A/C/Y/W-135135
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined - Menomune-A/C/Y/W-135; Neisseria meningitidis vaccine
Status: marketed; previously the main meningococcal vaccine in the U.S. and other countries
Organizations involved:
Sanofi Pasteur Inc. – Manuf.; R&D; Tech.; USA mark.
Sanofi Pasteur S.A. – Intl. mark.; Parent
Cross ref: See the entries for Meningococcal Vaccines (#497) and component vaccines. See the entry below for Menactra, an analogous conjugates vaccine which has largely replaced this vaccine.
Description: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined or Menomune is a lyophi-lized (freeze-dried) polyvalent/combination meningococcal polysaccharide vaccine for prophylaxis against disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. The vaccine contains Neisseria meningitidis bacteria capsular poly-saccharide fragments (50 µg each) from individually cultured, inactivated, and purified N. meningitidis strains A-1, C-11, 6306Y and W-135-6308; representing groups A, C, Y and W-135, respectively.
The vaccine is packaged in single-dose vials, along with 0.78 mL of diluent for reconstitution; as a vial containing ten doses with 6 mL diluent; and as a vial containing 50 doses with 27.5 mL of diluent. Thimerosal (mercury derivative antimicrobial preservative; see #939) is added as an antimicrobial preservative at a concentration of 0.01%. The vaccine should be stored at 2-8˚C (refrigerated) and has a shelf life of 18 months. The powder can tolerate up to 12 weeks at 37˚C (98.6˚F) and 6-8 weeks at 45˚C (113˚F).
Nomenclature: Meningococcal Vaccine, A/C/Y/W-135 [BIO]; Menomune-A/C/Y/W-135 [TR]; Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined [FDA]; NDC 49281-0489-01; Neisseria meningitidis Groups A, C, Y, W135 vaccine [SY]; MPSV4 [SY]; NDC 49281-0489-91, and NDC 49281-0489-95 [NDC]
Companies.: The vaccine is manufactured by Sanofi Pasteur Inc., CBER/FDA est. no. 1277, formerly Aventis Pasteur Inc.. It is marketed in the U.S. by Sanofi Pasteur Inc.; and perhaps internationally by Sanofi Pasteur S.A.
In late 2001, Aventis Pasteur signed an agreement with Pharmadule AB (Sweden) for supply of turnkey modular plants for the manufacture of meningitis vaccines. Pharmadule built the plants in Sweden and shipping them to Aventis Pasteur Inc. (Swiftwater, PA), now Sanofi Pasteur Inc. This was expected to increase capacity and ensure a dependable world supply of Menomune-A/C/Y/W-135.
Manufacture: The individual component N. meningitidis strains are grown in culture using Mueller Hinton agar and Watson Scherp media. Capsular polysaccharide is precipitated using a cationic surfactant/detergent (cetrimonium bromide) and separated by centrifugation and ethanol fractionation. Poly-saccharide solution is blended and passed through a bacteria-retentive filter. Each polysaccharide is dissolved under aseptic conditions in a sterile solution containing lactose. The filtrates from the different strains/subgroups are mixed/pooled, thimerosal, 0.01%, is added as a preservative. The combination vaccine is placed into sterile containers, lyophilized (freeze-dried), and sealed. The resulting vials contain white powder or pellet, readily soluble in water.
Production of the vaccine is based on a seed lot (stored starter culture). Each seed lot is subjected to microbiological examination including culture in appropriate media and microscopic examination of Gram-stained smears. The potency, stability, and low reactogenicity of the meningococcal poly-saccharide vaccines are accurately controlled by physio-chemical characterization of the molecular size, chemical composition, and bioassay of endotoxin. Quality control assays for the group A vaccine include determination of the amount of phosphorus per container. For group C, group Y, and group W135 component vaccines, testing includes determining the amount of sialic acid (calculated as N-acetylneuraminic acid) per container. Molecular size is determined by size-exclusion chromatography. Other tests include protein assay, molecular size and various serologic and immunoassays. Safety is tested in guinea pigs and pyrogenicity is tested in rabbits.
FDA class: Biologic PLA
CBER class: Bacterial Antigens and Vaccines
Approvals: Date = 19811123; PLA no. 81-105
Date = 19991209; approval revoked from Connaught Labs., Inc. and reissued to new owner, Aventis Pasteur Inc.
Indications: [portions of the "INDICATIONS AND USAGE” section from product insert/labeling]:
Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, is indicated for active immunization against invasive meningococcal disease caused by these serogroups. Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined may be used to prevent and control outbreaks of serogroup C disease.
The American College Health Association (ACHA) also recommends that college students consider vaccination to reduce the risk for fatal meningococcal disease.
Vaccinations also should be considered for household or institutional contacts of persons with meningococcal disease and for medical and laboratory personnel at risk of exposure to meningococcal disease. This vaccine will not stimulate protection against infections caused by organisms other than Groups A, C, Y and W-135 meningococci. Protective antibody levels may be achieved within 7 to 10 days after vaccination.
Status: FDA approval of this vaccine, essentially involving addition of Y and W-125 antigens to the previously-approved A/C vaccine, was not based on clinical trials. The low incidence of disease due to serogroups Y and W-135 made it infeasible to conduct clinical trials to show prophylactic efficacy. Approval was granted on the basis of induction of antigen--specific neutralizing antibodies as surrogate markers.
This vaccine is presumed to be approved and marketed in European and other countries.
Market: The 2007 Average Wholesale Price (AWP) is $109.24/1-dose vial ($83.68 in 2004), with a Direct Price (Manufacturer’s discounted price) of $91.16 ($69.79 in 2004); and $1,071.71/10 1-dose vial ($695.52 in 2004), with a Direct Price of $894.33 ($579.68 in 2004) (Red Book, 2007).
The Sanofi Pasteur list price (Jan. 2006) is $86.10/1-dose vial ($69.73 in 2004) and $430.50/five vials.
In its March 2004 price list, FFF Enterprises, a major biologics distributor, reported $351.48/package of five 1-dose vials ($70.23/dose).
Competition: See the entry below for recently-approved Menactra, which has captured the majority of the U.S. market for meningitis vaccines.
Companies involvement:
Full monograph
502 Meningococcal Vaccine,
Nomenclature:
Meningococcal Vaccine, A/C/Y/W-135 [BIO]
Menomune-A/C/Y/W-135 [TR]
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined - Menomune-A/C/Y/W-135 [FDA]
Neisseria meningitidis Groups A, C, Y, and W135 Vaccine [SY]
NDC 49281-0489-01; NDC 49281-0489-91, and NDC 49281-0489-95 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1981
Date of 1st FDA approval = 19811123
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, subunit
bacterial culture <!-- bacterialculture -->
Mueller Hinton agar
Neisseria meningitidis group W-135-6308
Watson Scherp media
calcium
cetyltrimethylammonium bromide (CTAB)
galactose
galactose, O-acylated
glucose
lactose
lyophilized (freeze-dried)
N-acetyl neuraminic acid
N-acetyl-O-acetyl mannosamine phosphate
sialic acid derivatives
thimerosal (mercury derivative)
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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