Sanofi USA
Diphtheria & Tetanus Toxoids Adsorbed
Status: marketed in U.S.
Organizations involved:
Sanofi Pasteur Inc. – Manuf.; R&D; Tech.; USA mark.
Sanofi Pasteur S.A. – Intl. mark.; Parent
Cross ref: See the Tetanus Toxoid Vaccines (#543) and Diphtheria Toxoid Products (#418) entries; and the DTP and DTaP vaccines from Sanofi Pasteur Inc. essentially incorporating this vaccine as a component. See the Diphtheria & Tetanus and Pertussis Vaccine (DTP/DTaP) Products entry (#429). See the entry above for DT vaccine manufactured by Sanofi Pasteur Ltd. (Canada) (#423).
Description: Diphtheria & Tetanus Toxoids Adsorbed (For Pediatric Use) or DT vaccine is a combination vaccine formulation containing a suspension of aluminum potassium sulfate (alum)-precipitated, formaldehyde-inactivated diphtheria and tetanus toxoids (inactivated toxins) for pediatric use.
Diphtheria & Tetanus Toxoids Adsorbed is packaged in 5 mL, 10-dose and 0.5 mL single-dose vials. The product is currently thimerosal-(mercury derivative; sodium ethyl-mercu-rithiosalicylate; used as an antimicrobial preservative; see #939)-free, but it formerly contained 1:10,000 thimerosal. A trace amount (≤0.3 µg) of thimerosal remains (residual from its use in culture media) in the product. Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, and not more than 0.17 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%. Both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test. The vaccine, after shaking, is a turbid liquid, whitish-gray in color. The vaccine is stored between 2-8° C (35-46° F; refrigerated).
Nomenclature: Diphtheria & Tetanus Toxoids/Sanofi USA [BIO]; Diphtheria & Tetanus Toxoids Adsorbed [FDA]; Diphtheria and Tetanus Toxoids Adsorbed USP (For Pediatric Use) [FDA; USP]; NDC 49281-275-10 [NDC]
Companies.: This DT vaccine is manufactured by Sanofi Pasteur, Inc. (Swiftwater, PA), CBER/FDA est. no. 0711, formerly Aventis Pasteur Inc. It is marketed in the U.S. by Sanofi Pasteur Inc.; and perhaps marketed internationally by Sanofi Pasteur S.A. (parent company; formerly Aventis Pasteur S.A.) affiliates. Aventis merged into Sanofi Aventis S.A. in late 2004.
Manufacture: The vaccine is manufactured by mixture of independently prepared Tetanus Toxoid Adsorbed and Diphtheria Toxoid Adsorbed vaccines. manufacture of each lot of Tetanus Toxoid Adsorbed has been reported to require 11 months. Corynebacterium diphtheriae bacterium is cultured in a modified Mueller and Miller medium. Clostridium tetani bacterium is cultured in a peptone-based medium. Both toxins are detoxified by incubation in solution with formaldehyde. The inactivated toxins (toxoids) are separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum adjuvant. Thimerosal 1:10,000 was formerly added as a preservative. No thimerosal is currently added, although a trace (≤.3 µg) remains from the manufacturing process (culture media). The two toxoids are mixed in an isotonic sodium chloride solution containing sodium phosphate buffer to control pH, and sealed in vials.
FDA class: Biologic PLA
CBER class: Multiple Antigen Preparations
Approvals: Date = 19840918, first approval, PLA
Date = 19991209; approval revoked from Connaught Labs. and reissued to new owner, Aventis Pasteur Inc.
Date = 20030129; BLA supplement; Indication = preservative-free, single dose vial
Indications: [portions of the "INDICATIONS AND USAGE” section of product insert/labeling]:
PRIMARY IMMUNIZATION: This vaccine is recommended for children 6 weeks through 6 years (up to the seventh birthday), ideally beginning when the infant is 6 weeks to 2 months of age. For infants 6 weeks through 12 months, the primary series consists of 4 doses: administer three 0.5 mL doses intramuscularly 4 to 8 weeks apart. A reinforcing dose is given 6 to 12 months after the third injection.
For children 1 year through 6 years (up to the seventh birthday), the primary series consists of 3 doses: administer two 0.5 mL doses intramuscularly 4 to 8 weeks apart. A reinforcing dose is given 6 to 12 months after the second injection. In the event the final immunizing dose would be given after the seventh birthday, use Tetanus and Diphtheria Toxoids Adsorbed for Adult Use.
BOOSTER IMMUNIZATION: For children between 4 and 6 years of age (preferably at time of kindergarten or elementary school entrance), a booster of 0.5 mL should be administered intramuscularly. [truncated].
Status: The source for approval of the diphtheria toxoid component for this and other Diphtheria Toxoid-containing Sanofi Pasteur vaccines is unclear. There are no currently approved non-adsorbed monovalent Diphtheria Toxoid products (reported by CBER/FDA). Sanofi Aventis, the largest vaccine company, presumably manufacturers its own diphtheria toxoid vaccine components. The approval for this DT vaccine or another DT-containing vaccine, e.g., DTP, from the company may effectively cover approval of the diphtheria toxoid component in this and other diphtheria toxoid-containing vaccines from the company; or CBER/FDA approval listings may be incomplete.
Market: The 2005 Average Wholesale Price (AWP) is $126.12/10-dose vial, with a Direct Cost (DC; manufacturer’s discount price) of $105.10; and $162.00/10 prefilled syringes, with a DC of $135.
The Sanofi Pasteur list price (Jan. 2006) is $168.00/10 1-dose vials, and for 10 prefilled syringes ($16.80/dose). A federal excise tax of $.75/component vaccine/dose ($1.50/dose of DT vaccine) to fund the national vaccine insurance program is added to the sales price by the manufacturer.
Companies involvement:
Full monograph
424 Diphtheria & Tetanus Toxoids/
Nomenclature:
Diphtheria & Tetanus Toxoids/Sanofi USA [BIO]
Diphtheria & Tetanus Toxoids Adsorbed [FDA]
Diphtheria and Tetanus Toxoids Adsorbed USP (For Pediatric Use) [FDA used on insert/labeling; USP]
DT Vaccine [SY]
NDC 49281-275-10 [NDC]
FDA Class: BiologicPLA
Year of approval (FDA) = 1984
Date of 1st FDA approval = 19840918
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Clostridium tetani
Corynebacterium diphtheriae
Mueller and Miller medium
peptone (medium)
aluminum potassium sulfate (alum)
ammonium sulfate
Diphtheria Toxoid
formaldehyde
sodium chloride
Tetanus Toxoid
thimerosal (mercury derivative)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
EU000 Not yet/Never filed with EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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