Typhoid Vi Polysaccharide Vaccine - Typhim Vi
Status: approved; marketed
Organizations involved:
Sanofi Pasteur S.A. – Manuf.; R&D; Tech.; Intl. mark.; Parent
Sanofi Pasteur Inc. – USA mark.
Cross ref: See Typhoid Vaccine Products entry #560,
Description: Typhoid Vi Polysaccharide Vaccine or Typhim Vi is an aqueous formulation of cell surface polysaccharide extracted from Salmonella typhi strain Ty2 cultured in a semi-synthetic medium without animal proteins. The capsular polysaccharide is precipitated from concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide (a surfactant), and the product is purified by differential centrifugation and precipitation. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. The vaccine contains residual polydimethyl-silox-ane (silicone) or fatty-acid ester-based antifoam compounds.
Typhim Vi is packaged in 20- and 50-dose vials and pre-filled single-dose syringes for intramuscular injection. Each single 0.5 mL dose contains 25 µg of purified Vi polysaccharide in isotonic phosphate buffered saline (pH 7 ± 0.3); 4.150 mg of sodium chloride; 0.065 mg of disodium phosphate; and 0.023 mg of monosodium phosphate, in Sterile Water for Injection. Phenol, 0.25%, is added as an antimicrobial preservative. The vaccine is stored at 2–8°C (35-46°F; refrigerated).
Nomenclature: Typhoid Vaccine/Sanofi [BIO]; Typhim Vi [TR]; Typhoid Vi Polysaccharide Vaccine [FDA]; ViCPS [SY]; Salmonella typhi vaccine [SY]; NDC 49281-0790-01, 49281-0790-20, and 49281-0790-50 [NDC]
Companies.: The vaccine was developed and is manufactured by Sanofi Pasteur S.A., CBER/FDA est. no. 1279, formerly Aventis Pasteur S.A. It is marketed in the U.S. by Sanofi Pasteur Inc., formerly Aventis Pasteur Inc., and internationally by Sanofi Pasteur S.A. Aventis merged into Sanofi Aventis S.A. in late 2004.
FDA class: Biologic PLA
CBER class: Bacterial Antigens and Vaccines
Approvals: Date = 19941128; first approval, PLA
Date = 20000204; license revoked from Pasteur Merieux Serum et Vaccins, S.A., reissued Aventis Pasteur S.A.
Indications: [portion of the "INDICATIONS AND USAGE” section from product insert/labeling]:
Typhim Vi vaccine is indicated for active immunization against typhoid fever for persons two years of age or older. Immunization with Typhim Vi should occur at least two weeks prior to expected exposure to S. typhi. Routine immunization against typhoid fever is not recommended in the United States. Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (i.e., continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who work with S. typhi.
Status: Typhim Vi is marketed worldwide.
Trials: Protective efficacy was demonstrated by placebo--controlled testing in highly endemic areas. Efficacy in field trials ranged from 55% to about 74%. This vaccine was developed without testing in a human challenge model.
Medical: The dose for adults and children is a single injection of 0.5 mL. A single-dose booster is recommended every two years for those potentially exposed to S. typhi.
Market: The Sanofi Pasteur Inc. list price (Jan. 2006) is $42.94/single-dose prefilled syringe ($40.47 in 2004) and $772.89/20-dose vial ($728.52 in 2004).
The 2007 Average Wholesale Price (AWP) is $53.08/single-dose vial, with a Direct Price (Manufacturer’s discount price) of $43.23; and $955.28/20-dose vial, with a Direct Price of $796.07 (Red Book, 2007).
In its March 22, 2006 price list, FFF Enterprises, a major biologics distributor, reported $45.85/single-dose syringe ($45.86 in 2005; $45.52 in 2004) and $816.16/20-dose vial (same in 2005; $810.68 in March 2004).
Companies involvement:
Full monograph
561 Typhoid Vaccine/Sanofi
Nomenclature:
Typhoid Vaccine/Sanofi [BIO]
TYPHIM Vi [TR]
Typhoid Vi Polysaccharide Vaccine [FDA]
Salmonella typhi vaccine [SY]
ViCPS [SY]
49281-0790-01, 49281-0790-20, and 49281-0790-50 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1994
Date of 1st FDA approval = 19941128
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, inactivated
bacterial culture <!-- bacterialculture -->
media, semi-synthetic
Salmonella typhi Vi (Ty 2 strain)
disodium phosphate
fatty-acid esters
hexadecyltrimethylammonium bromide
monosodium phosphate
phenol
polydimethylsiloxane
sodium chloride
Sterile Water for Injection
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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