Status: approvals withdrawn

Organizations involved:

Wyeth/Lederle Labs. – Manuf.; R&D; Tech.; Former

Wyeth – World mark.; Parent; Former

Cross ref: See the entries for Tetanus Toxoid Products (#543). and the other tetanus toxoid entries. See the combination vaccines, e.g., DTP (#449), DTP & Hib Vaccine (#451) and DTaP Vaccine (#435), formerly incorporating this vaccine.

Description: Tetanus Toxoid Aluminum Phosphate Adsor-bed or Tetanus Toxoid Purogenated is an aqueous formulation of inactivated tetanus toxin (tetanus toxoid) manufactured from tetanus toxin, obtained by fermentation of Clostridium tetani bacteria inactivated with formalin (formaldehyde in solution), adsorbed onto aluminum phosphate adjuvant. This vaccine was used in the manufacture of combination vaccines containing a tetanus toxoid adsorbed component, including both DTP and DTaP vaccines.

The vaccine was supplied in multiple dose 5.0 mL vials and in packages of ten 0.5 mL single dose Lederject disposable syringes. Each 0.5 mL dose contained 5 Lf units of tetanus toxoid. Total aluminum content did not exceed 0.80 mg per 0.5 mL dose. The vaccine contained thimerosal (mercury-based antimicrobial preservative; see #939) at a final concentration of 1:10,000.

Nomenclature: Tetanus Toxoid Adsorbed/Lederle [BIO]; Tetanus Toxoid Adsorbed, Purogenated [TR Purogenated is the reg. trademark]; Tetanus Toxoid Adsorbed [FDA USAN]; Tetanus Toxoid Aluminum Phosphate Adsorbed [FDA for-mer; replaced by current name in July 1970]; Tetanus Toxoid Aluminum Phosphate-Adsorbed [FDA on product insert/labeling, but apparently not current proper name according to regulations]; NDC 0005-1938-31; NDC 0005-1938-47 [NDC]

History: Lederle had previously marketed Tetanus Toxoid Fluid (originally approved June 15, 1935; no longer approved).

Companies.: The vaccine was originally developed by Lederle-Praxis, then a subsidiary of Lederle Labs./American Cyanamid, later American Home Products Corp., now Wyeth. The product was manufactured by Lederle Labs./-Wyeth (Pearl River, NY), FDA CBER/FDA est. no. 0017. It was marketed in the U.S by Wyeth, and, perhaps, internationally by Wyeth.

Manufacture: Tetanus toxoid was prepared by the classic method of Mueller and Miller (Factors Influencing the Production of Tetanal Toxin, J. Immunology, vol 56, p. 143-7, 1947). The toxin was detoxified (inactivated to toxoid) by addition of formaldehyde, and refined using the Pillemer ethanol fractionation method (J. Immunology, vol. 54. p. 213-24, 1946). The purified toxoid was diluted with a solution containing sodium phos-phate dibasic, sodium phosphate monobasic, glycine, sodi-um chloride, thimerosal (final concentration of 1:10,000) as a preservative (see #939), and adsorbed onto aluminum phosphate adjuvant.

FDA class: Biologic PLA

CBER class: Toxoids And Toxins For Immunization

Approvals: Date = 19540605; according to Wyeth/AHP

Date = 19700729; first approval date according to CBER FDA database and other FDA sources; However, according to an approval letter on this date, Lederle’s license was revoked and a new product license was granted (reissued) using the new (current) FDA proper name.

Indications: [portion of the "INDICATIONS AND USAGE” section of product insert/labeling]:

Tetanus Toxoid Adsorbed is indicated for active immunization against tetanus in adults and children 2 months of age and older.

Status: In Jan. 2001, Wyeth-Ayerst announced it was discontinuing manufacture of tetanus toxoid and all combination vaccines containing a tetanus toxoid component. This vaccine no longer appears on CBER/FDA approval lists, indicating its license was voluntarily withdrawn.