Merck
Measles and Rubella Virus Vaccine Live - M-R-Vax II
Status: approved but not actively marketed
Organizations involved:
Merck & Co., Inc. – Manuf.; R&D; Tech.; World mark.
Cross ref: See the entries for component vaccines – Measles Vaccine (Attenuvax) (#491) and Rubella Vaccine (Meruvax II) (#533), both from Merck. See the Measles, Mumps and Rubella Virus Vaccine Live (M-M-R II) entry (#493). See also Measles & Rubella Virus Vaccine/GSK (#495), with the same basic components at M-R-Vax II.
Description: Measles and Rubella Virus Vaccine Live or M-R-Vax II is a bivalent combination vaccine formulated from Measles Vaccine (Attenuvax) and Rubella Vaccine (Meruvax II), both from Merck & Co., Inc.
Nomenclature: Measles & Rubella Virus Vaccine/Merck [BIO]; -M-R-Vax II [TR]; Measles and Rubella Virus Vaccine Live [FDA]; Measles and Rubella Virus Vaccine, Live [FDA former]
History: Dow Chemical Co. (est. no. 0110) was licensed to manufacture Measles and Rubella Virus Vaccine, Live from April 1974-June 1978.
Companies.: M-R-Vax II was developed and is manufactured by Merck & Co., Inc. (West Point, PA), FDA CBER est. no. 0002. It is marketed in the U.S. by Merck & Co., and internationally by Merck affiliates.
FDA class: Biologic PLA
CBER class: Viral And Rickettsial Vaccines
Approvals: Date = 19710422; first approval, PLA
Date = 19860106, product license revoked and granted (reissued) under new (current) FDA proper name
Indications: prevention of disease due to measles and rubella virus infection [unofficial]
Market: Average Wholesale Price (AWP) not available (product not in 2007, 2005 or 2004 Red Book), indicating the product is not actively marketed in the U.S.
Nearly all children receiving vaccination for mumps and measles now receive the combination measles, mumps, and rubella vaccine (M-M-R II) or newer ProQuad.
Companies involvement:
Full monograph
496 Measles & Rubella Virus Vaccine/
Nomenclature:
Measles & Rubella Virus Vaccine/Merck [BIO]
M-R-Vax II [TR]
Measles and Rubella Virus Vaccine Live [FDA]
Measles and Rubella Virus Vaccine, Live [FDA former]
FDA Class: Biologic PLA
Year of approval (FDA) = 1971
Date of 1st FDA approval = 19710422
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
bovine materials used<!-- bovinesource -->
chicken source materials
human materials used<!-- humansource -->
live microorganisms (as active agent)
vaccines, combination
vaccines, live
vaccines, viral
cells, human
chicken embryo (egg) culture
Edmonston strain, measles virus
Ender strain, measles virus
mammalian cell culture
measles virus, Ender strain
RA 27/3 Wistar Inst. strain, rubella virus
rubella virus Wistar Inst. RA 27/3 strain
virus culture
Albumin (Human)
bovine serum, fetal (FBS)
ethanol
gelatin (bovine source)
glutamate
neomycin
sodium chloride
sodium phosphate
sucrose
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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