Status: approvals withdrawn

Organizations involved:

Wyeth – Manuf.; R&D; Tech.; World mark.; Former

Cross ref: See the Typhoid Vaccine Products entry.

Description: Typhoid Vaccine is an aqueous formulation of heat and phenol inactivated whole Salmonella typhi (Ty2 strain) in saline suspension containing not more than (1 x 109) 1 billion Salmonella typhi (Ty2 strain) inactivated bacteria per mL. S. typhi Ty2 strain is cultured on veal infusion agar (containing 0.5% sodium chloride, 2% peptone and 5% agar). The bacteria are harvested, suspended in buffered sodium chloride solution, and inactivated by exposure to heat and phenol. Phenol is added (0.5% concentration) as a preservative. Typhoid Vaccine is tested for safety, potency, purity, and standardized according to 21 CFR 620.10-620.15.

The vaccine is packaged in multi-dose vials containing 5 and 10 mL, each containing 8 units S. typhi per mL.

Nomenclature: Typhoid Vaccine/Wyeth [BIO]; Typhoid Vaccine [FDA USAN]; Salmonella typhi vaccine [SY]; NDC 0008-0343-01; 0008-0343-02 [NDC]

Companies.: The vaccine was manufactured by Wyeth Pharmaceuticals (Marietta, PA.), CBER/FDA lic. no. 0003. It was marketed Wyeth in the U.S. and, perhaps, internationally. Wyeth has closed its Marietta, PA, facility which manufactured this and other older vaccines.

FDA class: Biologic PLA

CBER class: Bacterial Antigens and Vaccines

Approvals: Date = 19140206; first approval; granted to Dr. H.M. Alexander, est. no. 0003 (now Wyeth); as reported by Dr. J. Petricianni, former CBER/FDA official

Date = 19440519; approval date according to 1979 Office of Technology Assessment (OTA) vaccines approvals list

Date = 19520716; approval; according to CBER/FDA

Date = 19670000; first approval; according to Wyeth

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

Typhoid Vaccine, USP is indicated for active immunization against typhoid fever. Based on data obtained from field studies, it has been estimated that typhoid vaccine is 70% or more effective in preventing typhoid fever, depending in part on the degree of exposure.

Status: Approval was revoked several years ago.

Wyeth-Ayerst also reportedly manufactures an Acetone-Inactivated/Killed, Dried (AKD) Typhoid Vaccine, in lyophilized form, exclusively for use by the U.S. Department of Defense for vaccination of military personnel (presumably under an IND, since this does not appear on CBER/FDA approval lists).

Trials: In a trial in 3,454 subjects in Katmandu, Nepal, the overall protective efficacy was 74% during 20 months of post-vaccination follow-up. Studies have shown that a single dose produces a four-fold increase in S. typhi antibody levels within one month in 88-96% of subjects.

Medical: Primary immunization for persons over age 10 involves two 0.5 mL subcutaneous injections at an interval of four or more weeks. Children under age 10 receive two 0.25 mL doses subcutaneously at an interval of four or more weeks. A booster injection may be given every three years. The reactogenicity and adverse effects of this vaccine are greater than the other two U.S. marketed typhoid vaccines.