Status: FDA approval revoked; formerly distributed free intrastate

Organizations involved:

Massachusetts Biol. Labs. – Manuf.; R&D; Tech.

Massachusetts, State of – Parent

Cross ref: See the entry for Tetanus Toxoid Adsorbed (#553), a component of this vaccine. See the Diphtheria & Tetanus and Pertussis Vaccines (DTP/DTaP) Products entry (#429). See the Tetanus Toxoid Vaccines (#543) and Diphtheria Toxoid Products (#418) entries.

Nomenclature: Diphtheria & Tetanus Toxoids/Mass. [BIO]; Diphtheria & Tetanus Toxoids Adsorbed [FDA]; Diphtheria & Tetanus Toxoids Combined Aluminum Phosphate Precipitated [FDA former]; DT Vaccine [SY]

Companies.: The vaccine is manufactured by Massachusetts Biological Labs., CBER/FDA est. no. 0064, affiliated with the State of Massachusetts.

FDA class: Biologic PLA

CBER class: Multiple Antigen Preparations

Approvals: Date = 19500523; first approval; according to 1979 Office of Technology Assessment (OTA) vaccines approvals list

Date = 19700727; first approval date reported by the CBER/FDA BRMS database; However, an FDA letter states that on this date the product license was revoked and the license granted (reissued) under the current FDA proper name

Indications: product insert/labeling not available; used for prevention of disease due to tetanus and diphtheria

Status: This product is distributed only within the State of Massachusetts at no cost. This vaccine’s FDA approval, allowing interstate distribution, was voluntarily revoked in recent years. Vaccines manufactured by the Massachusetts Biological Labs. are primarily distributed within Massachusetts through the state’s Universal Childhood Immunization Program.

The Massachusetts Biological Labs., according to available information from CBER/FDA, has never received approval for either non-adsorbed Diphtheria Toxoid or Diphtheria Toxoid Adsorbed, so the source for approvals of the diphtheria toxoid component is unclear. This DT vaccine approval may cover manufacture of the diphtheria toxoid component; or CBER/FDA approval listings may be wrong.