the entries for Diphtheria and Pertussis Toxoids and Pertussis Vaccine (DTP/DTaP) Products (#429); Tetanus Toxoid Products (#543); and Diphtheria Toxoid Products (#418).

Description: This was a DTP vaccine manufactured by the Michigan Biologics Products Institute (MBPI), which became BioPort Corp., which later became a subsidiary of Emergent BioSolutions Inc. MBPI/BioPort held only a very small market share for DTP vaccines.

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

Companies.: Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed was manufactured by BioPort Corp. (formerly Michigan Biologics Products Institute; before that, Michigan Department of Public Health, now part of Emergent BioSolutions Inc.), FDA CBER est. no. 0099.

FDA class: Biologic PLA

CBER class: Multiple Antigen Preparations

Approvals: Date = unknown; original approval date not available from FDA

Date = 19700827; first approval granted to Michigan Department of Public Health, according to the CBER BRMS database. However, an FDA letter to the company on this date states that approval was revoked and granted (reissued) using a new (the current) proper name, i.e., it was renamed Diphtheria & Tetanus Toxoids & Pertussis Vaccine Adsorbed

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

Date = 20001020; license voluntarily revoked

Indications: product insert/labeling not available

Status: The product is no longer approved, manufactured, or marketed. Voluntary license revocation was reported in the Federal Register, May 29, 2001, vol. 66, no. 103, p. 29148-9.