Status: marketed internationally; FDA approval withdrawn

Organizations involved:

Berna Biotech Ltd. – Manuf.; R&D; Tech.; Intl. mark.

Crucell N.V. – Parent

Berna Products, Corp. – Former

Acambis plc - Parent; Former

Swiss Serum and Vaccine Institute Berne – Former

Cross ref: See the Tetanus Toxoid Vaccines (#543), and the other Tetanus Toxoid entries.

Description: Tetanus Toxoid Adsorbed or Te Anatoxal Berna is an aqueous formulation of formaldehyde-inactivated toxin (toxoid) obtained from fermentation of Clostridium tetani bacteria adsorbed on aluminum phosphate adjuvant.

Te Anatoxal Berna is supplied in 5 mL vials and packages of 10 pre-loaded 0.5 mL syringes. The vaccine contains 10 Lf units of tetanus toxoid, a maximum of 0.85 mg aluminum (determined by titration after reaction with zinc sulfate), and less than 0.02% formaldehyde. Other ingredients include sodium chloride and 8-10 mg of non-tetanus toxoid protein per dose. Thimerosal is added at a concentration of 1:10,000 as an antimicrobial preservative (see entry #939).

Nomenclature: Tetanus Toxoid Adsorbed/Berna [BIO]; Te Ana-toxal Berna [TR]; Tetanus Toxoid Adsorbed [FDA USAN]; Tetanus Toxoid Adsorbed USP [USP]

Companies.: The vaccine was developed and is still manufactured for use in various countries by the Swiss Serum and Vaccine Institute (Berne, Switzerland), now Berna Biotech Ltd., FDA CBER est. lic. no. 0021. Berna merged into Crucell N.V. in Oct. 2006. The vaccine was marketed in the U.S. by Berna Products Corp., Berna’s U.S. marketing subsidiary, which was acquired by Acambis plc in Aug. 2003, and is marketed internationally by Berna Products/Crucell affiliates.

Manufacture: The tetanus toxoid is manufactured by culture (fermentation) of Clostridium tetani bacteria anaerobic (microaero-philic) conditions in a semi-synthetic medium containing peptones, supplemented with glucose, mineral salts, and vitamins under. Harvested toxin is detoxified (converted to toxoid) by incubation in 0.4% formalin (formaldehyde in solution) for 21 days at 39˚C. The toxoid is purified by precipitation with ammonium salts and ultrafiltration, diluted with sterile physiologic saline, and adsorbed onto aluminum phosphate adjuvant.

FDA class: Biologic PLA

CBER class: Toxoids And Toxins For Immunization

Approvals: Date = 19701211; first approval, PLA; according to the CBER/FDA database and other FDA sources; However, this date was likely a supplemental PLA; Product licenses for tetanus toxoid adsorbed products were revoked and granted (reissued) under the current FDA proper name in 1970; FDA often erroneously reports these dates as original approval dates.

Status: The FDA product license was recently voluntarily revoked. This vaccine is still approved and marketed in European and other countries worldwide.