Meningococcal Polysaccharide Vaccine, Group A – Menomune-A; Neisseria meningitidis group A vaccine
Status: approved as component of multivalent vaccine
Organizations involved:
Sanofi Pasteur Inc. – Manuf.; R&D; Tech.
Sanofi Pasteur S.A. – Parent
Walter Reed Army Institute of Research (WRAIR), U.S. Army – R&D; Tech.
Cross ref: See the entries for Meningococcal Vaccines (#497) and Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined (#502).
Description: This product is used by Sanofi Pasteur Inc. for manufacture (as a component) of a combination vaccine – Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined (#502).
Nomenclature: Meningococcal Vaccine, A [BIO]; Meno-mune-A [TR]; Meningococcal Polysaccharide Vaccine, Group A [FDA]; Meningococcal Polysaccharide Vaccine Group A [USAN]; Meningococcal Polysaccharide Vaccine Group A USP [USP]; Neisseria meningitidis Group A vaccine [SY]
Companies.: The vaccine is manufactured by Sanofi Pasteur Inc. (Swiftwater, PA), CBER est. no. 1277.
FDA class: Biologic PLA
CBER class: Bacterial Antigens and Vaccines
Approvals: Date = 19751019; first approval, PLA (75-737), granted to Merrell-National Labs., Richardson-Merrell Inc.
Date = 19780103; approval revoked and granted (reissued) to new owner, Connaught Labs., Inc. (CLI)
Date = 19991209; approval revoked from CLI and granted (reissued) to new owner, Aventis Pasteur Inc.
Indications: for prevention of disease due to Neisseria meningitidis group A infection [unofficial]
Status: This product is approved, but is not marketed. It is used by Sanofi Pasteur Inc. for manufacture (as a component) of combination vaccines – Menomune-A/C/Y/W-135 (#502) and Menomune–A/C (#499). It is not approved or used as a monovalent vaccine in the European Union or other markets.
Companies involvement:
Full monograph
498 Meningococcal Vaccine, A
Nomenclature:
Meningococcal Vaccine, A [BIO]
Menomune-A [TR]
Meningococcal Polysaccharide Vaccine, Group A [FDA]
Meningococcal Polysaccharide Vaccine Group A [USAN]
Meningococcal Polysaccharide Vaccine Group A USP [USP]
MPSV4 [SY]
Neisseria meningitidis Group A vaccine [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1975
Date of 1st FDA approval = 19751019
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
intermediate/precursor products
vaccines, bacterial
vaccines, subunit
bacterial culture <!-- bacterialculture -->
Mueller Hinton agar
Neisseria meningitidis group A-1
Watson Scherp media
Bacillus anthracis prophylaxis
cetyltrimethylammonium bromide (CTAB)
lactose
N-acetyl neuraminic acid
N-acetyl-O-acetyl mannosamine phosphate
Neisseria meningitidis capsular polysaccharides
polysaccharides
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
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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