Tetanus Toxoid Concentrate (For Further Manu-facturing Use)
Status: formerly used in a combination vaccine
Organizations involved:
Statens Seruminstitut – Manuf.; R&D; Tech.
Cross ref: See the Tetanus Toxoid Vaccines (#543), and the other Tetanus Toxoid entries. See the entry for DTaP Vaccine/NAVA or Certiva (#434), a vaccine formerly manufactured using this concentrate as a component.
Description: Tetanus Toxoid Concentrate (For Further Manufacturing Use) is a formulation of tetanus toxoid, i.e., inactivated Clostridium tetani toxin. Tetanus toxin is derived from Clostridium tetani cultured in modified Mueller and Miller Medium, containing casein hydrolysate (bovine source). Toxin is purified by precipitation with ammonium sulfate, and is detoxified/inactivated by incubation with formaldehyde.
This product was exclusively provided to North American Vaccine, Inc./Baxter Hyland Immuno along (mixed) with Diphtheria Toxoid Concentrate (For Further Manufacturing Use), also manufactured by Statens Serumin-stitut, for mixing with acellular pertussis toxoid to prepare Certiva (DTaP vaccine). The dating period is 36 months from the date of manufacture, defined as the date the bulk purified toxoids are sterile filtered prior to final product release testing.
Nomenclature: Tetanus Toxoid/Statens [BIO]; Tetanus Toxoid Concentrate (For Further Manufacturing Use) [FDA]; Clostri-dium tetani toxin, inactivated [SY]
Companies.: This product was developed and is approved by FDA for manufacture by Statens Seruminstitut (Copenhagen, Denmark), FDA CBER est. lic. no. 1255. It was provided exclusively to North American Vaccine, Inc./Baxter Hyland Immuno for the manufacture of Certiva (DTaP vaccine).
FDA class: Biologic BLA
CBER class: Toxoids And Toxins For Immunization
Approvals: Date = 19980729; BLA ref. no. 95-1530, 95-1531 and 95-1532; Note, the BLA was actually granted to the combination of this novel product and Diphtheria Toxoid Concentrate (For Further Manufacturing Use)
Indications: [from approval letter]: for further manufacture to Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with North American Vaccine, Inc.
Status: This product is currently approved exclusively for further manufacture of Certiva. However, Certiva is no longer being manufactured or marketed, and this is not reported to currently be used in any other U.S. combination vaccine. This or an equivalent product from Statens Seruminstitut could well be used in European and other ex-U.S. tetanus toxoid-containing vaccines.
In Dec. 2000, CBER/FDA reported that the Tetanus Toxoid component of Certiva was being manufactured by Statens Seruminstitut using bovine-derived materials from countries on the official USDA list of countries known to have cattle with BSE. The company resolved this situation (was taken off the list). See the Vaccine Products entry (#400) for further information about BSE/TSE.
Companies involvement:
Full monograph
547 Tetanus Toxoid/Statens
Nomenclature:
Tetanus Toxoid/Statens [BIO]
Tetanus Toxoid Concentrate (For Further Manufacturing Use) [FDA]
Clostridium tetani toxin, inactivated (see tetanus toxoid entries) [xref]
tetanus toxin, inactivated [SY]
FDA Class: Biologic BLA
Year of approval (FDA) = 1998
Date of 1st FDA approval = 19980729
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
bovine materials used<!-- bovinesource -->
intermediate/precursor products
vaccines, bacterial
vaccines, subunit
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
casein hydrolysate
Clostridium tetani
Mueller and Miller medium
ammonium sulfate
formaldehyde
Tetanus Toxoid
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
bovine source warning, BSE country
North American coral snake
North American coral snake
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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