Tetanus Toxoid Adsorbed for Adult Use
Status: approval withdrawn; component of combination vaccine
Organizations involved:
Massachusetts Biological Labs. – Manuf.; R&D; Tech.
Massachusetts, State of – USA mark.; Parent co.
Cross ref: See the Tetanus Toxoid Products entry, (#543), and the other Tetanus Toxoid entries. See Tetanus and Diphtheria Toxoids Adsorbed for Adult Use, entry #558, which incorporates this product as a component.
Description: Tetanus Toxoid Adsorbed is a formaldehyde inactivated toxin (toxoid) vaccine obtained from fermentation of Clostridium tetani bacteria adsorbed onto aluminum hydroxide adjuvant.
Nomenclature: Tetanus Toxoid Adsorbed/Mass. [BIO]; Tetanus Toxoid Adsorbed [FDA USAN]; Tetanus Toxoid Aluminum Phosphate Precipitated [FDA former]
Companies.: The product was manufactured by Massachusetts Biological Labs. (MBL), FDA CBER est. lic. no. 0064, affiliated with the State of Massachusetts.
FDA class: Biologic PLA
CBER class: Toxoids And Toxins For Immunization
Approvals: Date = original approval date unknown
Date = 19700729; CBER/FDA database and other FDA sources report this as the original approval date; However, an FDA approval letter on this date reports that the product license was revoked and granted (reissued) under the new proper name, Tetanus Toxoid Adsorbed
Indications: product insert/labeling not available; was approved for use as an adult booster
Status: The vaccine’s approval was valid until recentt years (dissappearing from FDA lists of approved biologics within the past year). The vaccine was only used as a component of Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td vaccine) manufactured by MBL, which was primarily used for state public health vaccination programs. The vaccine may also have been used as an adult tetanus booster.
The Massachusetts Biologic Labs. was one of only a few manufacturers of tetanus vaccine in the U.S., when a shortage of the vaccine occurred in 2001. MBL increased production and provided an additional 1 million doses for people living outside the state.
Companies involvement:
Full monograph
553 Tetanus Toxoid Adsorbed/Mass.
Nomenclature:
Tetanus Toxoid Adsorbed/Mass. [BIO]
Tetanus Toxoid Aluminum Phosphate Precipitated [ [NAM FDA; name revoked in 1970, renamed to current name]]
Tetanus Toxoid Adsorbed [FDA USAN]
Tetanus Toxoid Adsorbed USP [USP]
Td [SY CDC]
Td vaccine [SY]
tetanus toxin, inactivated [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1970
Date of 1st FDA approval = 19700729
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, subunit
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Clostridium tetani
aluminum hydroxide
formaldehyde
Tetanus Toxoid
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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