Status: approvals withdrawn, manufacture ended in 2003
Organizations involved:
Sanofi Pasteur Inc. – Manuf.; USA mark.; Former
Sanofi Aventis S.A. – Parent; Former
Cross ref.: See the entry (#504) for Mumps Vaccine Live (Mumpsvax) for mumps virus-related information.
Description: Mumps Skin Test Antigen (MSTA) is a sterile suspension of formaldehyde-inactivated mumps virus used to detect and diagnosis (in)adequate delayed-type hypersensitivity, a type of cellular immunity. Since essentially every person has had exposure to mumps virus, and has been sensitized to mumps antigen, intradermal injection of the antigen is a convenient way to test for adequate overall delayed hypersensitivity reactions. A positive skin-test reaction indicates previous antigenic exposure, T-cell competence, an intact inflammatory response, and indicates adequate cellular immune responses.
MSTA is prepared from the extraembryonic fluid of mumps virus-infected chicken embryos (eggs) concentrated and purified by differential centrifugation. Concentrated virus is killed by incubation with formaldehyde solution, 1:1000, and diluted with isotonic sodium chloride solution. The resultant product contains ~0.012 molar (M) glycine and less than 1:8,000 formaldehyde solution. Thimerosal (mercury derivative; see entry #939) at 1:10,000 (0.01%) is added as an antimicrobial preservative. The skin test antigen is formulated to contain at least 40 complement fixing units (CFU) per mL of virus, at the time of release, as determined by the Complement-Fixation Test. MSTA is packaged in 1 mL multi-use vials, enough for 10 skin tests. The product is stored at 2°-8°C (35°-46°F; refrigerated).
History: Eli Lilly & Co. was licensed to manufacture Mumps Skin Test Antigen from March 14, 1915, to Dec. 2, 1985.
Companies.: MSTA was manufactured by Aventis Pasteur Inc., CBER/FDA est. no. 0711, a subsidiary of Aventis S.A. It was marketed in the U.S. by Aventis Pasteur Inc. Aventis Pasteur merged into Sanofi Pasteur Inc., a subisidiary of Sanofi Aventis S.A., in late 2004.
FDA class: Biologic PLA
Approvals: Date = 19850201; first approval, PLA
Date = 19991209; approval revoked from Connaught Labs., Inc. and reissued to new owner, Aventis Pasteur Inc.
Indications: [full text of the "INDICATIONS AND USAGE” section of the product insert/labeling]:
MSTA, Mumps Skin Test Antigen, is indicated when detection of a delayed-hypersensitivity (DH) reaction is desired. MSTA has not been tested in persons immunized with live mumps vaccine; therefore, its safety and efficacy in this population group has not been established. MSTA is not indicated for the immunization, diagnosis, or treatment of mumps virus infection, or determination of immune status to mumps virus.
Status: In Feb. 2003, Aventis Pasteur announced it was halting manufacture and marketing of MSTA. The company cited declining demand and increased costs of manufacture. Approval was recently (2004/5) withdrawn, with the product no longer appearing on CBER/FDA lists of approved products.
Medical: An intradermal injection of 0.1 mL of the antigen is made on the inner surface of the forearm. The reaction should be examined in 48-72 hours. A mean diameter (i.e., the longest width plus the longest length, divided by 2) of induration of 5 mm or more indicates a positive delayed hypersensitivity (DH) reaction to the mumps antigen, indicating the patient has a normal cellular immune-type response. A negative reaction, usually indicates either anergy or nonsensitivity. False positive reactions may develop in persons highly sensitive to egg proteins.
Market: Average Wholesale Price (AWP) not available (product not in 2007, 2005 or 2004 Red Book).
Companies involvement:
Full monograph
932 Mumps Skin Test Antigen
Nomenclature:
MSTA [TR]
Mumps Skin Test Antigen [BIO]
49281-240-10 [NUM NDC]
FDA Class: Biologic BLA
Year of approval (FDA) = 1985
Date of 1st FDA approval = 19850201
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, viral
allantoic fluid
chicken embryo (egg) culture
mumps virus
Complement-Fixation Test
formaldehyde
sodium chloride
thimerosal (mercury derivative)
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
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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