TDVAX

Generic name:tetanus and diphtheria toxoids adsorbed
Dosage form: intramuscular injection
Drug class:Vaccine combinations

Medically reviewed by Drugs.com. Last updated on May 1, 2021.

TDVAX Description

TDVAX™ manufactured by MassBiologics is a sterile vaccine for intramuscular injection. After shaking, the vaccine appears as a homogeneous milky white suspension.

Each 0.5 mL dose of MassBiologics' TDVAX is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Each 0.5 mL dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde, and a trace amount of thimerosal [mercury derivative, (≤ 0.3 mcg mercury/dose)] (not as a preservative) from the manufacturing process.

The Corynebacterium diphtheriae and Clostridium tetani organisms are grown on modified Mueller's media1,2 which contains bovine extracts. The bovine material used in these extracts is sourced from countries which the United States Department of Agriculture has determined neither have nor present an undue risk for bovine spongiform encephalopathy. Tetanus and diphtheria toxins produced during growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by ammonium sulfate fractionation. The diphtheria toxoid is further purified by column chromatography. The tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.

The tetanus and diphtheria toxoids induce at least 2 units and 1 unit of antitoxin per mL of serum, respectively, in the guinea pig potency test.

TDVAX - Clinical Pharmacology

TETANUS
Tetanus (also known as lockjaw) is a serious, often fatal disease caused by an extremely potent neurotoxin produced by C. tetani.

Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of 0.01 IU/mL measured via a neutralization assay is considered the minimum protective level.3,4 The efficacy against tetanus of MassBiologics' TDVAX is supported by the following:

1. Response to primary series. Of 20 adults with less than 0.0025 units/mL of tetanus antitoxin in pre-immunization serum, 14 (70%) had antitoxin concentrations of 0.01 or greater after 2 doses of TDVAX (2 Lf tetanus toxoid do..