Status: approval withdrawn

Organizations involved:

BioPort Corp. – Former

Emergent Biosolutions Inc. – Parent; Former

Michigan Biologics Products Institute – Former

Cross ref: See the entries for Tetanus Toxoid Products (#543), and the other tetanus toxoid products. See also the combination vaccines, e.g., DTP (entry #395), from BioPort that incorporated this vaccine.

Description: Tetanus Toxoid Adsorbed is an inactivated toxin (toxoid) obtained from fermentation of Clostridium tetani bacteria adsorbed onto aluminum hydroxide adjuvant.

Nomenclature: Tetanus Toxoid Adsorbed/BioPort [BIO]; Tetanus Toxoid Adsorbed [FDA USAN]; Tetanus Toxoid Aluminum Phosphate Adsorbed [FDA former]

Companies.: The product was manufactured by BioPort Corp. (formerly Michigan Biologics Products Institute; before that, Michigan Dept. of Public Health), CBER/FDA est. no. 0099. BioPort is now a subsidiary of Emergent BioDefense Operations Lansing Inc., Emergent Biosolutions Inc.

FDA class: Biologic PLA

CBER class: Toxoids And Toxins For Immunization

Approvals: Date = original approval date unknown

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database and other FDA sources; However, an FDA letter to the company on this date states that PLA/ELA approval was revoked and granted (reissued) using the current FDA proper name.

Date = 19981112; approval revoked and granted (reissued) to new owner, BioPort Corp.

Date = 20001020; license voluntarily revoked

Indications: See other Tetanus Toxoids Adsorbed entries.

Status: The product is no longer approved or marketed. License revocation was announced in the Federal Register, May 29, 2001, vol. 66, no. 103, p. 29148-9. This vaccine was likely only marketed in the U.S.