Status: approval withdrawn

Organizations involved:

Wyeth – Manuf.; R&D; Tech.; Former

Cross ref: See the Tetanus Toxoid Products entry (#543), and the other Tetanus Toxoid entries. See also the combination vaccines, e.g., DTP and DTaP, from this manufacturer formerly incorporating this vaccine.

Description: Tetanus Toxoid is a vaccine containing formaldehyde-inactivated toxin (toxoid) obtained from fermentation of Clostridium tetani bacteria. This unadsorbed toxoid was not marketed (in recent years), and was likely used for further manufacture of Tetanus Toxoid Adsorbed and combination vaccines containing a tetanus toxoid component.

Nomenclature: Tetanus Toxoid/Wyeth [BIO]; tetanus toxoid [FDA]

Companies.: The product was formerly manufactured by Wyeth, CBER/FDA est. no. 0003. Wyeth has closed its Marietta, PA, manufacturing facility, and halted manufacture of this and other vaccines manufactured at this site.

FDA class: Biologic PLA

CBER class: Toxoids And Toxins For Immunization

Approvals: Date = unknown original approval date

Date = 19440519; first approval, according to CBER/FDA database and other FDA sources; However, FDA letters on this date report license withdrawal and reissuance to a new owner, Wyeth. In 1944, American Home Products, now Wyeth, acquired two vaccine companies, Gilli-land Labs. and Reichel Labs. It is not clear which company originally manufactured the vaccine.

Date = 19700729; first approval; according to other CBER/FDA sources; However, this is the date on which most tetanus toxoid product licenses were revoked and granted (reissued) under the current FDA proper name.

Status: In Jan. 2001, Wyeth-Ayerst discontinued manufacture of tetanus toxoid and all combination vaccines containing a tetanus toxoid component. This vaccine recently disappeared from CBER/FDA approval lists, indicating its license was voluntarily withdrawn.