Status: approvals withdrawn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 (#450) and DTaP (#435), from Wyeth likely incorporating this vaccine as a component.

Description: Tetanus Toxoid Adsorbed is an aqueous formulation of formaldehyde-inactivated tetanus toxin (toxoid) obtained from fermentation of Clostridium tetani bacteria adsorbed with aluminum hydroxide adjuvant. It is not currently marketed, but is apparently used by Wyeth for further manufacture of combination vaccines, e.g., DTP and DTaP.

Nomenclature: Tetanus Toxoid Adsorbed/Wyeth [BIO]; Tetanus Toxoid Adsorbed [FDA USAN]; Tetanus Toxoid Aluminum Phosphate Adsorbed [FDA former]; Tetanus Toxoid Adsorbed USP [USP]; Td [SY CDC]

Companies.: Tetanus Toxoid Adsorbed was manufactured by Wyeth, FDA CBER est. no. 0003, now Wyeth. Wyeth recently closed its Marietta, PA, facility that manufactured this and other vaccines recently abandoned by Wyeth.

FDA class: Biologic PLA

CBER class: Toxoids And Toxins For Immunization

Approvals: Date = original approval date unknown

Date = 19700911; first approval; PLA; according to the CBER/FDA database and other FDA sources; However, an approval letter reports that the product license was revoked and granted (reissued) using the current proper name on this date.

Status: In Jan. 2001, Wyeth-Ayerst announced it was discontinuing manufacture of tetanus toxoid and combination vaccines containing a tetanus toxoid component. The product license was recently voluntarily withdrawn.